chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Improperly stored vaccine was administered on 25-JAN-2021 - GARDASIL 9; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 injection, lot # T026954, expiration date 13-APR-2022, for prophylaxis (strength,  route and frequency were not reported).  The temperature excursion was above 9 Centigrade degrees (°C)(13.4°C), during 2 hours 9 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No PQC reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026954; expirationdate: 13-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Within 1 hr after vaccine - developed generalized - hives without dyspnea and dysphagia. given CORTICOSTREROID and antihistamine - resolution
At 4PM, about 6-6.5 hours post vaccine, I developed an extremely itchy rash on both of my elbows and on the palms of my hands and wrists. The rash was flat and very red and began to spread down my arm and was extremely irritating. I used hydrocoritsone cream on the itchy rash but it did not provide relief. I went to sleep and woke up at midnight due to the severe itching I had. Within about 30 minutes, or around 12:30AM, I felt as though I was going to faint, my lips were swelling and I was having itching in my throat and a feeling as though I could not fully swallow. I took 2 tablets of Benadryl at 2AM. The swelling and itching did not subside with the use of Benadryl I called the on-call doctor who instructed my to go to the ER. The ER administered oral steroids and instructed my to take additional Benadryl and Pepcid AC. This was around 8AM, on 10/20, almost 24 hours post vaccine. I took the additional Benadryl and Pepcid AC, as well as used Benadryl lotion on the rash which was causing swelling and irritation on my hands. I have yet to find relief from the rash, but my throat is no longer itching. The swelling in my lips and hands is still present as of 12:30PM on 10/20.
She experiencedrash at the injection site; She experienced flu like symptoms; She experienced body aches; She experienced headache; She experienced chills; She experienced fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills) and PYREXIA (She experienced fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills) and PYREXIA (She experienced fever). On 07-Apr-2021, the patient experienced INJECTION SITE RASH (She experiencedrash at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills), PYREXIA (She experienced fever) and INJECTION SITE RASH (She experiencedrash at the injection site) outcome was unknown. Not Provided          Concomitant product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up  received on 08-July-2021 and Reporter email address provided. On 12-Jul-2021: Follow-up received on 12-JUL-2021 and contains non significant information
tingling sensation in fingers or toes; lowered blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "disclosed high blood pressure, otherwise unknonwn" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "tingling sensation in fingers or toes"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "lowered blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient said she experienced lowered blood pressure. She no longer experienced tingling sensation in fingers or toes that she had been experiencing over the past two weeks. She did say that she had some concurrent medications increased within the past two weeks.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
DTaP-IPV is only licensed for use as the 5th dose of DTaP and 4th dose of IPV. Therefore, the administration of  Kinrix prior to the age of one years is considered a medical error. The patient did not have any notable signs or symptoms. The patient parents also did not report any signs and symptoms.
Moderna fever second night; Moderna fever second night; vaccine causing incontinence; This spontaneous case was reported by a consumer and describes the occurrence of INCONTINENCE (vaccine causing incontinence), the first episode of PYREXIA (Moderna fever second night) and the second episode of PYREXIA (Moderna fever second night) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (nasal Test) on 26-Jan-2021 and Incontinence (2 MONTHS) in October 2019. Concurrent medical conditions included Penicillin allergy. Concomitant products included ATORVASTATIN, COLECALCIFEROL (VIT D [COLECALCIFEROL]) and OMEPRAZOLE from 04-Jun-2021 to an unknown date for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced the first episode of PYREXIA (Moderna fever second night). In May 2021, the patient experienced INCONTINENCE (vaccine causing incontinence). On 16-Jun-2021, the patient experienced the second episode of PYREXIA (Moderna fever second night). At the time of the report, INCONTINENCE (vaccine causing incontinence) and the last episode of PYREXIA (Moderna fever last night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, COVID-19: positive (Positive) Positive.          No Treatment Medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: ADR : Reporter contact information, vaccination date, patient demographics updated
I had flu systems which I knew of. But my under arm pit was  hurting real bad, so I looked in the mirror and saw that it was swollen and had a large pocket of fluid. I went back to the Pharmacy and was told to Ice and take Tylenol and not to get a Mammogram for 3 months , but my arm is still tender and my left shoulder blade. I was also told to report this for Data!!
