chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On 21-JUN-2014, the patient received one dose of Hep B vaccine (manufacturer unknown) (lot number, dose and route unknown) and Hep A vaccine (manufacturer unknown) (lot number, dose and route unknown). On 15-AUG-2007, the patient received another dose of Hep B vaccine (manufacturer unknown) (lot number, dose and route unknown) and Hep A vaccine (manufacturer unknown) (lot number, dose and route unknown). On 03-DEC-2015, the patient received the third dose of RECOMBIVAX HB (lot # L026598, expiration date 26-JUN-2017, dose and route unknown). It could not determine whether the unspecified vaccines were Merck products. No adverse effects were reported. Additional information has been requested.
Hospitalized two days from May 17-19th. Chest pain and pressure severe, left arm pain, muscle weakness, fatigue, diagnosis of NSTEMI myocardial infarction(heart attack), diagnosis of Myocarditis
Headache; nausea; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 31-year-old female patient, who is also 31-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EN 5318, via an unspecified route of administration on right arm on 29Jan2021 09:45 as SINGLE DOSE for COVID-19 immunization.  Medical history included none.  The patient's concomitant medications were not reported. On 29Jan2021 18:00, the patient experienced headache, nausea, chills, and fatigue. The outcome of the events was recovered. No treatment was given for the events. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Persisting left shoulder pain suggestive of subacromial bursitis following the injection and without other identified trigger.
Bell?s palsy  Trigeminal nerve tingling and numbness started about 4 hours after vaccine. Treated with prednisone and valtrex. Improved after three days on medication.
Received Influenza vac split quad susp. 0.5ml in right deltoid. Became swollen, felt warm to touch, swollen and very sore from elbow to clavicle neck area. Rec'd inj on 9/25/2015 -> present - site is still sore and stiff from elbow to shoulder.
Hot flush after 5 mins.  Tingling in feet and numbness.  Tingling in fingers. Raised blood pressure 190/110 sustained for 1.5hrs.  Went to ER. Results of Chest X-ray, EKG and blood tests normal. Feelings of agitation. BP 140/90 on discharge from hospital. BP lower but elevated. Took Alprazolan at night. Saw doctor next day. BP more normal, Doctorsaid she had the same reaction on Pfizer shots. BP elevated again that evening 149/90.  Took Alprazolam.  BP came down to 125/72. This morning BP higher again.  Have taken another Alprazolam. Very concerned about second shot.  Doctor advised no coffee, take Alprazolam and hour before, and BP med if BP elevates. I do not suffer with hypertension and take no meds for it!!!
Here 24 hours ago, had right arm subcutaneous injection of Pneumovax. Last night had fever 100. Chills, sweats. Painful redness of right upper arm, not involving the elbow or shoulder joint.   ROS: afebrile today    Redness and heat on right upper arm over the trapezius muscle area   No induration   MS:  Full ROM of right shoulder and elbow, no synovitis
After assessing the client she was given (0.3) ml) of  the Pfizer vaccine IM in the left arm. 5 minutes later the client c/o nausea and feeling warm. Denied any dizziness but safety was maintained. Client stated that she had nothing to eat and did have coffee before she arrive to clinic. Vitals were taken and upon client request she was given Cool water. Vitals were taken B/P 122/76, r-20, p-81, O2 9%7, T 96.9. A few minutes later client stated she needed to have a bowel movement (I accompanied her), and was assisted to the bathroom. Her gait was steady and unimpaired with self ambulation. She did have an extra large bowel movement and stated the she felt better afterward.  I kept her for an additional 20 minutes after her original exit time. Client left via self-ambulation with her sister  whom was also vaccinated.
I have always had "silent" acid reflux but the day of my shot and still today, 3 full days later, my reflux has been out of control. It is much worse than normal. This is the abnormal side effect I am reporting. I tried to Google it and see if others had this same issue. Very little is mentioned. Just minor heartburn. I also had all of the other typical side effects for the second vaccine. My arm is very sore, swollen, itchy, hot, red. I had 2 days of fatigue, tiredness, extreme body aches, joint pain, headache, nausea, diarrhea.
The site of the injection is inflamed (red and warm), hard, and itchy, 13 days after the injection.
