chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Tinnitus in both ears. Low and high ringing; hearing didn't get affected too much; Just the loud ringing noise that is absolutely unacceptable to live with; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Dec2021 11:30 (Lot number: FJ8762) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose lot number: ER8732, Prev dose administration time: 10:00AM, Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 02Apr2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Prev dose lot number: EW0164, Prev dose administration date: 23Apr2021, Prev dose administration time: 10:30 AM, Prev dose dose number- 2, Prev dose vaccine location- Right arm), administration date: 23Apr2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Severe Tinnitus in both ears. Low and high ringing"; HYPOACUSIS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "hearing didn't get affected too much"; IMPAIRED QUALITY OF LIFE (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Just the loud ringing noise that is absolutely unacceptable to live with". The events "severe tinnitus in both ears. low and high ringing", "hearing didn't get affected too much" and "just the loud ringing noise that is absolutely unacceptable to live with" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, hypoacusis, impaired quality of life.  Additional information: Adverse event: Severe Tinnitus in both ears. Low and high ringing. Just unbearable. Went to ENT and did Ear test and hearing didn't get affected too much. Just the loud ringing noise that is absolutely unacceptable to live with. Patient did not had any other vaccine in four weeks not any other medications in two weeks. Patient did not had covid prior vaccination and was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
complained of quarter sized erythema 06/25/2003 AM.  Progressively larger area of erythema 14:40 06/27/2003.  12.5 cm x 16 cm with some ecchymosis.  On upper right thigh.
Fever, chills and body aches Large raised red rash on left arm below injection site aprox 5" around
Symptoms tarted about noon the day after my vaccination. Except for arm pain which was immediate.  Started feeling warm and weak.  quickly advanced to headache, chills, fever that was at one point 102.2. Severe body aches and the headache became severe.  Had a couple of painful muscular spasms when trying to sleep.  I took melatonin to help me sleep but nothing for the pain as I had heard not to.  Severe symptoms lasted for approximately 15 hours. Still weak, achy and have a headache 24 hours later.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
9OCT around 3-4PM pt noticed pts eye had a clear, watery discharge; the next AM noticed a whitish/yellowish discharge from the rt eye; t102; skin on eyelids peeled off & noticed 2 "fever blisters"; rash;  Stevens/Johnson like react;
Sweating, enlarged R lymph node, jaws hurt, hair follicles ache.
Saturday - Headache (pain level 7), mild nausea, dizziness, mild fever Fever broke around 1:30 am Sunday - General flulike symptoms, abdominal discomfort Monday 3:30 am, severe abdominal pain (level 8-9), diarrhea, fever, 10am muscle soreness in upper left arm, 12pm, joint pain in left hip, knee and shin.  All symptoms abated by 9:30 pm.  Tues 9:00 am tingling and numbness in hands and fingers, mild abdominal discomfort. resolved by 3:00 pm.
Patient received 0.25 mL of the COVID-19 Moderna Bivalent vaccine instead of 0.5 mL as prescribed. Pt refused to come back to clinic to receive other half of dose.
being tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (being tired and fatigued) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOFLOXACIN, RIVAROXABAN (XARELTO), LISINOPRIL, HYDROCHLOROTHIAZIDE, OXYCODONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (being tired and fatigued). On 14-Feb-2021, FATIGUE (being tired and fatigued) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.   This case was linked to MOD-2021-090660 (Patient Link).
