chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PRODUCT STORED AT ROOM TEMPERATURE FOR 6 HOURS; VACCINE ADMINISTERED FROM VIAL STORED AT ROOM TEMPERATURE FOR 6 HOURS; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 05-MAY-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced product stored at room temperature for 6 hours. On 12-APR-2021, the subject experienced vaccine administered from stored at room temperature for 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product stored at room temperature for 6 hours and vaccine administered from stored at room temperature for 6 hours was not reported. This report was non-serious.
No additional AE/PQC reported at time of call; a labeled expiry of 5/12/2022 was administered to a patient on 5/13/2022.; This spontaneous report has been received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 13-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 mL, lot # T016352, expiration date 12-MAY-2022 (route of administration and anatomical location were not provided) as prophylaxis (expired product administered). There was no report of temperature excursions. No additional events were reported (no adverse event).
Patient stated that she was vomiting, having severe abdominal pain, dizziness, sweating, and chest pain.
no adverse reactions noted; 7yo male was given MMRV; This spontaneous report was received from a healthcare provider via Pfizer on 30-DEC-2021 concerning a 7-year-old male patient. No concurrent condition or medical history was reported. Concomitant therapies included hepatitis b vaccine (recombinant) (manufacturer unknown), covid-19 vaccine, polio vaccine and influenza vaccine (FLU).   On 16-DEC-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, and route were unknown; recombinant Human albumin; lot # U026799 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 26-FEB-2023) in the left arm for prophylaxis (product administered to patient of inappropriate age). The patient was observed for 30min and no adverse reactions noted.
Information has been received from a nurse concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown) injection. Immediately following the injection the patient experienced nausea and vomiting. Medical attention was sought. At the time reporting the patient recovered from the nausea and vomiting shortly afterwards. No additional information was provided. Additional information has been requested. This is in nfollow-up to report (s) previously submittedon 8/14/2007. No additional information is available.
I got my second dose of vaccine on Saturday afternoon 4:30pm. I was fine the first day, and started getting low grade fever the whole day on Sunday. I took Tylenol, then I would feel better and just slept it off. On Monday, I had a fever (38C). Again I took Tylenol and felt better. Then followed by low grade fever. Today I woke up fine but now I?m having low grade fever again. I have been feeling very tired, body ache and headache all these days, and I?ve slept most of the time. My lymph near my armpit has been swollen. It hurts even when I don?t touch it.
HAD BODY ACHE; HAD HEADACHE; PULMONARY EMBOLISM IN BOTH LUNGS; SHORTNESS OF BREATH; CHARLIE HORSE IN LEGS IN MIDDLE OF NIGHT; LOWER EXTREMETIES HURTING AND SWELLING; HAD FLU-LIKE SYMTPOMS; TIRED/LETHARGIC; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient was a non alcohol user and non smoker, and he took vitamins.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date progressively 4 days after receiving vaccine the patient had headache and had body ache. On 21-MAR-2021, the patient had flu-like symptoms and felt tired/lethargic. On 24-MAR-2021, the patient had lower extremeties hurting and swelling. On 26-MAR-2021, the patient felt charlie horse in legs in middle of night. On 01-APR-2021, the patient had shortness of breath and he could not catch her breath. At that point patient went to emergency room. In emergency room the patient underwent CT scan and revealed with small clots in lower lobe of both lungs. The patient was treated with 40 mg Eliquis for treatment. The emergency room doctor advised consumer to saw pulmonary specialist and follow up with him primarily. On 15-APR-2021, the patient had pulmonary embolism in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from had flu-like symtpoms, and had not recovered from pulmonary embolism in both lungs, lower extremeties hurting and swelling, shortness of breath, tired/lethargic, charlie horse in legs in middle of night, headache, and body ache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a 49 year old female patient, African American, who experienced pain on lower extremities and was noted to have small clots in the lower lobes 5 days and 13 days, respectively, after receiving the the COVID-19 vaccine ad26.cov2.s. Patient's height and weight were not reported. Patient is a non smoker and non alcoholic beverage drinker. Past medical history not reported and patient denied taking medications, except vitamins. Four (4) days after receiving the vaccine, patient experienced flu like symptoms. lethargy, headache and body ache which were noted to resolve. Five (5) days after receiving the vaccine, patient developed pain on the lower extremities and patient noted to fell charley horse (muscle spasm and pain). Thirteen (13) days after receiving the vaccine, patient experienced shortness of breath, which prompted consult at the emergency room. CT Scan done revealed small clots in the lower lobe of both lungs. Patient was noted to have pulmonary embolism. The temporal relationship may be consistent but there is insufficient evidence for the vaccine to cause the events; hence this is assessed as indeterminate per causality classification of adverse events following immunization. Additional information requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant medications were reported. On 27-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L037356, expiration date 28-SEP-2017, albumin status, dose and route of administration not provided) for prophylaxis. The dose was exposed to a temperature of 67F for 68 hours. Data logger was not involved. There was no prior temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000290.
Patient received bivalent vaccine as a series dose, rather than the monovalent. No adverse events were reported or observed
Fever, diarrhea and body aches about 12 hours after vaccine. Last ~2 days.
