chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke - Blood Clot in M2 Brain Artery Friday, May 21, 2021 - Air lifted from Hospital to Hospital Admitted to Neuroradiology Dept and immediate Thrombectomy to remove blood clot behind left eye via angiogram through the groin via catheter.  Proceedure was sucessful in removing 100% blocked artery and he was transfered to Resovery, observation and follow-on diagnostic testing in ICU for 4 days.  Discharged May 24, 2021
Severe itching at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional case details were reported as follows: The batch number was updated from SKK99 to 5KK99, as per sales data sheet. The patient received Shingrix and experienced severe itching at injection site and no rash. The reporter asked how to proceed with 2nd dose of Shingrix.  Adverse event was collected. The reporter did not consent to follow up.
i have known 3 people who have had heart attacks, and one is in rough shape; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "i have known 3 people who have had heart attacks, and one is in rough shape".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a nurse at a physician's office and a physician concerning a 23 month old white female patient with no pre-existing allergies or medical conditions, who on 07/01/2003 was vaccinated subcutaneously in the right leg with a first dose of varicella virus vaccine live.  Other vaccines administered concomitantly on 07/01/2003 included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live administered subcutaneously in the left leg and a third dose of poliovirus vaccine inactivated, administered subcutaneously in the right leg.  The patient was not ill at the time of vaccination and did not have adverse events following prior vaccination.  On 05/24/2004, the patient developed fever, followed by vesicular/pustular lesions on her buttocks, abdomen, arms, legs, oropharynx.  On 05/25/2004 the patient was seen in the physician office and was suspected to have a breakthrough varicella infection.  The lesions were reported to be in multiple stages of healing.  The physician noted possible attentuated varicella as it was 10 months post vaccination.  It was unknown as to whether or not treatment was required.  The patient recovered.  There was no product quality complaint reported.   No additional information is expected.  The nurse also mentioned another patient, a 5 year old male who had a similar experience following vaccination with varicella virus vaccine live.
Patient received the Pfizer Covid 19 vaccine and after waiting in the waiting room for a couple of minutes began having a seizure.  The seizure lasted about 1 minute.  911 was called and the paramedics arrived shortly after.  The patient was conscious and alert, but appeared very sluggish.  The mother of the patient insisted that she be carted away to the hospital and the paramedics took her to the ambulance.
injection site itched after every shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itched after every shot) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESYLATE for Blood pressure high, FAMOTIDINE, TIMOLOL MALEATE (TIMOPTIC), BIMATOPROST (LUMIGAN) and PRAVASTATIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (injection site itched after every shot). At the time of the report, VACCINATION SITE PRURITUS (injection site itched after every shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.  Every time, around the day of the injection or the next day patient´s injection site itched. It was not red nor had a rash. This lasted between 10 days and 2 weeks each time.   This case was linked to MOD-2022-454488, MOD-2022-454495 (Patient Link).
Lethergy, disorientation, and general malaise that occurred at appromately 1:00PM and resolved by 6:00PM.
Approximately a week after vaccine, I experienced chest pain.  I am a teacher and went to school nurse. My blood pressure was high even though I am on blood pressure meds and it is controlled. She heard a pause and a skip when listening to my heart. She told me to call my doctor, I had an appt for the next morning. While at the doctor, I had an EKG. I was told I was several having PVC's. I was ordered a Holter monitor for the weekend. I was put on on Metoprolol once daily. I had went to the ER due to having chest pressure and pain. While at ER, I had an EKG and monitored. Was told to follow up with a stress test and echocardiogram. My stress test and echocardiogram was normal. I did have a heart murmur. I was told the Metoprolol would control the arrhythmia.