on 3/31/2020 a patient was administered an improperly stored dose of GARDASIL 9 (lot 9029515, expiration 7/8/2021). Temperature (0.7C). Time frame 3,048 hours.; The patient experienced no symptoms; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 31-MAR-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (dose and frequency were not reported) (lot number 9029515 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date was reported as 08-JUL-2020) as prophylaxis.  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 0.7 Celsius degrees for 3.048 hours (information captured by a data logger). The patient did not experience symptoms.
Moderate body aches; Severe headache; Mild nausea; Moderate fatigue; This is a spontaneous report from a contactable company representative, the patient. A 55-Year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in left arm on 23Mar2021, at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications received within two weeks of vaccination reported as no. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E23247), via an unspecified route of administration in left arm on 01Mar2021, at 10:00 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 09:00, the patient experienced moderate body aches, severe headache, mild nausea and moderate fatigue. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of headache included treatment with TYLENOL. The clinical outcome of the events moderate body aches, severe headache, mild nausea and moderate fatigue was resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201), on 18Mar2021 as dose 2, single (Lot number: EN6204) and on 30Sep2021 as dose 3 (booster), single (Lot number: 30135BA) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOESTRIN 24 FE; FLONASE [FLUTICASONE PROPIONATE]; SINGULAIR; HYDROXYZINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: For COVID 19 Treatment patient took Paxlovid on 16jun2022 and stopped on 21Jun2022. Rebound case sinus headache, sneezing, drainage, runny nose, stomach ache, positive at-home test.  Follow-Up (01Jul2022): Follow-up attempts are completed. No further information is expected.
The Moderna booster was administered on December 4, 2021. I developed severe itching and blistering rash. I was diagnosed on Jan 13, 2023 with bullos pemphigus vulgaris, a rare auto-immune skin disease that required massive doses of prednisone and two infusions. I will have to undergo transfusions possibly the rest of my life. The prednisone has caused other problems, including severe edema.
receiving a third dose by accident; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix by accident from another HCP (health care professional), which led to extra dose administered.  The reporter unable to provided any patient and vaccine details. The reporter inquired about any information on a third dose of Shingrix administered. The reporter did not consent to follow-up.
Flu vaccine 10-28-2011, that day f's & that night febrile seizure. Also dx with viral illness 10-28-11 - no fever at the visit.
Patient notified nurse after observation time of 15 minutes was up that she had a headache and neck pain that started after she received Covid 19  Pfizer vaccine booster. Patient did not report symptoms prior to vaccination or after until she had been cleared from observation at 11:27 am. Patients vitals were taken and BP was found to be 150/100 , T 36.5, HR 76, RR 15, patient was AAOx4, denied any SOB, CP, changes in vision, or dizziness. She was provided with water to drink and observed for another 30 minutes, during that period vitals were taken every 5 minutes with no significant change in value,  last  set of vitals taken  at 12:00pm BP 148/110, T 36.5, HR 84, RR 14.  No other symptoms were reported during this time and she was provided information on urgent care and ER precautions. Advised patient to see health provider ASAP within the next 2 days. Stated she had a hx of HTN and is not taking medication.
