chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ulcer developed at injection site; ulcer developed at injection site which is painful to the touch; Blisters; fatigue; muscle pain; headache; This case was reported by a other health professional via call center representative and described the occurrence of injection site ulcer in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache. The patient was treated with valaciclovir (Valacyclovir) and dermatologicals nos (Ointment). On an unknown date, the outcome of the injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache were unknown.   It was unknown if the reporter considered the injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows:  The patient had blisters after shingrix shot. The patient experienced ulcer developed at injection site which was painful to the touch, fatigue, headache and muscle pain. The patient received treatment Valcyclovir and (unknown) ointment. When asked for batch number, expiration date, number of dose and date of vaccination the health care professional stated she was not aware of this details. The reporter consented to follow up.
syncopal event, no loss of consciousness. Fainted from standing position after vaccination. Moved from prone position to wheelchair then to stretcher with EMT care. Neurologically intact. A&Ox3. No signs of head trauma. Evaluated by EMT, stable condition. He declined further care and treatment options. Escorted by EMS with his wife. Left via private vehicle with his wife.
Pt vaccinated with Pneumovax/Influenza experienced an asthma attack which required a visit to a hospital ER & therapy with steroids.
Patient had flu shot and pneumococcal simultaneously. Pt's arm in which he had pneumococcal vaccine became red and painful by evening. By next morning arm (upper) was painful and swollen and pt was nauseous and had fever of 102 degrees. Saw doctor on 3rd day when arm wasn't better. Doctor prescribed antibiotic and reaction resolved. Pt advised to avoid further shots.
Shots 445?pm by 11pm fever of 102.5. Next day very fussy, clingy, throwing up/spit up, tired & diarrhea. Low grade fever the following day, fussy & little appetite, throw up/spit up for six days.
Fever, 101F. Headache, joints hurt, super tired. Left arm pain.
STRONG ACHES AND PAINS; SWEATS; CHILLS; FEVER 99.8; TIRED; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis, alcohol use, non smoker, penicillin allergy (PCN), and wheat products allergy, llosone allergy, drug allergy (codeine), influenza vaccine allergy and diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid vaccine allerggy. and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, dose number in series 1, 1 total, administered on 18-JUL-2021 to left arm for prophylactic vaccination. Subject was recovered from event. On 18-JUL-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced aches and pains (mild) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, dose number in series 2, 1 total, administered on 02-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-DEC-2021, the patient experienced strong aches and pains, sweats, chills, fever 99.8, and tired. These symptoms lasted for 24 hours (dose number in series 2). On 02-DEC-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong aches and pains, sweats, chills, fever 99.8, and tired on 03-DEC-2021. This report was non-serious. This case, involving the same patient is linked to 20211258204. This case, from the same reporter is linked to 20211258945 and 20211258986.
One episode of rash 5 days after vaccine and 2nd episode of rash at 11 days after vaccine administration.
Stomach problems, loss of appetite, upset stomach progressed to pain in stomach, ankle stiffer, nausea, diarrhea, allergies more prominent.  3/20 visited doctor for stomach problems, given Sucralsate and another over the counter medicine.  Today took medicine.
Initial report received from a reporter on 19-November-2013. An eight patients, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID via intradermal route (lot number and site of vaccination not reported) on 2013. On 2013, patients experienced swelling at the injection site, the size of a softball and widespread rash over their body. Corrective treatment was not reported. At the time of this report the outcome of events was unknown. Documents held by sender: none.
Sharp pain very specific to the left side of head, and in the left eye towards the back, and neck. The pain is sharp at times, and at times very painful, and dull rest of the time.  Pain at the site of the injection on left arm which diminished and is now only painful on raising my arm where my left shoulder and neck seem sore.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding a 4 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2016 the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Grand mal seizure lasting 45 minutes.  Went back to Dr. and she confirmed it was a seizure and said if it happens again to go to ER.
