chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left arm down to the elbow, tiredness, weakness. 100.2 F fever started the next day (3/15) and lasted several hours.  Painful and swollen lymph nodes (left breast, armpit, under arm) started on 3/15 and gradually subsided by 3/18.
Had all of the normal symptoms but also included severe rash all over back/chest/body.   Immunity has been down ever since, lungs are now showing signs of asthma.
chills; fever; did not feel good; pain at injection site; This is spontaneous report from a contactable nurse (patient). A female patient (Age: 56; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 15:00 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever, did not feel good, pain at injection site, all in Dec2020, chills on an unspecified date. The patient was worried she had gotten COVID again after her first dose of COVID vaccine. Would like to know if fever was one of the reported side effects. Received vaccine at 3:00 pm, fever. Took paracetamol (TYLENOL) this morning because temperature was 101. This afternoon she did not feel good, laid down, did not check her temperature. Checked again at 103.9 on second time. Also reported that she had 'pain at injection site and chills. No nausea.' Second dose scheduled for January. Caller was worried she might infect her husband, who was a health risk and diabetic because she was feeling feverish. Wondering if she could sleep in same room as her husband or if she will infect him. The outcome of events was unknown. The events were reported as non-serious.   Information on lot/batch number has been requested.
isolated hypertensive event occurred approximately 1 hour after vaccination, pt proceeded to go to urgent care, at which point they identified this as an isolated hypertensive event, no treatment changes. Pt was advised to return home that evening.
vaccine was given to person under age 18. she has only headaches a few days after vaccine was given.
Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency.  Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).
Terrible headaches that last all day.  Take Advil and/or Excedrin to help. Been everyday since shot.
No adverse event; ROTATEQ was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 13-JUL-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1837116, expiration date: 24-MAR-2023, administered for prophylaxis, orally (strength was not provided) after a temperature excursion (Product storage error) with a temperature of 10.8 degree Celsius for a time frame of 4 hours and 12 minutes. No previous temperature excursions were reported. No adverse event was reported.
First noticed blood in urine on 1/15/21. By next day Saturday, 1/16/21, patient states it was a dark "Coca cola color" urine in toilet after urinating. Sunday, 1/17/21, urine was lighter in color.  Monday 1/18/21, urine looked clear in color but test results showed that blood was still present in urine.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU (dosing regimen unspecified). No concomitant medications were reported. On an unknown date pharmacist reported that 2 patients experienced a good amount of swelling about 5 to 6 inches long at the injection site after receiving ZOSTAVAX. Pharmacist reported the injection site was red and warm. Pharmacist reported physician thought it could be cellulitis and prescribed KEFLEX as a prophylactic. The outcome of cellulitis, pharmacist reported the injection site was red and warm and a good amount of swelling about "5 to 6 inches long" at the injection site after receiving ZOSTAVAX was reported as recovered/resolved on an unknown date. There was no product quality complaint (PQC) involved. Patient sought medical attention and saw the doctor. Causality assessment was not provided. This case is linked to: 1410USA000642 (Same reporter). Additional information has been requested.
Skin rashes, wheals, like bug bites or poison ivy.  Started below neck right side, under left knee, left upper behind, top right knee spread with out breaks up and down both legs and arms.  Now new spot on chest.  Painful burning and itching
Patient received Varicella Vaccine on 9/2/09 and came down with low grade temp and numerous bumps on 9/12/09.Went to Dr. and diagnosed as Chicken Pox with no labs done.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA (lot no J011712, Expiry date 21-SEP-2015) (dosing regimen and frequency unknown). On 16-DEC-2013 the patient was inadvertently administered an incomplete dose of VAQTA and the needle hub separated from the barrel of the pre filled VAQTA syringe, during administration, the needle hub separated from the barrel of the pre-filled VAQTA syringe. No adverse effects reported. Additional information has been requested.
INFLAMMATORY HEART DISEASE; INFLAMMATORY HEART DISEASE; This spontaneous report was received from literature. This report concerned a patient of unspecified age and sex of unspecified race and ethnicity. The patient weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced inflammatory heart disease (cardiac disorder) and inflammatory heart disease (inflammation). The 67 patients identified with inflammatory heart disease, 21 (31.3%) had a SARS-Cov-2 vaccination within the previous 60 days. Overall, 914 611 patients received a SARS-CoV-2 vaccine, resulting in an inflammatory heart disease rate of 2.30 per 100 000 vaccinated patients. The relative risk of inflammatory heart disease for the vaccinated patients compared to the unvaccinated patients was 2.05 times higher rate within the 30-day window and had a trend toward increase in the 60-day window (relative rate 1.63) All vaccinated patients with inflammatory heart disease were treated successfully. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inflammatory heart disease (cardiac disorder) and inflammatory heart disease (inflammation). The author emphasized that the rate of inflammatory heart disease was greater in a SARS-CoV-2-vaccinated population than the unvaccinated population. This risk is eclipsed by the risk of contracting coronavirus disease 2019 and its associated, commonly severe outcomes. Nevertheless, clinicians and patients should be informed of this risk to facilitate earlier recognition and treatment. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220236455-covid-19 vaccine ad26.cov2.s-inflammatory heart disease (cardiac disorder), inflammatory heart disease (inflammation). 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). Therefore, this event(s) is considered unassessable.
