chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 102 F; severe vomiting; Joint pain; patient was pregnant, second trimester (24 weeks); This is a spontaneous report from a contactable consumer, the patient. A 28-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration on the left arm on 30Mar2021 at 10:15 as a single dose (at the age of 28-years-old) for COVID-19 immunisation. Medical history included Blood pressure high and migraine. The patient had no known allergies. The patient's last menstrual period was on 08Oct2020. Concomitant medications included nitrofurantoin (MACROBID), escitalopram oxalate (LEXAPRO), propranolol (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in the right arm on 09Mar2021 at 09:00 as a single dose (at the age of 28-years-old) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was pregnant, second trimester (24 weeks). The patient reported the delivery date on 19Jul2021. On 30Mar2021 at 09:00, the patient experienced fever of 102 F, severe vomiting 24 hours and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcomes of the events fever, severe vomiting and joint pain was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Pt was riding with parents through drive through clinic. Received vaccine and proceeded to observation area, after approximately 13 minutes, pt's parent honked the horn and flagged down paramedic. Upon arrival, paramedic stated pt had a blank stare and was unresponsive. Supervisor notified and EMS was called.  Pts hand began to tremor at 0940. VS were: BP 120/74, HR 100.  Pt broke his blank stare, and stopped tremoring at 0949. EMS arrive at 0950. blood sugar taken- 123. Pt able to  confirm orientation to self and location.
deltoid area of her left arm is swollen; hard to move from muscle pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   Co-suspect products included MENQUADFI (MENINGOCOCCAL ACYW VACCINE) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Bexsero (intramuscular, left arm) and MENQUADFI (MENINGOCOCCAL ACYW VACCINE) (right arm). On an unknown date, an unknown time after receiving Bexsero, the patient experienced swelling arm (Verbatim: deltoid area of her left arm is swollen) and myalgia upper extremities (Verbatim: hard to move from muscle pain). The outcome of the swelling arm and myalgia upper extremities were not resolved.   It was unknown if the reporter considered the swelling arm and myalgia upper extremities to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the swelling arm and myalgia upper extremities to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 06-JUL-2023 The reporter also stated that the patient received her Menquadfi vaccine on the same day as Bexsero. A Nurse practitioner reported that the patient came into the doctor's office yesterday, 5-JUL-2023, because the patient's entire deltoid area of her left arm was swollen and hard to move from muscle pain. The patient did not provide a date when these adverse reactions started. It was unknown if the reporter considered the adverse events to be related to Menquadfi vaccine. The reporter was consented to follow up.
had the vaccination and still got them\ suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and got the shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Client received PPD, Hep A, and Varicella while seated on exam table. After approximately 3 minutes, client got up from table, took a few steps, and began to fall. Her father caught her and placed her on the table. Client did not lose consciousness. Client vomited into bedside trash can. Client was given water and ice pack. Client recovered within 10 minutes. Parents declined offer to call EMS.  11:40am BP: 84/47 11:50am BP: 96/55 HR 86
Pretty high fever; This is a spontaneous report from a contactable nurse (patient's parent) through a Pfizer sales representative. A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA, Lot number and expiration date were not reported), with route of administration and therapy date, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a pretty high fever "about 10 hours" after vaccine administration. The patient underwent laboratory tests and procedures which included normal complete blood count (CBC) and physical examination. The outcome of the event, 'pretty high fever', was recovering.  No follow-up attempts are possible. No further information is expected.
she had a blood clot and a week later she was dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: THROMBOSIS (death, medically significant), outcome "fatal", described as "she had a blood clot and a week later she was dead". The patient date of death was unknown. The reported cause of death was thrombosis. It was not reported if an autopsy was performed.  Clinical information: The reporter stated she would love to take the vaccine to be safe, but she was still afraid, my next door neighbour across the street died from the covid shot, she walked 5 miles every day and I am petrified. The reporter asked "Could I get a blood clot, That's what happened to her (the neighbour) she had a blood clot and a week later she was dead.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: she had a blood clot and a week later she was dead
arm red swollen/hot to touch, body aches, chills, fever, headache. All day after shot and slightly the day after that.
Received vaccination on 10/10/17 LMP 9/20/27 so pregnancy not suspected, on 10/23 tested positive for pregnancy, 10/27-10/31 light spotting associated with pregnancy,  11/1 spotting diminished, OB provider ordered HCG (second HCG draw 11/7 determined declining HCG levels and miscarriage likely), 11/3 swelling in sinuses and lymph nodes of the neck, fever, cough and swelling of lymph nodes persisted through 11/21. 11/15 bleeding began and miscarriage occurred. Visited Urgent Care 11/18 and was tested for influenza and strep with negative results on both. Symptoms cleared by 11/22.
Vestibular neuritis- 4/23/2021 first symptoms Atrial Fibrillation- 6/4/2021
The following morning around 7:30am, the patient had a seizure after indicating he was light headed, thirsty, and sick.  He was transported via ambulance to the hospital for further testing.  He arrived at the hospital  just before 9am.  The patient will be following up with neurology at a local university.
