chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID 19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE, start date: Mar2013; CLONIDINE, start date: Mar2013. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took COVID-19 treatment PAXLOVID on 26Apr2023. The patient had no known allergy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175658 same patient/reporter, different drug/event;
This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Nov2021 at 10:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date; both as single doses for COVID-19 immunisation. On 27Nov2021 at 19:00, the patient experienced fever of 100.3 (unspecified units), headache, chills and aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever of 100.3, headache, chills and aches was unknown at the time of the report.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient developed a fever, swelling, redness and pain in the left deltoid/shoulder area. The patient was treated with cold compresses and Motrin.
Client called and reported Jan 10th he began experiencing high fevers, chills and decreased appetite lasting until January 14, 2019. All symptoms subsided until January 18, 2019 where high fevers, decreased appetite and nausea started. He was seen in the ER on January 21 and Dx was "dehydration" and given fluids and then returned to the ER on January 22, 2019 with the same symptoms and given fluids again and discharged. Symptoms are ongoing as of today.
WHEN THE TECH ADM THE  SPIKEVAX IN THE PT RIGHT ARM AT 2.20. PM AND started prepaping the pt to get a shot on the left arm for flu, th pt fainted . hr mom was holding her, because of afraid of needs. the pt came back immedialtey and was nausea. cold pack was put on her haid, she refused to called 911. mom explain  that she had started a new birth control that was causing her to get faint spells, nausea, vomiting, abdo cramping. mom took th pt home. Syncome is a side effect of spike vax, and dissziness also
Passed away; Found unconscious; Coma; Lack of oxygen to the brain; A spontaneous report was received from a consumer, concerning his mother, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away, prior to death, patient experienced lack of oxygen to the brain and was found unconscious and went to coma.  The patient's medical history reported included seizures. Concomitant medications included phenobarbital, lamotrigine and levetiracetam.   On 27 Jan 2021, approximately six days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Feb 2021 at 4 am, the patient was found to be unconscious on the couch, hence she was rushed to the hospital with lack of oxygen to the brain. Later, she went into a coma, hence she was in hospital for 30 hours and then was transferred to a different hospital for a second opinion on 06-Feb-2021, where she was passed away at 02:20 PM. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of events, lack of oxygen to the brain, found unconscious and coma were considered unknown.  The outcome of event passed away was fatal as she died on 06 Feb 2021 at 2:20 pm.  The cause of death was not provided.  Plans for an autopsy were unknown.; Reporter's Comments: This is a case of 71-year-old female subject with a history of seizures who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away
Few seconds after completion of both vaccinations pt experienced bad/weird taste in mouth, flushed/warm feeling, feeling of anxious/overwhelm. Immediately sat back down. No trouble breathing, wheezing, rash. After a few minutes reaction moved to a dull throbbing pain in lower back/tailbone area. Approx 30 minutes later most of reaction cleared. Pt had little pain in lower back.
Pt developed an 8-10 cm local induration. Treated with oral Tylenol and observation.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of an unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was provided. On multiple unspecified dates, the patients were vaccinated with an unspecified number of doses of improperly stored PEDVAXHIB lot # L030868 and expiration date 09-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Patient says shot was given; was sore at time given since then has gotten progressive worse. Seen MD has been given antibiotic, been to ER and PCP has ordered MRI.
6/20/02 L arm was war, pink-swollen. Temp 102 degrees-sent to medical center-was admitted. DX: cellulitis (10pm 6/20/02) left arm. Discharge DX: cellulitis of arm/drug reaction 6/21/02. Discharged 6/21/02.
Approximately 9 days after the vaccination, tender left axillary lymphadenopathy, malaise, chills, and high fever (to 104F) developed; followed several days later by development of marked erythema and warmth over the left chest wall, left axillary region, and onto left back. This presentation required brief hospitalization for treatment of a presumed cellulitis and further diagnostic workup of fevers and lymphadenopathy.  The patient was treated with antibiotics for cellulitis and empirically for possible tick-borne illness (early Lyme, glandular tularemia) with notable improvement in the skin erythema and fevers.
