chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A consumer report has been received. The report concerns a 38 year old, female consumer, height: 63.0 inches; weight: 130.0 pounds, who had been receiving FLUMIST Quadrivalent (intranasal) 0.2 milliliters, once/single administration. Concomitant medications included ethinylestradiol, levonorgestrel for birth control. FLUMIST Quadrivalent started on an unknown date. The patient experienced headache which started on 11-Oct-2015, nasal congestion and malaise. The outcome of the event of headache, nasal congestion and malaise was unknown. The report was considered to be non-serious.
Dose 1, no reaction.  Dose 2, woke up at 2am to use bathroom and Passed out.  Took a whole minute to come to.   Called ambulance.  Taken to hospital and kept for 12 hours.  Head, both legs and back hurt so bad.  Fever stayed at 100.3-100.6.  Sent home slept for a couple hours and fever finally broke 36 hours later.
The patient received the immunization and then took a seat on a chair in the pharmacy waiting area. After about 15minutes, he explained that he got very sleepy and then passed out and fell back to the side of the chair. The chair then tipped over and he fell on the floor and hit his head on the water dispenser in the pharmacy. He woke up after a second or two and sat back down in the chair. He claimed feeling very nauseous and weak and numb in his hands. We called 911 right away and they came after about 10 minutes. They performed a pulse ox and EKG and everything was within normal limits. He was taken to hospital for further medical treatment.
Had 2 weeks of vaginal bleeding that started in May. I received vaccine in feb.  My last period was over 18 months before the bleeding started.
rash that are itchy; small blisters all around face and neck; rash on face; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine, the patient experienced itchy rash, blistery rash and rash. On an unknown date, the outcome of the itchy rash, blistery rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, blistery rash and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: The patient had a rash on his/her face after receiving the shingles vaccine 2 days ago. The reporter mentioned It looks like very small blisters all around my face and neck that are itchy.  The patient could not find information about this type of reaction online and want to check In with someone about it.
Reaction:   Headache, muscle aches, nausea,   Treatment: None Outcome:  Symptoms improved after 1-2 days
Redness on her left arm at the injection site; A bump on her left arm at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on her left arm at the injection site) and VACCINATION SITE SWELLING (A bump on her left arm at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on her left arm at the injection site) and VACCINATION SITE SWELLING (A bump on her left arm at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on her left arm at the injection site) and VACCINATION SITE SWELLING (A bump on her left arm at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
She had another patient with the exact same rash after the vaccine.; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, patient experienced rash after the vaccine. The outcome of event was unknown.    Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148608 same reporter, product and AE, different patient
Patient reported to the Health Department that 1-2 days after her vaccines given on 10-21-2020 that she had swelling of both lips. One day after the swelling onset she reports she took an Oral Antihistamine and it began helping. She said the swelling lasted 2-3 days.
Brain fog; Confusion; This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 30Dec2020 at 16:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. Medical history included type 1 diabetes and hypothyroid. The patient has no known allergies. Concomitant medications included insulin, levothyroxine, amitriptyline hydrochloride (AMITRIPTYLIN), and escitalopram all taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine and has not been diagnosed with COVID-19 prior vaccination. On an unspecified date, the patient experienced brain fog and confusion. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date with duration of 4 weeks. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the right arm) on 20Jan2021 (at the age of 44-years-old) for COVID-19 immunisation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient presented to Clinic stating she would like to receive an RSV vaccination as she was currently pregnant. Myself, a nurse practitioner, brought the patient back to the room and verified her name, date of birth, and the intended vaccination requesting to be received. Patient verified all information and stated she needed the RSV vaccination. I accidently mixed up the names of the RSV vaccinations and therefor the patient was accidently given Arexvy vaccination instead of Abrysvo vaccination. I was unaware of the incident until I was recently contacted by my manager on 11/14/23 who discovered the mistake. I have attempted to contact patient via telephone with no answer. HIPAA-safe voicemail was left by myself asking patient to return call to clinic at earliest convenience with a brief reason for call explained. Clinic telephone number provided. At the current time of submitting this form, I have not yet made contact with patient to explain what happened and see if any adverse reactions occurred.
Patient complained of lightheadedness, clammy skin, sweating, and headache. I had patient sit, gave him a sugary drink, and a cool compress for his neck. He felt better in about 5 minutes
Information has been received from a consumer concerning her relative who was now a 63 year old male who was vaccinated with MMR II (mfr. unknown) about 50 or 60 years ago and experienced a high fever and seizures. The consumer reported that the patient can not speak and was epileptic. Upon internal review, seizure and epilepsy were determined to be other important medical events. Additional information has been requested.
At approx 1300-scratchy throat and cough. 2130-SOB, tight chest, cough. 2145-severe SOB, unable to talk due to SOB, severe coughing. 2200-arrived at ED, treated with Albuterol and nebulizer, Benadryl IV, Pepcid IV, Solumedrol IV.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (after 1st dose, refer case US2018GSK124969, same reporter). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The pharmacist was the patient. The age at vaccination was not reported. The patient experienced sore arm that lasted for 2 to 3 days. He also stated that the first vaccination was more painful than the second.
