chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose: left arm swollen like a cannonball; first dose: left arm swollen like a cannonball / it was hard, awful, and painful; This is a spontaneous report from a contactable consumer. This 59-year-old female consumer (patient) reported for herself that:   A female patient of an unspecified age received bnt162b2 (Pfizer COVID-19 vaccine, Formulation; Solution for Injection, Batch/Lot Number: EW0168 and expiry date was not provided), DOSE 1 via an unspecified route of administration, administered in Arm Left on 20Jul2021 (Age at vaccination was 58-years) as DOSE 1, SINGLE for Covid-19 Immunisation. And second dose was administered on 11Aug2021 with Lot Pfizer EW0170 in her right arm. The patient medical history and concomitant medications were not provided. The patient experienced First dose: Left arm Swollen like a Cannonball and first dose: left arm swollen like a cannonball / it was hard, awful, and painful on an unspecified date in 2021. The events were assessed as Non serious. The outcome of events was Unknown.    Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a patient who on 28-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 665991/0338Z; expiration date 05-MAR-2012). Secondary suspect vaccine given on the same day included a dose of MMR II (MSD) (Lot # 667190/0406Z; expiration date 18-MAR-2012). Concomitant vaccine given on the same date included a dose of HAVRIX. It was reported that on 07-AUG-2010, the patient experienced a rash at the injection site for VARIVAX (Merck) or MMR II (MSD). It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was not reported. The office requested a lot check for lot# 665991/0338Z. Upon internal review, a lot check was requested for MMR II (MSD) lot number 667190/0406Z. A lot check has been initiated. This is one of several reports from the same source. Follow up information has been received via telephone call from a registered nurse concerning a patient who experienced the reaction after the second dose of VARIVAX (Merck). Information on the other vaccinations was not available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (Lot# 665991/0338Z and lot# 667190/0406Z) in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 18-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given a Pfizer booster during a migrant and seasonal farmworker Covid-19 vaccine event, at age 16 years.  At the time of the clinic, Boosters were not being given to anyone under 18 years. Patient did not experience any adverse events to our knowledge, either at the vaccine site or afterwards.
Notes that she felt overall fatigue and pain in bilateral legs, along with heart flutter within 2 hours after receiving J&J vaccine, with the worst of the bilateral leg pain being from 7:00 pm until most of the night. Woke up in the morning of 4/1/21 feeling general achiness. The episode of reported severe leg pain lasted less than 24 hours.
Patient stated feeling hot, dizzy and headache. Patient provided water and cold air turned on Patient stated symptoms improved Patient refused medical transport and signed form Will be driven home by spouse
Metallic taste in mouth after 15 minutes. About a half hour later, tingling began around my mouth then my entire face and labored breathing ( used Ventolin inhaler)and a cough and very sore arm. The next day, Saturday, I had tingling in my fingers in the morning that spread up my arms and my toes up through my thighs along with my face . I took a Benadryl Sat. PM.  By Sunday the tingling intensity decreased. Monday-dizzy when I woke , then okay. Wednesday I saw my doctor. Today , a week later, and I still have tingling. Doctor recommended I take Claritin for 2 days and get the second shot  due April 16th. I am afraid to get it!!!!
Information has been received from a registered pharmacist concerning a 61 year old male with no medical history who on 10-JUL-2009 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Merck) (lot number 664029/0196Y). There was no concomitant medication. On 11-Jul-2009 after a bike ride, the patient experienced swelling and numbness in the arm where he received ZOSTAVAX (Merck). The patient also had ringing in his ears and deafness in the ear on the same side where ZOSTAVAX (Merck) was administered. The patient was not recovered at the time of report. Unspecified medical attention was sought. Upon internal review, deafness was determined to be other important medical event. Additional information has been requested.
Hospitalization: 12/4/2022 - 12/5/2022 (32 hours) Presentation to the ED: chest discomfort/flutter.  COVID + date: 12/3/22. Treatment: none. patient was asymptomatic.  Discharge to: home.  Pfizer Lot # EL9263 1/22/2021 Pfizer Lot # EL9267 2/14/2021 Pfizer Lot # FF2588 9/3/2021 Pfizer Bivalent Lot # GJ2524 9/25/2022
11/23 1 wk of itching rash started <24 hours after immunizations, tried Xyzal for itch (papular rash).  11/26 No success with Xyzal, changed to Prednisone 40mg BID tapered close for 10 days (papular firm rash) not hives.
