chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt Dizzy; Fallen to the floor; Banged her head; Fever  99.6F; Passed out/ Unconscious; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out/ Unconscious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 047B21A and 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021 at 9:30 PM, the patient experienced CHILLS (Chills). On 20-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out/ Unconscious) (seriousness criterion medically significant). On 20-Nov-2021 at 6:30 AM, the patient experienced DIZZINESS (Felt Dizzy), FALL (Fallen to the floor), HEAD INJURY (Banged her head) and PYREXIA (Fever  99.6F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 20-Nov-2021 for Fever, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out/ Unconscious), DIZZINESS (Felt Dizzy), FALL (Fallen to the floor), HEAD INJURY (Banged her head), CHILLS (Chills) and PYREXIA (Fever  99.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 99.6f (High) 99.6F.         No concomitant medications were reported.  Company comment- This spontaneous case concerns a 59-year-old female patient with no relevant medical history who experienced serious unexpected events of loss of consciousness. The event occurred approximately one day after the third dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-396447, MOD-2021-395855 (Patient Link).; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with no relevant medical history who experienced serious unexpected events of loss of consciousness. The event occurred approximately one day after the third dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: (RA). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, single), for COVID-19 Immunization, reaction(s): "flu like thing/flu like symptoms", "sleepy/feeling sleepy". The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy/feeling sleepy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like thing/flu like symptoms".  Additional information: patient ´ve had that before with some of your earlier Pfizer vaccines.  After getting vaccine, had flu like symptoms day after, was feeling sleepy. These things pretty typical, has had this experience with Pfizer vaccines.Thinks he had four doses Covid-19 vaccine prior to this dose, all Pfizer.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Felt like "rubber band snapped" at her ankle. Being evaluated for tendonitis or rupture
Information has been rec'd from hlth professional concerning a pt who on 7/15/97 was vaccinated with 1 dose of varicella virus vaccine live. On 3/14/01 the pt experienced chicken pox with a fever of 101F, sore throat, and approximately 10 lesions. Medical attention was sought. F/U 6/18/01: The pt had no known allergies. The varicella vaccine lot (621192/1550D) SC in the left arm. He had approx. 50 lesions. On 3/20/01, the pt recovered from her chickenpox. Additional info is not expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receiving her first dose of the Pfizer vaccine for covid 19. She\r\nwas laid down on her back. Fainting spell lasted about 2-3 minutes. She said it was usual for her to faint after immunization as a child. She didn't mention this because she thought she had outgrown it. She complained about quizziness in her stomach after the fainting spell. She was given 1 tablet of 25mg Benadryl.
noted quarter size bruise @ inj site w/sl raised appearance rt deltoid region-measurement comparison of arms (deltoid areas) noted 1/4 difference w/lt arm larger than right-cool to touch;referred to PMD who began medrol dose pack;
she had covid vaccine 12/29/20 at 9:45 am  in L arm, had increased pain in L shoulder which she thought was due to vaccine SE.  However, pain inc and she saw ortho MD 12/30 who dx her w/ acute bursitis due to high vaccine placement , improved 1/4/21 then worsened after some inc activity but overall improved
Patient says she experienced a really bad migraine starting the same day after she received the shots. The next day the migraine started getting better but it was still lingering. She also was experiencing the sore arms.
Pfizer-BioNTech COVID-19 Vaccine EUA  Tinnitus Began day after injection, off and on for two days. Third day through now, the 6th day, constant tinnitus all day and night.  Causing difficulty sleeping.  Causing some dizziness.
03/23/2021 -Left ear Single-sided deafness and loud tinnitus 05/17/2021-ENT visit with prednisone treatment, MRI, referred to another medical facility with bilateral asymmetric sensorineural hearing loss with tinnitus. 10/18/21-Audiologist testing and referral for cochlear implant Determined cochlear implant candidate, patient still suffering from tinnitus
Pt recvd a series of 3 Engerix B vaxs. Serology done 31Aug90 (about 1 mon /p 3rd vax) indicated that pt failed to develop titers, revax was offered, pt restarted 3 shot vax series,1st inject 29Oct90, no treatment required
Had a metal taste in mouth for a couple hours after vaccination. Made food taste bland, or strange. Went away by the evening.
Fever, NauseaVomiting, chills, body aches (unspecified) Narrative:
Rash at injection site and around it about 2 inches in diameter as well as a red pimple looking thing where injection was given. This appeared shortly after the injection was given and is still there three days later.  Approx 24 hours later, i started feeling achy all over and the night of 17th, woke up middle of the night with a slight fever and drenched in sweat all over. It was mostly gone when I woke up at 6am to go to work , it was mostly gone and dissipated sometime that morning.
