chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US022842 is an initial spontaneous report received from a nurse on 29 Oct 2013: This report refers to a 48-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) 0.5 ml intramuscularly on an undetermined date in the first week of Oct 2012. On an unknown date after vaccination, she experienced pain (arm) that lasted several months. She ended up seeking medical treatment because of the pain and difficulty in range of motion. Her physician said it was inflammation of the nerves and put her on anti-inflammatory. The reporter stated that even now, there were times when she had a quick reaction (like if something was falling and she went to reach for it) her arm hurt. She would not get an injection in the deltoid because of this. Final outcome of the events was unknown. No further information about causality and seriousness was reported.
Onset of symptoms 1-2 days after 2nd Pfizer Dose. Presented to ER with fever, myalgia, headache, mild thrombocytopenia/leukopenia, elevated hepatic function test. Also noted mild swelling of upper eyelids.
Vaccine administrator realized that patient was pregnant and she shouldn't hve given the live, intranasal vaccine.
Around day 9 post vaccine, injection site was swollen, hard, and hot to touch. Site then started to become itchy, and on day 13, site became large rash around injection site.  Rash is red, warm/hot to the touch, and painful on touch. Feels like it is burning or raw. Cortisone cream applied starting on day 16. Day 17 rash still continues
Out-of-sorts feeling, lethargic, achy, tired, sore arm, itchy eyes This continued for 4-5 days but the out-of-sorts, zoomed out feeling returned yesterday. The itchy, runny eyes has been constant
Patient asked for the Shingrix shot and given the Modera COVID-19 shot instead.
patients who have received vaccines that were previously exposed to temperatures below 32 degrees F.; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to cases 2019SA193105, 2019SA193107, 2019SA193109, 2019SA193110, 2019SA193111, 2019SA193112, 2019SA193113, 2019SA192698, 2019SA192699 and 2019SA192700 (Same reporter).  This case involves a 7 years old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] (lot PIA461M, expiry date: 03-May-2020 via intramuscular route in unknown administration site) on 28-Jun-2019, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 08-NOV-2013 the patient had received a dose of VARIVAX (Merck) (lot number #J004162, exp.date: 08-APR-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences was reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA011524; #1312USA008561). Additional information has been requested.
Patient became lightheaded, pale and nauseated about 10 minutes after receiving the vaccines.  She was lowered to the floor. She never blacked out.  Pulse 70 Resp 20.  Color slowly returned in about 10 minutes.  Sat up, was given some apple juice.  Patient left on her own power with mom 20 minutes after the incident occurred.
pretty bad case of COVID-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (pretty bad case of COVID-19) and DRUG INEFFECTIVE (lack of efficacy) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment Information was provided by the reporter.
DIZZY; HEADACHES ON RIGHT SIDE BY EARS; GROGGY; FELT OUT OF IT; SOARED AROUND ARM; TIREDNESS; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was 380 pounds, and height was 71 inches. The patient's concurrent conditions included pre-diabetes, high blood pressure, pollen allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced groggy. On 02-APR-2021, the subject experienced felt out of it. On 02-APR-2021, the subject experienced soared around arm. On 02-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced dizzy. On 07-APR-2021, the subject experienced headaches on right side by ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from soared around arm, and tiredness, and had not recovered from groggy, headaches on right side by ears, dizzy, and felt out of it. This report was non-serious.
A dose of pediatric Pfizer covid vaccine was administered to the boy who just turned 12. No adverse events reported.
VAQT A which was administered to a patient which was 3 weeks expired; This spontaneous report was received from a Nurse, referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.      On 14-MAY-2021, the patient was vaccinated an expired dose of with hepatitis a vaccine, inactivated (VAQTA), with lot # T014590 and expiration date on 15-APR-2021 (route of administration was not provided) for prophylaxis.   The nurse also reported  "another issue" they had with an expired hepatitis a vaccine, inactivated (VAQTA) (MARRS # 2105USA007618).   This is one of two reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2105USA007618:
I was nauseous and vomiting, chills, slight temperature 99 - 99.8  And body aches and a bad ache where I was injected in my left arm
Had severe difficulty breathing, wheezing, rapid heartbeat and weakness. Started having difficulties breathing around 5:00 p.m. Emergency transported me to ER where I was treated and released at approximately 8:45 p.m. to return home.
