chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 34 year old Female with a past medical history of pseudo-seizures. Her past allergies are shrimp (Unknown), Tylenol/ Advil/ Alieve (Unknown).  She has 4 anti-seizure medications on her medication list: Zonisamide, Lamotrigine, Lyrica, Levetiracetam. She has had these pseudo-seizures in the past, but according to her sister who was her emergency contact, she has not had one in the past 1.5 years. The vaccinator did not she had baseline right hand weakness as well pre vaccination.  The patient was vaccinated at 1406 in her right arm.  A staff member noticed that the patient was not feeling well and went to check on the patient. She started presenting with grand-mal seizure symptoms at 1442, and she was lowered to the ground. Staff was with her and was protecting her head and trying to keep her on her side. EMS was called around 1445  and arrived around 1455. At this point the seizure symptoms continued. The patient would appear to be coming out of it and then when someone would say anything the convulsions would get stronger. At 1506 EMS administered 5mg of versed, which did not bring the patient out of the seizure. The patient was seizing for 24 min at this point and was still breathing, but the thought was in case it is not a pseudo-seizure.   At 1509 the patient?s sister arrived and had explained that this happens in the past and she is able to be talked out of her seizure.  Her sister describes them as ?behavioral seizures? At 1515 the patient came too and was alert and oriented.  Around 1525 the patient was taken to Hospital with EMS. EMS staff that transported the patient. The patient and sister were agreeable to the plan as the event lasted 33 minutes. It is unclear if the vaccine caused this seizure or if it was provoked by anxiety and stimulation. It was recommended to consult their provider on receiving a second dose.
This spontaneous report was received from a pharmacist refers to a patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with first dose of VARIVAX (Merck) at age of 1 year old (indication and lot # not reported), 0.5 ml, subcutaneous. On an unknown date the patient was vaccinated with second dose of VARIVAX (Merck) at age of 17 years old (indication and lot # not reported), 0.5 ml, subcutaneous. No adverse effect reported. Additional information has been requested.
I had coughing, chills, fever, SOB, headache, cognitive, running noise, nose smell, and tried. I had a phone visit with my doctor and did a Covid-19 test, which was positive. I also went to the ER. They did a chest x-ray, which showed promontory vasal congestive with slightly enlarged heart.
died a few months after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 16-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died a few months after getting the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Consumer called to find out the status of the safety effects she reported 13 months ago after getting the Pfizer BioNTech Covid-19 Vaccine and asked why no one was able to follow up on her. Consumer stated that she had called pfizer's (option 1) and was referred to Pfizer to inquire about the adverse event status she had reported 13 months ago. consumer stated that she experienced 30 hours after she got the second dose of the Pfizer BioNtech Covid-19 vaccine on 13Apr2021. Consumer also stated that she had to be put on a walker/wheelchair because of the side effect and stated that she was previously active and doing "ms 150 backride" prior to getting the vaccine. Consumer also stated that she was connected with 2 other people who got the same lot number of the vaccine, one was a 16 year old who died a few months after getting the vaccine (still connected with the father) and the other one was a mother who had "intravenous globular syndrome. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died a few months after getting the vaccine
Information has been received from a RN concerning a 4 year old female who on 01/18/2005 was vaccinated with a dose of varicella virus vaccine live. On 01/20/05 the pt developed a significant localized rxn characterized by red, raised lesions. Unspecified medical attention was sought. The pt was treated with Zithromax and her significant localized rxn improved. AT the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
bumped up blood pressure; Swelling around her eyes; Fatigue; This is a spontaneous report from a Pfizer-sponsored program. A Non-contactable nurse reported for the patient. A 86-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter is a nurse calling about her mother. Asking if there have been reports of elevated blood pressures following administration of the covid vaccine, Patient had her first covid vaccine 8 days ago and experienced swelling around her eyes, a bumped-up blood pressure and fatigue. Caller reports that her mother normally has a and it systolic b/p of 120/130 went up to 180 with activity and walking the other day. She questioned if elevated blood pressures were reported during the clinical trials and if it will be worse with the second dose. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with LIQUID PEDVAXHIB, lot number L035878, expiration date 11-AUG-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as LIQUID PEDVAXHIB were administered to an unspecified number of unspecified patients following a temperature excursion that was originally reported on 21-MAR-2016. The temperature was 62 F for 2 hours and 12 minutes. No adverse event was reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pt given shot on 4-26-10. On 4-28-10, pt developed warm, red patch on (R) thigh.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; BUPROPION; SERTRALINE; HUMALOG; OMEPRAZOLE; METFORMIN. Vaccination history included: Pertussis vaccine, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: Tested positive after being completely negative; (20Sep2022) Positive, notes: Tested positive after being completely negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Has a flush feeling over entire body, then broke out in a sweat.  Felt prickly (pins and needles] in my arms on and off all day.
