chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; VERY BITTER/ASHY TASTE IN MOUTH; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: exercise induced asthma, and The patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) 1 total, dose was not reported, administered on left arm on 11-APR-2021 for prophylactic vaccination.  On 24-OCT-2021, the patient received non-company suspect vaccine included: Moderna/ spikevax (elasomeran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 091D21A expiry: unknown) dose was not reported, administered at left arm for prophylactic vaccination.  Concomitant medications included cetirizine hydrochloride, vitamin d supplement, magnesium supplement, famotidine, salbutamol, and vitamin b complex.  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2) and suspected clinical vaccination failure (dose number in series 1). The patient was prescribed with non-company suspect drug Paxlovid (form of admin and route of admin were not reported, batch number: GA3581, expiry: Unknown) dose was not reported administered first dose on 21-MAY-2022 and last dose on 25-MAY-2022 for treatment of covid 19. On 21-MAY-2022, 12 hours after the first dose of paxlovid, the patient experienced very bitter/ashy taste in mouth (dose number in series 2). On 29-MAY-2022, on day 9 after taking the full course of paxlovid, the patient tested negative for covid. On 30-MAY-2022, on day 10 after taking the full course of paxlovid, the patient had recurrence of symptoms (rebound covid) and tested positive on rapid test (dose number in series 2). On 09-JUN-2022, on day 20 after taking the full course of paxlovid, the patient finally tested negative on rapid test (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from suspected covid-19 infection on 09-JUN-2022, and very bitter/ashy taste in mouth on 27-MAY-2022, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000237574.; Sender's Comments: V0:20220649475-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
5 hour after vaccine , suddenly couldn?t breath. Oxygen dropped to 84. Difficult breathing for an hour. Chills, body shakes, sweats, nausea . These all lasted 5 days besides breathing . On day 6, breathing got worse . Became short of breath. On day. 11, chest pain, random bruising , continued severe short of breath , head aches. Currently day 16, still short of breath , chest pain, headaches, fatigued
Patient developed nonpruritic maculopapular rash over torso, upper extremities (inclusive of palmar surface of hands) and neck 48 hours after vaccine admin. No symptoms such as cp, sob, fever, abdo pain, vomiting, diarrhea, etc.
lost his only very athletic son due to 2 doses of your vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "lost his only very athletic son due to 2 doses of your vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: a reporter's dear friend lost his only very athletic son due to 2 doses of Pfizer vaccine for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: lost his only very athletic son due to 2 doses of your vaccine
Fever, chills, sweating profusely, achiness all over my body, shaking, severe headache, diarrhea.
1. Rash Around Neck - itching lasts and still recurs. 2. Bruise-looking marks on both arms - no pain - recurs even after the booster shot. 3. Large left toe swelling turning black and blue and nail coming off - has returned to almost normal - only slight pain. 4. Appearance of pain and rash (diagnosed as shingles two months after booster shot. First two symptoms still recur. Pain under ribs on left side caused an appearance in ER at Hospital on Dec 23, 2021
Shingles, both had the SHOT two to 3 weeks prior; This case was reported by a consumer via and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were reported as follows: Age at vaccination was not reported. The reporter knew a  patient with Shingles, who had the shingles shot two to 3 weeks prior from the date of reporting. No contact details were reported. The case had been linked with US2021AMR178300.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178300:Same reporter.
her husband got hospitalized yesterday due to his pancreatitis; his heart rate is getting lower; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. A male patient (consumer's husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient was scheduled for his second dose of the vaccine today. Unfortunately, the patient got hospitalized yesterday (15Mar2021) due to his pancreatitis and his heart rate was getting lower. The outcome was unknown.   Information about lot/batch number has been requested.
Patient received primary series of Sinopharm 5/11/21, 2nd dose Sinopharm on 6/6/21. Patient also received a booster dose of Sinopharm on 11/24/21. Therefore, the patient should not have received a second booster dose.
1 hr after vaccines given, pt's right thigh had red rash, generalized pallor, lethargy. PEDVAXHIB and PREVNAR 13 given in right thigh.
