chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began developing a red rash at site of injection. Over the period of several hours the rash spread to cover the majority of her upper arm.
his arms are sore; This is a spontaneous report received from a Pfizer sponsored program  from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient mentioned that his arms are sore. He received his first dose of the vaccine today. The patient said that he is reading the fact sheet and asked if what are the medications that he can take for pain reliever. The outcome of the event was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Angioedema of (L) upper arm at site of injection swelling extended into (L) lateral cervical area.
vaccinated with a Covid-19 vaccine has been diagnosed with mild Covid-19; vaccinated with a Covid-19 vaccine has been diagnosed with mild Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number (unknown), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccinated with a Covid-19 vaccine has been diagnosed with mild Covid-19".The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: The reporter stated that the patient was vaccinated with a Covid-19 vaccine and has been diagnosed with mild Covid-19. The physician would prescribe Paxlovid if the patient's condition worsened.  No follow-up attempts are possible. No further information is expected
Dizziness; Tachycardia; Nausea; Diarrhoea; This is a spontaneous report from a contactable patient. A 36-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date in Jan2021 as single dose for COVID-19 immunization at hospital. Medical history was not reported. Patient had no known allergies. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks of Covid-19 vaccine. Patient did not have covid prior vaccination and was not tested for Covid post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EK5730) intramuscular in left deltoid on an unspecified date at 08:45am as single dose for COVID-19 immunization and experienced nausea and diarrhoea. On 11Jan2021 at 12:30 after second dose of vaccination, patient experienced dizziness and tachycardia [24th-48th hours after the vaccine]. On an unspecified date in 2021, after second dose patient experienced nausea and diarrhoea again. Patient underwent lab tests which included Heart rate monitored as 155 vesting (range 60-100). Adverse event did not result in a visit to Emergency room and Physician room. No culture was performed and there were no predisposing factors. Treatment received in response to the events was unknown. Outcome of the event was recovered on an unspecified date of Jan2021. Outcome of nausea and diarrhea was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2020508576 same patient, vaccine first dose events
A report  has been received from a Health Professional concerning a 52 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that FLUMIST Quadrivalent was administered to a 52 year old patient last month on 26-SEP-2014.  The outcome of the event of FLUMIST Quadrivalent administered to a 52 year old patient last month is unknown. The report was considered to be non-serious.
5 month old male patient administered expired dose of PENTACEL vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a Physician via other health care professional via Medical Information (MI) (Reference number- 00607806) and transmitted to Sanofi on 19-May-2021.  This case involves a five month old male patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 13-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6622AB and expiry date: 12-Mar-2021) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Caller states that a Nurse provided an expired PENTACEL to a patient. Nurse states that on 5/13/2021, another nurse administered a PENTACEL vaccine that was later noted to have expired on 3/12/2021.   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 the 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.
Rash is red; Rash is very itchy; Burns, Still has burning pain; Is painful, Still has burning pain; Still has the itching; Suspected vaccination failure/Both doses in 2018, now experiencing a mild case; Experiencing a mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In April 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced red rash, itchy rash, burning sensation, pain burning and pruritus. The patient was treated with aloe barbadensis (Aloe Vera) and lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, red rash, itchy rash, burning sensation, pain burning and pruritus were not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the red rash, itchy rash, burning sensation, pain burning and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 26-Apr-2022 and 28-Apr-2022 Reporter's comment: The caller was the patient. The caller reported that she received both doses of Shingrix in 2018 and was believing that they were experiencing a mild case of shingles. In April 2022, the shingles episode began approximately 10 days ago.   The caller reported that she had a rash the covers the left side of the thoracic area down to the umbilicus and wraps around to the left side of the back, left shoulder and in the left ear.  The rash was red, very itchy, burns, and was painful.  The caller reported that she was using Lidocaine and real aloe very to reduce symptoms. The caller reported had appointments with a dermatologist and their general practitioner for the day of reporting, to confirm the diagnosis. Consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Vaccine administration error by the nurse. Surgeon explicitly ordered "Prevnar 13" but nurse administered Pneumovax 23.
Immediately at onset of giving the influenza vaccie the recipient developed large area of redness on site of injection. Ice pack applied immediately. Offered to have her take BENADRYL but she did not want to.
Pharmacy was called by outpatient provider, Dr regarding a reaction in a patient who received their 2nd dose of the Pfizer Covid-19 vaccine (lot EL3247) on 1/21 at LMC. On 1/22, the patient reported with tachycardia, hypotension and arm numbness. Dr was concerned that the injection was given too high on the patient's arm and potentially into the shoulder joint. Patient was directed to the LMC ED for treatment. The patient was given fluids and was discharged home. The ED provider did not believe the vaccine was given into the joint.
At  about 6pm he received his two vaccines HAVRIX and FLUZONE. He was well and with his mother. At 4am that night he woke up in extreme pain, headache, myalgias and he was taken to ER. The end diagnosis was presumed Aseptic Meningitis. He never was sick enough upon presentation for LP so no organism was identified.
