chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive COVID test; Positive COVID test; This is a spontaneous report from a contactable pharmacist (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EH9899) intramuscularly into the left arm on 29Dec2020 08:30 am and second dose (Lot Number: EL1283) intramuscularly into the left arm on 21Jan2021 08:30 am (at the age of 34-years-old) and both at single dose for Covid-19 immunization. No other medical history was reported. The patient had no known allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included zinc and MVI (MVI-ADULT). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 30Mar2021, the patient tested positive for Covid test. No treatments received for the adverse events. On 04Mar2021, laboratory tests showed positive COVID test and on 02Apr2021, polymerase chain reaction (PCR) showed Covid test result positive. No other vaccines were taken in four weeks. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and COVID 19 and the suspect drug.
elevated BP 144/90 at 19:30 and Elevated HR 115 at 19:30. 7 and 1/2 hours after injection. only treatment was rest and everything is normal
ARM HURTS VERY BAD, COULDN' LIFT UP ARM LAST NIGHT, A LITTLE BETTER TODAY. PAIN IN SHOULDER.  THE PAIN IS A LITTLE BETTER TODAY.  TOOK ALEVE YESTERDAY AND WILL TRY SOME TODAY TOO. WILL TRY ICE OR HEAT WHICHEVER RELIEVES PAIN.
Per mom and patient, within the first 48 hours of the vaccination, the patient had fevers to 103 F with chills and myalgias that responded to Tylenol. Patient has remained w/o fevers since 6/14. On 6/15, patient developed L chest pain which was reported as moderate in intensity, dull in sensation, constant and non-radiating. Pain worsened with deep breaths with no interval development of SOB, no dizziness, no lightheadedness or LOC.
vaccine that underwent a temperature excursion was administered; No additional adverse effects were reported; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 11-JUN-2021 and 20-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356: US-009507513-2106USA004368: US-009507513-2106USA004370: US-009507513-2106USA004372: US-009507513-2106USA004384: US-009507513-2106USA004374: US-009507513-2106USA004375: US-009507513-2106USA004376: US-009507513-2106USA004378: US-009507513-2106USA004379: US-009507513-2106USA004382: US-009507513-2106USA004366: US-009507513-2106USA004365: US-009507513-2106USA004377:
3 1/2 hrs developed fatigue, hip and low back pain, and bilateral legs discomfort   Pain scale 6/10  Using Advil
Site very tender, fever of 101, chills, flu symptoms, pain in shoulder and chest 5" raised welts at injection site. (Day after)
The pt experienced extreme fatigue, malaise, after 3 days, it began resolving. The pt also had back pain 24 hours after fatigue onset.
This case was reported by a pharmacist via out of hour services and described the occurrence of injection site erythema in a adult patient who received SHINGRIX (batch number A2JL7, expiry date 22nd March 2021) for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist (Rph). The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. There was no redness or swelling for the patient after dose 1. The call was an AHVM (After Hours Voice Message) left by pharmacist on Sunday, 23rd September 2018 at 3:15 PM. On her message, she noted that GSK might contact the other pharmacist, who would be on duty the next day, 24th September 2018. A call back to the mentioned pharmacist was made, but there was no further information about the individual patients. This is 1 of the 5 cases, reported by the same reporter.
(L) thigh 5cm Diameter, Red, Raised NT/warm skin. (L) thigh cellulitis
Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient presented to the ER on 3/8/21 after being sick the prior 2 weeks with loose, bloody/tarry stools, frequent falls, and hypotension. Hospital course progressed to worsening encephalopathy secondary to decompensated alcoholic cirrhosis. Developed pneumonia that did not improve with antibiotics and progressed to palliative care with him passing away on 3/24/21. Comorbidities include COPD, alcoholism, Takotsubo cardiomyopathy, HTN, cirrhosis, HLD, former smoker.
On 7-12-2022, I started noticing a scratchy throat. The next day, i started noticing a cough and I thought it may have been a seasonal allergy. I took a home COVID-19 test and it was negative. On 7-14, I called my primary care office and we done a telehealth visit. She suggested a COVID-19 PCR test which was done on 7-19 with negative results. The doctor's office stated this was probably viral. On 7-15, I started to have body aches, a headache, runny nose, watery eyes and my sore throat was getting worse.  7-20, I went to an urgent care because I was not feeling any better. They performed a COVID-19 test and FLU A/B, all were negative. They determined it was bronchitis from a viral infection. They ordered me to have albuterol inhaler. On 8-4, I called my primary care doctors office again and had a telehealth visit due to continued symptoms and now a possible eye infection. I spoke with the Nurse Practitioner and she ordered dextromethorphan and trimethoprim. She diagnosed me with bronchitis. On 8-9-2022, I had a chest xray and it was negative. On 8-18, I went to the local ER due to the same symptoms but now chills, fever up to 100.3 and more body aches. They done  alot of bloodwork and diagnosed me with a Bronchitis. They gave me a prescription for Cephalexin. It seemed like my cough and sore throat was getting better but last night it came back. I still have the scratchy throat and a persistent cough.
