chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not yet had 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not yet had 2nd vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not yet had 2nd vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not yet had 2nd vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment Information was not provided by the reporter.
286060 - for this report (VAERS temporary e-report) I meant to report that I had arm pain for first 24 hours after the vaccine. Second dose symptoms: Sore arm; 102 fever x two days unrelieved by tylenol or ibuprofen; also had nausea; body aches; headaches; moderate-severe fatigue unrelieved by anti-nausea medicine, ibuprofen or tylenol that lasted several days; Still not back to my baseline activity of running 5 days a week and surfing on weekends. I become severely fatigued after walking one mile now. I work around COVID patients and am exposed to COVID at work but not until receiving the vaccine have I expressed any like symptoms. Still have general mild fatigue.
Patient was receiving COVID vaccinations with her three children. She received the pediatric 5-11 dose instead of the 12+ dose.
Lasted 5 days, arm red, hot to touch, swollen at injection site. Size of baseball.
EF now 34%; Lightheadedness; Sudden drop in BP; Pre ventricular contractions; Pacemaker mediated tachycardia; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 09Apr2021 11:00 (Lot Number: ER8737) as single dose for COVID-19 immunization. Medical history included ventricular tachycardia from Nov2019 and ongoing (Ventricular Tachycardia seen on remote heart monitor in Nov2019), cardiomyopathy from Nov2019 and ongoing (Echo- EF 42% cardiac MRI scanning in lateral and apical LV wall), COVID-19 from 10Nov2020 to an unknown date (In Nov2020 my wife contracted Covid-19. Days later I tested positive), arrhythmia from an unknown date. Concomitant medications included metoprolol succinate taken for arrhythmia from Dec2019 and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:00 AM (Lot Number: ER2613) as single dose for COVID-19 immunization and experienced Pacemaker mediated tachycardia and PVCs. No prior vaccination within 4 weeks. The patient experienced sudden drop in BP on 22Apr2021, EF now 34% on 27Jul2021, lightheadedness on 22Apr2021, pre ventricular contractions on Apr2021, and pacemaker mediated tachycardia on Apr2021. The patient reported that, "On 16Mar2021 I received first dose of vaccine within days developed PVCs then what I later discovered was DMT (device mediated tachycardia). Second dose vaccine on 08Apr2021. PVCs and DMT worse. On 22Apr2021 developed sudden severe low BP (lightheaded) while hiking. Stopped all exercise. On 22May2021 Ep changed settings on ICD to stop DMT (PVCs creating feedback loop DMT). In Jun2021 I resumed exercise but still having doubts of PVCs and lightheadedness. Stopped all exercise again. On 27Jul2021 Echo done EF now 34%." The patient underwent lab tests and procedures which included blood pressure measurement: sudden severe low BP on 22Apr2021, COVID-19: positive   on 10Nov2020 (Detected), echocardiogram: EF 42 % on Nov2019, echocardiogram: EF 34 % on Dec2019 (LV dysfunction), echocardiogram: EF 34 % on 27Jul2021, heart rate: low on Oct2019, magnetic resonance imaging heart: non ischemic on Dec2019 (LV dysfunction lateral and apical LV wall). Therapeutic measures were taken as a result of pre ventricular contractions, pacemaker mediated tachycardia. The outcome of the event EF now 34% was unknown, pacemaker mediated tachycardia was recovered with sequelae in May2021, while for other events was recovered with sequelae in 2021.   Follow-up attempts are completed. No further information is expected.
Nausea; Lethargy / sleepiness; Body aches / pains; Soreness at injection site
2nd dose of Moderna COVID Vaccine administered 21 days after 1st dose to prevent wastage of expiring doses.  No adverse reaction noted.
Initial temp of 100.4, upon recheck 101.9 with 650mg Tylenol given. IV initiated due to low blood pressure - 78/35. 400mL NS given then converted to D5 due to GFT being 55.  O2 Sats 64% RA when vitals assessed and quickly climbed, ordered to apply continuous O2 at 2LPM via NC and sats climbed to 96%. Last BP 78/35, Dr. ordered for pt to be sent in to hospital if pressure doesn't come up in the next 30 minutes. Pt in trendelenberg position, responds to verbal stimuli. Denies pain. Only complaint was feeling weak. BS up to 197 after tolerating 120ml cranberry juice. Pressures continue to stay low, last BP 72/27, Discussed with Dr. with orders to send to hospital. Admitted to hospital with Hypoglycemia and Hypokalemia.
Hives (severe for 3 days post symptom onset, then mild for two weeks -- ongoing)
Just discovered that the immunization the patient recieved had expired on 9/30/2022
Fainting episode for 5 min. Occurred 21 hours after Moderna booster vaccine injection. Headache for 2 hours after fainting.