burning sensation when urinating; his urine is black; lower back pains; had chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (burning sensation when urinating), CHROMATURIA (his urine is black), BACK PAIN (lower back pains) and CHILLS (had chills) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020. Concurrent medical conditions included Penicillin allergy.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced DYSURIA (burning sensation when urinating), CHROMATURIA (his urine is black), BACK PAIN (lower back pains) and CHILLS (had chills). At the time of the report, DYSURIA (burning sensation when urinating), CHROMATURIA (his urine is black) and CHILLS (had chills) had not resolved and BACK PAIN (lower back pains) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, SARS-CoV-2 test: positive (Positive) POSITIVE.         No concomitant were reported. It was reported that patient had no Acute and Chronic illnesses at the time of vaccination.Patient stated that had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was reported that back pain has gotten Better, everything else is the same. No treatment were reported.   Reporter did not allow further contact
Pfizer Bivalent booster given instead of 2nd Pfizer dose no reactions
This is a spontaneous report from a contactable office manager from a family medical office calling on behalf of the healthcare. A 66-year-old female patient received PREVNAR 13 (lot R94917, Expiration date 31May2018, NDC# 00005197105), via an unspecified route of administration in left deltoid on 24Jul2017 10:33 at 0.5 ml, single for immunisation. Medical history included foot fracture on 07Mar2017 (It was the 4th toe and it was a healing fracture), ongoing insomnia, ongoing gout, ongoing hyperlipidaemia. Concomitant medication included zolpidem for sleep, phentermine hydrochloride for weight loss, ibuprofen for pain. The patient had problems with her range of motion, she was sore, she experienced red, raised, swollen reaction at the site of injection. All the events occurred on an unspecified date and the outcome was not recovered.
pt recvd vax & had f to 105; shaking; chills or brief clonic sz activity; tx w/ acetaminophen & ibuprophen; brief clonic sz activity;
Muscles in both upper arms ached for several days.  A small patch of rash appeared below the injection spot, General feeling of being tired or exhausted at times.
Patient felt body ache; Patient received 0.5ML instead of 0.25ML; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Patient felt body ache) and ACCIDENTAL OVERDOSE (Patient received 0.5ML instead of 0.25ML) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (primary doses) in November 2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received 0.5ML instead of 0.25ML). On an unknown date, the patient experienced MYALGIA (Patient felt body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. On 05-Feb-2022, ACCIDENTAL OVERDOSE (Patient received 0.5ML instead of 0.25ML) had resolved. At the time of the report, MYALGIA (Patient felt body ache) outcome was unknown.            Concomitant product information was not provided.  Patient was worried because of the side effects.
Headache, Myalgia, Arthralgia, Fever, FATIGUE, RUNNY NOSE, SWOLLEN, RED RASH TO INJECTION SITE Narrative:
Fever 103 degrees due NOC of 10/01/2004. Red, slightly swollen 1 x 3 cm area left thigh while received Varivax injection on 9/23/04. Parents gave Tylenol and Ibuprofen.
extreme headache; extreme tiredness; muscle soreness; need to nap often even though I've slept 8-10 hours; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 79-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Endoscopy", start date: Sep2020 (unspecified if ongoing), notes: This was on late September.; "Stomach bleed", start date: Sep2020 (unspecified if ongoing), notes: This was on late September. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1 (Lot Number: Not provided)), for COVID-19 immunisation, reactions: "Headache", "Tiredness", "Dizziness", "Nausea". The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "extreme headache"; FATIGUE (non-serious), outcome "not recovered", described as "extreme tiredness"; MYALGIA (non-serious), outcome "not recovered", described as "muscle soreness"; SOMNOLENCE (non-serious), outcome "unknown", described as "need to nap often even though I've slept 8-10 hours".  Additional information: The patient experienced extreme headache within 10 minutes, extreme tiredness within 1 hour lasting a full week, muscle soreness in the next day - no pain from the shot. Milder headaches continued as well as muscle soreness. Tiredness continued and needed to nap often even though slept 8-10 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138669 Same patient and drug, different dose and events
Soreness at night in left upper arm then woke up with redness around biceps area of immunized arm measuring approx. 5 inches tall and encompassing arm, but less redness lateral arm, some swelling medial, inner aspect of arm biceps area.
No adverse events noted to date.  Client is 17 and received Moderna vaccine.  Person completing form is not the person that administered vaccine.
No adverse event; a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023) 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 EXPIRED PRODUCT ADMINISTERED (a patient who was administered with a dose of the bivalent vaccine from a vial which had been punctured for more than 12 hours/1st punctured was 28-Jun-2023 and the date of administration was 29-Jun-2023).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Vial was first punctured on 28-JUN-2023. Treatment details was not reported by the reporter.
