chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; chest discomfort; fever of 102.6 degrees Farenheight; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body aches), CHEST DISCOMFORT (chest discomfort) and PYREXIA (fever of 102.6 degrees Farenheight) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     The patient's past medical history included Toxic shock syndrome (At the age of 14 the patient suffered toxic shock syndrome and had two headaches) and Headache. Concurrent medical conditions included Tachycardia (20 year history of tachycardia). Concomitant products included ATENOLOL, CLOPIDOGREL, VENLAFAXINE (VENLAFAXINE ER), SIMVASTATIN and ALPRAZOLAM for an unknown indication.    On 26-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced PAIN (body aches), CHEST DISCOMFORT (chest discomfort) and PYREXIA (fever of 102.6 degrees Farenheight). At the time of the report, PAIN (body aches), CHEST DISCOMFORT (chest discomfort) and PYREXIA (fever of 102.6 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.6 degrees farenheight (High) fever of 102.6 degrees Farenheight.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient took Multivitamin concomitantly.
pt devel large red knot on rt leg that is warm & hurts to touch;informed to call MD;infection & is on ATB for 10 days;
pt recv vax 28OCT96 & 14DEC96 pt devel a cough & rhinitis;symmetrel was prescribed; 2 days later 16DEC96 pt t103 & put on APAP & ATB;temp down to 99.8 w/in 4 hr;pt expired that day cause unk. The death certificate states aspiration.
REDNESS AND SWELLING OF INJECTED AREA, ALSO WITH PRURITUS.
Vaccinated with adult Pfizer monovalent vaccine, 30 mcg/0.3ml instead of pediatric 5-11y Pfizer monovalent vaccine 10mcg/0.2ml. No immediate adverse outcome, called parent and informed of mistake and explained possibility of side effects due to higher dose, Local County Health Officer telephone consult with parent.
Rash (redness and itchy) in area of injection. 4x3 inches.  Showed approximately 1 week after injection.
Gardasil was administered in the left arm and Hepatitis B vaccine was administered in the right arm, both with the patient standing. Within less than one minute of the second vaccine administration, the patient fainted, falling against a counter and bumping her head before falling to the floor. She revived within about one minute. She was taken to an examining room and laid on the examining table for about 15 minutes before leaving the doctor's office. At that time BP was 102/62 and HCT was 36%. She experienced pain at the injection site in both arms immediately after the shots, with the left arm worse than the right. For 2-3 days afterwards she experienced headache, dizziness, malaise, nausea and somnolence. She continues to have headaches and dizziness daily. She has received numerous vaccinations over her lifetime and this has been the only occurrence of fainting.
This case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The event high grade fever and injection site pain occurred soon after second dose, where the specific time was unknown. The patient was on bed for one week. The events were resolved within one week following the second dose. The patient did not consented to follow up.
sick; couldn't go to work; fever and chills; fever and chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (couldn't go to work), ILLNESS (sick), CHILLS (fever and chills) and PYREXIA (fever and chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Hot flashes and Asthma.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (fever and chills) and PYREXIA (fever and chills). On 05-Mar-2021, the patient experienced ASTHENIA (couldn't go to work). On 07-Mar-2021, the patient experienced ILLNESS (sick). On 08-Mar-2021, ASTHENIA (couldn't go to work), ILLNESS (sick), CHILLS (fever and chills) and PYREXIA (fever and chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include medication for hot flashes. Treatment details included Anti-nausea medication.
This spontaneous, non-valid report was received from a registered 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 RECOMBIVAX HB (lot# R007212, expiration date: 04-NOV-2020) (route of administration not provided), M-M-R II (N011005, expiration date: 05-APR-2019, therapy type: rHA) (route of administration not provided) and ROTATEQ (lot# R016791, expiration date: 16-APRP-2020, orally) (exact doses were not reported for any vaccine). M-M-R II, was reconstituted with properly stored sterile diluent. There was no adverse effects reported. Administered doses of vaccines experienced the lowest temperature excursion below 36 degrees Fahrenheit (F) (also reported as 35.2 F) for 41 minutes and the highest temperature above 47 F (also reported 47.4) for 17 minutes. Digital Data Logger was involved. There was no previous temperature excursion reported. This is a non-valid report due to lack of the patients' identifiers.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No Medical History information was reported.On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FATIGUE (Tired) and HEADACHE (Headache). In March 2021, FATIGUE (Tired) and HEADACHE (Headache) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.Patient was taking other medication. HCP was not aware of the side effects. No treatment information were provided. This case was linked to MOD-2021-404957, MOD-2021-404958 (Patient Link).