This is a spontaneous report from a Pfizer sponsored program, by a contactable consumer. A 49-year-old female patient of an unspecified race/ethnicity received the first dose of PREVNAR 13, via an unspecified route of administration at single dose on 01Jan2017 for immunisation. Medical history included pneumonia pneumococcal in 2016. Concomitant medications were not reported. The patient experienced upper respiratory infections/diagnosed with URI about every 6-8 weeks since February (2017), being tired all the time, getting winded easily/breathing so hard, depression on an unspecified date. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
15:20 Received flu shot. Approximately 19:45 PM started itching all over and sneezing; right eye started swelling; both eyes were itchy and watering; throat started itching and feeling tight. The only thing she did different that day was take the flu shot. Took BENADRYL and MOTRIN and went to bed. Woke up this AM itching and sneezing gone; (R) eye still little swollen. Had itchy throat all day today.
minimal reaction after second dose; tiredness after the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (minimal reaction after second dose) and FATIGUE (tiredness after the second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-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 (minimal reaction after second dose) and FATIGUE (tiredness after the second dose). At the time of the report, VACCINATION COMPLICATION (minimal reaction after second dose) and FATIGUE (tiredness after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
601 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (601 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine was placed in refrigerator on 22 Sep 2021 There was no temperature excursion. No adverse event was reported.
POTTS; SMALL FIBER NEUROPATHY; DYSAUTONOMIA; LOSING FUNCTION IN LEGS; VOMITING; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included heart palpitations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after vaccination the patient experienced vomiting for 6 hours. On an unspecified date in 2021, the patient said that he started to develop neurological issues including small fiber neuropathy, dysautonomia, potts, and began losing functions in legs. The patient also said that by MAY-2021 he was out of work and he had been visiting several specialists to manage his adverse events including a neurologist and cardiologist. The patient had upcoming appointment with his neurologist. The patient stated that he was experiencing a slow recovery. On 31-AUG-2021, Laboratory data included: Biopsy (NR: not provided) result not provided, and Electromyogram(EMG) (NR: not provided) result not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on APR-2021, and was recovering from small fiber neuropathy, potts, dysautonomia, and losing function in legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210903444- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pott's. This event is considered unassessable. The event 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.
At 10:26 pt rolled off the chair and fell face first on to the carpet. pt had a clonic seizure. His body was rigid with hyperextending extremities. I placed the pt in a side recoery position. 4 liters of oxygen via nasal canula was given. Staff member called EMS. Duration of seizure 1 minute. pt sat up after seizure and had no memory of seizure. As I was asking pt questions at 10:35 he had a 2nd seizure that lasted 5 secounds. I caught him and laid him gently on his side. pt appeared pale and skin was cool and clamy. EMT arrived at 10:36. His o2 was 99%, HR 39-42, BP 113/71. pt refused to go to the hospital. EMT waited with pt till a family member arrived to drive pt home. pt denies any headache, nausea, dizziness.
weak; diarrhea; tired; vomited; chills; low grade fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (low grade fever of 101) and VOMITING (vomited) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (low grade fever of 101). On 08-Apr-2021, the patient experienced VOMITING (vomited). On 09-Apr-2021, the patient experienced ASTHENIA (weak), DIARRHOEA (diarrhea) and FATIGUE (tired). On 12-Apr-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, ASTHENIA (weak), CHILLS (chills), PYREXIA (low grade fever of 101), VOMITING (vomited) and FATIGUE (tired) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information included water and gingerale for 2 days.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant followup. contact information updated.
kindeys started to fail; blood pressure 60/24; red spots around the injection site; nausea; vomiting; diarrhea; cellulitis at the injection site; A spontaneous report was received from a nurse who was also a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24.   Medical history included type 2 diabetes mellitus, lung disease, and high blood pressure.  Concomitant medication included unspecified cholesterol medicines, unspecified heart medicines, levopridsone, and unspecified type 2 diabetes mellitus medicines.    On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 057G20A) intramuscularly n the left deltoid for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced cellulitis at the injection site.    On 02 Feb 2021, the patient experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 (no units or reference range provided).  The patient was hospitalized from 04 Feb 2021 to 07 Feb 2021.    Treatment for the events included hydration, unspecified antibiotics, and levid for blood pressure.  Action taken with the mRNA-1273 was not reported.  The outcome of the events of cellulitis at the injection site, red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 was unknown.; Reporter'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.