PATIENT FELT "BAD", FATIGUED, FEVERISH (BUT DIDNT TAKE TEMP), AND VOMITED ONE TIME THE DAY AFTER THE VACCINATION (SATURDAY 12-8-18). STARTED FEELING BETTER ON SUNDAY (12-9-18) WAS ABLE TO KEEP FOOD DOWN ON 12-9-18. TOOK A BENADRYL TODAY 12-10-18 AND HAS FELT BETTER. HER ARM IS STILL INFLAMED AND WILL GO TO DR IF IT DOESNT GET BETTER.
Information has been received from a medical assistant concerning a 71 year old female patient with no known medical history and no known drug reactions/allergies who on 06-OCT-2010 was vaccinated IM in right arm with a 0.5ml dose of PNEUMOVAX 23 (Lot # 665924/0930Z, Exp. Date 17-JUL-2011). Concomitant therapy included pravastatin, levothyroxine and ZESTORETIC. On 07-OCT-2010 the patient experienced redness and swelling at the injection site. The patient sought medical attention by office visit. No diagnostic laboratory tests performed. On an unspecified date the patient recovered from redness at the injection site and swelling at the injection site. Medical assistant would like a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. This is one of several reports received from the same source.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M035456 with expiration date 01-MAY-2018 and lot # M039061 with expiration date 28-APR-2018, orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014902: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007305: US-009507513-1705USA007307: US-009507513-1705USA007308:
This spontaneous report as received from a medical assistant refers to a 26 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-DEC-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (albumin status rHA, lot # L041629, expiration date 22-APR-2017, for prophylaxis; dose and route were not reported) instead of M-M-R II. No adverse effects were reported. Additional information has been requested.
Entire left side of face and inside left mouse has a tingling sensation; Weird taste in mouth; Headache; inside left mouse has a tingling sensation; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration on left arm on 12Mar2021 at 13:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. The past medical history included thyroid and tetanus. The concomitant medication included SYNTHROID since an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient experienced a tingling sensation on entire left side of face and inside left mouse(mouth), weird taste in mouth and headache. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures taken in response to the event. The clinical outcome of the events tingling sensation, taste disorder and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Pt arrived in observation area with husband after receiving her first Covid 19 vaccine.  Pt sat through most of her allotted time  to wait but started to feel lightheaded and dizzy. Pt has a significant pmhx that makes her at risk for Covid 19 and wanted to be checked out in medical room. Pt was moved to a wheel chair and moved to medical room. Pt vs were taken and  initial bp was 123/50  and was increased to 137/64 a few moments later. Pt sat in the wheel chair and rested while vs were taken every 15 minutes. Pt bp decreased  to 104/47 and felt better. Pt was released  to observation  area and then to check out.
At 8 days, large hive appeared first on leg, then hives spread over legs and trunk.  Concomitant fever lasting 5 days.
12/26/2020 2:00PM ears itching, hives - left wrist to elbow -- Urgent Care Visit -- Solumedrol shot received and Benadryl advised to take. Hives cleared on skin 12/26/2020
No adverse effect reported; at the moment of vaccination, an unspecified "syringe problem" occurred; at the moment of vaccination, an unspecified "syringe problem" occurred; the pharmacist was not sure that the patient received the full dose of the vaccine; This spontaneous case was received from a pharmacist referring to a 60-year-old patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 13-APR-2019 (reported as "yesterday"), the patient would be vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #N034002 and expiration date: 04-DEC-2019) 0.5 mL, subcutaneously (frequency not reported) for prophylaxis.  On that day, at the moment of vaccination, an unspecified "syringe problem" (syringe issue, product quality issue) occurred and the pharmacist was not sure that the patient received the full dose of the vaccine due to this (inappropriate dose of vaccine administered). No adverse effect was reported. The outcome of the syringe issue and the product quality issue were not reported.  The causal relationship of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) with syringe issue and product quality issue was not reported.
Lost hearing; This case was reported by a physician via sales rep and described the occurrence of hearing loss in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The physician reported a patient came back the day after their first dose saying he could not hear anything.  It did not sound like it has resolved.  The patient was not going to get the second dose. Follow-up was not asked. No further details were available.
Fatigue, pain in finger tips and feet, tingling in left hand and both feet, dizziness, shortness of breath, neausea, loss of appetite, difficulty swallowing, headache. I can't report outcomes because it's still ongoing.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date approximately in NOV-2011 (also reported as 2 or 3 years ago) the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) and (dosing regimen and frequency unknown) for vaccination. On an unknown date (also reported as recently) the patient experienced shingles. It was reported that the patient sought medical attention and contacted a physician. The outcome of shingles was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Right axillary lymphadenopathy occurred about 24 hours after vaccination, worsened at 36-48 hours, then began to improve over the next 5 days.
