chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report (United States) was received from a healthcare professional concerning a patient, who was administered COVID-19 vaccine (mRNA-1273), and who experienced receiving half of a dose/ under dose and syringe fell apart/ device connection issue. The patient's medical history was not provided. No concomitant medications were reported. On 01 Feb 2021, prior to the onset of events, the patient received their first dose of  intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was administered, the syringe fell apart, and patient only received half of a dose. No treatment information was provided. Action taken in response to the events was not reported. The outcome of the events, receiving half of a dose and the syringe fell apart, was resolved on 01 Feb 2021; Reporter's Comments: This case concerns a patient of unknown age and gender who received their first dose  intramuscularly for prophylaxis of COVID-19 infection and while the vaccine was administered, the syringe fell apart, and patient only received half of a dose. There were no reported adverse events after the vaccine was administered in this case of syringe connection issue and under dose.
Extreme fatigue leading to a loss of 10 lbs in less than three weeks, Late menstrual period by 7 days(starting yesterday), exceptional pain and abnormally heavy menstrual flow. Celibate.
Approximately 2 weeks later awoke to swollen left wrist, over the course of the next 3 days swelling went from left wrist to fingers, to elbow. Then to right hand, both knees, and ankles. Unable to walk without pain, unable to bend knees to get up or down from sitting/floor. Needed assistance. Eventually both shoulder pain. Saw Dr. on Monday after weekend. She completed exam, prescribed prednisone did blood work for Lyme, rheumatoid arthritis, etc. All came back negative. She made referral to rheumatoid arthritis specialist. Approximately one week later all symptoms gone except right shoulder pain. Over the month of January 2018 right shoulder pain extreme. February 4th saw Dr. for shoulder pain, she stated she did not feel this was arthritis, gave me another round of prednisone and made a referral to orthopedic. Saw Senior Physican Assistant,  Xray was done. Showing mild arthritis on collar bone. Pain is still severe.
Ocular sensitivity to light; This is a spontaneous report from a contactable nurse, the parent. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 36-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on an unknown date (at the age of 36-years-old); both as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021, the patient experienced ocular sensitivity to light. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on 01Jul2021 and tested negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event ocular sensitivity to light was not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Vaccine error/Patient was given Covid orange top 5-11 yr vaccine that was past it's expiration time, vaccine had been drawn up in syringes and left at room temp for 19 hours. Vaccine is only viable for 12 hours at room temp.   Pfizer pharmacist recommended repeat vaccine since there is no data to support vaccine efficacy beyond the 12 hour room temp
(12:54-given vaccine);(14:05 patient complained of itching, got rash all over body, called MD and gave patient benadryl 25mg); (14:10 patient asymptomatic).
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 09-SEP-2015, the patient received an unspecified dose in immunization series for (Oka-Merck) PROQUAD (dose and route of administration were not reported) that was improperly stored. While lot # for adminsitered dose was not specified by reporter, lot # may include: lot # L023113 with expiration date 24-DEC-2016, lot # L008355 with expiration date 11-SEP-2016, lot # L019995 with expiration date 02-DEC-2016, lot # L019994 with expiration date 02-DEC-2016. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
SHORTNESS OF BREATH; THROWING UP; CHILLS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 28-JUN-2021, the subject experienced shortness of breath. On 28-JUN-2021, the subject experienced throwing up. On 28-JUN-2021, the subject experienced chills. On 28-JUN-2021, the subject experienced fatigue. On 28-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, chills, fatigue, headache, and throwing up. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious .
Patient was administered Pfizer dose for a 4 year old vs a 5 year old.  There were no adverse reactions.  Parent was made aware, on 7/29/22 and was to schedule patient for a repeat dose, 2 weeks out.
