chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and soreness in injection site, all over body aches especially up neck and in bones, fever, headache, chills, tiredness, vomiting (12 hours after vaccine but stopped after a couple of hours). All other symptoms lasted about 40 hours except the soreness at injection site which I still have.
To ED with weakness and low blood pressure.   She notes that she has been experiencing upper respiratory symptoms including cough, sneezing, and fever that started yesterday.  She reports that her temperature 10/26 was 102.  Originally presented to Hospital today for evaluation.  Upon arrival she was noted to be hypertensive and ultimately was given 0.2 mg of clonidine and discharged home with pending COVID-19 test.  Reportedly, she had normal oxygen saturations at that evaluation. Since evaluation, the daughter reports continued/progressive somnolence to the point they had difficulty getting her from the vehicle back into her house.  Given continued somnolence, she brings her mother to ED for further evaluation. Upon arrival to the ED, she is noted to be hypotensive with SBP of 80.  She has responded well to IVF bolus.  The patient is able to awaken and talk but quickly falls back asleep.  She is found to be COVID-19 positive as well as hypoxic with oxygen saturations in the low 90s.
Pain starting in right side lower back Saturday 10/20/18. Urgent care Monday 10/22/18 mis-diagnosed as kidney stone. Rash on back starting Thursday 10/25/18. Urgent care Monday 10/29/18 diagnosed shingles. Valacyclovir started Monday 10/29/18.
Developed severe swelling and redness of left upper arm associated with severe pain. Was seen in the ER and Diagnosed a week ago with cellulitis from ER. Patient received in the ER IV Clindamycin and monitored for several hours then discharged home on oral antibiotics.
This spontaneous report as received from a health care worker refers to a male patient of unknown age. The patient's pertinent medical history and current condition was not reported. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB (strength, dose and frequency was not provided). On an unknown date the child was vaccinated with LIQUID PEDVAXHIB at 2, 4, and 6 months of age and no adverse effects reported. Product quality complaint was not involved. The outcome of the event was unknown. Additional information has been requested.
Varicella spots - 20-25 on trunk/back, 20 groin - 6/30/11.
upper respiratory tract infection; Swelling eye; strep throat; acne on chin; jaw locking; gland swelling; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin) and TRISMUS (jaw locking) in a 60-year-old female 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.     Concurrent medical conditions included Chronic migraine. Concomitant products included FREMANEZUMAB VFRM (AJOVY [FREMANEZUMAB VFRM]) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin), TRISMUS (jaw locking), LYMPHADENOPATHY (gland swelling), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with DOXYCYCLINE for Upper respiratory infection, at an unspecified dose and frequency. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory tract infection), EYE SWELLING (Swelling eye), PHARYNGITIS STREPTOCOCCAL (strep throat), ACNE (acne on chin), TRISMUS (jaw locking), LYMPHADENOPATHY (gland swelling), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
2 days after vaccines, left thigh w/confluent erythema, spreading to 12" x 10", non tender, mildly pruritic, & subsequent vesicle-papular lesions at palms, proximal thighs bilaterally, (+) blanchable.
This spontaneous report as received from a female patient of unknown age with sulfa allergy. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and site of administration were not provided) on 04-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. On 06-JAN-2013, two days later, the patient developed a large itchy, red rash, around the injection site (consumer described it as 6 inches in diameter). No treatment was given for the adverse event. No lab diagnostic test was performed. The patient sought medical attention by an office call. At the time of the report, the patient had not recovered. Additional information has been requested.
Weakness; Tiredness; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received Flu vaccine on an unknown date) and COVID Vaccine (received COVID vaccine on an unknown date).   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weakness, tiredness and pain in arm. On an unknown date, the outcome of the weakness, tiredness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the weakness, tiredness and pain in arm to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The age at vaccination was not reported. The  caller stated she had a dose of Shingrix in right arm in February of 2020 and she experienced flu like symptoms of weakness, tiredness and sore arm. The caller had limited information. The caller stated that further information might be obtained from Pharmacy at which she received the vaccine. The reporter consented to follow-up.
On 3/12/08 hives that were coming and going.  Treatment of Predisone and Claritin samples.  3/14/08 rash still coming and going with 2cm in left axillary.  Given Augmentin.
Headache after 1st dose; Chills after 1st dose; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), HEADACHE (Headache after 1st dose) and CHILLS (Chills after 1st dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included DILTIAZEM HYDROCHLORIDE (DILT-XR) for Blood pressure, ROSUVASTATIN for Cholesterol, NINTEDANIB ESILATE (OFEV) for Lung disorder NOS, ASPIRIN [ACETYLSALICYLIC ACID] and NIACIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). On an unknown date, the patient experienced HEADACHE (Headache after 1st dose) and CHILLS (Chills after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Chills, at a dose of UNK, bid. At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea), HEADACHE (Headache after 1st dose) and CHILLS (Chills after 1st dose) outcome was unknown.        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.   This case was linked to MOD-2021-250340 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received: Added events, medical history and treatment.
