chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Interchange of Vaccine products; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 047A21A), on 09Apr2021 as dose 2, single (Lot number: 008B212A), on 02Nov2021 as dose 3 (booster), single (Lot number: 039F21A) and on 13May2022 as dose 4 (booster), single (Lot number: 004M21A) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jun2022 (unspecified if ongoing), notes: took Paxlovid. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (Manufacture; Unknown, Lot/NDC/Expiry is unknown), administration date: Oct2022, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2023, outcome "recovered" (25Jan2023) and all described as "Tested positive for COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jan2023) Positive; (20Jan2023) Positive; (25Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Last Thursday, patient tested positive, had runny nose, head congestions, and cough. Patient called doctor and got Paxlovid. She is fully vaccinated with 3 boosters. Her primary series up to the 2nd booster is from Moderna. Her latest booster in Nov2022 was from Pfizer. On Sunday, 22Jan2023, she started Paxlovid, then within 24 hours her COVID symptoms went away. Her COVID symptoms started on Thursday. She sent her information about her symptoms and pictures of her positive COVID tests. She tested herself on 19Jan2023 and 20Jan2023 and both tests were positive for COVID. She was having upper respiratory symptoms which were getting worse; she had a runny nose, sneezing, body aches, and a dry cough. Her symptoms started at 6pm on Thursday, 19Jan2023, and she tested positive at 11pm that night.
Started to have hives all over my body, extra over in my chest and stomach area.; it was so kind of itching this morning; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Apr2021 (Lot Number: EW0169) (at 23-year-old) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included dormant asthma when she was kid. There's other products (unspecified). The patient reported she had been having some vaccine reaction she believed, but she went to the doctor today and they believed it to an environmental reaction but, she got the vaccine on "Sunday" (18Apr2021), the evening before around 11 pm, she started to have hives all over my body, extra over in chest and stomach area and then she called like UCM App which was registered doctor provider. They told me to take antihistamine so, took two diphenhydramine hydrochloride (BENADRYL) and the "last night" around 11 o' clock it came back still like around 24 hours and she took couple of more diphenhydramine and it was so kind of itching this morning, she took one more, but she was concern she went to the doctor, they said she reported these kind of symptoms. She had like reaction before (further clarification unknown) but this probably the most severe but she didn't believe that was an environmental was just the correlation between she getting the vaccine. The outcome of event hives was unknown, of event itching was resolving. (the second dose and further course refer to AER 2021552482)
PT PRESENTED WITH ALTERED MENTAL STATUS, DELERIUM WHICH RESULTED IN LETHARGY; POSITIVE FOR COVID-19, HX OF CLL AND A FIB; PT'S CONDITION WORSENED WHERE SHE DIED IN THE HOSPITAL
Body Aches Headache Felt heart fluttering Abdominal discomfort Chest Pain Fatigue Arm hot and swollen at injection site Arm bruised at injection site 7 days following vaccine Persistent itching at injection site
This spontaneous report was received from other health professional concerning to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On a unspecified dates, the patient, was vaccinated with two doses of M-M-R II for prophylaxis (strength, dose, route of administration, lot number and expiration date were not reported). The reported stated that to the unspecified patient, on an unspecified date, a serological testing was performed and the results revealed: negative titer for mumps and positive titer for measles and rubella. The outcome of the event mumps antibody test negative was unknown and the causal relationship between the event and the M-M-R II was not reported. Additional information has been requested.
This spontaneous report was received from a physician concerning an approximately 1 year old male patient. On 24-DEC-2012, the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Mother of the patient was concerned about the development of the patient and stated that there was a regression in language skills. It was reported that the patient said more words at 1 year of age than now (2013). The patient sought medical attention (office visit). The patient was sent for a hearing test. The outcome of the event was unknown.
Patient was originally nervous about the vaccine to begin with. Patient was given the vaccination and sitting their 15 minutes in the waiting/observation area.  Patient became nauseous and decided to go to the restroom to possibly throw up. Upon doing so, patient passed out and cracked chin open. Patient was treated by a paramedic already present, so ambulance wasn't called; the offer to call was given to parents. Parents took child to the emergency room of their own accord after patient was sitting up and feeling better, where she was treated and released.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: patient was eligible for >65 vaccine but declined so was administered regular flu vaccine
1st dose was administered on 12-DEC-2018 and the 2nd dose 12-JAN-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received first dose of Shingrix on 12th December 2018).   On 12th January 2022, the patient received the 2nd dose of Shingrix. On 12th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 21-Jun-2022 Reporters comment: The patient wanted to receive a third dose of Shingrix as the second dose was administered late. The reporter confirmed that no third dose was administered. The reporter wanted to know if any information available. The reporter consented to follow up. Additional Supportive Information: The patient received two doses of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history, concurrent conditions  and concomitant were not reported. On 03-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(dose and strength were not reported, lot # R019235 and expiry date 04-JUL-2020) via unknown route for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent (dose, strength, route, lot # and expiration date were not reported). There was a previous temperature excursion and the time frame and temperature was unknown. There was involvement of Digital data logger was involved. There was no involvement of Product quality complaint (PQC).  This is one of the several reports received from the same reporter.