Per Client feedback.  Reports At 1bout 1:30am the following day she woke up with intense muscle/upper arm pain, pain extended up next into jaws/bilaterally, (states jaw pain may have been from clenching her teeth), chills/shakes, fever of 100 and severe headache.  The next day Headache and arm pain persisted and was "down" all day, no appetite, would not have been able to go so work if she had been scheduled.  Client self medicated with Ibuprofen, cold packs on arm etc.  States today (Oct 19/noon) she is feeling better, has mild headache and arm pain. Discomfort is dissipating.   Client denies any redness or swelling at the site.  Client denies any history of headaches. Client had PPV13 last year with no side effects.   Patient had influenza vaccination last year with not side effects or complaints of.
hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 75XA2, expiry date 28th January 2023) for prophylaxis.   Concurrent medical conditions included drug allergy (thimerosal).   On 13th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The NDC number was provided  as 58160-828-03. The patient received dose of Shingrix and  2 or 3 days later started with hives and patient was still with this symptom. The patient allergist doctor realized that patient was very allergic to thimerosal but they were trying to discover if Shingrix caused this reaction on this patient. The reporter consent to follow up via personal email.
Woke up Monday AM 1/25/21 with mild discomfort at injection site. Are red oval about 3 inches wide and 4 inches long. Itchy. Put Benadryl lotion on area. No impact. Some very mild discomfort when sleeping on that arm. This morning 1/27/21 area of redness is about 6 inches long and 4 wide.
Reddish, raised, hard, hot area surrounding the injection site. 11 cm wide by 8 cm in length.  Symptoms appeared slowly, with inflamed site increasing in size. Patient visited Care facility due to the spread of the affected area.
Sudden hearing loss in right ear on the day following booster. Moderate to severe hearing loss confirmed in hearing test 4/18/22 and 4/28/22. Continued hearing loss and tinnitus 4 weeks later. Continued numbness in face (mostly right side), tongue, lips, throat (right side).
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. Pertinent medical history and drug reactions/allergies were unspecified. On an unknown date the patient was inadvertently administered with second dose of ZOSTAVAX subcutaneous. Concomitant medications were unspecified. On an unspecified date over three years ago, the patient was administered with dose on of the vaccine. No adverse effects were reported. Outcome of the event, in appropriate schedule of drug administration was unknown. Causality assessment was not provided. Additional information has been requested.
Patient had a Left cerebellar ischemic stroke from an acute stenosis of the PICA . no previous vascular history or embolic history
no adverse events--reporting vaccination of 17 y/o male with his family doctor's written approval
Information has been received from a healthcare worker concerning unspecified patients of unknown demographics. Relevant medical history and drug reactions were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and expiration date unspecified. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
redness / rash around injection site; redness / rash around injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 28Sep2022 as dose 1, single; METFORMIN. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FM0698), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: 32030BD), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0179), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8731), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 11Oct2022 at 12:00, outcome "recovering", VACCINATION SITE RASH (non-serious) with onset 11Oct2022 at 12:00, outcome "recovering" and all described as "redness / rash around injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site rash.  Additional information: Patient has not been diagnosed with covid-19 prior to vaccination and was not tested again for covid-19 after vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236504 same reporter/patient/product/dose; different events;
Fever, Chills, Headach, Body Aches, Redness of skin. Very Bad. Almost went to the ER.
Information has been received from a certified medical assistant concerning a 14 year old female patient with a history of anaemia and no drug reactions/allergies who on 10-AUG-2010, was vaccinated IM with the 0.5 ml first dose of GARDASIL (Lot#: 666118/1539Y). There was no concomitant medication. On 11-AUG-2010, the patient experienced fatigue and depression. The patient was evaluated in the office on 22-AUG-2010. Blood glucose and hemoglobin levels were normal. There was no treatment prescribed. At the time of the report, the patient had not recovered. Follow up information has been received from the certified medical assistant who stated that after further evaluation fatigue and depression were not a reaction to therapy with GARDASIL. Additional information is not expected.
Chills; fever; Exhaustion; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever), FATIGUE (Exhaustion) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (fever), FATIGUE (Exhaustion) and NAUSEA (Nausea). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (fever), FATIGUE (Exhaustion) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case was considered medically important (OMIC). Information regarding Hib-TITER vaccine was received from a patient's mother regarding her 4 year old son who developed autism. At 19 months of age, the patient received the third dose on 2/15/02, the second dose on 9/25/01, and the first dose on 5/9/01. The child received other childhood vaccines on the dates of HIB-TITER administration. The patient has a past history of ear infection (12/02). He was treated with antibiotics (unknown). Per the reporter, the patient generally has been a healthy child. Indication for HIB-TITER vaccine was immunization. The third dose of the vaccine was administered on 2/15/02. Dose regimen was 1 dose. Additional suspect vaccines included Acel-Imune Vaccine, Prevnar, Infanrix, Engerix B, IPOL, MMR, and Varivax. Concomitant medications were not reported. A male child, now four years old developed autism on 5/1/02, when he was two years of age. The patient's mother indicated that her son was talking appropriately at 2 years of age; however, his speech then deteriorated. She reported that her son was bothered by noise, he became picky as to what he ate, he became clumsy with awkward movements - not transitioning well moving from one place to the next, and did not like to be in large groups of people. The patient's mother suspects the events are due to the preservative thimerosal. No addititional information was available at the time of this report.