No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    No concomitant information was reported.  It was reported that the dosage was changed to 0.5 ml. For the past month, nurse had been given 0.25 ml to 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Client woke up on 6/30/08 with a temperature of 100.2 F.  Left deltoid area was edematous, warm to touch, & tender. Complained of severe headache, dizziness, loss of appetite, & shortness of breath. Took Tylenol throughout the day.  On 6/27/08, she still had a temp. of 100.2 F and a slight headache. Saw her physician who said he thinks it was a reaction to the latex in the stopper of the vial.  Feeling much better on 6/30/08.
Severe nausea, emesis, diarrhea, myalgias, arthralgias (severe). Never had this constellation of symptoms before. Husband had same food all day and did not get sick. Worst total body pain of my life. Resolved within 8 hours.
pain to that area when lifting arm; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), via an unspecified route of administration, in Jan2021 (reported as "3 weeks ago"), at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had complaints of pain to that area when lifting arm (pending clarification) in Jan2021. The patient was scheduled to have the second dose in the afternoon of 27Jan2021. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Vaccinated patient admitted to hospital with COVID detected PCR. Provider d/c note:  "Pt is a 94 YO male with a PMHx of complete AV block s/p cardiac pacemaker, paroxysmal Afib not on Eliquis, TIA, CKD stage IIIb, HTN, T2 DM, and hypothyroidism who presented with altered mental status after a ground level fall. Pt was found to have traumatic rhabdomyolysis and was given IVF. His acute metabolic encephalopathy was likely due to rhabdomyolysis in the setting of dehydration, as Pt was on lasix and HCTZ before admission. Pt's mentation improved to his baseline after fluid resuscitation. Pt's discharge was delayed due to Pt's COVID-19 requiring isolation. Pt did not require any oxygen. He did not get Remdesivir due to renal function and Paxlovid was not indicated due to Pt being  beyond 5 days of symptom onset. Of note, Cardiology was consulted due to failure to capture on tele monitoring. His pacemaker was reprogrammed to max threshhold and output without adjusting leads. He will need to follow up in the device clinic at the local Vascular Institute. Pt discharged to care facility in stable condition.  "
RA Flare-up; extremely painful pain in my lower back; extremely painful pain in sacroiliac joint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) at single dose for COVID-19 immunisation and experienced a couple of rashes and rheumatoid arthritis (RA) flare-up. The patient previously took Xeljanz for RA since 2017. The patient experienced RA flare-up and extremely painful pain in lower back and sacroiliac joint. The clinical course was reported as: The patient was unsure why the patient received this letter regarding Enbrel. The patient contacted Pfizer in Mar2021 when the patient was informed that funding on Xeljanz rebate program had run out, so the patient had to apply for another rebate program, which the patient got accepted into until the end of the year. The patient had not been on Enbrel for over 15 years. The patient had been on Xeljanz since 2017. It worked for RA. After the first and second Covid-19 vaccines from Pfizer, the patient was told to not take Xeljanz for a week. The patient got off of Xeljanz for 5 days after the first shot and on day 6 after the second shot, the patient had a RA flare-up and had to contact the rheumatologist who put the patient on a prednisone burst; 15mg for 2 days, 10mg for 2 days and 5 mg for two days. This was on days 7 through 12 after the second vaccination and was due to the fact that the patient had been off of Xeljanz for 6 days. The patient did get a couple of rashes after the first Covid-19 shot and extremely painful pain in lower back and sacroiliac joint, beginning the afternoon of the second shot and continuing, but fading over the next 10 days. This was reported and the patient went to the doctor for it as well. All of this, however, had nothing to do with Enbrel. The outcome of event RA flare-up was unknown. The outcome of events pain in lower back and sacroiliac joint was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
little fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 01Sep2021 13:00 (Lot number: FC3182) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 01Sep2021, outcome "unknown", described as "little fatigue".  Additional information: There were no any relevant tests.  No follow-up attempts are possible. No further information is expected.
Right after the shot about 3 am, I could barely walk because of lack of strength and balance.  The following day, I sat in the chair all day and could not get out of the chair; that lasted until 10pm that night. About month later, I could not voice my words. I was messing up on how to talk. It was like I had a stroke or something. There was some imbalance with my legs but it was mostly with my mouth. I went to the ER. They did bloodwork, CT scan, MRI, and echocardiogram. They diagnosed me with MS, recurrent that I had 40 years ago. I came out of remission.
injection site pain, redness at site, 2 days later abdominal pain, chills, aches, still ongoing.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional via other manufacturer and concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: mild intermittent asthma, obesity (body mass index 35), stage 1 ovarian cancer, attention deficit hyperactivity disorder, and allergy. The patient previously received (Pfizer) tozinameran (dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Pfizer (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on 15-MAR-2022 for prophylactic vaccination. Age at time of vaccination 46 years old. The batch number was not reported and has been requested. Concomitant medications included estradiol, hydroxyzine, and salbutamol sulfate. On 05-JUN-2022 the patient started symptom (confirmed covid-19 infection) (dose number in series 2) and on 07-JUN-2022 tested positive (confirmed clinical vaccination failure) (dose number in series 2). The patient additionally received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 08-JUN-2022 till 12-JUN-2022 for covid-19 treatment. The covid symptoms (headache, cough, fatigue, shortness of breath, chest wall pain) initially improved, however recurred and were worse than previous on 17-JUN-2022 2022 and had continued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and paxlovid was drug discontinued . The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000241590.; Sender's Comments: V0: 20220714846 -Covid-19 vaccine ad26.cov2.s-CONFIRMED CLINICAL VACCINATION FAILURE. 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. Therefore, this event(s) is considered not related.
