chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-JUN-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a nurse practitioner, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 21-JUL-2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed acyclovir and gabapentin for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Terrible/Chronic Diarrhea, nauseous, vomiting,  massive stomach pains.
I had COVID19 Vaccines EUA on 1/12/21 & 2/9/21. Most adverse effects I had after the first shot. On the same day around 7:30 p.m. head started to burn and the rest of my body shiver. Whole body skin became super sensitive - it hurt to move sharply. I took Tylenol 1300mg and Advil LiquiGel 400mg. Temperature was up & down (97 to 100.7) for 2 days. Friday 1/15 temperature became normal, but my body started to feel severe muscle twisting aches and that continue for 4 days straight. I've continue to take Tylenol and Advil every 4-6 hours. After muscle aches subsided on Tuesday 1/19, all joints started to hurt (two days of nagging & strong pain, most-knees & hands). Suddenly I started to cough for no apparent reason.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On 11-SEP-2013, the patient was vaccinated with an expired dose of 0.5ml M-M-R II, (lot # 1123AA, expiry date 12-JUL-2013, route was subcutaneous). No adverse effect reported was unknown. Additional information has been requested.
the patient had night sweats for four or five nights after having his second dose; he would wet his bed sheets with sweat and they had to be changed; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 3-year-old male patient received BNT162b2 (BNT162B2), as dose 2 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 (MAROON CAP), SINGLE), for Covid-19 Immunization. The following information was reported: NIGHT SWEATS (non-serious), outcome "recovered", described as "the patient had night sweats for four or five nights after having his second dose"; HYPERHIDROSIS (non-serious), outcome "recovered", described as "he would wet his bed sheets with sweat and they had to be changed".  Additional information: The patient got the first two doses of the Maroon cap Pfizer Biontech COVID-19 vaccine. The doctor referred the patient had night sweats for four to five nights after having his second dose, he would wet his bed sheets with sweat and they had to be changed. He had no other symptoms and after five nights the sweats stopped. This report is not serious.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4/5/07 appears in office Had rash from head to toe, started at trunk with macular erythematous lesions with pinpoint vesicles.  Also noted fever, sore throat and cough.
L arm swelling and redness at site of injection. This moved into deltoids with swelling and pain on day 2-3. On day 4-5, became L tricep swelling and pain. Seen in MD office day 10, still having significant L paraspinal muscle and tricep swelling and pain. Also dizziness with standing without orthostatic hypotension starting day 4-5. Also new elevated HTN (from 120-130s systolic to 160 to 170s systolic) despite no change in medication.
arm is very sore; exhausted!; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Covid vaccine with an associated reaction of adverse drug reaction.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and exhaustion. On an unknown date, the outcome of the pain in arm and exhaustion were unknown.   It was unknown if the reporter considered the pain in arm and exhaustion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had horrible reaction to this shot, much worse than Covid vaccine. However, Shingles pain was worse than labor so the reaction to the shot was better than that. The patient just got the first dose. The patient's arm was very sore, and he/she was exhausted. The patient had shingles and never wanted it again.  The follow up would not be possible as permission denied.
This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a child female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient received Flu shot for the first time and she suffered a seizure behind it. These lies started way back before date of reporting.
Breakthrough case after 5th dose. Family came down with COVID-19. Started having a cough and fever. Took a home COVID-19 test and tested negative three days in a row. Then on the 4th day 08/02/2022, tested positive. Had a telehealth appointment and was prescribed Paxlovid and Teflon Pearls.  Feeling better but hasn't taken another COVID-19 to verify Negative result.
Pt was found deceased at home on 3/10/21. He had had a cough prior to, recent hospitalization for pneumonia/acute on chronic resp. failure.
the area was red and swollen at the injection site; the area was red and swollen at the injection site; It's feels like a big knot and feels tender just like the last time; It's feels like a big knot and feels tender just like the last time; the area was red and swollen at the injection site; the area was red and swollen at the injection site; It's feels like a big knot and feels tender just like the last time; It's feels like a big knot and feels tender just like the last time; This spontaneous report was received from a medical assistant and refers to a 31-year-old patient of unknown gender. The patient's concurrent conditions included allergy to ceftriaxone sodium (ROCEPHIN). Concomitant medications included metformin and birth control pills. He/she had no pertinent medical history.   On 15-FEB-2023 and 12-APR-2023, the patient was vaccinated with the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, (lot # W013165, expiration date: 14-DEC-2024 [for both doses]) administered as prophylaxis (route of administration was not provided).   The reporter stated the patient developed injection site reaction after receiving the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient mentioned to the medical assistant that the area was red and swollen at the injection site, and that it felt like a big knot and tender just like the last time. At the reporting time, the patient had not recovered from vaccination site erythema, vaccination site pain, vaccination site swelling or vaccination site induration (onset date: April 2023).  The reporter did not provide a causal assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
The infant presented in the office with a nosebleed, evolving  bruising and pinpoint petechiae 12 days post MMR. Diagnosed with Thrombocytopenia purpura. Hospitalized for dropping platelet count and administration of IVIG. Eventually flown to another hospital for continued treatment. Secondary diagnosis - microcytic anemia & iron deficiency. Eventual recovery in progress; discharged 5/9/02, presently on Prednisone & iron.
