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62,940
|
pt recvd vax @ hops p/birth of daughter; pt was breastfed & on 20MAR94 mom noted a fine red rash on body of baby; rash lasted 2-3 days & then resolved;
| 0No event
|
421,659
|
Erythema, pain, around injection site. 2 days after injection.
| 0No event
|
1,071,229
|
Severe Headache, body aches. Treated with Tylenol, rest
| 0No event
|
105,818
|
pt recv vax 22OCT97 AM & 1PM mom reported pt had a car accident p/left clinic several blocks away;pt reported seeing dots before her eyes & having trouble moving arms & legs & then hit 2 other cars;pt treated & released from ER;
| 1ER_VISIT
|
128,002
|
p/vax pt devel inj site rxn @ pnu-imune 23 vax characterized by swelling, redness & warmth;
| 0No event
|
1,582,502
|
Edema, fatigue, palpitations,
| 0No event
|
475,383
|
Stuffed nose, baby was crying for 2 hours in a row, high pitched screaming, like absent and not responding to me. He was like in shock. Unable to eat due to stuffy nose. I have him Tylenol and finally he felt sleep for 8 hours (he usually sleeps only 5 hours in a row). This morning he woke up and acted normal, smiling, etc. He ate a bottle.
| 0No event
|
269,313
|
Parent stated pt's right arm was red and swollen on 12/16/06. On that day mom talked to MD by telephone and was told to put ice to area and give tylenol for pain. Today 12/18/06 mom reports pt's right arm continue to be red and swollen but less than 12/16/06.
| 0No event
|
899,602
|
Woke up next morning with low grade fever 100.3, and congestion which lasted a little over 12hrs. Then had mild cough which lasted 24hrs.
| 0No event
|
1,985,074
|
Beginning 12/22, I experienced a sore throat. Beginning 12/23, I also experienced a cough. The sore throat resolved on 12/27. The cough has yet to fully resolve.
| 0No event
|
851,153
|
pain and weakness of left upper arm; normal passive ROM, but is unable to actively raise her arm past 15 degrees
| 1ER_VISIT
|
959,271
|
Recieved injection on Wednesday, 1/6/2021. On Friday, 1/15/2021 woke up with a small red area on arm near injection site. Each day rash increased in size. On Wednesday, 1/20/2021 seen by provider and given steroid injection. Size of rash had increased to 4 inches by 6 inches, red, raised rash.
| 0No event
|
2,559,234
|
tested positive after vaccination Narrative:
| 0No event
|
1,621,767
|
got sick" for two days; some days she can't taste/taste "comes and goes"; "got sick" for two days; didn't feel right" for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("got sick" for two days), FEELING ABNORMAL (didn't feel right" for a week), FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes") in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 20-Nov-2020, Hashimoto's disease, Upset stomach and Scalp disorder. Concurrent medical conditions included Drug allergy (ibuprofen, causes rash on chest) and Drug allergy (Claritin (increases heart rate and causes anxiety).). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN 15 for an unknown indication. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS ("got sick" for two days) and FEELING ABNORMAL (didn't feel right" for a week). On an unknown date, the patient experienced FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes"). At the time of the report, ILLNESS ("got sick" for two days), FEELING ABNORMAL (didn't feel right" for a week), FEELING ABNORMAL (got sick" for two days) and AGEUSIA (some days she can't taste/taste "comes and goes") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable.
| 0No event
|
905,665
|
receiving both doses of the Shingrix vaccine she has been getting shingles/ suspected Vaccination failure; receiving both doses of the Shingrix vaccine she has been getting shingles; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included herpes zoster (first experienced when she was 21 years old and it developed 2 to 3 times a year since then). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 9th July 2019, refer case US2020AMR246180). On 4th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and injection site pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. Additional information was provided as follows: The patient reported that since receiving both doses of the Shingrix vaccine she had been getting shingles every 2 months. Patient reported pain at the injection site during administration of both doses of Shingrix and said it lasted a few seconds and then resolved. This case was considered as suspected vaccination failure as details regarding time to onset for target disease was unknown at the time of reporting. The reporter consented to follow up.; Sender's Comments: US-GLAXOSMITHKLINE-US2020AMR246180:same patient
| 0No event
|
1,860,831
|
After 2 hrs, light headed.Became lethargic. Generally not feeling well. After 6 hrs feeling nausea. Vomiting after another hour. Nausea and vomiting lasted about an hour. Went to bed. Next day, 21 hrs later felt ok. Day proceeded normally.
| 0No event
|
461,464
|
10 days after immunization patient developed flu like symptoms with pharyngitis, tonsillar exudate and injected scleras. On 6/1/12 patient woke up with multiple arthralgias. Unable to walk neck and back pain. Referred to ER for further eval.