Numbness tingling in bilateral hands and feet  at 4 1/2 hours post vaccine then swelling of hands face lips and tongue. At 6 hrs post vaccine.  Core temperature below 95. Severe headache , lightheaded dizziness at 4 1/2 post vaccine Severe muscle weakness and pain start at 8 hrs post vaccine . All symptoms last 48 hrs post vaccine  Took aspirin, ibuprofen and Benadryl
Pt received 4 immunizations on 2/26/03, two on each deltoid. (MMR and Pneumovax on the right; he is right handed). Next day developed fever, chills and swelling of right posterior arm, and started taking motrin and tylenol regularly. Pain and swelling increased overnight, with raised confluent tender erythematous area but no striae or adenopathy (Dx: Cellulitis)
4 x 3 cm induration reddened area over site of injection. R arm SQ.
The pt experienced fever, fussiness followed by hives starting on feet and ankles progressing up to torso persisting for 2 days. The pt experienced rapid respiration's last night as well.
Symptoms started around 4pm with muscle ache all over and the body chills. Severe muscle spasms followed in back and chest area, hard to relax.  By 6pm, very high fevers - T-105.5, 105.6. interventions didn't drop temp unless stripped completely naked and temp would drop to 103.3 at lowest, Tylenol administered  and temp and no clothes - just a sheet on temp is 101.9.  and bad body aches currently.
COVID positive test; COVID positive test; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FN2908) for 1 day, in left arm, as dose 3 (booster), single (Lot number: 320308D) for 1 day, in left arm, as dose 2, single (Lot number: EM98910) for 1 day, in left arm, on 16Jan2021 as dose 1, single (Lot number: EL8982), in left arm and (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Heart failure" (unspecified if ongoing). Concomitant medications included: ALOPURINOL; CALCIUM; DAILY VITAMINS; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022, outcome "unknown" and all described as "COVID positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300245529 same patient and drug; different dose and event;US-PFIZER INC-202300247071 same patient and drug; different dose and event;
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 09-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
AFTER 5 MINUTES OF VACCINATION PATIENT GOT UP TO SEE SOMETHING, FELT LITTLE DIZZY AND FELL ON THE FLOOR. NO BRUISING OR CUTS OR BLEEDING WAS NOTICED. PATIENT ALSO COMPLAINED ABOUT NAUSEA BUT NO VOMITTING. PATIENT STARTED FEELING BETTER AFTER COUPLE OF MINUTES, ASKED NO MEDICAL ATTENTTION WAS NEEDED.
Client not feeling well on 10/27, c/o fever and malaise. On 10/28 went to emergency department and they referred him to MD for confirmation on 10/29. Dx'd with Varicella. Treated with Acyclovir, will be home x 5d or till sores scabbed. Client doing well and will be back to school on 11/5.
left arm pain and weakness for 6 weeks following vaccination with worsening pain and weakness over time
I got a headache a couple of days afterwards. Some of the first adverse events where I got extremely tired, and I had to go back to work and I felt really tired. I ended up calling off the next day. I was very cold. I was under a lot of blankets. I developed a low-grade fever. They wanted me to keep an eye on it just in case. The next day and the rest of the week my arm was really sore. The second vaccine was so bad. I had an even stronger headache. It took awhile for the swelling for my arm to go away. I had a bruise at the injection site and it kept getting darker and would spread. I took some medicine for the pain and headache. I could not even function. I was so tired and in so much pain. Most of the pain was in my arm. I was having a GI issue, I had diarrhea for a day or two afterwards. I had a telehealth visit with a nurse practitioner and they instructed me to go to urgent care if I did not feel better. Then I started having more GI issues, so I ended up going to urgent care. They told me to take Imodium to stop the diarrhea and take a lot of electrolytes. I had to take a Covid test at that time. Then I was off for like a week from work. I ended up going back to work and then I left like an hour after because I was having a bad GI issue, I was constipated. I was in pain and miserable. I went home and not only having diarrhea, but I had a stomach bug, I was throwing up. I could not keep anything in. Sometimes I still have diarrhea or constipation.
vaccines got switched, received tdap instead of dtap with no reported adverse event; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old and unknown gender patient whose vaccines got switched, received Diphtheria, Tetanus, AC Pertussis and IPV Vaccine instead of Diphtheria, Tetanus and Acellular Pertussis Vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria, Tetanus, AC Pertussis and IPV Vaccine produced by unknown manufacturer formulation, strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) instead of Diphtheria, Tetanus and Acellular Pertussis Vaccine and vaccines got switched, received tdap instead of dtap with no reported adverse event (wrong product administered) (latency: on the same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event vaccines got switched, received tdap instead of dtap with no reported adverse event.  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.
