chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; the temperate excuration occurred, vaccines have been administered; This spontaneous report was received from a medical assistant and referred to 1-year-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 23-MAR-2022, the temperate excursion occurred to verified viability vaccine varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion. The digital data logger was involved.   On 27-APR-2022, at a private doctor's officer/hospital, the patient was vaccinated by a healthcare professional with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot # U025790 with expiration date: 19-AUG-2023; strength and dose not provided) administered subcutaneously for prophylaxis (product storage error). This initially used vaccine was not available for return/evaluation due to being given to the patient. There was no prescription drug treatment for the experience required. No additional adverse event details (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
Pt became swollen with big blisters all over his body and these blisters itch.  Pt also had a fever with body aches.  Treated with steroids, hydrocortizone, cream benylin, and advil.
The mother of a 6 month old female reported that her daughter inadvertently received a "double dose" of Prevnar on 8/1/00. The infant also, received Hib and Hep-B vaccines. That day, the infant developed irritability and a decrease in appetite. The mother treated the infant with acetaminophen.
Patient was in clinic for an annual. Upon arrival, She was offered a flu shot. Patient stated that she don't remember getting the vaccine and would love to get it. After giving her the flu shot, upon charting it into System, System informed me that she had already received  the vaccine on 11-2022 and wasn't suppose to get another vaccine until 07-2023
DIZZY; TEMPERATURE; LEG MUSCLES REMAIN WEEK; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-MAY-2021, the subject experienced dizzy. On 02-MAY-2021, the subject experienced temperature. On 02-MAY-2021, the subject experienced leg muscles remain week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, and temperature on MAY-2021, and had not recovered from leg muscles remain week. This report was non-serious.
This spontaneous report was received from a a registered nurse referring to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On approximately 27-MAR-2017 (reported as 8 weeks ago), the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided). In approximately March 2017, the patient developed a lump which could be felt under the injection site. No product quality complaint was involved. The outcome of the lump under injection site was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
went to the ER on 10/12/21 with shortness of break and pain in chest.
Chills; fever; sore arm; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "chills", "fever"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "chills", "fever"; Bnt162b2 (Dose 3), for Covid-19 immunization, reaction(s): "chills", "fever". The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional Information: It was reported that the patient got the new omicron booster. The patient had all regular and all boosters. The patient mostly had chills and fever, but with the bivalent the patient had a little sore arm, and maybe tired.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A nurse reported that a 4 year old female received a 6th injection of Acel-Imune and subsequently, developed an injection site reaction characterized by "severe" swelling, redness and pain. No further information was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of 2 different lots of Acel-Imune.
Pt in COVID-19 Observation Area and complained of Dizzyness and headache. B/P @ 211/100 p-135 Sat 99%. Manual B/P @ 200/110. Warm and dry to touch. Pt alert and oriented. Code Assist called. Pt evaulated by code asist team and taken to Clinc for furter evaluation.
Erythema, Edema, Warmth to left arm deltoid readiating distally to left forearm.  Benadryl, Tylenol given. Ice packs to area RTC 3 days for F/U.
I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 (I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective) had resolved.            No concomitant medication information was reported. No treatment medications were provided.
Patient with history of Multiple Sclerosis, complains of body aches, lump in throat, fatigue, states causing an "Multiple Sclerosis flare".
Vaccination site warmth; Vaccination site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (arm sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (arm sore). At the time of the report, INJECTION SITE PAIN (arm sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported  Treatment information was not provided
15AUG95 mom reports pt very ill p/last vax 7MAR95; fever of 101 or 102, inc pitched crying for @ least 4 hrs; eval @ ER felt it was a rxn to immun; s/sx lasted 3-4 days;
No adverse effects reported; patient received improperly stored VARIVAX; Information has been received from a medical assistant referring to a 12 months old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided.  On 19-JUN-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R030612, expiration date 23-OCT-2020, for prophylaxis (strength, dose, frequency and route were not provided) (improper storage of product in use). The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects reported. The outcome of the events was unknown.  The storage temperatures of the varicella virus vaccine live (oka/merck) (VARIVAX) were reported as between -14 and -10 degree Celsius (-13 degree Celsius) for a time frame of 30 minutes, 9 to 25 degree Celsius (17.8 degree Celsius, multiple) for a time frame of 32 minutes. There was no previous temperature excursion. The call was due to a data logger.
