chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive COVID-19 test via PCR 14Sep2021; COVID-like symptoms 10Sep2021; This is a spontaneous report from a contactable consumer or other non hcp ). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 17Feb2021 11:00 (at the age of 35-year-old) (Batch/Lot Number: EN5318) as dose 2, single, dose 1 intramuscular, administered in Arm Left on 28Jan2021 11:00 (at the age of 35-year-old) (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Sep2021 16:00, the patient had COVID-like symptoms.On 14Sep2021, the patient had positive COVID-19 test via PCR. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Sep2021 Nasal Swab. No treatment received for the events. The adverse events were result in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were not recovered.   Follow-up attempts are completed. No further information is expected.
Swollen, red painful arm at injection site with swelling extending to left axillary area and left side of neck that made turning neck even uncomfortable. Has subsided after 3 days.
Warm spot on left arm where shot was given.  Red circle around shot area about 4-5 inches in diameter.
pt awoke w/rash on face,arms & neck. Taken to MD;rx Benadryl;MD felt it may be a rxn to DATP;pt OK @ 4PM per grandma;
Client received Tdap and Hep B vaccine. Developed hives the next day after receiving the shots.
No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 30-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
Information has been received from a registered nurse concerning herself, a 64 year old female with drug allergies to DARVOCET, DEMEROL and TALWIN who on 29-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). On 29-APR-2011 she was also vaccinated with a dose of tetanus toxoid (manufacturer unknown). Concomitant therapy included FIORICET, ROBITUSSIN, DIMETAPP and guaifenesin. On 29-APR-2011 the patient developed headache, cough, congestion, fever (102 degrees F) and a single vesicle on her leg after receiving ZOSTAVAX (Merck) and an unspecified tetanus booster shot from her physician. Patient reported that she was "not feeling well" at the time of the injection. Patient sought unspecified medical attention. Treatment given for the adverse event included AUGMENTIN. At the time of reporting, the patient had not recovered. Additional information is not expected.
Pt experienced local itching at injection site, -within 5 minutes of receiving the vaccine, at 01:10pm itching/rash became generalized-both upper arms, EMS notified, pt monitored, by 1:25pm symptoms were no longer progressing, pt given 50mg oral diphenhydramine at 1:37, escorted to the clinic in the same building, by 2:05 pm pt symptoms resolved and released to home.
Had sore arm for first two days. On the third day started getting palpitations and racing heart. This came and went and woke me up in the middle of the night and early morning several times. Today is day 10 and I was prescribed a 24 hour holter monitor. In the last 3 days I've had several episodes of facial nerve pain in my jaw and teeth, numbness in my face and also pins and needles in various parts of my body. Sore and painful spot to the touch under left ribs. Extreme palpitations and heart racing that make me feel like Im going to pass out, sudden pressure on the left side of my neck and ear heartbeat in my left ear during these episodes, trouble breathing , pain and tingling in upper left chest and coughing that goes away in about 30 minutes. Each episode ends with uncontrollable urge to sleep.  Almost feels like an intense food allergy reaction but it happens on a completely empty stomach. They seem to be getting progressively worse
Arm soreness, enlarged/ tender right posterior cervical chain lymph node and preauricular lymph node
arm itching; arm swelling up; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE SWELLING (arm swelling up) and VACCINATION SITE ERYTHEMA (arm is red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE SWELLING (arm swelling up) and VACCINATION SITE ERYTHEMA (arm is red). On 28-Jan-2021, VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE SWELLING (arm swelling up) and VACCINATION SITE ERYTHEMA (arm is red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported they did not have any concomitant medications.  Treatment information was not provided.
Severe vomiting for 12 hours, which started 12 hrs after the first dose of COVID vaccine; decreased urination and lack of peristalsis for 9 days.
6 month pregnant. adverse reaction: nausea, vomiting, >30 second seizure, loss of conscious. patient had reported no history of allergies or any severe side effects before she was given the vaccination and also marked "no" on her consent form for any serious reactions in the past from a vaccination. she regained conscious within 30 seconds. after emergency services arrived she mentions that she had similar reaction in the past to pfizer vaccine but had thought she would be okay now.
After my daughter received her 1st shot of 3 (to complete full dose) she started having problems soon after.- light headed, dizziness, fainting, fatigue, loss of appetite, change in menstrual cycle, blurred vision, headaches, joint hip pain, irritability, depression, throwing up and bad cramps. FYI- we opted out of the last two shots. Took patient to regular Dr. appt. We were than told that she should get the HPV shot I was reluctant because I don't have or never had cervical cancer and neither had my mother. They said she would need 3 series of shots all together. After the 1st shot (3/12/08) we started to notice all the symptoms that are describe on page 1. She was a tract runner for her school and very good at that. But after the shot anytime she would run she would throw up and cramp right after. Once she was able to make it half way when she was running 100 yard dash.  1/22/09 Received PCP clinic medical records of 3/12/08 FINAL DX: none provided Records reveal patient experienced rash on abdomen waxing & waning since 12/07.  Only dry skin found on exam & tx w/lotion.  No other records available. 02/01/2010 Still has side/hip pain whenever she over erats herself insports.
