chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Concomitant medications included norethisterone (MANUFACTURER UNKNOWN) and escitalopram oxalate (ESCITALOPRAM). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 15:00, the patient experienced sore arm and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm and tiredness were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
RECEIVED BOTH SMALLPOX AND INACTIVATED INFLUENZA VACCINES ON 11/18/2005.  HE PRESENTED TO THE VACCINE HEALTHCARE CENTER ON 12/01/05 FOR EVALUATION OF FATIGUE, FEVERS, POOR SLEEP, LEFT SHOULDER PERSISTENT PAIN, AND CONCERNS REGARDING HIS INOCULATION SITE.  THE PATIENT WAS EXAMINED AND FOUND TO HAVE AN ORAL TEMPERATURE OF 99.2F.  HE DID APPEAR FATIGUED.  HE WAS DIAGNOSED AS HAVING A ROBUST REACTION AND SENT HOME ON CLARITIN, MOTRIN, AND LIDEX CREME. THE PATIENT CONTINUED WITH FATIGUE ON THE FOLLOWING TWO DAYS BUT NEVER COMPLAINED OF CHEST PAIN OR SHORTNESS OF BREATH. THE PATIENT WAS FOUND DECEASED IN HIS BARRACKS BED ON THE MORNING OF 12/04/05. ACLS PROTOCOL WAS INITIATED IN THE FIELD AND CONTINUED IN THE HOSPITAL EMERGENCY ROOM TO NO AVAIL.   THE PATIENT WAS PRONOUNCED DEAD AT 0933 HOURS. THE PATIENT'S INITIAL AUTOPSY WAS NEGATIVE FOR ANY SIGNS OF FOUL PLAY, FRACTURE, ACUTE INJURY, TRAUMA, ALCOHOL OR ILLICIT DRUG INTOXICATION OR OVERDOSE. 8/3/06 Received medical records & autopsy report which stated COD as hypersensitivity myocarditis.  Final autopsy diagnoses also include sudden death in apparent healthy 26 year old; history of recent smallpox & flu vax; lymphocytic eosinophilic myocarditis, pulmonary edema.
Patient developed shingles. Received valacyclovir 1 gm 1 tablet Q12 hours x 7 days.
Itchiness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
PALPITATIONS; LESS STRENGTH IN ARM AND HAND; FINGERS ARE COLD; NUMBNESS IN HAND AND FINGERS; SHORT WINDED; LITTLE OFF BALANCED; This spontaneous report received from a patient concerned a 65 year old of unspecified sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included abstains from alcohol, and abstains from drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 01-APR-2021, the subject experienced short winded. On 01-APR-2021, the subject experienced little off balanced. On 10-APR-2021, the subject experienced numbness in hand and fingers. On 10-APR-2021, the subject experienced fingers are cold. On 16-APR-2021, the subject experienced less strength in arm and hand. On an unspecified date, the subject experienced palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from short winded, little off balanced, numbness in hand and fingers, and fingers are cold, and had not recovered from palpitations, and less strength in arm and hand. This report was non-serious.
She had her vaccine, and 11 days later noticed her stool was very black like tar, and on the side had bright red blood.  She went to the ER and she was admitted.  They did an endoscopic exam but did not find anything.  She then was discharged after a couple of days.  She had an APT with her PCP on 2/9/21 and she had ordered blood work, and nothing changed.  She ordered a repeat blood work on 2/13/21 and said that her count was 6.9, and was told to come in for some blood, and admitted again for a couple of more days.  She had one unit of blood.  She was discharged on 2/15/21.  She saw a gastroenterology NP and she drew blood and her count was 8.4, and advised to start taking some iron.   She does not show any further signs of bleeding, but does feel very weak, feels cold and the usual signs of anemia.   She did have light headedness throughout this entire time as well.
tachycardia; shortness of breath; Chest pressure/tightness; balance issues; muscle aches; cough; nausea; severe headache[s]; fatigue; racing heartbeat; dizziness/balance issues; She can't work at all.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart issue" (unspecified if ongoing), notes: Exclusive- Women injured by Pfizer shot forced to get vaccine despite pre-existing heart issue. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "balance issues", "chest pressure", "chest pressure/tightness", "Cough", "dizziness/balance issues", "Shortness of breath", "fatigue", "severe headache[s]", "muscle aches", "nausea", "Heart racing", "Tachycardia". The following information was reported: TACHYCARDIA (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest pressure/tightness"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; COUGH (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "severe headache[s]"; FATIGUE (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "racing heartbeat"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/balance issues"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "She can't work at all.".  Additional Information: It was reported that the patient, 45 couldn't get a medical exemption from her employer's COVID-19 vaccine mandate despite a pre-existing heart condition-now she can't work at all. The patient received her second Pfizer shot on 03Oct2021 and experienced the same severe reactions as with first dose. The symptoms included severe headache[s], severe muscle aches, racing heartbeat, nausea, severe fatigue and dizziness/balance issues, chest pressure/tightness, shortness of breath and a severe cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a licensed visiting nurse concerning a 15 year old female patient with no pertinent medical history and no know drug allergies, who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL (lot# 660391/0063X) 0.5ml intramuscularly.  There was no concomitant medication.  Subsequently the patient experienced insomnia that lasted for a period of three weeks.  Patient was seen at the practice.  No lab diagnostic studies performed.  At the time of this report the patient had recovered.  Additional information has been requested.
