chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable Physician received via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 32-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 15Apr2021 (at 32 years old, not pregnant) (Batch/Lot Number: EW0153) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included TRI-SPRINTEC. The patient experienced suspected myocarditis or pericarditis, chest pain all on 20Apr2021 with outcome of not recovered. Treatment given for all events was colchicine. No covid prior vaccination. Not covid tested post vaccination.  No follow-up attempts are needed. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events myocarditis and pericarditis and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
pt recv vax & now presents in hosp ER w/red area over inj site; area swollen & warm to touch; also c/o pain in arm that shoots across back & chest; also states has h/a, runny nose & watery eyes;
Bodyaches and fatigue, one bump under the skin at site of injection, warmth and redness 1-2 inches around site of injection.  Advised patient to take an antihistamine and to monitor if it gets worst and to let us know if it does get worst. We have not heard from patient since first day of informing us. Tried to call patient back to follow up today (6/27/23) but no answer.
Red spot on injection site 9 days after vaccine.faded by day 7 but still seen in shower.
Date of Admission: 5/23/2023  Discharge Date: 05/27/2023 Discharge Disposition:  Home with home healthcare patient was asymptomatic not requiring oxygen the treatment was all supportive care   5/23/23 COVID+  039K20A  2/15/2021 030A21A 3/15/2021 041J21A  12/17/2021
9/12/21 6:00am vomiting began                     7:30am diarrhea began                     7:30am severe exhaustion began  Slept through the night 9/11/21-9/12/21. Napped from 10:00am to 1:00pm. Then again napped 3:00pm to 6:00pm.                      6:00pm headache began   Slept again through the night.   Severe fatigue and headache continued through 09/13/21
Tinnitus of right ear and hearing loss after waking  up about 2 days after the shot. Tinnitus became permanent every second 24/7 on right ear. As days and weeks went by, tinnitus of left ear developed as well and the right ear's hearing loss became severe. Saw ENT doctors and both diagnosed tinnitus and hearing loss after audiology hearing tests. Prescribed 2 weeks of Prednisone tablets, but no effect. Till this day (today is 4/4/2022), hearing loss and tinnitus remains with no improvement at all based on the follow up audiology tests. MRI scan performed and ruled out tumors or cancer.
My right lymph node in my arm pit became extremely swollen and sore to the point that I could not sleep.
8 days after vaccine, had increased pain, slightly swollen arm with big red rash. A little itchy.  Less red today.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 17-OCT-2013, the patient was vaccinated inadvertently with an expired dose of 0.5ml PNEUMOVAX23, (lot number 1477AA, expiry date 14-MAY-2013). No adverse effects reported. Additional information has been requested.
Patient is 34 yo female s/p full COVID-19 Pfizer vaccination: dose 1 on 1/19 and dose 2 on 2/9. Patient is an employee of this institution with new loss of taste/smell and congestion/runny nose. Denies known exposure to COVID-19. PCR test results positive on 7/28.
pt recv vax 25JUN96 & pt color pale, nonresponsive, eyes rolled back & to upper rt, jerking in rt upper extremities, sl diaphoretic, face became red;pt not responding to stimulation, ammonia inhalant used;BP 114/60, P50, resp 20;
Vital signs upon presentation were: T-98.1, BP-120/80, HR-93, Sat-98%, Ht:5'4", Lbs, 324.  Pt reports noticing her right upper arm had a small red itchy rash while at the movies around midnight after recieving the Varivax vaccine. Physical exam noted a 50 x 50 mm induration, erythema, edema, pruritic area. She was treated with Depo-Medrol 80 mg IM, Clobetasol topical ointment BID x and Fexofenadine PO daily. Pt instructed to return to clinic in 24 hours if the rash got worse. She denied, fever, chills, difficulties breathing, swelling of mouth, tongue or any other allergic symptoms when asked.
30 minutes after vaccines reported achiness/pain of hip and lower extremities, processed 10/1, requiring help to get in and out of car, also reported headache 10/5 felt 75% better 10/13 initial call, 100% better
After receiving the 2nd dose of the Pfizer vaccine for work, I started approximately 1 month later with Atrial Fibrillation in February of 2021 then again in the end of February beginning of March of 2021 and then again April 2021, Then again October of 2021 again in in December of 2021 again in February of 2022 and just recently March 7th of 2022. I've had Atrial Fibrillation a total of 7 times since receiving the Pfizer vaccine 1st dose in December of 2020 and the 2nd dose in January of 2021. I am now looking to receive an Ablation to hopefully stop this. All they do is keep adding medication after medication. I'm very tired of going to bed and wondering if I'm going to wake up to Atrial Fibrillation again in the middle of the night or have panic attacks while working due to side effects of medications being prescribed for something that I did not have prior to the Pfizer ovid-19 vaccination.