The day before I received my second dose (02/18/2021), I noticed a rash on my body. After seeing my dermatologist, on 02/22, it was diagnosed as shingles. It was on my chest, around my waist and around my back. A biopsy was performed on two of the blisters on my back. They lasted about six weeks.
Your old vaccine is worthless against omicron and preventing infection; Your old vaccine is worthless against omicron and preventing infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, (booster), single (Batch/Lot number: unknown) and as dose 4, (booster), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Your old vaccine is worthless against omicron and preventing infection".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A physician reported that approximately 40 to 50% of 25 pts experienced an injection site reaction described as either redness or swelling following the receipt of Flu-Shield in September of 1999.
pt recv vax 19FEB97 & titer results on 2APR97 revealed a lack of seroconversion;
mom reports p/14MAY92 DTP pt was fussy x 3 days & did have high pitched cry;
Back in June I noticed I wasn't feeling well in the morning when I woke up, I was hot. General not feeling well. My blood pressure was really high 179/about 100 and pulse rate was about 110. I let it go on for a couple of days to make sure it wasn't something> I went to see my Cardiologist and he started me on blood pressure medications. It's gone down. But I've had blood pressure issues before so it's kind of out of the blue. Blood pressure seems to be controlled now.
This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2001, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (experienced an anaphylactic reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was unknown.  Company Comment: 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.; Sender'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.
Fever; Feeling sluggish; This is a spontaneous report from a contactable consumer. A 6-decade-old (mid-to-late 50s) male patient (brother-in-law) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Apr2021 at approx. 14:55 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunisation. The next day, 09Apr2021, he had a fever and was feeling sluggish. The outcome of the events was recovered on 10Apr2021.  No follow-up attempts are needed. No further information is expected.
Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (ended in C sections). Concurrent medical conditions included Headache. Concomitant products included PARACETAMOL (TYLENOL) for Headache, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Dec-2020 to an unknown date for an unknown indication.    On 17-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Nov-2020 and the estimated date of delivery was 29-Aug-2021. On 17-Feb-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 17-Feb-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2020, Pregnancy test: positive (Positive) Positive. On 08-Feb-2021, Blood test: normal (normal) blood work within normal limits. On 08-Feb-2021, Ultrasound scan: 160 (High) Heart beat 160. On 12-Feb-2021, Blood test: normal (normal) blood work within normal limits.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had conception on 06-Dec-2020. Number of fetus was found to be one.   Treatment information was not provided.
8/3/11 9:05 am - Gave pt 2 shots in (R) deltoid with no problems, gave GARDASIL in (L) deltoid. Pt immediately eyes rolled in head and head sagged down. Laid pt down. Took vitals called RN to assist, cool wash rag to head.
This is in follow-up to report(s) previously submitted on 3/14/2007.  Information has been received from a consumer's mother and physician concerning a 16 year old female with a MOTRIN allergy, and no medical history who on 10-FEB-2007 at 10:00 was vaccinated IM into the left arm with a first 0.5 ml dose of Gardasil (lot# 655617/1447F). There was no concomitant medication.  On 12-FEB-2007, the patient experienced "heart racing, nausea, dizziness, temp of 99.7, abdomen cramps, vomiting, bad headache and diarrhea." The patient's mother reported that the patient "had been out of school all week and was not feeling well." She also stated that "there was a follow up visit with the physician who associated the experience with the vaccine and she was given TIGAN for the nausea and cramps." No labs or testing was needed.  At the time of this report, the patient had not recovered according to the consumer's mother. The physician reported that on 17-FEB-2007 the patient recovered from diarrhea, dizziness, nausea, headache, vomiting, abdomen cramping and low grade fever. No product quality complaint was involved. Additional information is not expected.
