chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash that was very itchy/arm look different; Hives/ rash from the jaw to the neck; Painful circle of rash at the site of the injection; Painful circle of rash at the site of the injection; When they received the vaccine they noticed some liquid dripped; A spontaneous report was received from a consumer concerning 70 year old female patient.  The patient's medical history was not provided.  Concomitant medication included unspecified blood pressure medication, unspecified cholesterol medication, unspecified thyroid medication, Women's One A Day, Aspirin, Colace, Vitamin C, Vitamin D, two unspecified nasal sprays, and allopurinol.  On 29Jan2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 011L01A) in the left arm for prophylaxis of COVID-19 infection.  On 29Jan2021, the patient noticed some liquid dripped during the vaccination, and experienced a very painful circle of rash at the injection site.  On an unspecified day, 7th day after the vaccination, the patient experienced her arm looking very different with a bigger rash that was very itchy.  On an unspecified date, the next day, the patient experienced a rash that reached her neck and it turned into something like hives and was very itchy.  The patient was treated with Keflex, clindamycin, and hydroxyzine.  Action taken with the mRNA-1273 was not reported.  The outcome of the events of incorrect dose administered, vaccination site rash, vaccination site pain, rash pruritic, and urticaria was unknown.; Reporter's Comments: This report refers to a case of vaccine underdose,  administered for mRNA-1273, lot # 011L01A with  associated adverse events of vaccination site rash, vaccination site pain, rash pruritic, and urticaria. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
(L) deltoid area - erythematous, slightly swollen, warmth & slightly tender to touch.
Three days after receiving one dose of varicella virus vaccine live the pt experienced a fever and gastroenteritis symptoms including vomiting.
Patient returned to the office approx. 15 minutes after getting Hepatitis A vaccine presenting with hives. 1 tsp of BENADRYL was given. Hives faded within 10 minutes.
Nausea, BP: 114/68, Pulse: 64/min - Patient lay down on gurney - Had sips of water - Stated she hasn't ate breakfast - Felt better after 10mins - Adviced to notify PHP if symptoms worsens. - Patient stated she is ok now and wants to rest at home, left with mother.
This client requested just the COVID19 vaccine but was given Fluarix Quad. Client notified of the mistake and still wanted the COVID19 vaccine so received both vaccines the same day.
extreme arm pain that does not go away with ice pack, hot pack, etc. pain traveled up through neck by 1/28/2021
Patient was found unresponsive "guppy breathing" at home on 6/7/2021. Intubated by EMS at home, administered rapid SARS-CoV-2 test in field which resulted as positive. Admitted to ICU on ventilator. Remains in same condition as of reporting date (6/10/21).
fatigue; nausea; left arm tenderness (administration site); This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "left arm tenderness (administration site)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administration of a Twinrix vaccine stored at freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th April 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that Twinrix vaccine stored at freezing temperatures and administered to a patient, which led to incorrect storage of drug. The reporter had no further information on the patient nor the expiration or lot number of the product. No further events were reported. The reporter did not consent to follow up.
hard section on her left breast; whole left side of her chest and breast is red till her arm; had a "mini" anxiety; light headed, passed out and fell cold flat on the floor; Blood pressure dropped; fever; passed out and fell cold flat on the floor; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) (seriousness criterion medically significant), ANXIETY (had a "mini" anxiety), DIZZINESS (light headed, passed out and fell cold flat on the floor), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PYREXIA (fever). On 20-Apr-2021, the patient experienced BREAST INDURATION (hard section on her left breast) and ERYTHEMA (whole left side of her chest and breast is red till her arm). On 17-Apr-2021, LOSS OF CONSCIOUSNESS (passed out and fell cold flat on the floor) outcome was unknown. At the time of the report, BREAST INDURATION (hard section on her left breast), ERYTHEMA (whole left side of her chest and breast is red till her arm), ANXIETY (had a "mini" anxiety), DIZZINESS (light headed, passed out and fell cold flat on the floor), BLOOD PRESSURE DECREASED (Blood pressure dropped) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Blood pressure measurement: low blood pressure dropped.     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. Treatment included acetaminophen.