| 2ER_VISIT, HOSPITAL
|
105,573
|
macular plaques on torso DPH PRN;aveno bath bar;
| 0No event
|
1,652,138
|
numbness and swelling of the tongue; numbness and swelling of the tongue; mild blurred vision; back pain; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via intramuscular route of administration on 21May2021 at 15:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in left arm on an unknown date for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 15:00 the patient experienced numbness and swelling of the tongue, mild blurred vision and back pain. Therapeutic measures were taken as a result of the events (Unspecified) checked for vitals. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events numbness and swelling of the tongue, mild blurred vision and back pain were recovered on 21May2021. No follow-up attempts are needed: information about lot number cannot be obtained.
| 0No event
|
123,449
|
p/ pt recv vax approx 3yr later pt devel breakthrough case of classic chickenpox & fever of 102f, continued to develop lesions for 5 days. seen by MD who noted approx 300-500 lesions.
| 1ER_VISIT
|
1,843,306
|
There were no adverse events from the first or second Covid vaccine. I received the booster on 10/11 /2021 and my arm hurt very bad for a week. Right after that I developed dry patches on my skin. An area on my back, one on my stomach and one on my neck. About one week after that I started getting a rash. It was small at first, just a few bumps. Then it began to spread until there were itchy raised bumps all over my entire body, from my head to my feet. The itching is maddening.
| 0No event
|
217,335
|
11:40 complained of severe itching all over. She was immediately taken to MD. She was given Solumedrol 12 mg IM, Benadryl 50 mg IM, Epinephrine 0.33 cc SC etat. Given Rx of Benadryl orally and Epi pin and Prednisone to take home. Slept well during the night and plans to return to work 11-7-03. 11-6-03 follow-up unable to work today due to sleepiness. Plans to work. 11-7-03 Doing well.
| 1ER_VISIT
|
754,748
|
This non-serious initial spontaneous case, was received on 22-Sep-2017, concerning a 29-year-old, adult pregnant female patient. The patient did not use contraceptives. The patient's last menstrual period date was on 22-Jan-2017, foetus status was not reported. The patient had no pregnancy in the past. The infant gestational age was 34.5 weeks and there was no evidence of defect or adverse findings from prenatal test. Concomitant medication included: Prenatal vitamins. On 21-Sep-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, batch number: WT54607, expiry date: 30-Jun-2017 (expired dose), route of administration and anatomical location: not reported). It was reported that the pregnant patient received the expired vaccine. The patient experienced adverse event, but no adverse reaction was experienced in the foetus. The estimated date of delivery was on 29-Oct-2017. It was stated that, the mother and the baby was good with no problem. No other information was provided. The outcome of the event was not reported. Follow-up report received from the reporter on 17-APr-2018: The reporter confirmed that the estimated date of delivery was 29-Oct-2017 and the patient was not enrolled in the registry. It was stated that, the mother and the baby was good with no problem. No other information was provided. Amended narrative accordingly.
| 0No event
|
882,229
|
Patient began to have excruciating pain left shoulder with low range of motion. following injection. Temp 100.4 with pain that comes and goes over the course of the following week.
| 0No event
|
679,714
|
Attached events for both 2015 and 2016 flu shots.
| 0No event
|
1,265,127
|
I woke up with ringing in my ears the next morning 4/23. It has been constant and has not gone away. I also have ear pain that has started from the constant ringing. My ears have been ringing for 5 days now. I am starting to get very concerned as I have not had this problem before. I am wondering when the ear ringing is going to go away, and why my body has responded this way to my first dose of Covid vaccine. I had an appointment with my Primary Care Dr. today who is referring me to an ENT now. I wish I could make the ear ringing go away and am concerned as to why the vaccine would give me this side effect.
| 0No event
|
582,676
|
This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. The medical assistant reproted that the patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # K006960, expiration date: 19-FEB-2017) (route of administration and frequency were not reported) on unspecified dates since 21-MAY-2015. No adverse effects reported. Concomitant medications were not reported. This is one of two reports from the same source. Additional information has been requested.
| 0No event
|
1,210,789
|
Hard, red lump at injection site (2nd dose), itchy. Low grade fever. Achy arm, neck, back.
| 0No event
|
2,539,259
|
PT RECEIVED MONOVALENT INSTEAD OF BIVALENT, NO ADVERSE EVENTS AT ALL. PT WILL GET VACCINATED WITH BIVALENT IN 8 WEEKS.
| 0No event
|
388,212
|
Information has been received from a licensed practical nurse concerning a 28 month old male with autism who on 06-MAR-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 662201/1544X), SQ, 0.5ml. There was no concomitant medication. On 16-MAR-2009 the patient experienced vesicular lesions at the injection site of the left upper arm. The patient was examined in the office on 19-MAR-2009 and was prescribed topical antibiotic ointment. At time of the report the patient was recovering. Follow-up information has been received from a licensed practical nurse concerning the patient on 06-MAR-2009 was vaccinated with first dose of VARIVAX (Merck) (lot # 662201/1544X) in left arm, SQ, 0.5ml. On 16-MAR-2009 the patient's skin at site of vaccine 3 blisters with slight scab and faint erythema of 3 cm. Antibiotic ointment was applied to the area. No further information is available. This is one of several reports received from the same source.