After taking the 1st dose I felt the left side of my body  heavy (specially the area of the vaccine), my left arm and leg was a little numb after a while.  Around 8:30pm on the same day I felt as my heart was being ?squeezed? and a little pressure. There was no pain per say, but it was definitely a constant pressure. This symptoms least until the end of the day. On the next day I only felt my left arm sore.  On 5/31/21 I?ve noticed a red rash on my left arm (near my hand), it did not itch. (I have a picture ).
Injection with Zostavax given 12/18, Friday. Saturday evening 12/19, patient experienced right arm pain, redness, irritation, warmth at injection site, chills with "crawly feeling" in skin. Patient seen in clinic 12/22 at which time she was experiencing right sided neck pain, stiffness, frequent nausea with watery mouth. Patient treated symptomatically.
10 min p/shot became unconscious & drove car into a pole & was rushed to ER;
felt tired and sleepy on the same evening; then went to bed; woke up at night feeling a mild headache; took two pills of Acetaminophen; no fever; a few sneezes
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted, was given EPI then came back, EMTs came and said it was a vagal response. Patient recovered, but was taken to ER by ambulance because EPI was given.
RECEIVED EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 28-DEC-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 28-DEC-2022, the patient experienced received expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150340, 20230150255, 20230150600, 20230150423, 20230150157, 20230149982, 20230150588 and 20230150716.
Started with itching all over body. Itchy palms and neck. Itchy scalp. Then red scratch marks wherever I would scratch. Then horrible hives/raised bumps and burning sensation in different parts of my body. Would last about a half hour in each location before moving on to the next. Had hives on my feet, legs, back, flank, chest, arms and neck.
Fever; Chills; Shakes; Vomiting; Abdominal cramping; Diarrhea; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 04Sep2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), ergocalciferol (VIT D), unspecified probiotics and zinc (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 07Aug2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 05Sep2021 at 00:00, the patient experienced fever, chills, shakes, vomiting, abdominal cramping and diarrhea. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the events fever, chills, shakes, vomiting, abdominal cramping and diarrhea were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Intractable nausea and vomiting with sever headache x 48 hours  requiring intervention with zofran
5hrs after vaccines-crying, felt warm unable to walk mom gave TYLENOL. Woke up morning after with temp 101.6 - Mom gave TYLENOL 730AM - 10AM feeling fine no temp, walking, playing. Mom using TYLENOL & ice to affected areas on legs.
Pt said he felt as if he was going to faint. Laid pt down on the floor elevated his feet, checked for pulse and breathing all present but pulse was low. Called 911. EMT arrived pt was checked out by then pulse back up and BP was normal. They check the pt's blood sugars after the finger stick the pt had the same reaction. They have him in the ambulance outside monitored him. All was fine. No hospital or emergency room visit needed.
Leg pain; Painful arm; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), PAIN IN EXTREMITY (Leg pain) and PAIN IN EXTREMITY (Painful arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN (Ache). On 21-Jul-2022, the patient experienced PAIN IN EXTREMITY (Painful arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain). In July 2022, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, PAIN (Ache) had resolved and PAIN IN EXTREMITY (Leg pain) outcome was unknown.     No concomitant medications was reported. No treatment medications was reported.
Narrative:  after the flu vaccinem patient developed puffy and itchy eyes, gave Benadryl to resolve. pt recently had a similar reaction to his shampoo
product was exposed to a temperature of 72.0 degrees Fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves an unknown age and unknown gender patient who experienced product was exposed to a temperature of 72.0 degrees fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ773AA, expiry date: 30-JUN-2022, via unknown route in unknown administration site (dose, formulation, strength not reported) as prophylactic vaccination.  On an unknown date the patient developed a non-serious event "product was exposed to a temperature of 72.0 degrees fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event " (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (product was exposed to a temperature of 72.0 degrees Fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event).  At time of reporting, the outcome was Unknown for the event product was exposed to a temperature of 72.0 degrees fahrenheit and were out of range for a total of 6 days (144 hours), due to it being left out of refrigeration with no reported adverse event.  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.
Day 3 it also turned red and itchy; Injection spot felt like a bruise for 2 days.; Day 3 it also turned red and itchy; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0168) via an unspecified route of administration, administered in right arm on 20May2021 18:00 (at the age of 49-year-old) as dose 1, single for covid-19 immunization. Medical history included seasonal allergy from an unknown date and unknown if ongoing. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 24) taken for contraception (reported as birth control), start and stop date were not reported, valacyclovir hydrochloride (VALACYCLOVIR HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. On 21May2021 07:00 the patient experienced day 3 it also turned red and itchy,this lasted 5 more days, injection spot felt like a bruise for 2 days. No treatment received for the events. Outcome of the events resolved on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
1/10 I started feeling ill. Abdomen feeling sore. I have burning in my ears throat swelling, dizzy, feels like I have a fever, Feel out of it, lock jaw , hard to stand/ walk Nauseous. I called the COVID hotline and no answer.