21SEP91 pt woke up @ 230AM w/rash @ inject site which he was scratching; area was red & swollen; by the next morning rash covered pts trunk, arms, legs, face & neck; had fever & h/a also taken to ER MD did not feel was related to vax;
Initially felt heart start racing then had entire body itching which occurred at 7:45am. I had pre-medicated on 12/28 with prednisone 10mg & zyrtec 10mg, 12/29  @ 5am with prednisone 10mg & zyrtec 10mg and @ 7:15 am with Benadryl 50mg.  When reaction occurred Dr. met me at the vaccine clinic, I chose not to go to ER. I took xyzal 5mg at 9:30 am and at 10am another 10mg of prednisone as the reaction didn't worsen only continued and took 50mg of benadryl at 6pm. Saturday woke with slight itching and took Prednisone 10mg & zyrtec 10mg at 5 am and zyrtec 10mg at 7pm.
Fever to 99.6, chills, vomiting, muscle and joint aches.  Never knew I could have pain in knee caps and jaws! So stiff could barely move.  Worst of it was 18-27 hours after shot.  Did not take any Tylenol or such after shot but took an Aleve last night, slept well, and back to "normal" today.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EM9809), in right arm, on 18Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 04Nov2021 at 17:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis. There was no known allergies. Concomitant medication(s) (other medication in 2weeks) included: MUCINEX, start date: 11Aug2022, stop date: 16Aug2022; NYQUIL, start date: 11Aug2022, stop date: 18Aug2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Aug2022, outcome "not recovered" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Aug2022) Positive, notes: On Wednesday,10Aug2022, I tested positive for COVID-19; (17Aug2022) Positive, notes: tested positive again on Wednesday the 17Aug; (18Aug2022) Negative, notes: Negative on thursday the 18th and Friday the 19th. I woke up with Thursday the 18Aug and Friday the 19Aug; (19Aug2022) Negative, notes: Negative on Thursday the 18th and Friday the 19th. I woke up with Thursday the 18Aug and Friday the 19Aug; (21Aug2022) Positive, notes: Sunday the 21Aug and tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid which started from 12Aug2022 and ended on 16Aug2022. Clinical course: On Wednesday, 10Aug2022, patient tested positive for COVID-19. He was isolated and was prescribed Paxlovid, which he started taking on Friday the 12Aug. He finished that course on Tuesday the 16Aug.
Chills, low grade fever 100.5 and tachycardia, hr increased to 131 while standing
Not additional adverse event were reported; received possible improperly stored vaccines due to lack of temperature; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 01-FEB-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), which lot # T020655 has been verified to be a valid lot number with expiration date: 16-JUN-2022, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided).  The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown by the reporter. There was no previous temperature excursion. No additionally adverse events were reported, and no further information was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000533: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560: US-009507513-2205USA000525: US-009507513-2205USA000535: US-009507513-2205USA000545: US-009507513-2205USA000553:
Patient reported feeling an irregular/racing heart rhythm on Friday night after receiving the vaccine. He had this all day Saturday and could not sleep at all due to this. He went in to be seen at the emergency room on Sunday morning and was prescribed metoprolol succinate.
rash started left clavicle and shoulder 2 days post vaccine. Other areas of rash started on right arm, left arm , down back and legs a week later. Tried to use hydrocortisone cream and benadryl with no help.
Underdose; expired dose administered; Inappropriate age at vaccine administration; This case was reported by a nurse and described the occurrence of underdose in a 44-year-old male patient who received HAV (Havrix 720) (batch number 3hr79, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2021, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose, expired vaccine used and adult use of a child product. On an unknown date, the outcome of the underdose, expired vaccine used and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Nurse reported an expired pediatric dose of Havrix was administered to an adult patient earlier today, which led to expired vaccine used, adult use of a child product and underdose. The reporter consented to follow up.
This spontaneous report was received from a nurse practitioner and refers to a 8 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-MAR-2018, the patient was vaccinated with a dose of ZOSTAVAX lot number N020945 with expiration date on 26-OCT-2018 (dose, route of administration and anatomical location were not reported) for prophylaxis. It was stated that the sterile diluent (manufacturer unknown) used as reconstitution of the vaccine was properly stored (lot number and expiration date were not reported). There was no adverse effect reported. No product quality complaint was involved.
Severe headache; Body pain; Dizziness; Low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiry date: unknown) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 61-year-old) as Dose 2, Single for COVID-19 immunisation. Medical history included osteoporosis, raised cholesterol, anxiety, depression, and migraine. The patient had known allergies to many plant pollens, dust, mold, mildew and sulfa. Concomitant medications included atorvastatin, venlafaxine hydrochloride (EFFEXOR), lisdexamfetamine mesilate (VYVANSE), topiramate (TOPAMAX) and unspecified vitamins. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and Expiry date: unknown), via an unspecified route of administration in the left arm on 24Mar2021 at 13:15 as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. 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. On 15Apr2021 at 01:30, the patient had severe headache, body pain and dizziness which started 12 hours after vaccination. Body aches and dizziness stopped by second day, but low-grade fever and headache continued for an additional 48 hours. The headache persisted for more than four days as a nagging ache. Tylenol and Motrin were not able to stop the pain. At day four, the patient was still having the headache, it was not going away. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event headache, low-grade fever and body pain and included treatment with paracetamol (TYLENOL) and ibuprofen (MOTRIN). It was unknown whether any therapeutic measures were taken as a result of the event dizziness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe body pain and dizziness were recovered on 16Apr2021, while the outcome of the events low grade fever and severe headache was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Arm pain,  swelling, redness, itching, swelling of underarm also. Pain in armpit and outside of left breast as well as down inside of arm toward elbow. Additionally, joint pain. All of these symptoms began on May 25, the day after the injection and almost all symptoms finally alleviating by today.
