chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published article. This literature case was initially reported on 29-Mar-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 32 of 32, a 20 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 20 year old female on an unspecified date was vaccinated with the second dose and third dose of RECOMBIVAX HB (lot number, route and site not reported) respectively. There was no concomitant medication. Three days after the second dose and four days after the third dose vaccination, the patient developed uveitis. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient outcome was unknown. The patient also experienced symptoms of headache. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES # 1004USA01716, WAES # 1004USA02327 to WAES #1004USA02352, WAES # 1004USA02354 to WAES # 1004USA02356). A copy of the published article is attached as further documentation of the patient's experience.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 40-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational diabetes from 2017 to 11-Sep-2017 and Delivery (Mother developed gestational diabetes, child was born with hipo) on 11-Sep-2017. Concurrent medical conditions included Pregnancy since 08-Sep-2020. Concomitant products included VITAMINS NOS for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Sep-2020 and the estimated date of delivery was 02-Jun-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2020, Pregnancy test: positive (Positive) Positive. In January 2021, Scan: normal (normal) 20 week anatomy scan normal. On an unknown date, Scan: normal (normal) 16 week anatomy scan: Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications was provided by the reporter.  Estimated date of conception was 8 Sep 2020. Previous pregnancy end date on 11 Sep 2017 with events. mother developed gestational diabetes, child was born with hipoglucemia.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
A spontaneous report with serious event of pregnancy induced hypertension and non-serious event of inadvertent administration of H1N1 to a pregnant woman was received from a registered nurse/healthcare professional concerning a 25-year-old female, subsequent to H1N1, Intranasal. the patient had a medical history of first trimester nausea and maternal medical history included PI hypertension. The obstetrical history included two gravida and two para. The gestation period at the time of vaccination was 26 weeks and three days and the reported expected date of delivery was 27-Feb-2010. The concomitant medications included promethazine for nausea and ondansetron was prescribed for nausea later in the first trimester. The patient was also on prenatal vitamins. On 21-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. The patient experienced pregnancy induced hypertension during current pregnancy on an unknown date. The patient delivered a baby boy on 10-Feb-2010 via C-section. The patient had a full term delivery and there were no complications with the delivery. The gestational age of the child was 38 weeks, weight was 8 lbs 2 oz and the neonatal status was a normal, single birth. The apgar score was 9 for both one and five minutes. The outcome of pregnancy induced hypertension was unknown and that of inadvertent administration of H1N1 to a pregnant woman was considered resolved. Additional information was received on 07-Dec-2009 and incorporated into the narrative: Medical history, obstetrical history, concomitant medication, gestation period, expected date of delivery. Additional information was received on 21-Apr-2010 and incorporated in the narrative-Adverse event of pregnancy induced hypertension was added which was considered to be a medically important event and as it is an unexpected event, the case was upgraded to be a 15-day case, reporter information, patient's medical and obstetrical history, concomitant medications, neonatal information. Other information received was patient name and address.
Information has been received from an office manager concerning a 12 month old male child with no known allergies, benign heart murmur and eczema who on 10-JUN-2008 at 11:15 hour was vaccinated SQ "right" with a first dose of MMR II (lot # 655486/0426U) (rHA).  There was no concomitant medication.  Subsequently, on 14-JUN-2008 (previously reported as 15-JUN-2008) the patient experienced 3 days of fever of 103 F and then on 19-JUN-2008 the patient developed (broke out in) a rash.  Medical attention was sought.  On 19-JUN-2008 the patient was seen in the office.  There were no lab studies performed.  At the time of the report the patient recovered from the rash on an unspecified date.  There was no product quality complaint involved.  Additional information is not expected.
Headache; Tired; Muscular ache; Cold; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, tired, muscular ache, cold. The patient got little bit headache, tired, muscular ache and some cold. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received the Pfizer COVID-19 vaccine on 1/28/21 and 2/18/21, so was fully vaccinated when he tested positive on 8/14/21.
On 2/7/21, had minor gnawing chest pain (2-3/10) which progressed to 7/10 chest pain , throbbing headache with positional changes and numbness down both arms (L>R). Went to the ER and was admitted.
hives; Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 10:00 (Lot number: EW0171, Expiration Date: 31Aug2021) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset Aug2021, outcome "recovered" (28Aug2021), described as "hives"; RASH (non-serious) with onset Aug2021, outcome "recovered" (28Aug2021), described as "Rash". Therapeutic measures were taken as a result of urticaria, rash.  Additional Information: Calling about Pfizer COVID-19 Vaccine. States that she works in dietary at the hospital. One of the nurses told her she should call. When she first got the vaccine 2-3 weeks ago, she broke out in hives really bad about 2 days later. She got her shot on a Wednesday, then Thursday or Friday she broke out in hives. States that she kept forgetting to call. She gets the 2nd dose tomorrow. Treatment: She just put ice on it at home. States that she still needs to call her primary care doctor and let him know what happened. She broke out on her arms, legs and thighs. Asked, when getting in contact with her primary care doctor will someone contact her first or let her know and make an appointment with her.   No follow-up attempts are possible. No further information is expected.
