chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe migraine; severe hives and itching; body aches; swollen tonsils; lymph nodes swelled to point couldnt turn head; severe hives and itching; fatigue; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2022 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: MIGRAINE (medically significant) with onset 20Feb2022, outcome "not recovered", described as "severe migraine"; URTICARIA (medically significant), PRURITUS (non-serious) all with onset 20Feb2022, outcome "not recovered" and all described as "severe hives and itching"; PYREXIA (non-serious) with onset 20Feb2022, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 20Feb2022, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 20Feb2022, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 20Feb2022, outcome "not recovered", described as "lymph nodes swelled to point couldnt turn head"; TONSILLAR HYPERTROPHY (non-serious) with onset 20Feb2022, outcome "not recovered", described as "swollen tonsils". The events "severe migraine", "severe hives and itching", "fever", "body aches", "fatigue", "lymph nodes swelled to point couldnt turn head", "severe hives and itching" and "swollen tonsils" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Feb2022) negative. Therapeutic measures were taken as a result of migraine, urticaria, pyrexia, pain, fatigue, lymphadenopathy, pruritus, tonsillar hypertrophy.  Additional information: Known allergies: No. Other medical history: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Total body rash, target lesions, erythema, urticaria. 1/23/2003 reoccur next day was better.
Pt presents with a potential reaction to the COVID19 vaccine. I was called to see the patient in her car after she had a vasovagal event with syncope. She was diaphoretic, but interactive and feeling improved with hydration and position change. Though she felt at baseline, given her fatigue, she wanted her husband to drive her home.  Patient with vasovagal syncope. Improved with position change, hydration, and increased monitoring. Returned home with husband as the driver.
10/22/14 chills, 10/24 weakness. 10/26 numbness and weakness in arms and spasms in legs. Went to ED and was treated with IV fluids and CBC and CMP and CU/CUMB done. 10/30/14 went to ED again for temperature, cough and ear pain and then diagnosed with URI. 11/3/14 reported all about to occupational medicine and rx for otitis media amoxicillin - arm numbness had resolved by then.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 63 year old female patient with Graves disease, hypertension, hypothyroidism, postural hypotension, bone loss, eczema, insulin resistance, allergy to codeine, allergy to CECLOR, allergy to KEFLEX, allergy to penicillin and LEVOQUIN. On 06-DEC-2012 the patient was vaccinated with 0.5ml PNEUMOVAX 23 (lot # H012972, expiry date 09-MAR-2014) intramuscularly in the left arm. Concomitant therapies included lots of medications. The patient experienced pain and decreased range of motion of the left arm. The date of onset of the adverse symptoms was not known. The patient came to the office on 26-MAR-2013. No treatment was given for adverse event. Metabolic panel, complete blood count, lipid profile, HA1C, thyroid panel were performed and results were not provided. Blood work was drawn and results were pending. The outcome of adverse events was not recovered. The patient had sought medical attention via office visit. The patient had been referred to doctor for further evaluation. Additional information has been requested.
ATRIAL FIBRILLATION; This spontaneous report received from a patient of unspecified age, sex, race and ethnic origin. The patient's weight and height were not reported. The patient's medical history included: On unspecified date, in JAN-2021, the patient's resting heart rate was 61 beats per minute and heart rate variability was 30 milliseconds. On 15-JAN-2021 the patient had last annual physical examination and heart was normal. On unspecified date, in FEB-2021, the patient's resting heart rate was 57 beats per minute and heart rate variability was 32 milliseconds. On unspecified date, in MAR-2021, the patient's resting heart rate was 58 beats per minute and heart rate variability was 33 milliseconds. On 04-APR-2021, the patient's heart rate variability was 25 milliseconds. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, the patient's heart rate variability was 36 milliseconds. On 06-APR-2021, the patient's heart rate variability was 40 milliseconds. On 07-APR-2021, EKG (Electrocardiogram) was performed and diagnosed with atrial fibrillation. On the same day, the patient experienced atrial fibrillation (heart rate variability increased) and heart rate variability was 203 milliseconds. On unspecified date, in APR-2021, the patient's resting heart rate was 69 beats per minute and heart rate variability was 185 milliseconds. On unspecified date, in MAY-2021, the patient's resting heart rate was 67 beats per minute and heart rate variability was 184 milliseconds. The patient reported that prior to JANSSEN COVID-19 VACCINE patient had no symptoms of heart condition and the patient's resting heart rate prior to JANSSEN COVID-19 VACCINE was usually below 60 beats per minute. Since 7-APR-2021 the patient's resting heart rate had shown large swings of 30-50 beats per minute change from the day before. The patient reported the adverse event to the Vaccine Adverse Event Reporting System (VAERS) as suggested by patient's cardiologist. The patient concerned about the risk of Blood clot, strokes, stress and other condition including death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the atrial fibrillation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210529871-covid-19 vaccine ad26.cov2.s-Atrial fibrillation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient experienced tingling on the lips after 5-10 mins of the shot, after 25 mins patient was given epipen into left thigh and 911 was called. upon arrival patient was given IM benadryl. Patients tounge was swollen and her throat was begining to close up.