Seen in local ER day following injection: 8/31 for left arm rash ,edema and erythema. Dx with a skin infection and given oral antibiotics and steroids. Erythema, rash, and edema continued to worsen and was past her elbow. Went back to ER on 9/1 and given IV antibiotic. Sent home with additional antibiotics and symptoms started to improve by 9/4.
Information has been received from a pharmacist referring to a 88 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates in 2014 (reported as "two years ago"), the patient was vaccinated with 2 doses of ZOSTAVAX 19400 PFU (dose, lot # and expiration date not reported) subcutaneously on two separate occasions. On unknown dates in 2014, following the administration of ZOSTAVAX, the patient developed shingles on two separate occasions. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information is not expected as there was no consent to contact the reporter.
COVID-19 breakthrough. My son gave me COVID-19 on Tuesday. On Saturday I knew that I wasn't feeling great. On Sunday is when I knew for sure, I had a headache, runny nose. I went to the doctors office the following Monday to be tested and it came back positive. I was sick for 14 days. I was given a inhaler because it felt like someone was sitting on my chest
Thursday/Friday of vaccination pt reports soreness in arm, Saturday/Sunday reported "flu-like symptoms" Patient reports redness at injection on 1/21/2021 and has doubled in size today 1/22/2021 (referred to PCP)
Developed sore arm which became progressed. Reported to clinic 10/17/11. Dx bursitis and started on physical therapy.
Mom gave APAP p/vax 8PM became limp, pupils were not nl, quit breathing turned blue-mom did CPR-had a sz a/got limp; mom said it was a 2min sz; generalized sz; pt taken to ER; currently tires easily, t105;
This took place in Pod 3 purple chair 3. The vaccinator saw the patient roll out of her chair. Patient states that she  got dizzy after the vaccine, that she came through right away. I asked if the patient ever fainted before and she stated that she fainted in the past from vertigo. Patient stated that she was feeling better and we sent her home with family members that were here with her today.
This spontaneous report was received from a pharmacist via consumer (patients wife) regarding her husband who is his 80s. Pertinent medical history and drug reactions were unknown by the reporter. Approximately on an unknown date of 2010 (reported as about 6 years ago) the patient was vaccinated with ZOSTAVAX (unknown lot number and expiration date) at an unknown pharmacy. Concomitant medications were unknown by the reporter. On an unknown date (reported as a couple of days ago) the patient was diagnosed with an active case of shingles (herpes zoster). The outcome of herpes zoster was reported as not recovered. Causality assessment was not provided by the reporter. No PQC filed. Additional information has been requested.
pt came in on 18NOV recvd vax & on 19NOV92 rt deltoid swollen & warm to touch; no fever-told to use warm compress to area & use APAP; MD advised to return if worsens or go to ER;
Yesterday afternoon 6/20/23 he had 30 minutes of intense body pain, screaming, crying, shaking, improved over the next hour, he napped an hour.  Later in the evening he was awake, eating a normal diet, took a shower.  No resp distress, no nausea or vomiting, no hives.  No local pain, redness or swelling and injection.  This was his second Trumemba.  His appt was at 11 am, had vaccine at 11:30 am and reaction happened at 4:10.  Only gave the one dose of ibuprofen 600 mg at 4:40 pm 6/20/23
This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory problem), HOT FLUSH (hot flashes), DYSPNOEA (trouble in breathing), SARS-COV-2 TEST POSITIVE (covid 19 positive) and CHEST PAIN (chest pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), ALFUZOSIN HYDROCHLORIDE (ALFUSIN) and METFORMIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced AMNESIA (memory problem), HOT FLUSH (hot flashes) and DYSPNOEA (trouble in breathing). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (covid 19 positive), CHEST PAIN (chest pain), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (brain fog) and NAUSEA (Nausea). At the time of the report, AMNESIA (memory problem), HOT FLUSH (hot flashes), DYSPNOEA (trouble in breathing) and NAUSEA (Nausea) outcome was unknown, SARS-COV-2 TEST POSITIVE (covid 19 positive), CHEST PAIN (chest pain) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved and FEELING ABNORMAL (brain fog) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.     Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: TCR On 10-May-2021: Follow-up :- Email id updated
First influenza vaccination; within minutes c/o "not feeling well" ; clutching chest; c/o difficulty breathing; became panicky. EPIPEN given; sx began to subside in < 1 minute. Transported to ER via ambulance.
Forehead puffy; Forehead red; Rash on chest, back, face-forehead; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (Forehead puffy), ERYTHEMA (Forehead red) and RASH (Rash on chest, back, face-forehead) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Related to alka-sulphur).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH (Rash on chest, back, face-forehead). On 18-Apr-2021, the patient experienced FACE OEDEMA (Forehead puffy) and ERYTHEMA (Forehead red). At the time of the report, FACE OEDEMA (Forehead puffy), ERYTHEMA (Forehead red) and RASH (Rash on chest, back, face-forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. Treatment information was not provided.