Information has been received from a physician concerning a 14 year old female student with no drug allergies, who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Experienced covid rebound starting on 19Mar2023; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 03 (booster) single (Batch/Lot number: unknown), as dose 02, single (Batch/Lot number: unknown) and as dose 01, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 3 booster, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose number: 1 & 2, Primary series immunization complete, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 19Mar2023, outcome "recovering", described as "COVID-19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 19Mar2023, outcome "recovering", described as "Experienced covid rebound starting on 19Mar2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
c/o dizziness, lightheadedness, itching, Nausea and feeling hot. Client vomited x1. No hives noted.
Approximately 3 1/2 hrs post vaccine administration I experienced onset severe headache which over the next hour progressed to generalized body aches, chills and nausea. I then began to feel lightheaded and dizzy and over a period of about 15 minutes I gradually lost consciousness. I quickly regained consciousness but continued with severe chills and aches over the next several hours. The next day I experienced some lethargy but was back to normal state 48 hrs after the vaccine.
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022 No concomitant product use was reported. Patient received half dose. On 04-Jun-2022 the vials were initially stored in the refrigerator. Total 35 vials were affected. Vial did not undergo any temperature excursions. No treatment information was provided.
Patient reported dizziness and nausea within 1 hour of vaccination. She said she was extremely exhausted and had to leave work and go to bed. She said she was having bad dreams that night and overall just felt unwell. She woke up the next day and felt back to normal. She had no reactions to the first Shingrix vaccine but had previously had a similar experience with a flu vaccine.
Initial unsolicited report received from a pharmacist on 19 Oct 2016. This case involves a 65 year old female patient who was vaccinated with a dose of FLUZONE HD (Batch number, expiry date, dose in series, route and site of administration was not reported) on 04 Oct 2016. The patient illness at the time of vaccination, preexisting physician diagnosed allergies, birth defects, medical conditions was reported as not provided and any other vaccinations within four weeks of vaccinations was not reported. The patient concomitant medications were not reported. On 12 Oct 2016, eight days following the vaccination, the patient developed pleurisy. The patient Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Right ear had odd sensation, headache that became migraine, difficulty breathing, lightheadedness/faintness, numbness on right side. Also had flu like symptoms.
Patient's mom reports that she had a rash across her lower back that presented the night of the vaccine. The rash went away within a 12 hour period. Patient does report getting acne and other bumps on her back on occasion. Rash on back has resolved as of day after the first vaccine on 8/8/21.
Had 18 hours of torture. It started when I got cold, my hands and nose was cold, and I got really thirsty. I got colder and colder, and shuttering. I took my temp and it was 101.9,  and I would keep shuttering. My whole body would tense up every min. It acted just like the flu. I had every symptom of the flu, except I did not cough. I had a headache, a little bit of sore throat, little bit sick to my stomach, but I didnt throw up, I had chills and fever. I could hardly move or stand up. I did not have diahrea.  I took two tylenol about 8:00 at night. That lasted till about 4am this morning.
product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune disease" (unspecified if ongoing), notes: Immune disease, in process of determining actual disease. Concomitant medication(s) included: METHOTREXATE; HYDROXYCHLOROQUINE; LEUCOVORIN [CALCIUM FOLINATE]; FOLIC ACID; CALCIUM; VITAMIN D [COLECALCIFEROL]; ALPHA LIPOIC ACID; ROSUVASTATIN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 22Apr2022, outcome "recovering" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Apr2022) Positive, notes: Took another test when symptoms recurred and got a very immediate, strong positive; (19Apr2022) weak positive, notes: got very weak positive. Therapeutic measures were not taken as a result of covid-19. Clinical course: Patient stated that, 5 days after completion of Paxlovid, I had relapse of extreme sinus congestion, runny nose and weakness, fatigue. After two days that, I had recurrence of coughing and also developed UTI at same time. Took home antigen test 2 days after completion of anti viral, and got very weak positive. Took another test when symptoms recurred and got a very immediate, strong positive.
Varicella vaccine was mistakenly administered instead of zoster vaccine. After contacting Merck, it was determined that there was "no specific safety concern that existed and the pt should be given zoster during same visit. No adverse effect occurred.
pediatric patient received adult Engerix-b; pediatric patient received adult Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B adult) (batch number 5DL22, expiry date 22nd March 2020) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B 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 Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The reporter believed that, a pediatric patient received a pediatric dose of Engerix-B but might have got recorded as adult Engerix-B. The Engerix-B was administered in 2018. The reporter believed that, a pediatric patient received a pediatric dose of Engerix-B but might have got recorded as adult Engerix-B, filed as there was a potential for adverse event.  The reporter was unable to pull up the lot number provided by the healthcare professional. The reporter did not consent to follow-up. Additional Supportive Information: The reporter believed that, a pediatric patient received a pediatric dose of Engerix-B but might have got recorded as adult Engerix-B, which led to overdose and adult product administered to child.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No concomitant medication was reported.  Date vaccine was placed in refrigerator was on 22-Sep-2021. No adverse event and no temperature excursions was reported.   This case was linked to MOD-2022-491837.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 31-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.