chrisvoncsefalvay/vaers-outcomes huggingface dataset:
May 31, 2022 - twitching began in legs back and feet. June 1, 2022 - fever began  along with more intense twitching and fluttering in chest June 2-7, 2022 - arrhythmia regularly all day, tachycardia, twitching in face, back, stomach, arms, legs, glutes, and feet, numbness in fingers and toes, tingling in fingers and toes, petechiae in fingers, pressure headaches & sharp pains in head, light sensitive, pressure behind eyes, nausea, lightheadedness, and dizziness June 7-15, 2022 - slightly more mild numbness, arrhythmia and tachycardia, pressure in eyes felt more mild, fever broke, less nausea, lightheaded, headaches became more intense, muscle twitching became more intense some jerking involves in neck (worse at night) Probably 300-600 in a day, would wake me up at night . June 15 - did bloodwork, came back as normal,  June 16 - appointment with family Doctor   Had me get panels done for Sed rate, Ck, and high sensitivity CRP, TSH with T4 - all results came back normal. June 17-20 - nausea still the same, loss of smell to vinegar kicked in (for about 5 day), and muscle twitching and palpitations were the same. June 21 -  current - exercising helped twitching but the are still prevalent, still have random petechiae more frequently than normal, muscles twitching still occur 100-300 times a day.
Tightness in chest, felt like my heart was throbbing. This persisted for ~3 weeks, and has come back every so often. Over the last month or so, 3-4 times I've had this happen again. This had never happened prior to being vaccinated. Concerned I may have had myocarditis because of my gender/age/health profile.
Swollen and painful injection site, limited upper arm mobility, fatigue, muscle and joint pains
Pfizer-BioNTech COVID-19 Vaccine EUA. Moderate soreness in left upper arm several hours after vaccination.
Patient reported having moderate to severe left sided chest pain 4 hours after receiving both vaccinations. Her first  vaccine was in april and second was in september.
High temp 102 degrees; Shortness of breath; Severe headache; sweats chills; nausea; Body ache; Dose Number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 13:45 (Lot number: Fh8027) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: er2613, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 19Mar2021, when the patient was 65 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en2603, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Feb2021, when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "High temp 102 degrees"; DYSPNOEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Shortness of breath"; HEADACHE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Severe headache"; COLD SWEAT (non-serious) with onset 27Nov2021, outcome "not recovered", described as "sweats chills"; NAUSEA (non-serious) with onset 27Nov2021, outcome "not recovered", described as "nausea"; PAIN (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Body ache"; IMMUNISATION (non-serious) with onset 26Nov2021 13:45, outcome "unknown", described as "Dose Number: 3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, dyspnoea, headache, cold sweat, nausea, pain.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. At the time of report, no known allergies were reported. The patient was administered vaccine in a pharmacy.  No follow-up attempts are possible. No further information is expected.
Went on Plaxivid same day I tested positive/4 days later tested positive with symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Went on Plaxivid same day I tested positive/4 days later tested positive with symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unspecified drug.) and Asthma (Minor). Concomitant products included AMLODIPINE BESILATE, VALSARTAN (AMLODIPINE/VALSARTAN) for an unknown indication.    On 14-Dec-2021 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced COVID-19 (Went on Plaxivid same day I tested positive/4 days later tested positive with symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency; AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AMOXICILLIN/CLAVULANIC ACID [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. In May 2022, COVID-19 (Went on Plaxivid same day I tested positive/4 days later tested positive with symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive Positive. In May 2022, SARS-CoV-2 test: negative Tested negative for 3 days. On 23-May-2022, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient went on Paxlovid same day the patient tested positive. After 5 days of COVID, patient tested negative for 3 days, 4 days later patient tested positive with symptoms.  Company comment: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR , after which they tested negative and then positive again for COVID-19. Other treatment provided included amoxicillin-clavulanic acid and methylprednisolone. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. The patient received treatment with NIRMATRELVIR, RITONAVIR , after which they tested negative and then positive again for COVID-19. Other treatment provided included amoxicillin-clavulanic acid and methylprednisolone. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Prev dose Product: COVID 19, Prev dose Dose number: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Prev dose Product: COVID 19, Prev dose Dose number: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Arm sore, swollen, hard, warm to touch. Good use of arm. Using Tylenol. Warmer to touch 11/15/2010.
