chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stroke; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 72 year-old male patient received BNT162b2 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no history of COVID-19 prior vaccination. Vaccination history included: BNT162b2 (Dose 1), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, life threatening) with onset Nov2021, outcome "unknown", described as "stroke". After receiving the second dose of the vaccine, patient suffered a stroke. Adverse event resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient's mother called a month after the event to report what happened (patient had swelling of the testicles with pain to the area; states the were tender for anything to touch them, warm to touch and red). She stated she did not want anymore HPV vaccinations for him.
get the first shingrix shot and an an unknown time later developed sinusitis; This case was reported by a consumer via call center representative and described the occurrence of sinusitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sinusitis. On an unknown date, the outcome of the sinusitis was recovering/resolving.   The reporter considered the sinusitis to be unrelated to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient did get the first shingrix shot and an unknown time later developed sinusitis.  The patient inquired, if the patient could get 2nd Shingles shot as the patient was recovering from sinusitis. The patient had been advised to speak with the patient's health care provider regarding use of Shingrix if a patient who has sinusitis. The patient did not seem to be indicating that Shingrix caused the sinusitis.
Had a near death one night; crawled from the bathroom to the couch, and his wife would help him walk; blacked out a couple times; Palpitation; Lower Legs started to get numb; Diarrhea; Nausea; Getting itchy, entire body; Weak/Weakness; This is a spontaneous report from a contactable physician (patient)  A 71-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3248), via an unspecified route of administration in the left arm on 25Jan2021 at single dose for COVID-19 immunisation.  Medical history included seasonal allergy. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (Batch/lot number: EK9231) on 04Jan2021 at single dose in left arm for COVID-19 immunisation and experienced non serious slightly sore arm lasted for 2 to 3 days. On 25Jan2021 the patient experienced blacked out a couple times (serious due to disability, life threatening), palpitation (serious as life threatening), lower legs started to get numb (medically significant) with outcome of recovered on 25Jan2021, diarrhea and nausea (both medically significant) with outcome of recovered on 26Jan2021; Getting itchy, entire body and weak/weakness (both medically significant) with outcome of recovering. The patient has also a near death one night with outcome of unknown. The patient reported that received the second was on 25Jan2021, and about 10 hours later, he started getting itchy, his entire body was itchy, this was all in about 20 minutes, he was weak, then he got diarrhea, nausea, he blacked out a couple times, he had the weakness, then he crawled from the bathroom to the couch, and was afraid and his wife would help him walk, as he didn't think he would make it, he was on the couch with palpitations and was itchy all over, and after an hour he fell asleep, and he came within seconds of going to the ER, the palpitations got worse, and he has no heart problems in the family, but it was a terrible reaction, he didn't think he would make it through the night, and he was not an allergic person, the only thing he was allergic to was seasonal, in the spring time. Also, his lower legs started to get numb in between all that. Started to get itchy 10 hours after the second shot. He was much better the following morning, he just has a little weakness from the havoc on the body. Numbness in lower legs lasted only about 10-15 minutes.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021082193 Same Reporter/Patient, Different Dose of vaccine/Event
Narrative: Covid+, Moderna #3, NH, pulmonary fibrosis, hypoxic, readmit, acute resp failure, tachy, high oxygen demand due to pulmonary fibrosis.Received remdesivir and was placed on pred, dc then readmitted. placed on steroid. pt declined hospice
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 29-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
4 hours after receiving vaccine pt developed pruritic rash on arms and legs. Treated initially with Claritin without relief so then took Benadryl.  The following day the rash persisted so took Zyrtec.  Also was prescribed triamcinolone cream.  The rash resolved after the second day.
Got vaccines at recent WCC (see below) on 5/1/13. Broke out w/ 2-3 mm papular rash on hands, feet, and around mouth on 5/4/13. Erythem. but does not seem to itch. Has spread to arms, legs and trunk. Episodes of extreme irritab. x 30 min/episode. No fever.
Client received a 3rd dose of Moderna intentionally, on consent form denied having been vaccinated previously.
