chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large blisters on the forearms, legs, back and particularly scalp / suffer with skin and scalp blisters/ small vesicles appeared on soles; Thining hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 13:15 (Lot number: 30135ba) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "seasonal (spring) hay fever" (unspecified if ongoing), notes: I have a history of seasonal (spring) hay fever that was cured by hypersensitization.; "Known allergy-grass pollen" (unspecified if ongoing), notes: Grass pollen. Concomitant medication(s) included: FLUZONE HIGH DOSE QUADRIVALENT taken for immunisation, administration date 08Sep2021; SYNTHROID; SIMVASTATIN; FISH OIL; CALCIUM; TURMERIC CURCUMIN [CURCUMA LONGA]. Vaccination history included: Bnt162b2 (Dose 2, lot number: EN6204, Vaccine location: Left arm), administration date: 21Mar2021, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "I got hives shaped rash on calves and forearms"; Bnt162b2 (Dose 1, Lot number: EN6205, vaccine location: Left arm), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No side effects"; Bnt162b2 (Dose 2, lot number: EN6204, Vaccine location: Left arm), administration date: 21Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "I got hives shaped rash on calves and forearms", "itching", "two pea-sized blisters appeared above the heel and on the shoulder".  The following information was reported: BLISTER (non-serious) with onset 05Oct2021, outcome "recovering", described as "Large blisters on the forearms, legs, back and particularly scalp / suffer with skin and scalp blisters/ small vesicles appeared on soles"; ALOPECIA (non-serious) with onset 05Oct2021, outcome "recovering", described as "Thining hair". The events "large blisters on the forearms, legs, back and particularly scalp / suffer with skin and scalp blisters/ small vesicles appeared on soles" and "thining hair" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister, alopecia.  Additional information: No covid prior vaccination. No covid tested post vaccination. Ae treatment was Prednisone tablets, Clobetasol cream and solution.  Follow-up attempts are completed. No further information is expected.
Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up document contains no new information.
2 weeks after vaccine, there was a light going back and forth in my eye sight, it did that for about 14 days little better, pain in my left leg.
Redness and swelling at injection site 8days after injection, day 9 redness swelling getting bigger
This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On 05-MAR-2019, the patient would receive a dose of M-M-R II (lot # R015162 and expiration date 29-MAY-2020), administered subcutaneous for prophylaxis (dose and anatomical location were not reported). Other suspect therapies included MERCK STERILE DILUENT (lot # M044952 and expiration date 01-JUL-2019) (dose, frequency, and route of administration were not reported) for an unknown indication.  On that same day (05-MAR-2019), the pharmacist reported that during administration of the dose of M-M-R II some vaccine squirted back out of the injection site, resulting in topical exposure on the patient's arm (exposure via skin contact) and a possible partial dose (incorrect dose administered). No adverse effect reported. No additional information provided.
C/O redness, no itchiness over Rt. arm. No pain. No fever.
This spontaneous report was received from a registered nurse via a company representative and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 13-DEC-2016, the patient was vaccinated with an expired dose of ROTATEQ 2 ml, orally, lot # L008053, expiration date: 30-NOV-2016. No adverse effects were noted. Product quality complaint was not involved. Additional information has been requested.
Patient experienced pain, swelling, and redness to the injection site and most of the upper arm within 24 hours of vaccinations. Patient went to her Doctor and was diagnosed with cellulitis. Patient was put on KEFLEX and a pain medication for treatment 3 days after vaccination.
