chrisvoncsefalvay/vaers-outcomes huggingface dataset:
being exposed to freezing temperatures; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 31-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   On 06-NOV-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: being exposed to freezing temperatures). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-NOV-2023 The reporter reported that a patient received a Flulaval QIV vaccine after being exposed to freezing temperatures, which led to incorrect storage of drug. Flulaval QIV Vaccines were exposed to a lowest temperature of 17F from 5th November 2023 to 7th November 2023. Vaccines were not frozen, they were all liquid. The reporter consented to follow up.
tested positive/Treatment of COVID-19; tested positive/Treatment of COVID-19; Dose 1,2,3 and 4 are Moderna vaccine and Dose 5 are Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 at 09:30 as dose 2, single (Batch/Lot number: unknown), in right arm, on 22Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "known allergies: sulfa allergy" (unspecified if ongoing), notes: known allergies: sulfa allergy. Concomitant medication(s) included: FOSAMAX. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 12:00, outcome "unknown", described as "Dose 1,2,3 and 4 are Moderna vaccine and Dose 5 are Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "tested positive/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Negative; (15Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. Other medication in 2weeks reported as Yes includes Fosamax and OTC vits. Anti-viral details: as COVID 19 Treatment patient received Paxlovid, from 06Dec2022 to 10Dec2022. The patient reported she took the full course of paxlovid. She tested negative for COVID on 13Dec2022 and currently, on 15Dec2022 she tested positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I almost fainted after the injection. I felt nauseous, and very dizzy. I felt my blood pressure drop. I broke out into a sweat. I couldn't stand up. My heart is beating  rapidly, and I am still nauseous, and light headed. I have severe pain in my arm, and a feeling of pressure in my head. Also, I had watery stool.
SkinRash, Rash, pruritus. Diagnosed with dermatitis/lichen sclerosis. Reported partial resolution 3/26/2021.  Narrative: Employee reported itching and rashes with skin discoloration "it was severe" . Diagnosed with dermatitis/ lichen sclerosis. Reported partial resolution 3/26/2021.
Initial misuse report received from medical assistant on 13 December 2013. An unknown age and gender had received ACTHIB. (No information was provided regarding the patient). Patient stated that yesterday (12 December 2013) and also in October 2013 took the dose of FLUZONE. She also asked if she could take anything to counteract the over dosage. List of documents held by sender: none.
Autism - Severe.  5/22/07 Received provider medical records which include records from hospital, school, audio/speech & labs. Language delays noted approx age 2 & was referred to early intervention which did reveal language & social delay, diminished eye contact & short attention span.  9/03 started 5-day program at special school w/ST, PT & OT. FINAL Dx: Autism Spectrum disorder; global developmental delay; pica; intellectual limitation. Autism, no speaking
pt recv vax 29FEB96 & 11NOV96 pt devel a symmetrical, papular, gen rash w/no vesicles;biopsy was negative for hepatitis C;
pt recv vax & exp soreness @ the inj site;the initial soreness resolved;6 days post vax pt devel an inj site rxn characterized by tenderness, warmth & a 3-4cm area of induration;
Headache, Myalgia, Arthralgia, Fever, Chills Narrative:  Other Relevant History:
Discovered after vaccination with Pfizer that patient had received Moderna COVID-19 vaccine on 2/13/21.
On June 19, 2021 I woke up around 6:00 a.m. having extreme chest pains. I went to the Emergency Room to be treated. They did an EKG, blood work, and an ultrasound of my heart. My EKG was negative for a heart attack, but my blood work was positive because of my Troponins were elevated. They gave me some aspirin and the chest pain went away. I was admitted into the hospital where I stayed until the end of the day on June 21, 2021. On June 20, 2021 they continued to watch my vitals, took tons of blood for blood cultures and for pretty much every virus you can get along with urine samples as well. All of the test for any virus and the blood cultures were negative. The urinalysis and urine culture were negative as well. Once all test came back negative, the cardiologist ordered a Heart cath. The heart cath was performed on June 21, 2021 and there was no blockage in any of my arteries and everything was clear so I was discharged that afternoon from the hospital. I was diagnosed with Myocarditis or Pericarditis. The doctor prescribed me 25MG Captopril to take 3 times daily and 25 MG Metoprolol Tartrate to take 2 times daily. I have only experienced any other affects a few times since being released which was a burning sensation in my check. I spoke with the doctor and they told me it could be indigestion or heart burn.