| 1ER_VISIT
|
1,825,113
|
On June 21, 2021 (Four weeks after receiving second Pfizer Covid-19 shot) I developed peripheral neuropathy in my arms , hands, legs, and feet. The symptoms are severe with burning-jabbing pain that is relentless. October 1, 2021 started Electric Cell Signaling Therapy at two days per week until the end of November. No Improvement so far.
| 2ER_VISIT, HOSPITAL
|
2,028,261
|
December 1 2021 Vial moved from Freezer to Fridge January 6, 2022 Vaccine administered.
| 0No event
|
2,142,853
|
right knee still swollen; diagnosed with Baker's cyst; A lot of soreness in the arm; Tightness in upper back up to my neck/ tightness in the (right) calf; bad calf cramp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (A lot of soreness in the arm), MUSCLE TIGHTNESS (Tightness in upper back up to my neck/ tightness in the (right) calf), MUSCLE SPASMS (bad calf cramp), SYNOVIAL CYST (diagnosed with Baker's cyst) and JOINT SWELLING (right knee still swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included UBIDECARENONE (COQ 10), COLOSTRUM (COLOSTRUM 6), VITAMIN D NOS, AMOXICILLIN TRIHYDRATE, BROMHEXINE HYDROCHLORIDE (MOX BRO) from an unknown date to 09-Mar-2021 and DOCOSAHEXAENOIC ACID (DHA) for Immune system disorder (NOS). On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (A lot of soreness in the arm), MUSCLE TIGHTNESS (Tightness in upper back up to my neck/ tightness in the (right) calf) and MUSCLE SPASMS (bad calf cramp). On 08-Jul-2021, the patient experienced SYNOVIAL CYST (diagnosed with Baker's cyst). On an unknown date, the patient experienced JOINT SWELLING (right knee still swollen). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Muscle tightness, at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date for Muscle tightness, at an unspecified dose and frequency and CORTISONE on 08-Jul-2021 for Baker's cyst, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (A lot of soreness in the arm) and MUSCLE SPASMS (bad calf cramp) had resolved and MUSCLE TIGHTNESS (Tightness in upper back up to my neck/ tightness in the (right) calf), SYNOVIAL CYST (diagnosed with Baker's cyst) and JOINT SWELLING (right knee still swollen) had not resolved. TIce pad treatment on the calf reported. In Jun-2021, patient underwent 3 X-rays, result unknown. This case was linked to MOD-2021-027570 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information will be processed with the initial report. Updated information includes patient demographics, concomitant drugs and event of right knee still swollen. On 26-Jul-2021: Follow-up received on 26-Jul-2021 contained for event diagnosed with Baker's cyst outcome as not recovered (previously captured as unknown). Treatment drug cortisone used for bakers cyst (previously captured as back of the knee).
| 0No event
|
505,629
|
This case was reported by a pharmacy student and described the occurrence of sore eye in a 23-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 September 2012 at 16:20 the subject received unspecified dose of BOOSTRIX (unknown). On 24 September 2012, at the time of vaccination with BOOSTRIX, the subject experienced eyes splashed with vaccine. On 24 September 2012, within minutes of vaccination with BOOSTRIX, the subject experienced sore eye and eye irritation. The pharmacy student, who is also the subject, reported there was pressure in the bottle of BOOSTRIX and thinks it sprayed from the bottle into her right eye. The reporter did not consider there to be anything wrong with the BOOSTRIX vial. The subject's right eye was a bit sore and irritated however she said it could be from rinsing it. The reported planned to seek medical attention. At the time of reporting the sore eye and eye irritation were unresolved.
| 0No event
|
674,850
|
Information has been received from a clinical practice manager concerning a female patient of unknown age. There was no information about concurrent condition, concomitant medication and medical history. On 13-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # reported as M041811, expiration date 25-MAY-2018) (dose, frequency and route unknown) for prophylaxis. On an unspecified date in December 2016 after vaccinated with PNEUMOVAX23, the patient developed cellulitis, which extended beyond the injection sites. Treatment with unspecified antibiotics was given to the patient. The outcome of the event was unknown. The causality between the event and PNEUMOVAX23 was not provided. Upon internal review, cellulitis was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow-up. Sender's Comments: US-009507513-1612USA009590: US-009507513-1612USA012869.
| 0No event
|
244,651
|
Swelling pain, erythema, hypopigmentation at injection site
| 0No event
|
1,552,259
|
Red rash; Pain on top of arm to the elbow/arm hurt; Tired; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on top of arm to the elbow/arm hurt), FATIGUE (Tired), RASH (Rash) and RASH ERYTHEMATOUS (Red rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on top of arm to the elbow/arm hurt), FATIGUE (Tired) and RASH (Rash). On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). At the time of the report, PAIN IN EXTREMITY (Pain on top of arm to the elbow/arm hurt), FATIGUE (Tired) and RASH (Rash) was resolving and RASH ERYTHEMATOUS (Red rash) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Treatment included Cortisone cream to treat her symptoms. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No new information.