pt recv vax & devel localized sm area low back pain-progressed over 9 wk to severe low back & spinal pain;hosp dx transverse myelitis w/loss bladder & bowel function;14wk later pt beginning to get better;MD unsure if vax related;
Formed red lined on nose that started bleeding and would not stop (bled for hours).   Wound was small (size of a pin prick) but would not clot (stop bleeding).  Had difficulty with bleeding for 2 days.     Excessive bleeding during menstrual cycle.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-JUN-2011, the patient was vaccinated by a healthcare provider with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions prescribed by a healthcare provider. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
patient has swelling down the arm, patient went to urgent care clinic and was diagnosed with cellulitis. patient was given ceftriaxone 1 g IM at urgent care resulting in basal vagal event. 911 was called and patient was transported to hospital where patient was precribed Keflex 500 mg QID for cellulitis
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "recovered" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Two days after stopping Paxlovid he retested; (18Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included Paxlovid. Clinical course: The reporter's husband (patient) had 2pfizer vaccines + 2pfizer boosters. He tested "positive" on 18Aug2022. He took 5-day regimen of Paxlovid. Two days after stopping Paxlovid he retested "negative".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200054571 same reporter/product, different patient;
I got my second Covid vaccine yesterday 11/5/21 around 1p.m by 2a.m i had extreme body aches, fever, chest pain, and exhaustion. I had the same symptoms for my first does 3 weeks prior.
COntact dermatitis that started a few hours after vaccine- spread all over body. Prescribed steroids 2 days out.
Was at the golf course.  His arms flew up and he had a seizure falling to the ground and striking head on ground.  Blood from nose and mouth.  He was transported to hospital.  Diagnosed a brain bleed.
On Thurs. 02-25-2021,  I woke up noticing that my left arm where the shot was given was itching and a little sore.  I was surprised because the initial soreness had gone away.  Later, when I looked at my arm in the mirror, I saw a rough-looking blochy rash area where the shot had been given  and it extended around the arm and down toward my elbow.
pt in SNF; pt tested for COVID and was positive on 9/30/21, was asymptomatic at the time and for several days; eventually developed SOB and low O2 levels requiring O2 supplementation via NC; pt passed away in the SNF on 10/5/21
Fainting ...causing patient to be involved in a car accident (patient was allowed to immediately leave following administering vaccine and accident happened within 7 minutes of leaving doctors office).
pt recv vax 12APR96&exp severe rt sided hip pain&was seen by an orthopedist;tx w/Indomethacin&recovered w/in 3 days;
ACHY; FATIGUE; HEADACHE; SINUS-ALLERGY LIKE SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 12-MAR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAR-2021, the patient experienced achy, experienced fatigue, headache and sinus-allergy like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy, fatigue, headache and sinus-allergy like symptoms was not reported. This report was non-serious.
pt c/o numbness in lt arm from site of inj for second in the series of Hep B vax down lt arm to hand, accompanied by tingling in the tips of lt thumb & lt fingers/also c/o pain in lt shoulder trapezius area; tx DPH
Headache, Diarrhea, NauseaVomiting, Fatigue Narrative:
Received shot on a Friday and symptoms showed up on Sunday. Swelling upper quadrant of shoulder, knot around lymphnodes, cheek turned yellow and left arm swollen. She received Moderna all three shots.
Shingrix 2 of 2: sore arm, tired, achy, headache, slight fever (99.8 deg F)
Hospitalized for 4 days approx. 1-1/2 weeks after vaccination.  Diagnosed with Epstein Barr and Guillain Barre.  Still have numbness of legs and hands 3 months later.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine that underwent a temperature excursion in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 95-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. No adverse event reported. Treatment medications were not reported.
Bilateral purulent conjuctivitis 8 hours after injection of flu shot. Treated with TOBREX Eye Drops.
Pt recv vax on 12/1/98; 6 hr post vax pt exp fever, rash, red/sore rt leg, fussy
Chest pain which started 6/17, improved 6/19 and 6/20. Chest pain worsened 6/21 and persisted through the week. Became acutely short of breath and passed away 6/25 at hospital
Given Varicella on 2/22/10. Came to clinic 2/24/2010. L arm with approx. 15cm urticaria area, warm to touch. Denies any other symptoms. Fever, sore throat, coughing difficulty in breathing.
