chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive for covid; Positive for covid; cough; sore throat; dizziness; diarrhea; Booster; Off Label; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4244366-00 (AbbVie).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150528). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 01Aug2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 01Aug2021, outcome "unknown", described as "Off Label"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Positive for covid"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "sore throat"; DIZZINESS (non-serious) with onset 2022, outcome "unknown", described as "dizziness"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive. The action taken for upadacitinib was unknown. It was mentioned that the patient had fever for three days, cough, sore throat, dizziness and diarrhea.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality reported for suspect Rinvoq was not reported for COVID-19  and dizziness. Causality reported for Pfizer Biontech Covid-19 Vaccine was possible for COVID-19  and dizziness.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rota given after indicated time frame of 32 weeks. Patient is 34 weeks of age. Patient took rota well with no reaction. Patient observed in office. 15 min. after rota.
Warm Red rash started 6 days post injection.  rash was itchy and itch was relieved with benadryl.   Bilateral warm red rashes over deltoid muscle.
fever 105.2;irritability;HEENT: exudative tonsillitis;rest of exam unremarkable;neuro exam negative p/fever went down no more irritability;
COUGH, CHILLS, LOW GRADE FEVER (99.8), BODY DISCOMFORT, MUSCLE ACHES, SORE THROAT, STUFFY NOSE, HEADACHE. LASTING 18 HOURS, TREATED AT HOME WITH TYENOL, 500MG. SOME SYMPTOMS ON GOING. GETTING BETTER?
No adverse effects were reported in the patient; Patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.       On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) ( GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).         On 25-OCT-2019, it was detected the temperature excursion was lowest temperature below 36 degrees Fahrenheit (F)/ 2 degrees Celsius (35 Fahrenheit) for a time frame of 430 minutes, and no had the previous temperature excursion (product storage error).  It was reported that not call was due to data logger. No adverse effect were reported in the patient.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA000826: US-009507513-1911USA000833:
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 04-APR-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) (lot # R022117 and expiry date 02-AUG-2020) for prophylaxis (product storage error). Other suspect therapy included sterile diluent (strength, dose and route of administration, lot# and expiry date were not reported). There was no adverse effect reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.
Cellulitis, swelling, treated with KEFLEX and BACTRIM (went to ER).
2 apnea episodes @ home post vax;(pt on apnea monitor);pt went limp w/dec respirations & apnea alarm went off;No SOB, feeding problems, fever, vomiting or diarrhea;
Slight palpitations and a little dizziness and tiredness.; Little dizziness; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 20Mar2021 at 13:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure and high cholesterol. Concomitant medications were not reported. The patient was allergic to Gluten. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. The patient had received medications within 2 weeks of vaccination, the details of which were not given. The patient experienced slight palpitations and a little dizziness and tiredness on 20Mar2021 at 02:45. The patient did not receive any treatment for palpitations, dizziness and tiredness. The clinical outcome of the events slight palpitations, little dizziness and tiredness were not recovered.   Information about lot number cannot be obtained. No further information expected.
localized swelling, redness, hot to touch, and slight itch starting within 24 hours of injection. Increased in severity over the following 72 hours. Patient took Advil with no relief.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were unknown. On an unknown date, the patient started therapy with GARDASIL 9 (lot# reported 36301, expiration date December 2017; dose, frequency and route were unknown). On an unknown date, the patient was given a dose of GARDASIL 9 that underwent a temperature excursion. The vaccine had been exposed to a temperature of 32.1 Fahrenheit degree for 7 hours. The patient did not experience any adverse event. It is unknown if any relevant tests were done. At the time of the report, it was unknown if the therapy was continued. This is one of the several reports received from the same reporter. Additional information is not expected as the physician did not have time to provide further information.
all over rash; mild, active Shingles infection, prior to receiving first dose of Shingrix; This case was reported by a consumer and described the occurrence of generalized rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (reported previously having mild, active Shingles infection).   On 14th July 2020, the patient received the 1st dose of Shingrix. On 14th July 2020, unknown after receiving Shingrix, the patient experienced off label use. On 15th July 2020, the patient experienced generalized rash. Shingrix was interrupted. On an unknown date, the outcome of the generalized rash and off label use were unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient had mild Shingles infection which was active prior to receiving first dose of Shingrix. It was reported that the day after the vaccination patient had all over rash. Patient received the dose of shingrix at the time of active shingles, led to off label use. HCP recommended not getting the second dose of Shingrix. The reporter consented to follow up.