This retrospective study aimed to assess the prevalence of non-immunity to varicella zoster virus (VZV) and measles in previously immunized pediatric liver transplant (LT) recipients and identify correlative factors. Children who received LT were evaluated for pre-LT immunization and post-LT VZV and measles titers during clinic visits from January 2016 to November 2017. Those who did not receive VZV or measles vaccine prior to LT were excluded from the respective cohort. 72 patients were included in the analysis of measles immunity, and 67 in the analysis of VZV immunity. Median time from LT to titers for measles and VZV were 4.0 (range 0.8-16.3) and 3.2 (0.8-14.0) years, respectively. In the measles cohort, the median age at LT was 3.2 (0.7-16.2) years. Age at LT, age at last pre-LT vaccine dose, number of pre-LT vaccine doses, height and use of whole-liver grafts were each significantly lower for non-immune versus immune patients, and the proportion of patients of ethnicity was greater in the non-immune group. It was concluded that non-immunity to measles and VZV among pediatric LT recipients was common within 3 years after liver transplantation, despite immunization prior to transplant. This literature marketed report as received from the authors of the published literature article, titled as stated above, refers to 16 children of unknown ages and genders. The patients' concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacture unknown) (dose, route, lot# and expiration were not reported) for prophylaxis. On unknown dates, at the post-transplant follow up point, the patients were measles non-immune (therapy non-responder). The outcome of the event was not reported. The reporter considered the event to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacture unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same literature. Sender's Comments: US-009507513-1811USA005719.
low appetite; Limited mobility due to pain; Pain throughout arms, legs, and back; Fever; Chills/Mild chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (low appetite), MOBILITY DECREASED (Limited mobility due to pain), CHILLS (Chills/Mild chills), MYALGIA (Pain throughout arms, legs, and back) and PYREXIA (Fever) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced CHILLS (Chills/Mild chills) and PYREXIA (Fever). On 02-May-2021, the patient experienced MOBILITY DECREASED (Limited mobility due to pain) and MYALGIA (Pain throughout arms, legs, and back). On 08-May-2021, the patient experienced DECREASED APPETITE (low appetite). On 03-May-2021, CHILLS (Chills/Mild chills) and PYREXIA (Fever) had resolved. On 04-May-2021, MOBILITY DECREASED (Limited mobility due to pain) and MYALGIA (Pain throughout arms, legs, and back) had resolved. On 08-May-2021, DECREASED APPETITE (low appetite) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received and contains NNI
Half-dollar size nodule under skin at injection site lasting one week. Tennis ball size redness around injection site lasting one week. Lethargic, body aches, headache lasting 3 days. Then neck pain starting lasting one week, then lower back pain lasting 1 - then severe thoracic pain started lasting 3 weeks.  Severe sore throat started on 3/11/2013 and continues with sinus congestion for past 16 days.
FROZEN VACCINE ADMINISTERED; EXPIRED VACCINE USED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced frozen vaccine administered, expired vaccine used, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the frozen vaccine administered, expired vaccine used and incorrect product storage was not reported. This report was non-serious.
HSV stomatitis symptoms started 2 days after patient received COVID vaccine-erythema, pain in mouth and blisters.  On 4th day after onset of symptoms, was started on Valtrex.  Started to improved 2 days after starting treatment.  Resolved by day 7 after treatment.
At 2:30PM on day of vaccination had rapid heart rate. The next morning (8/18/05) woke with severe migraine headache. Could not lift head from pillow; eyes sensitive to light. Continued to feel weak on 8/18/05. Could not ascend stairs without extreme weakness.
fever (100.2), severe headache, body aches, seating, mild nausea.
pain in glutes; restless muscles; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional). This female consumer reported for herself.   An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion.), for Covid-19 Immunization, reaction(s): "No reactions after 1st dose".  The following information was reported: MUSCULOSKELETAL PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "pain in glutes"; RESTLESS LEGS SYNDROME (non-serious) with onset 2021, outcome "recovered" (2021), described as "restless muscles"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of musculoskeletal pain, restless legs syndrome, pyrexia.   Additional information: Dose Number: 2, Batch/Lot No: Not available/provided to reporter at the time of report completion. Reaction/event as reported by primary source: No reactions after first dose, after second dose: pain in glutes, restless muscles, fever, after third dose: pain in both elbow joints. Hospitalization Prolonged: (NO), Treatment Received: (YES). On 17Nov2021, the patient received third dose of BNT162B2 (Solution for injection, Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. Proprietary medicinal product name: Pfizer. Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received treatment with Tylenol for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Results of tests and procedures for investigation of the patient: Test: Nasal Swab. Result: Negative.   No follow-up attempts are possible. No further information is expected.