Reported approximately 20-30 minutes after vaccine injection experienced facial flushing, upper extremity tingling feeling, itching and redness to injection site. Resolved by the next day. Denied shortness of breath.
pt did well w/inj very little crying-5min p/vax pt was diaphortic, BP 80 systolic;
A little dizzy, temporal headache (mild), nausea-will go home and rest.
pt developed T, emesis X 3 /win 3 hrs of receiving vax on 19Feb91. Pt taken to MD in pm on 21Feb91 when mom noted persistent T, emesis, "funny cry" & apparent back arching, T @ Dr's ofc 99(R), pt given Phenergan,parent instructed to observe
Right arm sore; itching; hurting all over; no appetite; Sick; This is a spontaneous report from a contactable Nurse (daughter) reporting for her mother in response to the HCP letter sent in cross-referenced case.   An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via intramuscular route of administration on 03Feb2021 at 13:00 (at the age of 84-year-old), as dose 2, single in right arm for COVID-19 immunization in Public Health Department. The patient medical history included hypothyroidism long term diagnosis, arthritis, palpitations- SVT, diverticulitis, diverticulosis, placement of PVD stent in left leg in 2019, peripheral neuropathy, osteoporosis, obesity, colon resection x 2 with last one being in Feb2014 and COVID-19 in Jun2020. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via intramuscular route of administration on 06Jan2021 at 01:00 PM (at the age of 84-year-old), as single dose in left arm for COVID-19 immunization and patient was in bed for 2 days, had left arm sore after injection with lump and itching, could not eat, hurting all over and joints aching, fever and was really cold and really sick on 06Jan2021 at 11:30 PM. Events were recovered on unknown dates. She recovered fully in 3-4 days other than her arm being sore and injection site itching which lasted 1.5 to 2 weeks. Arm was fully recovered, and reactions were worse with her 1st dose felt worse symptoms more intense. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 at 02:15, patient experienced right arm sore, itching, hurting all over, no appetite and sick. 2nd COVID vaccine made her sick. No emergency room or physican room visit was required due to adverse events. Pfizer product BNT162B2 had a casual effect to the adverse event. There was a causal relationship and a reasonable possibility that the events were related to suspect product. Therapeutic measures were taken as a result of sick and she took Acetaminophen every 4-6 hours for 2-3 days. Outcome of all the events was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received injection on 8-24-2011. Pt went in sun over the weekend and developed a reaction. Injection site experienced burning sensation whenever sun touched skin, a rash developed initially on chest then encompassed arm/leg extremities, mostly on legs where area was exposed to sun. (No explanation given on V.I.S. to stay out of sun). Pt also developed lower lip swelling & pain in area. Pt was prescribed steroids for treatment.
suspected vaccination failure/ shingrix vaccination in 2020, yet I recently developed shingles; shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included zostavax (had both the zostravax vacination in 2015 and amp (unspecified)).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient received both doses of Shingrix in 2020 and recently developed shingles. The patient asked that need to do another shingles vaccination. This case was considered as suspected vaccination failure as details regarding the laboratory test confirmation for shingles were unknown at the time of reporting.
Approximately 2 minutes after receiving the vaccine, the patient lost consciousness while driving to observation. He continued traveling through the barricades, hit a curb and ran into a light pole and secondarily hit a tree with the back end of his car. He immediately regained consciousness and denied having any head, neck, or back pain. He relayed that he is terrified of needles and shots, and has a history of passing out from receiving shots in the past. He also informed us that he has not had anything to eat or drink since dinner the night before. His vitals were as follows: BP 123/87, HR 104, EKG; Normal Sinus Rhythm. His girlfriend was in the backseat without a seatbelt and she had a hematoma on her forehead. Her vitals were: BP 138/90, HR 98, GCS-15. They both denied transport to the hospital and relayed that they would wait for the tow truck and seek medical evaluation at an urgent care center after.
Patient received higher than the recommended dose of the vaccine due to accidentally reconstituting it with the Pfizer adult dose vaccine instead of saline.  0.20 micgrograms in 0.2 mL syringe given of both Pfizer vaccine lot Fl8094 Exp May 31, 2022 and vaccine lot Fk9894 Exp June 4,2022.
Stomach cramps, nausea, constipation, bloated abdomen, abdomen hard to touch, some diarrhea. The symptoms continued daily and are just starting to subside as of today, 2/27/13.
