chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore bruised arm at the injection site; Slight cough; Sneezing; Runny nose; Feeling like a cold is coming; Weird feeling in head/ears; Tired; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included post-operative hypothyroidism, fibromyalgia, depression, anxiety and migraines. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient previously took codeine (MANUFACTURER UNKNOWN) and sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. On 22Apr2021 at 06:00, the patient experienced very sore bruised arm at the injection site, a slight cough, sneezing, runny nose, felt like a cold was coming (that weird feeling one gets in head/ears) and was a little extra tired but had no fever till the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore bruised arm at the injection site, slight cough, sneezing, runny nose, felt like a cold was coming (weird feeling in head/ears) and tired were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
2year old /received an adult /Havrix.; 2year old /received an adult /Havrix.; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAV (Havrix 1440 adult) (batch number 5S945, expiry date 6th April 2023) for prophylaxis.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, unknown after receiving Havrix 1440 adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were reported as follows: This case was reported by healthcare Manager (also physical therapist). Two year old patient received an adult formulation of Havrix, which led to adult product administered to child and overdose. The reporter consented to follow up.
This spontaneous report as received from a pharmacist via a poison and drug center, refers to a 68 year old female patient. No medical history provided. ON 29-AUG-2013, the patient was vaccinated with ZOSTAVAX (0.5ml, once, in the left arm). Concomitant medications are unknown. ON 31-AUG-2013 the patient experienced continuous increase in swelling in her left arm. It is unknown if there is relevant laboratory data. As of 31-AUG-2013, it is unknown if she will continue to take ZOSTAVAX and she does continue to experience increased swelling in her left arm. The outcome of continuous increase in swelling in her left arm was reported as not recovered/not resolved. The pharmacist did not have access to the lot or expiration date. The patient was coming into the pharmacy for the pharmacist to look at her arm. Additional information has been requested.
Product storage error; no adverse event; Patients administered vaccine after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients administered vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication information provided. Date moved to refrigeration was 06-Jan-2023. 1 vial of bivalent beyond use date was 05-Feb-2023. No treatment information provided.
Pt received 2 vaccines (singrix and prevnar ) in one arm ( right arm) and developed redness, swelling, and arm soreness at the site of injection the next day. She returned to the pharmacy in  4 days and showed her arm. Pt saw the dr today (4/3/23) and has been told that it is some kind of allergic reaction and was prescribed steroid. She was also advised not to receive the second dose. she also not sure if it was due to shingrix or prevnar
as a result of the broken finger glange the medical assistant cut her finger / the cut was deep enoguth to bleed and need a Band-Aid; Was the product administered or exposed to patient's bodily fluids? Yes, the medical assistant was cut by the broken finger flange; Was the product administered or exposed to patient's bodily fluids? Yes, the medical assistant was cut by the broken finger flange; medical assistant removed the GARDASIL 9 syringe from the tray and discovered the finger flange was broken; This spontaneous report was received from an administrator and refers to a female patient of unknown age, who was also a medical assistant. There was no information regarding her medical history, concurrent condition nor concomitant therapies provided.  On 24-NOV-2021, the medical assistant removed HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # U008897, expiration date 16-MAY-2021) syringe from the tray and discovered the finger flange was broken; 3 pieces of the broken finger flange were found in the tray (discrepant information, also reported as the syringe was broken into less than 2 pieces) (syringe issue). The syringe tray was intact and undamaged on receipt and the syringe carton was not damaged prior to use. The product did not come with a cellophane cover. There was no crack noticed on the syringe. The tip of the syringe and Luer lock adaptor were not loose or broken off of the syringe tip. It was unknown whether there was difficulty trying to attach the syringe needle to the syringe as the medical assistant did not attempt.  On 24-NOV-2021, as a result of the broken syringe, the medical assistant cut her finger; the cut was deep enough to bleed and a Band-Aid was needed. It was reported, that exposure to the vaccine via body fluid occurred (occupational exposure to product, exposure via blood). No additional medical attention was needed for the cut. At the time of the report, the medical assistant was recovering from the finger cut.  The reporter confirmed the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not administered to a patient.  The causal relationship between the event and the suspect vaccine was not reported.