Received 1st dose of Rabavert on June 30th 2020 under pre exposure schedule; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert. On an unknown date, unknown after receiving RabAvert and an unknown time after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Rabavert on 30th June  2020 under pre exposure schedule but already passed the 7 days for next dose, which led to  incomplete course of vaccination. The reporter consented to follow up.
feel vertigo; lightheaded; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 35 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination : Yes. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset Apr2021, outcome "unknown", described as "feel vertigo"; DIZZINESS (non-serious) with onset Apr2021, outcome "unknown", described as "lightheaded". Therapeutic measures were not taken as a result of vertigo, dizziness. Additional information: The patient had no known allergies to medications, foods or other products. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. After 3 weeks the patient started adverse events. The 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. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 01/13/2023, I started feeling symptoms around the middle of the day and it just kept getting worse. The next day, I called my doctor's office to inform them of the positive results I received on an at home COVID-19 test. I was experiencing headache, nausea, diarrhea, sore throat, fatigue, aches, a slight fever, and chills. My temperature was 100.5. He sent a prescription of LAGEVRIO. I wasn't able to get that filled until the next day 01/16/2023. He prescribed 40 capsules to take for 5 days. I stayed pretty sick even after taking the prescription. The second night I was taking it, I couldn't keep anything on my stomach. I felt a lot worse for a few days and then I started to feel a little better. After I finished the medication, I was still testing positive. My doctor advised that I could test positive for a while but to watch it. After a few days, I finally tested negative but was still very tired. At this point, I finally feel back to normal.
pt recv vax SEP96 & NOV96 pt exp loss of appetite, aches, & pains, backache,  diarrhea;pt examined by MD;CXR & profile 6 were both negative;pt has not yet recovered;pt recv vax w/one of the recalled lots, unable to ID specific lot#:
Headache, fever/chills, insomnia, muscle aches, swelling at injection site. Most symptoms dissipated after 2 days.
Extreme dizziness when I am laying down or turning from side to side while in bed. Feels like room is spinning. Getting worse by the day this week.
Had flu shot on 1/19/2018 that evening arm really hurt and could not lift left arm I waited for 3 days and still hurting went back to doctor office on 1-22-2018 was told to take aleve and put heating pad, I did that another week and at this point i could not sleep or lift arm at all went back to doctor and she refered me to a ortho doctor he done xrays and could not say it was from shot he prescribed Prednisone for 7 days and that I should have been using ice not heat and if that did not work that i may need a cordizone shot  and possible physical therapy.
10?21/21 10:10am: Employee received flu vaccine and developed left sided numbness about 15 minutes later. Numbness is improving a little. No prior hx of this reaction from a flu vaccine. Patient did react the same way from her COVID vaccine 1/6/21. She later had partial loss of use and strength in her legs which lasted about 10 days. Referred to PCP.
I did not have an adverse reaction to the vaccine. On 03/23/2022 is when I started feeling a drooping eyelid on my left eye. I went to my doctor, and I had conjunctivitis. I was referred to other doctors for diagnosis. I was diagnosed with myasthenia gravis primarily in my eyes. It is a chronic autoimmune disease that will not get better.
My wife and I were vaccinated on the same day/time. Dec10 she tested positive. Dec10 she took Plaxivid. By Dec14 she tested negative. On Dec23 she experienced rebound from the Plaxivid. We had not distanced for several days. I tested positive on Dec25. Became very ill.
Pharmacist administered Fluzone Quadrivalent High-Dose to patient who is 63 years old without a prescription from their doctor. Patient was recommended high dose by their doctor, but did not have prescription. The recommended age for this vaccination is 65 years and older.