Herpetic eruption on face, mouth and rash covering head, neck, face. Herpetic eruption was on 9/29/20 and rash began on 10/4/20. Patient also experienced increased lethargy and sleepiness, sleeping 1-2 hours longer each day. Insomnia symptoms have worsened over the past week.
all gotten covid after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (all gotten covid after receiving the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (all gotten covid after receiving the vaccine). At the time of the report, COVID-19 (all gotten covid after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant and treatment medications were reported.  Caller stated she was preparing for the second booster dose, and she had spoken with 4 or 5 people who had COVID-19 after receiving the vaccine and even with unspecified number of people who had  vertigo after receiving the vaccine. Reporter went to the hospital in May for Vertigo and She wanted to know is there increase of people reporting vertigo as a side effect after receiving the vaccine.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, on an unknown lapse of time after an unspecified dose of mRNA-1273. Clinical findings, course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-644586 (E2B Linked Report).; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, on an unknown lapse of time after an unspecified dose of mRNA-1273. Clinical findings, course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-644586:MOD-2022-644586 ( Case For Female Patient)
85-year-old female with a PMH of Parkinson's disease and arthritis who presents with 1 week cough, nausea and vomiting. Has been exposed to family members at home positive for COVID-19. She took an at home tested few days ago which is reported as inconclusive. Daughter also reports a fall about 2 weeks ago with head injury which she was not evaluated for. Daughter reports increasing confusion over the last couple of days unsure if this is related. She is vaccinated for COVID-19.  In the ED, documented VS on arrival are 118/61, heart rate 87, RR 20, O2 sat 95% on room air with a temp of 97.5° her O2 sat did drop to 89-90% and she was started on 2 L of O2. CTH shows chronic changes with cerebral loss but no acute pathology. CXR reported as bilateral airspace disease, official report still pending, but appears minimal to my eyes. She was given sepsis bolus fluids as well as Decadron and Zofran. She developed a wheeze and was treated with albuterol. She is admitted to medical for further evaluation and treatment pending ID consult
Patient had come to county clinic on 3/18/2021 and received a first dose of the Pfizer vaccine. Patient missed second dose appointment and returned on 5/7/2021. Clinic scheduled for that day was a Janssen clinic. Patient answered no to the screening question that he had received a previous COVID vaccine. Patient received a one dose Jansseen vaccine. Called patient on the phone on 5/11/2021, reports no significant side effects, reports a head ache and feeling tired. Reviewed with medical director.
Initial case received from a pharmacist, via another manufacturer, on 22 November 2010.  An 80-year-old male patient received an intramuscular right deltoid injection of DECAVAC (lot number U1927EA) on 15 March 2007.  The patient was subsequently admitted to the hospital and diagnosed with encephalitis.  No other information was provided.
This spontaneous report was received from a Registered Nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # L020015, expiration date on 16-AUG-2017 (dose number, strength and anatomical location were not provided). Concomitant therapies were not provided. The vaccines were stored in a temperature of 52F during 30 minutes, 46.9F during 12 minutes, 46.9F during 12 minutes and 47.1F during 16 minutes. No previous temperature excursion was reported. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
A large, red, painful and warm spot on her arm; A large, red, painful and warm spot on her arm; A large, red, painful and warm spot on her arm; chills; Low grade fever went up to 103.; A spontaneous report was received from a consumer concerning a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events the large spot, red, painful, warm spot on her arm (Vaccination site warmth, vaccination site rash, vaccination site erythema, Rash) chills (Chills), and fever (Pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot number: 029A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 10-Mar-2021, the patient experienced the low grade fever that went up to 103 degree Celsius followed by chills. On 11 Mar 2021, the patient experienced the events a large, red, painful, warm spot on her arm.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  On 12 Mar 2021 the outcome of event, chills, fever were considered as recovered/resolved.  The outcome of events, large, red, painful, and warm  spot on her arm were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Firmness at site of administration. Left thigh with very mild swelling and redness. Redness moved a little past original mark. Was seen at another hospital on day one and prescribed Keflex.