toothache; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation; solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a toothache on an unspecified date. The patient scheduled for the second dose of COVID 19 Vaccine tomorrow (21Feb2021) and she asked if Advil could take before the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; Information on lot number, batch number could not be obtained.
tingling in left lip - progressed to sore throat by 8:45, by 9pm increased resp rate, pain upon i nspiration, tingling in face, and sore throat continued - went to ED by 10pm, given benadryl 25mg, placed on O2 chest xray, lab work.  Sent home from ED at 5am - decreased resp rate and tingling subsided
Arthritic pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthritic pain) in a male patient of an unknown age 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 ARTHRALGIA (Arthritic pain). At the time of the report, ARTHRALGIA (Arthritic pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-129705 (E2B Linked Report).; Sender's Comments:  MOD21-129705:
Received AFLURIA that reached 47F for 8 hours - no adverse event This spontaneous case initially received on 01-Sep-2016, was reported by a health professional and concerns a 22-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 31-AUG-2016 to 31-AUG-2016. Dose regimen: 0.5 ml 1 time dose, Route of administration: Intramuscular. Batch number: WT54006. No additional suspect drugs. Special circumstances: On 31-Aug-2016, the patient was administered AFLURIA that reached 47F for 8 hours - no adverse event (special circumstances: drug administration error without adverse event). The outcome was reported as unknown. Reporter comments: The reporter considered the event as non-serious (medication error).
Rash on chest; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the arm right on 06May2021 at 14:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included barrett's esophagus, COVID-19 and rash on chest 10 days after the patient recovered from the virus in Nov2020. The patient previously took AVALOX on an unknown date and experienced allergy. Concomitant medications included esomeprazole sodium (NEXIUM), aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), loratadine (CLARITIN) from unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021, the patient underwent nasal swab and the result was negative. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158) via an unspecified route of administration in the arm left on 15Apr2021 at 14:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. On 14May2021, at 18:00, 10 days after second dose, the patient developed a rash on chest. Therapeutic measures were taken as a result of event and included treatment with anti-itch cream from unspecified date. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event rash on chest was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt vaccinated with DT became lethargic, floppiness, & decreased feeding for 5 days. No rx.
Pt vaccinated w/ Hepatitis A vaccine inactivated,laboratory  evaluation revealed a lack of seroconversion.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-MAY-2017, the patient was vaccinated with an expired dose of, PNEUMOVAX 23 (lot # L035882 and expiration date: 19-APR-2017), for prophylaxis (dose, frequency, route of administration were not reported).
Chills, nausea, headache, diarrhea (lasted 2 1/2 days).
Second day bedridden with extreme fatigue, sore arm, nausea, vomiting, fever up to 103° Fever began to go down and stomach began to be relieved by third day Fatigue remained until 4th day Sore arm remained until 5th day Still experiencing foggy brain
Patient passed out in corner of Health Services Room of pharmacy after receiving flu shot (2-3 minutes). She came to after about 30 seconds. Patient was with her mother who requested us to call 911. Patient does have a history of anxiety/panic attacks with which she has sought help for at the hospital before. It was reported to pharmacist later in the day that the patient did receive medical attention at hospital and was released an hour or two later healthy and well.
Patient returned to nurse who administered vaccine to report that his right hand and wrist area were swelling and his right 4th and 5th finger and outer side of hand and wrist were cool to touch.  This area was also darker in color than the rest of his hand.  25mg of Benadryl was administered and parent notified.
Mom states she broke out in rash all over body.Mom took her to Urgent care and stated that it was allergic reaction.
By the time pt reported situation to nurse was feeling fine; reported by pt queasy few mins p/vax; started seeing blotches, felt faint; very light-headed; throat started swelling & tongue became numb; felt heat beat inc;
Horner's syndrome; A spontaneous report was received from a 66-year-old female physician who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed Horner's syndrome.    The patient's medical history was not provided. Concomitant product use was not provided.  On 28 Dec 2020, approximately two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported after receiving the vaccine, she developed Horner's syndrome on 30 Dec 2020. She reported having a droopy eye on the left side and her left eye having a small pupil. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, Horner's syndrome, was unknown.; Reporter's Comments: This case concerns a 66-year old female patient. The medical history is not provided. The patient experienced an expected medically significant event of Horner's syndrome approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot 011J20A). Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Swelling of lips and eyes on one side of face. No difficulty breathing. He had also been outside at the time.
