chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; hives over ears, face, neck, chest, and arm of injection at two hours; coughing; shortness of breath; This is a spontaneous report from a non-contactable consumer (patient).  A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17May2021 10:00 (Batch/Lot Number: EWO171) (at the age of 44 years old) as dose 1, single for COVID-19 immunisation.  Medical history included asthma, migraines, allergy to latex, possible food allergies and allergy to sulfa. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; and ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took fluoride and experienced drug allergy.  The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17May2021 12:00, the patient experienced rash, hives over ears, face, neck, chest, and arm of injection at two hours, then coughing and shortness of breath not responding to asthma medicine. The adverse event resulted in any Doctor or other healthcare professional office/clinic visit. Treatment was given for the events including stronger asthma inhaler and epi-pen prescription. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient  had not been tested for COVID-19. The reporter assessed the case as non-serious and no hospitalization. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Memory Loss, Dizziness, Balance Off, In a Fog, Visual Disturbances
Dull Headache , vasculitis, upset stomach, diarrhea, and fatigue
Acute Hemorrhagic Leukoencephalitis; Vasogenic edema; This case was reported in a literature article and described the occurrence of acute hemorrhagic leukoencephalitis in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.  On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced acute hemorrhagic leukoencephalitis (serious criteria GSK medically significant) and vasogenic cerebral edema (serious criteria GSK medically significant). The patient was treated with operations and procedures (Plasma Exchange) and corticosteroid nos (Corticosteroids (Drug Name Unknown)). On an unknown date, the outcome of the acute hemorrhagic leukoencephalitis and vasogenic cerebral edema were recovered/resolved.   The reporter considered the acute hemorrhagic leukoencephalitis and vasogenic cerebral edema to be related to Influenza vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of acute hemorrhagic leukoencephalitis in a patient of unspecified age and gender, who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. No information on patient's medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient presented to acute hemorrhagic leukoencephalitis (AHLE) that was promptly diagnosed with magnetic resonance imaging (MRI) brain, which showed significant areas of hemorrhage with vasogenic edema including involvement of the pons. The patient was aggressively treated with plasma exchange and corticosteroids and had a favorable outcome. The authors stated, "Acute Hemorrhagic Leukoencephalitis (AHLE) is a rare but devastating and fatal form of Acute Disseminated Encephalomyelitis. Very rarely, this can be a complication of vaccination. There is currently no consensus on the optimal treatment strategy of AHLE." This article corresponding to this case is not available for regulatory submission due to copyright restriction.
This case was reported by a consumer via out of hour services and described the occurrence of diarrhea in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included rheumatoid arthritis. Concurrent medical conditions included thyroid disorder and acid reflux (esophageal). Concomitant products included HUMIRA, PEPCID and SYNTHROID. On 13th August 2018, the patient received SHINGRIX. On 14th August 2018, 1 days after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was previously reported to the physician. The patient reported the day following the vaccination, he started to experience diarrhea for about a week before on 21st August 2018 it turned into loose, watery stools which continues to present day.
Power outage 11/21/10. Medication should have been pulled from stock. Discovered 12/7/10. Pt vaccinated with FLUMIST 0.2 mL via nares on 12/3/2010.
Tested positive for covid after receiving the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for covid after receiving the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included CALCIUM, VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMINE D) and Multivitamin (Mulltivitamin) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 20-Jan-2021, the patient experienced COVID-19 (Tested positive for covid after receiving the vaccine). At the time of the report, COVID-19 (Tested positive for covid after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided .
RASH DEVELOPED ON BACK OF ARMS THEN SPREAD TO  PARTS OF BACK AND BUTTOCKS. DESCRIBED AS VERY ITCHY.
Patient administered IM in left deltoid. Patient became light headed. Patient laid down for 20 minutes. HR was 41. Patient denies any SOB chest pain. No wheezing noted. HR went up to 62. Patient provided fluids and father picked patient up. Patient encouraged EMS. Patient refused. ER symptoms provided
facial paralysis on the one side of his face; rash; pain in the bottom of the feet; pain in his joints; This spontaneous report was received from a consumer referring to his father who was 58 years old. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as "none".  The patient's historical drug included two shots of Zoster Vaccine Recombinant, Adjuvanted(SHINGRIX) given on unknown dates in October 2018.   On an unknown date in December 2018, the patient was vaccinated with one shot of Zoster Vaccine Live(ZOSTAVAX), one dosage form (strength, expiry date, lot number, frequency, route of administration were unknown) to prevent shingles(prophylaxis).   On an unknown date in December 2018, the patient experienced pain in the bottom of the feet (pain in extremity), and pain in his joints(arthralgia) immediately after receiving the Zoster Vaccine Live(ZOSTAVAX) shot and the pain was random and it comes and goes. About two months ago (May 2019), the patient experienced rash. On an unknown date, the patient experienced facial paralysis on the one side of his face.  On 01-JUL-2019, the patient was seen by a physician (sought medical attention) for the facial paralysis and no treatment was provided. There were no lab diagnostics/studies were performed. No product quality complaint (PQC) was reported.   Outcome of the events pain in extremity, arthralgia and facial paralysis was reported as not recovered. Outcome of the event rash was reported as recovered/resolved. Causality of the events were not reported.   Upon internal review, the event facial paralysis was determined to be medically significant.
