chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist refers to a male patient, age reported as '18" (units unspecified). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient had titer for varicella before administration of vaccine. On an unknown date the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous (lot# and expiry date not reported). Then on and unknown date, the patient developed shingles. The outcome of event was unknown. Causality assessment was not reported. No product quality complain (PQC) involved. Additional information has been requested.
Headache, extreme fatigue, nausea  cough, shortness of breath,  body aches,
This spontaneous case reported by an other healthcare professional, describes the occurrence of malaise (felt sick) in a patient, of an unknown age and gender, 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), unknown route; 1 dosage form. On an unknown date, patient experienced malaise (felt sick). At the time of the report, malaise (felt sick) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments. No concomitant medication or treatment information reported.
This case was reported by a consumer and described the occurrence of neuropathy in an adult female subject who received LYMERIX (GlaxoSmithKline) as part of a clinical trial. A physician or other health care professional has not verified this report. On an unspecified date in 1995 the subject received 2nd dose of LYMERIX. An unspecified amount of time following administration of the 2nd LYMERIX vaccine, the subject experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. The outcome of these events was not reported. On 17 August 2008, approximately 13 years after the 2nd vaccination with LYMERIX, the subject again experienced neuropathy, electric shock sensation in the right ankle and tingling of the toes. It was reported that MRIs and other miscellaneous testing was performed on the subject (dates and specifics not provided) and all were negative other than arthritis. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. Follow up information was received on 29 September 2008 via clinical trial information for this subject. The subject was initially enrolled in protocol 215274/008. She was subsequently enrolled in 215274/013. The subject received LYMERIX vaccine administered on 15 March 1995 and 18 April 1995. The subject did not receive the third dose of LYMERIX. On 18 March 1995, the subject experienced sinus congestion and aches and pains assessed to be possibly related to LYMERIX, which resolved on 24 March 1995. On 13 May 1995, the subject experienced contact dermatitis of the chest assessed to be unrelated to LYMERIX, which resolved on 01 June 1995. On 01 September 2005, the subject experienced neuritis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. On 22 January 1996, the subject experienced degenerative cervical disc disease and cervical spinal stenosis assessed to be unrelated to LYMERIX, which was unresolved at study conclusion. Treatment included aspirin, Naprosyn, and prednisone. None of the preceding adverse events were assessed to be serious.
I got the booster vaccine (my third Pfizer) 12/4/21 around 10:30am and was fine until the sore arm started that evening around dinner.  I woke up around 12:30am 12/5/21 with fever, chills/sweating, my entire body was sore, intense migraine, heartburn, and for a short period that night a rapid heartbeat.  I ate some tums and continued drinking water and gatorade, and took ibuprofen Sunday morning to help.  Muscle soreness, migraine, fever, and body aches were almost all gone by Sunday evening.  Monday morning, 12/5, I woke up with what looks like a viral rash on my chest/stomach/back.  I still have that now but it doesn't seem to be spreading or getting worse (maybe a little better at this point but marginally, if at all).  I have a doctor's appointment scheduled for a physical in January at a new primary care doctor closer to where I live, but no symptoms at this time seem serious enough for me to go to an urgent care.  I had only a sore arm and migraine after shot 1.  After shot 2 I had a migraine, body aches, and a fever which resolved in under 2 days.  This is the first time I've gotten the rash and the rapid heart rate.
Dry cotton mouth; This case was reported by a pharmacist via call center representative and described the occurrence of dry mouth in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In June 2019, several days after receiving Shingrix, the patient experienced dry mouth. On an unknown date, the outcome of the dry mouth was unknown.   It was unknown if the reporter considered the dry mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Few days to weeks after vaccination with 1st dose of Shingrix, the patient experienced horrible dry cottonmouth. The patient reported this when he got 2nd dose of Shingrix. No other patient identifiers were provided. Further details regarding dose given or adverse event were unknown. The pharmacist was not in the office at the time of the report.
Fever secondary to smallpox vaccine DC DX for DOS: 8/16-8/17/06 Fever fever likely secondary to small pox immunization. Treated with IV fluids and Toradol. Temp on admission 102.