This patient had 70 mm x 50 mm erythema, left deltoid, 70 mm x 60 mm induration, left deltoid. Decreased range of motion left arm with pain on abduction onset 6 hours post administration 11/15/00.
doesn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "doesn't feel well". Additional information: The patient received first dose 1 week ago today. She had no reactions until today. But currently doesn't feel well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient received the Moderna booster vaccine less than 6 months out from her second dose (second dose of the Moderna series was on 08/20/2021 and booster shot was administered on 12/09/2021).  To my knowledge, no adverse events have been recorded so far.  My supervisor requested that I make a report to VAERS just in case any issues do arise from administrating the booster vaccine before the 6 month timeline was met; which is what our policy recommends.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Severe neuropathic pain all over my body especially legs and feet, difficulty walking or standing, weakness, burning and tingling of nerves, lasted 3-4 days, followed by itching all over body for 2 months. Treatment includes Gabapentin, Norlco, morphine  to control pain when onset. Itchiness was treated with antihistamine for 2 months
DEATH; This spontaneous report received from a consumer via a social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 died from an unknown cause of death two days after receiving the vaccine. It was unspecified if an autopsy was performed. The reporter stated that, "My best friend got your vaccine. He was dead two days later." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220136974-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
December 2, 2021 Swolling in lower right leg  from knee to foot with pain behind right knee
double vision, palsy of third optic nerve in right eye; Glycosylated Hemoglobin A1C 5.8; headache every day after second dose for 2 months; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Arm Left on 03Feb2021 (Batch/Lot Number: EL3302) at the age of 73-years-old as 2ND DOSE, SINGLE for COVID-19 immunization.  Medical history included ongoing tachycardia and blood cholesterol abnormal (reported as cholesterol). Ongoing concomitant medications included metoprolol (METOPROLOL) taken for tachycardia; rosuvastatin calcium (ROSUVASTIN) taken for blood cholesterol abnormal (reported as cholesterol); and clopidogrel bisulfate (PLAVIX) taken for prophylaxis, all taken since unknown dates. The patient received the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE on 13Jan2021 (Batch/Lot Number: EL0142) at the age of 73-years-old as COVID-19 immunization. Then, the 2nd dose on 03Feb2021. After the second dose on 03Feb2021, she had a headache that started that day and every day for two months which she never got headaches before this. Her headaches have resolved about three weeks ago (Apr2021) and the doctor prescribed her medication, but she did not have to take it.  Then on 18Mar2021 (6 weeks after the second dose), she woke up, got up, walked down her hall and saw three front doors - she mentioned that she was having double vision. She went to the hospital where she was admitted on 18Mar2021 to an observation decision unit for 26 hours (19Mar2021). She was tested for a stroke but was not having a stroke. She was then diagnosed with eye palsy in third optical nerve of her right eye. Her right eye was somewhat improved as she can move it up down left and right. Her right eye was no longer paralyzed, her eyelid will now open and close where initially it just wanted to stay closed, but her vision was still distorted. She was still treating it with patching her eyes off and on. The patient also had glycosylated haemoglobin (A1C) was 5.8 - borderline taken on unknown date and waiting for A1C results. The patient recovered from headache in Apr2021 while recovering from "double vision, palsy of third optic nerve in right eye"
Pt left arm swollen red, warm to touch, spreading down arm. Itchy and painful.
Patient was feeling fine the day of receiving 3 shots (afternoon time between  3pm and 4pm possibly of 09/15/2023). Patient says that he received 2 shots in one arm and 1 shot in the other. The next day the patient did not feel like himself. He went to work and could not work the whole day. He probably worked about 3 hours from being there around 8am. He could not set up his table at work as usual. Patient believed that he blacked out upon arriving back home. He found his van in an unusual spot by his home. He doesn't remember any of that from yesterday (parking his van home and getting home). He felt really down the next day (09/16/2023-SAT).  He did not go to work today (09/17/2023). He says he has lost track of time especially remembering who he was on the phone with and when from yesterday afternoon. He states that people were calling him and he was unaware yesterday. He had a hard time getting out of bed this morning. Patient is starting to feel better today though.
On the first one he was sleepy tired the next day; On the first one he was sleepy tired the next day; This is a spontaneous report from a contactable consumer, patient. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration, in the right arm on 24Mar2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from Jan2021 to an unknown date (Verbatim: Blood pressure high). Concomitant medications included losartan for blood pressure measurement from an unspecified start date and ongoing; lorazepam for somnolence from an unspecified start date and ongoing.  The patient received the first shot 24Mar2021 at 1115AM in the upper right arm muscle and was sleepy tired the next day. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
I experienced fatigue and soreness at vaccination site. I tested positive for COVID virus after being fully vaccinated.