| 0No event
|
1,167,018
|
The injection site is 5 degrees warmer than the rest of the arm, and still sore to the touch. Slightly pinker to the rest of the arm, also the rest of the arm is colder as well than a normal arm. Normally is not noticable unless touched, hence was not noticed for two weeks.
| 0No event
|
236,605
|
Shortness of breath. Stridor, could not breath. Swelling around both eyes.
| 1ER_VISIT
|
1,072,147
|
Rcvd first COVID shot in Left deltoid on 12/27. After shot, arm very sore, and progressed over the last 8 weeks to reduced ROM, weakness, pain, and intermittent numbness. Contacted employee health and their MD stated the following: "Here is the information I received from, the Director of Infectious Diseases . She suggested that you follow up with your pcp to start. The syndrome is called Parsonage-Turner. Management and prognosis ? There is no specific treatment for neuralgic amyotrophy. Management is conservative. Physical therapy may be helpful to preserve range of motion but will not hasten recovery. Glucocorticoids have been advocated by some [34], but no clinical studies have demonstrated efficacy. In the first weeks, analgesic drugs, including narcotics, may be required to manage patients with severe pain. Recovery occurs slowly over one to three years, and some patients have persistent disability." I have contacted my PCP who has ordered a PT consult (scheduling next week), also seeing an acupuncturist for treatment.
| 0No event
|
1,198,423
|
After injection pt was escorted by RN to observation area. In route, patient passed out. Color became dusky. Spo2 was 88-100 %. Dr ordered Epi Pen to be administered to left thigh at 1258. EMS was notified and patient taken to Hospital. Upon arrival to ED pt reports she became suddenly dizzy then woke up in the ED. She experienced chest tightness, sore throat, tongue swelling. Second epi was given in the ED. Developed muscle stiffness in the ED.
| 2ER_VISIT, HOSPITAL
|
828,382
|
Day 1, sore arm. Day 2 chills, fever to 101.4. Day 3 OK, Day 4 lethargy, Day 5 chills, fever to 102.0, diarrhea, sore joints
| 0No event
|
925,506
|
Left axillary lymph node swollen and very painful Hard to move left arm.
| 0No event
|
79,780
|
rash @ site given MMR & DTP
| 0No event
|
518,549
|
Patient called today 1/6/14 stating he started experiencing tingling and numbness in right hand sometime between 11/4/13 when he received immunization and 11/23/13. Since then it has also moved to other hand both wrists and shoulder. Saw family MD 11/23/13 - also saw pain doctor who referred to neurologist: none could diagnose unsure of dates.
| 1ER_VISIT
|
1,421,452
|
Error: Improper Storage (temperature)
| 0No event
|
2,584,441
|
2 Days after injection, developed extreme inflammation in all joints. Could barely get out of bed. By the 3rd day I was almost crippled. Had to find an endocrine doctor and was placed on prednisone for 10 months till the markers came down. Since tapering off the prednisone, I have been much better, and markers have been down consistently. I am a perfectly healthy 65 year old man who is extremely active, and still works.
| 0No event
|
282,157
|
3cm indurated erythematous warm circular lesion at site of vaccination.
| 0No event
|
2,287,863
|
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was a refrigerated packaging tote to maintain a temperature of 36 F - 46 F. However, that is not approved by the Regulatory Authority for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
| 0No event
|
2,511,735
|
Moderna 030a21a 4 days in bed with terrible flu symptoms
| 0No event
|
1,580,775
|
This spontaneous case reported by a pharmacist, describes the occurrence of COVID-19 in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced COVID-19. At the time of the report, COVID-19 outcome: unknown. Diagnostic results: On an unknown date, COVID-19: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. Most recent follow-up information incorporated above includes: On Jul 8, 2021: Follow-up received. No significant information updated.
| 0No event
|
800,743
|
During vaccination the MA pulled HIB instead of Hep A and administered vaccine.
| 0No event
|
561,332
|
Case number PHEH2014US020230 is an initial spontaneous report from a health care professional (allergy technician) received on 08 OCT 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medication were not provided. It was reported that on 03 OCT 2014, she received a dose of expired FLUVIRIN (batch number: unknown) intramuscularly on 03 OCT 2014. No adverse events were reported following maladministration.
| 0No event
|
937,175
|
Injection around 9:25am. She became dizzy at 9:30am in the chair in the waiting area after vaccine. Juice provided as well as water. @9:30 her BP was 120/88 Pulse 70. Pt talking. Felt slightly better after juice- still a bit shaky and dizzy. At 9:56 am she still was not feeling right- stating head heavy and now her chest had a tightness in the center- still Alert and oriented. BP recheck was 160/96 in left and 160/100 in right with a pulse of 88. 911 was called at this time. Ambulance arrived and patient went to the ER at 10:15am
| 1ER_VISIT
|
2,298,771
|
PATIENT RECEIVED VACCINE ON 3/26/21 A DAY EARLY
| 0No event
|
1,619,764
|
Patient is experiencing every side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Patient is experiencing every side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Patient is experiencing every side effect). At the time of the report, ADVERSE EVENT (Patient is experiencing every side effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter.