Patient report feeling warm. Narrative:  Patient was seen by MD. on sight vital were stable DR .prescribed a Benadryl 25mg PO. Patient was sent home to transported by coworker.
Day after receiving 2nd shot, I felt a lot a pain around my right-side neck, shoulder, chest and back. Pain was to the point I could not lift my right arm. On the morning on 5/4/21, I woke up to a red rash and blisters in the same area that was affected with pain. In the evening of 5/4/21, I was diagnosed with shingles.
Patient received vaccine on 6/22 then on 6/24 she experienced flu-like symptoms including chills, sweating, horrible aches and pains, fever, sneezing, runny nose, and nausea. These symptoms occurred for approximately 5-6 days but patient has still had aches on and off and chest congestion as of today. Patient has had a bad headache every day since 6/24 and has taken Tylenol, Dayquil, aspirin, and ibuprofen to help with some of these symptoms but all of the adverse effects keep reoccurring and have not gone away. Patient does not have a PCP so I recommended she go to an urgent care clinic to be evaluated, but if her headache gets any worse she should go to the hospital instead.
This spontaneous report was received from a nurse practitioner concerning a 24 years old female patient. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. Approximately in 2007, 2008 and 2013, reported as "at age 15 years, 16 years and 21 years", the patient received a complete series of GARDASIL (strength, dose, route, lot # and expiration date were not provided). In approximately May 2014, reported as "2 and 1/2 years ago", the patient experienced myeloblastic lymphocytic leukemia. On an unknown date, the patient developed two genital warts and had a pap test that showed human papillomavirus (HPV); the reported stated that HPV was not the type of high risk for neoplasm. It was reported that the patient was treated with chemotherapy for myeloid leukaemia and lymphocytic leukaemia and that the patient sought medical attention. At the reporting time, the patient events of myeloid leukaemia and lymphocytic leukaemia were in remission since an unknown date. In addition, the outcome of the event of papilloma viral infection was unknown. The causality between GARDASIL and the events of myeloid leukaemia, lymphocytic leukaemia and papilloma viral infection was not assessed. Upon internal review, the events of myeloid leukaemia and lymphocytic leukaemia were considered to be medically significant. Additional information has been requested.
This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unspecified dates, improperly stored doses of MMR II (strength, dose number, dose, frequency, lot number and indication were not reported) were administered to an unspecified number of unspecified patients. No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter (linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000551, 1406USA000552). Additional information has been requested.
pt recv vax 16AUG95 & states was very nervous about shot & felt nauseated but didn't say anything; lt clinic & walked to parking lot approx 50 yards & passed out; had contusion- small abrasion
On 3/18/21 (day of injection) about 1 hour after felt fatigued - then very tired. Past about 4-5 hours later. Injection site sore On 3/19/21 woke up and had a really bad headache - an hour or so later bad chills and body aches. That lasted a little over 25 hours. Injection site still sore. 3/21/21 felt fine no other symptoms - injection site a little less sore. 3/26/21 noticed a red spot at the injection site - no longer sore - did not hurt or itch Over time the spot got a slightly bigger but still did not hurt and no itching or soreness 4/3/21 woke up and the  noticed the spot had doubled in size and was a lot redder, scaly and a little itchy.  I called our doctor and he told me to use cortisone cream with itch relief and take claritin
49 y.o. female who presented to the emergency department on 1/14/21 for possible allergic reaction.  Patient states that she got her first Covid vaccine yesterday afternoon and states that she has noted some swelling in her hands and also feels as though she has burning pain and pins-and-needles in her hands.  She denies any weakness in her distal extremity.  She states the sensation extends from her fingertips to her mid forearm.  She also states that she has noted some lymph node pain in her groin and neck.  She denies any fevers or chills.  She denies any throat tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting or rash associated with her symptoms.  Patient is alert and oriented ×3, cranial nerves II through XII intact bilaterally, no pronator drift, paresthesias in glove like distribution from hand to mid forearm bilaterally. Sensation intact in bilateral lower extremities, 5/5 strength in upper and lower extremities, cerebellar function intact with finger to nose bilaterally.  No visual field deficits by confrontation.   Discussed laboratory findings with patient.  She did also does have a mildly elevated creatinine outside of kidney injury however suspect may be source for mildly elevated phosphorus.  Given 1 L of fluids.  Recommended close follow-up with PCP for laboratory recheck and further evaluation.  No signs of acute anaphylaxis or angioedema.  Discussed return precautions with patient if she were to have worsening symptoms
Patient described painful arm swelling at the injection site that began 4 days after injection and resolved after a week.
