chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer on 02-MAY-2017. This case involves a 78 years old female patient who was vaccinated with a dose of ADACEL (batch number, expiry date, route of administration was dose was not reported) in arm on 21-APR-2017. Patient's medical history was not reported and Illness at time of vaccination was reported as none. Concomitant medications was not provided. On 21-APR-2017, few hours (reported as that night) following the vaccination the patient experienced upper arm soreness in arm she had received vaccination, slight swelling of site, headache, chills, and nausea. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment was not provided. On 22-APR-2017(reported as next day), patient recovered from the chills, nausea and headache. On unspecified date patient recovered from swelling. It was reported that upper arm soreness lasted about 3 to 4 more days and then decreased to soreness at only the injection site. It was also reported that patient continued to experience soreness at the injection site. List of documents held by sender: none.
pt recvd vax; SIDS approx 30-36 hrs after vax;
lost her sense of taste; tired; lost her appetite; had an upset stomach; low grade fever 2 days later; Lost her sense of smell; she also had body aches; she had colds after the vaccine; This is a spontaneous report from a contactable consumer(patient herself)..   A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205) via unknown route of administration on 03Mar2021 at single dose in left arm for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient got the first Covid vaccination on 03Mar2021, stated she had Covid, tested positive after the vaccine on 08Mar2021. stated she got symptoms 2 days afterwards she tested positive after the vaccine, patient stated she was assuming she had it when she got the vaccine. patient stated she tested positive on 08Mar2021, was asymptomatic at the time, started feeling symptoms, lost her sense of taste on Sun 07Mar2021, stated her other symptoms where she was really tired, she lost her appetite, had an upset stomach in Mar2021, stated she was feeling much better now, next vaccine was due on 24Mar2021, some people were saying she shouldn't get it should wait 90 days. Patient lost her sense of taste and sense of smell in Mar2021. she also had body aches and was feeling very tired and had a low-grade fever 2 days later after that in Mar2021. she had colds after the vaccine in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Guillain-Barre Syndrome, shivering, couldn't walk because shivering was too intense, nausea, vomiting, aches, heavy fatigue.
Member was given additional influenza vaccination today. Member was given initial influenza vaccination on 11 July 2015. Member was supposed to get an IPPD today but received additional influenza shot. No adverse reaction noted. Physician on-call notified. Patient was made aware.
G40.909 EPILEPSY, UNSPECIFIED 4/18/2023 ABDOMINAL PAIN G40.909 EPILEPSY, UNSPECIFIED 4/18/2023 ABDOMINAL PAIN
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided  No treatment medication information was provided
Day 1- body aches, fatigue Day 2 - headache, decreased bodyaches, fatigue Day 3 - chills, heat flashes, headache, fatigue
Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.    Treatment medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
24 hours, post vax, the pt developed inflammed, red and warm to touch area at site of injection. After 48 hours, the area increased in size. The pt was seen on the 3rd day for antibiotic treatment with Duricef.
she had first dose of Pfizer on 08Apr2021 and first dose of Moderna on 18May2021; Caller had the first dose of the Pfizer COVID-19 vaccine on 08Apr2021 tested positive for COVID-19 on 18Apr2021.; I got sick; went to a physician with severe symptoms; Physician told her she needed to start over with the Vaccine with first and second dose; This is a spontaneous report from a contactable consumer(patient).   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Apr2021 as, 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated that she  received the Pfizer vaccine the first dose on 08Apr2021 then came down with COVID on 10Apr2021, just two days later, went to a physician with severe symptoms on 18Apr2021 and he diagnosed me Positive and he told me that since she had the Pfizer Vaccine just before I got sick I was going to have to start over another first dose and then a second dose, so not knowing you know there may be any difference she received first dose of Moderna on 18May so, she had first dose of Pfizer on 08Apr2021 and first dose of Moderna on 18May2021  and she don't know since the first dose of Pfizer was a long ago and  she asked do I go ahead with the second dose of Pfizer or do I go ahead with the Moderna since I got it on 18May2021 and get the second dose of Moderna. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 18Apr2021. Reporter seriousness for Had her first dose of Pfizer COVID-19 Vaccine on 08Apr2021 and came down with COVID on 10Apr2021, 2 days after: Unspecified. The outcome of the events was unknown.    Follow up (10Jun2021): This is a Follow up spontaneous report from a contactable consumer. This consumer (patient) reported that: event details.  Information about lot/batch number has been requested.
Vaccinator, was administering child's first Moderna COVID19 vaccine dose into R arm, and she saw the vaccine spill out of child's arm upon vaccination and engaging safety mechanism for needle.  Mother, was made aware of this happening and then Vaccinator obtained a second syringe with needle (vanishpoint, same brand as first needle/syringe) after informing manager staff.  Then, she successfully vaccinated child with Moderna COVID19 vaccine in L arm with mother's consent.
metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142) intramuscular on the left arm on 30Dec2020 10:30 at a single dose for COVID-19 immunization. Medical history included pre-diabetes and known allergies: Penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO). Immediately after the 1st dose on 30Dec2020, the patient experienced metallic taste in mouth followed by itchy throat that felt constricted. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.