Vaccine Reaction: Per pt, shortly after receiving the vaccine, she felt like the left side of her throat was swelling, and had some drainage on the left side of her throat. Eyes also red.  Per pt, she does have seasonal allergies and did not take any medication this morning. Pt. A&O x 3, able to converse in clear full sentences, denied difficulty breathing or SOB.   Description of Event: see above   VitalsExpand by Default Vitals:   03/22/21 1208 03/22/21 1212 03/22/21 1217 03/22/21 1240 BP: (!) 159/95 (!) 159/107 125/77 131/82 Pulse: 70 77 60 60 Resp: 18 18 18 18 SpO2: 99% 98% 98% 98%      Intervention: Epi Pen available, but not needed, EMS called due to feeling of "tightness of throat" and back of throat drainage. 25 mg of Benadryl offered. Pt. Declined. Pt. Declined further evaluation at ED. Pt. Stated she had her dog in the car, and no one to contact for her. Pt. Declined any further medical evaluation/intervention AMA.   Observation time: 60 Minute Evaluation   Medications given: None   Response to interventions and/or medication: 12:45 pt. Stated she felt like the swelling in her throat was decreasing and the drainage was also decreasing.    Additional Information: Pt. Instructed to follow up with PCP and given ED precautions.
A 74-year-old female patient received a 0.5 mL pneumovax injection on 17Jul2007. On 18Jul2007, the patient presented to a triage nurse with redness to left upper arm. There was a large irregular area of redness around the injection site. The patient stated that the area was not painful, but the area itched and was warm to touch. The nurse attributed the event to an allergic reaction. The patient had no history of a previous allergic reaction to a pneumovax injection.
weird muscle spasms all over my body; Fever; Diarrhea; Loss of appetite; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (weird muscle spasms all over my body), PYREXIA (Fever), DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and DIZZINESS (lightheaded) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced MUSCLE SPASMS (weird muscle spasms all over my body), PYREXIA (Fever), DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and DIZZINESS (lightheaded). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Jan-2021, PYREXIA (Fever) had not resolved. At the time of the report, MUSCLE SPASMS (weird muscle spasms all over my body), DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite) and DIZZINESS (lightheaded) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 14AUG95 & that same day pt devel a low grade temp of 102, vomiting & possible sz;in f/u a nurse stated pt devel a swollen, sore arm;tx w/med;
Nine months subsequent to receiving one dose of Lymerix, the pt gave birth to an 8lb 6oz boy via C-section. The C-section was not necessitated by an adverse event. There were no complications during the course of her pregnancy and the baby was normal at birth. The most recent information reports the condition of the pt as resolved.
Menstrual cycles have been disrupted for every period since the 2nd dose, including longer and heavier periods, and a shortened cycle of 14 days (very typically every 26 days) for the 3rd cycle after 2nd dose.
severe back pain; unable to urinate; may have passed a kidney stone; Bladder infection; This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL3247; expiry date: May2021), via an unspecified route of administration on 26Jan2021 at 12:00 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were both reported as none. The patient did not receive any other vaccines on the same date as the COVID-19 vaccination or within four weeks prior to the vaccination. On 08Feb2021 the patient experienced bladder infection and may have passed a kidney stone; on unspecified dates the patient experienced severe back pain and unable to urinate. The clinical course was reported as follows: "The patient received the first dose of the COVID-19 vaccine two weeks ago. She reported no side effects from the first dose of the vaccine; however, she was currently on an antibiotic for a bladder infection. She was scheduled to get the second dose on 16Feb2021; however, this weekend she developed a bladder infection and was on an antibiotic. She had symptoms on Sunday, and she saw her doctor on Monday. She also may have passed a kidney stone, but she was not certain. She had severe back pain and was unable to urinate." The patient read to not take any shots while taking the antibiotic. She would be off of the shot (as reported) for four days when she would get the next dose of the vaccine. The patient wanted to know "how many days would she need to be off of the antibiotic before she could get the next dose?" She stated that she would stop taking the antibiotic if she had to. She took one dose of the antibiotic on Monday and two doses today. The patient also inquired whether the side effects were different after the 2nd dose of the vaccine and how long she had to be off her antibiotics before getting her second dose of the COVID vaccine. The patient was taking sulfamethazole-TMP DS as treatment for the bladder infection since 08Feb2021. The patient sought care at the physician's office for the event bladder infection. Relevant tests were reported as none. The clinical outcome of the event bladder infection was recovering/resolving; the clinical outcomes of the events may have passed a kidney stone, severe back pain and unable to urinate were all unknown.
Subsequent to receiving one dose of varicella virus vaccine live, the pts parents noticed his movements were unstable. The physician did not examine him because the symptoms were not striking.
Pt became nauseous on 7/17/07, injection site became red, hot, sore. Pt took Benadryl r/d at office given Keflex, warm compresses 7/23 doing much better.
Patient started experiencing right arm pain, difficulty moving arm, intermittent paresthesias in right arm et hand, faint bruising to posterior aspect of right upper arm the evening after the injections were administered.