HUSKY VOICE; FEELING A BIT TIRED; SALINE, HISTAMINE AND LITTLE AMOUNT OF VACCINE ADMINISTERED WITH A PLASTIC PRESSOR; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anesthetics allergy, perfume allergy, and smoke allergy, and other pre-existing medical conditions included: Patient has multiple allergies that causes laryngitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205AZIA expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced saline, histamine and little amount of vaccine administered with a plastic pressor. On 06-AUG-2021, the patient experienced husky voice. On 06-AUG-2021, the patient experienced feeling a bit tired. Laboratory data (dates unspecified) included: Laryngoscopy (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling a bit tired, husky voice and saline, histamine and little amount of vaccine administered with a plastic pressor was not reported. This report was non-serious.
Swelling and redness in left upper arm portion, round about 10 cm in diameter, non painful. Started yesterday afternoon, RX'd today with Benadryl/PRN.
Moderna COVID-19 Vaccine EUA Experienced body soreness/sensitivity, soreness in arm, Fever, Chills and shivering, headache. Took Tylenol which helped with the shivers, and ibuprofen which helped with the headache. Woke up at about midnight on 2/9 with chills and then felt better by 2pm on 2/9.
p/vax pt c/o having to vomit then vomited & did not respond to commands, but was awake; pt to ER where he seized x1;EEG dx seizure disorder according to mom
Temp 100-103 x 4 days 14JAN-18JAN generalized rash on 4th day of temp;
A report received from a Health Professional concerning a patient of unknown gender. The patient received Nasal FLUMIST QUADRIVALENT, 0.2 Millilitres, Unknown, on 30-Mar-2016 that was expired on 25-Mar-2016. The outcome of the event of expired FLUMIST administered is unknown. The report was considered to be non-serious.
Diagnosed with CIDP. Currently having 5 hour infusions every other week of Gamunex C to try and stop my nervous system from being attacked an destroyed. Have numbness and loss of feeling in legs and feet and thumbs. Trouble with walking and balance.
SWELLING FROM FEET TO ABOVE KNEE, NO RASH, NO REDNESS, NO FEVER, STARTED THE EVENING AFTER VACCINATION, ABOUT 7 HOURS LATER, AND HAS CONTINUED THROUGH TO TIME OF REPORT 45 HOURS LATER
Pfizer COVID vaccine administered 04/27/21. Reports that she started feeling unwell almost immediately after injection.  Immediate Reaction (onset <5 min) associated with the following symptoms:  ? Visible swelling and pain at the injection site  ? Increased nasal secretions and eye tearing ? Chills Around 30 minutes after, she had also developed: ? Swelling of the tongue (felt "heavy") ? Flushing, diaphoresis, and nausea, followed later by vomiting ? Dizziness/lightheadedness/weakness ? Dyspnea, wheezing, and cough ? Hives on arms and chest    No throat tightening or tachypnea. She did not attempt speech.  No one in the clinic took her blood pressure or pulse ox   The patient brought her epi pen with her but elected not to use it. Left after 30 minute observation period.  Thinks that the people at the vaccine clinic did not recognize that she had hives because of her dark complexion.  The people administering vaccines were not medically trained    Patient's mom recognized that she was not feeling well when she picked her up.  She took benadryl which helped with allergy symptoms.  She then developed fever up to 102.3, chills, headache, nausea, and myalgias x 5 days
- Dizzy at first , then difficulty breathing (throat closing) - Pharmacist administered Epi pen - Received steroid at hospital
1) Metallic taste in mouth with blurred vision that was persistent; 2) Increased salivation with muffled speech;  3) Trouble swallowing with "cotton wool" feeling and then felt like lips were swelling and mouth was very hot "on fire"; 4) Flushing with bright red face and chest.; 5) Tachycardia with diaphoresis; Epi number one given 1300 - 911 called; 5) cold clammy extremities and diaphoresis; 6) Gagging with nausea and tachycardia; 7) increased flushing and global tremors (S/P EPI); 8) Return of tongue and roof of mouth symptoms with trouble swallowing.
right ear was numb/right side of head was numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (right ear was numb/right side of head was numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (right ear was numb/right side of head was numb). At the time of the report, HYPOAESTHESIA (right ear was numb/right side of head was numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Small swelling around my neck area - I went to see my doctor and after a couple of tests, was diagnosed with Anemia.