101.5 Fever - 24 hours body aches - 24 hours headache - 36 hours fatigue - 36 hours
Sixteen hours after the vaccine, I experienced an itchy feeling on my body.  My forehead was swollen. It lasted for 12 hours.
first had an upset stomach for a little over a week / 8 days, and then she started breaking out in hives. They became progressively worse until we brought her to the ER at  ER about 3 days later on about May 27. At the ER, they administered prednisone and observed her until it was safe to send her home. The ER doctors prescribed prednisone for several days, which she took. The hives did eventually subside.
hasbeen over 10 weeks since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (hasbeen over 10 weeks since the first dose) 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 24-Apr-2021, 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 DOSE OMISSION ISSUE (hasbeen over 10 weeks since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (hasbeen over 10 weeks since the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter. Patient stated that patient did not go to receive the second dose because patient did not have a ride to go to the clinic. Patient declined providing additional details. Patient did not confirmed gender.     Reporter did not allow further contact
sudden hearing loss; severe tinnitus in right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002642.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2022 as dose 2, single (Lot number: EN6205) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 2022, outcome "unknown", described as "severe tinnitus in right ear"; SUDDEN HEARING LOSS (medically significant) with onset 2022, outcome "unknown".  Clinical course: On 17Jul2022, it was reported that a patient started treatment on 12Mar2022 with Pfizer Biontech Covid-19 vaccine dose 2 for an unknown indication. It was reported the patient experienced sudden hearing loss and severe tinnitus in right ear.   No further follow-up is anticipated.
10/29/2021 Patient went to the ED with CC shortness of breath. Patient was 82% on 3L NC. Patient on 6L NC 90%. Patient had tightness in chest and it was difficult to take a deep breath. 10/30/2021 AP: COVID-19 pneumonia/acute hypoxic respiratory failure. On sup O2. 11/2/2021 O2 wean.
Tinnitus, it occurred after the first dose too. It seemed to get better and now after second shot is worse that the first time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 29 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 16Sep2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], start date: 01Aug2020, stop date: 26Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (16Jul2022) Positive, notes: Treatment of COVID-19; (20Jul2022) Positive, notes: Rebound infection after testing negative on day 5; (26Jul2022) Positive, notes: Tested positive with recurrence of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was received other medication in 2weeks of vaccine. Antiviral details included COVID 19 Treatment, Brand was Paxlovid started on 16Jul2022 to 20Jul2022. Other medication in 2weeks product was Prenatal vitamins, One a day started on 01Aug2020 to 26Jul2022. The patient was Covid positive on 16Jul2022. Started paxlovid that morning. Rebound infection after testing negative on day 5. Tested positive with recurrence of symptoms 26Jul2022. No known allergies were reported.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Mom states after receiving flu vaccine on 12-1-10 patient became ill with a cough & runny nose for 1 month and fever for 1 week.
I received the Flu shot on Monday 10/5/20 between 1pm -3pm. ( hospital does not have time). 1 Week later on the dot 10/12/20 @ 1pm, My ears started to ring. My right ear stopped and my left ear continued to ring and has since.  Also my left ear lost hearing. I only have about 4% hearing compared to my right at 96%. I was not sick and had nothing else different in my life other than the Flu shot 1 week prior.   On 10/12/20- I had a phone appointment with a doctor , and they said I should be seen.   On 10/14/20- I was told to go see the nurse to get my ears cleaned out, 3 nurses looked at my ears and they were clear. Dr. looked at my ears, said that it may be my Eustachian tube to take Flonase and sudafed for 10 days even though I wasn't sick. I took the regimie for a couple days and contacted my main doctor and was adamant that I needed to be seen by a specialist as  I didnt feel like it was my Eustachian tube.   On 10/22/20 I went to the Audiologist and saw the ENT. They tested my hearing and confirmed I have no blockage in my Eustachian tube.  AUDIOLOGICAL RESULTS: Pure Tone Air and Bone Testing:  Right ear: hearing within normal limits, Left ear: moderately severe and sensorineural hearing loss. Speech Reception Threshold:  10 dB at the right ear and 80 dB at the left ear. Speech Discrimination Score (Word Recognition Score):  96% for the right ear and 4% for the left ear. Acoustic Impedance Testing:  Right ear: type A tympanogram consistent with normal middle ear function, Left ear: type A tympanogram consistent with normal middle ear function. Ipsilateral Stapedial Reflexes:  Right ear: present at expected levels, Left ear: absent. I was prescribed steroids to see if it will help. So far as of today no change.   10/24/20- I had a MRI and it was negative of abnormalities.
Injection site pain and swelling; Injection site pain and swelling; This is a spontaneous report from a contactable consumer (patient). This 69-year-old Male consumer reported in response to consumer letter sent via follow-up letter which included that:  A 69-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration on 01Mar2021 (69-year-old at the time of vaccination) as dose 2, single for Covid-19 immunization. Medical history included Seasonal pet allergies from 04Jan1968 to an unknown date, asthma from an unknown date and unknown if ongoing, bronchitis chronic from an unknown date and unknown if ongoing, obesity from 1990 to an unknown date, uterine cancer from 2018 to an unknown date, Skin rash from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6201), via an unspecified route of administration on 08Feb2021 (69-year-old at the time of vaccination) as dose 1, single for covid-19 immunization and experienced injection site pain, swelling and mild headache, sensitivity to light. On 01Mar2021, the patient experienced injection site pain, swelling. The patient did not received any treatment. The outcome of events recovered on unspecified date on 2021.  No follow-up attempts are needed. No further information is expected.
