chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was examined by his pediatrician and cleared for physical exercise on 06/01/2021; 4 days before receiving his 1st COVID19 shot on 06/05/2021. On 06/07/2021 we dropped patient off at Soccer Camp. At 10am he started basic soccer ball control drills, which did not include rigorous exercise. At 10:30am we received a call from him, asking for us to pick him up as he had almost blacked out a few times.  We arrived at the sports field at 10:40am. I found patient to be red faced, sweaty, but cohesive. He described the following symptoms occurred during mild exercise: difficulty breathing, thirsty, fast heartbeat, "black things" over eyes, preventing clear vision, difficulty focusing, difficulty hearing, feeling faint  He took a water break and used his pro-air inhaler, as he thought he might have been having his 1st asthma attack (he's only ever presented with slight wheezing or night time cough). After a short break, his symptoms subsided, so he re-joined the group. After one more soccer drill, the symptoms came back again, but this time he experienced very hard palpitations and the feeling that his shoes were squeezing his feet. At that point he asked for permission to call to us and have us collect him.  We took him home and monitored him for a while. He seemed calm and symptom free. I had him shower and he was fine for the rest of the day.  The following day I had him jog on our treadmill for a period. He was symptom free. I increased inclination on the treadmill and he handled it ok without any of the previous symptoms. However, now realizing that he was within the 3 day window of his COVID shot, I decided not take him back to the soccer camp.   As of 06/13/2021 he has not complained of any symptoms returning. That said, he also has not performed any significant outdoor exercise since then either, besides walking.
I had a allergic reaction that I break out in hives; I had a allergic reaction that I break out in hives; had a little bit of difficulty in breathing; This is a spontaneous report from a contactable Nurse. A 31-years-old patient of an unspecified gender received bnt162b2 (BNT162B2) at age of 31 years via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Batch/Lot Number: EW0164) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and methylprednisolone acetate (METHYLPREDNISOLONE ACETATE), injection via an unspecified route of administration on 13Sep2021 (Batch/Lot number was not reported) as an unspecified dose for an unspecified indication. Medical history included fibromyalgia and rheumatoid arthritis. Concomitant medications included hydroxychloroquine (HYDROXYCHLOROQUINE) and sulfasalazine (SULFASALAZINE). On 13Sep2021 patient reported that "I had a allergic reaction that break out in hives and "I had a little bit of difficulty in breathing. All events with outcome of unknown. The patient reported that "bit of difficulty in breathing was not to the point that I have got I called the ambulance but I got 25mg Benadryl intramuscular and I got Solumedrol both as treatment. Patient underwent lab tests and procedures which included c-reactive protein: 0.4, red blood cell sedimentation rate: 11. Clinical course: patient received "COVID 19 shot on the 10th of September which is Friday. Today I went to my orthopedics and got methyl prednisolone injection in my 'wrist'. 5 min after leaving my orthopedic I had allergic reaction". I have a question the methyl Medrol the oral and the injection are they different or no?".; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 and methylprednisolone acetate cannot be excluded for the reported events urticaria, hypersensitivity and dyspnoea occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
16 days subsequent to receiving one dose of varicella virus vaccine live the pt developed a fever of 102F. The next day the pt developed a rash with more than 50 lesions all over her body. The pt sought unspecified medical treatment. A specimen was obtained four days later and sent to a lab for DNA analysis. Results indicated that the specimen was VZV positive and wild type virus was identified. Follow up information indicated that the pt was diagnosed with chickenpox. The reporter considered the pts experience disabling because she was out of work. The pt was vaccinated with a second dose of varicella virus vaccine live and then developed a large 2.5 X 2.5 inch area swollen, red and hot at the injection site. Additional information has been requested.
demyelination with brain inflammation; demyelination with brain inflammation; seizures; Fever; 2 seizures fever vomiting and demyelination with brain inflammation; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 01Apr2021, 06:45 PM, at 38-year-old. Medical history included: diabetes and hypertension; known allergies: penicillin. No other vaccine in four weeks and no other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on unknown date, 06:45 PM, at 38-year-old. On 02Apr2021, the patient had 2 seizures, fever, vomiting and demyelination with brain inflammation. Emergency room/department or urgent care visited and hospitalization for 10 days. Treatment included: plasma exchange, steroids, fluids and IV antibiotic. Lab data included: negative COVID test on 02Apr2021. Outcome of the events was resolving.  Information about lot/batch number has been requested.