Day of vaccination started  getting very tired, napping on and off throughout the afternoon, and by bedtime around 10-11pm got severe chills and then got very hot right after. Woke up around 3am with 104 fever. Next morning felt fine but fever went up to 100 again, and remains to be seen how day progresses. Sneezing and also had diarrhea the first day but could be unrelated. Arm very sore unable to put weight on it or lift it much.
dizzy; Not feeling that well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 14Oct2023, outcome "unknown", described as "Not feeling that well"; DIZZINESS (non-serious) with onset 14Oct2023, outcome "unknown", described as "dizzy". Additional information: Patient woke up dizzy that she went flying across the room and mostly if she try to look down or if she get up too fast. The patient also reported not feeling that well. Patient don't have any heart conditions.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Admit to hospital, ICU on 12/10. Intubated on 12/10. Extubated 12/14 and re-intubated on  12/16
Fever over 103 for 48 hours then over 101 for five days Malaise Severe body aches Headache Out of it
7/24/21: past 3-4 days, patient had low energy, decreased appetite, drinking very little, and more confused than his baseline. Patient weak and breathing quickly, so came in to ED. found to be COVID positive. Diagnosed with: COVID-19 pneumonia, acute hypoxic resp failure, shortness of breath, acute encephalopathy. Note: patent previously vaccinated with COVID-19 vaccine in April 2021. 7/27: patient still admitted at the time of this form submission.
Vaccine Not removed From Freezer at 2wk Mark - at 3 wks and administered After consult CKD HE/Immu / Manuf.  Notified Pt offer Repeat dose Repeat dose 1/31/22.
painful lymphadenopathy on the ispilateral side; painful lymphadenopathy on the ispilateral side; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2021 (Lot number: EL1284) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 administration on 17Dec2020., Name: Pfizer Sars-coc-2 Vaccination, Manufacturer: Pfizer, Inc, Location: (place name)), administration date: 17Dec2020, when the patient was 30 years old, for COVID-19 IMMUNISATION. The following information was reported: PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "recovered" and all described as "painful lymphadenopathy on the ispilateral side". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
About 13-14 days after I received the covid booster shot I broke out in hives and rashes. I also began experiencing blurred vision, numbness and tingling in my hands and feet. The all over body rashes occurred with intensity and over a period of days. I?m on day 10 and still experiencing hives and rashes.
nausea; General malaise; diarrhea; localized pain 3-4/10; This is a spontaneous report from a contactable nurse (patient). The nurse reported 2 reports for same patient, same product. This is the first report. A 39-years-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), intramuscular at arm left on 22Dec2020 at the age of 39-years-old at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included VITAMIN B complex (B COMPLEX), collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM), saw palmetto [serenoa repens] and zinc. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to Tramadol and Lexapro. The patient experienced general malaise with nausea and diarrhea, localized pain 3-4/10 after first dose on 22Dec2020 for 5 days (as reported). Therapeutic measures were taken as a result of general malaise with adverse event included antihistamine (as reported). The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148928 same patient, same product (second dose), different events with time gap
ON 05/18 /21 AT 6PM I STARTED HAVING VERY LOUD HISSING SOUNDS IN BOTH EARS / TINNITUS.  IT IS INTERMITTENT AT THIS TIME. ALSO LEFT EAR PAIN ON AND OFF SINCE THE VACCINATION. ON 05/11/21
Severe depression x 6 days - sudden onset of depressed mood, suicidal ideation
left arm extremely sore and stiff, generally unable to raise the arm higher than 45 degrees. Constant pain, numbness down the back of the arm thru the hand and fingers.  The shoulder has been treated with prednisone and a steroid injection, neither worked.  I am presently in physical therapy with very lim9ited success.
Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition were not provided. On unknown dates the patients received improperly stored doses of RECOMBIVAX HB (strength, lot#, expiration date, therapy type, dose and route were unspecified). No adverse effect was reported. This is one of the several reports that received from the same source. Additional information has been requested.
A 3 day old infant inadvertently received the 2 month shots on 5/5/08. On 5/7/08, was seen by pediatrician and had a normal exam. No adverse reactions. The child was born at 38 weeks gestation. Infant did NOT receive birth dose of hepatitis B vaccine.
02/13/22 presents to EC ED for "fevers, rigors, tachycardia". PMHx of "complex HLA-incompatible deceased donor (DBD) renal transplant on 5/12/21 with Campath induction, ESRD due to chronic interstitial nephritis"
Rash. Posterier aruiculear lymphaedema. slight periorbital edema