Patient did NOT have an allergic reaction to the COVID-19 vaccine.  Patient was given a second series Bivalent Moderna vaccine due to patient being adimate about getting a second booster dose along with partner.  Patient did not tell the Nurese: RN that she had already received a bivalent vaccine.  Patient was administered one on 09/20/2022 per record and then clinical nurse administered a bivalent Moderna dose on 12/15/2022 .  Patient is fine with no adverse reaction to the second Bivalent.  Process was talked about and new protocol put in place prior to giving the COVID-19 bivalent booster vaccine.
Underarm lymph nodes swelling Chills Fever Body aches Lethargy  Tired Brain fog 4 days after - add headache and nausea  5 days after - more nausea
2nd dose sore arm x 2days, fatigue x 2 days; 2nd dose sore arm x 2days, fatigue x 2 days; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1696; Expiration Date: Jun2021), intramuscular administered on left deltoid on 12Jan2021 (age at vaccination: 50 years) as single dose for covid-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, via an unspecified route of administration on 18Dec2020 7:45 (24-hour clock) (Batch/Lot Number: EL0140; Expiration Date: was not reported) as single dose for covid-19 immunisation and has experienced muscle aches in legs. On an unspecified date, the patient experienced 2nd dose sore arm x 2days, fatigue x 2 days. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Short of breath; Blur vision; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Short of breath) and VISION BLURRED (Blur vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had mild case of COVID-19) in December 2020. Concurrent medical conditions included Cancer and Depression. Concomitant products included ANASTROZOLE for Cancer, LURASIDONE HYDROCHLORIDE (LATUDA) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Depression.    On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced DYSPNEA (Short of breath) and VISION BLURRED (Blur vision). At the time of the report, DYSPNEA (Short of breath) and VISION BLURRED (Blur vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sore left arm, chills, feverish feeling, vomiting starting around 5:50 PM today
Patient had erythematous papular rash that started on face and spread to involve trunk associated with mild rhinorrhea and cough.
Approximately 11 hours  after second dose of the Phizer covid 19 vaccine, I woke up in a daze. I felt as if I couldn?t move my body it felt heavy and numb. I was able to walk to the bathroom. I stood up from the bathroom and passed out. My fainting resulted in me falling onto tile floor and cutting a 4cm cut onto my chin. I do not remember anything from standing to falling and waking up hearing the fall and feeling blood on the ground. I lost consciousness.
Information was received on 16-JAN-2018 from a lawyer regarding a case in litigation concerning a female patient, age not reported. The patient was vaccinated with ZOSTAVAX on or about 19-AUG-2017 at a pharmacy for as recommended for adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2017, only a few days after being vaccinated, the patient was treated at a community health facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which had been present for three days, and was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Outcome of herpes zoster and weakened immune symptoms was unknown. Additional information has been requested.
3 patients received doses punctured past 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received doses punctured past 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received doses punctured past 12 hours). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received doses punctured past 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.  Vial was punctured 12-16 hours prior while maintained at proper refrigerated temperature and protocol for revaccination.
Extreme confusion, I was in the shower and could not remember if I had washed my hair or my body or eaten that day. This went on for at least an hour for that episode and then later   I also stopped at a redl ight and then  went through it, it really freaked me out and almost got t-boned.
Same as first shot.  102 fever, joint aches.  This time I have a headache and upset stomach
In the early morning of 11/18 I noticed rash on the left leg of patient.  It was raised and red, but not oozing or seeping. The rash did not go away over the weekend, and in fact seemed to spread by Monday, 11/21 when we took him to the Dr.
ear infection; This is a spontaneous report from a contactable other HCP (patient). A female patient of an unspecified age received bnt162b2 (reported PFIZER-BIONTECH COVID-19 VACCINE, Covid-19 Vaccine), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. PCT asked, "I got the Covid 19 vaccine yesterday, and this morning I woke up and went to the doctor because I had an ear infection. I was prescribed with oral antibiotics. Is it okay to take the antibiotics?". Patient stated, "I had a question about it actually. I got the vaccine yesterday and then today I was at the doctor, I have an ear infection and I was wondering if that would be a bad thing if I took antibiotic while still recovering from the vaccine."  The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Begin June 1, 2021 as rash on arms, shoulders, back, stomach and  inside of knees accompanies by shortness of breath. Fever ranging from 101 degrees to 103 degrees started on June 8, 2021 with increase in difficulty breathing.
