chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Has an active case right now; This case was reported by a pharmacist via sales rep and described the occurrence of suspected 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. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information were received as follows: The age at vaccination was not reported. Till the time of reporting, the patient was having active case of shingles even after receiving the Shingrix shot, both doses were received in 2019. The physician contacted the patient's insurance to have another shot covered because he did not think her immunity had built up appropriately. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation test were unknown at the time of reporting.
Right axillary painful tender lymphadenopathy; Right eye facial swelling; Right eye facial swelling; This is a spontaneous report from a contactable physician (patient). A 31-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9264) via an unspecified route of administration in arm right on 08Feb2021 12:00 (at the age of 31 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medication(s) received within two weeks of COVID vaccine included ethinylestradiol, etonogestrel (NUVARING) taken for birth control, start and stop date were not reported. The patient previously took benzoyl peroxide and experienced Allergy. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1283) via an unspecified route of administration in arm right on 12Jan2021 16:00 (at the age of 31 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced right axillary painful tender lymphadenopathy, right eye facial swelling on 09Feb2021. No treatment were given for the adverse events. Patient was not tested for COVID post vaccination. Outcome of all the events were not recovered.  Follow-up attempts completed. No further information expected.
No adverse event; doses were administered prior to temperature excursion/ stated there may have been additional previous temperature excursions for these products; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-NOV-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033047, expiration date: 21-OCT-2023 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. It was informed that the vaccine underwent two previous temperature excursion. No adverse event was reported.  This is one of several cases reported by the same reporter.
Vaccine 4/7/15-small area of redness right thigh. 4/8/15 AM mom noticed more redness right thigh. Worsening 4/9/15 0945 apparent right thigh w/ local reaction approximately 6cm diameter and most consistent w/ reaction to DTaP #4. Mildly tender. Ambulating. Afebrile.
I had no problems after booster shot until Covid-19. Symptoms started on 12/29/2021 with weakness, fever, fatigue, and I spent new years weekend in bed the whole time before going to the ER on Monday. In the ER they checked me in as inpatient and treated me with Remdesivir IV medicine for 5 days before being discharged. After being discharged, I was still real weak and it took me awhile to get my strength back and my PFT is still reduced but it's coming back up slowly. I'm not really recovered fully from Covid-19 as far as back to my full strength but I'm not sick.
Headaches, myalgias, fatigue, palpitations, dizziness, lightheadedness, mild shortness of breath, normal PE.
Patient first noted right arm pain on 11/1/19, sudden onset, without previous injury.  She was seen by PCP on 11/4/19. The patient was referred to Rheumatology and is still being seen (as of 5/12/20). She experienced pain, paresthesias and progressive weakness of the right arm. Work up included ultrasound (suspicion of shoulder syndrome although the ultrasound was negative) and nerve conduction study. She is currently on Cymbalta and Lyrica, suspect complex regional pain syndrome due to influenza vaccination.
p/vax pt lt arm ached; next few days; arm & hand ached; 1wk later very uncomfortable, muscle ache both arms; across chest, back & rt hip; lasted 20min; next morning felt fine; then arrhythmia began & cont to this date;
Following her vaccination after she got home she experienced muscle aches and pain, also at sites different than the administration site. Feelings of faintness for about two days, blurred vision for a couple days. Hairloss. Vasculits in the arms and legs. Atrial Fibrilation which lasted only the night of the vaccine. Vaccine administration arm coldness and temperature drop. Patient reported the symptoms to her doctors and they recommended she get the second shot
Low-grade fever, dizziness, headache, decreased appetite, chills. Began 12 hours after the shot and lasted for 18 hours.
got COVID-19 from his son and tested positive; got COVID-19 from his son and tested positive; This is a spontaneous report from a contactable physician.  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient got COVID-19 from his son and he tested positive 31Dec2020. The patient's son got the COVID-19 virus on 20Dec202020. The patient is due to have 2nd vaccine on 07Jan2021. Outcome of the events was unknown.   Information on batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
I had a breakthrough with the COVID Shots; I had a breakthrough with the COVID Shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had a breakthrough with the COVID Shots".  Medical Information Were any medical questions addressed by this program forwarded/referred to Medical Information? (Live Operators Only): N/A: Customer's questions addressed or no medical questions asked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client stated he has been experiencing fever, headache, nausea and body aches.  Sites of injections are normal. No redness or swelling.  Taking OTC Tylenol. Also states congested.