No adverse events, administration error. Received Pfizer past BUD. Patient has no symptoms or issues currently (10 hours post). Based on CDC and Pfizer guidance and stability information they are going to be revaccinated. Waiting several days to ensure no issues with incorrect dose. Patient will call or go get seen if symptoms develop and know what to look out for.
blotchy red rash on right shoulder, 1-2 inch soft tissue swelling , TTP of upper right arm
Fatigue; 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 FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt was seated on mother's lap getting seasoal flu vaccine, almost immediately lost conciousness and fell forward out of mom's lap, hit her head on floor and began having seizure. Pt was jerking arms and legs and moving head. Pt regained conciousness approximately 15 seconds later and was brought by EMS to Hospital. There her EKG, Head CT, BMP and Mg blood tests were all negative and normal.
The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; This is a literature report for the following literature source.  A 55 year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "DMII" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: Patient presented to the allergy clinic after the rare reaction to her first shot of the Pfizer-BioNtech mRNA vaccine. Patient developed, THROAT TIGHTNESS (hospitalization), WHEEZING (hospitalization), HEADACHE (hospitalization), outcome "recovering" and all described as "The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine"; TINNITUS (hospitalization), outcome "not recovered". The event "the patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the sars cov2 pfizer vaccine", was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: no abnormalities found. She was treated with epinephrine in ER and was admitted for extensive workup and special consultations. No significant abnormalities were found and while she improved clinically, her tinnitus has persisted for months despite treatments with corticosteroids, levetiracetam and antibiotics. Therapeutic measures were taken as a result of throat tightness, wheezing, tinnitus, headache.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the available information in the case, the causal association between the event throat tightness, wheezing, tinnitus, headache and the suspect drug BNT162B2 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.
Woke up early on the morning of 04/03/2021 with ringing, roaring, and deadness in left ear.
Pt experienced severe arthus reaction from DTap requiring  PO steroid  His arm was very red, a little swollen a few hours after the vaccine was administered Over the weekend the swelling got a lot worse - extended from the injection site down his arm to just past his elbow He couldn't bend or move his arm Symptoms improved in 24 hours after PO Prednisone
experienced symptoms of (primarily cough, fatigue and congestion) and tested positive for covid-19; experienced symptoms of (primarily cough, fatigue and congestion) and tested positive for covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (COMIRNATY), on 15Nov2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: O36A21A) and on 09Apr2021 as dose 2, single (Lot number: O32B21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Aug2022, outcome "recovering" and all described as "experienced symptoms of (primarily cough, fatigue and congestion) and tested positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (cough syrup, antihistamines).  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19
Approximately 14-15minutes after receiving Moderna vaccine (dose 1), patient c/o itching to scalp, ears, arms, legs and nausea.  MD evaluated patient who recommended transferring of patients to ER.  Patient transferred to ER.
fever of 103; feeling terrible; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a day after receiving Shingles vaccine, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were recovering/resolving.   It was unknown if the reporter considered the fever and feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received his/her 2nd dose of the Shingles vaccine yesterday (day before reporting date). On 30th October 2021, at around 1 am last night at midnight he/she woke up feeling terrible with a fever of 103-degree F and on morning the patient was feeling much better. The patient stated he/she had dinner with his/her daughter last night around 6 pm, he/she should be concerned. The follow-up could not be possible as no contact details were available.