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Right anterior thigh swelling, tender, red, blanch 6.5 in x 3.5 in.
as if someone had given her a bump; hard; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE OEDEMA (as if someone had given her a bump), INJECTION SITE MASS (hard) and INJECTION SITE ERYTHEMA (red at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE OEDEMA (as if someone had given her a bump), INJECTION SITE MASS (hard) and INJECTION SITE ERYTHEMA (red at the injection site). At the time of the report, INJECTION SITE OEDEMA (as if someone had given her a bump), INJECTION SITE MASS (hard) and INJECTION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Ice at the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new information was provided.
This spontaneous report as received from a pharmacist refers to a 35 week old female patient. The pharmacist reported that the patient received her first dose of RECOMBIVAX HB (lot# was not reported, 0.5ml, intramuscular) on 11-MAY-2013 and her second dose of RECOMBIVAX HB (lot# was not reported, 0.5ml, intra-muscular) on 28-MAY-2013. No adverse effect reported. Additional information has been requested.
About two weeks following vaccination, my son started to complain of dyspnea on exertion, palpitations, and chest pain.  It seems the complaints have gotten more frequent in the last 10 days.
Information has been received from a registered nurse reporting on a 14 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, when the patient was 13 years old, she received an unspecified dose of GARDASIL for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, "about a year later" (inappropriate schedule of drug administration) she received an unspecified dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (interchange of vaccine products). No adverse effects were reported.
within 2 days of receiving vaccine, pt had erythema, induration, and multiple vessicles formed around immunization site.  Pt was treated with Keflex 500 mg po bid for secondary infection.
Shortly after receiving vaccine she developed numbness/tingling in hands that lasted 3-4 days. One week post vaccine developed pain, redness and swelling at injection site. All discomfort has resolved 2 wks post vaccination.
Received the shot on Thursday evening & a week later on Friday I felt some indigestion, than the back of lungs (both) hurt terrible. I could take a deep breath unhindered but the pain in the back of the lungs was something I've never experienced.  The pain didn't change with my breaths, they just hurt. It lasted the entire day. The pain was more tolerable standing so I stood most of the evening & got through it. I also noticed my heart was weird. Kinda racing. Saturday morning woke up fine. As the day went on felt the indigestion start to come back & then my heart was racing. Noticed my heart more so than the lungs on Saturday. Took a shot of whiskey & it subsided until later in the afternoon. I had 1-2 more episodes. Then in the evening of Saturday I felt pain in my neck (left side) & a tingly sharp transfer of something up the side of my head & going around my brain. I just remember thinking "now what the hell is this?" Then from Saturday night until Tuesday I dealt with those symptoms. The occipital area of my head hurt for days and that shooting pain around my brain would come at whim. I went to my chiropractor on Tuesday & he did numerous things & I've felt better since. I'm not sure about shot #2 cause that all really sucked.
Initial unsolicited report received from the literature (abstract article) on 24-Apr-2019. This case is linked to cases 2019SA114648 and 2019SA114647 (same literature article). This case involves a female patient (middle-aged) who experienced chronic rheumatoid arthritis, while she received vaccine Influenza Vaccine (Trivalent). The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Vaccine (Trivalent) produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious chronic rheumatoid arthritis (rheumatoid arthritis) with unknown latency following the administration of Influenza Vaccine (Trivalent). This event was assessed as medically significant. Lab data was not provided. Final diagnosis was chronic rheumatoid arthritis. An unknown corrective continuous standard treatment was received. The patient outcome is reported as Unknown for chronic rheumatoid arthritis. The reporter assessed the causal relationship as association exists between immunization and the onset of RA. List of documents held by sender: none. Sender's Comments: This literature article reports about adult female patient who presented with rheumatoid arthritis with chronic presentation after vaccination with Trivalent Influenza vaccine. The time to onset is unknown. There is no information regarding patients condition at the time of vaccination, nor are any lab/radiological results provided refuting alternate causes. Based upon the reported information, the role of the vaccine cannot be assessed.