55 year-old patient received 1 mL of Fluzone QIV instead of 0.5 mL/No adverse event; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA263223, 2020SA263253 and 2020SA263271 (same reporter)  This case involves a 55 year-old male patient who was vaccinated with 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] instead of 0.5 mL(overdose).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.  On 22-Sep-2020, the patient received 1 mL (once) of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (injection) (lot UJ475AA and expiry date 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of overdose (latency was same day).  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.
By the middle of April 2021, I developed mild bilateral forelimb neuropathy primarily in my hands and toes slowly extending over the next two months to include my arms and thighs and lower half of my feet. I started to have difficulty neck and lower back pain.
administration of Adacel to 4 year old patient instead of DTAP; administration of Adacel to 4 year old patient instead of DTAP; Initial information received on 15-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 12-Jul-2019, the patient received a 5th dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA and expiry date: 13-Jun-2020 via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was not reported if any adverse event occurred or not.  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.
18APR devel itching of face, neck 20APR worse to include nose & scalp; 23APR 2AM pt devel palpitations in chest & queezy feeling for 2 hrs; pt talked to MD feels it poss an allergic reaction;
the administration of a second dose of Arexvy to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number g2mg3, expiry date 24-FEB-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   In OCT-2023, the patient received the 2nd dose of Arexvy (intramuscular). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: the administration of a second dose of Arexvy to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 25-Oct-2023 The pharmacist asked for information regarding this situation.  Permission to follow up was not requested during the call. The patient received 2nd dose of Arexvy, which led to extra dose administered
/She felt a thing brush her arm, like a finger but no needle plunging inShe did not feel any penetration from the needle; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration on 26Jan2021 02:15 as SINGLE DOSE for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced she did not feel any penetration from the needle, she felt a thing brush her arm-like a finger but no needle plunging in and headache. She received the 1st dose of the covid vaccine on Tuesday at 2:15. She was told by the nurse that it was all practice or something like that. When it came time for him to inject the vaccine, she looked straight ahead and did not feel anything. She did not feel any penetration from the needle. She asked him if he was done and he said yes and asked her to just go sit over there for 10 minutes. She did not think she got it. Assuming she did not get the vaccine. She is scheduled to receive the second one 23Feb2021. She would like to know if it would be ok for her to get the second one if she did not actually receive the first one. His name was not specified at the fire and rescue. She wondered why they would do that. Maybe he thought it would be harmful for her and did not want her to get it. She did not wish to provide an address or email. She did not wish to complete report and requested to be transferred to have her question answered. No further details provided. She felt a thing brush her arm, like a finger but no needle plunging in. She was then told to come back on the 23Feb2021 for her second dose. She believed he did not actually give her the vaccine. She was experiencing a mild headache but thought it was from distress rather than a side effect of the covid vaccine. She did not wish to provide an address or email. She did not wish to complete report and requested to be transferred to have her question answered and no further details provided. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild
chest pain; Chest pressure; This is a spontaneous report from a contactable pharmacist. A 64-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced chest pain and chest pressure on unspecified date. Reporter is a pharmacist who is seeking further guidance on a patient (64 y/o female) who experienced an AE after the first Pfizer Covid vaccine dose. States the patient experienced chest pain and pressure within 30 mins after receiving the dose and then a similar response later in the day. He states that the patient has experienced similar symptoms in the past. Reporter added that he had a patient who on the initial dose experienced chest pain initially and afterwards had chest pressure in the evening. This information was reported to the doctor and the vaccine website as well.  Reporter stated he does not feel this is a big adverse effect. However, he is looking for clinical guidance on how to proceed in regards to this patient should get the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever of 103 Tue and Wed 9/31-10/1/08, headache, body aches. Man requested symptoms be reported.