Nausea Seen by onsite EMT Pt. self dx as anxiety rxn. She stated that she was nervous coming in. EMS reports pt. reports extensive medical history and reports anxiety issues. -RN Pt. discharged home at 15:35 -RN.
Fri. AM when patient woke up he noticed a 4inch rash around injection site. He also noticed he was having body aches.
Muscle pain; This case was reported by a consumer and described the occurrence of myalgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknwon date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle pain.
Information has been received from a health professional concerning a 4 yr old white female who on 23Apr02 was vaccinated with a SC dose in the right thigh of varicella virus vaccine live (lot639778/0981L). Concomitant vaccine administered on the same day included a SC dose in the left thigh of measles-mumps-rubella vaccine (lot641023/1485L). It was reported that on 26Nov05, in the morning, the pt experienced clustered erythematous papules, and possibly some vesicles, on her labia. There were also scattered papules on her trunk with a few scabbed over, and several papules or scabbed lesions on her face, neck and forehead. The pt was treated with diphenhydramine hydrochloride (Benadryl). It was reported that the pt recovered. Additional information is not expected.
When I was driving home from my vaccine my throat got itchy and felt like I was having an allergic reaction, when I get home I took Benadryl and went to bed. Friday morning I woke up with a large injection site lump and felt like I was hungover. As the day progressed I felt like I had covet again. Headache body ache fatigue and later that evening a fever that went up to 101.3°, then finally I broke a sweat later that evening and my fever went down, on Saturday and Sunday I felt tired and weak and winded. Today is Monday I still feel tired weak and winded. If I exert myself I feel like I'm gasping for air and dizzy like I'm going to pass out.
Pt vax /w PROHIBIT developed T104 approx 10 hrs /p injection, T up to 104 x 2 days. Took 5 day to defervesce.  Suspect vaccine inadvertently given at onset of a viral illness.
funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FK4176), intramuscularly on 07Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 13:30 on the right arm for COVID-19 immunization and experienced funky lightheadedness, vertigo, normal tinnitus got louder and oscillating up and down, and sinus headache. Concomitant medication included colecalciferol (VITAMIN D). On 07Jan2021 at 13:30 (as reported), patient experienced funky lightheadedness, weird feelings in head, and tinnitus was noticeably oscillated up and down. The events were assessed as non-serious. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on 07Jan2021 at 15:30.
Patient felt dizzy, fainted, nauseous and tingling sensation all over her body.  Allowed to rest with feet higher than her head, 911 called, water given. Refused to go to the hospital. Her friend took her home with no symptoms.
Nausea, vomiting, rapid heart rate at 11:00 pm, followed by dizziness, nausea, again vomiting pm.
Regression in speech ability change on sleep pattern lasting approximately 1 month.  Enrolled in developmental, speech, physical, and occupational therapy.
Inflammation under left arm pit. It is swollen the size of golf ball or larger.  I noticed it the day after the vaccine.  I had a similar reaction with the first dose but this time it?s much more swollen.  If it doesn?t get better I am going to my physician for treatment.
Patient received a dose of the J&J vaccine and came in to get the Moderna booster.  Communication we received from corporate looked like those who got J&J would receive the full 0.5ml dose of the Moderna booster so that is what this patient got.  Much later in the evening, we learned that everyone who gets a Moderna booster should get 0.25ml with the exception of those who are immunocompromised.  Spoke to this patient to inform that he got the full 0.5ml dose and he was fine with it.  Patient was feeling fine, just had a sore arm.
Pt states she has tingling in both upper and lower extremities and a thickening feeling in her tongue. Pt given 10mg cetirizine. Pt observed for 30 minutes. Pt states feeling are resolved. Pt released to work.
diabetes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes".  Additional information: patient was given Pfizer vaccine shots for COVID and he/she now had Diabetes. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received Pfizer COVID vaccine on 1/15/21 (lot # EJ1686), 1/31/21 (lot # EN5318), 10/20/21 (lot # FE3590), and Moderna COVID vaccine on 5/4/22 (lot # 057M21A), and 10/6/22 for bivalent formulation (lot # AS7162B). On 10/25/22, patient admitted to our inpatient facility (med/surg unit) with  acute hypoxemic respiratory failure due to COVID-19. He was discharged back to nursing home on 11/2/22 and re-admitted later in the evening. Patient was discharged to short-term rehab on 11/4/22.