Area of erythema and mild induration  1 1/2 in from the injection site 3 in long
Patient with history of COPD and atrial fibrillation. He was brought to the ED by EMS on 2/22/23 for evaluation of weakness that began the day prior. He additionally reports fevers, chills, headache, cough, and some shortness of breath. A COVID PCR test performed in the ED resulted positive. He was admitted 2/22/23-2/25/23 with discharge diagnoses including COVID-19 infection, generalized weakness due to COVID, and acute hypoxic respiratory failure. Of note, the patient has received the primary COVID vaccine series, two boosters, and the bivalent vaccine.
Fever of 99.3 accompanied by sluggishness and dizziness. Treated with ibuprofen and rest. Fever continued when not medicated for several hours.
a couple days later started getting a rash pretty much/ have rash pretty much all over my whole body; hives; he was up until 1:30am for 3 hours on hold last night and didn't get through and fell asleep; The is a spontaneous report received from contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0150, NDC number: Unknown, UPC number: Unknown, Expiry Date: Unknown), via an unspecified route of administration at left arm on 31Mar2021 as a single dose for COVID-19 immunisation (everyone is saying he should take it). There was no patient history. There were no AE prior vaccinations. There were no prior vaccinations within 4 weeks. Concomitant medications included allopurinol, atorvastatin, gemfibrozil (patient states he takes these). The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Patient stated took the Pfizer-COVID-19 Vaccine on 31Mar2021, last Wednesday around noon, a couple days later Saturday morning he was breaking out with hives and rash. Started getting a rash pretty much all over his whole body. As of today, he has a rash, second dose is scheduled for 20Apr2021, Patient asked have other people reported the rash and gotten second dose. Patient states the rash is over his whole body now and he doesn't know if it is clearing up. States he is taking Benadryl, that he called his doctor and was told to take Benadryl and see what happens. Patient states he has some questions, he is wondering if he should take something else and he is scheduled for his 2nd shot and he needs help with what to do. Patient relays that it seems the rash may be drying up a little and is wondering is he should still get the 2nd shot. Patient relays that the rash started about 48 hours later on 02Apr2021 in the evening, Saturday, Sunday and a little worse yesterday and today he doesn't know if it is drying up but he still has it all over his body. States the card says 0.3mg and believes that is the dose. Patient asking if his healthcare provider is going to know any information as it's a brand-new drug, states he has 3 friends that are doctors and they have all said to call Pfizer. Patient was asking if other people have reported this. Patient states he was up until 1:30 am for 3 hours on hold last night and didn't get through and fell asleep. Report was not related to a study or programme. There was no investigation assessment. The outcome of event was unknown.  No Follow-up attempts are needed. No further information is expected.
blinding headache; Neck swelling - warm; taste buds affected adversely; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 (Lot number: FC3183) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; HUMIRA. The following information was reported: HEADACHE (non-serious) with onset 11Sep2021, outcome "recovering", described as "blinding headache"; SWELLING (non-serious) with onset 11Sep2021, outcome "recovering", described as "Neck swelling - warm"; TASTE DISORDER (non-serious) with onset 11Sep2021, outcome "recovering", described as "taste buds affected adversely". Therapeutic measures were not taken as a result of headache, swelling, taste disorder.  Additional Information: Neck swelling warm, taste buds affected adversely, blinding headache in middle of night, rheumatoid medications not working for inflammation. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no.  No follow-up attempts are possible. No further information is expected.
Patient fainted about 5 minutes after I administered Hepatitis A vaccine. His chair fell back and he hit his head on our First Aid shelving. We called 911. He woke up within 20 to 30 seconds. He was breathing, but his coloring was off. EMT's arrived and checked his heart rate, blood pressure and blood sugar. He checked out fine. He did have a bump on his head and an abrasion on his shoulder.
Pt. had reaction to PNEUMOVAX vaccine. Got red spots on arm and experienced pain. Went ER room. Doctor said it was cellulitis. Pt. is to follow-up with Dr. in 4 days. Wife got same shot, same vial no issues.
