chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in left arm on 06Feb2021 at 14:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, hypertension, known allergies: Food allergies (known allergies: Banana, kiwi), known allergies: Histamine reaction. Concomitant medications included levothyroxine, cetirizine hydrochloride (CETRIZINE), ergocalciferol (VITAMIN D), iodine (KELP), metopro; All drugs were received in two weeks within the vaccination. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that, the patient experienced itchy rash all over body, 2 days after vaccination small pustules, strange tingles on 08Feb2021 at 16:00. No fever. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with IV fluids and medications. The outcome of the events was recovering.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.49   Concomitant products were not provided. On 07-jan-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 34 respectively. Total doses given for the day was 96 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM and 10AM vaccine was moved to fridge on 05-Jan-2021 and. Vial was moved to clinic on 07-jan-2021. 6 vials from 9 AM and 10 AM were sent to clinic. Vaccine BUD date was 27-jan-2021 for 9AM,10 AM respectively. On 07-jan-202 no hourly temperature recordings available The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt recvd 3 doses of Engerix-B & exp a neg titer result p/3rd dose;
light rash on top of my feet and across my stomach/ rash on top of her elbow, feet, and stomach; petechiae; red bumps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 15:00 (Lot number: FC3184) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Past drug history included: Sulfa drugs, reaction(s): "known allergies : Sulfa drugs". The following information was reported: RASH (non-serious) with onset 04Sep2021 05:00, outcome "not recovered", described as "light rash on top of my feet and across my stomach/ rash on top of her elbow, feet, and stomach"; PETECHIAE (non-serious) with onset 2021, outcome "unknown", described as "petechiae"; RASH PAPULAR (non-serious) with onset 2021, outcome "unknown", described as "red bumps". Therapeutic measures were not taken as a result of rash. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts are possible. No further information is expected.
Low grade fever, started crying 1 hrs p/immun lasted x 8 hrs shrill & high pitched;
This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy (pregnant female received Moderna COVID-19 vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030B21A) for COVID-19 immunization. No medical history reported. On Apr 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. The patient's last menstrual period was on Aug 27, 2020 and the estimated date of delivery was Jun 3, 2021. On Apr 8, 2021, patient experienced maternal exposure during pregnancy (pregnant female received Moderna COVID-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 vaccine) beginning around the thirty-second week of the pregnancy. On Apr 8, 2021, maternal exposure during pregnancy (pregnant female received Moderna COVID-19 vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
6 days post shot, my arm had a shooting pain from the injection site down my arm and into my wrist.  The pain did not subside and the next morning a large rash and bump appeared at the injection site and across my arm. The shooting pain is not constant any longer (9 days post shot) but does occur from time to time. The pain now is more of a throbbing in the area of the rash. The rash is traveling, as is the large bump. It is now moved down my arm and into my elbow region.
Sore at site of injection, left arm.  became sleepy.  severe aches in legs and arms and feet.  chills and sweats.  very thirsty. sore head. diarrhea
90 min p/recv vax pt c/o pain at inject site; 30 min later had odd taste in mouth for 1hr; other sx exp p/inject include h/a, lethargy, arm had swollen size of orange, black & blue; limited rom
Reddened, swollen, tender "welt" to (L) posterior upper arm mother reports approximately the size of an orange. Reports no improvement yet at this time.
pt recv vax & devel a rash @ the inj site which spread down the lt arm; pt was treated w/DPH & rash partially resolved but some of the rash persisted on 10JUN94;
Patient stated that she has gotten flu 4 times since her vaccination. She says it comes and goes every 4 weeks. Patient has not visited a doctor about Adverse Reaction.
Pt. developed cellulitis at IZ site and was treated the following day with an antibiotic, Motrin and antihistamines.
Parent notified health department staff at approximately 1:30 PM on 3/8/00 same day as vax, the child had a complaint of chest discomfort and wheezing. At 4:00 PM same day, the nurse called and was advised that the mother did not call 911.
body shaking; trouble breathing; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 90 years old female patient who experienced body shaking (tremor) and trouble breathing (dyspnea), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2019, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ251AB via unknown route in the arm nos.  On an unknown date, The patient developed a non-serious body shaking (tremor) and trouble breathing (dyspnea) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab test reported.  Final diagnosis was trouble breathing and body shaking.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for body shaking and as Unknown for trouble breathing.