Pt returned to school after vaccination and stared, stuck his arm out and experienced a seizure. Pt was taken to urgent care with no further experiences.
No additional AE details; 1 lot of VARIVAX was administered after non-supported excursion; This spontaneous report has been received from an office manager, regarding an unspecified number of patients of unknown gender and age. Information regarding the patients' historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.   On 19-JUL-2022, the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U008181, expiration date: 16-JUN-2022 experienced 08-FEB-2023) was administered after non-supported excursion (product storage error). Temperature excursion of 10.2 Celsius degrees (C) for 182 hour. No additional adverse events (AE) reported (no adverse event).  This case was classified as non-valid due to the lack of patient's identifiers.  Follow-up was received from the office manager on 09-SEP-2022. It was updated, that not properly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to 16-year old female patient, and her sister. There was reported, that temperatures were misread and misrecorded, and that is why the medication error occurred. It was confirmed, that no adverse reactions were reported.; Sender's Comments:  US-009507513-2207USA008558:
Information has been received from a Registered Pharmacist (R. Ph.) concerning a 60 year old female who on 09-MAR-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 663178/1414X). On 16-MAR-2009 the patient developed a rash on her hand and neck 7 days after the vaccine. At the time of reporting the patient had not recovered. The patient's physician felt the rash looked like "poison ivy". Pharmacist would be interested in PCR analysis. The patient sought unspecified medical attention. Additional information has been requested.
One of our medics vaccinated an individual with the Moderna vaccine on 29 March 21. The vial containing 1 dose was kept in the refrigerator from Friday morning (26 Mar, 0800-1030), the medic drew the final dose and administered it to a patient on 29 Mar around 1130 hours; it was the patient's second dose. The patient experienced noted COVID-19 symptoms: chills, fever, night sweats, headache, body ache, and tiredness. The patient was monitored daily from 29 -31 March. Experiencing severe symptoms on 29 March after the injection, the patient stated feeling much better by 0800 hours on 31 March.
Woke up at 4:30am the morning after my shot vomiting profusely, including bile. I also vomited at 10am, as well as 12:30pm. Throughout the day my body felt weaker, I had a 100°F fever (which is a rare symptom for me to get a fever). I had a pounding headache that lasted for four days. I lost my appetite for five days, unable to keep much food or water down for two days. I thought I was going to die, but couldn?t afford to go to the hospital so I waited it out. I tested negative for covid at home.
CHOKED ON FOOD; BONES HURT; HEART GOES REALLY FAST/ IRREGULAR HEARTBEAT; SWALLOWING DIFFICULTY; DIFFICULTY BREATHING AND FORGETS TO  BREATHE; SHE COULD NOT GET OUT OF BED (LITERALLY THE DAY AFTER SHE COULD NOT MOVE)/ COULD NOT LIFT HER PHONE; TINGLING IN FEET; MUSCLES HURT; This spontaneous report received from a patient concerned a 4 decade old female with unspecified race and ethnicity. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included: The patient used to be very active but currently not. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 30 years old. No concomitant medications were reported.  On an unspecified date (since the vaccination), the patient experienced swallowing difficulty, that patient chokes on food, had difficulty breathing and forgets how to breathe, had tingling in feet and had lots of issues. The patient had been recording these issues with doctor. The patient thought she had Guillain Barre Syndrome. The patient cannot function properly and it was annoying. The patient also reported that after receiving the vaccine she could not get out of bed (literally the day after she could not move) and was not able to lift her phone. The patient had gone to doctor and doctor had kept a list. The patient had muscles and bones hurt. The patient also had to stand up because her heart goes really fast/ irregular heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscles hurt, bones hurt, heart goes really fast/ irregular heartbeat, swallowing difficulty, difficulty breathing and forgets to breathe, tingling in feet, choked on food and she could not get out of bed (literally the day after she could not move)/ could not lift her phone was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230119928.; Sender's Comments: V0: 20230118624-CHOKED ON FOOD. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Dysfunctional Uterine Bleeding. March 30th very heavy period started with extreme cramps. Soaking thru overnight extra heavy pads several an hour on top of filling a DIVA cup. Amount was 2 cups a day at least.  Continued non stop until April 3rd, Re started April 8th to April 10th very heavy. 11th to 28th/current light/heavy bleeding with strong cramps. Still not fully under control
Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Tinnitus-Medium, Additional Details: Patient had an immediate reaction (within 5 minutes of getting the vaccine) of feeling hot, flushed, sweating, having ringing in both ears, and being nauseous. I gave her an ice pack, she stated she started to feel better, at the end of 15 to 18 minutes she stated that she was feeling better and she was ready to go home.
Fever; chills; headache; Injection site pain; This is a spontaneous report from a non-contactable physician (patient). A 29-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL3248), intramuscularly on right arm at 09:45 on 11Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient previously received her first dose of BNT162B2 (Lot number= EL1284) intramuscularly on left arm on 22Dec2020 at 20:30 for COVID-19 immunization. The patient experienced injection site pain 6 hours after second dose, fever, chills, headache that started 14 hours after the second dose on 11Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.