Redness at injection point on arm. 60 hours after dose, red and hot to touch on left arm. Pain if pressrd
PT FELT FATIGUED AND WEAK ON RIGHT SIDE ON 5/21. ON 5/22 AT 3AM FELL GOING TO BATHROOM AND COULD NOT GET UP. WENT TO ER AND MRI SHOWED MILD STROKE IN THE BASAL GANGLIA
Patient felt hot and then she felt syncopal then appeared to have a grand mall seizure. She displayed posturing and was unresponsive for ~ 10-15 seconds.  No loss of bladder control.  BP 125/78 HR 42.  Squad was called.  BP 136/76 HR 75 O2 sat 99%  Squad arrived.  Patient is now responsive.  Nursing staff has called her husband.  He states this happens when she has an injection. He stated that he will come pick her up and he did not want her going with the squad.  Patient spoke to her husband.  Patient is refusing transport with squad stating that her husband is a PA  and is on his way to pick her up.  BP 126/80 HR 69 O2 Sat 98%.  Squad left.  Patient states that she feels better,  She sat up.  Patient now reports that she feels nauseated.  Patient vomited.  BP 127/55 HR 76 O2 Sat 99%.  Patient's husband has arrived.  Patient reports feeling well.  Vitals standing BP 117/86 HR 69  O2 Sat 100%.
Fainted following strenuous activity. Headache, fatigue, chills, body aches, frequent stools, upset stomach. Headache lasted through the night along with loose stools (no vomiting). Now 9/11/08 4:45 pm feels better, sx subsided
pt recv vax 26JUN95 & 26JUN95 devel an immed rash consisting of raised welts/hives, w/in half an hr p/vax
pt recvd vax;exp localized edema at inject site extending fr elbow to deltoid; on f/u,the responsible MD refused to provide further info;
Tingling lips; arm felt heavy; numb lip; funny feeling in throat; felt like she had been to a dentist office; Chemical in throat feeling; wake up every 2 hours during sleep to drink a glass of water to help with the feeling; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Allergy to chemicals (IV Iodine), Soy allergy, Latex allergy, Seafood allergy and Asthma. Concomitant products included GABAPENTIN for Back pain, ZOLPIDEM for Insomnia.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (funny feeling in throat), ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling). On 05-Apr-2021 at 4:05 AM, the patient experienced HYPOAESTHESIA ORAL (numb lip). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lips) and LIMB DISCOMFORT (arm felt heavy). On 15-Mar-2021, LIMB DISCOMFORT (arm felt heavy) had resolved. On 06-Apr-2021, ORAL DISCOMFORT (felt like she had been to a dentist office), THROAT IRRITATION (Chemical in throat feeling) and SLEEP DISORDER (wake up every 2 hours during sleep to drink a glass of water to help with the feeling) had resolved. On 08-Apr-2021, HYPOAESTHESIA ORAL (numb lip), OROPHARYNGEAL DISCOMFORT (funny feeling in throat) and PARAESTHESIA ORAL (Tingling lips) had resolved. Not Provided      Action taken with mRNA-1273 in response to the events was not applicable.  Patient would wake up every 2 hours during sleep to drink a glass of water to help with the feeling.   This case was linked to US-MODERNATX, INC.-MOD-2021-079459 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Reporter's address, Patient demographic details, Medical history, Product and concomitant information and event details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079459:1st dose
swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trunk, face, and arm; throat started to close; mouth started to itch; swollen itchy eyes; swollen itchy eyes; sneezing; swollen lump in shoulder immediately; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0167), via an unspecified route of administration in the left arm on 21May2021 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma, allergies, leaky heart valve, fusion feet, cholesterol, triglycerides, ulcers, and allergy to sulfa and bananas. The patient had a negative COVID-19 nasal swab in Jan2021, and twice in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: montelukast sodium (SINGULAIR), fexofenadine hydrochloride/ pseudoephedrine hydrochloride (ALLEGRA D), diphenhydramine hydrochloride (BENADRYL), citalopram hydrobromide (CELEXA), eicosapentaenoic acid ethyl ester (VASCEPA), budesonide/ formoterol fumarate (SYMBICORT), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 19:00, within 2 hours of vaccination, the patient experienced swollen itchy eyes, mouth started to itch, sneezing, throat started to close; swollen lump in shoulder immediately. Two days later (23May2021), hives under chin on left side. The next day (unspecified date) she got hives on left cheek, then a few days later (unspecified date), hives on her left trunk. It was also reported she had hives on left side of trunk, face, and arm, and had a swollen arm. For treatment, the patient took 3 BENADRYL and 20 mg of prednisone. The outcome of the events was recovering. Since the vaccination, the patient has been tested for COVID-19 on an unspecified date (unknown results).