The child was at 10 years old when the adult Pfizer COVID vaccine was administered for this patient.
chills; body ache; breast Feeding; breast Feeding; This is a spontaneous report from a contactable Nurse(patient). This nurse reported information for herself and the baby. This is a maternal report. This 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, first dose), intramuscular on 21Dec2020 at single dose for COVID-19 immunization.  Medical history included none.  Concomitant medication included ascorbic acid/betacarotene/calcium sulfate/ colecalciferol/ cyanocobalamin/ ferrous fumarate/ folic acid/ nicotinamide/ pyridoxine hydrochloride/ retinol acetate/ riboflavin/ thiamine mononitrate/ tocopheryl acetate/zinc oxide (PRENATAL VITAMINS).  The patient(healthcare worker) wanted to report a possible side effect that she had chills and body ache on 5th day after she got her first dose on 26Dec2020, there was no treatment received and she was also breast Feeding. It didn't say they did not write the expiration. When probed for the causality, patient stated she thought so.  Lab data included blood work was normal. Outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020514624 same drug/reporter different patient(baby case)
Information has been received from a registered nurse concerning a 50 year old male who in Mar 2004, was vaccinated with the first dose of hep A virus vaccine inactivated. Concomitant therapy included zolpidem tartrate (Ambien). In July 2005, the pt received the second dose of hep A virus vaccine inactivated (lot 649456/0174R). On 22Oct05 (previously reported as an unspecified date), the pt developed asymptomatic Hep A. The pt sought unspecified medical attention. At the time of this report, the outcome of the event was unk. Follow up was received from the nurse on 11Nov05. The pt was a white male with allergic rhinitis and a family a history of prostate, skin, and colon cancer, heart murmur (mother and father), and multiple lipomas. On 19Jul05 at 4:00PM, he was vaccinated with the second dose of hep A virus vaccine inactivated (lot 649456/0174R), IM into the left arm and with the third dose of hep B virus vaccine rHBsAg (yeast) (lot 647548/0032P), IM into the right arm. He had no adverse events following prior vaccinations and no illness at the time of vaccination. The nurse reported that lab work done on 22Oct05 came back with a positive hep A result. He was not symptomatic of hep C signs/symptoms pt feels fine. On 27Oct05, the pt again tested reactive for hep A, and was negative for hep C. He was to make an appt with ID (infectious disease) as soon as possible. No further information is expected.
Instead of a 0.25ml dose for the booster, a 0.5ml dose was administered
Dizzy/ Light headed/ she almost fell a couple of times; Stumbling/ Walking from side to side; Headache; Nausea; Room spinning; Elevated Blood Pressure; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 15-MAY-2023 17:00, the patient received the 1st dose of Shingrix. On 15-MAY-2023, 3 hrs after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizzy/ Light headed/ she almost fell a couple of times). In MAY-2023, the patient experienced gait disturbance (Verbatim: Stumbling/ Walking from side to side), headache (Verbatim: Headache), nausea (Verbatim: Nausea), increased blood pressure (Verbatim: Elevated Blood Pressure) and spinning sensation (Verbatim: Room spinning). The outcome of the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation were resolving.   It was unknown if the reporter considered the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation to be related to Shingrix.     It was unknown if the company considered the dizziness, gait disturbance, headache, nausea, increased blood pressure and spinning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The patient self-reported this case. The patient reported that she received 1st dose on Monday at 5 pm and within 3 hours of vaccination she began to feel light headed, and dizzy. When the patient got up, she began to stumble, walking from side to side. She also began to experience a headache and later became nauseated. The patient stated that almost fell a couple of times.  The patient's blood pressure was usually 90/60, but her blood pressure rose to 145/105.  The patient felt the room began spinning.  The patient subsequently went to the emergency room (ER), where they ran tests, but results were negative, and nothing was found.  At the time of reporting, the patient felt much better. The patient stated that some of the nurses in the emergency room told her that they have been seeing a lot of patients come to the adverse event with similar symptoms as this patient after having the Shingrix vaccine.  The reporter consented to follow up with health care professional (pharmacy).
Tinnitus started on 4/8, had a deep tissue massage that eve, noticed ringing that night... cold sore on my lip started around 4/12
Information has been received from a registered nurse concerning a 26 year old female with no relevant medical history reported who on 03-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. There was no concomitant medication. on 04-JUN-2007, the patient returned to the office for her second dose of Gardasil. Dose 2 was not given because she tested positive for pregnancy on that day. In June 2007, the patient had a miscarriage. It was determined that the patient experienced an ectopic pregnancy. The patient returned to the office on 06-JUL-2007 to receive dose 2 of Gardasil. The nurse reported that the patient was "fine now". Upon internal review, ectopic pregnancy and miscarriage were determined to be other important medical events. Additional information has been requested.
