chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She reported severe headache and right neck pain for 2 days after vaccine - beginning the night of the day she got the vaccine with, severe fatigue, was unable to work.  On 11/17, she noted red spots, which were diagnosed as petechiae at routine clinic appointment on 11/18.  Labs performed included CBCPD and d-dimer.  Platelets were lower than her baseline but still in normal range. D-dimer mildly positive at 0.83, repeat showed rapid rise to 4.05 and had normal results for CTPE, CTA of head/neck and CTV of head/neck with d-dimer even higher at 7.64 that same day, but symptoms had all resolved except mild neck pain.   Symptoms seemed resolved but follow-up d-dimer very elevated at > 35.   Additional studies are pending and Hematology consult, and patient remains off work until further workup, and ideally normalization of labs.
Pfizer-BioNTech COVID-19 Vaccine .  Tiredness, headache, muscle pain, chills, fever. The symptoms lasted for 24 hours.
Bad reaction to shingles shot on 9/6/13. Local redness, hot to touch. Seen by ARNP for possible cellulitis - Rx' d
Pt vaccinated with Engerix-B 20 days later experienced moderate pain in rt arm; numbness in my arm & tingling in fingers; /W ea day the pain progressed to my lt arm, & lower extremities; general feeling of malaise, fever.
The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; The first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards; This is a spontaneous report from a contactable consumer.   A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in the left arm on 20Mar2021 as single dose for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included etonogestrel (IMPLANON) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported. The patient was also taking unspecified multivitamins. No other vaccines were administered within four weeks of vaccination.  On an unspecified date in 2021, the patient noted with the first shot I had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Details were as follows: patient noted that she never had period due to birth control methods. Following the  first shot, she had a slight headache hours after the shot, and then got light embryos bleeding a few day afterwards.  No treatment was given for the events. No COVID infection was noted prior to the vaccination, no COVID test was performed post vaccination. The outcome of events was unknown.
72 hours after second Phizer vaccination had right heart pain that was sharp. I assumed it was Pericarditis from SLE Lupus but didn?t flare until fifth day. Lasted about 5 days. Took extra OmegaBrite.
First presented as trouble breathing, later moved to fatigue and aches, loss of appetite and by end of day, a fever. This was 6 days after the vaccine. Appetite still gone next day, temp elevated, but no longer a fever, body aches and fatigue. 3rd day, still little appetite, no more fever, body still hurt, but not nearly as bad, voice was hoarse. By day 4, feeling much better. Appetite still not quite back, but fatigue wasn't a big issue anymore.
PT VACCIATED WITH MODERNA ON 3/15/21 (LOT 001B21A) + 4/12/21 (LOT 030B21A). S/O BEGAN 12/30/21, TESTED + 1/03/22
on 11/15/2021 patient was admitted to hospice after a steady decline with increased falls and mental status changes and severe weakness since the day after she received her pfizer booster, per family. Patient expired on December 12 2021
The third vaccination provider apparently got it right but he now has received 3 doses and only one of them was valid; unnerving; that shot of the vaccine was also invalid because the county said it was one day expired.; ended up shutting down because of temperature excursions; ended up shutting down because of temperature excursions; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program. A male patient of an unspecified age received 3 Pfizer Covid doses. The first dose on 07Apr2021, this was from the vaccination clinic that they ended up shutting down because of temperature excursions. That first dose he had was considered invalid and tossed out and they ended up closing on the 30Apr2021. As per the guidance from a Pfizer document that was online was that if you had a temperature issue and get a dose that was invalid to get the dose again immediately. However, as per the state recommendation, stated that to wait 3 weeks and then restart the regimen unless you have already had two and then only get a third dose. So, per the states recommendation, patient waited for 3 weeks to get his first dose again (a second dose). Patient received 2nd dose (revaccination of his first dose) on 28Apr2021, it was stated that shot of the vaccine was also invalid because the county said it was one day expired. So, two different providers got it wrong, and he said it was possibly for 3000-9000 doses (unable to verify the number he stated). He stated it was more than one agency and he thinks the staff even confiscated doses and was told to receive next shot in the series. Patient received the second dose (a third dose) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 20May2021 at a single dose for Covid-19 immunization. The third vaccination provider apparently got it right but he now had received 3 doses and only one of them was valid. Patient enquired whether like to know how to proceed and if he should receive a 4th Pfizer Covid vaccine in this situation. He stated it was unnerving to have 3 doses when you are supposed to have 2. The outcome of the events was unknown.  Information about lot/batch number has been requested.
This spontaneous report was received from a physician via a company representative concerning a 1 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of 2 milliliter (ml) of ROTATEQ (lot number and expiry date unspecified), orally as per the schedule. No concomitant medications were reported. On an unknown date, the patient was hospitalized for rotavirus. The patient sought medical attention. An unspecified treatment was provided. The outcome of the event was unknown. This is one of the two reports from the same source. Additional information has been requested.