MSA called to the lobby and another donor saw donor get up and then he fell and hit his head. Donor in lobby states that this donor had LOC for 30 sec. Twitching was noted in arms and legs. Event occurred at 1718. When MSA arrived donor was alert and orientated to time and place. No laceration or bump was noted on donor's head. During waiting period for immunization donor states he started to feel tingling all over and heard ringing in his ears.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, dose and route not reported). On an unknown date the patient experienced heavy rash that lasted for two weeks. It was unknown if patient sought medical attention. The outcome of heavy rash was reported as recovering/resolving. Additional information is not expected.
patient inadvertently received a moderna COVID 19 booster dose (0.25ml) as a second dose on 3/8/2022 instead of a full Moderna COVID 19 vaccine second dose to complete their primary series. Patient was notified of the administration error and came back to get another Moderna COVID 19 half dose on 3/16/2022 to complete a full dose of Moderna COVID 19 vaccine and be considered fully vaccinated with Moderna primary series.
Received 6 shots on Monday 10-03-2005. Was cranky and clingy all week after but not much of a fever. Then on 10-9 (six days later) she developed a high fever (maybe around 102) with no other symptoms that lasted about 3 days. I recall that she also had this same reaction after her last immunizations and I believe it is a result of the MMR shot. So her total 'down time' was about 10 days of crankiness, wakefullness and fever. We had to keep her out of daycare because she was such a handful and wanted to be held constantly. I always hear of these reactions from other parents but no one ever reports it (as I also failed to last time) so this time I wanted to make sure it was documented so the 'side effect' %'s will be more accurate in the future.
Low grade fever, with cold like symptoms (chills, lethargy, inappetence) within 24 hours of vaccination. 84 hours post vaccination, hives covering back, torso, and chest. 96 hours post hives spread to buttocks and thighs, sore throat and cold symptoms began as well no fever.  At 1st symptom of hives, 25mg Benadryl taken and cold shower & air dry, repeated every 6-12 hours since. Benadryl and shower gives temporary relief, but no lasting improvement.
swelling, redness of arm p/vax given reportedly twice the size of usual arm (lt arm) using the arm w/o problems, not painful;
Eye pain; headache; nausea; some weakness later; dehydrated; watery eyes; felt horrible; eyes got to burning; This is a spontaneous report from a contactable patient (nursing aid). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunisation. The patient medical history included Potassium high, she was already sick and she had a sinus infection and was on an antibiotic when she took the first COVID-19 Vaccine shot. The patient concomitant medications were not reported. The patient experienced headache, nausea & some weakness later that day after the vaccine. The following day experienced pain & watery eyes. The patient got her first COVID-19 Vaccine shot on 10Mar2021 shot and had a reaction in her eyes. She said she was on a sinus pill and steroids at the time she received her first COVID-19 Vaccine. She said her doctor told her it was ok for her to take the COVID-19 vaccine. She said her eyes got to burning and running after she got the COVID-19 Vaccine. She said she was dehydrated at the time too. She said she was feeling better. She said she was taking an antibiotic and prednisone to build her body up. She said she was already sick anyway, saying she had high potassium. She said she felt horrible, and her eyes got to running, so her doctor called an antibiotic in and everything for her. She stated her eye doctor told her she was having an adverse effect to the COVID-19 Vaccine shot. She said the person who administered her first COVID-19 Vaccine shot told her she would be sick for 48 hours. She said she felt a little better now, but her eyes were bad. She said she was scheduled to get her second COVID-19 Vaccine on 05Apr2021 and was scared to take the second COVID-19 Vaccine. She said her eyes were runny, burning and painful after she got the first COVID-19 Vaccine shot. The outcome of event headache, nausea, some weakness later, Eye pain, watery eyes, dehydrated, felt horrible, eyes got to burning was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is not a reasonable possibility that event dehydration is related to BNT162B2.  It's most likely intercurrent medical condition. 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.
Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of neck and tongue began to swell Extreme fatigue took over body  Mar 29-8pm Rash and itching in following regions: Around collar area/bra line/buttocks/back of thighs/lower back/behind knees/in elbow crease/back of arms Injection site swollen and painful  Mar 30-2am Painful abdominal bloating and gas nausea frequent urination chills/arms and feet would not warm up  muscle pain joint pain  Mar 30 2:30-3:30am vomiting-multiple times and loose stool elimination/turning to diarrhea continued chills and inability to warm up hands and feet complete fatigue Continued muscle pain/joint pain and injection site pain/swelling  Mar 30 2:30pm Low grade fever (99.8) all other symptoms remain and limbs begin to warm up Slept from Mar 30th @ 7pm-Mar 31st-7am  Mar 31  Woke at 7am and felt much better Injection site on arm still tender, but improving Fever gone/temperature normal (97.5) rash dissipated Joint and muscle pain lingering  (reported side effects to Pfizer reporting mid day of Mar 30
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 26-FEB-2003 the patient was vaccinated with VARIVAX (Merck) dose 1 (subcutaneous; dosage and lot number unknown). On 08-AUG-2013 the patient was vaccinated with VARIVAX (Merck) dose 2 (subcutaneous; dosage unknown, lot # G007461 exp 02-AUG-2013). The healthcare worker reported that the patient received an expired VARIVAX (Merck) dose. No adverse effect was reported. Additional information has been requested.