| 0No event
|
254,833
|
Seriousness criteria other medically significant (OMIC). Initial report received on 4/19/2006 from a physician. A 13 year old female patient with no reported illnesses, pre existing medical conditions, or use of other medications, had received an administration of Menactra, lot number U2003AA, in the right deltoid, and an administration of Decavac, lot number U1619BA, in the left deltoid in 4/11/2006. The route of administration was not reported for either vaccine. 24 hours post immunization, the patient experienced severe pain in her arms bilaterally, generalized aches, bilateral leg weakness, and shakiness. She was taken to the ER where laboratory data was collected, and the results were within normal limits. She was released the same day. The patient was seen by her physician on 4/19/2006 and at that time, she was still shaky when walking, and continued with generalized weakness that was accompanied by absent bilateral ankle/plantar reflexes. Per the reporter, no foot drop was present. The patient had not recovered from these events at the time of this report.
| 1ER_VISIT
|
428,990
|
Information has been received from a medical assistant concerning a 60 year old female patient with asthma, gastrooesophageal reflux disease, hypertension, arthritis, cardiac failure congestive, pulmonary embolism and rhinitis allergic and no drug reactions/allergies, who on 26-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665925/0932Z Exp 18-JUL-2011). Concomitant therapy included warfarin, SINGULAIR, SYMBICORT, PREVACID, prednisone, potassium (unspecified), NASONEX, NAPROSYN, lisinopril, DARVOCET-N, calcium (unspecified), ALLEGRA-D, albuterol sulfate and albuterol sulfate. On 26-OCT-2010, at night, the patient began to develop redness, swelling, and heat at the injection site. She also had a fever. She was diagnosed with cellulitis. She received CIPRO. She recovered on 04-NOV-2010. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665925/0932Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received from a medical assistant who stated that the patient with no illness at time of vaccination "healthy", on 26-OCT-2010, was vaccinated IM in the right arm with a dose of PNEUMOVAX 23 (Lot# 665925/0932Z) at 14:30. It was reported also that on 26-OCT-2010 (also reported as 28-OCT-2010) at 12:45, the patient complaint of redness, pain, swelling at injection site, within 8-10 hours. The patient was seen in the office on 28-OCT-2010 for the same reason. Patient was given Ciprofloxacine 750 mg for 7 days. And on 01-NOV-2010 (previously reported as 04-NOV-2010), the condition resolved and patient recovered. The reporting physician considered cellulitis an other important medical event. No further information is available.
| 0No event
|
1,992,737
|
Woke up and my hands were both itchy, and my right hand hurt along the top of the palm, where the knuckles are. Itching has persisted in both hands for 12 hours, but has been far worse on right. Also have a round patch of itchy skin on right wrist two inches long by one inch wide (roughly). If I squeeze the fingers of my right hand into a fist, I feel significant pain up my fingers starting at the knuckles on the palm-side of my hand. I have the same reaction on my left hand, but far less. My hands have been dry recently due to frequent washing, so I originally attested the itching, pain and redness to that, but when it didn't fade like it normally does when I applied lotion, I became a little concerned. I took an allergy pill (Loratadine - Generic) and it reduced the symptoms a bit, but the pain and itching are still very present.
| 0No event
|
1,296,296
|
Arm soreness, itchiness directly following injection and continuing to a lesser degree to this day, nearly 3 months later.
| 0No event
|
195,051
|
11/16/02 Complained of edema and redness at site; slight yellow discharge from site where vaccine given; describes as if pimple burst. Applied warm compresses. Notified physician and seen on 11/18/02. Was told area was slightly infected. No antibiotics given. Rx warm compresses and observe.
| 0No event
|
1,123,720
|
One day after vaccine my eye felt slightly irritated. The next day I felt a little swelling in the corner of my left eye on the same side of vaccine. It became visible as an irritation on the outside corner of my eye. It was very painful and my lower eyelid was swollen. I was trying to massage but the pain seemed to be internal. There was a large red pimple like lesion inside my eyelid. I went to an eye doctor and was diagnosed with an internal sty on my eye. I have never had a Sty before. I was prescribed an antibiotic and it not not resolve so I was prescribed a antibiotic cream which helped. The lesion burst by then. I took two to three weeks to resolve. I since also received the second dose. I had a very strong immune response to the second dose. Chills, headaches and all over body ache. I was unable to work for two days. I was bed ridden for two days. My Asthma seemed very reactive during that time. My Asthma seemed worse for a few weeks and it is still a little worse than normal.
| 0No event
|
739,119
|
This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 27-JUL-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
| 0No event
|
962,989
|
Headache, body aches, hot flashes, blurred vision.
| 0No event
|
2,241,120
|
I woke up in the middle of the night with itching. I took an antihistamine. That helped but when it wore off the itching came back and its been persistent. It caused hives around my bellybutton, shoulders, back and chest. It does affect my arms and legs, but not as prominent. It definitely seems like an allergic reaction, but I don't know the cause. I have eliminated foods that could cause it. I even changed my laundry detergent and nothing is changing it. I think it is a reaction to the shingles vaccine and Pfizer booster being taken in close timing. On 03/06/2022, I did see my doctor. He advised to keep taking the antihistamines. On 03/10/2022, I was prescribed a topical cream for the hives. I now take antihistamines three times a day and it helps, but if I don't take it on time the itching starts all over.
