chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a massive stroke; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose at the age of 83-year-old for covid-19 immunization. Historic vaccine was bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. Concomitant medications were not reported. The patient had 2 terrible reaction followed by a massive stroke within a week of the 2nd shot. She was still recovering (as reported) from the stroke. It was terrible. Stroke was too much to handle. She was still going to Dr. She had a caregiver paid at home. The seriousness of event was reported as life threatening and hospitalization. The patient was hospitalized duration of stay: 3 days. AE required visit to: Intensive care unit (3 Days). The outcome of event was not recovered.  Information on the Lot/Batch number has been requested.
Day 8 after vaccination,  left arm in area of injection developed a rash with swelling, warmth,  and soreness that had previously disappeared several days after injection. Coincidentally my left eyelid was also swollen and itchy .
Fever; Body aches; Migraine; Exhaustion; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 14Jul2021 at 16:00 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. Medical history included graves disease, known allergies to narcotics, analgesics, sulfa drugs and other antibiotics, latex, dyes, fragrances and suspected COVID-19 from unknown date in Mar2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); all for unknown indication from unknown start date and unknown if on going. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 23Jun2021 at 14:30 (at the age of 52-year-old), as a single dose for COVID-19 immunisation and experienced no adverse event. On 15Jul2021 at 06:00, the patient experienced fever, body aches, migraine and exhaustion. The patient was sure, but had no proof that patient had contracted COVID-19 in Mar2020 and was ill for 2 months, no hospitalization was needed then. The patient had the same symptoms after second dose as she had when she contracted COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, migraine and exhaustion was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
The pt complained of extreme swelling with the arm 3 times the normal size. No increased temp. Seen in the ER on 4/6/01 PM. Places on antibiotics. Told had infection from shot. Called her mother on 4/9/01 she states arm remains swollen. States he told her shot should have been in leg and not deltoid. On 4/10/01 mother states the pt is on antibiotics. On 4/13/01 it is reported that the arm is blistered down to the elbow. On 4/24/01 is completely healed.
I did not have an adverse reaction to the vaccine. I tested positive for pneumonia on 12/06/2022. I went to my doctor and got prescriptions for 5 days. As of today, I feel exhausted all the time.
Dizziness after about 5 minutes of the booster  (3rd dose), Cold extremities, wanting to vomit (DID NOT VOMIT), Blood pressure 93/67 HR 58 at 10:15a. Patient lie flat on the floor and got better after 15 minutes. EMS came and checked patient blood pressure and blood sugar.
Benign paroxysmal positional vertigo (BPPV); This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Aug2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Aug2021, the patient experienced benign paroxysmal positional vertigo (BPPV). The event resulted in doctor or other healthcare professional office/ clinic visit. Therapeutic measures were taken as a result of the event and the treatment included vestibular physical therapy. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event benign paroxysmal positional vertigo (BPPV) was resolving at the time of this report.   No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA: Nausea & vomiting, diahrrea. Treated with Zofran (generic) and OTC Immodium
Information has been received from a physician concerning an 18 year old female student (weight 131#, height 66.5") who on 14-DEC-2006 at 2 pm was vaccinated with the first dose of Gardasil (lot #654540/1162F), IM in the right arm. Concomitant therapy included Menactra (lot #41974ab), IM in the left arm. On approximately 14-DEC-2006, the patient developed fever T > 100 within 24 hours of vaccination, her arm was very sore and she "could not use for 48 hours". Subsequently on 16-DEC-2006, the patient recovered from fever T > 100, arm was very sore and could not use arm for 48 hours. Additional information has been requested.
This spontaneous report was received from a nurse and refers to two unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unspecified dates in December 2015 (reporter as since 04-DEC-2015), the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # reported as L029466, expiration date 06-AUG-2017, exact doses and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Patient developed nausea (no vomiting), transient numbness of the feet, dizziness, and some palpitations starting about 45 minutes following the vaccination.
Patient was administered extra booster dose of 0.25 ml , previous dose was administered in Nov of 2021
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Additional information has been requested.
At 1500 pt developed nausea, pallor, dizziness. EMS was called and vitals were periodically taken. PT was layed supine on foam matt. At 1503 pt vomited about 100mL of stomach contents. At 1510 pt sat up. At 1513 pt. stood up and denied dizziness. At 1516 pt sat on a chair and claimed she felt okay.