Sore throat,  swollen throat, coughing, tongue feels scraped on both sides, feels like it is swollen, so hurts to eat or chew.  Chronic constant headache, swollen glands, ears feel plugged.  Bloody nose.  Lips suddenly extremely chapped and raw.  Hurts to swallow.
Day 11 a light red area around site of the vaccine appeared, slightly warm, no temp and no complaint, sleep not interrupted and appetite unchanged, legal rep informed and PHN that provided the vaccine informed. Advised Tylenol and cool pack to site if requested/needed.  Not needed but PHN asked that we inform this site of the event . We have circled the area to determine spread. Staff noted lighter in color late today.
This spontaneous report was received from a nurse via a company representative concerning a 12 year old male patient. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose, route, lot# and the expiration date were not reported) for prophylaxis. There was no concomitant medication provided. On 04-AUG-2017, the patient experienced lightheaded-ness, tingling in his arm and abdominal pain. He was diagnosed with appendicitis. The outcome of appendicitis, paraesthesia and dizziness was unknown. The relatedness between the therapy with GARDASIL 9 and the events was not reported. Upon internal review, appendicitis was determined to be medically significant.
Patient received vaccine at workplace clinic at 1:26PM. Patient sent message the following morning, reporting, "... I woke up around 3AM with my entire body cramping and severe headache as well. I'm working from home today, I'll take the ADVIL and hoping this will go away soon. It's a little better but not by much." Spoke to physician and let patient know that she may take ADVIL. Also alerted patient that symptoms should resolve within 2-3 days per SHINGRIX prescribing information sheet and CDC website. Advise patient to call if symptoms change or worsen.
Left arm sore that night and next day - when waking up 11-10-11. Redness 3" x 6 " very tender to touch. No fever.
This spontaneous report as received from a nurse refers to a 6 months 8 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
1. VACCINIA FROM VACCINATION LOCALIZED: I believe that this patient has the beginning of vaccinia because the lesions are on the opposite side or where they would be if it were eczema.  Due to the proximity of his deployment and the possibility of a vaccinia, the patient has been suspended from deployment at this time and he will receive a 10 day home leave anyway she will remain at home and he will be reevaluated in a week's time.  Public health has been alerted and has notified his squadron that the patient's deployment will be delayed.  The patient understands and acquiesces everything that we have told him regarding this.  We feel that the wife is out of danger because she is also active duty and she has been previously immunized against smallpox. Released w/ Work/Duty Limitations:  Profile: VACCINIA FROM VACCINATION LOCALIZED 999.39 from 25 Oct 2011 to 15 Nov 2011; Comment: May not deploy for three weeks.  Follow up: 1 week(s) with PCM or sooner if there are problems. - Comments: Convalescent leave for 10 days given to isolate patient.  Discussed: Diagnosis, Medication(s)/Treatment(s), Alternatives, Potential Side Effects with Patient who indicated understanding. - Comments: Wife in presence also.
Brief psychotic episode; Patient Drug Start date: 27Aug2021, Dose Number: 1/Dose Number: 2, Date of start of drug: 10Sep2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) via regulatory authority (RA). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Tension headaches" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, prev dose product= COVID 19, prev dose brand= Pfizer covid 19 vaccine, prev dose vaccine location= Left arm), administration date: 27Aug2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 10Sep2021, outcome "unknown", described as "Patient Drug Start date: 27Aug2021, Dose Number: 1/Dose Number: 2, Date of start of drug: 10Sep2021"; PSYCHOTIC DISORDER (non-serious) with onset 14Sep2021, outcome "recovered" (2021), described as "Brief psychotic episode". The event "brief psychotic episode" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of psychotic disorder.  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Reason why batch/lot is Unknown: Misplaced/discarded. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Multivitamin with C and Zinc. Reported Event: Brief psychotic episode - no prior history of psychosis or related mental disorders. Did the adverse event result in any of the following: Doctor or other healthcare professional office/clinic visit. Did the adverse event result in any of the following: Emergency room/department or urgent care. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Device Date: 23Oct2021. If treatment ae: No. Known allergies: No known allergies. Other medical history: tension headaches, anxiety, high cholesterol, overweight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report based on the information received by Pfizer from AbbVie Pharmacovigilance (Manufacturer Control No: 21K-163-4077839-00) from a contactable male consumer reported for himself.  A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 25Mar2021, at the age of 66-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for psoriatic arthritis. The patient had received the first dose of bnt162b2 on 02Mar2021 at the age of 66-year-old. The patient medical history and the patient's concomitant medications were not reported. On 09Sep2021, the patient had a SARS-CoV-2 test positive. The outcome of the event was recovering.   The reporter's causality for the event of COVID with HUMIRA (ADALIMUMAB) was a reasonable possibility.  The reporter's assessment of the causal relationship of the event with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medication information was reported.   This case was linked to MOD-2021-392458 (Patient Link).