Simple febrile seizure, no tx required Separately admitted to hospital for hypoxia/PNA, not for seizure
This spontaneous report as received from a certified medical assistants refers to unspecified a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown date in 2015 (reported as "since March 2015"), the patients were vaccinated with an improperly stored GARDASIL (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. No adverse effects were noted. There was no treatment given for adverse event. Additional information has been requested. This is one of several reports received from the same reporter.
Suspected vaccination failure; till breaking out with Shingles / still breaking out on left shoulder / shingles all over patient shoulder; but painful / very painful no lesions though / still hurts; burning sensations; and some itching; a lot of discomfort.; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date 12th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 455KD, expiry date 4th May 2021) for prophylaxis.   On 12th April 2019, the patient received the 2nd dose of Shingrix. On 5th February 2019, the patient received 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), shingles, pain, burning sensation, pruritus and discomfort. On an unknown date, the outcome of the vaccination failure, pain, burning sensation, pruritus and discomfort were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, pruritus and discomfort to be related to Shingrix and Shingrix.  Additional details were provided as follows: Patient received two doses of Shingrix and one month before reporting patient broke out with shingles across left upper shoulder and back area,no lesions but painful / burning sensations and some itching but a lot of discomfort. Patient asked about how to get rid of shingles. This case was considered as suspected vaccination failure since the details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. The reported batch number 2P3P9 was not found in sales data sheet sheet so updated as ZP3P9
I had severe stomach cramping. I felt a gush of blood and found that my IUD came out in a huge blood clot. I have since had abnormally heavy periods with clots.
A report has been received from a pharmacist concerning a 47 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 13-Oct-2013. It was reported that the clip was messed up on the FLUMIST syringe he used so he thought the entire dose went into one nostril which started on 18-oct-2013. The outcome of the event of the clip was messed up on the FLUMIST syringe I used so I think the entire dose went into one nostril is unknown. The report was considered to be non-serious.
Less than 24 hrs after receiving the vaccine - pt reports severe muscle weakness/aches/pains. Pt. also experienced a painful earache and reports a stripe-like rash near her knee.
Mother noted reddened area to left posterior arm approximately 1 day after vaccine received, approximately quarter size. Today surrounded by approximately 1/2 inch light reddened area. area edematous and itches. Mother has applied Benadryl Clear topical x 2 to area today (8/1/07)
Patient was only able to describe non-specific symptoms (e.g. "I felt sick", "I had the flu"). He went to the doctor 3 times in 3 days, but doctor didn't prescribe any treatment and symptoms resolved.
She got her vaccine, she had a sore arm/shoulder area but that went away within 24 hours.  Then about 2 days later her upper lip had tingling, and then burning, and three different places on her upper lip had clusters of blisters.  They were painful sores.  Right now three places are red, burning, and she bought an Vibrant Health Gigartina Red Marine Algae ointment that bought in store and the pharmacist told her to get it.  It was good for cold sores, chapped lips, and kept putting it on her lips, which did not help. The blisters have finally gone away and has a wound like area in three spots on each corner of her mouth and one in the middle, especially the right side the two are closer in the middle.   She said she feels like she is dying, bombarded with these symptoms and you don't know how to fix it.    She wishes that they  had studied the vaccines more and that there was a treatment know to treat Herpes Zoster or that these symptoms were out there and what to expect.
Big hive/ Covid arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Big hive/ Covid arm at the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (Big hive/ Covid arm at the injection site). The patient was treated with CETIRIZINE at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. On 12-Feb-2021, VACCINATION SITE URTICARIA (Big hive/ Covid arm at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter   This case was linked to MOD-2021-069744 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received(TCR form)  contains non-significant information; Sender's Comments:  MOD-2021-069744:Second dose of vaccine case
Left arm where she got the shot was a little sore; Headache; This is a spontaneous report from a contactable consumer. This 65-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Jun2021 in left arm as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization and her arm was sore for a day. On an unknown date in Jun-2021 after the second dose her left arm where she got the shot was a little sore. Caller mentioned she had a headache and wanted to know if it is safe to take Tylenol Extra Strength. Caller mentioned that a friend told her not to take Advil after 24 hours because you will lose the effect of the shot. The outcome of events was unknown.  Information on lot/batch number has been requested.