I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: SEIZURE (disability, medically significant) with onset 01Feb2021 at 13:15, outcome "not recovered", described as "I went home and had 2 seizures right after I got 2 of my vaccinations. I had received all 3 vaccinations, and I need proof of that.". The events "i went home and had 2 seizures right after i got 2 of my vaccinations. i had received all 3 vaccinations, and i need proof of that." required emergency room visit. It was unknown if therapeutic measures were taken as a result of seizure.  Clinical information : She went home and had 2 seizures right after she got 2 of her vaccinations. She had received all 3 vaccinations, and She need proof of that. Facility type vaccine was hospital. Received other vaccine in four weeks. Received other vaccine in two weeks. No know allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Seizure and the suspect drug cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
15Jul90 pt vax w/ hepta B.  w/i 48hr ex skin tingling, joint pain inhips and knees and myalgia in thighs. Aft 2nd hepta sx peaked and then diminished. Tx w/ non-steroid med w/o effect. 3rd vax was given 06Jan90 same sx occured. pt tx w/ DPH
Soreness at injection site; chills, muscle aches, fever 101.0  Symptoms began at 9am 4/6/2021; this report made at 1pm 4/6/2021
Heart attack (10/11/21). Two stents installed on same day, blockage in varies arteries. Prescribed medications: Lisinopril 5ml, Metoprolol Tartare 25ML, Brilinta 90ML, Atorvastatin 40ML, and Aspirin 81ML.
Injection given up in the shoulder joint.  Pain from shoulder blade down to finger tips.  Spoke with doctor who wants to monitor for potential rotator cuff injury, but suspects tendon inflammation from injecting too high in the shoulder and not in the deltoid muscle.
could not sleep; second dose hurt / arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date. For tolerance of 1st dose of Shingrix, refer linked case US2020080768).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and difficulty sleeping. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the pain in arm and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in her left arm. The patient reported that, after receiving 2nd dose of Shingrix, the patient's arm hurt but it did not hurt as bad as first dose and also she could not sleep on her side . The reporter was consented to follow up. This case was linked with case US2020080768, reported by the same reporter for same patient. This case was 1 of the 4 cases, reported by the same reporter.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included LOSARTAN, PANTOPRAZOLE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ROSUVASTATIN, BACLOFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-044170 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-044170:Husband case
Fever; Muscle and joint aches; Muscle and joint aches; Pain; Tiredness; Some diarrhea; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 06Jan2022 at 10:30 (Lot number: unknown) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: High blood pressure. Concomitant medications included: HYDROCHLOROTHIAZIDE; METOPROLOL ER and AMLODIPINE. Past drug history included: Toradol, reaction: "Drug allergy", notes: Known allergies: Torodol. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 16Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 11May2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 06Jan2022 at 10:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Fever"; MYALGIA (non-serious), ARTHRALGIA (non-serious), all with onset 06Jan2022 at 21:00, outcome "recovering", and all described as "Muscle and joint aches"; PAIN (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Pain"; FATIGUE (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Tiredness"; DIARRHOEA (non-serious) with onset 06Jan2022 at 21:00, outcome "recovering", described as "Some diarrhea". Therapeutic measures were not taken as a result of pyrexia, myalgia, arthralgia, pain, fatigue and diarrhoea.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient started complaining of dizziness around 10 minutes after vaccine administration. BP was measured - 102/53. Provided with apple juice. Second BP reading 123/57. Another apple juice provided. Around 10 minutes after second BP reading, patient complained of 'paralysis' in lower left arm (used a translation app on her phone). This did not resolve and 911 was called. EMTs evaluated patient, advised observation in ER. She did not have the funds to pay for the ambulance - EMTs agreed she was stable enough to get in a car - they would follow her.
Chills - (L) upper extremity cellulitis. Noticed redness in area of injection followed by marked confusion noted by husband. Patch of erythema over (L) upper extremity. Admitted to hospital. IV ROCEPHIN started. Erythema nearly resolved upon discharge - continue KEFLEX 500 tid x 4 dys - FU with Dr. 1-6-12.
7/30/21: admitted for multiple falls 8/5/21: Transitioned to Inpatient Rehab. 8/13/21: He became altered and hypoxic, prompting testing for COVID-19. Resulted positive COVID PCR on 8/13/21; breathing comfortably on 2L nasal cannula 8/17/21: completed remdesivir course, worsening confusion and altered mentation; using heated-high flow at 35L, non-rebreather 8/19/21: patient discharged to hospice.  8/22/21: patient passed. Time of death 0508.
Patient is experiencing worsening Large Local Reaction on day 3 with intense itching, swelling and pain. Area is notably warm to touch and a small vesicular lesion is noted, indicating potential cellulitis. RX for cellulitis coverage given and also educated on common side effects associated with vaccine.