| 0No event
|
1,610,651
|
2nd Moderna Vaccine given > 42 days past 1st Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine given > 42 days past 1st Vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine given > 42 days past 1st Vaccine). On 22-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna Vaccine given > 42 days past 1st Vaccine) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided No treatment medication information was provided
| 0No event
|
133,369
|
Significant swelling at inject site-L tricep, redness, soreness lasting 1 wk. Told to take Tylenol for pain.
| 0No event
|
1,036,188
|
Red, painful flat rash, upper arm anterior to injection site. Severe anterior upper arm pain
| 0No event
|
306,829
|
01/30/08 730AM vomiting x1, fever 100.5, headache, chills - No treatment; 1030 AM "feels little better"; 1200AM "vomited x4 and still has headache"; was not feeling well before shot on 1-28. 01/31/08- no nausea and vomiting - still has chills, chest congestion - MD appt. 2/16/08; 2/18/08 received call back from client - evaluated by me on 2/1/08 "flu or view" "not related to shot(Tdap)/ I'm back to full health" RN
| 0No event
|
340,117
|
Fever of 102.5 one hour after the DTaP1/Hib/IVP shot administered. Also signs of severe distress, screaming and crying. He continually grasped my shirt. I immediatley reported it to the doctor, and gave him motrin for the fever. Symptoms subsided. However I felt suspicious something worse happened. No one could give me a medical/scientific explaination.
| 1ER_VISIT
|
916,127
|
rash at injection site
| 0No event
|
1,837,409
|
Patient received an extra dose of HPV that was not needed.
| 0No event
|
2,655,110
|
Given 10 mcg Moderna Bivalent instead of 25 mcg
| 0No event
|
953,956
|
Stomachache started on 1/13/21 and lasted for 5 days. Headache started on 1/14/21 and lasted 2 days. 1/15/21 diarrhea for 2 days. 1/16/21 chills, fever, body and joint aches. Severe fatigue started on 1/14/21 and lasted for 5 days.
| 0No event
|
674,671
|
This spontaneous report was received from a medical assistant, referring to multiple unspecified patients of unknown age and gender. Information about the patients' medical history, concurrent conditions and concomitant medication was not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 dose: 0.5 ml, intramuscularly (lot # M017983, expiration 30-MAY-2018) (dosage schedule and frequency were not provided) for prophylaxis. The vaccine had a temperature excursion of 31.9 Fahrenheit degrees in a time frame of 19 days and 12 hours. The temperatures were logged with a data logger and there were no previous excursions. No adverse effects were noted. No product quality complaint was involved. Additional information has been requested.
| 0No event
|
1,207,350
|
15 days after the 1st dose of Pfizer Covid19 vaccine developed measle like rash on back, backs of legs, and buttocks. By the afternoon on day 15th, rash had spread to other parts of legs and stomach. Tongue also felt funny. Metallic tasting and felt like rash was inside of mouth. On day 16, rash erupted on arms, inside of ear, tops of feet- full body. Extremely extremely itchy. Top of both arms rash is very red and more prounounced. Arms in those areas are warm to the touch and hurt. Taking Claritin (brand name) and Benadryl (brand name) - only taking an edge off. Today 4/14, day 7 of rash, it is still extremely itchy especially at night.
| 0No event
|
1,199,703
|
Bells Palsy with trigeminal neuralgia, not resolved with treatment
| 1ER_VISIT
|
530,427
|
This spontaneous report as received from a health worker refers to unspecified patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX (Merck) (dose and lot# not reported). It was reported that the temperature excursion of -13c up to 808 hours to VARIVAX (Merck) which was supported. Multiple individuals had been vaccinated post excursion. And no individual had reported any adverse effects post vaccination. This is one of the several reports from the same reporter. Additional information has been requested.
| 0No event
|
488,535
|
Pain so strong it woke me up. I took 3 aspirin. I could not lift my arm from my side the pain was so severe. Level 6-7. It felt like someone had hit me with a stick very hard. The pain kept me awake for several hours. Now, 3 PM the following day, the pain is still bad (I've been taking aspirin and ibuprofen) but I can raise my arm a litle. There is no swelling or redness.
| 0No event
|
693,245
|
This spontaneous report was received from a consumer via an online article concerning her daughter, a female patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dosing details, lot and expiration date unknown) for prophylaxis. On an unknown date, the patient experienced paralysis. The outcome of paralysis was unknown. The reporter warned that GARDASIL vaccine was to blame for her daughter's paralysis (reporter causality: related). Upon internal review, the event of paralysis was considered to be serious as disability and medically significant. Additional information is not expected as reporter contact details are not available.
