chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high fever; This is a spontaneous report from a contactable consumer (patients brother).  A male patient of an unspecified age receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, on 28Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), on unknown date for COVID-19 immunization). The brother reported that the patient is currently experiencing high fever, on an unspecified date. The event was reported as non-serious. The patient had tests and procedures which included body temperature: high on unknown date. The clinical outcome of high fever was not recovered.  Information on the lot number has been requested.
Left upper arm red, swollen, and painful in the area of the Tdap shot she received on 10/19/2014. Exam shows redness and mild swelling extending out over most of the upper arm. She has a decreased ROM secondary to pain with movement, can abduct to 30 degrees. No problem with movement at the elbow.
No adverse symptoms reported; the patient was administered the 2nd dose of GARDAISL 9 (Lot: R025729, Exp: 06/18/2021) in the series on 02/11/2020 and was then administered the 3rd dose of GARDAISL 9 (Lot: R025729, Exp: 06/18/2021) in the series on 03/13/2020.; This spontaneous report was received from a physician assistant referring to a 24 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 11-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R025729 with expiration date 18-JUN-2021; frequency and route were not reported) for prophylaxis. On 13-MAR-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R025729 with expiration date 18-JUN-2021) (inappropriate schedule of product administration). No adverse symptoms were reported. No additional information was provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.devicelotnumber: R025729; expirationdate: 18-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
PATIENT WAS GIVEN 0.25ML OUT OF MODERNA BOOSTER VIAL INSTEAD OF GETTING 0.5ML
Pediatric patient presented to Covid vaccination clinic for scheduled second dose of Pfizer. Inadvertently patient received 0.3ml of Janssen vaccine instead of 0.3 ml of Pfizer vaccine.  Patient has had fever, headache, nausea, vomiting, muscles aches, fatigue and diarrhea off and on since vaccination. On 6/24/21 at 12:30AM went to ER due to headache, vomiting, diarrhea and weakness. Diagnosed with a bacterial infection in his stool. Given medicine for pain and vomiting. Per mom, all tests done including for concerns with blood, heart and brain were all normal.
Severe knee and leg pain, spasms and swelling in the knee and ankle on just one leg. . Started two days after receiving the Covid19 vaccine. Great difficulty walking. without assistance. Pain began to subside on the fourth day and is less intense today, the fifth day following vaccination but is still present.
47 year old female patient ends her observation time at the Center without reporting any symptoms, an hour later they call from the shopping center reporting patient started to present 2nd level symptoms while shopping. Nurse leader proceeds to evaluate the patient. Patient is vomiting, reports nausea, weakness and heaviness when opening her eyes. Ambulance is activated, vital signs are taken. BP no audible; Resp 18; Sat 97%; Dxt 109mg; dl/pulse86; Adm ox c/n 2lts/min. IV is not administered as the ambulance arrives at 1:10pm
Varicella is a subcutaneous injection.  The RN administered is IM in the left deltoid.
Pallor, diaphoresis five minutes after administration "blacked out", lost hearing & tremored for a few moments. Patient remained seated, was monitored by pharmacist.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 25Jul2023 and 29Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300269473 Same patient, different event/drug;
Tested positive for COVID; Slightest back pain a little more intense; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and BACK PAIN (Slightest back pain a little more intense) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID) and BACK PAIN (Slightest back pain a little more intense). At the time of the report, COVID-19 (Tested positive for COVID) and BACK PAIN (Slightest back pain a little more intense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up was received on 03 June 2021 and it contains no new information.
I got my 2nd dose of the Pfizer vaccine on April 7, 2021. I got positive Covid test results both from a rapid and a pcr test 13May and 14May2021; I got my 2nd dose of the Pfizer vaccine on April 7, 2021. I got positive Covid test results both from a rapid and a pcr test 13May and 14May2021; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), the 1ST DOSE, SINGLE on an unspecified date and 2ND DOSE, SINGLE on 07Apr2021 both via an unspecified route of administration (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that "I got my 2nd dose of the Pfizer vaccine on 07Apr2021. I got positive Covid test results both from a rapid and a pcr test 13May and 14May2021. I would like to report my breakthrough case and/or find someone/a study I can report to in hopes to maybe be part of research on Covid in fully vaccinated people. Thank you!" The outcome of the events was unknown.   Information about batch/Lot number has been requested.