Four inch red circle on injection site , swollen; red 4 inch circular rash on the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (Four inch red circle on injection site , swollen) and VACCINATION SITE RASH (red 4 inch circular rash on the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Four inch red circle on injection site , swollen) and VACCINATION SITE RASH (red 4 inch circular rash on the injection site). On 01-Feb-2021, VACCINATION SITE SWELLING (Four inch red circle on injection site , swollen) and VACCINATION SITE RASH (red 4 inch circular rash on the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   . No treatment medications are reported.
I did not have a reaction to the vaccine. I started to feel COVID-19 symptoms on 6/21/22 which was nasal congestion and I did the at home COVID-19 test and it was positive. We where out-of-state at the time I was feeling sick. I had a telehealth visit with a provider on 6/23/22. I was given a prescription for PAXLOVID. As of today, I still have a little congestion.
patient states that arm ached soon after getting injection and continues to this day.  No treatment, told family physician about this.  He feels ache is tolerable
Information has been received from a physician concerning a 13 month old female patient with a history of reactive airway disease who in approximately late September 2003 or early October 2003, was vaccinated SC with a dose of varicella virus vaccine live. It was noted that the patient was healthy at the time of vaccination. Additional information regarding concomitant medications/other medical history was not provided. Shortly after vaccination (exact timeframe unknown), the patient developed signs/symptoms of a respiratory infection, and was hospitalized as a precaution due to her underlying reactive airway disease. The patient was subsequently diagnosed with adenovirus pneumonia. The physician indicated that neither the patient's hospitalization nor the pneumonia were related to vaccination with varicella virus vaccine live. While hospitalized, the patient was treated with high dose steroids, and approximately 3 weeks after admission, began to break out, in what the physician described as typical varicella lesions. The physician reported that the child had very mild varicella, with no other complications. It was noted that the adverse event of varicella was not considered to be a serious adverse event. The physician described the lesions as typical varicella-like lesions. At the time of this report, the patient was almost completely recovered from the varicella. The physician indicated that the high dose steroids the child received during the hospitalization may have played a role in precipitating the patient's breakthrough varicella. She also indicated that they had at least 1 lesion specimen which was DFA positive for varicella but has not grown anything. Additional information has been requested.
Pt recvd 1st & 2nd dose of Hep B vax on 23MAR91 & 26APR91 & on the evening of 26APR91, pt exp malaise, fever, chills & sweats; By the following afternoon, sx had subsided; pt declined to recvd 3rd dose of vax;
Left hand tingling and cold.; Left hand tingling and cold.; This is a spontaneous report from a contactable consumer (patient).  A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9264), via an unspecified route of administration in left arm on 06Feb2021 15:30 at single dose for COVID-19 immunisation. Medical history included asthma. She had no known allergies. Concomitant medication included beclometasone dipropionate (QVAR) and mometasone furoate (FLONASE). The patient experienced left hand tingling and cold on 06Feb2021 15:30. No treatment received for the events. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. The outcome of the events was recovering.
The next morning she experienced hot flashes; Heart palpitations reaching 124-127 beats per minute; Tingling in the arms and back; Felt weird but not flu like; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old female patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection Batch/Lot number was not reported) at an unspecified route of administration on 21Mar2021 03:30 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Mar2021 (next morning) she experienced hot flashes (hot flush), heart palpitations reaching 124-127 beats per minute (palpitations), tingling in the arms and back (paraesthesia), felt weird but not flu like (feeling abnormal). The patient underwent lab tests and procedures which included palpitations: heart palpitations reaching 124-127 beats per min on heart palpitations reaching 124-127 beats per minute. The outcome of the events was recovered.  No follow-up attempts are possible, no further information is expected.
Onset of headache, chills, fever and extreme fatigue came on at 07:00 on 1/12/2021, about 12 hours after vaccination.  Tmax was 102.0F. 600mg of ibuprofen was taken at 1900 on 1/12/2021 and symptoms (with the exception of headache) subsided.
Initial unsolicited report received from a nurse via other company (Novartis) on 16 November 2015. Manufacturing control number: PUS2015US130007 This case involves an 86-year-old female patient who was vaccinated with FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination, the patient developed a reaction about one inch away from the injection site that was eight inches in length and six inches in diameter. The reaction at the injection site was hot and red to the tough. On an unspecified date, the patient complained of discomfort and swelling. Laboratory investigation and corrective treatment were not reported. The outcome of the events was not reported. Documents held by sender: none. Follow-up information received from a nurse via other company (Novartis) on 19 January 2016. No new information was provided.