After a few days very fatigue, went to get a sleep study and doctor said he needed a sleep pap machine The sleep study was completed on 4/20/21. Also had shortness of breath on  after shot called pcp on 4/23/21  and told him to go to the ER. Went to ER pulse rate was high and showed signs of a heart attack. Stayed over night got a echocardiogram and he passed out as he was trying to walk on 4/24/21. 4/25 echocardiogram turned out good. 4/26 found blockage in heart and was told he needed bypass surgery.  He had surgery 4/28/21 during heart surgery they did and ultrasound on the artery between the lungs and he had a 4 inch saddle embolism which they removed and continued with the heart surgery. All his problems was actually caused by the embolism.
The morning following the injection, patient was incredibly fatigued, dizzy and nauseated. She also had chills/sweats. States she slept for over 12 hours just after waking for the day. Dizziness and fatigue lasted just under 48 hours post injection.
Noticed hives Tonight at around 9pm, It is on upper left arm, Top part of back shoulder, and around to upper left chest area. Have had tightness of of chest muscle going to bottom of front left side of neck along with normal achyness around upper left arm.
Bleeding from her gums; Felt she has gingivitis; Dizziness; Shortness of breath; Heart racing; Rash on injection site; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLEEDING (Bleeding from her gums), GINGIVITIS (Felt she has gingivitis), DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath) and PALPITATIONS (Heart racing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Asthma. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart racing), VACCINATION SITE RASH (Rash on injection site) and NAUSEA (Nauseous). On 25-Mar-2021, the patient experienced GINGIVAL BLEEDING (Bleeding from her gums) and GINGIVITIS (Felt she has gingivitis). The patient was treated with PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) at an unspecified dose and frequency. On 24-Mar-2021, DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart racing) and NAUSEA (Nauseous) had resolved. At the time of the report, GINGIVAL BLEEDING (Bleeding from her gums), GINGIVITIS (Felt she has gingivitis) and VACCINATION SITE RASH (Rash on injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Fever reaching as high as 39C, aching, weakness, occasional coughing. Fever was gone by 11/12, took a whole week to regain normal energy level. I did not even have a significant cold in the prior 6 months.
NERVE STUDY SHOWS DAMAGE; HYPERSENSITIVITY ON RIGHT SIDE; STROKE; This spontaneous report received from a consumer via social media through a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date (a couple weeks after vaccination), the patient experienced hypersensitivity on right side. Patient wears a fleece jacket all the time because the air irritates his arm. On an unspecified date, the patient underwent nerve study Laboratory data included: nerve study which shows damage but doctors did not say that it was from the shot. On 02-JAN-2022, the patient experienced stroke and got into the emergency room (ER) in time to prevent permanent damage. Patient was on blood thinner for the rest of his life. Patient will be having magnetic resonance imaging (MRI) in a couple of weeks to check for multiple sclerosis (side effect of J and J). The patient visited to physician office and emergency room. Reporter stated that, "My husband started having hypersensitivity on his right side a couple weeks after his J and J. He wears a fleece jacket all the time because the air irritates his arm. Nerve study shows damage but doctors won't say it's from the shot but I sure will. He is having an MRI in a couple of weeks to check for Multiple Sclerosis (side effect of J and J). Then he had a stroke on Jan. 2. Got to the ER in time to prevent permanent damage that time, but is on blood thinner for the rest of his life". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hypersensitivity on right side, stroke and nerve study shows damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220627822-covid-19 vaccine ad26.cov2.s-Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
This spontaneous report was received from a physician and refers to a 35 year old female patient. The patient's concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with a one dose of GARDASIL 9 (concentration, route of administration, lot # and expiry date were not reported). No adverse effects was reported.
Covid19 breakthrough.  1st Vaccine received on 09/02/2021.  Pt presented to the ER with c/o excessive thirst and urination and feeling like his blood sugars are uncontrolled.  Pt has not been taking his diabetic medications due to lack of insurance.  Pt had a positive Covid test at MD office.
Patient reported double vision, then loss of field of vision which lasted 8-10 hours. Event started within 12 hours of vaccine administration. Vision returned to normal following episode.
No adverse reaction to the vaccine. The vaccine is administered, after the deadline of 1/April/2022. Vaccine is not expired.
Booster shot hives burning and itching across my entire body, same as the Covid arm i got with my second shot. More wide spread
In May of 2022, I started to have a dry cough that was nonproductive. I made an appointment with my doctor, to discuss my symptoms. He gave me a prescription of benzonatate to help with the cough. The coughing continued off and on throughout 2022 until I started having shortness of breath in January of 2023. I went back to the doctor to have x-rays of my back. The doctor noticed that spot from 2021 was now bigger. He ordered a CAT scan, that I had in April of 2023 that showed that I had cylindrical bronchiectasis, collapsed lower right lobe. My doctor has referred my me to a pulmonologist.
