chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; Fibromyalgia development; Chest pain; palpitations; Joint pain; Fatigue; Muscle aches; This is a spontaneous report from a non-contactable consumer (the patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was unknown due to misplaced/discarded) via an unspecified route of administration on 25Aug2021 08:30 at age of 24-year-old at single dose for COVID-19 immunisation. The patient had no medical history (reported as "None never"). No known allergies. The patient had no COVID prior vaccination. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. On 28Sep2021, the patient experienced myocarditis, fibromyalgia development, chest pain, palpitations, joint pain, fatigue and muscle aches. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. No treatment received for the events. COVID-19 test=Nasal Swab was taken on 15Sep2021 with negative result. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
As with the first two doses I was exhausted for about three days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 12:30 (Lot number: EP7534) at the age of 54 years as dose 1, single and administered in arm left, administration date 05Apr2021 12:30 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ASTHMA" (unspecified if ongoing); "Narcolepsy" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypo thyroid" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex; "known allergies: sulfa Drug" (unspecified if ongoing), notes: known allergies: sulfa Drug; "known allergies: nitrile gloves" (unspecified if ongoing), notes: known allergies: nitrile gloves; "known allergies: Many many seasonal" (unspecified if ongoing), notes: known allergies: Many many seasonal. Concomitant medication(s) included: POTASSIUM; FENOFIBRATE; LEVOTHYROXINE; OMEPRAZOLE. Past drug history included: Prednisone, reaction(s): "known allergies: prednisone", notes: known allergies:prednisone; Ghb, reaction(s): "known allergies: ghb", notes: known allergies: ghb; Demerol, reaction(s): "known allergies: Demerol", notes: known allergies: Demerol; Morphine, reaction(s): "known allergies: morphine", notes: known allergies: morphine. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "As with the first two doses I was exhausted for about three days.". Therapeutic measures were not taken as a result of fatigue.  Follow-up attempts are completed. No further information is expected.
Hives started at 7pm on 5/28/14 per mom. Resolved spontaneously after 3 hours.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, between late December 2014 and early January 2015, the patients were vaccinated with improperly stored GARDASIL. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Hello! I got my second covid vaccine on Wednesday (Pfizer) and I believe I maybe experiencing a side effect. My lymph nodes in my arm pit (under the arm of the shot) are swollen and tender to the touch.   On Thursday night (11th and 24 hours after receiving the shot) I had the chills and a low grade fever(100.4). I took ibuprofen and went to bed. I woke up this morning (the 12th) with a swollen underarm but no chills or fever.   The swolling in my underarm as gotten larger and is getting ?more? tender. The swelling is larger than this morning. I have taken ibuprofen with no relief.   Is there anything I should do or now. I have been researching side effects and it appears to be common.... in women....?   Thank you for your time.
Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions; Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) and PRODUCT STORAGE ERROR (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) and PRODUCT STORAGE ERROR (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) and PRODUCT STORAGE ERROR (Possible 7 doses administered from unknown # of vials which the lot had 2 different temperature excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Received the COVID vaccine at age 16; Injecstion site pain; A spontaneous report was received from a physician regarding his daughter who is a 17-year-old female, unknown race and ethnicity, who was administered Moderna Covid-19 vaccine and experienced pain at injection site.  The patient's medical history was not provided. No concomitant medications were reported. No information on allergies.  On 22-Jan-2021, prior to the onset of events, patient received her first of two planned doses of Moderna Covid-19 vaccine intramuscularly for the prophylaxis of Covid-19 infection. (Lot#011J20A). The physician who is patient's father would like to give her the second dose. Also, he wanted to consider her for pediatric trials.  Action taken with vaccine is physician showed willingness to give his daughter a second dose.  The outcome of the events, inappropriate age at vaccination and pain at injection site is unknown at the time of report.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (Lot # 011J20A) with pain at injection site reported. Based on the current available information and temporal  association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
stroke; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Previously administered products included for Product used for unknown indication: Covid-19 vaccine (two vaccines). Past adverse reactions to the above products included COVID-19 with Covid-19 vaccine.   On 12-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.            Concomitant medication not reported.   She had the initial two vaccines, then she ended up with COVID and was treated, and her last Moderna COVID-19 bivalent vaccine was on 12 Sept 2022. Last week, she was in contact with someone who may have tested positive last night 10 Sep 2023. She did not have any symptoms or fever. She was hoping that she was protected. She was hoping that she wasn't protected when she saw her. She had a stroke and was not able to have transportation to the hospital. She took the flu vaccine on the same day that she took the Moderna bivalent vaccine on 12 Sep 2022. Her doctor said it was ok.  Company comment:  This spontaneous case concerns an adult female patient, with no relevant medical history reported, who received a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine (reported as third dose of her COVID  19 vaccination schedule), and experienced the unexpected, serious (medically significant) AESI of cerebrovascular accident. Latency cannot be properly assessed since exact onset date was not provided. No further clinical details were provided for medical reviewing. Co-suspect product includes Influenza vaccine which was administered on the same day as mRNA  1273.222. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included ulcerative colitis (diagnosed back in the 1980's). On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th June 2018, 31 days after receiving SHINGRIX, the patient experienced ulcerative colitis (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the outcome of the ulcerative colitis and condition aggravated were not recovered/not resolved. It was unknown if the reporter considered the ulcerative colitis and condition aggravated to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient, who received SHINGRIX vaccine in an unknown arm. The patient was seen by physician. On 19th September 2018, the patient planned to follow-up with her physician.