Warm, red 2" diameter local Rx 25 mg benadryl Q6hr & tylenol 100mg/5mL take 12mL Q6 hrs/call tomorrow if not improved
Slight tightness in the chest; Fatigue; A spontaneous report was received from a consumer, concerning himself, a 52-year-old, male patient, who received Moderna's COVID-19 vaccine and experienced slight tightness in the chest and fatigue.  The patient's medical history reported included COVID-19. No relevant concomitant medications were reported.  On 31 Dec 2020 at 11:00 AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number not provided) via unknown route for prophylaxis of COVID-19 infection.     On 31 Dec 2020 at 02:30 PM, after vaccination, the patient was notified to be positive for COVID-19, which was tested on 29 Dec 2020. The patient experienced fatigue and slight tightness in the chest. No treatment information was provided.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome for the events, slight tightness in the chest and fatigue were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Waited 30 minutes  due to history  in 2000 of allergic reaction to food.  Shot received at 12pm, waited 30 minutes & returned to work.  At1:30pm I experienced tingling  sensation  in lips, slightly  numb tongue and had to clear throat, this lasted for about 1 hour.  Next  day I experienced  sore  arm & swollen right lymph node for 2 to 3 days
Two blood clots in left leg; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunisation. Medical history included back disorder, ATTR amyloidosis, and allergies: caffeine from an unknown date. Concomitant medication included allopurinol (ELAVIL); meloxicam; tizanidine; tafamidis (VYNDAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), on 05Feb2021, administration time: 06:00 PM, vaccine location: Left arm for COVID-19 immunisation. The patient experienced two blood clots in left leg on 03Mar2021 23:00. Treatment for the event includes Aspirin. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The outcome of the event was resolved on an unspecified date.
29 year old male with no previous medical history and no allergies, but history of syncope when receiving shots, had a syncopal episode 5 minutes after receiving the Janssen vaccine. VS were as above. Pt was pale, clammy, and snoring. He was not responding for about 2 minutes, but was still breathing with a pulse.  He was placed on the floor with his legs up. When pt woke up he was alert and oriented and confirmed this happens every time he receives any shots. Fire department was called and responded. Pt. vital signs were normal, his color returned, and was not clammy anymore. Pt refused medical attention.
Patient was given first dose of Pfizer at 1:20pm by Contract LPN. Daughter notified staff of patient's possible reaction. When staff arrived to patient at 1:32pm, patient was outside of vehicle reporting she was pale,  wheezing, chest pain, and pressure. 911 was called by LPN. HR was 167:BP 136-84, HR at 1:36pm 146. EMS arrived at 1:48pm and took patient to hospital.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild
body aches, chills, temp 101.4, mild SOB, site pain (site hot and swollen)
diagnosed with active Covid 19; diagnosed with active Covid 19; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; Expiry Date of COVID-19 vaccine was Not Provided. COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Heart condition" (unspecified if ongoing), notes: 65 year old patient with heart condition (waiting for a hear surgery). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with active Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: He is very sick and has all the symptoms and this Tuesdays he went to urgent care and was diagnosed with active Covid 19.  Clinical course: It was reported that the patient got booster dose ( 3rd dose of vaccine ) about 3- 3.5 or 4 weeks ago. Then he got really sick on Sunday, he was very sick and had all the symptoms and this Tuesdays he went to urgent care and was diagnosed with active Covid 19 and on Sunday the patient started coughing, sneezing, nose started running, sore throat, and complaining about back pain on lung side in patient's right upper quadrant. Patient had an elevated temperature but no fever. Patient mentioned last night that he is loosing smell and taste.. The patient was suffering with heart condition (waiting for a hear surgery). Reporter also reported that the vaccine did not work in the patient's body to build up antibodies and that's why he got full blown covid.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Patient received 1st Dose of Moderna COVID vaccine at 1304.  At 1345, patient reported that she was feeling tingling in her limbs and her eyes appeared to be blood shot red.  Patient was placed in a wheel chair and a rapid response was called.  Patient was transferred to a stretcher and an IV was started; patient stated that she felt that she "was falling and very cold." Vitals were obtained BP 117/72, O2 sat 88% on Room Air.  O2 placed via nasal canula and O2 sat read 99%. Given 12.5mg Benadryl IV and 20mg Pepcid IV.  Patient was advised to go to Emergency Room for further evaluation, however patient and husband felt they wanted to go home and not go to emergency room.  Patient eye color returned to normal and patient was able to stand without difficulty.
Double vision started 5 days before 2nd dose, Dr, new prescription with prism correction, weakness in eye muscle Bells palsy 6 days after 2nd dose, Dr, 2/18.21 prescribed Methylpredisolone, left side of face drawn down and trouble swallowing, second round of meds again on 5/29/21when symptoms became strong again. Some time during this time frame my ears began stopping up and popping.  I will be seeing an ENT on 8/30/21.I have also seen an allergist to try to pinpoint the cause of these symptoms.  The Bells Palsy continues to pull daily but particularly when talking too long or eating something cold like ice cream.
Headache, diffuse muscle pain, diffuse joint pain, pain at injection site, fatigue, abdominal pain (primarily left upper quadrant), decreased appetite, fever (100 degrees), chills.  All symptoms disappeared completely after 48 hours