After 7 days , my blood pressure was high . I started to have a-fib , 7 days more . I was worried. I went to my local ER . I was in a-fib . They did blood work and than a CT scan of my brain, and a Echo cardio exam. They gave me blood thinner and a beta blocker metoprolol tartrate 25 mg , and Apixban 5 GM.  It has been two days . My blood pressure is normal , and my heart rhythm is normal.
received an expired dose of adacel with no reported adverse event; Initial information was received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 36 years old male patient who received an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past vaccination(s) included TDAP in 2014. The patient's past medical history, medical treatment(s) and family history were not provided.   On 09-Sep-2023, the patient received a 0.5 ml, once (dose 2) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot C5921AA, expiry date: 29-Jul-2023, strength: standard) via intramuscular route in the left arm for Immunization and received an expired dose of adacel with no reported adverse event (extra dose administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Onset of fatigue and fever 9.21.23, decreased appetite and  vomiting, development of koplik's spots on buccal mucosa 9.23.23, eruption of measles-like rash on 9.25.23
Body aches Pain in injection arm and into armpit and breast Fever Chills Fatigue
3 MONTHS AFTER THE SHOT VEINS STARTED SWELLING; MUSCLES STARTED SWELLING; VEINS STARTED COLLAPSING; MUSCLES STARTED COLLAPSING; PAINFUL ARMS HANDS AND LEGS; PAIN IN BACK OF HEAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced 3 months after the shot veins started swelling, muscles started swelling, veins started collapsing, muscles started collapsing, painful arms hands and legs, and pain in back of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 3 months after the shot veins started swelling, pain in back of head, painful arms hands and legs, muscles started swelling, veins started collapsing and muscles started collapsing was not reported. This report was non-serious.
Pt experience 1st grand mal seizure @ 6:30 am, 4Mar91, no fever or illness apparent @ the time. He was on no medications, drug & ETOH screen were negative.
mild, consistent and persistent itching all over his body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (mild, consistent and persistent itching all over his body) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (mild, consistent and persistent itching all over his body). At the time of the report, PRURITUS (mild, consistent and persistent itching all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reportedly, the patient already reached out to Centers for Disease Control and Prevention (CDC) to ask if he can proceed with the 2nd dose after experiencing these symptoms and CDC advised him not to proceed with it. He called to get Moderna's recommendation on his situation before going to his healthcare provider for advise. Concomitant medications and treatment details were not reported.
fever at 102.6; Heart Rate 103; muscle/big joint pain; muscle/big joint pain; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 09:30 (Batch/Lot Number: EL9265) as SINGLE DOSE (30mcg/0.3 mL) for covid-19 immunisation. Medical history included Type 2 Diabetes. Concomitant medication(s) included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021, 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE (30mcg/0.3 mL) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Known allergies was None. It was reported that the patient had fever at 102.6 Heart Rate 103, muscle/big joint pain 12th hr after 2nd dose on 09Feb2021 10:00 PM (22.00). fever reduced to 99.9F heart Rate 72 by 36th hr after vacinned, no muscle/joint pain temperature 98.6, heart rate 62 by 48 hr after. temperature 97.9 heart rate 66 by 72 hr after. No treatment received for AE. Outcome of the events was resolved in Feb2021.
8/9/11 varicella given (L) arm subcutaneously. 8/10/11 client reports noticed red area on (L) arm 3 fingers widths/ 8/12/11 seen at center, area is now about 4 inches in diameter where varicella given, warm to touch/raised swollen, tender to the touch/client c/o area feeling "itchy". Client afebrile.
COVID Arm? Rash, hot to touch, swelling itchy around site and all the way down arm later. A week after 2nd shot.
Fever; chills; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: en6208), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 16:30 PM (Batch/Lot Number: en6208) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Diabetes, sleep apnea, low hdl from an unknown date and unknown if ongoing. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included metformine [metformin] (METFORMINE [METFORMIN]), insulin glargine (LANTUS), eicosapentaenoic acid ethyl ester (VASCEPA), glimepiride (GLIMEPIRIDE), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. On 13Mar2021 15:00 PM patient experienced fever and chills. The patient underwent lab tests and procedures which included body temperature: 101 on 13Mar2021. Patient did not receive treatment medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible; No further information is expected.