chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; headache; nausea; General malaise 22Dec./ On 24Dec malaise; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 21Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included Crohns disease, Penicillin allergy. The patient previously took nystatin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received other unspecified medications within 2 weeks of vaccination. The patient experienced general malaise 22Dec2020. On 23Dec2020, experienced fever, chills, headache, and nausea. On 24Dec2020, experienced malaise. No treatment received for the adverse events. Events outcome was recovered on Dec2020.  Information about lot/batch number has been requested.
Stomatitis; lips completely peeled off; submandibular lymph nodes; headache; This is a spontaneous report from a contactable physician. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular in left arm on 17Dec2020 11:00 at first single dose for COVID-19 immunization. Medical history reported as none. No other concomitant medications were received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient experienced stomatitis on day 11 post vaccine (lips completely peeled off) Day 14- submandibular lymph nodes and headache. Adverse event start date: 27Dec2020 16:00. Events were considered as non-serious. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
APPROXIMATELY 30 MINUTES FROM VACCINE INJECTION  MOM RETURNED WITH PATIENT HAVING HIVES, REDNESS OF FACE AND UPPER BODY AND INCREASED WORK OF BREATHING .  PULSE OX 95%  BEFORE GIVING (1MG/ML) EPINEPHRINE GIVEN 0.15 IM LEFT THIGH - AND SINGLE  (COMBINATION OF ALBUTEROL / IPATROPIUM) BREATHING TREATMENT.  REDNESS GREATLY IMPROVED , PULSE OX INCREASED TO 98%  ON  ROOM AIR  SCHEDULED FOLLOW UP TOMORROW
Narrative:  HPI: 74-year-old gentleman complain day and half of chest pain not exertional in nature but in the left precordium. It does not radiate anywhere. He also has shortness of breath and a mild cough, sinus congestion etc. some colored mucus has been produced primarily yellow. He denies fevers he thinks he had a chill 2 or 3 nights ago but nothing persistent there is been no rigors. No known sick contacts he has been vaccinated against Covid. Patient went with his wife to a local urgent care physician in city and did receive furosemide as well as amoxicillin, he does not think his urine output is increased since being on the furosemide. He relates being on furosemide prior to his coronary artery bypass which occurred in December 2020. Patient has some nitroglycerin but did not think of taking it, he is never used it since he had his bypass in December 2020 patient does relate having been on furosemide prior to his bypass but since then has not needed that in his is not been prescribed Admitted 2/18/2022
administering an expired product, with no adverse event; Initial information received on 21-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient of unknown age to whom expired HIB (PRP/T) Vaccine [ACT-HIB] was administered, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2022, the patient received a dose of expired HIB (PRP/T) Vaccine (expired product administered) (latency: same day) (lot UJ586AAA and expiry date - 16-Oct-2022) (strength, dose, route, formulation unknow) via unknown route in unknown administration site for Immunization.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Drowsiness, pain in arm and up shoulder. Chills and fatigue 10-13 hours after shot. Felt better 24 hours after shot except for arm tenderness, which lasted an additional 24 hours.
Myalgia, Arthralgia, Fever, chills Narrative: not feeling well with chills, body aches and chills
Extreme vertigo, full feeling behind ears, nausea, vomiting, involuntary eye movements left right like pendulum   Started  7 days after 2nd dose.  Worse into 8th day.
unconsolable crying, started 3 hrs p/vax, lasted more or less 2-3 hrs;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 28.69.  Concomitant medication information was not provided by the reporter.  Vial was moved to fridge on 05-Jan-2021. Product moved to clinic on 08-Jan-2021. Batch number 041L20A underwent temperature excursion on 11-Jan-2021with temperature 34 degrees Fahrenheit from 09:00 AM. Beyond use date for the vial was reported as 04-Feb-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
"Lump in throat, hoarseness, sensation of tongue being thick". Took po Benadryl within 1 hour. Went to Emergency Room-was treated with Prednisone. Symptoms resolved-discharged home. "Denied shortness of breat, fever, or vomiting".
Pt states she has had hives all over her body and streaks  since 12/08/2021  Pt says they go away with Benadryl but they come back and are worse at night
Caught  covid after frist dose; Cough; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught  covid after frist dose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). On 22-Mar-2021, the patient experienced COVID-19 (Caught  covid after frist dose). On 24-Mar-2021, COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) had resolved. At the time of the report, COVID-19 (Caught  covid after frist dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-250630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up received on 07-JUL-2021. Lot number of first dose vaccine updated. Additional information about second dose and events of second dose were provided.