Tinnitus in both ears, began about 22 hours after second dose of Pfizer vaccine
This case was reported by a pharmacist via call center representative and described the occurrence of increased blood pressure in a 81-year-old male patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 13th August 2018 13:00, the patient received SHINGRIX (intramuscular) .5 ml. On 14th August 2018, 1 days after receiving SHINGRIX, the patient experienced increased blood pressure and pulse rate increased. On an unknown date, the outcome of the increased blood pressure and pulse rate increased were unknown. It was unknown if the reporter considered the increased blood pressure and pulse rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient was given the vaccination on 13th August 2018 and on 14th August 2018 he called the pharmacist to report an increase in his blood pressure and his pulse.
Still a little exhausted; awful taste in mouth/taste in her mouth like she was eating steel; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (awful taste in mouth/taste in her mouth like she was eating steel), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (Still a little exhausted) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CHLORTALIDONE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DYSGEUSIA (awful taste in mouth/taste in her mouth like she was eating steel) and PAIN IN EXTREMITY (soreness in arm). On 06-Feb-2021, the patient experienced FATIGUE (Still a little exhausted). At the time of the report, DYSGEUSIA (awful taste in mouth/taste in her mouth like she was eating steel), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (Still a little exhausted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported to be taken by the patient.
Pediarix was given, but patient should have only received Dtap. Pt received 2 polio vacs with the Pediarix.
Injection site soreness, tiredness on 4/27/21.  At 2 a.m. on 4/28/21 woke up with chills, sweats, fever of 102, headache, muscle pain, joint pain, nausea, feeling unwell, dizziness, weakness, injection site soreness, somewhat fast heartbeat, shortness of breath. If he talked then short of breath and would cough.  About 8 a.m took 1 Tylenol.  About 9:30 a.m. had major stomach cramps, barely walk but made to bathroom to throw up.  Used cold wash cloth for his fever then after he threw up he ate one piece of toast, took his medications and 1 Tylenol (since he threw up the first one).  Heart rate better and breathing better.  Went back to bed to go to sleep about 10:30 a.m.
This spontaneous report as received from a physician refers to a patient. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, (lot number unknown) subcutaneous at 12 months of age. Approximately one year later, she developed shingles on an unspecified date. The outcome of shingles is unknown. Unspecified medical attention was sought via office visit. Additional information has been requested.
Father called on 6/12/06 5:15pm to HD, stated wife told him pt was taken to UC (urgent care) on  6/11/06 2AM with fever started 11PM 105deg and seizure, not sure what UC did for her and not sure f/u instructions since he and his wife are in custody battle. He will take pt to see Dr in couple days. Pt has no fever or seizure activation noted since he has pt today, just finishing dinner. Dad has pt 4 nights a week, last saw her on 6/8/06.
I felt close to passing out as my first  symptom after receiving the booster.  Since I had not heard this as a reaction, I thought I should report it.  I felt faint numerous times up to 90 hours afterward.  Then complete resolution.  I also had 101 fever for 24 hours, chills, body aches, but these symptoms have been listed as common.
Difficulty breathing and seeing, dizziness, nausea, diaphoretic, very pale
Fever to 101 degrees F - Night of flu shot is afebrile the morning after with malaise and body aches.
I had a runny nose, stuffy headache, fatigue, chills and cough. I tested with a at home test and at the doctor. I was prescribed PAXLOVID. I have seen improvement 48 hours after starting the medication.
Felt dizzy; Very tired, little fatigue; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, 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: DIZZINESS (non-serious) with onset Oct2023, outcome "unknown", described as "Felt dizzy"; HEADACHE (non-serious) with onset Oct2023, outcome "recovered" (Oct2023); FATIGUE (non-serious) with onset Oct2023, outcome "unknown", described as "Very tired, little fatigue".  Additional information: Caller stated her daughter felt really dizzy immediately but caller had same experience with hers. She stayed home with headache. After about a day went away. Caller stated that it felt like very much not that much, a little fatigue. It was mild symptoms, and she didn't have headache. Stated that it was herself and caller's sister that had headache on 1st day. Caller stated that they all Pfizer Covid vaccines. Caller was very tired but nothing out of the ordinary.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333483 same reporter/drug, different patient/AE;US-PFIZER INC-202300334599 same reporter/drug, different patient/AE;
Injection site soreness starting 1 hr. after injection, then chills, fever, body shuddering,generalized myalgias, feeling cold all over starting 10-11 hrs. after injection, then night sweats on second night after injection.  All symptoms have resolved after 48 hours.
My son woke up the next morning with horrible headaches, chills, temperature elevation (37.8C), loss of balance, nausea, vomiting. I took him to the emergency room. Labs were done and an emergency CT scan of the head. Later on, he saw a neurologist, a neurosurgeon, and an endocrinologist. He was sick for a month and was unable to go to school.