Pericarditis, Pleural effusion, Pericardial effusion, elevated inflammatory labs and D-Dimer
Teeth chattering but not cold or feverish Feeling there was movement within my head that a piece of the brain was moving up and down like my mouth (not dizzy or felt like room spinning) Feeling there was darkness/stuffiness in my head (not congestion) Feeling like my brain was not in control of my body Feeling sluggish   The chattering lasted less than a minute, the motion in the head has weakened but still present and the darkness in the head is gone.
Upper arm at injection site red, hot, swollen in a 6 x 6 area, malaise.
runny nose-pain, change in bowels, croup, diff breathing, sleeplessness, restlessness, fever 103;
Tdap, MENACTRA, and HPV given 7-21-15. Definitely had morphea Aug 2015. Don't known if had before 7-21-15. Immunosuppressives started May 2016.
NONE - Patient received an expired dose of HIB as packaging was confusing. The expiration was written as 18OCT17 and it was thought that the vaccine expired October 17, 2018 when it actually expired October 18, 2017. This was not found until the end of January 2018 when all of our vaccines were brought back to office after the 2 1/2 months of the vaccines being at the main hospital due to the vaccine refrigerator being broken.
Got very cold; This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for three patients; this is the second of three reports. A 92-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that last night her husband, her mom and herself all got very cold. The reporter stated that her mom was actually doing better than she was. The clinical outcome of got very cold was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
PATIENT RECEIVED FIRST DOSE OF PFIZER VACCINE TODAY. AFTER 30 MINUTES OF OBSERVATION PATIENT COMPLAINED OF FEELING FAINT AND HAD A SYNCOPALL EPISODE. PATIENT WAS ASSISTED TO THE FLOOR ,VITALS SIGNS TAKEN AND MONITORED BY HEALTH CARE PROFESSIONAL. PATIENT COMPLAINED OF CHEST PAIN BUT UNABLE TO RATE PAIN . AED MACHINE APPLIED PATIENT IN SINUS RYTHM WITH BP 130/90,HR 88 ,BLOOD GLUCOSE 102 AND SPO2% 99% ON ROOM AIR. 911 CALLED .PATIENT WAS ALERT AND TRANSPORTED TO MEDICAL CENTER BY EMERGENCY MEDICAL SERVICES
Information has been received from a medical assistant, referring to an unspecified number of  patients (ages and genders not reported). The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number M028323 with expiration date on 26-SEP-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported and no additional information was provided. The vaccines had a temperature excursion of 9 Celsius (C) to 25 C during 20 minutes, also was confirmed that the vaccines did not have previous temperature excursions and a digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA005670: US-009507513-1706USA005672: US-009507513-1706USA005673: US-009507513-1706USA004421.
15CM X 15CM localized reaction. area was war., red, and edematous but only central area measuring 5cm x 5cm. First Dtap/Poilo combination but 5th Dtap in the series.
After receiving vaccine, pt complains of extreme dizziness, rapid pulse and chest pain that continued to get worse.  Rapid response was called for pt assessment. After continued symptoms, pt was brought to ED for further work up
pt recv vax 11MAR96 & w/in 5 to 10min p/vax pt devel a rash;no further details were provided;
SHAKING; WEAKNESS; CHILLS; HEAD PAIN; TIREDNESS; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication. On 07-APR-2021, the subject experienced shaking. On 07-APR-2021, the subject experienced weakness. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced head pain. On 07-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: moringa oleifera, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, chills, and head pain on 07-APR-2021, and had not recovered from tiredness, and weakness. This report was non-serious.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous, (dose, frequency, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient suffered a lot of injection site pain. The patient called the pharmacist, on an unspecified date, to sought medical attention. The outcome of injection site pain was unknown. The reporter did not assess the relationship between ZOSTAVAX and injection site pain. Additional information is not expected as no reporter details were provided.