Right arm only 7/27/19 itching & painful to touch,  7/28/19 itching & swelling & very red! 7/29/19 itching, swelling & red at least 5 inches wide 7/30/19 itching, still red little swelling 7/31/19 itching & red 8/01/19 itching & pink 8/02/19 itching & pink maybe about 3 in wide now
May not be related, reporting just in case. Bp and pulse went up around 11:00pm on 6/6/21. Normal 115/75 and pulse 75 at rest. Went to 140/90 and 100. Felt heart palpitations. Went to bed hoping it would go away. Woke up feeling unwell again and still high. Also, developed a large subconjunctival hemorrhage in my right eye. BP and heart rate normalized a few hours later. Went to doc and normal EKG and BP/pulse. Went to eye doc and confirmed vessel burst. No loss of vision (was 20/20). Told would self resolve in 2-3 weeks. However, on 6/10/21 at around 10:00pm my husband got one in his left eye. He had heart palpitations prior too. He's never had one in his entire life. Because of this, I thought it best to report it just in case it was not a strange coincidence but related to the vaccine or COVID. Will follow up with COVID testing to rule that out. He also will be submitting his experience on Vaers.
She skipped her second dose scheduled 16May2021; mouth ulcers; lethargy; throat ulcers; fever of 101.1; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (She skipped her second dose scheduled 16May2021), MOUTH ULCERATION (mouth ulcers), LETHARGY (lethargy), PHARYNGEAL ULCERATION (throat ulcers) and PYREXIA (fever of 101.1) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Denture wearer. Concomitant products included ALPRAZOLAM and BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, TELMISARTAN for Blood pressure, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN) for Infection, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and CANNABIS SATIVA (CBD) for Pain, TRAZODONE for Sleep problem, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Viral infection.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced MOUTH ULCERATION (mouth ulcers), LETHARGY (lethargy), PHARYNGEAL ULCERATION (throat ulcers) and PYREXIA (fever of 101.1). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She skipped her second dose scheduled 16May2021). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (She skipped her second dose scheduled 16May2021), MOUTH ULCERATION (mouth ulcers), LETHARGY (lethargy), PHARYNGEAL ULCERATION (throat ulcers) and PYREXIA (fever of 101.1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Difficulty swallowing, tongue numbness, throat tightness, hives, tachycardia 45 minutes following vaccine Benadryl 50 mg, Prednisone 40 mg and will continue higher dose for 5 days, Pepcid 40 mg, rx for epi pen
hepatic injury; This literature-study case was reported in a literature article and describes the occurrence of LIVER INJURY (hepatic injury) in a 65-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER INJURY (hepatic injury) (seriousness criterion medically significant). At the time of the report, LIVER INJURY (hepatic injury) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LIVER INJURY (hepatic injury) to be related.    Concomitant product use was not provided by the reporter.    ?No treatment information was provided. Company Comment: This literature case concerns a 65-year-old, male patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.   This case was linked to MOD-2021-419607, MOD-2021-419608, MOD-2021-419558 (Patient Link).; Sender's Comments: This literature case concerns a 65-year-old, male patient with no medical history reported, who experienced the unexpected serious AESI of Liver injury, at an unknown day after an unknown dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
(R) leg is red, swollen and warm to the touch. TX: Monitor reaction. If worsens will treat with antibiotics.
Seizure without fever 10/9/04 and 10/10/04. Started on Phenobarbital by neurologist. Patient had negative blood, urine, and spinal fluid cultures. EEG WNL. CT Head WNL.  Nurse follow up on 10/20/04 states: "aspiration pneumonia."   Follow up 03/02/05: Patient has recovered from the adverse event(s).
11:00 am - Received vaccine 2:00-5:00 pm - tired, lethargic  6:00pm - 8:00am - aches, chills, headache, nausea, very painful/tight back, neck and shoulders, unable to sleep, dark urine despite drinking lots of water  04/02/2021 - 8:00 am 1st dose of Acetaminophen, symptoms persisted the whole day but less intense 04/03/2021 - feeling about 80% back to normal
Patient reported tingling above left eye started within 2 days. Patient present to office 1 week after vaccine given (1/27/2016) with signs and symptoms consistent with shingles outbreak and optic neuritis. Treated with acyclovir 500mg 5x per day for 1 week and referred to ophthalmology.
Upon administration of H1N1 when pushing the plunger the vaccine leaked from the sides of the needle - causing an insignificant amount of vaccine to be administered.
fever, chills, body aches, headache, stuffy nose drainage, diarrhea,  foggy brain