chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called with a swollen, feverish, red upper arm; we advised antihistamines be started at once and call again if fever develops or if symptoms do not begin to resolve; a fever developed; she went into prescriber and was prescribed prednisone and cephalexin which was filled at our pharmacy; patient told us that her doctor had reported the PNEUMOVAX vaccine to medwatch due to multiple complaints of cellulitis. (the previous statement is heresay, our effort is to contribute information that could be useful).
About three weeks after second shot, 05/18/2021, my hearing in both ears has become stuffy and muted, like when you have a head cold. I did not note the exact time a day because I thought it would just clear up. My stuffy hearing has been constant since roughly 05/18/2021. Also, I have had a constant bloated upset stomach during roughly that same timeframe. Again, thinking it would go away but has not.
Malaise; Having trouble getting out of bed; This case was reported by a consumer via call center representative and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on an unknown date, refer case US2019143109).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced malaise and activities of daily living impaired. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the malaise and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the malaise and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient received 2nd dose at different pharmacy than the 1st dose and experienced malaise for 3 days. Malaise described as having trouble getting out of bed. The reporter consented to follow up. This case had been linked with case US2019143112 and US2019AMR143602, reported by the same reporter.
Left arm had excessive redness and was swollen and hot to the touch from the top of the deltoid to the elbow starting the day after the injections.   When patient presented to the pharmacy on the second day after the injection, the area was still very red, but was no longer hot to the touch.
Patient here to receive Pfizer bivalent booster.  However, vaccinator incorrectly gave the monovalent(primary series) pfizer formulation instead.  No ADE noted following vaccination. Pt's caregiver was contacted and notified of error.
allergy to vaccine; A spontaneous report was received from a Healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm.  The patient's medical history was not provided.   No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  It was reported that the patient has covid arm following first vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, covid arm was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Covid arm is consistent with the product safety profile.
Systemic: Fainting / Unresponsive-Mild, Additional Details: patient received covid vaccination and passed out immediately. patient revived in about 30 to 45 seconds and was disoriented and nauseated. ems was contacted. ems came on scene and evaluated patient. vital were normal patient seemed alright just disoriented and left with family and was not taken by ems to hospital or any were
My 6th month old was having vomiting/pain/ blood in stool/lump in the stomach/he was rushed to have emergency surgery to save his life. Hospital removed his appendix and to to go in and straighten his intestines back to normal.
11/17/21 pt started having COVID-19 symptoms 11/22/21 tested positive for COVID-19 11/27/21 admitted with SOB 11/29/21 intubated after failing bipap 12/01/2021 pt expired
Muscle pain with inability to raise arm, cellulitis to arm, thrombophlebitis.
Vial expired on 3/16/23 but was not pulled from refrigerator.  Patient was given dose that was 5 days expired.
I got a rash on left forearm below elbow. About 12 hours devolved rash on left thigh. When to doctor on 2/23/2021 because rash was getting worst.
Moderna COVID-19 Vaccine EUA  Noticed small hives/mild rash on torso after a workout, ~56 hours after receiving 1st dose. Affected skin is slightly itchy but have not noticed any other side effects at this time. Outcome unknown as symptoms are ongoing at time of writing.
Eyes went bright red, Heart rate went up to 187 on my fitness watch, 150 heart rate by the time the paramedics arrived, I couldn?t feel my arms or legs, I had a high blood pressure and sugar level of 220. Went to the hospital and ran tests.  Fever of 99.9-100.5 for two days straight. There was a red, warm, and inflammation in my left arm for two days. My heart felt like it was pounding out of my chest and I had a high rate for 5 days straight. I would be sitting down and it would be at 100.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history was not provided. On 19-SEP-2014, the patient was vaccinated with expired dose of ZOSTAVAX (frequency and route of administration were not provided) (lot # J006156, exp date: 30-AUG-2014). Concomitant medication was not reported. No adverse effects were reported. Additional information is not expected, as there was no consent to follow up.
Case tested positive for COVID-19 on 12/7/2020; vaccinated on 1/8/2021 and 2/5/2021 with Moderna; re-tested positive for COVID-19 on 4/1/2021.  Case was admitted to hospital on 4/2/2021 for surgery due to a previous fall.  Case had altered mental status and fever.  Case was found to have an acute CVA.
Given just the adjuvant portion; Given just the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant reported that, the patient was given just the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021215490 and US2021215489, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215490:same reporter US-GLAXOSMITHKLINE-US2021215489:same reporter
Hospitalized after receiving the Moderna vaccine booster dose.; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalized after receiving the Moderna vaccine booster dose.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalized after receiving the Moderna vaccine booster dose.) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalized after receiving the Moderna vaccine booster dose.) outcome was unknown.     The patient is hospitalized after receiving the Moderna vaccine booster dose.  Company Comment - This is a spontaneous case concerning a 80-year-old female patient with no relevant medical history reported, who experienced serious, unexpected event of Hospitalization. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient was hospitalized after receiving the Moderna vaccine booster dose. No other information provided. Consent to follow up denied. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 80-year-old female patient with no relevant medical history reported, who experienced serious, unexpected event of Hospitalization. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient was hospitalized after receiving the Moderna vaccine booster dose. No other information provided. Consent to follow up denied. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received Td shot and PPV23 on 06/21/2006. Today she states that her arm is sill swollen from the PPV23. On examination, the patient has developed cellulitis to the left deltoid (site of PPV23 vaccination).