After one week I suffered a TIA and have to be hospitalized From April 11 to April 15. After I was discharged I went back to the hospital April 18 with a second TIA. I was hospitalized from the 18 to the 21. Both times at same facility.
Swollen/raised red area around vaccine site that appeared at day 12 after receiving first dose of COVID vaccine.  Patient reports it was approx 2" x 6" and very itchy. Patient applied hydrocortisone cream to it for mild relief. Reporting this on day 14 where symptoms have started to resolve. patient's arm is still red and itchy, but symptoms seem to be less severe than at onset
The day after the vaccination, the pt walked into the living room and fell to the floor. She states that she blacked out. NO dizziness, headache, confusion before or after the incident. She felt fine afterwards did not go to the doctor's till two days later. Doctor started her on baby asprin 1 daily.
12/17/01 Arm where pneumovax was given started to itch. 12/18/01 Arm began to swell. Seen by provider in clinic. Noticed redness, warmth in left upparm. Given Allegra 60mg bid. Use cold packs.
Small red bumps on left arm the first day on Sunday the April 3rd.  Then on Next day slight swollen red bumps covering chest and abdomen and right arm. Then next day after taking Benadryl more red bumps on face and neck slightly swollen. No problem breathing or other symptoms. It is the 8th of  April still taking Benadryl and bumps haven?t gone away. Did call Dr. office  and spoke with pharmacist. We?re told to take Benadryl. If not better by tomorrow will go to urgent Care.
pt recv vax 1996 & pt exp mild case of chickenpox w/approx 15 spots;
On 6-6-2022, I had a runny nose and dry cough. The next morning, I had head/throat congestion. I took a Covid19 home test on 6-7 and it was positive. I called my PCP office and left a message. She called back on 6-7 (same day) and told me that she was ordering Paxlovid. I started taking the medicine at 2pm that day. I feel alot better but I am still having intermittent fatigue (exhaustion). I am reporting a breakthru case of Covid.
This spontaneous report was received from an office manager regarding unspecified number of patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. The reporter reported that on an unknown date in 2014 an unspecified number of patients was vaccinated with GARDASIL (strength, dose, frequency, product lot #, expiry date not reported) that was improperly stored since 09-MAY-2014. This was not supported. No adverse effects reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
I do not feel anything during the first 4-5 days after I received the 1st shot of Moderna vaccine. However, my arm, where the shot was given, becomes redness, hard with hot, swelling, and very  itching  since the 4th or 5th day. The area is about 10cm X 10cm. Then, I feel a peanut size pump in my right neck from the 7th or 8th days after I received the 1st shot, These side effects lasts about 7 to 10 days, Then  they are gone. I do not use any treatment.
had a positive COVID test; had a positive COVID test; O2 Saturation of 80% / Hypoxia; shortness of breath; He has a CT scan which showed extensive infiltration in the lungs; muscle pain; chills; body aches; low grade fever; cough; This is a spontaneous report from a contactable physician (pulmonary medicine). This physician reported similar events for 2 patients. This is 1st of 2 reports.   A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Caller stated that his close friend who was ER physician (front line worker) and within 24 hours after receiving the COVID vaccine, developed COVID or symptoms of COVID. Patient received the COVID vaccine on 18Dec2020 and the same night patient started with a low grade fever, body aches, chills, muscle pain, shortness of breath, cough, O2 saturation of 80% (hypoxia) and was in the intensive care unit now. Patient swore this was related to the vaccine. This patient tested positive for COVID. He had a CT (computerised tomogram) scan which showed extensive infiltration in the lungs in Dec2020. Patient was admitted to the hospital on 24Dec2020 and then was moved to the ICU 2 days later, on 26Dec2020. Caller thought patient had a positive COVID test at another hospital. Caller did know that tested positive at the current hospital on 26Dec2020 which was done to confirm the previous positive test. Caller thought patient had his first positive COVID test either the same day or the next day after receiving the vaccine. Event of O2 Saturation of 80% / hypoxia was reported as hospitalization from 24Dec2020 and life threatening; infiltration in the lungs and shortness of breath caused hospitalization from 24Dec2020, muscle pain, chills and positive COVID test was reported as medically significant; and other events were reported as non-serious.  Outcome of O2 saturation of 80% / hypoxia and shortness of breath was not recovered, outcome of cough was recovering; and outcome of other events were unknown.    Information about lot/batch number has been requested. ; Sender's Comments: Based on the information currently available, a lack of efficacy with suspected vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-2020519020 same reporter/drug , different patient/AE.