A report was received from a healthcare professional on 23/Oct/2006 concerning a 37 year old female vaccinee. No details were provided regarding the vaccinee's medical history or concomitant medications. On 13/Oct/2006 the vaccinee received Fluvirin 0.5ml. Two days later the vaccinee experienced severe muscle aches and joint pain which was ongoing at the time of reporting. Further information will be requested. Addendum: We received additional information on 05 SEP 2007: A 37-year old woman, born on 18 FEB 1969, was vaccinated with 1.0 ml Fluvirin, batch-no. 69427, i.m. on 13 OCT 2006. Multiple paresthesia and pain in arms less than legs, blurred vision and trouble walking were reported on 13 OCT 2006. The patient has not yet recovered at the time of report (05 MAR 2007).
3 days after shingrix vaccine developed tingling & mild discomfort on left back/chest 10 days after shingrix Developed Rash & was evaluated in office 11/16/2021 with classic shingles rash in dermatome on left back/chest
Positive for Covid-19; Positive for Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4443121-00 (Agency). A 16-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history included: "Nontobacco user" (unspecified if ongoing), notes: Nontobacco user; "Abstains from alcohol" (unspecified if ongoing), notes: Abstains from alcohol. The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 13Jun2022, outcome "recovered" (17Jun2022) and all described as "Positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: Positive for Covid-19. Therapeutic measures were taken as a result of covid-19. The patient was treated with Tylenol and Mucinex.   The reporter's assessment of the causal relationship of "positive for covid-19" with the suspect product(s) 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 reporter considered "positive for covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Patient got second dose of the vaccine on 2/4/2021.  He was diagnosed with COVID 19 on 5/15/2021 (he was negative on 3/19/2021).  He was hypoxic, developed changed in mental status.  Died on  5/16/2021
Patient had received Fluzone QIV NP vaccines that expired on 30-Jun-2021 with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional consumer non-healthcare professional via Agency number: 00814542  This case is linked to cases 2021SA344343, 2021SA344107 and 2021SA345249(CLUSTER).  This case involves a 14 years old female patient who was administered an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number: UT7108MA and expiry number: 30-JUN-2021 via intramuscular route in unknown administration site prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Very sore arm around injection site Backache Fatigue Nausea Chills Began 24 hours after immunization
This spontaneous case, initially received from pharmacist on 01-Mar-2018, concerning a 3-year-old, male child. The patient had no medical history and concomitant medications. On 01-Mar-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XF35309 and expiry date: 30-Jun-2018) (explicitly coded as inappropriate age at vaccine administration). It was reported that, the patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. Non-significant case correction received 01-Mar-2018: Grammatical mistake in case comment was corrected. Non-significant follow up received on 10-Apr-2018: The reporter confirmed that, the patient did not experience any adverse reactions.
Suspected vaccination failure; Mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of 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 shingles (severe shingles episode prior to taking the Shingrix shots).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), rheumatoid arthritis (serious criteria GSK medically significant) and shingles. The patient was treated with methotrexate. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the rheumatoid arthritis and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, rheumatoid arthritis and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported but it could be 76 or 77 years old. wanted to ask if it was okay to get the Moderna or Pfizer Covid-19 vaccine if she was taking Methotrexate for rheumatoid arthritis Prior to taking the Shingrix shots, the patient had shingles episodes which were more severe. The patient had received Shingrix shots two or three years ago and did fine. The patient mentioned that the shingles she had presently was only a light case and milder one. The reporter wanted to get off the phone and did not wanted to answer any further questions, hence she could not be asked for MD contact information.
Late Entry 04/13/18 1400 Patient received Walk In immunizations at the Mobile clinic. 15 minutes after receiving KINRIX, MMR and VAR, patient started with itching on the legs, arms, anterior and posterior trunk of the body. Noted red flat smooth patches to the legs, abdomen and arms. Lungs clear to auscultate x 4 lobes. No resp. distress noted. Unable to look at the throat due to fighting however able to swallow without difficulty. BENADRYL 12mg/5ml, 8ml orally given and tolerated well. Observed for 15 more minutes. Explained ER precautions to mother. Go to ER with SOB, difficulty swallowing, rash getting worse. Mother verbalize good understanding. Patient discharged home with red patches going away denies itching.
brain fog, dizziness, strange sensation in sinuses difficulty in concentrating, difficulty focusing eyes when reading, eye events such as "flaters" flashing at outer sdges of eyes, exhaustion and needing more sleep than usual
Vaccine had expired prior to being administered.  No adverse reaction noted.  Physician order new vaccine to be administered.