Fever; muscular pain; joint pain; fatigue; headache; pain in the eyes, shaking; sweetness;
Date of Admission:                11/29/2022 Date of Discharge:                12/9/2022   Discharge Diagnoses: Generalized weakness due to vitamin b12 deficiency and acute covid-19 infection Age related physical debility Acute on chronic bilateral lower extremity DVTs, provoked  AKI on CKD IIIA due to dehydration Essential Hypertension BPH Vitamin D deficiency Presbycusis
Literally within a few minutes of receiving the vaccine my tongue started to swell a bit.  That sensation lasted about 4-5  hours.  About an hour after receiving the vaccine my lips also swelled a bit(that lasted about 2-3  hours).  I did speak with a paramedic at the vaccination site (about the tongue) and we both felt like I was ok enough to go without further care.  I was informed by him that if I felt worse during the day to call 911.  The tongue and lips swelling was never severe enough to feel it warranted calling 911 or going to emergency room.  I would classify them both as "slight" swelling. That evening I also suffered from the flu-like aches and pains that were expected as possible side effects.  Those flu like symptoms went away 24 hours later.  It was really the swelling that I felt important to properly report.
A non-serious, spontaneous report of administration of expired product, dehydrated, elevated white blood cell, vomiting, diarrhea and lethargic was received from a nurse concerning a 46-month-old female subsequently to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received expired FLUMIST, intranasal on 23-Dec-2008 for Flu Vaccination. The lot of FLUMIST expired on 18-Dec-2008. On 06-Jan-2009 the patient began experiencing vomiting and diarrhea the morning of 06-Jan-2009. The patients mother contacted the pediatricians office and stated she was also lethargic and dehydrated although without fever. The nurse instructed the mother to take the patient to the emergency room where blood work was taken which was normal with the exception of elevated WBC. The patient sibling experienced similar events of vomiting and diarrhea on the same day which did not require a visit to the emergency room, reference case MEDI0007734. As of 09-Jan-2009 the events resolved.
12/31/2020-Received vaccine at 11:38am by 9pm began experiencing nausea, vomiting, trembling. Friday 1/1/2021-woke up @8:40-slight fever of 99.5, headache, attempted to take medication for migraine-sumatripitan 50mg, 10 minutes later vomited. Experienced headache, body ache, continued vomiting, fatigue, no appetite for remainder of day. 6:00pm woke up feeling well, fever had gone down, enough to eat, took tynelol to relieve headache. 11pm headache was returning took another tynelol and slept. Sat-1/2/2021 woke feeling out of it but fine, appetite slowly returned, still a little fatigued. By Sunday I was 100% better.
After the second dose , I had body aches and it went away after I took a nap.
uncomfortable side effects.; Adverse event; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced discomfort and adverse event. On an unknown date, the outcome of the discomfort and adverse event were not recovered/not resolved.   It was unknown if the reporter considered the discomfort and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix experinced all of the uncomfortable side effects. The reporter did not consent to follow up.
DIED; BLOOD CLOTS; This spontaneous report received from a consumer via Agency via a company representative concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was a man with a new baby. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had blood clots and died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20231022488.; Sender's Comments: V0: 20231022451-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20231022451-blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
about one month after #2 shot in L arm,  whole left side from toes toes to head affected. toes/left foot/side tingling, constant felt like foot asleep continuously even awakening in sleep at night L calf on outer side felt cramped occiput, left side of head achy some constipation tired every late afternoon
Approximately 15 small pencil point red bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot.; This is a spontaneous report from a contactable nurse (patient).  A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730 intramuscular in the left deltoid, from 22Dec2020 15:00 at a, single dose, for COVID-19 immunization. Patient received another Pfizer vaccine on the same date. Medical history included hypertension (HTN), guillain-barre syndrome from 2008. Patient's allergies included penicillin and ASA. Concomitant medication included paroxetine and amlodipine. On 23Dec2020 08:00, approximately 15 small pencil point res bumps on arms and legs. Itchy. Not raised. Did not increase in size. Kept appearing within 5 days after the shot. The outcome of events was recovered. no treatment or hospitalization was required.  Follow-up attempts are completed. Information on the batch/lot number has been obtained.