No adverse event. Patient is too young to receive Pfizer Booster. Current guidelines only allow for 16 year old and up  to receive a Pfizer booster vaccine.
Nausea and Vomiting  within 10 minutes of administration, Chills  & Light headedness
Fever to  102.8, acute dyspnea, chills, sweats, myalgias.
Patient was administered Pfizer for ages 11 and under.  Patient is twelve years old and appropriate dose is Pfizer for ages 12 and up.  Patient and mother were made aware of the medication error immediately.  All questions answered and mother stated there was no concern.  Patient and mother waited in observation  area for 15 minutes; no adverse events onsite.
Fever, chills, headache, body ache, fatigue and swelling at injection site. The last symptom has not subsided yet
19 or 20th increase tenderness, and it was itching, redness that extending 2 inches across the arm and from shoulder down to my elbow.  It is light pink area now. slowly getting better. per monderna they said it was a delayed reaction. I haven't put anything on it.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure medication" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional Information: Reporter states she got the booster shot and it has a different name from Pfizer, as it is called Comirnaty and the last 2 booster shots said just Pfizer and not this other new name. she always went with Pfizer for the Covid virus and never had any side effects. she just had a sore arm from the needle when being injected that goes away in 3 days, had this after all the injections. She states it is the same like when she gets the flu shot where she has a sore arm for a few days.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300332935 Same reporter, patient, product, events and different dose;US-PFIZER INC-202300332933 Same reporter, patient, product, events and different dose;US-PFIZER INC-202300332934 Same reporter, patient, product, events and different dose;
Vaccine listed as "Flu Vaccine (1)" on after visit summary received at ~4:45 PM on September 9th 2020. Minor arm soreness at site of injection from that afternoon to sometime in the late morning on September 12th 2020. At ~6:30 AM on September 12th 2020, symptoms including whole body soreness and muscle aches, fever of ~101F, nausea, sweating, and chills. These remained in varying severities until ~1:30 PM September 12th 2020, reduced to only body soreness, severe headache, and fever of ~102F. I managed to sleep for approximately three hours and woke with only body aches and no fever. At ~6 PM September 12th 2020 nausia and fever returned with temperature reaching a peak of 104.1F at ~7:10PM September 12th 2020. Took 2 Tylenol gel caps and used damp towel to lower temperature. Temperature at ~102F at time of writing September 12th 2020.
Left arm rising with very large red swollen area - warm to touch and patient reports painful; Patient given course Clindamycin
This case was reported by a consumer via call center representative and described the occurrence of welts in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced welts and product supply issue. On an unknown date, the outcome of the welts and product supply issue were unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX in the first week of June 2018, at that time he made an appointment for the 2nd dose in December. The patient kept the appointment only to find out that the doctor did not have vaccine, they had ordered and been shorted. The patient then checked with their local pharmacy where the pharmacist informed him that not only had they been out for weeks, but no other pharmacy in the area had any. They had heard anecdotal reports from many customers regarding their inability of finding the vaccine at this point, if he wish to get the vaccine, was to start the sequence again. Of course, there was no guarantee that the 2nd dose would be available after he restart. It would seem that either he or their insurance carrier would had to pay for the initial dose a second time. The patient was asking asked how many customers would find themselves in this state. A nice bump to GlaxoSmithKline bottom line he thought. The patient had developed welts on the inside of both arms and belly. The patient asked if this was a delayed reaction to the 1st dose or perhaps a side effect of not getting the 2nd dose.