I passed out on street about 20 minutes after receiving the flu shot, was taken to the emergency room and spent 2 days in the hospital where they tried to determine cause of faint.  I had severe bruises on my face. 1/18/07 Received medical records from hospital which reveal patient admitted 10/30-11/1/06 after being found on the street by passerby with ecchymoes & abrasions to face & knees after leaving flu clinic.  Taken by EMS to hospital.  Regained consciousness while in ambulance w/o memory of the event. FINAL DX: Syncope.
This spontaneous report as received from a nurse refers to a unspecified patients of unknown age and gender. In approximately 2017, reported as between 05-SEP-2017 and 26-SEP-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB (doses and anatomical locations were not reported, lot # M020101 expiration date: 07-MAR-2019, intramuscularly) for an unknown indication. Data logger involved (28.5F for 5 minutes). There was no previous temperature excursion. No adverse events reported. This is one of severel reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1709USA013890.
niece who is pregnant and got both shots of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (niece who is pregnant and got both shots of the Moderna vaccine) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (niece who is pregnant and got both shots of the Moderna vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (niece who is pregnant and got both shots of the Moderna vaccine) outcome was unknown.            No concomitant medications reported. no treatment details reported. Reporter informed that the due date is in Jun 2021.   This case was linked to MOD21-060896, MOD21-060411, MOD21-060585 (Linked Report).; Sender's Comments:  MOD21-060896:cross link case MOD21-060411:cross link  case MOD21-060585:cross link case
Nausea, diarrhea, chills, tingling and numbness,in feet and hands, could not sleep, all within 24 hours 48 hours tingling and numbness but not as severe, body aches, sore
Significant swelling in lymph node under right armpit. Significant swelling in cheek- a knotty spot just above jawline and slightly behind edge of mouth-likely a lymph node?
It was reported that a female pt received a Fluzone unspecified vaccination sometime in 1998. reportedly the pt claims she has experienced left side weakness since 1998. No specifics provided. Further information requested.
patient had a syncopal event following the administration of the dose; This spontaneous report was received from a registered nurse, via a company representative, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown by reporter.  On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were unknown by reporter) and following the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had a syncopal event (syncope). It was reported that the patient sought for medical attention, but it was unknown if he received treatment for the event or if any diagnostic laboratories or studies were performed.  At the time of the report, the patient had recovered from the event. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and syncope was not reported.  Upon internal review, syncope was determined to be medically significant.
High blood pressure, trouble breathing, swallowing, sharp abdominal pains. Fever  Crushed 2 Benedetto and swallowed within 0 minutes of taking shot.  Took Tylenol and Pepcid AC. Took third Benadryl later in evening.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  ADMINISTRATION ERROR:   Resident received first and second doses of Pfizer COVID-19 vaccine on 1/6/21 and 1/27/21 respectively.  On 2/17/21, the resident screening form and consent form reported in error that they had not previously received any doses of COVID-19 vaccines.  The individual was vaccinated with a third dose of Pfizer COVID-19 Vaccine in error.
BODY ACHES; CHILLS; FEVER OF 100.7; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, chills, and fever of 100.7. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, body aches and fever of 100.7 was not reported. This report was non-serious.
Two days after the COVID19 vaccination I developed a red blotchy rash below the injection site.  Skin was also warm and swollen in this area.
Patient started to experience severe eye pain "earlier this morning; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Patient started to experience severe eye pain "earlier this morning) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EYE PAIN (Patient started to experience severe eye pain "earlier this morning). At the time of the report, EYE PAIN (Patient started to experience severe eye pain "earlier this morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.
day 1-2 minor soreness. around day 7-8 injection site began to get itchy. day 10 itchy, red circle and somewhat warm to touch around injection site
pt recv vax 14MAR96 & 19NOV96 pt exp rash;the reporter also indicated the pt sibling exp rash subsequent to vaccination w/the varicella vaccine (WAES 97020393);
Child received MMR, a few minutes after injection mother noted some redness. Nurse addressed pt a few minutes later, enlarged to 10mm.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 83-year-old female patient. No information was received regarding medical history, concurrent conditions, or concomitant medications.  On approximately 01-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided for long-term prevention of shingles and zoster-related conditions. The vaccine was administered by a pharmacist at the pharmacy. The patient was approximately 73 years old at the time of the vaccination. On an unknown date, the patient experienced shingles and was treated by a physician for the injuries.  The outcome of the event was unknown.  The reporter considered the event to be related to the zoster vaccine live (ZOSTAVAX).