Left arm warm, red and swollen from elbow to shoulder. Slight rash on lateral side of arm. TX Tylenol and cold packs. Problem resolved by 9/17/06.
rash; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 07Nov2021 10:00 (Lot number: FK5127, Expiration Date: Jan2022) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 26Oct2021. The following information was reported: RASH (non-serious) with onset 08Nov2021, outcome "recovered" (11Nov2021), described as "rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: For causality she suspected the Pfizer Pediatric Covid19 vaccine is related to the reported event. The patient was not taking any medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was n/a. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. Prior Vaccinations (within 4 weeks) included a flu shot in her thigh and was not sure if it was the right or left thigh and was not 100 percent sure but thought it was in the left. AE(s) following prior vaccinations, Family Medical History Relevant to AE(s) were reported as none. Relevant Tests included ANA test done that was elevated and they could not figure out why and she had no specific results for that test.  No follow-up attempts are possible. No further information is expected.
Rash, itching and red patch of skin bilateral thighs at injection site and swelling.  Right thigh: Red area 13 X 12 cm. left thigh 10 X 8.5 cm red area.
Patient received quadrivalent flu shot and caregiver reported two days later patient was treated in ED for hives - unknown if flu shot was the culprit however given the time frame and the lack of any other changes in patient's medical history recently chances that flu shot caused hives in this patient are more likely. Patient received flu shot every year in years previous without any reportable adverse effects.
7 days p/vax sx began w/ h/a, rt arm weakness & ataxia;progressively worsening weakness requiring hosp admission 2NOV96;
pt devel edema of the thigh (inject site) to twice its nl size, w/no evidence of erythema or fever w/in 5 days of flu vax; pt was treated w/DPH & ice packs were applied to area; 2 days later 12NOV91 thigh still appeared very swollen;
Severe muscle pain, nausea, tiredness, severE headache - took migraine meds and tramadal and diazepam. - did not help much
(+) red papules on the legs then spread to other body parts. Papules initially red -> vesicles -> open -> crusted papules (different stages) noted 10 days after varicella vaccine given. No symptoms of varicella illness. Patient in for itchy red papules initially on the legs and now from head to toe since 5 days ago. Rashes came out not at the same time. It started on the right leg. It starts as red papules then become blistery then open up then dry up. Most of it are on his extremities. No contacts with anybody with Varicella or similar rashes. Mother denies cough, colds, or fever. Patient's appetite is good and active. 12 month old vaccines were given on 1-4-16.
Cerebral infarction due to embolism of right Vertebral artery.Hemiplegia unspecified affecting left nondominant side. Encounter for pallistive care. Hemiplegia and hemiparesis following cerebral infrction affecting right dominate side Hospitalization 8 days Medical Center
My sister in-law is nurse, she has kept up on it, she told us to take super C with Zinc, and Vitamin D3, Pepcid and a Claritin, and Mucinex twice a day. They suggested we get a pulse oximeter and track to watch if we got below 93% to call.  The nurse had us check in with her twice daily. My oxygen never got below 98%. We felt like we had a cold and really didn't think we had COVID-19 till we lost our taste and smell completely. I have a history having Bronchitis so my PCP put me on antibiotic.
Information has been received from a certificated medical assistant (also reported as registered nurse) referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. On an unknown date, the patients each was vaccinated with VARIVAX (dose and route unknown, lot # M042495 with expiry date 19-OCT-2018, lot # M047661 with expiry date 02-DEC-2018 and lot # N012131 with expiry date 17-APR-2019) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature of -11.8 degree Celsius (-14 degree Celsius to -10 degree Celsius) for 3 hours and 35 mins. There was no previous excursion. A data logger was used. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004610: US-009507513-1709USA004610.
Missed the recommended interval inter doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the recommended interval inter doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Patient had fever of 101.9 and vomited on 03/25/05. On 03/28/05, had rash on chest and stomach. Went to ER, given tylenol for fever. By 03/29/05, rash was all over her body. She was treated with predinisone 20 mg daily for 1 week.