Expired Kinrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment:  The nurse reported that a patient received an expired dose of Kinrix on 29Aug2022. The vaccine expired on 26Aug2022. No symptoms reported. The reporter gave consent to follow up. Additional Supportive Information: The patient received expire dose, which led to expired vaccine used.
No Adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A and 5/6/6979) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
This spontaneous report was received from a physician and referred to a female patient of age between 24 and 26 years old. On an unknown date, the patient was vaccinated with one unspecified dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported) as "academic program requirement". The VARIVAX was reconstituted with sterile diluent (MERCK). On 07-AUG-2017, the "varicella titer" was performed to the patient, the result showed "negative titer". The patient sought physician office visit. The outcome of varicella "negative titer" was reported as not recovered. The causality assessment was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA012381.
pt recvd vax;became ill at 8pm w/ low abdo pain; emesis (projectile x 2), diarrhea x 4, lasted for 3 hrs;had SOB; was not seen by MD or in er;
Gross hematuria starting about 6 hours after vaccination and lasting about 36 hours; intense arm/muscle pain, fatigue, and headache starting about 4 hours after vaccination and lasting about 48 hours
hives/rash 8x 10 inch area right buttock without accompanying pruritis, some hives left buttock and bilaterally inner thighs benadryl 50mg PO hydrocortisone cream 1% applied topically  resolving at time of this report
expired dose of ACTHIB that was administered with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00635920) and transmitted to Sanofi on 10-Jun-2021.  This case involved 18 month old female patient who administered second dose of 0.5ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ263AA, expiry date: 02-Jun-2021, strength: standard) via intramuscular route in right thigh on 09-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's past vaccination(s) included ACT-HIB on 27-Jan-2020 with First dose.  Relevant medical history, medical treatment(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel) for prophylactic vaccination.  This was an actual medication error case due to expired vaccine used (latency was same day).  Receptionist stated that states that they knew that there was an ActHIB that was getting ready to expire so they placed an order to replace it 3 weeks in advance, however there was a delay and it did not get approved until yesterday, 09Jun2021. When the nurse pulled up the ActHIB vaccine and they double checked it, they did not catch the expired date. The dose is valid or needs to be re-administered.  At the time of reporting, no adverse event 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.
24 hr after vaccine face felt sore/hot, added moisturizer and cucumber compress woke of 36 h after vaccine to red swollen lips and blisters under bottom lip
Pt. reported joint pain in knees started on 5/3/11. She saw MD on 5/10/11 when lab work was done. The joint pain and swelling continued and spread to other joints this started on 5/5/11 and is on-going. Pt reported some improvement on 5/10/11.
Patient went to Medical  for fever and trouble breathing for COVID symptoms.  Workup at hospital revealed sepsis and bilateral PNA.  Despite aggressive care, including intubation patient continued to decline.  Patients family decided to extubate and focus on comfort measures with hospice.  Patient was then admitted to Hospice services on 03/30/2022.  Patient expired on 04/01/2022.
HEADACHE; NAUSEA; This spontaneous report received from a parent via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea. This report was non-serious.
Dizziness, Myalgia, Fever, NauseaVomiting, FATIGUE, LOSS OF APPETITE, SORENESS AT INJECTION SITE,  AND LIGHTHEADEDNESS Narrative:  PT WITH C/O FEELEING LIGHTHEADED IMMEDIATELY  AFTER RECEIVING FIRST VACCINE. REPORTS MORE SYMPTOMS RIDAY NOC AND SATURDAY MORNING.
patient received an expired dose of YF-VAX (with no reported adverse event); Initial information received on 06-Jan-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves an unknown age and unknown gender patient received an expired dose of yellow fever vaccine - [YF-VAX] (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine - Solution for injection (strength: unknown) (batch number: UJ412AB) (expiry date: 25-Nov-2022) via unknown route in unknown administration site for immunization.  On an unknown date the patient received an expired dose of yf-vax (with no reported adverse event) (expired product administered) (unknown latency) following the administration of yellow fever vaccine.  Action taken with yellow fever vaccine (YF-VAX) was not applicable.  Outcome: Unknown.   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 the guidelines. 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.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
At appt 7/30/14 it was noted that client was approx 6 weeks pregnant at date of #2 HPV vaccine 10/7/13.
Lengthy (4 weeks plus) extreme soreness in upper arm, unable to sleep on side. No strength in arm to lift my own body or roll over in bed. Had to have a friend drive me, unsafe/unable to drive myself for 8-10 days. Had to cancel mammography appointment next day because i couldn't lift my arm. Unable to lift arm high enough to comb hair, shower/wash hair, brush teeth etc. Extreme difficulty in lifting arm high enough to dress or pull shirt over my head. Wore blouses with button front for 4 weeks. Still experiencing some mild discomfort 13 weeks later. Reported reaction to Family doctor and my oncology surgeon.
A week after first dose, had difficulty standing and walking normally. Followed by muscle spasms in uncommon places across body. Had tremors in arms and legs a couple week.