2 days after vaccine 4 inch by 4 inch raised reddened area aroung vaccine site.  Pt given Attarax and cold compresses.
Patient complain of sudden onset of redness to face, bilateral arms, chest. Stated she felt like throat was closing, difficulty swallowing Symptoms started approximately 20 minutes after injection.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 9/19/2022 Discharge Date:  9/21/2022  PRESENTING PROBLEM: Acute hyponatremia [E87.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 85-year-old female with a history paroxysmal atrial fibrillation, CKD stage 3, depression, who was admitted on 9/19 with significant fatigue, nausea, vomiting and diarrhea.  Patient began to have symptoms of sore throat and cough beginning on Thursday 9/15.  Patient was noted to be fully vaccinated, but over due for booster.  In addition to sore throat and coughing, the patient began to have significant diarrhea, with decreased oral intake.  At the time of presentation she was noted to be positive for COVID, but stable on room air.  Chest x-ray was negative for acute cardiopulmonary process.  Laboratory studies showed acute hyponatremia with sodium of 122. Patient was also noted to have orthostatic hypotension.   Patient was admitted for further treatment of her acute hyponatremia, as well as COVID infection.  The patient was stable on room air, and was not a candidate for remdesivir or dexamethasone.  Patient was treated with supportive care.  With regards to the patient's hyponatremia, she did receive 2 L saline in the emergency department, and was subsequently treated with fluid restriction, with her sodium rising to 131.  The patient's orthostatic hypotension did resolve with hydration.  Initially Cardizem was held, however this was restarted, with stable vital signs.  With supportive care, and improvement in her hyponatremia the patient had significant improvement in her symptoms.  As patient was clinically stable she was discharged to home on 09/21/2022.
Pt vaccinated with HIBTITER 8 days later had a seizure; Admitted to hosp. Pediatric infectious disease consult felt seizure not from vaccine.
Approximately 5 minutes after receiving injections, pt. fell to the floor from a seated position. Her body became rigid for about 30 sec then she was able to sit up. She had no recollection of the event. ER no diagnosed. Pt: with anxiety RT receiving shots for school.
pt recvd vax; site swollen & reddened approx size of 50 cents piece; t 99.3 tymp; tx w/ apap;
My injection site is really swollen on my arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered on Arm on 05Aug2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug 2021, the patient had my injection site is really swollen on my arm. At the time of reporting, the outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A non-serious spontaneous report of pregnancy was discovered after H1N1 LAIV given and nasal stuffiness has been received from a consumer concerning 32-year-old female, subsequent to H1N1, Intranasal vaccination. Neither relevant medical history nor concomitant medications have been reported. On 15-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. After vaccination the patient came to know that she was pregnant. On 17-Nov-2009, two days after vaccination, the patient experienced nasal stuffiness that lasted for two weeks. The reporter noted the patient seemed to be fine at the time of report. The outcome of vaccine exposure before pregnancy and nasal stuffiness was resolved.
THE PATIENT IS IN HOSPITAL. THE WIFE CALLED AND SAID HE GOT SICK FROM THE VACCINE.
TOOK TWO UNREFRIGERATED DOSE; This spontaneous case report was received from a caregiver (PVX2019-703) on 22-Mar-2019. It described a 26-year-old adult male consumer who "took two unrefrigerated doses". The consumer was receiving oral Vivotif (one dose every other day) for typhoid prophylaxis.  It was reported that the consumer took the first two doses of Vivotif on 15-Mar-2019 and 17-Mar-2019, respectively. Then, he left the doses unrefrigerated at room temperature and took the third and the fourth dose on 19-Mar-2019 and 21-Mar-2019, respectively.  The action taken with Vivotif with respect to the event "took two unrefrigerated doses" was not applicable.  The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
an expired dose of Daptacel was inadvertently administered to 16 month old, no AE; Initial information received on 10-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 month old male patient who was received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA) via intramuscular route in the right thigh for prophylactic vaccination on 10-Feb-2020, that was expired on 30-Jan-2020.  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
no additional ae; Caller reported AE on behalf of a patient who was administered PROQUAD that was improperly stored. No symptoms reported. Obtained consent to contact HCP. Additional AE Filed (Case #02470635). No additional AE/PQC.  Product:; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 24-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml/dose, lot #X009730, expiration date: 30-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided)(incorrect product storage).   The vaccine was stored in temperature of 6 degrees up to 14 degrees Farenheit  for 1 hour 10 minutes. There was no previous temperature excursions. There was no additional adverse events reported.
