chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a field representative refers to a patient of unknown age and gender. There was no information about patient's concomitant therapies, concurrent conditions or medical history provided. In approximately 2009 (reported as "about six years ago"), the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot # and expiration date not specified). In approximately 2009, the patient's arm swelled up. The time of swelling relative to receiving ZOSTAVAX was unspecified. The outcome of the swelling arm and relatedness between the event and ZOSTAVAX was unspecified. The outcome of swelling arm relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Within 48 hours of vaccine, left arm was unusable.  Pain, heat and severe arm muscle and shoulder pain.  MY left arm was complete unusable and required constant OTC pain meds. This lasted for over 2 weeks.  At 5 days after the shot, when visiting Dr., he suggested that the inflammation from the vaccine was affecting my shoulder as well as my arm.   10 days after the vaccination, I visited Dr..  She stated there was still a hard spot on my arm at the vaccination site.  My arm was still unusable; I was unable to lift it and was in constant pain.  After much research, I believe my injection was improperly given.  Both Dr. and I realized I was experiencing SIRVA.
experienced itchy scabby rash; This is a spontaneous report received from contactable other Healthcare Professional via Pfizer-sponsored program . A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, as a SINGLE DOSE for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was reported that patient had experienced itchy scabby rash after administering her first dose and her daughter was asking if her mother will experience the same adverse event if she took the second dose. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
This spontaneous report was received from a healthcare worker/medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 27-APR-2015, the patients were vaccinated with exposed to temperatures outside of the recommended range GARDASIL (dose, route of administration were not reported, lot number: K005881, expiry date: 14-JAN-2017). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/18/2021 and 4/15/2021. Presented to ED on 8/16/2021 with complaints of weakness and fever over the past day. Patient's nephrostomy tube was changed two weeks prior for an infected kidney stone and patient just started noticing blood in his foley bag the morning of presenting to the ED. Admitted for UTI. On 8/17/2021 patient expressed concern for COVID status since family at home is COVID positive. Patient has mild cough but feels it is chronic at baseline. Patient tested positive for COVID on 8/18/2021 and spiked a fever that afternoon. On 8/19/2021 patient reported feeling cold and having chills overnight as well as dry cough, but denies shortness of breath. On 8/20/2021 patients SPO2 dropped (86-88%) on 6L O2. Patient was placed on NRB with 96% sats. On 8/21 patient on HFNC with escalating oxygen requirements, patient started on dexamethasone. On 8/25 patient experienced destauration to 87% while on 6L NC. On 8/30/2021 patient wished to discuss comfort care. On 8/31/2021 patient was transitioned to inpatient hospice, and patient expired on 9/1/2021.
Fever / her temperature is down to 99; chills; sweating; headache; muscle aches in shoulders, neck and back; tired / still feels tired; weak / still feels / weak; arm was very sore; sore / extended to her neck; sore / extended to her / back; Nausea; This case was reported by a consumer and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea. On an unknown date, the outcome of the fever, chills, sweating, headache, muscle pain, pain in arm, neck pain, back pain and nausea were unknown and the outcome of the tiredness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right deltoid and fever, chills, sweating, nausea, headache, muscle aches in shoulders, neck and back, tired and weak. The patient's arm was very sore the next day and extended to her neck down her left arm to her back.  The patient just got up a while ago and temperature was down to 99 degree F but still feels tired and weak.  The reporter asked would second shot be as bad.
Swollen red injection site that spread as time passed. Emergency room doctor gave antibiotics in case it was an infection.