Facial itching post vaccine. ER physician notified. 25 mg Benadryl and 40 mg Pepcid given by mouth. Dr. attended patient. Patient moved to extended observation in ER after complaints of "Lump in throat". At 1525,  no more complaints of throat issues or any SOB. Patient VS stable and discharged to home.
fatigue; minimal chest discomfort; minimal  breathing issue; sore throat; complains of no energy/fatigue/low energy; Very sleepy; Aches all over; 2 patients tested positive for covid (corona virus) yesterday on rapid test; 2 patients tested positive for covid (corona virus) yesterday on rapid test; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She had a breast augmentation done" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Apr2022, outcome "unknown" and all described as "2 patients tested positive for covid (corona virus) yesterday on rapid test"; FATIGUE (non-serious), outcome "unknown"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "minimal chest discomfort"; DYSPNOEA (non-serious), outcome "unknown", described as "minimal  breathing issue"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; ASTHENIA (non-serious), outcome "unknown", described as "complains of no energy/fatigue/low energy"; SOMNOLENCE (non-serious), outcome "unknown", described as "Very sleepy"; PAIN (non-serious), outcome "unknown", described as "Aches all over". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) Positive. Therapeutic measures were not taken as a result of covid-19, fatigue, chest discomfort, dyspnoea, oropharyngeal pain, asthenia, somnolence, pain.  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 information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19,Vaccination failure.
The upper left arm where the COVID vaccine was administered was very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 11:45 as dose 1, single, (Lot number: HF9275) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Sep2023 at 19:00, outcome "recovered", described as "The upper left arm where the COVID vaccine was administered was very sore". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: Patient recevied vaccine at PRIVACY Clinic. Pateint took over the counter pain killer (Ibuprofen).
Fever of 100 degrees F on day of vaccination, cough, lethargy. Next day, cough and fever up to 102 degrees F. Trip to doctor and treated symptomatically.
Bitter, metal, tinny taste in mouth within one hour or less of vaccination. I am not sure of exact time because we ate directly after the fifteen minute waiting period. I didn't notice the sensation until right after we ate. It lasted about three days and then was gone. It was strong enough for me to notice immediately and think how weird, and it was strong enough for me to notice it off and on the next three days-gradually lessening. I have also had a sore throat the whole week since the vaccination-it started the day after. It hasn't turned into a cold-maybe a little drippy nose occasionally so not sure if sinuses etc, but the sore throat is persistent. Occasionally I feel it up higher in the nasal-pharynx also.  I didn't report to my doctor or treat in any way. And for statistics, my arm was sore for about two days. The worst was that evening and pretty mild after that.
Patient today reported right arm pain and loss of mobility from shortly after vaccination to present. No treatment sought or provided at this time.
Immediate soreness in left arm.  That evening, I felt flue like symptoms  of severe ache of upper shoulders and back . Of more concern, when I lay down for bed, I felt a heavy weight in my upper chest, making breathing painful.  Use of my CPAP machine allowed me to get some sleep.  these symptoms continues for 4 days, after which they subsided.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm, fever, malaise and pain. On an unknown date, the outcome of the pain in arm, fever, malaise and pain were unknown. It was unknown if the reporter considered the pain in arm, fever, malaise and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated his wife's arm was a little more sore than his after SHINGRIX, and she was achy, feverish, and had malaise the day after, but nothing exceptional. Declined to complete full safety report. No further information provided. This case has been linked with US2019056560, reported by the same reporter.
This is a spontaneous report based on the information received by Pfizer from Merck (Case Number: 00668915) from a contactable consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13 on an unknown date in 2015 at single dose for immunisation. The patient medical history and concomitant medications were not reported.   The patient experienced swelling and injection site pain on an unspecified date after receiving the vaccine injection with outcome of unknown. No further AE information to report. This information has not been reported to the FDA. No follow-up attempts are possible. No further information is expected.
Per pt's mother pt began to show rash on arms the day after vaccines were given to pt. Rash looks bumpy with red spots from wrist up to past the elbow, doesn't seem to be bothering him and is not warm to the touch.