diagnosed with COVID on Saturday; diagnosed with COVID on Saturday; tunnel vision; sick; I never felt like my self; This is a spontaneous report from a contactable consumer(patient). A 47-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021, as single dose (Batch/Lot number was not reported) and  received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on May2021, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The age at both doses was 47-year-old. Medical history included blood pressure high from 2021 to an unknown date, high cholesterol from 2021 to an unknown date. Concomitant medications included amlodipine taken for an unspecified indication by oral from 2021 to an unspecified stop date; atorvastatin taken for an unspecified indication by oral from 2021 to an unspecified stop date. The patient reported in 2021: "I took the two Pfizer covid shots and i was diagnosed with COVID on Saturday and now I'm in quarantine. The 2nd shot made me feel sick, but it was not for long. I never felt like myself or like i used to feel after getting the vaccine, I have tunnel vision. Now they are talking about a booster shot will the booster cause side effects?"  The patient stated he got both shots of the Pfizer COVID-19 vaccine, he had been to the doctor and right now he had been diagnosed with COVID after on Saturday having his nose swabbed. He said they didn't have the rapid test thing so he had to wait 24- 48 hours for results, and it came back positive on 2021. The patient had a physician office visit for all events. The outcome of all events were unknown. The case was serious due to medically significant condition.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Arm pain  I pain around midnight the night of injection continuing through next day.  Night sweats  Fever and chills  March 27th all day   StIff and painful joints and muscles everywhere Slight headache  Energy drain was almost immediate and ongoing.
Constant pain in entire body, severe joint pain in ankle, wrist, knee and shoulder; needle-like pains in right arm, deterioration of vision, shooting pains in arms and legs, traveling pains in upper back, sleeplessness, fatigue, stiff neck and myalgia. 60 day follow-up states the pt us unable to function without medication.
Vomiting, joint pain, swelling and redness in arm, asthma attack.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 2400 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Soreness in muscle at injection site persisting (at time of this filing, one month after vaccination).
OUT OF SPECIFICATION PRODUCT USE; 10 VIALS UNDERWENT A SHORT TEMPERATURE EXCURSION LASTING FOR 3 MINUTES EXCEEDING IN 0.74 F THE MANUFACTURER'S UPPER RECOMMENDED LIMIT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 10-JUL-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced out of specification product use, and 10 vials underwent a short temperature excursion lasting for 3 minutes exceeding in 0.74 f the manufacturer's upper recommended limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and 10 vials underwent a short temperature excursion lasting for 3 minutes exceeding in 0.74 f the manufacturer's upper recommended limit was not reported. This report was non-serious.
I had my first dose, in Jan 28th of 2021, and the 2nd dose in Feb, by March the 17th I went to an urgent care, and my heart was racing. They did an EKG, they thought I had afib. They wanted me to go to the ER but covid was running rapid so I did go. I talked to a relative who is a nurse and she told me that I did not sound like I was in distress. I had some reoccurring episodes after that. In September  27th, I went to urgent care for a problem with my shoulder but my heart rate was also really high so they did an EKG> October 2nd another EKG was done. At some point, not sure if it was before or after in October, I saw a cardiologist. She put a heart monitor on me and saw no issues.  In January, another bad episode happened, in which I had another afib.  Irregular heartbeats that last a couple of hours, that stop and then come back hours later. In January, the biggest episode happened where it was consistently happening for 2 days.  I stopped taking medication that causes higher heart rate, and seafood that causes it to happen.
Pruritus, 8 discrete scabbed, excoriated lesions.  3@ site or near site of injection in R/Deltoid.  5 on upper back, no urticaris at time of examination by physician.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-FEB-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Severe pain on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain on injection arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00M00A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Severe pain on injection arm). At the time of the report, VACCINATION SITE PAIN (Severe pain on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
rash that looks like shingles; rash; painful; itching on his back; This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than 3 weeks after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced vesicular rash, itchy rash, painful rash and pruritus. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vesicular rash, itchy rash, painful rash and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash, itchy rash, painful rash and pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not repoted. The patient received Shingrix about 2.5 weeks ago. Several days ago the patient started having itching on his back. More recently the areas that were itching started becoming painful. The patient looked at his back and saw that there was a rash that looks like shingles.  The patient had started taking Valtrex.