Narrative:  70yo male patient fell 10-15 feet from his deer stand and was taken to non-agency trauma hospital. Pt coded in route to hospital arrived with traumatic pneumothorax. on 10/24/21. Pt died later on same day at same hospital. Death due to injuries from fall. Pt had received covid vaccines on 2/15/21 & 3/14/21. This death is not related to covid vaccines.
This spontaneous case reported by a consumer, describes the occurrence of pain (body aches), headaches, arthralgia (joint pain), pyrexia (fever) and chills in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030M20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Feb 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain (body aches), headaches, arthralgia (joint pain), pyrexia (fever), chills, myalgia (muscle aches) and fatigue. At the time of the report, pain (body aches), headaches, arthralgia (joint pain), pyrexia (fever), chills, myalgia (muscle aches) and fatigue outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
patient received pfizer as second dose . patient had received moderna as 1st dose - no true adverse events - vaccine error
pt recvd vax & 2 hrs later stomach bloated, pt exp nausea, diarrhea, & was hot & sweaty & devel itching w/o rash; these events were felt to be unrelated to the vax;
Patient is a breastfed baby and had always had a bowel movement every time he nursed. The day of his first round of vaccinations he stopped having regular bowel movements. For about 4 months after the vaccinations he would have one bowel movement every 5 to 7 days.  Now he has a movement every 2 days.
his arm was sore for about two days after the second dose if he applied pressure to it; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (his arm was sore for about two days after the second dose if he applied pressure to it) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-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 MYALGIA (his arm was sore for about two days after the second dose if he applied pressure to it). At the time of the report, MYALGIA (his arm was sore for about two days after the second dose if he applied pressure to it) outcome was unknown.            Concomitant drugs includes cholesterol medication No treatment information was provided.   This case was linked to MOD-2021-265302 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date, the patient was inoculated with ZOSTAVAX at a clinic for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date, the patient was treated at the same clinic for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
No symptoms being reported.; Healthcare worker reporting vaccine was administered to patient after it had expired. VAQTA pediatric dose.; This spontaneous report was received from a RadiologicTechnologist referring  to a 15 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 06-APR-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) pediatric  (strength, route, dose, frequency, and anatomical location were unknown) with lot # S002507 and expiration date on 04-APR-2020 for prophylaxis. The patient was doing fine and no symptoms were being reported.
Patient stated experienced shakes from head to feet for 40 minutes, it felt like a seizure, then it was gone.
At 48 hours erythema and induration reaction at site of immunization on LLE resolved at 72 hours.
pt recvd vax & 10 days later exp rash on chest; was seen by MD 15DEC93 w/itchy, erythematous rash; pt exp dramatic perioral dermatitis which progressed to complete facial dermatitis; devel muscle weakness; rash consistent w/dermatomyositis
Tenderness at injection sight followed by redness, feverish skin, pain and finally pancake-sized welts on the underside of arm (L); symptoms increased until 4th day when doctor was contacted; medication was given. Above symptoms lasted abt. one week.
Developed very high fever after receiving vaccine. She also states developed fever again a few days later after eating eggs. No temp taken by patient. Reported on 9/20/10 to PA.
Normal reactions  sore arm -fatigue  lasted 3 days     3 weeks later he was getting some brain fog   and little confusion 2nd shot  fatigue- sore arm which lasted a week     more brain fog  more confusion  couldn't get his words out.  could not work his phone or computer    Went to doctorMay 24th
Patient received a Tetanus, diptheria, and acellular pertussis vaccine 10 days after receiving her 1st dose of COVID-19 vaccine instead of 14 days.  Patients suffered a bite wound from an animal and had to have stitches.  Provider ordered the Tdap vaccine as a preventative measure.
Allergic reaction; A spontaneous report was received from a nurse practitioner concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an allergic reaction.  The patient's medical history was not reported.  Concomitant medication use was not provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced an allergic reaction to the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, allergic reaction, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious unlisted event of allergic reaction.  Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the onset of the event following vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
A report has been received from a health professional concerning a 33 years old, male patient. The patient's relevant medical history or concomitant medications were not reported. On an unknown date the patient started receiving FLUMIST. On 16-Oct-2012 the nurse inadvertently administered entire dose of FLUMIST in one nostril. No symptoms were observed. The patient recovered from the event of gave whole FLUMIST dose in one nostril on an unspecified date. The report was considered to be non-serious by the company physician. Corrected report 11-Apr-2014: The case has been updated with full data due to term additions for FLUMIST / Q/Laiv.