Pain, numbness, and tingling in arms and hands within weeks of vaccine. Primarily in the arm that was vaccinated but eventually spread to the other arm. It is still occuring.
Patient was registered for pediatric vaccine dose (5-11 years old) in the system, paper sheet with identification information for patient also had circled that she was in 5-11 age group. She was with two younger siblings who also received pediatric dose appropriately. She was given pediatric dose as registered - it was discovered after they had left the vaccine site that the patient's record could not be saved as she was outside of age range for pediatric vaccine. Called parents phone number as listed and voicemail was left by DOH site lead to return call.
Expired vaccine administered beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was punctured at 9 AM on 15-Sep-2021 and used beyond the 12 hour expiry date in room temp on 16-Sep-2021.   No concomitant medications were reported. No treatment medication was reported.
Vaccine rced 6/5/17, leg swollen, warm to touch, red, irritated, pt. has no fever but states leg is painful. Local reaction or secondary cellulitis. Close monitoring for...see pt. note.
Sick after 2nd vaccine; Swollen Right Foot after 2nd vaccine; Tingling in arms, feet and legs after 2nd vaccine; Numbness in the arms, feet and legs after the 2nd vaccine; Fever 102F after 2nd vaccine; Chills after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine), HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine) and PYREXIA (Fever 102F after 2nd vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MALAISE (Sick after 2nd vaccine), PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine), HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine), PYREXIA (Fever 102F after 2nd vaccine) and CHILLS (Chills after 2nd vaccine). On 12-Sep-2021, MALAISE (Sick after 2nd vaccine), PYREXIA (Fever 102F after 2nd vaccine) and CHILLS (Chills after 2nd vaccine) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen Right Foot after 2nd vaccine), PARAESTHESIA (Tingling in arms, feet and legs after 2nd vaccine) and HYPOAESTHESIA (Numbness in the arms, feet and legs after the 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 102f (High) she had a Fever 102F.         No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-330949.   Reporter did not allow further contact
High fever (102 °), severe muscle pain back, arms, legs, throbbing headache. Unable to drive, or work. Went back to doctor today.
HEADACHE, NAUSEA. HAD TO LEAVE WORK TO RECOVER AT HOME.
Patient tested positive for Covid-19; Cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19), COUGH (Cough) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No past medical history reported.). Concomitant products included VALSARTAN, LEVOTHYROXINE, APIXABAN (ELIQUIS) and SOTALOL for an unknown indication.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PYREXIA (Fever). On 30-Dec-2020, the patient experienced COUGH (Cough). On 03-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for Covid-19), COUGH (Cough) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 100.8 °F. On 03-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
the patient reported that he took Tylenol for the pain in his arm but that it is still  hurting into his shoulder and down his arm  21 days after receiving the immunization
both presented arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "both presented arm pain".  Additional information: She and her husband received the vaccine last Friday, both presented arm pain, she was in a treatment with Penicillin which she suspended last Wednesday, after receiving the vaccine the patient and her husband went to eat seafood and short after the patient began to develop an allergic skin reaction in forearms and face, she went to see 2 different physicians who have given her different opinions about her allergic reaction; one of them stated it might be a reaction of vaccine with penicillin; another stated that it might be an allergic reaction to seafood since he do not think it is a reaction to penicillin due to suspension of treatment by patient (more than 24 hours before vaccination).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 1-2: soreness at injection site, also some warmth Day 10: swollen, red, itchy in entire deltoid area at and near injection site
HIVES, RASH, ITCHING, MILD SHORTNESS OF BREATH.
REDNESS AND PAIN THE FIRST DAY AND SWOLLEN AROUND VACCINATION SITE RA THE NEXT DAY
The day that I received my vaccine, I was fine. I had a minor headache, but that was it. The next morning, I went to get in the shower, the shower started spinning. I sat down and started getting a chest pain. I called my doctor and the nurse told me that if I wasn't feeling better by 1PM, I needed to go see him. If it was very bad, I needed to go to the ER. I called my husband to come home from work. By the time he got home, my chest was very tight. I went to  ER. I told them my chest was hurting. They checked my BP. It was 212/. They provided me with medicine and it brought my BP down. After a while my chest started to harden and I told the doctor it was coming back. He asked how I knew, and I told him that I just knew. They provided me with medication to make me feel better. About an hour and a half later, I started to have the pain again. I was admitted to ICU that day. I had EKG's with and without contrast, X-ray's and CT scans. I could only go up to my neck because I'm claustrophobic. Dr.  came Friday evening and said that all of my tests were good. They let me go home after a week. I still take all of my medicines regularly and I never experienced this again after I left the hospital. I believe it was myocarditis.