Short version The patient has long-standing health issues.  The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021.  CPR and treatment was begun and he was transported to the ED.  He was pronounced dead in the ED at 0846.  Long version 70-year-old male with past medical history of CAD with pacemaker, A. fib, COPD, hypertension/hyperlipidemia presenting in cardiac arrest.   911 call at 0724. Per EMS, patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive.  Patient was noted by family to be pulseless and CPR was started right away.  Patient received two doses of epi by police were on scene first (AED defibrillation x2)  and six doses of epi (plus 6 more AED shocks) by EMS when they arrived.  Patient had CPR performed for 45 minutes prior to arriving at the hospital.  On route, patient had episodes of paced rhythm and V. fib.  Patient received one amp of bicarb and one amp of calcium en route.  Patient also received 300 mg of amiodarone en route.  Arrived in ED at 0810 Patient received ongoing compressions, shocks and additional medications (epinephrine x6, lidocaine IV, sodium bicarbonate) until time of death called at 0846 in the ED.
Fever to 101.2, fatigue, myalgias, arthralgias, tachycardia  to 127, relatively low blood pressure 119/75 even without taking blood pressure medications, headache and right deltoid injection site pain and swelling.   Noticed these symptoms upon awakening Mar 29 2021.  Symptoms persisted throughout the day.  I slept most of the day and had decreased appetite.  Because of ongoing tachycardia and fever, I finally took one 500 mg tablet acetaminophen in mid afternoon without effect.  I then took Ibuprofen 400 mg around 7?30 pm and went back to bed.  I awakened feeling much better  and was able to function on Mar 30 although I was still fatigued.  I had no Shortness of breath, wheezing, rashes, dizziness or loss of consciousness.
Headaches,  blurred vision, sensitivity to light,  spots,  farsighted need reading glasses to read and work on the computer,  dizzy at times Saw the doctor on 5/4/2021 and am being evaluated ...Doctor is sending me to an eye specialist
headache; Chills; Jaw pain; Tiredness; Nausea; Vomiting; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; stress on my heart; have no energy and I cannot breath and it is just that I have not energy now; I cannot breath; This is a spontaneous report from a contactable consumer (patient). A 79-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3246; expiration date: unknown) at 79-year-old vaccination age via an unspecified route of administration on 05Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported getting both the shots of the vaccine (COVID Vaccine) and the patient was still having a lot of symptoms that the patient should not be having like headache, chills, jaw pain, tiredness, nausea and vomiting which the patient had both of them in both shots and the patient also have been in the hospital with this. The patient had bad, bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then, and then the patient got the second shot on 26Jan2021 and it got worse. The patient reported having several doctors which includes a cardiologist and stomach doctor. They did several tests (2021), the patient was bleeding, stool was black from blood, and the patient was vomiting blood. The patient reported that "I had stress on my heart and I did not have a heart attack but I had stress on my heart." The patient mentioned having no energy and the patient cannot breath and it is just that the patient having not energy now. When the patient was in the hospital, they gave the patient some medications and the patient don't have it in front of the patient. The outcome of the events was unknown.
swelling at injection site; redness at injection site; soreness at injeciton site/site is still tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site pain. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in left arm and reported that she experienced swelling at the injection site about the size of a grapefruit, redness and soreness.  The patient stated swelling and redness resolved but site was still tender to the touch, The patient also reported that she received a flu shot this year (product name unknown) and she experienced pain at injection site that resolved. The reporter did not consent to follow up. This case has been linked with case US2019104323 and US2019GSK105595, reported by the same reporter.
Flu symptoms that lasted 24 hours or so. Now one month later injection site red and itchy/tingling in hands and feet and aches all over body.
Left lower portion of my leg ached; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received first dose of BNT162B2 (lot number: EL3248), via an unspecified route of administration on the left arm on 28Jan2021 at 08:15 at a single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient had no known allergies. No other vaccine was given in four weeks. No other medications was given in two weeks. No covid prior vaccination. No covid test was done post vaccination. The patient experienced Left lower portion of leg ached. It felt like similar to growing pains experienced as a child. Lasted only one night, the same day as when I received the shot. No treatment was received in response to the adverse event. The next day (29Jan2021) the pain was gone. The patient was not allowed to contact hcp. The patient recovered from the event on 29Jan2021.
Pt. presented to EC for worsening of his chronic lower back pain on 04/13/2021; discharged on 05/02/2021 to extended care facility / sub-acute rehab.