Received the Moderna COVID-19  vaccine EUA on 12/27/2020, the next day my arm was sore and red.  Had minor muscle aches of my shoulders and neck.  This went away by the second day.  No more symptoms until the 8th day after injection (1/4/2021).  Woke up in the morning with injection site swelling, itching, redness, arm pain, and minor sore throat which lasted 24-48 hours.  No treatment was needed.
swollen fingers; itchy fingers; swollen tongue; swollen parts of face; full body rash; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 23 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Apr2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: pfizer coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FD8448), administration date: 19Aug2021, when the patient was 23-year-old, for Covid-19 Immunization; pfizer coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0170), administration date: 29Jul2021, when the patient was 23-year-old, for Covid-19 Immunization. The following information was reported: RASH (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "full body rash"; URTICARIA (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "hives"; PRURITUS (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "itchy fingers"; PERIPHERAL SWELLING (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen fingers"; SWELLING FACE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae", described as "swollen parts of face"; SWOLLEN TONGUE (hospitalization, disability) with onset Mar2022, outcome "recovered with sequelae". The patient was hospitalized for peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria (hospitalization duration: 2 day(s)). The events "swollen fingers", "itchy fingers", "swollen tongue", "swollen parts of face", "full body rash" and "hives" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Apr2021) Positive; (Nov2021) Negative. Therapeutic measures were taken as a result of peripheral swelling, pruritus, swollen tongue, swelling face, rash, urticaria with EpiPen, Steroids and Allergic medication.  Clinical Course: The patient did not take other vaccines in 4 weeks prior to vaccination. The patient did not take other medications within 2 weeks of vaccination. The adverse events initially started as swollen/ itchy fingers, progressed to swollen tongue, swollen parts of face, full body rash and hives. It was reported that the patient recovered with lasting effects. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent test for COVID-19 post vaccination.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested,
She reported on 4/15/21 that her left elbow started swelling and hurting a bit on 4/11/21. Then next day her neck started hurting. But it wasn't bothersome enough that she reported to her primary care doctor. By today, she reported that the symptoms mostly went away. We advised her to see her primary care doctor regarding her symptoms.
This spontaneous report was received from a medical assistant referring  to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA011654:
4 month old receiving second set of immunizations at well-baby visit on 5/17/04. On 5/18/04 returned to physician's office with reported temp of 105(?) but was 99.9 at physician's. Baby had been given Tylenol. Fussy; site swollen.
broken blood vessel in right eye; flu like symptoms; dull headache/ sharp pain on right side of head; slight fever; exhaustion; upset stomach; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 07Apr2021 11:00 as a single dose for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Apr2021, a day after the vaccine, the patient began experiencing flu like symptoms with dull headache, slight fever, exhaustion and upset stomach. 10 days later, on 17Apr2021, he developed sharp pain on right side of head, and broken blood vessel in right eye. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given in response to the events. The patient underwent COVID test post vaccination via Nasal swab on 17Apr2021 and was negative. The outcome of the events was not recovered.   Information about lot/batch number has been requested.
Experienced some numbness; Tingling in left leg; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old patient of an unknown gender received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150), via an unspecified route of administration in the right arm on 06Apr2021 at 08:15 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to nuts and eggs. Concomitant medications included albuterol sulfate (MANUFACTURER UNKNOWN) since an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 11:15, the patient experienced some numbness and tingling in left leg. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events numbness and tingling in left leg was not resolved.  No further information is expected; information about lot number cannot be obtained.
Chills  1 hour after injection, tightness and aching in upper arm just below injection site and radiating down arm to hand, sleepless night, took two oxycodone during night to alleviate pain
afib; 104.7 fever; tired; Third dose on 21Apr,  (second dose did not meet requirements of CDC guidelines).; Third dose on 21Apr; This is a spontaneous report from a Pfizer sponsored Program.  A contactable other HCP and clinician (as reported) reported that a 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown),via an unspecified route of administration on 01Mar2021 as single dose, second dose via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; axitinib (INLYTA, Film-coated tablet, Batch/Lot number was not reported), via an unspecified route of administration from 10Apr2021 to 22Apr2021, at 1 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced afib, 104.7 fever, tired, third dose on 21Apr. Verbatim and Event Description received as, fever, Atrial fibrillation (AFib), hospitalization, tired, and takes the medication as directed. Patient states Vaccination 01Mar2021, 31Mar2021. Called 4/1 wanted me to take the third dose (second dose did not meet requirements of CDC guidelines). Third dose on 21Apr2021, 22Apr2021 had 104.7 fever, AFib, in hospital four days. Stopped 22Apr2021 Inlyta. See oncologist 28Apr2021.  Felt good when I was on it. Little bit tired, doing okay. The patient underwent lab tests and procedures which included pyrexia: 104.7 on 22Apr2021. Therapeutic measures were taken as a result of afib, 104.7 fever and tired with the medication as directed. Outcome of the events afib, 104.7 fever and tired was recovered for on an unknown date and remaining events were unknown.  Follow up attempts needed. Further information is expected.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported events of atrial fibrillation and fever cannot be excluded, due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Treatment of COVID-19/Woke up with symptoms on Day. Tested positive on 26Dec2022; Treatment of COVID-19/Woke up with symptoms on Day. Tested positive on 26Dec2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 49 years, in right 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: "Known allergies: sulfa meds" (unspecified if ongoing); "TIA", start date: Oct2022 (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19/Woke up with symptoms on Day. Tested positive on 26Dec2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Positive; (05Jan2023) Positive; (06Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course detials: Woke up with symptoms on Day. Tested positive on 26Dec2022. Started Paxlovid that afternoon. Completed course of medication the morning of 31Dec2022. Started experiencing symptoms again on 05Jan2023. Tested and had a faint positive line on at home test. Tested again at home on 06Jan2023 with full blown symptoms and there was a very bold positive line now showing. No denying it! I'm positive for COVID again. 5-6 days after completing my course of Paxlovid. I did not miss a dose and took them all on schedule.
Headache, fever, vertigo, ear pain, blisters in mouth, facial paralysis on right side.  Symptoms began May 18/2021, ER visit 5/23 resulting in diagnosis of Ramsay Hunt Syndrome : shingles (herpes zoster virus) on 7th cranial nerve.
After HPV vaccine pt lied supine for a few min, drank some water (He had an episode of dizziness after last injection of HPV). He left the clinic with dad and as they were driving within 5 min he turned to Dad and said he was going to pass out, he got rigid, starting shaking and bit his tongue, unresponsive for aprox 15sec to a min. He came to and felt cold and clammy. He was able to get out of the car and walked into the house. Dad brought him some juice, he is sitting in the chair, and feels tired.
Left upper arm swollen, redness, warm, mainly on underside, but on outer aspect as well - elbow to shoulder; somewhat hardened to touch - compared to other arm.  No skin eruptions - smooth.  0 fever, 0 diff breathing or increased HR.  SXs still present.
Injected the Bivalent COVID booster into patient's left deltoid. The dose came from a vial that had expired, it was opened the previous day towards the end of clinic hours.
Light headed, almost passed out several time accompanied by nausea.  It would come and go and lasted about 2 hours.  Blood pressure spiked and then returned to normal within an hour.   Injection site painful for 2 days, extreme tiredness accompanied by headache lasted for 4 days.
Full body rash; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported.   A 35-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, Solution for injection,  Lot number: EW0161) via an unspecified route of administration on 18Apr2021 at 10AM, as dose 1, Single for COVID-19 immunization. Medical history included she has dermatitis and her skin was very sensitive. Had vaccinations long before. She never experienced skin rashes or allergic reaction. In general she has dermatitis and sensitive skin. PRIOR VACCINCATIONS WTIHIN 4 WEEKS: none. AEs FOLLOWING PRIOR VACCINATIONS: no. Since 28Apr2021, the patient was not on any concomitant medications (Other Products: No). Experienced full body rash. Dermatologist described rash as morbilli, a very tiny rash all over the body. Began 10 days after the vaccine. Didn't happen immediately. Wasn't itchy and took two weeks to clear (till 10May2021). It was stated that she had symptoms after both dosages of Pfizer COVID-19 Vaccine. Had different side effects after each dose. Spoke with different doctors after each dose. Confirmed she had no other symptoms after the first dose besides the full body rash. She did not undergo any Investigation Assessment. As of now, she has no symptoms. Provided LD or 1D from patient record card. Stated she can't read the writing on the card well. The event resulted in visit to physician office. Dermatologist prescribed Triamcinolone acetonide cream (NDC: 67877-251-30, LOT: W0127 EXP: Jan2024 0.1 percent 30 gram tube) for the full body rash to relive the skin. Cream wasn't very helpful because it took two weeks to clear up. Expected it would help the rash within a week, but stated she was mistaken. It didn't work as fast as she expected. As of day of this report (stated as today) 11May2021, she had no symptoms. The event did not require visit to emergency room. It was stated that she has had side effects for both first and second covid vaccine. The event was resolved on 10May2021.   Reporter seriousness for First dose: Full body rash: Unspecified   No follow-up attempts were needed. No further information was expected.
"COVID Arm".   Large (2"-3") redness and swelling at injection site, rash at injection site and across half of chest.