appears to be a delayed localized cutaneous reaction developing 6 days post vaccination, that spans about 6-8 inches in diameter and is hot and itchy.  referred to Md
pt recvd vax & was hospitalized;had surgery because of staph infect;father reported specialist told him that shot was contaminated & that it was given too deep & into the bone;father stated pt doing well now but may be paralyzed;also RSV
7 hours after vaccine: Fever up 102.4, Chills/terrible shaking for more than 30 minutes, Pain in feet (7/10), Lightheadedness, Headache, Fatigue Next morning: Pain in feet moved up to above my knees, lightheadedness, overall achiness, headache, fever, fatigue, took Theraflu and symptoms were better Next morning (2 days after vaccine): Low-grade fever (99.0), terrible neck pain and stiffness, mostly resolved by the next day
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 18 months old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L050910, expiry date 14-JUN-2017) dosing regimen unknown. Call was because of a data logger. It was reported that the vaccine was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. The age of patient was more than 18 years. The patient had received 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine. No treatment medications were reported.  This case contains information for the 4 of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798: US-MODERNATX, INC.-MOD-2022-648812:same reporter
Full body rash including face and entire body. The rash is itchy but not unbearable.   Giving child oral antihistamine pills and using hydrocortisone cream.
Patient received Pfizer COVID-19 vaccine which was beyond the manufacturer recommended use time of 31 days at the refrigerated temperature. Organization has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. No known adverse outcomes.
*Vaccine maladministered subcutaneously instead of approved intramuscular route. Pt reported fever of 101*F on 3/6/19.
Massive Headache and body aches.  Imitrex helped with the headache and Tylenol helped with the body aches.  I was feeling fine by the evening.
07/16/2015 Moderate other. Infant has experienced diarrhea and vomiting since 7/17/15. Started with runny nose on 7/16/15. Febrile with highest temperature 101 degrees F (Ax) on 7/17/15.
No additional AEs.; HBP with direct responsibility for vaccines and storage calling to report a TE for PROQUAD; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live  recombinant human albumnin (rHA) (PROQUAD) subcutaneous injection, 1x dose, lot #W034211, expiration date: 24-APR-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 07-MAR-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumnin (rHA) (PROQUAD) went under a temperature excursion. The vacines were stored in 22.3 Fahrenheit (F) for 4 hours 45 minutes 0 seconds (product storage error ). There were no previous temperature excursions. No additional adverse event (AE) was reported.
14 days after the vaccination, I woke up and felt itching all over my body. The itching continued throughout the day. In the afternoon I felt discomfort in the lower eyelid of my left eye similar to the discomfort you feel when you are about to get a cold sore. In the evening and after continuing with the itching I noticed that after scratching the area where I scratched it swells. The skin is marked and turns red. I am currently taking an antihistamine for the allergy. The areas that itch the most are the back of my neck. My legs, head, arms, hands, face, armpits and soles of my feet are also itchy. The antihistamine calms the itching but does not take it away completely.
got headache; kind of ached like she had the flu but not too bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 29Jul2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetic" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing), notes: She also takes supplements due to her osteoporosis. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EL3246, Administered Location: left arm), administration date: 21Jan2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "bone pain", "Bad headache", "Dizzy"; BNT162b2 (DOSE 2, SINGLE, LOT: EL9265, NDC, EXP: Unknown), administration date: 11Feb2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "just ached all over", "Bad headache", "Dizzy"; BNT162b2 (DOSE 3, SINGLE, LOT: FF2589, NDC, EXP: Unknown), administration date: 08Oct2021, when the patient was 75-year-old, for COVID-19 Immunization, reaction(s): "pain was terrible", "Headache was awful", "sick", "hardly eat". The following information was reported: HEADACHE (non-serious) with onset 29Jul2022, outcome "recovered" (29Jul2022), described as "got headache"; PAIN (non-serious) with onset 29Jul2022, outcome "recovered" (29Jul2022), described as "kind of ached like she had the flu but not too bad". Therapeutic measures were taken as a result of headache, pain.  Additional information: Concomitant drugs include medication for blood pressure and diabetes, and supplements due to her osteoporosis. She received a booster on 29Jan2022. The patient informed that the doctor really encouraged her to get it and just block out couple of days. She was going on a cruise, that is why they wanted her to have the next booster. With that one, got headache, kind of ached like she had the flu but not too bad. Took Tylenol, took a nap, got up, felt fine.  Clarified later that same day, 29Jul2022, she felt fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077890 same product, patient, different AEs, different dose;
Symptoms (tingling and numbness) presented intermittently at first, beginning in my feet and progressed up my legs. Then included my hands, arms, face and mouth. Symptoms were progressive, becoming more sustained with less remittance. Symptoms were experienced on both sides of my body, sometimes unilaterally and sometimes bilaterally. Had some subjective weakness but neurology exam was clear.