Pt had told us she had issues of passing out (not related to vaccines) and when vaccine was given, she said she could not hear and passed out.  She stated she normally cannot hear right before she passes out.  Pt came back around and her blood pressure was taken, it was elevated and we monitored her for about 30 minutes.  Her blood pressure was taken again and still elevated (150/95).  Pt was advised to keep an  eye on her blood pressure and call dr or go to urgent care if it doesn't go back down.  She said she would.
Over a month after 2nd booster, the injection site spontaneously began to ache deeply (like I had just been given another shot) and proceeded to ache for the next 12-15 hours. Took 2 Tylenol and used an ice pack. Did not ease symptoms.    Arm pain re-occurred 48 hours later and lasted approximately 4-6 hours. Did not take further medicines or seek professional treatment.  Previous to the arm pain incident, have had occasional heart palpitations (racing heartbeat, heavy heartbeat, even when at rest)  since 4/1/22. Visited health care clinics (3/28; 4/13) and ER (3/28) for irregular heartbeat testing and monitoring, bloodwork, and x-rays.
Report A0374185A describes jaundice in a 27 year old female who received hepatitis B vaccine recombinant. This report was received from the vaccinee's employer. The medical history included allergy to codeine. Concurrent medications included unspecified birth control pills. The vaccinee had no reported adverse experiences following receipt of prior immunizations. On 07/01/02, the vaccinee received her first injection of Engerix B. On 07/05/02, she experienced jaundice, fatigue, nausea, headache, and a pruritic rash. She was seen by a physician, who noted elevated concentration of unspecified liver enzyme. Treatment was not specified. The headache and nausea resolved on 07/08/02. The jaundice, elevated concentrations of liver enzymes, pruritic rash and fatigue persisted as of 07/15/02. Jaundice is considered medically serious. The follow up states the occurrence of an allergic reaction. The medical history also included tobacco use and "rare" alcohol use. On that same day, 7/1/02, she experienced elevated concentration of bilirubin, aspartate aminotransferase, and alanine aminotransferase. An abdominal ultrasound was negative. A diagnosis of allergic reaction to Engerix B was made. The Engerix B series was discontinued. The subject was referred to an infectious disease specialist. The most recent info received on 9/17/02 did not provide the outcome of the remaining events.
Headache, Myalgia, Arthralgia, Fever, fatigue, night sweats, throbbing pain at the injection site. Narrative:
Shock-associated circulatory or cardiac conditions; cardiac conditions, Unexpected death; Found pulseless; Ear infection; This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis and TOZINAMERAN (PFIZER CORONAVIRUS VACCINE) for prophylaxis.   On 16th September 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, PREVNAR 13, ROTATEQ and PFIZER CORONAVIRUS VACCINE. In September 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced ear infection (serious criteria death). On 26th September 2022, the patient experienced shock (serious criteria death and GSK medically significant), heart disorder (serious criteria death and GSK medically significant) and pulseless (serious criteria death). On an unknown date, the outcome of the shock, heart disorder, ear infection and pulseless were fatal. The patient died on 26th September 2022. The reported cause of death was shock, heart disorder, pulseless and ear infection.   It was unknown if the reporter considered the shock, heart disorder, ear infection and pulseless to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported that baby (patient) dies suddenly from cardiac conditions 10 days after receiving 4 vaccines.  The patient received Pediarix, FluLaval Seasonal Quadrivalent Influenza, Prevnar13, Rotateq, Pfizer coronavirus vaccine on 16th September 2022 and the baby experienced shock associated circulatory or cardiac conditions. It was an unexpected death, the patient was taking a nap in the afternoon and found pulseless in a crib and died on the 26th September 2022. The baby had an ear infection at the time. It was unknown if the reporter considered the shock, heart disorder, pulseless and ear infection to be related to Prevnar13, Rotateq, Pfizer coronavirus vaccine. Additional Supportive Information: As it was not clear if the patient had ear infection at the time of vaccination or death, hence conservatively captured as event.; Reported Cause(s) of Death: Shock; Heart disorder; Pulseless; Ear infection
Pt received 2nd dose of Moderna one week early. She was contacted and indicated she was given 2nd dose date as 4/16/21 (should have been 4/23/21) when she was initially scheduled. No adverse reaction per patient. Per CDC, no repeat dose indicated. Pt notified of this - denied side effects from vaccine.