Elevated heart rate beginning day after 2nd Pfizer dose administered; noted during exercise wearing heart rate monitor; about 15-20 bpm higher than normal; two weeks after 2nd Pfizer dose heart rate is still elevated.
Approximately 5 hours after vaccine administration: chills, severe headache, fever, nausea.  Injection site painful, swollen, erythematous.  Systems lasted throughout the night and into morning.  Fever and chills resolved by 11:00 am.  Took several doses of ibuprofen through out the course of the fever.  Fever never exceeded 100.4 F.
Rash on lower arms 10 minutes post vaccination. Patient had taken diphenhydramine prior to arrival, declined cetirizine or additional diphenhydramine. Rash slowly resolved, patient discharged.
I do not know if this was an adverse event to the vaccine or not. It was not like an allergy reaction which I really don?t get. Felt more llike a mild flu. I have read that some people had delayed effect. It started out as a eyestrain type headache last night that  got worse then I felt  somewhat queasy like I had to throw up  which I did three times. Then I had Somewhat loose stool. It could have been another ailment but I don?t know. I was feeling fine until this happened. I had a sore arm after the injection  at  injection site for maybe three or four days but it was gone by time this happened. I did not have a fever that I know of but I did have periods of becoming chilled or  hot. I do not feel like I drink anything including water. I did not have any rash, but I did have a bruise that showed up the day before and right lower arm above my right wrist. But who knows I might have bumped my arm I  or not I just don?t know. Today I feel a little better. Able to eat Jell-O. Headache almost gone.
Caught COVID (tested positive in home test); Caught COVID (tested positive in home test); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 at 14:15 as dose 5 (booster), single (Lot number: GJ6742) at the age of 63 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 at 10:30 as dose 1, single (Lot number: EN5318), in left arm, on 23Mar2021 at 15:15 as dose 2, single (Lot number: EN6199), in left arm, on 30Sep2021 at 10:45 as dose 3 (booster), single (Lot number: EP6955), in left arm and on 26May2022 at 11:00 as dose 4 (booster), single (Lot number: FH8028), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX; FOLIC ACID; METHOTREXATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2023 at 18:00, outcome "recovering" and all described as "Caught COVID (tested positive in home test)". The event "caught covid (tested positive in home test)" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2023) Positive, notes: Nasal Swab; (16Jun2023) Positive, notes: tested positive in home test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Adverse event resulted in: [Doctor or other healthcare professional office/clinic visit] and treated with Paxlovid, Flonase. The patient did not have Covid prior vaccination. The patient had no known allergies.
Fever of 100. Headache, Chills, Head Fog, Slight Body aches
INFLUENZA A; This spontaneous case report was received from a pharmacist (PVX2019-595) on 07-Mar-2019. It described a male child consumer who was diagnosed with influenza A following the intake of Vivotif for an upcoming trip.  The consumer was not taking any concomitant medication.  It was reported that the consumer took first two doses of Vivotif, probably 3 or 4 days ago. On 07-Mar-2019, he was diagnosed with Influenza A. He had a fever (approximately 100 degree Fahrenheit) and other upper respiratory symptoms like runny nose and cough.   The reporter did not think that Vivotif caused influenza A because the place where the consumer was located was an uptick of influenza A.  The action taken with Vivotif with respect to the event influenza A was unknown.  The clinical outcome of the event influenza A was not resolved.  Company's Comment: In this case, it was reported that a male child consumer was diagnosed with influenza A following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. However, influenza A is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, it was reported that a male child consumer was diagnosed with influenza A following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. However, influenza A is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif.
Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 04Mar2021 as dose 2, single (Lot number: EN6200), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FV8020) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VYVANSE; ATORVASTATIN; TRAZODONE and FISH. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Apr2023, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2021) Negative; (05Apr2023) Positive, notes: Nasal Swab. The patient had not received any other vaccines within 4 weeks. The known allergies were reported as none and other medical history was reported as none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300216196 same patient, different dose/AE.;