Child did well immediately after vaccine with minimal pain and soreness. About 36 hours after vaccination, she developed redness, tenderness, and swelling at the site of quadracel injection. She reported pain with walking, movement, and touch. Area was very hot to touch and firm.
Mom says pt devel rash @inject site shortly p/vax, now getting larger & has bluish discoloration; advised see MD; 15OCT91 unable to reach by phone(several attempts); no response to letter;
Experiencing decreased sensation in bottom lip. No decrease in function. No facial droop. Just decreased sensation/numbness. Started on the second morning after the vaccine. No exposure to known allergies.
doses were very painful; This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2019AMR122591').   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband via voicemail. The age at vaccination was not reported. It was reported that the Shngrix was very painful. The patient received Shingrix and experienced very painful. The patient's husband was told that it was normal, but was calling to find out why it was so painful. For the tolerance of 2nd dose, refere case US2019AMR122634.
Cough  Fatigue  Muscle or body aches  Headache  Sore throat
Missed her second dose appointment; a low body temperature; running a temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Missed her second dose appointment"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "a low body temperature"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "running a temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was scheduled to get the second dose last 16Apr2021 which is more than 21 days apart from the first dose. However, the reporter missed her second dose because she had a low body temperature on that day. Yesterday, she was released by her doctor and now she is ready to get the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
5min p/vax pt broke out in splotchy red rash on chest & face;chest resolved w/in 5min rash on face resolved 20-30min;later pt had no c/o diff breathing or  itching or swallowing;pulse 88;rt leg sl red & several whelps @ inj site;
Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Multiple epistaxis daily, severity and frequency is increasing
21 yo female return from 2nd dose ,  c/o SOB , Flushed, foggy brain. 1608 BP- 128/88, SPO2- 98, P-87, R-18  Administered 50 mg Benadryl, pt began to feel increased dizziness, lowered patient to the floor and administered 6L of O2.  doctor assessed patient, patient Alert and Oriented X3 lowered O2 level to 2L, Sat patient up in chair @1623 BP-146/98, SpO2-98, P-83, R-20.  Pt sated she felt better and was released to aunt @ 1627.
patient developed hives and itchiness around her neck and chest roughly 15 minutes post-vaccination. Pt was given 50mg of liquid diphenhydramine and water. pt refused ambulance, went home, reported the hives had cleared, and said she was going to take a nap and call back when she woke up. pt called back between 4 and 5pm same day and said the hives were still gone and she was feeling fine.
Low grade fever (100.00); significant fatigue; mild muscle soreness; chills; aches; This is a spontaneous report from a contactable nurse for herself. A 32-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176, Expiration date: Unknown) on 26Jan2021 10:00 via intramuscular route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the hospital. The patient's medical history included mild asthma and Antiphospholipid Antibody Syndrome from an unknown date and unknown if ongoing. The patient had no allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730, Expiration date: Unknown) on 06Jan2021 09:45 via intramuscular route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's concomitant medication included Pepcid (Famotidine) at 20mg twice a day, Lovenox (Enoxaparin sodium) 60mg daily, warfarin sodium (coumadin) 5g daily, fluticasone furoate/ vilanterol trifenatate (Breo ellipta) once a day, montelukast sodium (singulair) 10mg once a day and escitalopram oxalate (lexapro) 10mg once a day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Low grade fever (100.00), significant fatigue, mild muscle soreness, chills and aches on 27Jan2021 11:00. The events assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient underwent COVID-19 (Nasal swab) test and Covid Rapid Test on 02Feb2021 which was negative. The patient was given treatment with acetaminophen 1000mg. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
15 minute waiting period I had no events, but 20 minutes after receiving vaccine I had metal taste in mouth on right side along with numbness on right side of face, right jawline, ear area, and small portion of tongue.  No pain.  No swelling.  The metal taste dissipated  in approximately 1/2 hour but numbness lasted until evening.  By next morning, all symptoms were gone.
My first menstrual period following the vaccine was exceedingly heavy in flow for the first two days, which is atypical for me.  Heavy clots of menstrual discharge were observed. It is not yet known whether these side effects will continue for my next menstrual cycle. Lesser effects followed two days after the vaccine with fatigue, sore arm, armpit, and glands in the injection arm. These side effects dissipated by day 3 status post vaccine administration.