Patient vaccinated on 1.28.2021 in clinic; No reports of an adverse event and/or adverse symptoms post vaccination, and patient tolerated administration well. Patient seen in-clinic by PCP on 3.24.2021 for her annual visit, no reports of an adverse event post receiving the vaccine. Patient seen again by PCP on 3.24.2022 for her annual visit. No reports of an adverse event post receiving the TDAP in 2021. Patient seen again on 3.28.2023 for her annual visit, where the patient reports: Complaining of lingering dizziness and migraines since she received a tetanus vaccine (Tdap) in 2021, which progressively worsened since. She endorses a significant flare in the last couple of weeks. Her previous tetanus vaccine was in 1986, and she did not experience any side effect back then. She also endorses occasional nausea, severe migraines, off-balance and fatigue. The PCP & Patient advocate notified (myself), to which I am reporting the patient-communicated adverse event.
Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a COVID-19 vaccine dose from a vial which have been punctured more than 12 hours) had resolved. Not Provided      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.   No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 and Patient's Initial updated. On 16-Aug-2021: Non significant Follow up received.
Lacunar cerebellar stroke with multiple foci (4-5 sub-centimeter), signs included vertigo, constant sensation of falling to the left side, and extreme vomiting,
Pt. received MMRV on 2/13/17 at HD started with rash to face 2/16/17. Seen in office on 2/17/17 with increasing erythematous, papulovesicular lesions to face, neck, legs and abdomen.
Pt began feeling dizzy & nausea with blurred vision shortly after vaccine administered, vomited once.
Has started with impairment in eyes; Booster dose made it worst; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Has started with impairment in eyes) and CONDITION AGGRAVATED (Booster dose made it worst) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     The patient's past medical history included Eye disorder NOS (Degradation in eyes). Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Has started with impairment in eyes) and CONDITION AGGRAVATED (Booster dose made it worst). At the time of the report, VISUAL IMPAIRMENT (Has started with impairment in eyes) and CONDITION AGGRAVATED (Booster dose made it worst) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Blood pressure medicine and Thyroid medicine No treatment medications were reported
pediatric dose to adult pt; adult pt was administered a pediatric dose; This case was reported by a other health professional and described the occurrence of accidental underdose in a 38-year-old female patient who received HBV (Engerix B pediatric) (batch number Lx4xp, expiry date 6th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 26th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient received a pediatric dose of Engerix B by mistake which led to accidental underdose and adult use of a child product. The reporter did not consent to follow-up.
I began having a headache on 2/2/2021 around 1 PM. Around 3 PM, I was chilling and was achy-stomach, ribs, back-like the flu. I took Tylenol and acetaminophen  alternating every 4-6 hours.  2/03/2021- still a little sore and headache until about 2 PM.  Then I started feeling better.  2/04/2021- some headache-much milder and tired.
Patient got an incomplete dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The patient was administrated with an incomplete dose. No adverse event was reported. The patient's identifiers, vaccination date, LOT number and expiration date was not provided. The reporter consented to follow up.
GI issues; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient wife) from a Pfizer-sponsored program, via medical information team. A 26 year old male patient (non-pregnant) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number EL9261) via an intramuscular route of administration on left arm, on 21Jan2021, 08:00 as single dose for covid-19 immunization. The patient had celiac disease as a medical history with gluten, kiwi, and penicillin allergies and concomitant medications were vortioxetine hydrobromide (TRINTELLIX), methylphenidate hydrochloride (RITALIN), Metformin. The patient previously took amoxicillin and had allergy. On 22Jan2021 the patient had GI issues, nausea, vomiting. The outcome of events was not recovered.   Follow-up attempts have been completed and no further information is expected.
headache; injection site pain; fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food or other products. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 00:45, the patient experienced brain fog, headache, fatigue and injection site pain. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events brain fog, headache, fatigue and injection site pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Licensed Vocational Nurse and refers to a 14 years old female patient. Concurrent conditions, medical history and concomitant medications were not provided. On 09-SEP-2015, the patient was vaccinated with first dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 04-NOV-2015 the patient was vaccinated with the second dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 05-JAN-2016, the patient was vaccinated with the third dose of GARDASIL lot # L037003, expiry date 25-MAY-2017 (dose, administration route and anatomical site were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.