No adverse event; First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.   Patient did not have any relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 28-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 28-Feb-2023,after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023).    No concomitant medications were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19.  No treatment information was provided.
patient receiving FluLaval on 16Sep2019 and Fluzone Quadrivalent 0.5 mL on 11Nov2019, no AE; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 48 years old male patient who received 0.5 ml dose vaccines  INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLULAVAL) and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported via intramuscular route in the right deltoid, on 16-Sep-2019 and 11-Nov-2019 respectively.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was as actual medication error case due extra dose administered. It was reported that patient receiving FluLaval on 16-Sep-2019 and Fluzone Quadrivalent 0.5 mL on 11-Nov-2019 due to the consumer asked for a influenza vaccination on a subsequent clinic visit and the consumers record was not checked before administering the second vaccine.  At the time of reporting, 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 holders 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.
cough; colds; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Mar2021, the patient woke up with a cough and colds. She said that it could be that the vaccine was causing her cough. She reported that she had her first dose on Saturday, 27Feb2921 and said that she was fine on 28Feb2021, but on 01May2021, she woke up with a cough and colds. She asked if it was due to the vaccine. She asked if she can take guaifenesin (MUCINEX). She knows she can take Tylenol but not ibuprofen. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the maladministration of Infanrix in a 7 year old male patient.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: Sales representative that maladministration of Infanrix in a 7 year old male patient which led to inappropriate age at vaccine administration. No further details were provided at the time of the call. No more details about the vaccine or the patient were provided at the time of the call. The reporter mentioned the health care professional (HCP) who told her about the adverse event consented to follow-up by email.
Severe itching and burning. Redness noted around injection site. Onset actually not known. Treated with hydrocortisone cream and ALLEGRA (antihistamine).
dizziness, confusion, facial flushing, accelerated heartrate, hives and itchiness in throat. Followed by two days of soreness to arm and redness at injection site.
nothing has happened to the patient yet. patient received 0.5ml instead of 0.3 ml
This reporter inadvertently administered pediatric Pfizer bivalent covid vaccine instead of pediatric Pfizer monovalent covid vaccine as the first dose in the series.  Discrepancy was noted during charting after vaccine was given.  The health dept. and CDC were contacted; they advised that the dose administered was valid and did not need to be repeated.
sore arm; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer covid 19 vaccine on 12Jan2021. He wants to verify the Pfizer dose is 3 weeks apart and who can he contact to change his appointment. All of the websites are shut down because there are no appointments available. His second dose is scheduled for 29 days out. Wanted to know if that is okay. Mentioned that he had a sore arm on an unspecified date. Clarified that in the beginning that they were scheduling for Moderna vaccine. They did not have Moderna so they gave him the Pfizer Covid 19 vaccine. He was told that his second one should be in 21 days. The Moderna would have been 28 days. Later clarified that his second dose is scheduled for 30 days later. His is scheduled for 11Feb2021. He cannot get in to schedule anything. No one he asked has the correct answer. Patient does not want to take the vaccine and not have the right scheduling. The outcome of the event sore arm was unknown.  Information on the batch/lot number has been requested.
I gave the patient the 5-11 year old dose, but did not dilute it.  I spoke with dad and let him know that I gave his daughter a slightly higher dose than recommended.  He returned my phone call around 7pm today.  I let him know per our Clinical Specialist to be on the look out for increased side effects of headaches, arm ache and fever.  I asked him to reach out to us with any questions, and that the other pharmacist would reach out to them tomorrow between 12pm and 4pm.
Information has been received from a county health registered nurse concerning a 6 year old patient who on 03-OCT-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-Mar-2007  the patient developed varicella < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
In the waiting area, after pt got their shot they started appearing woozy and sweating. Pt said their pressure felt low and ice packs and water were given, as well as alcohol under the nose. Pt breathing appeared normal, and their blood pressure was normal. Pt feet were elevated and he was laid down on the floor. Pt took some time to recover and returned to a seated position. The pt later decided to leave, however they still felt woozy and still not fully capable of walking. Pt took some more time to recover. Later the pt was able to leave and appeared awake, alert and oriented as they did previous to the vaccination. Pt was accompanied by their wife.
PT RECEIVED VARIVAX ON 072605. PRESENTED IN OUR OFFICE ON 110505 WITH A RASH.