I started getting little red bumps 3 days after the shot. Approximately 7 days after the shot it turned into hives. Immediately after the shot I got a really bad headache. I was also nauseated and dizzy. I have also been very tired.
accidentally gave a Adacel vaccine to a 15 months patient instead of a flu vaccine/ No AE; accidentally gave a Adacel vaccine to a 15 months patient instead of a flu vaccine/ No AE; Initial information received on 30-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA273063 and 2019SA273055 same reporter.  This case involves a 15 months old patient who accidentally received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site instead of INFLUENZA VACCINE (lot number not reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
Moderna vaccine triggered a negative reaction causing muscles below the back part of the neck that connect to the back side of the head to cause migraine; Migraine Headache after second vaccine dose; Throat totally inflamed specifically uvula in the back of the throat; Huge purple bruise on his right arm; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine Headache after second vaccine dose), TRACHEAL INFLAMMATION (Throat totally inflamed specifically uvula in the back of the throat), CONTUSION (Huge purple bruise on his right arm) and MUSCLE DISORDER (Moderna vaccine triggered a negative reaction causing muscles below the back part of the neck that connect to the back side of the head to cause migraine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A. and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant in July 2016.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MIGRAINE (Migraine Headache after second vaccine dose), TRACHEAL INFLAMMATION (Throat totally inflamed specifically uvula in the back of the throat) and CONTUSION (Huge purple bruise on his right arm). On an unknown date, the patient experienced MUSCLE DISORDER (Moderna vaccine triggered a negative reaction causing muscles below the back part of the neck that connect to the back side of the head to cause migraine). At the time of the report, MIGRAINE (Migraine Headache after second vaccine dose), TRACHEAL INFLAMMATION (Throat totally inflamed specifically uvula in the back of the throat), CONTUSION (Huge purple bruise on his right arm) and MUSCLE DISORDER (Moderna vaccine triggered a negative reaction causing muscles below the back part of the neck that connect to the back side of the head to cause migraine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) results not available. On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) results not available. On an unknown date, X-ray: unknown (Inconclusive) results not available.         Action taken with mRNA-1273 in response to the events was  not applicable. Treatment information not provided. List of concomitant medication were not given.
Hypersensitivity.  This case was reported by a physician via a sales representative and described a subject of unspecified age and gender who developed allergies after vaccination with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received an unspecified dose of Engerix-B (10 mcg, unknown).  Immediately after vaccination with Engerix-B, the subject developed allergies.  At the time of reporting the outcome of the event was was unspecified.
patient moved leg and it is unknown how much of the vaccine was received believed some was administered but not all with no adverse event; Initial information was received on 09-Dec-2020 regarding an unsolicited valid non-serious case from an other health care professional.  This case involves a 19-months-old female patient who moved leg and it was unknown how much of the vaccine was received believed some was administered but not all (incorrect dose administered), DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] suspension For Injection (lot number: UJ341AAA and expiry date: 22-Jun-2021) at an unknown dose via intramuscular route in the unknown site for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A).  This was an actual medication error case due to incomplete dose administered (latency: unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Cold symptoms developed and stayed for several days approximately 48 hours after 1st vaccine.  Then began having enlarged clavicular lymph nodes on the right side that were sore and very palpable for 2 months afterward.   Now I am having a sore thyroid.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ectopic atrial tachycardia" (unspecified if ongoing); "depression" (unspecified if ongoing); "hyperhidrosis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: Onions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (02May2023) Negative; (05May2023) Positive, notes: tested positive starting on Friday 05May (after finishing Paxlovid and testing negative on 02May). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 27Apr2023, Treatment stop date: 02May2023.  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-202300182899 same reporter/patient, different drug/event;
Local reaction at immunization site.  Erythema and induration of 10 cm with firmness.  Non-tender
Patient stated that several hours after shot was given she started to experience sorness in the affected arm and felt achy and feverish.  Next morning her arm was significantly swollen and red. Went to personal dr the next day and they treated her for cellulits with bactrim ds and arm seems to be healing with decreased swelling and discomfort.
Initial unsolicited report received from the office manager on 21 May 2018. This case involves 20 years old patient (Gender was not reported) who was vaccinated with first and second dose of MENACTRA (batch number, expiry date, route and site of administration were not reported for both dose) on 03 Aug 2017 and 16 May 2018. The patient's medical history and concomitant medication were not reported. It was a case of actual medication error due to extra dose administered. It was unknown whether patient had adverse event related to vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: Question-Caller is an office manager calling to ask if there are any safety concerns with a patient who received the first MENACTRA vaccine on 8/3/2017 and a 2nd MENACTRA vaccine on 5/16/2018. No other information provided. Special Handling - Response - Verified demographics. Response per standards. Case copied to USPV.  ppd-ddm/kc/21May2018.
05/01/06 Rash all over body Mom reported welts on arm 4/29/06 headache steadily increasing. 4/30/06 decreased intake, Emesis x 1 5/01/06 and sore throat, chest pain, fever. also Diarrhea, tonsils 2x erythemic. ER reports fine papular rash. given PCN IM, Mom believes H/T Hep A.
Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232928:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
pericarditis detected 5 days after onset of symptoms. Exact timing of first vaccine is unknown to family ; however, second dose was on 9/13 so presumed 3 weeks prior.  Clinically stable Treated with ibuprofen and rest from activity
Neck pain up arm from injection sit, chills, fever of 101, nausea, vomiting, headache aches.  Very intense side effects from late Saturday night about 10 PM, to Sunday morning.  Sunday 3/28 continues chills, headache, fatigue, fever 100.1.  Took Ibuprofen the entire time to ease side effects.  Slept most of the day Sunday and Monday.  Still had fatigue on Tuesday but was able to return to work.
Time: 3:00 PM Adverse event: Fatigue  Treatment: bed rest for 8 hours  Outcome: no longer fatigued