First shot only a sore arm, 2nd shot onset of debilitating headache, body aches, fatigue x 3 days. My symptoms were severe enough that I was unable to go to work.
the night I went to sleep after the first dose I was awakened with pains in my teeth, nerve pain that shot through.  My teeth have remained sensitive on top and bottom, regardless of cold or hot sensitivity.  some nerve pain will be experienced randomly since 2nd dose.
Patient received first COVID vaccine on 3/26 . On 4/1 developed left 3rd cranial nerve palsy.
rash/hives (deep red) over chest, face, and ear treated with (1) benadryl 50mg capsule
hot flash minutes after vaccination, days to follow head soreness/itching, fatigue, warm/chills, hands shaking
Within 2 hours site was red, warm and swollen aprox 2 1/2 inches around entire site. Started to reduce on 2nd day and she went to PCP instructed to take 50mg Benadryl and now completely resolved on 10/16/2011.
PATIENT FAINTED & FELT DIZZY WHILE USING MEN'S URINAL SHORTLY AFTER HE WAS GIVEN HIS 1ST MONDERNA VACCINE. WIFE REPORTS  HE WAS HISTORY OF FAINTING & ANEMIA, ALTHOUGH THESE CONDITIONS WERE NOT MENTIONED DURING PRE-SCREENING NOR WHEN HE FILLED OUT HIS CONSENT FORM.  HE WAS TAKEN BY AMBULANCE AS A PRECAUTION, ALTHOUGH HE WAS ALERT AND RESPONSIVE
Vaccine provided on 1/15/21, patient admitted 1/16/21 with right thalamic intracranial hemorrhage
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: A young woman in the office did have the vaccine and, she got COVID-19, now has long COVID. She is dying to pieces right now.  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-202300147060 same reporter, different drug/pt; Report 3 of 3;US-PFIZER INC-PV202300064867 same patient and product, different dose and event;US-PFIZER INC-PV202300064904 same patient and product, different dose and event;
shingles/ went right up to the side of face, in my mouth; ill; will not be getting the 2nd vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient got a huge outbreak of shingles immediately after vaccination, that went right up to the side of his/her face, in my mouth and then cleared up, refer case US2021AMR205389 ).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (serious criteria hospitalization), sickness (serious criteria hospitalization) and incomplete course of vaccination. On an unknown date, the outcome of the shingles, sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that he/she had another shingles outbreak right after when the 1st outbreak was cleared up and was so ill and was hospitalized for it. The patient would not receive 2nd dose of Shingles, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available. This case was linked with case US2021AMR205389, reported by same reporter for same patient. Note: As it was not cleared if the 2nd dose schedule was over or not, hence conservatively captured 2nd dose as suspect and incomplete course of vaccine as event.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205389:same report
headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
A report has been received from a Health Professional concerning a 54 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The Health Professional reported that INADVERTENTLY GAVE FLUMIST QUADRIVALENT TO A 54 YEAR OLD. The outcome of the event of INADVERTENTLY GAVE FLUMIST QUADRIVALENT TO A 54 YEAR OLD is unknown. The report was considered to be non-serious.
Started swelling Wednesday night 3-14-18 got worse until 3/20 started getting better. She thought it was a normal side effect - had chills and HA.
ongoing burning pain in shoulder and arm formats 2 weeks. Severe rash on shoulder and arm. Over the counter pain meds not effective. Not getting better
12/6:Same day of vax-red splotches w/ scattered erythema.12/7: persistant splotches w/ some scattered wheals.12/8:Multiple areas of splotchy erythema & raised wheals.Tx w/ Atarax-cleared up entirely by evening of 12/8.
Rebound Covid; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Pacemaker" (unspecified if ongoing). Concomitant medication(s) included (other medication in 2weeks): ATENOLOL; ESCITALOPRAM; TRAZODONE. There was no known drug allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "not recovered", described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive, notes: Rebound Covid.  Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment with Paxlovid with indication treatment of COVID-19, treatment started from 22Aug2022 and stopped 27Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
student felt dizzy immed following vax & was given juice & dizziness resolved;came back 1hr later & c/o dizziness, h/a;sent home from school;encouraged to see MD if sx worsen or are not resolved;
Developed chronic recurring daily headache diagnosed as inflammation of the occipital nerve after receiving the Jensen Johnson and Johnson vaccine. The headache started several hours after the vaccine and has become chronic and ongoing. Currently being treated with tests and MRI scheduled at Neurology. Provider, PA
Induration and dusky erythema with heat and mild pain over right lateral deltoid area. Size 5 cmx 7cm. Onset one day after injection. 99 temp.
Dizziness, difficulty breathing, wheezing, paleness, weak, fast heart beat. This occurred about an hour after being administered the flumist vaccine. I was told by nurse that even if I have asthma I could still have vaccine as long as I'm taking medication for asthma.