Patient stated that she had throat tightness and dizziness with in 15 minutes of receiving the vaccine.  She report this to me on 03/04/2021.  She stated that the sensation lasted about 1hour and 30minutes.  She did not seek medical attention.
This spontaneous report was received from a health care worker referring to a 11 year old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 08-SEP-2015, the patient was vaccinated with unspecified improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017), (routes, doses and anatomical sites of vaccination were not provided). It was reported that the temperature of excursion were the following: 53.6 F for 392 hours, 58.5 F for 465 hours and 46.2 F for 15 hours, respectively. The outcome of excursion was not supported. Co-suspect therapies or concomitant medications were not provided. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
FEVER (99.4 TAKEN WITH TEMPORAL THERMOMETER WHICH IS USUALLY AN UNDERESTIMATE BY ONE DEGREE) WITHIN 12 HOURS OF THE VACCINE.
Patient appeared well and responded when spoken to after vaccines were given. Stickers were given to the pt and the pt's sibling. Reviewed the immunization record and VIS with parent. I directed them to the front lobby. A code blue for the second floor lobby was called over the intercom minutes later. I reponded along with several other employees/nurses. I saw that the code was called for this pt. When I arrived to the scene. Security was supporting the pt's head on the floor, and the mother was at the pt's feet with the pt's sibling. The mother reported that the pt told her he felt dizzy, and then he began to fall. She stated that she was able to catch him and lower him to the ground. RNs had arrived at the scene with the crash cart and glucometer. RN was checking the pt's pulse. RN checked the pt's blood suger level as well as respirations. The pt was alert and responded when spoken to. His face and lips appeared to be pale. Pt took small sips of water. I got an ice pack for his head. Pt appeared to be slightly sweaty. We stood there for several minutes. After his color came back and he stated that he was feeling better, he was assisted to a wheel chair. He was taken back to one of the clinic rooms to be monitored by myself. The pt was given more water and some crackers. After monitoring for several more minutes, the pt reported that he felt well. He stated that he felt completely normal and denied dizziness. I assisted him to stand up slowly. RN and myself walked with the pt down the hallway, in the elvator, and to the car. Pt stated that he still felt well. Mother was instructed to follow up with the pt's PCP and to inform him of this situation and the vaccines given today. Mother was also advised to call EMS or go to the emergency department if she notices anything out of the ordinary. Parent verbalized understanding.
TIA; his memory became affected; confused; he words were jumble up on the TV and when reading the newspaper; This is a spontaneous report received from a contactable consumer from Medical information team.  A 73 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "his memory became affected"; CONFUSIONAL STATE (non-serious), outcome "unknown", described as "confused"; EYE DISORDER (non-serious), outcome "unknown", described as "he words were jumble up on the TV and when reading the newspaper". The patient had a TIA but he felt a little confused after his second Pfizer Covid Vaccination (purple label) and by the next day he told her the words were jumble up on the TV and when reading the newspaper. The patient got his first Pfizer COVID-19 vaccination and everything was fine. The patient felt confused as he was going in the drive thru to get his second dose. When the patient took the vaccine, by the time he was home he told the caller that when he was looking at words on the TV the letters were jumbled. This lasted for several days, 2-3 days or whatever. Long term the patient's memory had been effected. The patient has never had a problem with his memory or remembering names or anything prior to this. Did the patient have a TIA? The patient never reported this event to Pfizer because it was ambiguous as to if this was caused by the product or not. This event could have been a TIA, the patient is 73 years old. The patient has never had one before with this kind of effect. The patient continues to have memory problems but the thing with the letters is okay. The letters looked jumbled up if the patient was trying to read something.  The lot number for bnt162b2 was not provided and will be requested during follow up.
had the people that got sick after they got the shot, it may not be the flu but it is a response to the garbage they make it with, i never got sick unless i took the shot, i haven't gotten sick in over ten years and i haven't taken the shot; Initial information received on 14-Nov-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via Social Media.  This case involved an unknown age patient who reported that had the people that got sick after they got the shot, it may not be the flu but it is a response to the garbage they make it with, i never got sick unless i took the shot, i haven't gotten sick in over ten years and i haven't taken the shot (Illness), after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient has not had a cold or flu since patient stopped taking the flu shot (Nasopharyngitis).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of nasopharyngitis was reported as resolving at the time of reporting.  There will be no information available on the batch number for this case.