Severe pain at injection site, redness, swollen, tenderness. Started with 24hrs of shot. It is being called COVID arm. Nausea for 24hrs , headache and fatigue.
pt recv vax;woke up w/ fatigue & impending migraine;general malaise; T 102 by afternoon w/ muscle tetani (yasonian type) of arms & legs;soak in tub,unable to get out w/o assistance;diaphoretic;on fri improved but leg muscles still weak;
Local erythema with severe itching and swelling around injection site 10-12 inches in circumference with induration 6 days after vaccination followed by urticarial generalized rash involving entire body.
LOST VISION IN RIGH EYE 10 DAYS HOSPILIZED  STERIOD TREATMENTS PLEXPHERIS (5 DAYS) ON STERIODS FOR ANOTHER 2 WEEKS  AFTER I CAME HOME STILL BLIND IN RIGHT EYE
Took fourth dose on day 6; Spontaneous report received on 17DEC2019.  A female consumer reported that she "took fourth dose on day 6" (PT: Inappropriate schedule of product administration) while being on oral Vivotif for typhoid fever prophylaxis. The consumer took the first three doses of Vivotif according to schedule on day 1, 3, and 5 respectively but took the fourth dose on day six instead of day seven. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took the first three doses of Vivotif according to the schedule but took the fourth dose on day 6 instead of day 7 (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took the first three doses of Vivotif according to the schedule but took the fourth dose on day 6 instead of day 7 (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
sweating; allergic to all medications since; reaction of pins & needles; This case was reported by a consumer via interactive digital media and described the occurrence of sweating in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced sweating, drug allergy and pins and needles. On an unknown date, the outcome of the sweating and pins and needles were unknown and the outcome of the drug allergy was not recovered/not resolved.   It was unknown if the reporter considered the sweating, drug allergy and pins and needles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported The patient reported that, he/she had the Shingles vaccine 3 years ago & his/her body has had a terrible reaction since, within 3 days the  patient was sweating & have been allergic to all medications since. The patient also had a reaction of pins & needles over all his/her upper body. The patient reported that, he/she was never allergic to anything in entire life. now the patient was miserable.
patient experience pain at site of injection which progress to formation of knot and the knot has continued to grow. Patient decided to call in because the knot appears to grow and pain increase. Patient has tried massaging area and moving arm around.
Office would draw up all COVID booster vaccines at the beginning of the day and discard vial. They kept a sticky note with bivalent  NDC, lot and expiration date and used that data to enter into the system. At some point the realized that on some days they had pulled and administered monovalent instead of the bivalent booster as intended. Office is unable to say with certainty who received monovalent or bivalent.
Noticed the vaccine seemed to burn; Pain at the injection site; Experienced a little fatigue; Large welt developed about the size of a baseball at the injection site; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches), BURNING SENSATION (Noticed the vaccine seemed to burn), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Experienced a little fatigue) and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Experienced a little fatigue) and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Noticed the vaccine seemed to burn). At the time of the report, PAIN (Body aches), BURNING SENSATION (Noticed the vaccine seemed to burn), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Experienced a little fatigue) outcome was unknown and VACCINATION SITE URTICARIA (Large welt developed about the size of a baseball at the injection site) had resolved.            No concomitant product reported by reporter. Patient noticed that the vaccine seemed to burn more than the previous doses. No treatment medication reported by reporter.
Fatigue; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. This consumer reported for 2 patients (Herself and Husband). This is 1st of 2 reports. This female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an intramuscular route of administration in left arm on 19Jan2021 01:30 PM (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were none. Prior vaccination was none. The following information was reported: FATIGUE (non-serious) with onset 19Jan2021, described as "Fatigue". Patient stated that they were not able to schedule the second dose until 3 weeks and 6 days later. The caller said there was no available appointment in 3 weeks and asked if this will affect the efficacy of the vaccine. The reporter also mentioned that she read from Israel that one dose of Pfizer's COVID vaccine was lasting a lot longer and could go 9 weeks out while the UK has moved the second dose to 12 weeks. Relevant tests were none. Therapeutic measures were not taken as a result of fatigue. The clinical outcome for the event was unknown.  Follow-up (05Feb2021): This is a follow-up spontaneous report from a Pfizer-sponsored program Pfizer First Connect. It was unknown if the reporter was a health care professional. The Occupation/Specialty was Unknown. The Reporter's contact information available to you or a sub-contracted party. The reporter was the prescribing HCP.   Follow-up (13Apr2021 and 10May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to non-hcp letter sent via follow-up letter which included: route of administration, anatomical site, vaccination time and dosage details of Dose 1 added, Event fatigue added.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143240 different patient, same drug/AE
Hives and itching x 3 days, started appx 26 hours after vaccination
11:04 C/O nausea, lightheaded, throat dry, difficulty swallowing.   BP: 170/101 (auto) and 150/98 (manual)  P: 86.  R: 16.  O2Sat: 99%.  1  11:21 C/O Difficulty breathing.  No facial swelling or edema noted.  R: 16 No  stridor noted.EMS activated.    BP:  110/76.  P:79.  O2Sat: 99%.  Feeling flushed.  Redness on Rt arm due to band-aid, not injection.   EMS activated.   11:30 difficutly breathing subsiding.   Arm burning decreased.  EMS transport offered and declined.   11:40 EMS vitals: BP: 152/10;3. P: 80.  O2Sat: 98%.  nauseated.  Lump in throat subsiding.  Possibly pregnant per vaccine consent. Discharge instructions given by EMS.  Standing vitals:  BP: 175/ 92.  P: 80.  O2 Sat: 100%.   Husband contacted; picked up client at 12:15.