Patient received his second dose of the moderna vaccine 3/30, and then at 5:30 pm the same day suffered vision loss in left eye. 62YM with history of carotid art stenosis who reports he was at a bar drinking beer with some friends, when he noted decreased vision in his left eye, like a graying out of his vision.  It was painless.  Went home and it did not improve so he came to the ER.  Loss of vision occurred around 5:30 PM 3/30.  He was evaluated in the ER by ophthalmology, who performed a dilated eye exam and diagnosed the patient with an acute central retinal artery occlusion, and performed an anterior chamber paracentesis to relieve pressure.  Patient had improvement in his vision over the next 24-48 hours, but has remaining deficits.
Ten minutes following her first flu shot, patient returned complaining of pain in her chest and feeling hot and nauseous. We called 911 while observing her and questioning about medical history, etc. Paramedics arrived in 15 minutes and confirmed hives on her spine and administered diphenhydramine and took her for observation.
Pt. became flushed, reporting she felt hot, then had 1 episode of emesis. Provided cool rag and water, nausea subsided after about 15 minutes.
Bright red rash 3 x 7 cm at injection site that lasted more than 4 weeks. No vesicle, or bulla. Non tender. No Rx - This was at ZOSTAVAX site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 at 10:00 as dose 1, single (Lot number: EN6202), in left arm and on 25Mar2021 at 10:00 as dose 2, single (Lot number: EN62555) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "polycystic liver disease" (unspecified if ongoing); "known Allergy: Strawberries" (unspecified if ongoing); "known Allergy: melons" (unspecified if ongoing); "known Allergy:Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  No follow-up attempts are possible. No further information is expected.
By 8:30pm, low grade fever, lower back pain, chills, couldn't get hands warm, very tired, heavy legs. No sore arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 14:00 as dose 6 (booster), single (Lot number: GJ6665) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Jun2022 at 13:00 as dose 5 (booster), single (Lot number: FK9727), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "asthma" (unspecified if ongoing); "murmur" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "stress incontinence" (unspecified if ongoing); "hypercholesterol" (unspecified if ongoing). Concomitant medication(s) included: MYRBETRIQ, start date: 01Jan2019, stop date: 07Apr2023; LEVOTHYROXINE, start date: 01Jan2019, stop date: 07Apr2023; CRESTOR, start date: 01Jan2019, stop date: 07Apr2023; CO Q10, start date: 01Jan2019, stop date: 07Apr2023; CALCIUM, start date: 01Jan2019, stop date: 07Apr2023; VITAMIN D2, start date: 01Jan2019, stop date: 07Apr2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from 07Apr2023 to 12Apr2023.
Blisters all over her neck, throat, upper arm, and chest; Blisters all over her neck, throat, upper arm, and chest; Rash that turned into welts; Red on neck; Uncomfortable on neck; Swelling on neck; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, High cholesterol and COPD.    On 02-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest) (seriousness criterion medically significant), BLISTER (Blisters all over her neck, throat, upper arm, and chest), URTICARIA (Rash that turned into welts), ERYTHEMA (Red on neck), MUSCULOSKELETAL DISCOMFORT (Uncomfortable on neck) and SWELLING (Swelling on neck). At the time of the report, OROPHARYNGEAL BLISTERING (Blisters all over her neck, throat, upper arm, and chest), BLISTER (Blisters all over her neck, throat, upper arm, and chest), URTICARIA (Rash that turned into welts), ERYTHEMA (Red on neck) and MUSCULOSKELETAL DISCOMFORT (Uncomfortable on neck) had not resolved and SWELLING (Swelling on neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. Treatment information was not provided.  This case concerns a 68 Y/O F with a serious unexpected event of oropharyngeal blistering along with nonserious unexpected events of urticaria, blisters, erythema, swelling and musculoskeletal discomfort. Event onset the same day as first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 68 Y/O F with a serious unexpected event of oropharyngeal blistering along with nonserious unexpected events of urticaria, blisters, erythema, swelling and musculoskeletal discomfort. Event onset the same day as first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Covid arm.  Red blotch at injection site, itch at injection site, warmth at injection site.  Not planning on any treatment as it is not bothersome.  Event in progress.
This spontaneous report as received from a 75 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had drug allergies to cortisone/prednisone. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) subcutaneously on 14-AUG-2012. Concomitant medications included: blood pressure, thyroid, cholesterol pills and vitamin D. It was reported that after having the vaccine the patient developed a burning sensation around her shoulders and back of her neck on 15-AUG-2012. The patient sought for medical attention via an ER visit. And the sensation was diagnosed as shingles. BENADRYL was given as treatment. Unspecified blood work tests were performed, no results provided. It was reported that the adverse event came and went. The outcome was reported as not recovered. Additional information has been requested.
Redness and erythema to left thigh starting 24 hours after shot and continued to progress. Warmth and fever. Tx with Abx oral steroid on going treatment.
Hard knot, red area expanding on arm and started itching within half an hour of the shot.  An area of small hives has also appeared.
Anthrax injection given 3-26-07 into L deltoid. 2 days later site with large area of erythema, warmth. Mild fever, L shoulder joint soreness and stiffness and L trapezius strain/tension by evening of 3-27-07.
No adverse reaction during first 30 minutes. Adult Pfizer (12+yrs) dose given in error. Patient should have received the Pediatric (under 12yr) dose.