Information has been received from  a licensed visiting nurse concerning a 4 year old white female with no medical history or allergies who on 12-JUN-2007 at 9:40 AM was vaccinated SC on left leg with 0.5 ml dose of PROQUAD (Lot # 655746/1093F). Concomitant therapy on the on the say day included an IM fifth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid on right leg, a third SC dose of IPOL on left leg. Previous vaccines included a first dose of VARIVAX and a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). It was also reported  that on 19-JUN-2007 patient has possibly developed shingles. The patient developed an injection-site reaction that was a little larger than a 50 cent coin that consists of small red dots. Additionally, the patient had a triangular area consisting of 3 small red dots on her torso. There were no blisters. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from the licensed visiting nurse who stated that the child developed several red lumps around site of injection. The patient complained of stinging and also developed 4 red lumps on rib cage on left area. At the time of the report the patient recovered. No further information is expected.
Moderate Headache and fatigue throughout day. Chills, generalized feeling of being unwell.
neck is swollen since getting 2nd vaccine.; He says it feels sore; he cannot move his arm as much; This is a spontaneous report from a contactable consumer and his parent. A 13-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 12Jun2021 at 11:15 (at the age of 13-year-old) as dose 2, single for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications in two weeks. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 22May2021 at 11:15 (at the age of 13-year-old) as a dose 1, single for COVID-19 immunisation. 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. On 13Jun2021 at 12:00, the patient experienced his neck was swollen after getting his second vaccine and he felt that the neck was sore, and he could not move his arm as much. It was unknown whether therapeutic measures were taken as a result of the reported events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was recovering at the time of this report.  Follow-up attempts completed. No further information is expected.
NO adverse effect, Adult dose (only labeled for patients >18 years old) given to 12 year old patient.
Chest pain on left side. Eventually diagnosed as pericarditis after weeks of tests and hospitalization. Currently on multi-week course of Indomethacin
I took the vaccine shot on June 2 and I started to have some rashes and allergic reactions on my face on the morning of June 5, on the morning of June 8 I also noticed a series of red bumps on both my arms. I visited a physician at a medical clinic on June 8 and the doctor prescribed me some medications that would reduce the allergic reactions and itchiness. As of right now, June 9 I did notice that some of the rashes on my face is starting to fade but the red bumps on my arm have not gotten better.
After FLUMIST administration pt became, pale nonresponsive, eyes rolled back, followed by body stiffness and seizure like movements, for approximately 45 seconds. Followed by crying and consecutively general weakness. Mother had denied ASE to vaccines in past, but after episode admitted that it had happened twice before once with a Hepatitis vacc & the Kinder Boosters and when pt experiences pain. Mother declined paramedic assistance. Pt had sm amount of urinary incontinence.
When injection was administered, LPN and patient noted a flash back of some clear fluid when needle withdrawn.  Patient requests a third dose of vaccine because she does not believe she received a full dose.  Small amount of clear fluid noted (two droplets) upon arrival.  No treatment needed at this time.  Recommended she see her PCP for further direction.
& Arm Weakness, Neuropathy LIDOCAINE UNITS use 1 5 % patch to R chest at night for 12 hours, remove during the day ,GABAPENTIN 300 MG HS
pt rt thigh had immun of erythema @ inj site; the area was painful to touch;erythema measured 4mm prior to leaving ofc;no other adverse sxs noted;
and just got both again, the 2nd today; got both, forgot about it, and got both again; This case was reported by a consumer via  interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got both doses in summer 2019).   On 1st December 2021, the patient received Shingrix. On an unknown date, the patient received Shingrix. On 1st December 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had got both Shingrix vaccines in summer 2019 and had frankly forgotten about it. The patient had just got both again, the 2nd one today, and just now had checked and realized the he/she already had the Shingrix vaccine. The patient enquired if he/ she should see the doctor or do anything.
heavy bleeding; bleeding from her vagina almost daily since she received the second shot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in right arm on 11May2021 11:00 (Lot Number: EW0168) as dose 2, single at the age of 38 years old for COVID-19 immunization. No medical history. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Historic vaccine was bnt162b2 (lot number: EW0162) administered in right arm, received on 16Apr2021 11:00 as dose 1, single at the age of 38 years old for COVID-19 immunization. The patient had been bleeding from her vagina almost daily since she received the second shot. It was sometimes light bleeding and sometimes heavy bleeding. Adverse event start date was 12May2021. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The outcome of event was not recovered.
Pt. noted severe pain at injection site 2/18/08 that radiated into forearm over the next 24 hours. Approx. 24 hours after the inj. her 4th and 5th fingers and ulnar apect of her left hand felt tingling with mild pain at the tips of her fingers. Her sx have continued. No erythema or drainage at inj. site. Normal ROM and sensation in fingers. She had taken ibuprofen 2/19/18 x 1. She is instructed to take ibuprofen 3x daily and apply warm compresses to the inj site.