pulmonary blood clot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), 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: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "pulmonary blood clot". The event "pulmonary blood clot" required emergency room visit. Clinical course: the patient went to the ER (emergency room) where was diagnosed with a pulmonary blood clot, supposedly as a result of the Pfizer COVID 19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199093 same patient, different dose and event;
Pt had transietn mild throat tightness after 2nd covid dose previously. However, all other covid vaccines were ok without reactions according to pt including dose #3 on 3.31.22. @this location. Pt received covid bivalent booster (Covid-19 #4 dose) @6:17 pm on 11.10.22 and was informed to wait at least 30 minutes in the store.  Around 6:38pm, pt complained about mild throat tightness so 1 dose of benadryl 50mg was given to pt. Pt declined EMS service. Pt stayed at pharmacy until 7:05pm and monitored and pt's mom stayed with her.  Pt stated pt's throat tightness is gone and felt normal when pt left pharmacy with pt's mom
This case was reported by a consumer and described the occurrence of shingles in a 59-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 16th June 2018, the patient received the 2nd dose of SHINGRIX. On 2nd July 2018, 16 days after receiving SHINGRIX, the patient experienced shingles and itchy rash. In July 2018, the patient experienced tingling and headache. On an unknown date, the patient experienced pain in arm. The patient was treated with Valacyclovir. On an unknown date, the outcome of the shingles, pain in arm, itchy rash, tingling and headache were unknown. It was unknown if the reporter considered the shingles, pain in arm, itchy rash, tingling and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 58 or 59 years. The patient's mother had a mild case of shingles that developed into postherpetic neuralgia (PHN), due to which the patient was proactive about getting the vaccine. The patient never had shingles. Aside from a sore arm for a couple days, there were no side effects. On 2nd July, the patient noticed an itchy rash on the left side of stomach. On 3rd July, the patient was diagnosed with shingles and started on Valacyclovir. On 5th July, the patient had additional shingles symptoms of headache (left side only) and tingling on the entire left side of body. The reporter knew the vaccine was not live and did not cause outbreak. However, it did not completely prevent outbreak either, though the patient was hoping the vaccine would lessen the duration and severity. The patient was a former medical reporter and was curious if they had received other reports like this and if she could be concerned about postherpetic neuralgia.
I got the shot at 4:45pm on Thursday and felt fine all evening. Around 6am Friday, I woke up feeling nauseated. I got out of bed, walked to the kitchen and passed out on the kitchen floor. My husband said that I was unconscious with dilated pupils. I was unresponsive to him holding my shoulders and calling my name. When I regained consciousness, I continued to feel nauseous for another hour (couldn't walk or stand without feeling lightheaded). 2.5 hours later,  I continue to have tingling in my arms, legs, and feet.
FEVER 5/27 ; FACIAL SWELLING ,REDNESS, BURNING SENSATION 5/31
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with a dose of GARDASIL (lot # K008931, expiration date 04-MAR-2017, dose, dose # and route unknown) which were improperly stored. Temperature and time frame was 11 degree for 35.5 hours as well as 0 degree for 241 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Right leg became wobbly (like overcooked spaghetti); unable to realized if I was lifting it to walk without concentrating on the act of walking.
Pt reported back to clinic with parent at 4:15pm  with complaint of rash for front office staff.  APN  called to clinic room to assess patient. Pt  having petechiae rash on face, shoulders, and back of neck. Denied difficulty breathing or feelings of malaise.  APN referred pt to PM Urgent Care  for further evaluation. Parent educated by APN to seek care at ER  if  any swelling , difficulty breathing , or abnormal behavior by child occur.
Patient received Arexvy on 10/20/23. Day after shot developed red ?goose egg? bump lasting about three days. Then the bump went away and a faint rash continues to appear causing inching and pain to the touch. These symptom have persisted through today, 11/5/23.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown demographics. Information regarding the patient's concurrent conditions and medical history was not provided. On an unknown dates, reported as "sometimes", the patient were vaccinated with doses of RECOMBIVAX HB which were sit on the counter for a few hours before being administered (dose, route of administration, anatomical location, lot number and expiration date were not reported). There we no concomitant medications provided. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
tiredness; feeling achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported FATIGUE (non-serious), outcome unknown; PAIN (non-serious), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.