Pt with cough, lump in throat, scratchy throat.  Headache severity 5 of 10.  Strong cough present.
Large red swollen lump near injection site. Hot, tender, slightly itchy. Getting larger. Showed up 1 week later.
extreme lymph node enlargement on L side of neck and armpit, malaise, headache, dizziness
Sore arm with moderate pain, redness and swelling; in addition, I also felt tired, had muscle pain, a headache, and shivering.
Patient sitting in observation area, fainted and slid out of the chair landing on left cheek.
pt recvd vax OCT93 w/ no adverse event; 18DEC93 pt recvd vax & w/in 2 hrs exp swelling & urticaria; pt recovered; APR94, pt rechallenged w/OPV w/no problems;
Tightening of the throat; head discomfort; This is a spontaneous report from non-contactable consumer reported that a 69-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 15Feb2021 at 14:00 as dose number unknown, single for COVID-19 immunisation. Facility type vaccine was other. The patient's medical history included chronic cholangitis. No known allergies. Concomitant medications included levothyroxine (LEVOTHYROXINE), pancreatin (CREON), ursodiol (URSODIOL), sertraline (SERTRALINE), omeprazole (OMEPRA); all were taken for an unknown indication and from an unknown date. No other vaccine in four weeks. On 15Feb2021 at 14:00, the patient experienced tightening of the throat and head discomfort. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested post the vaccination. No treatment received for events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On day 8 post-injection, a large, annular, serpiginous red rash developed at the site of the injection and over the entire deltoid skin area, with some central clearing.
Choked on vaccine; turned blue; This serious case was reported by a nurse via call center representative and described the occurrence of choking in a 2-month-old female patient who received Rota (Rotarix liquid formulation) (batch number YL9YN, expiry date 20-APR-2025) for prophylaxis.   Concurrent medical conditions included irritability and crying.   On 14-JUL-2023, the patient received Rotarix liquid formulation (oral). On 14-JUL-2023, immediately after receiving Rotarix liquid formulation, the patient experienced choking (Verbatim: Choked on vaccine) (serious criteria GSK medically significant) and cyanosis (Verbatim: turned blue).  The outcome of the choking was resolved and the outcome of the cyanosis was not reported.   It was unknown if the reporter considered the choking and cyanosis to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the choking and cyanosis to be related to Rotarix liquid formulation and Rotarix Oral Applicator 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: 04-OCT-2023 The reporter was a Certified Nurse Aide. Prior to administration the patient was fussy and crying and during entire administration. The reporter reported that patient choked during administration of Rotarix (liq) and turned blue. The patient started choking during administration, which was done while patient was lying down on table. The reporter reported that babies did not like it. The patient recovered after patting on back and sitting up. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The case had been linked to the US2023136407 case, reported by same reporter.; Sender's Comments:  US-GSK-US2023136407:Same reporter
Hot burning pain to injection site, radiating down forearm, across scapula, up right side of neck. Redness in blotchy pattern to upper arm down to elbow. Swelling to entire upper arm. Tender to touch. Unable to raise arm to shoulder level. Achy pain to all joints, febrile (102F, oral temp), chills, headache involving entire top of head, sore throat, ear ache. Fatigue, muscle weakness. Continue for three days, decreasing in intensity by 04/23.
Patient called the pharmacy on 8/30 and reported to the pharmacist that she had to go to the emergency department the day before, some time after the vaccination was administered. The patient was very brief and didn't give much detail about why she went to the emergency room other than that her arm was in a lot of pain after receiving the shot. She said on the phone that she believed it hurt more than the first time she received the shot. She also said on the phone that the emergency department staff said the vaccine was "under the muscle" as opposed to "in the muscle" which was the reason she was experiencing pain.
Patient received Pfizer COVID vaccine on 5/6/21 and 4/8/21. Symptoms started 12/30/21 and he had tested positive using a home COVID test on 12/30/21. On 1/2/22, patient came to our ED with presented with worsening  cough, congestion, runny nose,  fever, and generalized aches/pains. However, was not  hypoxemic, relatively asymptomatic, and was sent home. On 1/6/22, patient came back to our ED with acute hypoxic respiratory failure secondary to COVID-19 pneumonia (confirmed positive result) and was admitted to hospital after intubation in the ED. As of today (1/7/22), patient is still in hospital.
This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old male patient who received INFANRIX (batch number AT57M, expiry date 19th June 2016). On an unknown date, the patient received INFANRIX (injection) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administration and inappropriate age at vaccine administration were unknown. Additional information: The patient inadvertently received INFANRIX instead of BOOSTRIX. No adverse event reported.
Noticed redness (size of tennis ball) and minor swelling. Does not feel ill or anything.