ABOUT MONTH & A HALF AFTER I RECEIVED 2ND DOSE MY HAIR STARTED BREAKING OFF REALLY BAD & THEN I WOKE UP ONE MORNING & MY LEFT EYE WOULDN'T OPEN I NOTICED A RED RASH GOING DOWN THE SIDE OF MY EYE & DOWN MY NECK & MY ARMS THEY WERE BLOOD RED IT BURNED SO I WENT TO URGENT CARE & WAS GIVEN A Z-PAK THE DR SAID MY LEFT EYE & MY LEFT EAR WERE SWOLLEN & IRRITATED. SO THEN AFTER ABOUT A WEEK I WENT TO SEE A DERMATOLOGIST & WAS GIVEN 15 DAYS OF STEROIDS.
Vaccine administered 7-10-09, pt reported swelling the size of a grapefruit and pain on 7-11-09 in pm. Pt did not seek treatment.
Breakout of plaque psoriasis on chin; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Breakout of plaque psoriasis on chin) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Breakout of plaque psoriasis on chin). At the time of the report, PSORIASIS (Breakout of plaque psoriasis on chin) was resolving. Not Provided   Concomitant product use was not provided by the reporter.  The patient experienced breakout of plaque psoriasis on chin usually appeared right before next dose with Risankizumab Solution for Injection, Single-Dose Prefilled Syringe with Needle Guard.   On unknown date, the patient experienced breakout of plaque psoriasis on chin usually appeared right before next dose.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the event of Breakout of plaque psoriasis on chin usually appear right before next dose unknown onset with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.  Treatment information was not provided.
Case number PHEH2014US003830, is an initial spontaneous report from a pharmacist received on 21 Feb 2014. This report refers to a patient of unknown gender and older than 55 years of age. Past medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with MENVEO (batch number: not reported) intramuscularly on undetermined date. No adverse reaction was reported following the maladministration.
Fatigue, abdominal epigastric pain, dizziness, omeprazole from prn to daily use, labs ordered, call is symptoms persist, seen again 9/26/12 sent to emergency room.
Feeling tired; Fatigue; Injection site became sore again; Sensitivity on the injection site again; Exhausted; Headache; The pain in the injection site"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Sensitivity on the injection site again), FATIGUE (Exhausted), HEADACHE (Headache), VACCINATION SITE PAIN (The pain in the injection site") and VACCINATION SITE PAIN (Injection site became sore again) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AZ119 and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (Arthritis on thumb on other arm.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (Exhausted), HEADACHE (Headache) and VACCINATION SITE PAIN (The pain in the injection site"). On 08-Apr-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (Sensitivity on the injection site again) and VACCINATION SITE PAIN (Injection site became sore again). On an unknown date, the patient experienced FATIGUE (Feeling tired) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE HYPERSENSITIVITY (Sensitivity on the injection site again), FATIGUE (Exhausted), HEADACHE (Headache), VACCINATION SITE PAIN (The pain in the injection site"), VACCINATION SITE PAIN (Injection site became sore again), FATIGUE (Feeling tired) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medicines were reported. No treatment information were reported.
No adverse reactions have been reported since administration; first dose was administered on 10NOV 2017, the second dose given 30 OCT 2020, and a third dose was administered today 26 FEB 2021; This spontaneous report was received from a nurse referring to a 4-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 10-NOV-2017, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), on 30-OCT-2020, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). On 26-FEB-2021 the patient was vaccinated with an additional dose (extra dose administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) lot number T010092 and expiration date of 19-SEP-2021 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  Other suspect therapies included sterile diluent lot number T002832 with expiration date of 02-OCT-2022. No adverse reactions had been reported since administration.
This spontaneous report was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, unspecified patients were administered with improperly stored RECOMBIVAX HB lot# M026309, expiry date: 11-NOV-2018 for prophylaxis (dosing details were not reported). Temperature was reported as 51.6 F and time frame was 2 hours 20 minutes. There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
HCP reported an improperly stored administered VARIVAX.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 28-DEC-2020, it was administered to the patient an improperly stored of (product storage error) varicella virus vaccine live (oka/merck)(VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, anatomical site of vaccination and route of administration were not provided, lot number reported as S010296, which has been verified to be valid, expiration date reported and validated as 03-APR-2021). The vaccine administered experienced a temperature excursion of -13.3 degrees Celsius (C), for a time of 15 minutes. There was no previous temperature excursion reported and no data logger was involved.
I tested positive for COVID on 9/14/2021. I experienced mild seizure symptoms and migraines since testing positive for COVID. Referred to a Neurologist for additional testing.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A patient developed shingles following 1st dose of Shingrix vaccine. The reporter consented to follow up.