Patient presented at pharmacy with large red circular area that was hard in the center where the vaccine was administered. Area was not hot when I touched it.
severe shoulder pain thereafter.  Developed clinically SEVERE Adhesive Capsulitis, still unresolved.  Cannot abduct arm past 25 degrees
03/20/2006 reported general body ache, chills onset 3/18, 3/30/2006 reported itchy skin LU arm nodular erythema. Temperature normal. 04/03/2006 skin irritation, itching resolving. No other c/o.
Sore arm; Nagging headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Nagging headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE and ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Nagging headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Nagging headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wanted to confirm if he could take Motrin or something else for headache and pain. Reportedly, he was shocked to hear that the vaccine has not been approved by the FDA and said he needed to call his lawyer,  and needed to go to the news with this. Then his mother explained to him that the vaccine was approved. The agent read the disclaimer again to both (son and mother); the mother was able to understand the difference between, "approved", "authorized" and "Emergency Use". The patient then calmed down.  Most recent FOLLOW-UP information includes: The patient was feeling better and did not want any other follow-ups.   Reporter did not allow further contact
BLEEDING GUMS/SEVER BLEEDING IN THE MOUTH; BRUISES TO ARMS; PLATELET COUNT LOW; HEMATURIA; This spontaneous report received from a patient (retired nurse) concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy in 1992, removed thyroid gland in 2019, dental implant in 25-SEP-2021, and thyroid problems. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, the patient started to had hematuria, had blood in the urine. The color of the urine was like a cranberry color, then in the night there was some real blood clots observed in the urine. She spent a whole day in emergency room (ER). On 01-OCT-2021, 02-OCT-2021 and 03-OCT-2021, the patient started to had severe bleeding in the mouth/bleeding gums. She was very worried and she admitted to the hospital on 05-OCT-2021. On 17-OCT-2021 (last night), she started to bleed again from her mouth during her shower but she used some peroxide and put some sterile gauze and pressed on that area in her mouth and it stopped bleeding. Her dentist told her that there is no problem in the bones and the bleeding can be either from the soft tissue or due to the vaccine. On 18-OCT-2021 in the morning, she was doing some blood work. On an unspecified date in OCT-2021, the patient experienced bruises to her arms from many intravenous (IV's) while she was hospitalized for hematuria and severe bleeding in the mouth/bleeding gums. They did a several blood tests and didn't find out any reason for bleeding. During hospitalization, her platelets count was low as she was still bleeding and her hemoglobin was a little low. Two bags of plasma were received as a treatment. Patient discharged on 12-OCT-2021 and was hospitalized for 8 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding gums/sever bleeding in the mouth, and the outcome of hematuria, bruises to arms and platelet count low was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211034387.; Sender's Comments: V0: 20211032981-Covid-19 vaccine ad26.cov2.s-Hematuria, Bleeding gums/sever bleeding in the mouth, Bruises to arms, Platelet count low. This event(s) is considered unassessable. The event(s) 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(s).
After first DPT, blank stare, very limp - 3 month old. Never seemed to gain full alertness. Second DT: again seemed listless. First and second hepatitis B - blank stare again, started toe walking.
Severe bilateral hip pain/first day/treated with ibuprofen/followed by general muscle aches for one week/day 8 supressed appetite with febrile reaction/vertigo & fatigue for 2 more weeks
Patient's left arm become very hard surrounding administration site.  Mother describes deltoid as had in a 3 inch diameter.  No redness, itching, or pain reported.
Pediatric dose was given to adults mistakenly; Product temperature excursion; Poor quality product administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion ), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered ) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion ), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered ) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion ), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion ) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered ).    No Concomitant medication provided by reporter. No Treatment medication was provided by reporter.  051B22A was kept in the freezer upon receipt of shipment on 01Aug2022 and individual vials were put in the refrigerator on the day of use AR5186C was previously reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:MOD-2022-669791
Insomnia. Less than 12 hours of full sleep since Saturday night/Sunday morning.