chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The child qualified for a pediatric dose of moderna bivalent 0.25 mLs. In error, the patient received the adult dose of 0.5 mLs. This event is being reported in an abundance of caution, but there are not observable adverse reactions. There are no physical adverse events as of yet. Today the child has a sore arm and is otherwise feeling ok.
died; Underdose; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and underdose. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the underdose was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Flu vaccine.  Additional case details were reported as follows: The reporter was patient's grandchild. The age at vaccination was not reported. The patient received her first half flu shot, which led to underdose. On an unknown date patient was died. This was a medication error with harm. The follow up was not required.; Reported Cause(s) of Death: Unknown cause of death
headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Bad Headache, Flu like symptoms, and very sore arm after first shot.  After second shot, I developed shingles on my forehead.  Now a few months later, I am having difficulties and severe pain in my left knee, as well as aching in other joints, but especially in the knees. - 1/10/06 Reviewed 2-page medical record. Diagnoses included: recurrent cutaneous herpes, most likely HSV 1 rather than zoster or shingles; and bilateral knee pain left > right.  Initial crepitus was noted over right knee. Famvir prescribed.
feels quite lethargic. No  fever, cough, or sob.  Difficulty getting out of bed in the am at times.
Rash; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 07Jan2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included history of seafood allergy during the childhood and allergic reaction to shampoo, conditioner and skincares. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jan2021 (reported as around a week after the second shot), the patient experienced rash. The patient took an antihistamine as treatment for the event.  Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was unknown.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A12A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE, GLIMEPIRIDE, LAMOTRIGINE, LISINOPRIL, RASAGILINE, CYCLOBENZAPRINE, ATORVASTATIN and ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
SORE ARM; This solicited report received from a patient via RRA-18356: Nurse Navigators concerned a 24 year old male. The patient's weight, height, and medical history were not reported. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose and frequency were not reported from 13-APR-2021 for an unspecified indication. Product constituent parts included ultrasafe passive (route of admin, lot, serial number, model number, UDI number, and expiration were not reported); and ultrasafe passive accessory (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of sore arm was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and sore arm as possible; and between ustekinumab, and sore arm as possible.  This report was non-serious.
Sore arm; couldn't even lift arm; The patient had since not gotten the second dose; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, mobility decreased and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the mobility decreased and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd Shingrix dose. The pharmacy intern reported that the patient had an extremely sore arm and couldn't even lift it after the 1st Shingrix dose into the right arm.  This occurred over 24 hours after the vaccination.  The patient had since not gotten the 2nd dose till the time of reporting, causing the patient to be outside of the 2-6 month recommended time frame, which led to incomplete course of vaccination. The lot number and expiry date were unknown for the 1st dose.
11/15/98-Fever, chills, headache,11/16/98-rash conjunctival infection. Progression to involve oral mucosa, wheezing. 11/17/98-oral erosion, vesicular pustular lesions on trunk/face.  11/25/98-Suspect Toxic Epidermal Necrolysis from nsaids.
itching / It's still itching now; redness; I developed skin irritation; was sore at the injection site; I felt extremely tired, & was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching / It's still itching now), ERYTHEMA (redness), SKIN IRRITATION (I developed skin irritation), VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site). On 15-Jul-2021, the patient experienced PRURITUS (itching / It's still itching now), ERYTHEMA (redness) and SKIN IRRITATION (I developed skin irritation). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching / It's still itching now) had not resolved and ERYTHEMA (redness), SKIN IRRITATION (I developed skin irritation), VACCINATION SITE PAIN (was sore at the injection site) and FATIGUE (I felt extremely tired, & was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.   This case was linked to MOD-2021-284638 (Patient Link).
pt received flu vaccine and 1 hour later had hive on back of hand approx 2-3 cm,itchy.No other complaints. Went to dr office, had redness at nape of neck Received Decadron and Medrol pack
Patient is a 19 year old male admitted to emergency services 06/21/2021 for syncope 2 weeks ago and near syncope today. The patient's syncopal episode 2 weeks ago was after a physical fitness test and he stated that he felt everything going black and then fainted. The patient had also felt short of breath and had chest pain that day. Today the patient was participating in a run and had to keep falling out due to feeling like he was going to faint and had DOE/CP again. Upon having rest and coming to the ED the patient no longer had SOB or CP. However; he had positive Troponins. The patient denies any viral illness preceding his first event and denies tick, mosquito bites, new sexual partners or traveling anywhere. However; the patient did have his 2nd COVID-19 3 days prior to his first event. denies alcohol, tobacco or drug use
tested positive for Covid 19 on October 13, called doctor and had a virtual health visit. She prescribed Paxlovid because of my age and asthma. Had 2 tough coughing days, Ran a fever 1st night 101 but much better Saturday Oct 15 but rested all weekend. coughing less, worked after that and tested negative October 19.
About 2 AM- I woke up feeling really confused, I was having trouble speaking and I had terrible body aches, diarrhea and vomiting and I was in that state for approximately 4 hours. My husband found me on the bathroom floor and he made me drink water and the symptoms subsided (inability to talk, vomiting and diarrhea) but the body aches remained for about 72 hours.
4 vesicles in diff phases, 2 scabbed over and 2 vesicular with clear fluid, itchy too.