PATIENT REPORTED THAT SHE DEVELOPED AN ITCHY WARM RED INJECTION SITE RASH AFTER RECEIVING HER VACCINE.  SHE WAS TREATING IT WITH ICE AND HYDROCORTISONE CREAM. SHE WAS INSTRUCTED TO FOLLOW UP WITH AN MD IF IT DID NOT RESOLVE OR GOT LARGER.
SAFENA VEIN DAMAGED; CONSTANT PAIN; VERY LITTLE SLEEP FOR FEW DAYS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient was healthy and had no previous conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-JUL-2021 immediately after vaccination, the patient felt pain in the left leg and her veins began to feel inflamed, the inflammation began to show in the foot and developed upwards. On an unspecified date in JUL-2021, the patient experienced constant pain and very little sleep for few days until then the patient visited the physician's office and was told that the patient had her safena vein damaged for which she had to undergo unspecified treatment and potentially surgery. The patient reported that her leg was just fine prior to the vaccine and that the treatment would last for 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very little sleep for few days, safena vein damaged and constant pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210722944-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  venous injury-This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On 12/21/04, that PM a 3x5" welt had began. 12/22/04, the size of the welt had increased to 6x10", down over the elbow. The welt was a scarlet color, swollen, hot to touch and very sore to the touch also. 12/27/04, the swelling and redness decreased, there was positive pruritis.
No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
pt returned to clinic approx 10min p/vax;pt has approx 2 1/2 x 2 1/2 x 1 1/2 swollen area on rt arm @ inj site;approx 1/8" area of blue bruising noted @ inj site;
On June 19th I felt swelling on the left side of the face, then within few hours left side of the face become paralyzed, at the Emergency Room was diagnosed with Bell's Palsy.
pt recv vax 4APR96&broke out in red raised rash both legs on 6APR96&had 5-6 patches of circular dry scaly area on legs;seen on 8APR96 areas were still present;
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease", start date: 2011 (ongoing), notes: Other medical history:Crohn's disease since 2011. Concomitant medication(s) included: VALTREX, start date: 01Oct2020; AZATHIOPRINE, start date: 04Jun2012; ALBUTEROL [SALBUTAMOL SULFATE], start date: 04May2022, stop date: 21May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive; (16May2022) Positive; (18May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took other medication in 2 weeks. Patient finished the full round of Paxlovid from 10May2022 to 14May2022 and despite feeling improvement in symptoms, they had not all go away despite treatment. Fatigue, cough and nasal congestion remained. However, by Wednesday, 18May2022 at-home test was negative. (It had been faintly positive on 15May2022 and 16May2022.) Because nasal congestion worsened and chills returned today, patient took another at home test on 21May2022 3:00pm, which was strongly positive. The line appearing almost immediately. Patient took a second test to confirm and got an identical results. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt Deceased prior to dose 2. Reported by home health agency as unrelated to vaccination.
pt recvd vax & felt well during the day but layed down in the afternoon & found had wet the bed; that evening pt was found by mom in bed sweaty, incoherent, & unable to be aroused; pt states reflexes still feel hyper;
a 18 years old patient received an adult dose of RECOMBIVAX; This spontaneous report was received from another health professional and referred to an 18-year-old. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 ml, with a reported and validated: lot #U019139, and expiration date of 11-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided). However, the 18 years old patient received an adult dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (Drug use in unapproved age group).
no redness or swelling @ site of inj but arm hurt 7 or 8" on 0-10 scale for 2 days; 5 days p/vax pt had pain in arm pit;3NOV97 cramps & diarrhea;4NOV97 felt weak, faint, malaise, aching in legs & poss fever;unable to get around;