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II (albumin status not reported) (doses, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of M-M-R II experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, time and temperatures of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012038: US-009507513-1701USA012037: US-009507513-1701USA012035: US-009507513-1701USA009285.
Sore arm; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0140, expiration date unspecified), intramuscular on 28Dec2020 at single dose at left arm for COVID-19 immunization.  Medical history included depression and anxiety. The patient was not pregnant and had no known allergies. The patient had no allergies to medications, food or other products. Concomitant medications were not reported. On 29Dec2020, the patient experienced sore arm. The patient did not received therapy for the event. The most recent COVID-19 vaccine was administered at the hospital. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Outcome of event was recovered on an unspecified date.
Itchy hives appearing first on palms of both hands on 2/1/21, spreading over subsequent days to tops of hands, arms, lips, neck, and scalp.
Pt. reported feeling left sided cheek numbness 5 minutes. This RN performed Stroke Scale on pt and pt had no neurological deficits. When asked pt about decreased sensation pt denies any difference in sensation but reported numbness. Stated all areas of body felt the same when checked. Pt had clear breath sounds, bilaterally, no swelling noted, able to swallow secretions. Pt was A&Ox4 with GCS of 15. Pt was able to ambulate under own power and steady gait. Pt denies any other issues. Pt requested to go to hospital and EMS was then notified.
Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "Diagnosed with COVID". Additional information: It was reported that the patient is a healthy person.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Within  a few hours of receiving the vaccine, patient was experiencing severe  fatigue, headaches, tinnitus in both ears,, numbness and tingling on left side of face radiating down left arm, and 24 hours post dose began experiencing palpitations and shortness of breath. Symptoms have improved but still present after a week post dose.  No previous of these events prior to vaccine.
Heart was pounding and racing; Blood pressure was erratic; Dizziness; Bilateral weakness in my legs; Sore arm; A spontaneous report  was received from a heath care professional concerning a 56 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, dizziness, heart was pounding and racing/ palpitations, bilateral weakness in legs/muscular weakness and blood pressure was erratic/blood pressure fluctuation.  The patient's medical history included COVID-19. No relevant concomitant medications were reported.    On 21 Jan 2021, 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced sore arm that lasted for 2 days.  On 24 Jan 2021, at 2 PM the patient had dizziness and her heart was pounding and racing. She stood up and felt like she was going to fall due to bilateral weakness in her legs and was taken by ambulance to the hospital. She was given medication to control her BP because it was erratic.   On 27 Jan 2021, the patient was released from the hospital.  Laboratory details as reported by the reporter include systolic blood pressure (BP) of 215, electrocardiogram (ECG), echocardiogram, computerized tomography scan (CT), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) to check for transient ischemic attack (TIA), depleted oxygen to the brain, and circulation problems. All tests performed came back as normal.  Treatment for the events included unspecified blood pressure medication.    Action taken with mRNA-1273 in response to the events was not reported.   The event, sore arm, was considered resolved on 24 Jan 2021. The events, dizziness, heart was pounding and racing, bilateral weakness in legs and blood pressure was erratic, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Member had been given an (unknown) initial flu dose on 8/14/21 at Pharmacy and another at a flu clinic on 10/13/21 organized by the school. When the 2nd dose was attempted to be entered, it was then found out that member had already rec'd a dose on 8/14/21. Investigation was done; member was called. She was told the first dose given was not a "registered" vaccine and she required another flu vaccination for the purpose of her college course class requirement so she rec'd the 2nd dose in Oct.  She suffered no reported ill effects from either injection. Report completed.  ______________ Trade Name: AFLURIA   Dose Size: 0.5 mL (actual amount)  Date Provided: 08/14/2021 Ordering Authority:  Administered By: Form Body Site: RIGHT ARM Administered Route: INTRAMUSCULAR Disregard Primary Series: N Dose Eligibility: No Insurance VIS Date for Influenza: 08/15/2019     Date Presented: 08/14/2021 Org Name:  Address 1:  Address 2:  Phone Number:  Contact Name: