chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received their first dose of GARDASIL 9 at age 14 years; This spontaneous report has been received from a pharmacy technician referring to a 17-year-old female patient. The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not provided.   On an unspecified date in 2017, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, vaccination scheme, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.  The patient wanted to know about the recommendations for the vaccine dose scheme (inappropriate schedule of product administration).
Having reactions lasting for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Having reactions lasting for two weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Having reactions lasting for two weeks). At the time of the report, VACCINATION SITE REACTION (Having reactions lasting for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
extreme fatigue then patient passed away while asleep Narrative:  Unclear if the vaccine is connected to his death. Chart reviewed. He has medical conditions which could have caused his death. Unclear who completed his death certificate. Death was close to a month ago. Whether he had an autopsy or not is unclear. We can report as a suspicious death after vaccination.
During post vaccination observation reported mild tongue swelling. Treated in ED with IM Benadryl & discharged to home. Does have history PCN allergy & carries EpiPen.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PULMONARY EMBOLISM 12/3/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
On the first day 6 hrs after the injection felt a lot of fatigue and headache, next day same symptoms. On the 27th I felt as if I had a UTI.  After an hr I decided to call my OBgyn Dr. went to his office, they did a culture, have not gotten the results from this.  He prescribed an antibiotic, at this point I am not better, taken 2 doses at this time 8 PM.This reaction was from the booster. My first shot I did fine, the second shot I had a bad reaction as well for 4 1/2 days , could not function very well a whole lot of fatigue and aches then at 1 pm on the 5 day I felt fine.
Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JAN-2023, the patient received the 1st dose of Shingrix. In JAN-2023, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.   It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 The case was reported by patient's wife. Member called on behalf of patient.  The reporter confirmed spouse not available to speak.  The reporter stated spouse received the Shingrix and a week to 10 days later the patient got shingles.  The reporter mentioned that the shingles resolved quickly, was not a bad case and spouse was not really in pain.  The reporter stated that she guessed the Shingrix must have helped. The reporter enquired that if patient get the second Shingrix vaccine. The reporter did not consent to follow-up.
Patient reported swelling at the injection site, lymph node within the neck swelling, and pain at the injection site.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 56-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 20-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
diarrhea on 5th day; malaise; Slightly sore arm for 3 days; nausea on 3rd day; fatigue on 3rd day; This is a spontaneous report from a contactable 64-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing sporadic migraines. Concomitant medication included betacarotene, sitosterols (CHOLESTEROL HEALTH) taken for an unspecified indication, start and stop date were not reported. The patient previously took tylenol and experienced drug intolerance. The patient experienced slightly sore arm for 3 days on 30Jan2021 12:15, nausea on 3rd day on 30Jan2021 12:15, fatigue on 3rd day on 30Jan2021 12:15, diarrhea on 5th day on 01Feb2021, malaise on 30Jan2021 12:15. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of slightly sore arm for 3 days (pain in extremity), nausea on 3rd day (nausea), fatigue on 3rd day (fatigue), diarrhea on 5th day (diarrhoea), malaise (malaise). The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
FLOATERS IN EYE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced floaters in eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of floaters in eye was not reported. This report was non-serious.
Fever, Nausea, headache, body aches, facial and lymphatic swelling, swelling heat and rash at injection site, blurred vision, and fatigue.  Seems like every time I woke up from a nap, I would feel a little better.  Kept Tylenol on board and that helped with fever.  This morning, 2/14, I am feeling much better, just have the rash and light headache.
sinus infection; tested positive even though I have had all four shots, the vaccinations against COVID; tested positive even though I have had all four shots, the vaccinations against COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CIPRALEX taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "unknown" and all described as "tested positive even though I have had all four shots, the vaccinations against COVID"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: I tested positive even though I have had all four shots, vaccination against covid. Clinical information: Patient just talked to Health doctor and he told that patient tested positive even though she have had all four shots, the vaccinations against COVID and he is saying that she could receive the Pfizer drug, Paxlovid.  As it was not clarified over the call if consumer consumed Paxlovid while taking Cipralex hence event captured as per verbatim and both captured as suspect conservatively. Is there a product complaint to report: Yes. The patient who was recently diagnosed with Covid-19 and was advised to take Paxlovid. Stated that she has had four doses of the Covid vaccine. Information confirmed as provided. Stated that this feels like she has a sinus infection. Stated that she was with her family and in the last two weeks her grandchildren came down with Covid. Stated that she had called because one doctor said that she can take Paxlovid and one said not to take it because she has taken an antidepressant Citralex which is called Lexapro for the last 10 years. Stated that the agent stated that her doctor knows best. Event details: Stated that she was diagnosed with Covid 19 today.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient presented to ED with complaint of chest pain onset 1 day ago. She was here for infusion and sent to ED due to tachycardia. She endorses CP and SOB starting yesterday, and loss of appetite. Denies nausea currently. She is currently receiving Chemo therapy for Small cell lung cancer.  Patient was found to have pulmonary embolism with platelets of 22.  She was given a unit of platelets and started on a heparin drip.  Her WBC dropped and she was put on prophylactic abx. Patient continued to have drops in her platelets requiring numerous infusions. Once her plts stabilized and she exhibited no bleeding she was cleared for discharge by oncology on a decreased dosing of lovenox of 40mg q12h. Patient also had continued chest pain, primarily from radiation esophagitis. Palliative was consulted and helped put patient on a stable pain regimen. Patient also exhibited some psychotic behaviors, primarily involving delusions of persecution. Psychiatry saw patient and recommended nightly Seroquel. She tolerated this without difficulty.
bone/ joint pain 3 days after getting vaccine for all 3 doses. Pain everywhere. Rash was primarliy on elbows with white coating on it.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Patient became unresponsive with gasping but remained with normal pulse, pt came to within a minute
A 70 year old female consumer reported that she received pneumococcal vaccine polyvalent (mfr unk) when she was 64 years old. Concomitant medication included Prempro. Medical history includes Fuchs' Dystrophy of the eyes. Subsequent to immunization, she developed an injection site reaction characterized by redness, heat and swelling. The consumer reported she experienced a similar event following receipt of Pnu-Imune 23 vaccine in 2002. See case HQ1518028MAR2002. No additional information was available as of the date of this report.
Vertigo. Sporadic onset. Anywhere from 1-5 minutes. Head fog lasting longer
Upper left arm pain, temperature spike to almost 102 F, Dizziness, Body aches, upper leg pain.  Taking OTC med for fever reducer and mild pain reliever
her first dose August 2018 / is unsure that she received the second dose; The area was really inflamed; Scar; swelling went down but nothing else changed.; poison ivy; diagnosed her with shingles; This case was reported by a consumer and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2020, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, inflammation localized, scar, swelling and poison ivy rash. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were recovered/resolved and the outcome of the inflammation localized, scar, swelling and poison ivy rash were unknown.   It was unknown if the reporter considered the shingles, inflammation localized, scar, swelling and poison ivy rash to be related to Shingrix.  Additional details were provided as follows: After receiving 1st dose of Shingrix, the patient experienced area on her left leg that started small and grew. The patient went to urgent care and they quickly diagnosed her with shingles. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The patient believes that it could have been poison ivy because she was outside, however, her son had a mild case of chicken pox also. The area was really inflamed so they gave her a steroid shot and the overall swelling went down but nothing else changed. The patient still has a scar. The patient had steroid shot. The patient was unsure that she received the second dose because her HCP has no record of a second shot in their system and she cannot recall getting the second dose. The reporter consent to follow up.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 10:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.95 for dose administered on 31-Mar-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature range of 32 Degree Fahrenheit from 08:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported
Nine days following my first of two Moderna covid vaccines, I developed a bright red rash around the injection site, measuring at its largest approximately 6" by 4". It is very warm to the touch. It is sore and not itchy. It is splotchy. It is not hard. The skin feels normal except for the warmth. Today is the sixth day of this event, and while it has faded some, it is still there. My PA saw the rash yesterday via telemedicine and she prescribed Cephalexin, as she was suspicious it had become more like a cellulitis. Today, it is still warm and sore, but there is improvement.
2nd dose 9:30AM Friday 9/10 Symptoms Started at 8:30PM 9/10 c cold chills. Then at 2:30AM woke up c fever, Headache, body aches, muscle spasms sore arm/Lump/Lymph node L shoulder
Patient was vaccinated with first does of MODERNA on 7/13/2022. On 9/22/2022, patient was brought to vaccine clinic and received Pfizer dose instead of Moderna.  Patient did not have any adverse side effects as of tis writing and parent is aware he will need an additional dose of Pfizer in 2 months to complete his vaccination series.
Migraine headache severe  24 hours, continuing moderate migraine after effects 48 additional hours, moderate chills and nausea 24 hours Mild itching and swelling 7 days after injection, 24 hours
All symptoms of Guillain-Barre' syndrome, had x-rays, MRI's, and  spinal tap , I have all medical records from beginning to end. Unable to function from this shot, muscles and severe nerve damage, I can barely walk, and do any normal day to day functions.
redness on injection side; itching on injection side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side). At the time of the report, VACCINATION SITE ERYTHEMA (redness on injection side) and VACCINATION SITE PRURITUS (itching on injection side) outcome was unknown.            Reportedly, Patient was willing to know whether redness and itching on injection side  was normal.  Concomitant product use was not provided.  Treatment product information was not provided.
felt ill / got sick; This case was reported by a consumer via call center representative and described the occurrence of illness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 5th November 2020, unknown after receiving Shingrix, the patient experienced illness. On 5th November 2020, the outcome of the illness was recovered/resolved.   It was unknown if the reporter considered the illness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got sick after the first shot. The patient did not want to the 2nd dose. The reporter did not consent to follow up.
Confirmed no additional AE; Nurse called to report on behalf of HCP who inadvertently administered a 12-month-old patient their first dose of VARIVAX and PROQUAD concomitantly on 06/16/2023. Confirmed no additional AE/PQC.; This spontaneous report was received from  a nurse and refers to a 12-month-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously for immunisation (strength, lot #, and expiry date were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Accidental overdose). No additional adverse events were reported.
Area around elbow/lower under arm area by elbow is red, swollen, and itchy but no reaction around injection site
Approximately 15 mins post vaccination, patient returned to clinic with c/o feeling dizzy. Patient had gone to get food since he had not eaten. Patient was pale, skin was cold and clammy, he was instructed to lie down. Every time patient sat up he felt dizzy. Patient then stood up, took 2 steps and fainted, fell to floor but did not hit head. EMS was called. BP was low but steadily improved. 11:00 am BP=100/50, p=86, 11:15 am BP=102/50, 11:30 am BP=120/62. EMT asked him if he wanted to go to hospital and he said yes. Transported to Hospital by rescue. Doctor spoke with nurse later and he stated patient was doing fine.
I had minor tinnitus my entire life in both ears prior to vaccine but shortly after my shots my tinnitus has been very debilitating.
developed acute inflammatory demyelinating polyneuropathy, paralysis of lower extremities, global muscle weakness, severe polyarthritis, pharyngitis, dyspnea, hearing loss
Fevers, drenching sweats, body aches, arm soreness, hand stiffness, dyspnea on exertion starting one day after vaccine administration. Symptoms improving gradually with supportive care that included ibuprofen and acetaminophen.