Slight head heaviness; Low grade fever 99.2 degrees 19.5 hours after taking vaccine; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 59-year-old female patient received second single dose of BNT162B2 (Pfizer-BioNTech, Solution for injection, lot number: EL8982, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 22Jan2021 16:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included hypothyroidisim, osteoporosis, and kidney 'nephrectormy.' The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication/ other medications the patient received within 2 weeks of vaccination included levothyroixine and alendronate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first single dose of BNT162B2 (lot number: EJ1686) on 04Jan2021 11:00, vaccine location: left arm for COVID-19 immunization. The patient experienced low grade fever, with temperature of 99.2 degrees and slight head heaviness on 23Jan2021 11:30 (19.5 hours after taking vaccine). The events were considered as non-serious by the reporter. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given the events. The patient was recovering from the events at the time of reporting.
15 minutes after covid Pfizer had LOC, she had about 3-3 minutes. LC, rolling eyes and head, palor, mild writhing of trunk and arms, head rolling, flaccid muscles tone, she was manually restrained in her chair to prevent falling to ground and injury, there was urinary incontinence, no lip or cheek biting , when she regained consciousness she had emesis x2  (yellow liquidy) She was AOX3 when she came too, no apparent post ictal state,
Patient received a dose of Moderna COVID vaccine that was past the 12 hour expiration date.
Patient received their first dose on Pfizer on the morning of 04/17/2021 and later that night began noticing discoloration in numerous areas of her body including: inside of ankles, forearms, breasts,  back, lower abdomen, calves region. Over the next day or so those discolored areas mentioned previously began blistering and turned into open sores. She went to her primary physician where they completed blood tests, which returned as normal, and a physical exam. The physician's conclusion was a shingles-like reaction. Over several weeks the blisters and sores healed leaving a discolored area. The patient mentioned that the areas mentioned did not itch or produce any hives. They were only painful. The physician recommended the patient go back to the pharmacy where she received that first dose so she could discuss the reaction with the pharmacist and obtain the lot number, so this incident may be reported. The patient reported to me that she did in fact have a varicella infection when she was younger. She has numerous photos taken  if you decide to investigate further. She has received influenza vaccinations in the past with no reactions.
Back issues; Patient had all three vaccinations/just pain in arm; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Back issues), VACCINATION SITE PAIN (Patient had all three vaccinations/just pain in arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 18-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced BACK DISORDER (Back issues) and VACCINATION SITE PAIN (Patient had all three vaccinations/just pain in arm). At the time of the report, BACK DISORDER (Back issues) had not resolved and VACCINATION SITE PAIN (Patient had all three vaccinations/just pain in arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  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.
Patient presented for first dose of Covid vaccine.  Received Moderna vaccination without incident.  Client was only 17 and error was not discovered until after the clinic.  Patient is being scheduled for second dose per CDC guideline.  Nurse notified and admitted that when new registration started it was harder to verify birthdates and she wrongly assumed client was old enough.  New process has been put in place for all nurses to circle land initial age on paper registration form or write the age on the blue paper used in conjunction with electronic registrations.
All 4 injection sites became red, rt. arm where VARIVAX given very large about 2 " red spot, hot, itchy. Other spots have resolved.
blood pressure was going real high, then go low; dehydration; diarrhea; blood pressure would drop to 40; will go upto walking rate 95 to lower 100s; heart rate normally stays 60s - 70s (averages 66 for resting rate); heart rate going up now; A spontaneous report was received from a consumer who is a 82-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase, which led to hospitalization.   The patient's medication history included diabetes and high blood pressure. Concomitant medications included amlodipine , irbesartan and pravastatin.  On 21-Jan-2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch 012L20A ) intramuscularly in the the left arm for prophylaxis  of COVID-19 infection.  The patient referred he had diarrhea prior to the administration of the vaccine. Following the vaccine administration, he continued having the diarrhea during 3 weeks that made him lost a lot of fluids. He attended to the ER several times for dehydration but in the last visit, he got admitted due to increased blood pressure, dehydration, increased heart rate and prior history of diabetes.   Laboratory details included electrocardiogram, stress test. Treatment information included fluids,taken off metformin and metoprolol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, worsening diarrhea, dehydration, increased blood pressure and heart rate fluctuations with tendency to increase were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L027591, expiration date 23-JUL-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to a temperature excursion described as a minimum (MIN) of 33 Fahrenheit (F) degrees for 10 minutes and a maximum (MAX) of 48 F degrees for 10 minutes. The healthcare worker also stated that the MIN and MAX were not cleared previously. No previous temperature excursion was noted. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
NAUSEA, DIARRHEA, STOMACH ACHE, HEADACHE, BODY ACHE