Presented to ED w/progressive cough & SOB X 1 week; admitted for COVID-19 pna & UTI; tx w/abx, steroids, zinc; did not need O2 therapy; dc'd home
Sore neck; Swelling in the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN and VACCINATION SITE SWELLING in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Sore neck) and VACCINATION SITE SWELLING. At the time of the report, NECK PAIN and VACCINATION SITE SWELLING outcome was unknown.        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 product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-029619 (Patient Link). Sender's Comments:  MOD-2021-029619:same reporter, different patient.
Individual received 2nd dose of Moderna Covid vaccine on 1/19 at 6:30 pm.  Next day reported fever, vomiting, and body aches.  No other recent changes to health history.
Narrative: COVID infection following COVID vaccine series 02/20, Pfizer, dose #1 03/22, Pfizer, dose #2 COVID swab, result: detected 12/29 pt cc: exposure: unknown 12/29 CXR Impression: No acute cardiopulmonary disease. 12/29 CT Head impression: No acute intracranial abnormality. 12/29 PT: 12.5 12/29 INR: 1.12
First dosage left me with severe cramping that kept me from going to work. This time I have chills, severe migraine, extremely limited arm motion at site. Upper respiratory congestion and sinus pressure. Not going to be able to work today and tomorrow at minimum.
Flush feeling and rash started on chest and moved to top of head, Blood pressure 180/110, heart rate 120's. Trouble swallowing and icy cold feeling in right axillary. Swallowing issues lasted almost an entire week. Received Benadryl, steroid, and Pepcid in ER.
pt recvd vax; eyes were red; T 100.8;apap given;slept 1.5 cranky;woke up happy;fell asleep;pt had sz, eyes rolled back;drewling, head;pt put in bath water;still would stare but was coming around;v p/ sz;apap given;pt ended up w/ head cold;
Upper frequency hearing loss; Ringing in my ears; Really tired; Little bit spaced out; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced "ringing in my ears", upper frequency hearing loss, really tired and little bit spaced out.  The patient's medical history was not provided. Concomitant medication included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C.   On 28 Jan 2021, approximately 2-3 hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 28 Jan 2021, the patient reported that after the injection he noticed ringing in his ears with upper frequency hearing loss. He felt tired and a little bit spaced out. Treatment information was not provided.   On 29 Jan 2021, the patient reported ringing was a little better, but the upper frequency hearing loss was still there along with feeling spaced out.  Action taken with mRNA-1273 in response to the events was not provided.   On 29 Jan 2021, the patient was recovered from really tired. The outcome of the events "ringing in my ears", upper frequency hearing loss, and little bit spaced out was unknown.; Reporter's Comments: This case concerns a 75-year-old, male, who experienced serious unexpected event of deafness, non-serious unexpected event of tinnitus, feeling abnormal and, non-serious expected event of fatigue. The events occurred 1 days (2-3 hrs) after mRNA-1273 (Lot# Unknown). Concomitant medications included Clopidogrel bisulfate, Bromelain, Pantoprazole sodium, Atorvastatin, low dose aspirin and Vitamin C.  Treatment details were not provided. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Chills, low grade fever right away.  Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg.  Slowly got better after this with time and Pepto Bismol.
pt recvd vax; 12 hrs p/ dose 2, exp a fever of 104-105;t resolved on approx 16jun94;reporter indicated that pt had tonsillitis at time of vax;
THE PATIENT NOTED THE TYPICAL DELTOID MUSCLE SORENESS 2/25-2/27.  ON SUNDAY 2/28 SHE NOTED PRURITIS OF HER LEFT UPPER ARM.  SHE STATES SHE TRIED NOT TO SCRATCH IT.  SHE NOTED YESTERDAY ONSET OF RASH ON HER LATERAL UPPER ARM.  TODAY THE UPPER ARM PLAQUE WAS STARTING TO FADE AND WAS SLIGHTLY WARM.  THE DISTAL UPPER ARM PLAQUES (MEASURING 10 X 12 CM OVERALL) WERE RED, WARM AND SLIGHTLY THICKENED SKIN CONSISTENT WITH CELLULITIS.
15 year brought in to the pharmacy by his parents as walk in. Asked to give his son the Janssen shot, due to it being  a one shot and did not want to have to bring him back for a second shot. Father specifically said his son was 16. After the Vaccine was given parents and son waited 15 minutes and no reactions were noted. While batch processing it was then realized the child was 15. Tech giving the vaccine did not realize the age before giving.
No adverse reaction. patient received 2nd booster and did not meet the CDC requirements of being age 50+