2 x 3 inch area at injection site, reddened and hot to touch.  Recommended follow up with Urgent Care of PCP to r/o injection site infection vs. vaccine side effect.
Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The vaccine was removed from freezer on 14-Oct-2021 into refrigerator and never opened before the administration day and the temperature was never compromised.
Got shot 1 on last Sunday of a week off (4/18/2021).  Monday, day after shot I was experiencing sharp eye pain at end of workday.  At time I attributed the pain to eye strain after not looking at computer for a week.  I have a retina problem, so my eyes generally feel strained at end of workday. Got shot 2 5/22/2021.  May\June not sure exactly when, I noticed a new distortion in left eye.  The distortion continued to worsen so I made an appointment with eye doc for 8/6/2021.  Doctor said I may have an eye bleed, so I made a follow up with Dr., a retina specialist.  At annual physical on 10/26/2021 I was diagnosed with high blood pressure. Further research leads me to believe that my eye pain following COVID shot 1 was the result of a blood vessel ballooning or bursting as a result of a spike in blood pressure. The leakage slowly caused the retina damage causing the vision distortions. Have had the retina problem since 2006 but it had  been stable until the COVID shots.  My limited research indicates problematic blood pressure spikes from COVID shots have been reported
Patient presented at our office with several Varicella rash on 3/18/2004. The Varicella was not administered at our office.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient had no other medical history. Patient did not have other medication in 2 weeks. Patient started Paxlovid from Jul2022 to Jul2022 for COVID 19 Treatment. The adverse event stated was relapsed after testing negative on 02Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recvd vax JUN90 & on 07SEP90 was inadvertently revax again.
she experienced Flu-like symptoms; and had a mild reaction; headache; tiredness; chills; mild fever of 99; she felt out of sorts; This spontaneous report was received from a 54-year-old female patient regarding herself. The patient's concurrent conditions included seasonal allergies, antifungal drug and allergy to iron infusion. The patient's medical history included heart attack.  Concomitant therapy included unspecified blood pression (BP) medicine, clopidogrel bisulfate(PLAVIX) and alprazolam (reported as generic for alprazolam(XANAX)).   On 19-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the arm, lot number T020639, expiration date not reported but upon internal validation established as 13-MAR-2022 (dose, route, and anatomical location were not reported) to prevent pneumonia.   On the same day six hours after vaccination with of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient experienced a mild reaction to the vaccine, flu-like symptoms, headache, tiredness, chills, and a mild fever of 99 (units not reported), she felt out of sorts for four days (influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache). The patient enquired for the ingredients of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because she had pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) the year before (19-OCT-2019) and she did not have any symptoms. The patient sought medical attention by informing the doctor's office and no treatment was given for the events.  At the time of the report, on 23-OCT-2020, the patient had recovered from mood altered and on an unspecified date, she had recovered from the events.  The relatedness between the events of influenza like illness, mood altered, pyrexia, chills, fatigue, vaccination complication and headache and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T020639; expirationdate: 13-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
pt recv vax 18SEP95 & 16JUN97 pt devel full blown varicella;
they gave out 5 doses out of an expired vial beyond 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave out 5 doses out of an expired vial beyond 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave out 5 doses out of an expired vial beyond 30 days). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (they gave out 5 doses out of an expired vial beyond 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Vaccine facility centre information, Product Expiry date and Batch Number Updated.
3-4 days later hair started falling out, extreme fatigue, weight gain. Then started Rogaine for hair loss.
1 month later noticed thyroid nodules which were visible.  I had not ever had this before.
Information has been received from a physician concerning a patient (gender not specified) who was vaccinated with a dose of PNEUMOVAX. The physician reported that the patient experienced redness, swelling and pain at the injection site, on the arm, that extended to the shoulder and neck. The patient also experienced fever. The patient reported recovered on an unspecified day. No other information was available at this time. Additional information has been requested.
23Oct95 Pt recv 1 dose vax. Nov97 Pt devel varicella.Pt's sibling was also reported (WAES 98020510) 1 of the siblings required tx w/acyclovir for mucous membrane & conjunctival involvement.