Sore and swollen lymph node in neck; Sore and swollen lymph node in neck; Tired; Arm I was injected is sore; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on 20Jan2021 (14:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient had no relevant medical history and concomitant medications. The patient was not pregnant at the time of vaccination. On 20Jan2021 (17:30), at night on the day of vaccination, the patient had sore and swollen lymph node in the neck; was tired; and the arm she was injected in was sore. The patient did not receive any treatment for the reported events. The outcome of the events, 'sore and swollen lymph node in the neck', 'tired' and 'arm she was injected in was sore', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
Lack of drug effect; Tested positive twice after fully vaccinated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Tested positive twice after fully vaccinated) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028821A and 029921A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Tested positive twice after fully vaccinated). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Tested positive twice after fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, SARS-CoV-2 test: positive (Positive) positive. On 26-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications include Monoclonal antibody treatment.  Patient tested positive on 07Oct2021 for the first time and on 26Nov2021 for the second time, patient went to ER and Dr. give Monoclonal antibody treatment.  Company comment:This case concerns a 64-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESI  of COVID-19. Additionally, Drug ineffective is also reported. The event occurred approximately 186 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESI  of COVID-19. Additionally, Drug ineffective is also reported. The event occurred approximately 186 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
continues to have tenderness when he presses on the right deltoid; his pain is aggravated when he performs supine bench press so he avoids this as well; he is 6 weeks out from the dose that seemed to trigger this problem
I had a double ear infection, strep throat, and COVID-19. Coughing and fatigue, these are still ongoing. Low grade fever 99.1 up to 4/30. Paxlovid was prescribed for the COVID-19.
patient fainted for a few seconds 3 times in a row after receiving vaccine during her 15 minute observation time. after the 3rd time she was ok.
Generalized rash with biopsy consistent with granuloma annulare s/p 2 week after zostervax.
Woke up on March 12 with a bit of pain and swelling at the injection site.  By evening, around 7:00, the area was warm to the touch and beginning to turn red.  Today, March 13, symptoms continue.
Severe allergic reaction; Sweating; Nauseous; Felt like she was going to pass out; Blood pressure was low; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm on 18May2021 about 09:00  (at the age of 22-year-old) as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not received any treatment and diagnosed with covid 19 and had not been tested for COVID-19 Since the vaccination. She received her first dose on 18May2021. On the same day she had a severe allergic reaction and the paramedics were called and she was taken by ambulance to the hospital. She was fine now. Shortly after getting the vaccine, within 5 minutes (on 18May2021) of getting the shot, she was still in the waiting period, she began profusely sweating. She was nauseous and felt like she was going to pass out. They called the paramedics. When the paramedics came her blood pressure was low, like 55/48. Her blood pressure had dropped dramatically. The ambulance came and took the hospital, Emergency Room.The patient underwent lab tests and procedures which included blood pressure measurement: 55/48. Treatment included they monitored her with an EKG for several hours. She was given an IV to make sure stay hydrated. She was released mid-afternoon that day after being monitored for a number of hours. She was released after she began to stabilize and blood pressure normalized. The outcome of events severe allergic reaction and blood pressure was low was recovering and other events was unknown.  Information on the lot/batch number has been requested.
Subsequent to receiving one dose of varicella virus vaccine live the pt presented with an ear infection. The pts parent stated that the pt recently experienced varicella. The physicians office could not verify the time or the presence of the varicella.
Parent reported moderate to severe vomiting within 5 hours of vaccination. Vomited 4 separate times and experienced mild diarrhea all within 24 hours of vaccination. Patient is acting himself and still hydrated. MOC will continue to monitor him and requested this be reported.
Developed abscess in right arm slightly posterior in the upper arm with induration and welling, with associated fever, chills and rigors. Presented to ED with extremely large, tangerine sized abscess in her right upper arm, admitted for sepsis, placed on cefepime and vanco. Sterile abscess was incised and drained, with ongoing inflammation with unknown cause.
Edema in left arm, 2 weeks later. Edema in right arm, 3 weeks later. Ultrasound demonstrates non-occlusive clot left axilla, subclavian brachial vein.
tiredness; body aches; chills; mild fever (100.7 F); This is a spontaneous report from a contactable consumer (patient herself) reported that a 29-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3248 and expiration date: unknown), via an unspecified route of administration in left arm, on 01Feb2021 at 06:30 AM (at the age of 29 Years) as a single dose for COVID-19 immunisation. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL3248, Expiration date: unknown) via an unspecified route of administration in left arm, on 11Jan2021 at 03:15 PM as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported and has no allergies to food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. On 01Feb2021 at 06:00 PM approximately 12 hours after the 2nd dose the patient experienced tiredness, body aches, chills, and a mild fever (100.7 F). These symptoms had dissipated by the following morning and felt completely normal about 30 hours after the 2nd dose. The consumer considered the events as non-serious. Prior to vaccination the patient was not diagnosed with COVID-19 and not been tested for COVID-19 since the vaccination. No treatment received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 100.7 fahrenheit on 01Feb2021. The outcome of the events was recovered on 02Feb2021 at 12:30.  Follow-up attempts are completed. No further information is expected.