| 0No event
|
2,028,661
|
During a review of the internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
| 0No event
|
839,249
|
Flu vaccine was administered on 10/07/19 in clinic. Mother of patient presented through clinic triage on 10/9/19 with concern of child's right arm, site of where the flu vaccine was given, being red, itching, and swollen. Mother was given clinical advise on how to care for child's arm and was educated on signs to look out for that indicate need to go to emergency department vs. primary care clinic. Mother of patient verbalized understanding of plan.
| 0No event
|
1,299,979
|
Within 3 hours, flu-like symptoms of low grade fever, headache, fatigue, aches and chills. Next day a slight cough developed, and persisted through until 2 days after. Injection site remained sore. Just took hot showers, slept, and used alkaseltzer day/night tablets as needed for symptoms.
| 0No event
|
1,010,799
|
tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't smell; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 44-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Lot Number: ER5730 or EK5730), via an unspecified route of administration at Arm right on 18Dec2020 17:00 at the 44 years old at single dose for COVID-19 immunization. The medical history was none. The Family Medical History Relevant to adverse events was none. The concomitant medication was none. The patient was supposed to work the day she tested positive but had a stuffy nose on 01Jan2021. She wasn't sure if that was what it was but when she took a shower she couldn't smell the body wash and so she knew she had COVID. She had a rapid test used for the positive test for COVID on 01Jan2021. There was no hospitalization due to testing positive. The events did not require a visit to Emergency Room and Physician Office, but she did go to the urgent care to get the rapid test.There was no Prior Vaccinations (within 4 weeks). There was none additional Vaccines Administered on Same Date of the product. The patient underwent lab tests and procedures, which included tested positive for COVID on 01Jan2021. The outcome of the events was unknown.
| 0No event
|
1,830,745
|
got a weird thing on their hand after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got a weird thing on their hand after the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got a weird thing on their hand after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (got a weird thing on their hand after the second dose) outcome was unknown. Concomitant medications were not reported by the reporter. Patient 1 reported that patient 3 may be 65-57 years of age. This case was linked to MOD-2021-361534 (Patient Link).
| 0No event
|
2,583,983
|
Started approximately First of November with right upper extremity weakness, then falling frequently, then right leg weakness, then difficulty walking, then slurred speech. Seen by various Doctors, Neurologists local and also seen at local Clinics. Multiple tests ran. They advised no cure, I have had PT & OT, Staring Speech Therapy in March. Now diagnosed with Primary lateral Sclerosis , Hemiparesis of dominant side & Dysarthria
| 2ER_VISIT, HOSPITAL
|
632,488
|
This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 02-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
| 0No event
|
408,339
|
Swelling, redness.
| 0No event
|
738,513
|
Palindromic rheumatism might be related to the anthrax immunizations. Migrating arthritis with positive RA factor.
| 0No event
|
2,203,461
|
dose was given outside the 12-hour window; dose was given outside the 12-hour window; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (dose was given outside the 12-hour window) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose was given outside the 12-hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given outside the 12-hour window) and PRODUCT STORAGE ERROR (dose was given outside the 12-hour window) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medication was not provided. It was reported that number of doses/vials is 4 doses. On night of 22-MAR-2022 vial was initially stored in the refrigerator. On 23-MAR-2022 around 10:15 AM vial was first punctured. The doses were drawn out and stored in the fridge. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) is only for drawing up the doses, maybe 5 minutes. This case was linked to MOD-2022-523240, MOD-2022-523279 (Patient Link).
| 0No event
|
1,604,445
|
Allergies; Could not stand up weakness in legs; Head Foggy; Very tired, lot of time in bed; Could not stand up, weakness in legs; hypersensitive reaction; Concurrent medical conditions included Allergy and Sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection) and ASTHENIA (Could not stand up, weakness in legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. On 05-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection), ASTHENIA (Could not stand up, weakness in legs) and FATIGUE (Very tired, lot of time in bed). On an unknown date, the patient experienced VACCINATION COMPLICATION (hypersensitive reaction) and FEELING ABNORMAL (Head Foggy). At the time of the report, MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection), ASTHENIA (Could not stand up, weakness in legs), VACCINATION COMPLICATION (hypersensitive reaction), FEELING ABNORMAL (Head Foggy) and FATIGUE (Very tired, lot of time in bed) outcome was unknown. Relevant concomitant products were not provided by the reporter. Treatment details included antibiotics. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-068731, MOD-2021-069660 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added VAERS and additional event On 29-Jul-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
| 0No event
|
1,074,166
|
headache; This is a spontaneous report from a contactable consumer. A male patient (father) of unknown age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 22Jan2021 at single dose for COVID-19 Immunization. Medical history and Concomitant medications were not reported. The patient received the first dose of the Covid vaccine on 22Jan2021. On the 3rd day (25Jan2021) developed a headache that has now lasted 5 days. further stated that it was getting better, but still not going away. The outcome of event was recovering. Information on the lot/batch number has been requested.