She was taken to hospital 03/02/2021 where she died at 4 am from a heart attack.
pt recvd vax & w/in 1min,surrounding area about 2" diameter became blotchy red;MD evaluated;over next 30-40mins observation site became inc red & swelling appeared,which nearly resolved by end of 40mins;no tx required;
15 year old received a 0.2ml 5-11 year pfizer dose as a booster instead of 12+ booster dose.
02/11 Received vaccine @3:40P, she was observed for 15min without a reaction. She returned to work and began feeling nauseous , fatigue, and  went back and forth to Bathroom. (She reported " vomiting x2"  on2/11  and emesisx1 on 2/12)  Pt was seen by PCP who requested the she goes to ER 110/68  p72  R16. Ambulance was called and took her to Hospital @5:10p
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age (reported as a child) and gender. Patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with VARIVAX (dosage regimen. rote of administration, lot # and expiry date unspecified). On an unknown date, the patient experienced shingles. It was reported that the patient's mother, who was 14 weeks pregnant at the time of this report, may have contracted herpes zoster from the patient. The outcome and causality assessment for the event were not provided by the reporter. No product quality complaint (PQC) was involved. No further information was available. Additional information has been requested.
One big red circle around injection site also swollen and fever in it and another red blotch below that one. Severe pain, local pain and edema.
Father and mother reported temp. of 106.0 on 12-27; pt. was then seen for OV for possible ear infection on 12-27 and given antibitiotics.
On the 2nd day upper arm appeared red below the injection site. Over the next 2 days, redness grew, warm to touch and painful.  No itching. I took Advil, applied ice and cortisone cream.  Went to PCP today because redness spreading (11-5-21). PCP diagnosed as cellulitis. Prescription for Keflex 500mg cap. 3 x day for 7 days. told to take Advil x 2 Q 4 hours for the next few days.
How many people have to die before y'all stop injecting?; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "How many people have to die before y'all stop injecting?". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Reporter responded to the IVR as (misplaced comment) How many people have to die before we all will stop injecting and customer service. Any medical questions addressed by this program forwarded/referred to medical information were not applicable.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: How many people have to die before y'all stop injecting?
The night after administration at 3 am, she had shivering, and freezing. When she got up she had temperature of 101 degrees F. She took aspirin, temperature came down was 99 for a few hours. On Wednesday, 10/11/23 about 4 pm, you had double vision in both eyes, wet eyes, unable to navigate in chair and needed help getting up (could not walk on her own). Sat back down and stayed for a while, and it eased up, and then it did it again about 5:30 pm. Called eye doctor about 6 pm, to let know about double vision (informed doctor had shots on Monday). Was told by eye doctor to watch out for stroke like symptoms and if occurred patient should go to hospital.
Shots were given on 1/25/02. On 1/28/02, the pt had a temperature of 104F, extreme shortness of breath (requiring 10 liters of oxygen) to help alleviate. Also, had a heart rate of 180 +.
SINUS INFECTION; THYROID PAIN; This spontaneous report received from a patient 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced sinus infection. On APR-2021, the subject experienced thyroid pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sinus infection and thyroid pain was not reported. This report was non-serious.; Sender's Comments: V0- Medical assessment comment not required as per standard procedure since case was assessed as non serious.
2 hours post vaccine I was at observation at the ER due to reaction I had with the 1st dose. By 11:30AM I had a slight headache that progressed to a migraine, around 8PM I started feeling flu like symptoms and chills. At the ER my temp was 99.7F the symptoms lasted for 24 hours but the soreness of the arm that lasted around 2 days.
patient was administered an improperly stored VAQTA; no adverse events; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.     On 23-SEP-2019, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot #S007769, expiration date on 24-JUL-2020 (strength, dose, frequency, route of administration, anatomical location, and indication were not reported).  The administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (9 degrees Celsius) for 9 hours and 55 minutes. There was no previous temperature excursion reported. Data logger was involved.