10:55am: Pt complained of nausea, color pale but reached diaphoretic laid down with legs up.  BP taken, given fluids/ice chips.  BP improved had pt monitor for observation then went to home 12:05pm.
This spontaneous report as received from a nurse practitioner refers to a 19 years old female patient with no drug reactions or allergies. The patient was vaccinated intramuscularly with dose 1 lot # (672834/0131AE: exp date 26-OCT-2014) and dose 2 lot # (1696AA: exp date 12-SEP-2014), 0.5 ml of GARDASIL on 07-JUN-2012 and 16-AUG-2012 respectively. No other co-suspects were reported. There was no concomitant medication. The nurse practitioner mentioned that the patient had follow up treatment for cervical dysplasia. Nurse practitioner reports a colposcopy was done on 10-JUL-2012, a cervical biopsy that resulted in Cervical intraepithelial Neoplasia I (CINI) low grade and an endocervical component with a benign finding. The patient was going to have a repeat PAP smear in 4 months. Nurse practitioner reported that the patient was suppose to get DEPO-PROVERA and instead accidentally received the 2nd dose of GARDASIL on 16-AUG-2012. The patient had a pregnancy test prior to vaccination on 16-AUG-2012 and it was negative for pregnancy. The patient was suppose to go back in 10 days for another pregnancy test. The patient sought medical attention at the office and no treatment was given for the events. The outcome of cervical dysplasia, CIN1 low grade was reported as not recovered. The relatedness for cervical dysplasia CIN1 low grade was not reported for GARDASIL. Additional information has been requested.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 11-MAR-2021 , the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines for Children (VFC) program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003504: US-009507513-2105USA003503: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: U2-009507513-2105USA003542: US-009507513-2105USA003543:
Information has been received from a consumer (an office manager), via a company representative, concerning the consumer's 17 year old daughter, who in December 2006, was vaccinated with the first dose, 0.5ml, of Gardasil vaccine (yeast), and vaccinated with the second dose of Gardasil vaccine (yeast) (date not specified). In December 2006, three days after the first vaccination, the consumer reported her daughter experienced "dizziness, lightheadedness, vertigo, difficulty breathing, respiratory distress and bronchial inflammation." The consumer reported her daughter was taken to the ER, but she was not admitted. She added that a chest x-ray and "bloodwork" were performed (results not provided). In addition, she added that after her daughter experienced nausea, headache, and dizziness after the second vaccination was administered (dates not specified). At the time of the report, it was unknown if the patient had recovered. Additional information is not expected.
Patient is fully vaccinated. The patient was diagnosed with COVID recently after she was travelled to another state.  Hospitalized on 11/30/2021 for 3 days.  57-year-old female without significant past medical history, who presented to the hospital complaining of shortness of breath, fatigue, sore throat, cough, some nausea. Hypoxemia requiring supplemental oxygen. In emergency room, EKG was reviewed.  Chest x-ray showed questionable congestion and mild basilar atelectasis.  Due to her presentation, the patient was admitted to the hospital and she was started on appropriate treatment with steroid and correct lytes per protocol.  The patient showed improvement in presentation. Discharged home in stable condition.  Follow up with the primary care physician within 1 week of discharge for evaluation.  Medication list was adjusted and updated.  Upon discharge, the patient had no respiratory distress.
14FEB96 pt recvd vax & exp severe histamine react hives on arms & legs responded well to oral DPH
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, improperly stored RECOMBIVAX HB (lot # L010595, expiration date 12-NOV-2016 and lot # L019298, expiration date 22-JUN-2017) (dosage, strength and route unknown) (temperature: low 32.2 degree F, time frame: 53 hours and 25 minutes) were administered to the patients. There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient felt dizzy about 10-15 minutes after the shot. He was alert and able to speak while sitting in the chair. Then he vomited a lot. Patient felt fine afterwards and sat for over 30 minutes. Had a history of fainting and vomiting after shots
Chills, Fever, Cough, Achiness, Fatigue lasting more than 2 days
On 3/28/03 care was provided by MD w/the Dx's of cellulitis of right arm. Cephalexin 250 mg / 5 cc given w/discharge instructions and to see MD for appmt in 2-3 days.
C/O SOA, WHEEZING AFTER RECEIVING COVID VACCINE YESTERDAY; PT STATES NO RELIEF FROM ALBUTEROL INH
pt. was fully vaccinated - dose 1 - 5/21 Lot 041C21A., Dose 2 - 6/18 Lot 049C21A. SO 8/15/2021, + test 8/18/2021
MODERNA COVID #3 VACCINE GIVEN 11/5/21, LOT #058F21A; 2/16/22 EMS brought pt to ED, unresponsive, BG 44 - treated low blood sugar; NRB; hypotensive; positive for COVID; admitted; Remdesivir, ABX, steroids, bronchodilators; condition worsened requiring intubation; condition continued to worsen; status changed to DNR, comfort measures; pt extubated and passed away in the hospital