High fever, chills, aches, pain all over, nausea, congestion mild cough & thick mucus, unable to get up & do daily activity x3-4 days   On day 4 tested positive & day seven after shot tested negative
came into the hospital with COVID-19 pneumonia and acute hypoxic respiratory failure his O2 saturations were 80% on room air on arrival.  He was admitted to the hospital placed on isolation and was initially on 7-8 L oxygen nasal cannula he was aggressively treated with remdesevir, Actemra, antibiotics, Lovenox, seen by ID in the hospital gradually improved with decreasing O2 he was also seen by Neurology due to altered mental status.  Stroke was ruled out they recommended supportive care and treatment of delirium with p.r.n. medications
She developed little red bumps at the injection site immediately after her vaccine. She was seen on 11/29/18 because the erythema became larger, (12x12 cm) with edema and mildly pruritic. She had a local reaction last year as well and went to Urgent care and received Prednisolone. Dr. consulted with a local allergist, who recommended giving Prednisolone 2 mg/kg the day of vaccination prior to the vaccine and the day after to avoid reactions.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored COMVAX (lot # J013884, expiration date 19-AUG-2016) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Abdominal pain and cramping followed by diarrhea, about 3 hours after the shot. Arm tenderness and pain for a day and a half began about 6 hours after the shot. Slight fever, about 30 minutes following shot and lasted for a 1 and a half.    The patient waited the symptoms out, drinking orange juice and water, and laid down in bed for 2 hours. They continued to move their arm around and used it as normal to help with the pain.
Patient was experiencing mild headache after the shot on 05/27/21. As of 06/02, her headache has increased and she had a couple of dizzy spells. Advised patient to call PCP immediately.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests: SARS-CoV-2 test: (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash consistent with Henoch-Schonlein purpura- mild; no abdominal or renal symptoms, observation.
Headache, NauseaVomiting, fatigue, pain injection site, fever Narrative:
No additional AE's.; temperature excursion that occurred on ROTATEQ; This spontaneous report was received from a physician referring to patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 24-JUN-2021, the patient was vaccinated with oral rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose,  frequency, were not provided) for prophylaxis. Lot No. T028130 has been verified to be a valid lot number for [rotavirus vaccine, live, oral, pentavalent], expiration date reported as 28-JAN-2022, and upon internal validation established as the same.  The physician reported that the vaccine dose was administered on 24-JUN-2021 to the patient and the vaccine was improperly stored (incorrect product storage). The vaccine presented a temperature excursion with digital data logger, at a temperature of 36 Fahrenheit (F) to 46F (47.8F) for 0 hours 5 minutes and 0 seconds and a second temperature excursion with a temperature of 36F to 46F (47.8F) for 0 hours 5 minutes and 0 seconds. No previous temperature excursion had occurred. And no adverse events were reported.
Vaccine given and within 20 hrs, my urine turned reddish brown. Since I have a history of IgA nephropathy, I contacted my nephrologist and he ordered blood work and a urinalysis. The UA showed here was an increase in proteinuria and hematuria directly following the second dose of the COVID vaccination. Kidney function bloodwork appeared to be within normal limits. No treatment was necessary. Follow up blood work ordered within 5-7 days.
This spontaneous report as received from a consumer refers to her daughter a 12 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with first dose of GARDASIL (lot number unspecified) on 29-JAN-2013. No other co-suspects were reported. Concomitant medications included an unspecified generic product which started a couple of weeks ago. The reporter stated that the patient received GARDASIL and immediately began having dizziness, nausea, fatigue, headache, and issues with her muscles to the point that she was unable to walk and had to be wheeled out of the physician's office in a wheel chair. No treatment was given for the adverse event. No lab diagnostics studies performed. The patient had sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. The relatedness for the events was unknown for GARDASIL. Unable to walk was considered to be disability. Additional information has been requested.
I had no symptoms from the vaccine, but when I caught COVID-19 I had minimal symptoms. I had a heavy trachea and a cough. I told my doctor that I had COVID-19 so he prescribed me with Paxlovid, and I received the monoclonal antibodies. I was positive for COVID-19 for 10 days, and I have been negative for 2 weeks now. The heaviness in my trachea has gone away.
c/o weird tingling in throat and dry mouth, BP111/78 P81, water given and observed, s/s went away, staff walked pt to car, driver present
1st dose on July2018, 2nd not received; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose in July 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-OCT-2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient not received the second dose of Shingrix. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
?Moderna COVID?19 Vaccine EUA?  Severe skin rash, very itchy and sore