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of hives in a 19-year-old female subject whow as vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included aspirin allergy and asthma. Concurrent medications included ZYRTEC and ALBUTEROL. On 8 May 2012 at 16:15 the subject received 1st dose of HAVRIX (1 ml, intramuscular, left deltoid). On 8 May 2012 at 23:00, 6 hours and 45 minutes after vaccination with HAVRIX, the subject experienced hives. The patient was advised to tae ZYRTEC and BENADRYL. The healthcare professional considered the event was "possibly" clinically significant (or requiring intervention). At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with HAVRIX.
Dizzines, nausea. BP 125/84; HR 94; RR 18. No s/sx of respiratory distress. Pt monitored by RN, sx resolved & released home with father in stable condition
Narrative:  68yo male patient with metastatic prostate cancer,HLD,past HTN but on no BP meds,polyp-2023,osa,gerd,LBP,AAA,bilateral ureteral stents(changed out q6 months) died on 9/12/2021. He had received covid vaccines on 1/14/21 & 3/13/2021. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Red inflammation at injection site over 5 days post injection. BENADRYL ineffective, patient saw MD got prednisone day 5 which worked.
Patient with history of anoxic brain injury and persistent vegetative state.   She was brought to the ED by EMS on 10/31 after she had an episode of emesis and associated drop in sats at her LTCF. When she arrived to the ED, she had increased respiratory rate and hypoxia. Patient tested positive for COVID in the ED by PCR. Ultimately, she was admitted 10/31 - 11/16 for acute on chronic hypoxic respiratory failure, Serratia pneumonia, and COVID pneumonia. She was discharged back to her LTC on 11/16. She has received the primary COVID vaccine series and one booster.
D= decedent   D received the second dose of the COVID vaccine on 3/10/21 @ 10:45AM. His daughter, ************, transported him to the Pharmacy appointment. She notes that D did not have any complaints before or after the appointment?specifically she denies observing any weakness, dizziness, cough, and fever. D went on to have an uneventful day with normal appetite and bedtime.  ************ also mentions that there were no adverse reactions following the first dose either.   The next morning (3/11/21) at 6am the decedent?s wife found him in bed ?looking around the room? with gurgling agonal breathing. No seizure activity reported.
Caller wants to know if she can get a shot in her eye while waiting to take her second covid vaccine. Clarified that this eye appointment was made after the first dose of the covid vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: EYE DISORDER (non-serious), outcome "unknown", described as "Caller wants to know if she can get a shot in her eye while waiting to take her second covid vaccine. Clarified that this eye appointment was made after the first dose of the covid vaccine."  Additional Information: Reported as, eye appointment was made after the first dose of the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt noted pain at injection site (which she thought was too high on her L arm) immediately after the injection.  The pain is sharp and tearing in nature and will at times radiate down to her L elbow. Pain has remained the same for 3 weeks.