chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red cheeks and chin,hot to the touch; Face rash - acne/chicken pox like some with pus. Red cheeks and chin, hot to the touch, painful.; Acne/chicken pox like some with pus; Red cheeks and chin, hot to the touch; Red cheeks and chin,hot to the touch, painful.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 11Apr2021 at 17:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraine, severe back pain and latex allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), salbutamol (albuterol) (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN and vitamin D (MANUFACTURER UNKNOWN). On 12Apr2021 at 13:00, the patient experienced face rash, acne/chicken pox like some with pus, red cheeks and chin, hot to the touch and painful. Therapeutic measures were taken as a result of the events, face rash, acne/chicken pox like some with pus, red cheeks and chin, hot to the touch and painful, which included treatment with cortisone applied to the affected areas. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination the patient not been tested for COVID-19. The clinical outcome of the events face rash, acne/chicken pox like some with pus, red cheeks and chin, hot to the touch and painful were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt devel erythema & swelling @ inject site 48 hrs p/receiving Td following finger fracture; 9APR91 pt devel an abscess @ inject site; Nothing however, could be aspirated from the area; pt treated w/Keflex;
COVID-19; COVID-19; 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) 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), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: While in the I contracted COVID-19 and was sent home with a positive COVID-19 test.  Clinical Course: The patient received Pfizer COVID-19 vaccines two doses (at the time not ready to get a booster vaccine). While in the withheld patient contracted COVID-19 and was sent home with a positive COVID-19 test, which lasted for 12 days and the worse illness patient ever had, did not think patient would ever recover, but because had Pfizer vaccines patient did recover.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vomiting; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Stomach Acid" (unspecified if ongoing), notes: Verbatim: Stomach Acid. Concomitant medication(s) included: LISINOPRIL taken for blood pressure abnormal; OMEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: Bnt162b2 (Dose: 1), when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 03Apr2021 07:30, outcome "unknown", described as "Vomiting"; NAUSEA (non-serious) with onset 03Apr2021 07:30, outcome "unknown", described as "Nausea".  Additional information: I have been on Omeprazole for several years. I got it Friday and then Saturday morning I got up after like 7:30.  No follow-up attempts are possible. No further information is expected.
Minor reported itching, cough and stomachache.  When assessed by provider hives were noted on back and neck.  Benadryl was given immediately.  Minor had one emesis episode, one bowel movement while in observation, which she reported feeling better right after.
Received vaccines at 2:30 pm on 4/20/06.  There were no initial side effects.  On 4/27/06 at about 8:30 am she had a seizure.  I was not aware of any fever at that time.  The seizure lasted approximately 40 seconds.  Her eyes rolled back and to the left and her body went limp and fell to the left.  Her father caught her as she fell and she did not hit her head.  Her mouth was moving but she did not appear to be breathing.  Her lips began to turn purple.  There was no violent shaking.  She came out of it but was not able to sit unsupported or control her movements.  Her eyes were out of focus.  Her tongue was sticking out and moving from side to side.  She was gnawing on her tongue.  She was reaching toward the ceiling and moving her hands as if trying to grab something.  This lasted about 2 minutes.  Then she went to sleep.  She was barely responsive to stimulation. We took her to the Emergency Room.  I believe we arrived around 8:50 am.  She slept soundly until the nurses drew blood and checked her temperature.  She was alert and very upset, but there was no fever.  After the blood work, she went for a CT Scan.  She was very upset during the procedure.  After the scan she went back to sleep.  She did not wake up again at the hospital.  We were discharged at approximately 11:00 am.  We went home.  She did not wake during the drive or when when I put her in her crib.  She slept for the rest of the day only waking for short time periods.  For the next several days she was normal except that she was tired and slept more than usual and ate/drank very little.  She appears to be back to normal today, eight days after the seizure.
16 days after receiving the first dose of Modern, I experienced a painful inflamed rash on upperpart of my body including neck, back, chest, torso, ears, and hips.  No other symptoms.   I have not made any changes to soaps,medicines,  diet, or other environmental triggers. I saw my doctor immediately and was prescribed a steroid pack to relieve the swelling and pain of the rash.