pt with very bad headache two weeks ago. now in hospital with very large cerebral sinus thrombosis
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included wheelchair user. Concomitant products included medication unknown (Cholesterol Medication (Nos)). In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown. It was unknown if the reporter considered the pain in arm and neck pain to be related to SHINGRIX. Additional details were provided as follows: GlaxoSmithKline employee reported that the patient took high blood pressure medication, cholesterol and pain medication as concomitant medications. He had the SHINGRIX dose earlier previous week of reporting and a couple of days later, he reported that his arm was very sore and was still sore and his neck was sore within an hour of the injection. He had received no medical help yet.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Alcoholic (Alcohol use- social-Prior Aug 2020) in August 2020. Concurrent medical conditions included Drug allergy and Drug allergy. Concomitant products included DOXYLAMINE SUCCINATE (UNISOM 2) for Sleep disorder, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 21-Jul-2020 and the estimated date of delivery was 27-Apr-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2020, Pregnancy test: positive (Positive) positive. On 12-Jan-2021, Blood glucose: not provided (Inconclusive) Not provided. On 12-Jan-2021, Ultrasound antenatal screen normal: normal (normal) everything looked great, no abnormalities.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included fiber gummy.  No treatment information was provided. Estimated date of conception was 7 Jul 2020. Genetic test was resulted into negative genetic testing, CF, negative Downs Company comment:This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Right arm (arm that was injected) started to get numb and veins felt hot and cold and blood flow on right arm seemed irregular for about 10 hours. This happened 8 days after the vaccination.
I had joint pain in my knee after receiving the vaccine. I tested positive for COVID-19 on 02/23/2023.  My main complaint was having a headache. I also had a stuffy and congestion nose. I did not contact my doctor and I took either Tylenol or Advil as needed. As of today, I do not have any lingering symptoms of COVID-19.
Got J&J COVID vaccine on 4/10/21, at noon, in right arm.  About 24 hours later suddenly felt dizzy which lasted a minute, but since then has felt dizzy and right leg has felt tight and swollen.
Patient (PT) presented lightheaded and dizzy. He was asked to lay down on the floor. PT began to feel better and sat up after a few minutes. He began to feel dizzy again and laid down again and began to feel better. Patient reported numbness in tips of fingers. He was given crackers and chocolate. He denied feeling dizziness after a few minutes nor did he experience blurred vision. He was fully responsive and stood up, talking and was coherently answering questions by us. About 25 minutes later he left smiling and thanked us for our help. Vitals - 16hr:30: HR 57 - RR 16 - SP02 97% - Bp 122/74. 16hr45min: HR 60 - RR 16 - Sp02 97 - Bp 118/82
Patient is 28 weeks pregnant EDD 12/1/2019, presented to hospital on 9/11/2019.  Received the vaccine on 9/5/2019 and since then the injection site got worse. She started with redness on 9/8/2019 that spread and has a hard area at the center. It is very tender to touch. No fever or chills.
Generalized aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04GA21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Tobacco user (six to seven sticks per day), Abstains from alcohol, Diabetes and Hypercholesterolemia. Concomitant products included METHOTREXATE, METFORMIN, ATORVASTATIN, BENAZEPRIL and RISPERIDONE (RISPERDAL) for an unknown indication.   In 2011, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Generalized aching). At the time of the report, PAIN (Generalized aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-129574 (Patient Link).
90 year old vaccinated male was admitted for Respiratory failure from Covid-19 and given Remdesivir. He also has chronic a fib and was on NOAC on admission. He was in NSTEMI on admission and cardiology saw him. Limited echo was done with nothing  further planned. EP saw him today for low HR and recommend stopping NOAC for now. He will be discharged home today in stable condition to follow up with EP regarding decision on PPM placement. He will be discharged with HH services.
Chills (Intermittent) Fever (Intermittent) Loss of Appetite (Constant) Dehydration  (Intermittent) Muscle Ache (Intermittent) Coughing (Rarely) Lethargy (Constant)  Symptoms began occurring 2 hours after receiving the vaccine and have yet to subside. No further medical treatment has been provided.
fever and dizziness persist Will go to Hospital after he called his local clinic and was told to go into HCF
bump on for head X 1 week, rash all over body X 1 day, loss of appetite, fussy X 6 days as per 07/22/2019 office visit.
Problems with sleeping. Awoke every 2 hours on night 1. On night 2, baby also woke every 2 hours. On night 3, baby woke every hour, sometimes 2-3x per hour. Within 24 hours, baby had bright red, slightly raised rash covering entire back. Baby is very irritable since receiving shot. Also, baby has not been eating well.
Brain disorder; A spontaneous report  was received from a consumer concerning a unknown age of, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ended up in hospital, had brain surgery.  The patient's medical history, as provided by the reporter, included brain surgery. Concomitant medications were not reported.  On unknown date, prior to the onset of the events, the patient received their dose of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the unknown site for prophylaxis of COVID-19 infection.   On unknown date, the patient experienced a brain disorder, ended up in hospital, and had brain surgery. Treatment for the event included brain surgery.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the reported event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.Further information has been requested.; Sender's Comments:  MOD21-056185:Patient case