itchiness at injection site; flushing at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site) and FLUSHING (flushing at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LABETALOL HYDROCHLORIDE (TRANDATE), Salyres and THROMBIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site) and FLUSHING (flushing at injection site). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchiness at injection site) and FLUSHING (flushing at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K011492, expiration date 22-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and type of excursion (R/F) for each time were 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius and the type of excursion (R/F) for each time wee 176, 48 and R; 24, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Itching and bumps/hives at injection site.  Injection was given on a Tues, rash showed on Sat., then again the next Tues (one week after injection).  Treated with Benedryl and hydrocortizone cream.
Left thigh had pain, redness and swelling from PREVNAR injection (#4). Also running low grade temp and non weight bearing per mother.  Mother took patient to ED where a dx of cellulitis was given along with abx treatment. S/SX cleared within 3 doses per mother and 10 course was completed.
pt recvd vax; 2 days later lt arm was swollen; fever; 6oct94 seen in ofc & dx w/ cellulitis;  unk if flu vax or pneumovax;
My entire arm aches. I have a burning sensation along with a needle pricking feeling in the area of the shot. I'm lightheaded and dizzy.
shingles pain flair up. right mid riff and left arm, and left neck, cheek, and foot. A burning pain and dizziness.  the pain is very intense causing me to lay down and close my eyes. This has happened everyday for two weeks now. everyday is the same and has not gotten better.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: testing negative; (18May2022) Positive, notes: Tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product=COVID 19 Treatment (Paxlovid). Treatment received on 11May2022 and Stop date 16May2022. Indication is used for treatment of COVID-19. The patient experienced adverse event Symptoms returned 2 days after last dose of Paxlovid. Tested positive again after testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mild redness, non tender, half dollar size induration. No fever, ice pack applied to arm. Rechecked 9/15/03 - resolution.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 22-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Injection site reaction; now reported on 4/25/18 site is red larger and inflamed. Advise patient to follow up with family physician.
Tdap (Boostrix) administered on 9-17-14 at 1545. Mom reported on 9-19-14 at 1440 reaction on L arm including itching, warmth, pink, and pain in axilla. Physician exam measured redness and slight warmth mid-lateral LUE about 7x10cm. This was inferior to injection site.
fever; headache; nausea; chills; body aches and extremely sore arm/arm hurts less/soreness; fatigue; horizontal red rash; felt so awful; sick and went to bed; felt "dopey"; not feel comfortable; sore arm; This case was reported by a consumer and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (got the chickenpox as a young child).   In June 2022, the patient received the 1st dose of Shingrix. In June 2022, 1 day after receiving Shingrix, the patient experienced fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm. On an unknown date, the outcome of the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, nausea, chills, pain, fatigue, red rash, feels awful, sickness, dopiness, discomfort and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The patient self reported the case. The patient received Shingrix on left arm. The patient received a dose of Shingrix and experienced headache, nausea, fever, chills, body aches, fatigue, an extremely sore arm and about 2 inches beneath the injection site about 6 inches long horizontal red rash. The patient felt so awful the morning after the shot that they called in sick from work, and went to bed and slept for hours. They took the following day off as well as they felt dopey when they woke up and slightly dopey the following day and did not feel comfortable driving to the office or doing her job. The patient got the chickenpox as a young child along with my other siblings On the day of reporting her arm hurted less but still hurted. The red rash had slightly lessened but was still there. Her personal care physician told her it was probably a good idea to skip the second shot. The patient wanted to know if others still have soreness this far out after the injection and they was fatigued but didn't knew if it was because they had been working hard or if it was connected in any way to the shot.  Consent to follow up was requested.
24 patients who received a vaccine past the 30-day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (24 patients who received a vaccine past the 30-day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (24 patients who received a vaccine past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (24 patients who received a vaccine past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 01-SEP-2021 vial was initially stored in the refrigerator. Vaccine was administered on 06-OCT-2021, 07-OCT-2021, 08-OCT-2021, 09-OCT-2021, 10-OCT-2021, 11-OCT-2021. Vials were kept between 40 F and 42 F No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
A side effect; 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 VACCINATION COMPLICATION (A side effect) in a patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A side effect). At the time of the report, VACCINATION COMPLICATION (A side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication provided. The report states that the patient had a side effect after the Moderna vaccine.
Uncontrollable screaming, not able to focus or make eye contact, glossy eyes, terrible rash at insertion site and entire thigh that lasted many weeks.
pt had headache, body aches and tiredness pt was advised to take tylenol and adequate hydration.