4" X 5" induration and swelling area over anterior triceps. Patient reports much less pain today, able to flex/extend at elbow with no discomfort. Distal neurosensory/neurovascular intact Left arm.  No evidence for any necrosis. Intact, equivalent strength biceps/triceps compared to Right arm.
Three days after the shot he started vomiting, had diarrhea, and had fever. The fever lasted for one day and the vomiting and diarrhea lasted for seven days.He was takened back to the doctor three days after the shot and treatment was a BRAT diet. Bananas, rice, and toast. Child was takened back to the doctor on 5/5/08 and treatment was the same. Child was brought back in for weight check on 5/7/08 and a stool test was sent off around that date. It later came back negative for bacteria. After the 7th day of illness, the diarrhea stopped. Around 11 days after vaccination, child broke out in a rash. Child was brought back to the doctor who confirmed it was the measles.
patient was administered with Tenivac instead of Adacel, no AE.; Initial information received on 27-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 26 years old female patient who was vaccinated with 0.5 ml of vaccine Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] (lot number U6265AA and expiration date 19-April-2021) via intramuscular route in the left deltoid instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] (lot number and expiration date unknown) via unknown route in unknown administration site on 26-Dec-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong product administered.  No adverse event reported at the time of reporting.  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 and Module VI of the 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.
Very sore right arm; large lump in right armpit; This is a spontaneous report from a contactable other healthcare professional (HCP reported for self). A 47-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3246, expiry date not reported), via an unspecified route of administration on 19Jan2021 at a single dose in the right arm for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. The patient had no COVID prior to vaccination. Concomitant medications included vitamins nos (DAILY VITAMINS), and atorvastatin; both reported as other medications in two weeks.  The patient received the first dose of BNT162B2 (brand: Pfizer, Lot: EK 9231, expiry date not reported), on 29Dec2020 at 08:00 PM in the left arm. The patient had no other vaccine in four weeks. On 21Jan2021 11:00 AM, the patient had very sore right arm after shot; and large lump in right armpit formed about 20 hours after 2nd dose (20Jan2021). The events were reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatments were received in related to the reported events. The patient was not tested for COVID post vaccination. The outcome of the events very sore right arm and large lump in right armpit was not recovered.
possibly got COVID after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (possibly got COVID after vaccination) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (possibly got COVID after vaccination). At the time of the report, COVID-19 (possibly got COVID after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported  Treatment information was not reported
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, when the vaccine received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the correct expiry date for lot was 01-Apr-2022.  The vial was initially stored in refrigerator on 04-Apr-2022 and the vial did not underwent any temperature excursions.  No treatment information was reported.
mom reports eyes rolled back & not responding to voice, then jerking motions; took to hosp ER-t102.7 dx w/OM;
Lot # given to patient was discovered to be associated with last years flu vaccine (2020-2021). No other ADRs have been reported with situation.
This spontaneous report was received from a physician referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (lot # reported as N044022, exp date: 01-MAY-2018, which was not valid) for prophylaxis, following a temperature excursion of 40 F for 21 days. There was no pervious temperature excursion. Data logger was involved.
Patient reported to health unit on 7/31/08 with complaint of redness and pain on both upper arms since vaccines received on 7/29/08.  Right upper arm appeared red and swollen approximately palm size and left upper arm red and swollen approximately quarter size.  Patient was instructed to contact doctor concerning reaction or to go to the nearest ER for complaint of SOB, increased pain or as needed.
Information has been received from a male consumer who on 06-JAN-2008 was vaccinated with 0.65 ml of Zostavax (Oka/Merck).  On 06-JAN-2008 the patient developed redness and swelling at the injection site.  At the time of reporting the patient had not yet recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with VAQTA (dose, route and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
17 year old daughter administered a dose of the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna) in a 17-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 an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter administered a dose of the Moderna) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  No treatment medications were provided
About 20 hours after second dose, I had a fever (4 degrees higher than normal), aching joints and a very sore arm.  The fever and aches cleared by 36 hours after the injection.
Horrific pain behind my right eye; Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Horrific pain behind my right eye), CONDITION AGGRAVATED (Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EYE PAIN (Horrific pain behind my right eye), CONDITION AGGRAVATED (Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse) and HEADACHE (Headaches). At the time of the report, EYE PAIN (Horrific pain behind my right eye), CONDITION AGGRAVATED (Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patients medical history, concurrent condition and concomitant medication were unknown. In 2008, the patient was vaccinated with the first dose of VAQTA (dose and route unknown). On 28-OCT-2016, the patient mistakenly received a dose of TWINRIX (dose and route unknown) as the 2nd dose  in the Hepatitis A series, this was outside the recommendations per the VAQTA prescribing information. No adverse effects were reported. Additional information has been requested.