Breakthrough case of COVID. First developed very mild symptoms on Dec. 5, 2021. Mild symptoms continued through Tuesday, Dec. 7. Was informed that a colleague had tested positive and prompted me to get tested despite only mild symptoms.
Joint Pain.  Arthritis type pain in back, vertebrae, knees.    Most severe 2 - 3 days following the injection.  This was slight with injection 1 and more severe with the 2nd dose.
Individuals were administered Moderna vaccine booster doses after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individuals were administered Moderna vaccine booster doses after the published expiration date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individuals were administered Moderna vaccine booster doses after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individuals were administered Moderna vaccine booster doses after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Information unavailable.  Medical records have not been received from LTC facility.  Patient tested positive on 9/16/2021 with Covid-19 and passed away on 10/14/2021 with Covid 19 listed as a cause of death on death certificate.
From telephone contact with reporting physician's assistant, it was stated that an 18-year-old male patient received a Menomune A/C/Y/W-135 vaccination on 26-Jun-2001. Reportedly 12 hours after vaccination, the patient developed scattered hives and arthralgia. Patient was seen in emergency room.
Red area where vaccine given. Pt. states some pain & stiffness in arm - pt placed ice pack on area.
swelling & redness of inject area started few hr p/inj; pt c/o itching, no c/o pain;
Small red wheal 24 hrs after progressing to large 8x10 area of red induration at site. Tender & warm to touch.
Fever night of immun 102.2, screaming at top of lungs x 20 min, vomited once. One period of staring, limp, lethargic, unresponsive x 5-9 seconds.
Dose administered more than 12 to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s)). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Another pharmacist left out the vial past 12 hour marked on 14-Jan-2022 and on 15-Jan-2022 an Intern gave it to a patient.  The reporter wanted to know if patient would need to be re-dosed or not.  No treatment medication were provided.
Severe tingling / burning in legs, felt like acid running down body for several days. Hands are still burning and diagnosed with shingles. Never had them previously.
Within 2 hours this patient reported feeling feverish, clammy, backache headache, chills, shakes. Patient felt like she was in a fog or daze.
Rash noted morning after administration. Rash first noted close to injection site. At first fine red papules on left upper thigh, then spreading to trunk, then appearance of red raised plaques and target lesions on trunk.
nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Painful lymph nodes under left arm and behind left knee; swollen, hard, and itchy area about 4in diameter near injection site.
Body aches, sore arm, cold sweats, fever, fatigue, feeling over heated, and loss of appetite.
Pt. received MENACTRA yesterday; went to gym for work-out and sauna. Had small red bump on (R) arm at bedtime, awoke with 9.5 x 10cm red, warmth swollen area at site.
This spontaneous report was received from a physician refers to an unspecified patients. There was no information regarding the patient's medical history, concomitant medications drug reactions and allergies provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, (lot# N015475, expiration date 18-MAY-2019; lot# N020686, expiration date 27-JUL-2019) for prophylaxis. Other improperly stored vaccines involved included RECOMBIVAX HB (lot# M035487, expiration date 23-FEB-2019; lot# M044032, expiration date 03-JUL-2019), VAQTA (lot# M039202, expiration date 30-JUN-2018; lot# N008823, expiration date 26-MAY-2018), GARDASIL 9 (lot# M040412, expiration date 30-JUN-2019; lot# N010497, expiration date 15-JAN-2020), PNEUMOVAX 23 (lot# M042324, expiration date 10-JUN-2018) and ROTATEQ (lot# M040269, expiration date 28-APR-2018; lot# M041184, expiration date 31-MAY-2018). Sterile diluent used for VARIVAX reconstitution was stored properly. Doses of VARIVAX was exposed to -14 Celsius degree to-10 Celsius degree for 48 hours. Doses of GARDASIL 9, ROTATEQ, PNEUMOVAX 23, RECOMBIVAX HB, and VAQTA were exposed to temperature below 0 Celsius degree for 1 hour, 0 Celsius degree to 1 Celsius degree for 2.5 hours, and 9 Celsius degree to 25 Celsius degree for 82 hours. There was no previous temperature excursion. The call was because of digital data logger. No adverse effects were reported. Follow-up information has been received from the physician on 23-JAN-2018 referring to a female patient. The physician stated her freezer vaccines were not an issue and were found to be "ok to use" after a discussion with MNSC and the vaccine stability data. Specific lot numbers or dates of vaccination were not available at this moment. She was vaccinated with improperly stored doses of ROTATEQ. The following initials are patients who received vaccines that were stored in refrigerator and these patients are being contacted to be re-vaccinated. This is one of several reports received from the same source. Sender's Comments: US-009507513-1801USA004018.