Had 2 vaccine shots/currently have shingles!/Suspected vaccination failure; Currently have shingles!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In 2019, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 shots of Shingrix in 2019 and currently had shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
This spontaneous report was received from a medical assistant, referring to a 8 week old female patient with gastroesophageal reflux disease. The patient had no pertinent medical history or drug reactions/allergies. On 31-MAY-2016 the patient was in the office for their "2 month checkup". When the healthcare worker placed the open vial of ROTATEQ (lot # M004890, 10-NOV-2017, strength and dose were not provided) to the patient's mouth for administration "a trace amount of ROTATEQ may have gotten on the patient's lip prior to the patient's mother declining the vaccine"). Concomitant therapies included IPOL, PREVNAR 13, ZANTAC, DAPTACEL and ACTHIB. The patient's mother called to the office and reported that since 03-JUN-2016, the patient was "fussy" (irritability). The patient's mother called to the office again and on 06-JUN-2016 and reported that since an unspecified date in June 2016, the patient had looser stools than normal, and was still fussy. There were no laboratory diagnostics studies performed. At the time of reporting, the patient was not recovered from the events. Additional information has been requested.
Next morning,  2/26/2021 Approx. 2 degree fever,   chills, diarrhea,  body aches,  extreme fatigue,  chest congestion All except dinner muscle cramping gone by noon on the following day,  2/27/21
dry mouth/ metal taste/ excessive thirst, extreme dry eyes to the the point of burning/ gritty sensation (used multiple doses of natural tears to treat)
Per patient on 11/10/11 she woke up with chills, fever, body aches. Headaches and nausea. Arm pain and swelling, redness, rash. Admitted to hospital for cellulitis on 11/18/11 and D/C on 11/21/11 IV antibiotics.
About 9 hours after the shot my left arm suddenly hurt a great deal.  I noticed it when I went to raise up my arm a little bit.  I also became exhausted.  I realized I had been tired much of the first day but once my arm became so painful, I was completely exhausted.  I felt out of sorts for about  36 hours and then began to feel normal again.  It probably took a few more days to regain my energy completely.
The night of the day of the vaccines were placed, the patient noted redness and mild swelling at both upper arms at vaccine sites. Despite po Benadryl and ice applications, pt developed some itching, but significant progression of redness and swelling at vaccine site of right arm, but circumferentially taught and swellings at left arm with fine vesicles at Hep A site.
Significant swelling of right upper arm by two days after DtaP #4.  Minimal pain at injection site, no loss of function of arm.  Father described swelling as occurring from shoulder to just above elbow.
INITIALLY ADMITTED ON 5/17/2021 TO HOSPITAL AND SUBSEQUENTLY TESTED POSITIVE FOR COVID-19, >14 DAYS POST VACCINATION.  NOW ADMITTED TO ANOTHER HOSPITAL ON 6/1/2021 FOR ARDS.
SWOLLEN ALL THE TIME; ACHING ALL OVER; Flu like symptoms; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SWELLING (SWOLLEN ALL THE TIME), PAIN (ACHING ALL OVER) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced COVID-19 (COVID-19) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced SWELLING (SWOLLEN ALL THE TIME) and PAIN (ACHING ALL OVER). At the time of the report, COVID-19 (COVID-19), SWELLING (SWOLLEN ALL THE TIME), PAIN (ACHING ALL OVER) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: (Positive) Positive.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in; Sender's Comments: Company comment: This is a spontaneous case concerning a 81-year-old female patient with Ankylosing spondylitis on treatment with Adalimumab, who experienced the non-serious AESI COVID-19, on an unknown date on the same year after the second dose of mRNA-1273. A COVID-19 Test was performed with Positive result. Clinical course and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pain at injection site. Pain started imediately after recieving the first dose. I have had continuous ache/pain in left arm since my first dose. Not as intense as the day of the shot but have had a constant ache at the injection site. I have not been treated as I was hoping the pain would go away on its own. It has not.
Information has been received from a physician concerning a female who at approximately 8 weeks of age. On 08-NOV-2007, was vaccinated with a first dose of ROTATEQ. The patient was vaccinated with a second dose of ROTATEQ on 03 JAN 2008, followed by a third dose on 16 JAN 2008. The physician noted that there were no problems reported. There was no product quality complaint. Additional information is not expected.