Patient received vaccination and held in holding area for 20 minutes. Patient sent back to class where she complained of chest pain to teacher. Patient sent to school nurse, who then sent her to nurse that administered vaccine (employed by provider). Patient collapsed in hallway en route to nurse that administered vaccine. Nurse with provider contacted 911. Student was responsive, coughing, hyperventilating, and stated she was cold. Paramedics arrived and transported to hospital. 12/4/2009 ED records for 11/30/2009 patient with c/o's chest pain, fainting, dizziness, cough and pain in knees. Tx: Ibuprofen, cardiac monitoring,  f/up with cardiology
expired Ipol was administered to patient with no adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid non-serious case from nurse and consumer/ non health care professional via Media Information (under reference 00817126). This case involves a 10 years old female patient who received an expired IPV (VERO) [IPOL] (expired product administered).  Patient did not receive any concomitant medication.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a 0.5 mL third dose of suspect IPV (VERO) (Total, lot R1F80 and expiration date: 12-Oct-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine administered (same day latency).  At 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 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.
Expired Moderna doses given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna doses given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Dose number was reported as booster dose. It was reported that health care professional was unclear which doses these were only that they were boosters. Treatment details was not reported by the reporter.
CONTINUOUS RIGHT  ARM PAIN AT SITE OF INJECTION, STILL PRESENT, RADIATING DOWN ARM, CANNOT LIFT ARM UP OVER 90 DEGREES NOR SLEEP ON LEFT SIDE DUE TO PAIN. NEVER HAD THIS CONDITION BEFORE; NO HISTORY OF ARM OR NERVE INJURY IN PAST. FULL USE OF ARM TILL AFTER INJECTION. DISCOLORATION AND SWELLING AT SITE OF INJECTION FOR AT LEAST TWO WEEKS.
headache; nausea; fever; body aches; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 25-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (arm soreness), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tdap was given instead of Dtap by accident. Patient did not have any adverse reaction.
FEVER, CHILLS, EXHAUSTION, HEADACHE, TIRED, THIS  WAS SEVERE 7/10 FOR 3 DAYS, THEN SLOWLY LESSENED. ALL BUT THE HEADACHE WHICH STILL CONTINUES 6 DAYS AFTER SHOT,  Used nyquil for several days and slept.  headache seemed to worsen as other symptoms lessen. Tried, Tylenol several days little impact on pain.  Tried 60 mg ibuprophen 1x with little relief, tried tramadol 1x with little relief. tried alergy meds several times of  fluticasone and citirizine 10 mg with little relief.  changed sitting desk to standing desk with a little lessening.   I drink lots of fluids, 1 cup of coffee daily, and was active during most days but wed, thursday i was in bed.   Heachache felt better when i was out in the cold weather, but no fever.
Anaphylactic symptoms; This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient reported to hospital with anaphylactic reaction. The reporter consented to follow up.
After a week skin around vaccination area is red, warm and etchy. After another week petechiae appeared in that area.
This is a retrospective pregnancy case. This 26-year-old female subject was enrolled in a study. The subject received Flu TIV .5 ml on an unknown date. The subject's estimated date of delivery was 13 January 2015. The subject received Flu TIV at week 28 of the pregnancy and during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu TIV the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. Additional information: The reporter has 4 patients that she recently vaccinated. This is report 4 of 4.
At about 3:50 PM client was given vaccine. 10 min or so later reported lips feeling fuzzy. No trouble with breathing.  At 1610 B/P 130/94 P 80. At 4:16 PM 911 was called. About 4:20 PM client reported something is happening to me.  Client brought up both hands to head & stated feeling pressure behind both ears & in both ears. Pulse not racing. 2nd nurse speaking with client to support, calm, said she was having trouble finding words. EMS assessed & had client walk with them to the ambulance. RN
First dose of vaccine 13Apr2021 and tested positive for Covid 16Apr2021; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) via Pfizer Sponsored Program.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 on 16Apr2021 and was still testing positive at the time of report. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Apr2021, sars-cov-2 test: still positive on an unspecified date in 2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.