Given in right shoulder...next day I had an enlarged lymph node under the left arm and in my left groin area
pt recv vax 8FEB96 & lab eval 6JUN96 revealed that pt was not immune w/a titer of less than 0.86;had no other adverse exp;
8/31/21 PMH CAD s/p CABG x3, DM II, GERD, HTN, restrictive lung disease presenting for progressive chest discomfort and dyspnea
After moderna vaccine he having stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form once. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.
urticaria/ redness welts; bit her a couple of times; it's because of the tomatoes; it's because of the tomatoes she's growing in her yard and the weeds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "urticaria/ redness welts"; ARTHROPOD BITE (non-serious), outcome "unknown", described as "bit her a couple of times"; FOOD ALLERGY (non-serious), outcome "unknown", described as "it's because of the tomatoes"; ALLERGY TO PLANTS (non-serious), outcome "unknown", described as "it's because of the tomatoes she's growing in her yard and the weeds". The events "urticaria/ redness welts", "bit her a couple of times", "it's because of the tomatoes" and "it's because of the tomatoes she's growing in her yard and the weeds" required physician office visit. Therapeutic measures were taken as a result of urticaria, arthropod bite, food allergy, allergy to plants.  Additional information: Reporter stated that she has spent her entire life eating whatever she wanted, and recently she's been diagnosed with urticaria. Apparently, it was because of the tomatoes she was growing in her yard and the weeds and some bugs that are living under the forsythia bush that have bit her a couple of times and that have tripled her chance of getting like redness welts, or worse, if her airways closes up. The reporter said that her doctor told her last week that she had to get epipens. The reporter also mentioned that she had all the COVID vaccines from Pfizer, and with her last visit to her doctor, she was to say that as she got off of the Prednisone from her last Urticaria episode, she could get her COVID flu shot. The reporter wanted like to do that but was concerned because she had two sick dogs at home and the last thing she wanted to do was get sick and have to go to the hospital. The reporter question was: what was the likelihood that she would get a reaction from taking a Pfizer COVID flu shot. The reporter also stated that they were going to do her a test to see if she was allergic to it and said that would not help her if she got the flu shots. The reporter then said that she tends to wore a mask if she had to go into a store and tends not to went out socially like the rest of the world did.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300358100 same patient different drug/events;
The patient presented to receive his second dose of the COVID vaccine.  The patient did not disclose that he received the Phizer vaccine as his 1st dose until after he received the Moderna vaccine.
The pt complained of flu like symptoms and epigastric burning. He was treated with ranitidine. His symptoms worsened and he developed shortness of breath. He was hospitalized in intensive care at a tertiary care center on 8/2/00 with a diagnosis of dilated cardiomyopathy. He required balloon pump support and will require a heart transplant.
3RD DOSE PFIZER COVID VACCINE GIVEN 9/28/21, LOT #FF2587; 4TH DOSE PFIZER COVID VACCINE GIVEN 3/18/22, LOT #FK9894; pt had a positive COVID test on 8/7/22 and was admitted into the hospital; COVID pneumonia; pt's condition deteriorated considerably; admitted to inpatient hospice on 8/25/22 in ESRD; comfort measures; pt passed away in the hospital with hospice
on day 8 arm started to swell around  injection site ( area of about 4"x5"). area was  raised, red, hot and itchy. resolved slowly over the next week, although still slightly itchy (18 days).
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male. Initial information was processed along with the additional information received from regulatory authority on 08-Nov-2021. 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: 043A21A, and expiry: UNKNOWN) 1 total, dose was not reported, administered to right arm on 06-APR-2021 for prophylactic vaccination.  Concomitant medications included Pfizer booster dose (BNT 162) on 27-OCT-2021.  On 28-OCT-2021, the patient experienced symptoms of loss of taste and congestion and on 02-NOV-2021,COVID-19 virus test was positive (confirmed clinical vaccination failure).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000200244 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211107880-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
MAGNET STICKS TO ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced magnet sticks to arm. The action taken with covid-19 vaccine was not applicable. The outcome of magnet sticks to arm was not reported. This report was non-serious.
Information has been received from a physician who received an e-mail that was addressed to all physicians from another physician, a pediatric neurologist. The e-mail stated that the NVIC reported that 82 patients developed syncope and seizures after injection of GARDASIL. The patients sought medical attention. The patients' outcomes were not reported. The reporting physician who was not the physician of any of these patients expressed concern that GARDASIL was not safe. Upon internal review, seizures were considered to be an other important event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source.
PNEUMOVAX left arm. 1 hour later had knot in arm, later in evening redness started, couldn't straighten arm, "red band", rash on skin wrapping around to the inside from the front, hot to touch, next day knot still there, pt has not taken anything PO or topical for pn. PCP contacted recommended to go to ER.
Body aches, sleep disturbance, edema and erythema 3cm distal from injection site. Symptoms started night after injection and lasted at least two days following. Body aches treated with ibuprofen with temporary relief. No specific modalities attempted for arm symptoms.