Pt recvd 1st dose of Engerix-B "recently" & four days p/inject exp intense itchy rash & urticaria; MD visit was required; tx DPH;
Breakthrough COVID-19 case, hospitalization 9/4/2021-9/5/2021; death 9/5/2021. COD from vital records: LYMPHOMA, IMMUNE THROMBOCYTOPENIC PURPURA, COVID 19. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed. place of death: HOSPITAL-INPATIENT, MEDICAL CENTER; certified by: CERTIFYING PHYSICIAN; occ/ind: SETTER OPERATOR, INDUSTRIAL MANUFACTURING ."Did the patient die?" marked YES; "Is this a COVID-related death?" marked YES.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 07-JUL-2011 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-SEP-2016, the patient was treated by a physician for the onset of a blistering vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX for management of his painful symptoms. 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. Additional information has been requested.
Patient is a 70 y.o. male patient of MD with history of cerebral palsy, diabetes mellitus, hyperlipidemia, hypertension, legally blind, psoriasis, seizures presented to Doctors Hospital with chief complaint of altered mental status.   Sepsis Suspected gram-negative pneumonia COVID-19 virus infection  Elevated troponin  Acute metabolic encephalopathy Hypernatremia  Cerebral palsy Acute hypoxic respiratory failure  Seizure disorder DM2, non-insulin-dependent Hypertension, uncontrolled  Anxiety BPH Severe malnutrition with cachexia-POA Patient got significantly worse, Code status was changed to DNRCCA. Today he coded and went to asystole Date and Time of Death  Patient's time of death was 10:30 am   Patient's date of death was 3/10/2023
This spontaneous report as received from a physician via a company representative refers to a female patient of about 75 year old information about concurrent medical conditions, concomitant medication and pertinent medical history was not provided. On an unknown date the patient was vaccinated with a standard dose of ZOSTAVAX (lot # and route were not provided). On an unknown date the patient developed mild case of shingles after receipt of ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
This spontaneous report was received from a physician and refers to a 4 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. On 31-JUL-2017, the patient received another dose of improperly stored PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00235 with the expiration date of 26-OCT-2019) for prophylaxis. The administered doses of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.
Tonic seizure within 3-5 min of vaccine administration followed by 1 hr postictal state.
NUMBNESS OF THE EARS AND FACE (LEFT SIDE); This spontaneous report received from a pharmacist concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced numbness of the ears and face (left side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness of the ears and face (left side). This report was non-serious.
Initial report was received on 14 September 2011 from a health care professional which involved a cluster of six patients who experienced adverse events after receiving FLUZONE, lot number UH476AB. This case captures one of the two patients who had additional adverse events. The other patient with additional adverse events and the cluster of six have been captured in case numbers 2011-08637 and 2011-08644. An unidentified patient, had received FLUZONE, lot number UH476AB (route, site and date of administration not reported) and an unspecified amount of time later, experienced redness and swelling at the vaccination site. The patient also experienced redness and induration of the entire upper arm from shoulder area to the elbow. Concomitant medications and past medical history were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Pt received MMR vaccine on 6/20/13. On 7/16, pt. came to office with (L) jaw gland lymph node swelling, tender, mild fever (per parent), and overlying erythema. Pt. able to talk, open mouth. Pt. given PRELONE 15/5 - 5 mL BID x 5d. Told to use ice, MOTRIN, eat soft foods PRN.
Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death.     The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath.  Action taken with mRNA-1273 in response to the events was not applicable.  On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown.  Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death