| 0No event
|
701,162
|
WITHIN HOURS OF RECEIVING IMMUNIZATION, PATIENT BEGAN TO EXPERIENCE FEVER (102+), CHILLS, HEADACHES AND MALAISE. INJECTION SITE BECAME SWOLLEN AND SORE. SYMPTOMS PERSISTED THROUGH THE WEEKEND. ON 6/27/2017 SHE WAS EVALUATED AND TREATED WITH PREDNISONE. TO BE SEEN AGAIN 6/30/2017.
| 1ER_VISIT
|
185,285
|
Information has been received from the CDC concerning sixteen patients at one daycare who were each vaccinated with one dose of varicella virus vaccine live. Between 01 DEC 2000 and 01 FEB 2001 the patients experienced breakthrough varicella. The first reported case had a rash onset date of 01 DEC 2000 and the last reported date of rash onset was 11 JAN 2001. In the building, there were 78 full time students with 74 of the children greater than 12 months of age. Of these 74 children, 58 had no history of chicken pox, and 16 had a history of chicken pox. Of the 58 children with no history of chicken pox, 42 had previously been vaccinated with varicella virus vaccine live, one was vaccinated with varicella virus vaccine live during the outbreak, and 15 had no vaccination with varicella virus vaccine live. Of the 42 vaccinated children, 16 developed breakthrough varicella. Fourteen of the cases were mild as defined as less than 50 lesions, and two cases were moderate as defined as 51-250 lesions. The remaining 16 vaccinated children did not experience a breakthrough rash. Of the 15 unvaccinated children, 8 developed natural varicella (two mild cases, five moderate cases, and one severe cases defined as greater than 500 lesions, and seven had no rash (all of the seven children were offered serologic testing of which four agreed and they were all seronegative. No complications were reported during the outbreak. The median age of the cases was four years (range 1-8), 76% were male. No cases occurred among infants <12 months of age (n=4) and none occurred in a child who had a prior history of varicella disease. The 24 cases of varicella at the daycare were assigned WAES01010074. One patient at the daycare developed herpes zoster during the outbreak (WAES01072736). Of the 74 children in the building, 46 attended preschool or Pre-K continuously. Of the 46, 31 had no history of chicken pox, and 15 had a history of chicken pox. Of the 31 children with no history of chicken pox, 24 were vaccinated and 7 were not vaccinated. Of the 24 vaccinated, 12 developed breakthrough varicella and 12 did not have any rash. Of the seven unvaccinated children, six developed varicella and one was without rash. One patient in the group of students was the index case (WAES01022046) who developed a mild case of chicken pox following exposure to his sister who had herpes zoster. A susceptible parent of two breakthrough cases developed a severe case of varicella (greater than 500 hemorrhagic lesions) (WAES01072737). Her rash lesions were swabbed for PCR analysis and were found to be positive for varicella. In addition to exposure to her children, she spent approximately 10-15 minutes twice daily in the building of the primary outbreak during the outbreak period, and may had been exposed to other cases of varicella during the outbreak. Follow up information from a published article indicated that "ninety-five (100%) parent and 94 (99%) provider questionnaires were returned. The median age of the 76 (80%) children who attended was 4.2 years (range: 6 months-8 years); 74% were male. Vaccination coverage was 76%. Of 23 cases of varicella, 15 (65%) occurred in vaccinated children and 8 (35%) occurred in unvaccinated children. The index case was a four year old vaccinee who developed BT on 01 DEC 2000. The median age of cases was 4.4 years (range 1-7). VZV was cultured in one case and identified by PCR in another. Vaccine effectiveness was 40.5% (95% CI: -7.2. 67) overall and 41.7% in the building where the outbreak was centered. No further information is available. Reported on 04/11/2003: "Follow-up information from a published article as titled above indicated that in this outbreak vaccination provided poor protection against varicella, although there was good protection against moderate to severe disease. A longer interval since vaccination was associated with an increased rish of vaccine failure. Breakthrough infections in vaccinated, healthy persons can be as infectious as varicella in unvaccinated persons. Follow-up information from a journal editorial as titled above indicated that the varicella vaccine has proved to be extremely well tolerated with no serious safety issues emerging. The "breakthrough" varicella may develop in 10 to 15 percent of the vaccinated population. No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
| 0No event
|
57,608
|
screaming (high-pitch) nonstop from 330PM to 1130PM; unable to console pt; mom called pediatrician;
| 1ER_VISIT
|
1,880,779
|
VACCINE WAS HELD IN IMPROPER TEMPERATURE
| 0No event
|
305,803
|
4x5 cm erythematous patch at site of Varicella vaccine #2.
| 0No event
|
1,518,641
|
2 days after shot I became congested/hard to breathe. Went to urgent care. Chest X-ray was normal. Soon too weak to get out of bed or feed myself. Symptoms like a systemic yeast infection. Facial skin cracked and peeled, lips cracked. Fell 2x. After 4 weeks + Had to call 911 as couldn?t breathe properly. Gave me magnesium, oxygen and sent me home.. Hospital said no sign of infection but I had already started to improve.
| 0No event
|
123,516
|
p/vax pt exp chickenpox w/an unk number of lesions;
| 0No event
|
1,690,132
|
Dizziness, blurred vision Paramedics took to ER
| 1ER_VISIT
|
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