I experienced chest pain, elevated heart rate an shortness of breath instantly upon receiving the second dose of the Pfizer vaccine. It did not get better until hours later, and I am experiencing these symptoms intermittently over a week later.
Patient felt pre-syncopal was placed in trendelburg position, was hydrated and rested until symptoms resolved
2-3 minute generalized tonic clonic seizure that self-resolved. At ED at 5:00PM, had 1 minute generalized tonic clonic seizure that self-resolved.
tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012f2a) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse. Concurrent medical conditions included Cervical dystonia and Drug allergy (unspecified drug allergy). Concomitant products included ACYCLOVIR [ACICLOVIR] from 01-Jan-2009 to an unknown date for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced COVID-19 (tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again). On 15-Apr-2022, COVID-19 (tested positive for covid on April 7. eight days later on April 15 tested negative and felt good. new symptoms appeared on April 18 and tested positive again) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, SARS-CoV-2 test: postive (Positive) Positive. On 15-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On 18-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.         On 07 Apr 2022 patient started Pfizer medication as a treatment of COVID-19 and date of last administration was 11 May 2022.  Device Date was reported as 27 May 2022.  Company comment- This spontaneous case concerns a 67-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 5 months and 13 days after vaccination with a third dose of mRNA-1273. 5 months and 13 days after vaccination with mRNA-1273 the patient tested positive for Covid-19. Eight days later, she tested negative and felt good. 3 days after, new symptoms appeared and tested positive again. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 5 months and 13 days after vaccination with a third dose of mRNA-1273. 5 months and 13 days after vaccination with mRNA-1273 the patient tested positive for Covid-19. Eight days later, she tested negative and felt good. 3 days after, new symptoms appeared and tested positive again. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Child came to the pediatric COVID clinic with mother and 3 siblings. Client was to receive the flu vaccine only, and 2 of her sisters were to receive the COVID and the flu vaccination. RN administered the COVID vaccine to client by mistake as RN thought she was administering the vaccine to clients sister. Mother was attempting to calm clients sister down as she was scared about receiving her shots while client received the COVID vaccine. At time of writing this report, there are no  known adverse outcomes that have occurred to client.
left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "left arm soreness". Therapeutic measures were taken as a result of vaccination site pain.  Additional information:FOLLOW UP REPORT.Caller stated that he had both doses of Pfizer Covid vaccine. Stated that he had the second dose on 11 Mar and his lymph nodes in his neck was swollen, had nausea, lightheadedness and tiredness which he reported online to Pfizer. Stated that he has no reference number to provide. Stated that he reported the NDC, lot number and expiration date previously. Stated that he had the first dose in February. Reported today that before breakfast that he had not eaten or drank anything and his glands started swelling again. Wanted to know if he had come into contact with Covid or if something else is going on.Stated that his left gland is golf ball size. Stated that anytime he eats that it swells again. Stated that both palms of his hands felt like needles. Stated that his face gets extremely hot. Wanted to know if any recommendations other than seeing his primary care doctor. Does not have the NDC, lot or expiration to provide for the first dose.Reporter details: Is a pharmacy technician calling on behalf of self. Email address captured as provided.Event details: Stated that his hands felt like needles started at noon and went away in 30 minutes. Stated that with the first dose that he had left arm soreness 4-6 hours after the injection.Treatment: None. Stated that he has called the doctor but he has not returned his call yet. Stated that he used Tylenol and Ibuprofen every couple of hours and alternated it for left arm soreness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.