UNEXPECTED THERAPEUTIC BENEFIT /NO MORE TREMORS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included tremors. The patient was previously treated with primidone for tremors. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unexpected therapeutic benefit /no more tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unexpected therapeutic benefit /no more tremors. This report was non-serious.
Swollen pain full arm, extremely red, hot, kept spreading down the arm; Swollen pain full arm, extremely red, hot, kept spreading down the arm; Swollen pain full arm, extremely red, hot, kept spreading down the arm; There seemed to be almost a whited head in the center and it looked like it's bruising; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2587), via an unspecified route of administration, administered in right arm on 24Sep2021 (at the age of 56 years old) as dose 1, single for COVID-19 immunization.  Medical history included being diagnosed with COVID-19 from an unknown date prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) on 13Sep2021, taken as a single dose in left arm, for immunization. In Sep2021, the patient experienced a swollen pain full arm, extremely red, hot, kept spreading down the arm, and at the time of the report, there seemed to be almost a whited head in the center, and it looked like it's bruising. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unknown date prior to vaccination. The outcome of the events was recovering.
Fever; poor circulation in hands and feet; resting heart rate over 100; severe abdominal cramps; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant adult female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW150) via an unspecified route of administration in the arm left on 22Apr2021 at 18:00, as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in 2021, the patient experienced fever, poor circulation in hands and feet, resting heart rate over 100 and severe abdominal cramps. On an unknown date in 2021, the patient's heart rate was measured and the result was found to be resting heart rate above 100. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, poor circulation in hands and feet, resting heart rate over 100 and severe abdominal cramps were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Subsequent to receiving vax pt presented in office (08/07/2000) with whole body rash, papular lesions that itched; child uncomfortable; crying; temperature up to 102F.
This case was reported by a healthcare professional and described the occurrence of strange taste in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine ; manufacturer unspecified given on 9 December 2007; hepatitis B vaccine recombinant ; manufacturer unspecified given on 9 December 2007; hepatitis A vaccine inactivated ;manufacturer unspecified given on 9 December 2007. On 9 December 2007 the subject received unspecified dose Fluarix (.5 ml, unknown) intranasally (intramuscular administered by other route) and experienced a funny taste. The same day, the subject was later vaccinated with Fluarix and experienced accidental overdose. No other adverse events were reported. In December 2007, the events were resolved. Outcome of accidental overdose was not specified. The healthcare professional considered the events were probably related to vaccination with Fluarix (causality not provided for accidental over dose). Follow-up information received on 14 January 2008 indicated that the intramuscular formulation of vaccine was mistaken as "Flumist" and administered intranasally. There were no other adverse events other than "bad taste."
Patient reports the day after the second vaccine she had nausea and acid reflux.  Second day after the shot had severe body aches and acid reflux.  The 3rd day after vaccination she had a seizure.  Reported nausea for 5 days after the vaccine.  Reports chest pain on 5/11/21 for which she took tums for.  Reports similar issues after the first dose which she received 4/5/21.  States this date that she feels well.
Pt was accidently given a higher dose than approved, she was contacted by phone when the error was discovered and explained the situation to her and she reported no adverse affects about 4 hrs post dose, patient was contacted 8 hrs and 22 hrs post dose with no reported adverse affects, she did report a sore arm similar to previous immunizations.
I did have a mild headache; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was aware that his/her second dose should be completed within 2-6 months of the initial dose.  In the current state of the world with regard to the COVID virus outbreak the reporter was concerned to complete second dose. The reporter was fearful that if he/she developed symptoms following the injection it may be difficult to differentiate from COVID viral symptoms. After receiving the Shingrix, the patient did not have a fever but  did have a mild headache for about 24 hours.
Pt reported a rash with a bump. Stated it was warm and itchy but has since gotten better. Pt also reported difficulty breathing for a "couple minutes," nausea, and chills. Reaction occurred one hour after receiving vaccine. All reaction have resolved except rash.
5 minutes after administration-heart racing, diarrhea, dizziness, "felt like my heart would pound out of my chest." Pharmacist talked with client and lessened after approx. 10 min.   About one hour after administration-symptoms came back and client went to the Emergency Room. They monitored client, ran a WBC "normal," no treatments, testing or fluids per client.