Swelling; Pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) and PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling) and PAIN (Pain). At the time of the report, SWELLING (Swelling) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.  Patient stated that received vaccine on 26 May.
The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021; He had hardly any side effects for the 1st 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021). In 2021, the patient experienced IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses). At the time of the report, IMMUNISATION REACTION (He had hardly any side effects for the 1st 3 doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 04-MAR-2021 and 2nd dose on 13-APR-2021) outcome was unknown.            No concomitant product use was reported.  No treatment information was reported.   This case was linked to MOD-2022-563451, MOD-2022-563456 (Patient Link).
Lesions on palate were about 10 millimeter in diameter; Burning pain in my mouth; could not drink or eat anything acidic or crusty; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, lichen sclerosis, and penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 01Mar2021 at 14:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 23:00, the patient experienced lesions on palate they were about 10 mm in diameter. They caused burning pain in mouth. Patient reported that she could not drink or eat anything acidic or crusty. She sent photos to her doctor who referred her to an ENT doctor. The doctor thought it might be a side effect. The lesions were still healing as of 14Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events lesions on palate, burning pain in mouth, could not drink or eat anything acidic or crusty was recovering.  No follow-up attempts are needed. No further information is expected.
22JAN91-fever to 103(R) this AM, fussy, high pitched cry, Office exam -temp 101(R), P.E. irritable, lethargic, Rx: Tylenol; Avoid pertussis immun for future shots.
This spontaneous report as received from a physician refers to a patient of unknown sex and age. The patient was vaccinated with dose 1 GARDASIL (lot number not provided) in August 2012. No other co-suspects were reported. No concomitant medications were reported. On 08-JAN-2013 the patient came in the office to receive the second dose of GARDASIL. No adverse event was reported. Additional information is not expected.
Got the shot it turned into a sore & and it won't heal.; That area is tender and the sore is about the size of a pea; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Got the shot it turned into a sore & and it won't heal.) and VACCINATION SITE PAIN (That area is tender and the sore is about the size of a pea) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Got the shot it turned into a sore & and it won't heal.) and VACCINATION SITE PAIN (That area is tender and the sore is about the size of a pea). At the time of the report, VACCINATION SITE PAIN (Got the shot it turned into a sore & and it won't heal.) and VACCINATION SITE PAIN (That area is tender and the sore is about the size of a pea) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Got the vaccine this past winter in February or March. Where Patient got the shot it turned into a sore and it was not healed. Patient went to doctor, and it gave a salve which had not helped. That area was tender, and the sore was about the size of a pea. patient talked to the doctor, and now planning on seeing a dermatologist next.   Reporter did not allow further contact
Dizziness came over me while sitting at table working at computer about an hour and a half after experiencing moderate chills. Then apparently I blacked out for approximately 5 minutes and my wife noticed and tried to rouse me. When I came to, I was still dizzy and went to lie down. Symptoms abated within a half hour or so. After about 2 hours, following phone calls to primary care Dr., we went to hospital ER for examination. Following intake we were seen by ER Dr. after approx. 7 hours.
Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine.  Should I get the 2nd vaccine, scheduled for 4/15?
We were notified of a vaccine error of DTaP given to patient over the age of 6. Pediarix was given after a review of records that the patient brought with her from her school requiring these vaccines as well as system records showing 1st shot was administered on 10/27/2021 and listed as valid. Pt has not reported any adverse events following the first dose and has also not reported any problems after second dose was administered on 06/02/2022.
FLU SYMPTOMS; CHILLS "SHE WAS COLD"; DIARRHEA; VOMITING; LOSS OF APPETITE; FATIGUE; NAUSEA; This spontaneous report received from a consumer. The patient's concurrent conditions included lupus, non smoker, abstain from alcohol, and allergy, and other pre-existing medical conditions included no illicit drug usage. The patient was previously treated with ergocalciferol, meloxicam, alprazolam, pantoprazole, gabapentin, hydroxychloroquine sulfate, rosuvastatin, and acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, the subject experienced loss of appetite. On 14-APR-2021, the subject experienced fatigue. On 14-APR-2021, the subject experienced nausea. On 15-APR-2021, the subject experienced diarrhea. On 15-APR-2021, the subject experienced vomiting. On 15-APR-2021, the subject experienced chills "she was cold". On an unspecified date, the subject experienced flu symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, vomiting, nausea, fatigue, chills "she was cold", loss of appetite and flu symptoms was not reported. This report was non-serious.