On the day of the vaccine 1/12/2021, I did not react well. I had joint pain and flu like symptoms, fatigue and lethargic, no fever.  A few day later, my left knee was sore.  As the day progress, the soreness increased. In March 2021,  I went to my ortho surgeon.  Pain is 10 out of 10. X-ray and MRI was ordered.  Arthritis was detected on MRI.  No medications ordered but I got a hyaluronic shot about 6 week later once the insurance approved it. Within the 6 weeks time frame while waiting for approval, pain improved to 3 out of 10.  After the shot, pain is completely gone.  Currently, on left axillary area, there is a 3X6 inch red discoloration that  has appeared after the 1st shot.  No pain, discomfort or itchiness associated with the blotch.
Became positive for COVID; Became positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24May2021 (Lot number: EW0185) at the age of 27 years as dose 2, single and administered in arm right, administration date 03May2021 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2021, outcome "recovering" and all described as "Became positive for COVID". Patient had no covid prior vaccination. Became positive for COVID - loss of smell, minor headache, congestion from 14Nov2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal Swab): (16Nov2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
MD Called 1/25/22, medication error Adult Pfizer Dose given to patient Inform parents of error  Pediatrician also Called - Dr. (Privacy)  Patient c/o headache and fatigue VS Stable BP 104/80 P80 Oxygen Saturation 97%   Patient received Tylenol X 1 dose Patient monitored for at least 30 minutes Patient felt better and back to baseline after eating and discharge Pediatrician followed up that evening, marked improvement noted Patient seen in clinic the next day w/ Pediatrician Called (Privacy), spoke to (Privacy) , refer to CDC Appendix A, Medication Error  Patient to obtain Dose #2 as scheduled   Precaution Advised
large area of erythema 4x4 cm central with 8-10 cm larger halo erythema with clearing between, very tender to touch, warm, mildly swollen-pruritic after varicella/2 days after shot
Information has been received from an office manager that the physician heard from the physician's colleague that a 16 year old female colleague's patient was given an unspecified dose of GARDASIL (Lot not reported) on a Friday and on Monday the patient passed away (specific dates were unknown).  The reporter considered the event as disabling and life threatening.  Additional information has been requested.
About 5 minutes after receiving the flu vaccine, pt reported pulsating pain that started at her upper back then travelled down her back to just below hip.  It was intermittent pain, that came and went, which was observable with patient's physical reactions and verbal complaints.  No issues with airway reported and no obvious skin reactions.  Blood pressure at time was 170/90.  Pain came and went for duration of less than 10 minutes and pt was not experiencing pain by the time EMS arrived.  EMS did not administer treatment. Pt still reported lightheadedness & dizziness when stood up.  She was escorted out of store by EMS, daughter and husband.
Degraded thinking; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: er8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "Degraded thinking"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath". Clinical course: may have side effect shortness of breath degraded thinking.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-202300146260 Same patient/drug/ different dose/event;
Patient given Influenza vaccine, is not recommended for under age 6 months. CDC Hot line called 1-800-232-2522.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Child had the seizure in the lobby of pharmacy.
fever; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient had fever and chills only the day after the vaccination.  No treatment information was provided by the reporter.
Itching, anxiety, BP 151/85 (pulse 97). O2 sat 100%, given Benadryl.
Swollen lymph nodes in neck with sore throat and clicking when swallowing. Taking mortin for the swelling.
Patient was given her MMR vaccine intramuscularly instead of subcutaneously.  Patient had no immediate reaction, but counseled her to watch for injection site reaction and to notify us if she notices anything.  A twinrix vaccine was also given in the same arm.
Began with left elbow pain, progressed to right elbow, then to other joints. Peaked, with all over, achy body and high fever. Patient has been slowly getting better, according to patient on 12/23/2008.
A report has been received from a licensed practical nurse concerning a 4 year old, female patient, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT had been provided on 15-Jan-2014. It was reported that the patient had been administered expired FLUMIST QUADRIVALENT (Preferred Term: expired drug administered) on 15-Jan-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Face went numb for 8 hours. Swollen glands for 7 days. Migraine for 14 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 13:00 as dose 1, single (Lot number: HG4680) at the age of 69 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfur drugs" (unspecified if ongoing), notes: known allergies: Sulfur drugs. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (19Oct2023) Negative, notes: on day seven. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: After taking Paxlovid for five days (from 12Oct2023 to 17Oct2023), patient home tested negative on day seven. About three day later, she started sneezing and draining again and home tested positive and negative. She was feeling a little better but still stuffed up and tired. She had night sweats too.    The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.