Patient reported having red bumps around both arms. She applied hydrocortisone to rash. She described the rash as non-itching. I advised the patient to see physician if rash doesn't resolve within couple days and take BENADRYL. If she has trouble breathing or swallowing of lip, throat or tongue, she needs to go to ER.
7 hrs after vaccine - felt sick - rash 4 inches x 4 in. developed on site - low grade fever - 2 days.
Rash on back of both hands and fingers; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of both hands and fingers) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21N) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-May-2006. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 01-May-2006 to an unknown date for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (Rash on back of both hands and fingers). On 17-Apr-2021, RASH (Rash on back of both hands and fingers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used an old moisturizer evening of the day when patient received the first shot of moderna vaccine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient demographics , medical history and concomitant medications were updated. De-challenge andre-challenge  and stop date of the event  were updated. Outcome of the event was changed from unknown to recovered.
Patient was admitted for pancreatitis with history of cholecystectomy, no alcohol consumption, and unclear etiology. There is a concern of unknown effects of COVID vaccines. Patient received COVID Johnson and Johnson vaccine on 3/5 before developing nausea, vomiting, and diarrhea before being admitted for pancreatitis.
double pneumonia in the both lungs, they were fully vaccinated and still got a  Delta variant; double pneumonia in the both lungs, they were fully vaccinated and still got a  Delta variant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "double pneumonia in the both lungs, they were fully vaccinated and still got a  Delta variant". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: like for 2 weeks). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101587753 same reporter/drug/event, different patient
Received shot on Sept 14 at 1:30PM in left arm. A few hours later arm was sore. The next morning, entire arm & hand felt like it fell asleep. The armpit is swollen. the second morning arm & hand has a tingleing sensation and still swallon. Went to my primary physican. She prescribed, ice on arm pit and antihistamine.
This spontaneous report refers to a female patient of unknown age. Medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL (dose and lot number not provided). Concomitant medication was not provided. On an unknown date the patient was diagnosed with myoglobinopathy, shortly after having received the third dose of GARDASIL. After first calling the physician, patient went to a hospital where the diagnosis was made. It was unspecified whether or not the patient was hospitalized. The outcome of myoglobinopathy is unknown. The reporter did not suspect GARDASIL as causative, he believed that the patient's "intense exercise" the day after receiving the third GARDASIL dose might have contributed to the myoglobinopathy. Additional information has been requested.
covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid) in a  patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided Company comment This spontaneous case concerns a patient of unknown gender and age with no medical history, who experienced the unexpected non serious AESI event of COVID19, after receiving a dose of mRNA-1273 Vaccine. Current pandemic situation of COVID 19 can be risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age with no medical history, who experienced the unexpected non serious AESI event of COVID19, after receiving a dose of mRNA-1273 Vaccine. Current pandemic situation of COVID 19 can be risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient got a rash on abdomen which appeared 4 days after receiving the ZOSTAVAX immunization and was resolved after 7 days. Patient describes rash as rash with blisters and not painful.
Info has been received from a physician concerning a 5 year old white male, with no known drug allergies, who was exposed to his grandfather with shingles, who on 11/7/00, was vaccinated with a 1st dose in the left arm of varicella virus vaccine live, (lot 636571/0928K). Concomitant vaccine administered on the same day included a 3rd dose in the left thigh of Hep-B vaccine, recombinant (lot 637175/1266K). "Last week", on 1/27/05, the pt developed a mild case. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. The pt's brother had a similar reaction following vaccination with varicella virus vaccine live. Additional info has been requested.
July 30th around 4 a.m. I woke up with headache.  By 11:30 a.m. I was feeling  sick to my stomach and achy.  At 12:30 I left work to go home. I then had chills, headache, and upset stomach.  I took my temperature at 4:30 and had fever of 100 (I am normally 97).  I woke up on July 31st feeling much better- just slight headache and aching right arm.  I took Tylenol during all of this.
30 hrs p/receiving vax pt devel flu-like sx, pain, redness & edema of entire lt upper arm;
Approximately 10 days after my infant daughter was immunized with the chicken pox vaccine, I, her mother, developed the chicken pox.