An MD reported the occurrence of reduced antibody levels in a female of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's medical history included HIV infection. Concurrent medications were unknown. On unspecified dates, the subject received 2 injections of Havrix. Initially, it was reported that the subject was found to be a nonresponder to the Havrix immunization series because her antibody titers (NOS) were negative. The most recent info. was received on 12/27/02. The reporter stated that she had discussed the subject w/the CDC and prevention. She stated, "We later decided the PT probably had responded, w/lower than detectable antibody levels in serum."
This spontaneous report received from a medical assistant concerning a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-MAY-2017, the patient  received improperly stored dose of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014383: US-009507513-1706USA000288: US-009507513-1706USA000289: US-009507513-1706USA000290:
12/24- bad headache 12/25 bad headache, sore throat, swollen lymph nodes, fever 101.6, chills, nausea  12/26 headache, temp 99.5, sore throat
No reported patient side effects; An improperly stored dose of PROQUAD was inadvertently administered to a patient on 2/13/23; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 13-FEB-2023, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # W038815 rHA and expiration date 04-JUN-2024 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion in which it was stored in the refrigerator instead of the freezer for an unknown timeframe on 25-JAN-2023; no previous temperature excursions were reported.  No adverse symptoms were reported.  This case was classified as non-valid due to no adverse events.
Tested positive 24Mar Ag both asymptomatic; Tested positive 24Mar Ag both asymptomatic; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: FF2589) at the age of 63 years as dose 3 (booster), single, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 04Feb2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 24Mar2022, outcome "unknown" and all described as "Tested positive 24Mar Ag both asymptomatic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Mar2022) positive, notes: Covid test type post vaccination: Nasal Swab; (22Mar2022) negative, notes: Covid test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, asymptomatic covid-19. It was unknown if patient had covid prior vaccination and take other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the Vaccination failure, Asymptomatic COVID-19 cannot be completely excluded.
Pt developed hives and a "stuffy throat" w/in 20 min of receiving vaccine. He was given BENADRYL, EPI and taken to ER.
Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin; Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) and RASH (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) and RASH (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin). At the time of the report, URTICARIA (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) and RASH (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sore arm, body ache, joint pain, headache, fever, chills, nausea, fatigue. All started after waking up the day after injection.
SOB and chest tightness about 10 minutes after injection and a sharp pain that radiated down my arm starting at the injection site. Took Pepcid 20 mg and symptoms subsided after 10-15 minutes.  A few hours later began to vomit, which subsided quickly. The nest day had body aches which only lasted 1 day.
pt recv vax & 1 1/2 to 2 hr later exp nausea & vomiting & over 3 hr exp tachycardia, SOB & sweating; the nausea was alleviated p/phenergan & the SOB by proventil;
pt recv vax (1mo p/LMP) & preg test & ultrasound were positive;LMP 3/26/98;expected date of delivery 1/2/99;pt exp tightness in chest & SOB;pt sought unspecified medical attention;
Area is the upper arm/shoulder left side. Loss of mobility, can't reach back (pain) and hard to sleep on the left side because of the soreness. It wasn't until last week I put two and two together and figured out that it happened right after the shot. Called the pharmacy they looked up to confirm the shot was give in the left upper arm. Asked them about side effects but they didn't think it was related?? Haven't had any issues before the shot with pain or being able to reach backwards.
dizziness; can't walk straight; right arm is beginning to hurt/shooting arm pain; she sleeps for 10 hours; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, on 26Aug2021, as dose 3, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date (at the age of 72 years), as dose 1, and dose 2, both given for COVID-19 immunisation. On unspecified date in 2021, it was reported that the patient experienced a terrible reaction with pain shooting up her left arm (side of injection) and dizziness. She wanted to know what she can do for this and whether or not it's a side effect with the booster. The patient stated that her right arm was beginning to hurt, too. The patient stated that it hurts so badly. She reported that she went to the emergency ward 3-4 days ago for 5 hours and they did every brain scan, heart and blood scan, all kinds of scans and they came up with it is a reaction to booster, and then the patient was sent to her home. She also reported that she was very dizzy; she can't walk straight, walks towards the left. Patient queried is using a heating pad and what can she do. The patient got medication for dizziness, but when she takes it, she sleeps for 10 hours. She had hoped that someone would come to her house and talk to her, and she was just wondering if there is anyone to speak to about the arm pain, shooting arm pain, because she didn't know what to do, and had to get a prescription for dizziness because she can't walk around. She says she wanted to speak to someone who can tell her something she might do to help with the pain and dizziness, what to do, she didn't want to take pills the rest of her life. Patient said that she didn't want to sit and do questions while she is in pain, she wanted to know if she should hold her arm up or down, she needed someone who understands what was happening with her getting the booster shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had itching of my throat and ear, also shortness of breath, chest tightness.
Muscle Fatigue; HEADACHE; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (Muscle Fatigue), HEADACHE (HEADACHE), CHILLS (Chills) and PYREXIA (Fever) in a 66-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.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MUSCLE FATIGUE (Muscle Fatigue), HEADACHE (HEADACHE), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MUSCLE FATIGUE (Muscle Fatigue), HEADACHE (HEADACHE), CHILLS (Chills) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants and treatments were not provided.   Reporter did not allow further contact