THE SAME NIGHT OF BEING VACCINATED MONDAY 11/13/17. AT NIGHT PT FELT VERY SICK & PT COULDN'T SLEEP. THE NEXT MORNING AT WORK PT VISUALLY NOTICED WIDESPREAD REDNESS AT INJECTION SITE (LOCAL). PT NOTICED IT WAS WARM TO THE TOUCH (VERY HOT). BUT PT DID ADMIT LATER WEDNESDAY EVENING THEY FELT MUCH BETTER (NOT FEELING SICK BUT JUST ARM FEELING WARM TO THE TOUCH & RED).
STARTING THE DAY OF VACCINATION -SICK STOCHE AND HEADACHE. 2 AM FOLLOWING DAY BODY PAIN AND NOTICED VISION WAS BLURRY.THOUGHT IT WAS CAUSE OF EARLY HOUR.LATER THAT DAY HEADACHE CONTINUED TO GET WORSE STARTED RUNNING A FEVER.I WENT TO WORK 130PM (WORK@HOME CUSTOMER REP) AT 130 PM VISION WAS BLURRY BUT ABLE TO FOCUS ENOUGH.FEVER CONTINUED TO RISE. BY 3PM FEVER WAS 101.6 AND 423PM I HAD TO LEAVE WORK CAUSE OF HEADACHE AND BLURRY VISION WAS TO POINT COULD NOT READ COMPUTER SCREEN. BLURRY VISION CONTINUED TO GET WORSE.WAS BUMPING INTO FURNITURE AND DOOR FRAMES. FEVER OVER COURSE OF THURSDAY JUNE 17 TO SUNDAY JUNE 20 GOT AS HIGH AS 103.2  THE BODY PAIN, SEVERE FATIGUE,HEADACHE ,SICK STOMACH,AND DIZZINESS LEFT  ME NOT ABLE TO DO MUCH BUT LAY STILL WITH GETTING UP TO GO TO THE BATHROOM. AND OCCASSIONALLY CHECKING IF I COULD SEE WELL ENOUGH TO READ. i HAD TO LEAVE WORK EARLY tHURSDAY AND CALL OUT FRIDAY AND SAUTURDAY BECAUSE FELT SO BAD AND VISION .I CALLED DOCTOR THE 17 JUNE AND WAS TOLD TO ROTATE TWEEN IBUPROFEN AND TYLENOL  AND TO GIVE IT A FEW DAYS AND EVERYTHING WOULD GO AWAY.WHICH  HELPED KEEP FEVER BELOW 102. BY SATURDAY WAS NO LONGER BUMPING INTO FURNITURE OR DOOR FRAMES BUT STILL UNABLE TO SEE IN DETAIL.BY SUNDAY I COULD MAKE LETTERS IF THEY WERE HUGE.i USED AND AM USING CAMERA ON CELL PHONE TO MAGNIFY WHAT I READ.OTHER WISE LOOKS LIKE BLACK LINES.BLURRY VISION WAS NOT SOMETHING I WAS WARNED ABOUT. JUNE 21 STILL BLURRY VISION,HEADACHE,FATIGUE,DIZZINESS IF I MOVE TOO FAST,SLIGHT NAUSEA.ALSO EYES FEEL BIGGER THAN NORMAL WITH SOME TENDERNESS AND PAIN
There was no treatment. The vaccine made me sick to my stomach that I could not stand up while I was at work. I had to sit for about 10 minutes before I had to get back to work. It gave me headaches and made me very emotional (I am not an emotional person.) This lasted for a few days of continuous headaches and that suck feeling, along with bruising and the inability to raise my arm above my head for a few days due to the soreness. The headaches still continue now. (03/07/2016)
Patient calls, reports that he received his pneumococcal immunization  in his right arm. He shares that the shot itself was not painful. He said he noticed a burning sensation when the fluid was pushed in only.  By Friday night, his right arm was "throbbing" and was very painful.  By Saturday night, it was improving and is less painful. He is able to move his arm without issues.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 09-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA0097942:
COVID-19; Gastric disorder; Respiratory disorder; Nauseated; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), GASTRIC DISORDER (Gastric disorder), RESPIRATORY DISORDER (Respiratory disorder), NAUSEA (Nauseated) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19), GASTRIC DISORDER (Gastric disorder), RESPIRATORY DISORDER (Respiratory disorder), NAUSEA (Nauseated) and HEADACHE (Headache). At the time of the report, COVID-19 (COVID-19), GASTRIC DISORDER (Gastric disorder), RESPIRATORY DISORDER (Respiratory disorder), NAUSEA (Nauseated) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was unknown.  On unknown dates, the patient experienced stomach problem, breathing problems, nauseated, COVID-19 and headache. Moderna COVID-19 vaccine (Elasomeran) was also considered suspect.   The patient had stomach problem, breathing problems with Rinvoq. She felt nauseated and had headache after taking rinvoq. She took five pills. She took the Moderna vaccination and got COVID.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Treatment medication was not reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.