chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After checking out and leaving the doctor's office after a routine well-child exam, we got in our car. Right after my son closed the door and fastened his seat belt, he reclined his seat slightly. I jokingly asked if he was already feeling lethargic. We were warned that he might be lethargic for about 3 days. He did not respond. His eyes rolled back and his upper body began shaking. His head was shaking as well. I began yelling at him and grabbed his arm, but he didn't respond to me. The movement lasted approximately 30 seconds, but could be slightly more or less. (It seemed like forever.) I was about to get out of the car and run for help inside the doctor's office when his body relaxed, and his eyes closed completely. He then opened his eyes and looked at me. He did not know what had just happened and thought he had just fallen asleep. He was slightly  disoriented,  alert, but slightly lethargic. He was extremely pale, diaphoretic and his pulse was approximately in the 40s. It had been 84 in the doctor's office. He was able to stand and walk and we went back into the doctor's office. I explained what had just happened.  They took his temperature and led us into a room for him to lie down. The doctor came out and looked at him. He explained that he just passed out and that it is common after shots and blood draws. It was a blood pressure thing and he needed to rest. No exam was done and no vital signs taken. I took his pulse and it was 70. He was told to rest there for a bit. After 15 minutes, he felt stronger and we left the doctor's office.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 07-JUL-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion were 64 and 8 hours and the lowest recorded temperature reported were 34 and 31 Fahrenheit (F) (1.111111111 and 1-0.555555556 Celsius (C)) respectively. The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report as received from a phlebotomy technician concerning to a patient of unknown age and gender who on an unspecified date was vaccinated with RECOMBIVAX HB (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The phlebotomy technician reported that the patient received an improperly stored dose of RECOMBIVAX HB. No symptoms were reported. Additional information has been requested.
Allergic reaction to the Covid 19 vaccine; Itchy; Big red spot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to the Covid 19 vaccine), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Big red spot on her arm) 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 01-Feb-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 HYPERSENSITIVITY (Allergic reaction to the Covid 19 vaccine), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Big red spot on her arm). At the time of the report, HYPERSENSITIVITY (Allergic reaction to the Covid 19 vaccine) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown and VACCINATION SITE ERYTHEMA (Big red spot on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Reporter contact information and patient demographics were updated.
Patient developed right eye lid swelling and bilateral eye redness when he got home. Patient's mother called to inform and brought patient back to the clinic. Patient was given Benadryl 50mg IM.  Approximately 15 minutes after Benadryl administration, the patient's right eye lid swelling went down and bilateral eye redness went away.
Patient said that when she got home later that night, her left arm had a tingling and numbness sensation. She called the Health Department the next day. I told her to continue to watch it for changes on the skin and to put an ice pack for a few minutes. I followed up with her later in the week. She did not answer the phone after repeated attempts.
My arm got pretty swollen; runny eyes; runny nose; took Claritin for the allergies; I was wheezing; My lungs hurt to breath and laugh. My lungs are just really sore.; This is a spontaneous report received from a contactable 23-year-female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. The patient reported that her arm got pretty swollen, runny eyes, runny nose. She took oxymetazoline hydrochloride (CLARITIN) for the allergies and she was wheezing. She had allergy induced wheezing that she got. On 07Apr2021 a couple hours after she took the oxymetazoline. her lungs hurt to breath and laugh. Her lungs were just really sore. She looked it up on google and that scared her that she could be have a bad reaction so she decided to call. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Employee reports that later the same day she began to have chillls, exhaustion, body aches and HA. No fever.
Information has been received from a pharmacist via a physician concerning a patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient developed an injection site reaction.  The patient's outcome was unknown.  Additional information has been requested.
Six hours after the shot I began to shake. I was not cold and my temp was only 99 degrees. The shaking turned into uncontrollable jerking of my shoulders, torso and thighs. The jerking lasted 3 hours. My family became concerned and said I looked like I was convulsing. We were making plans to go to the ER when it started to calm down. I had no control over my body. I finally stood up and my body felt like I was made of led. Headache, slight fever, and weakness persisted until 48 hours post shot.
Hours after high dose flu injection pt reports head/neck pain, uncontrollable shaking, pain from injection site to hand. Next day her arm turned warm, red, et very painful from above the injection site to just above the elbow.
9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; No adverse event; 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date).    This case contains information for the 6th of 9 patients described by the reporter.  No concomitant medications were reported.  Dates of administration of vaccine on different dates, one dose given on the 13-Jan-2023, 4 doses on the 14-Jan-2023 one dose on the 16-Jan-2023, one dose on the 17-Jan-2023 and two doses on the 19-Jan-2023.  Patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine reported as unknown.  Date vial was initially stored in the fridge 14-Dec-2022.  Vial size reported as 2.5 milliliter.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704964 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704964:Master case - 1st adult patient (vaccine start date: 13-Jan-2023)
Received egg free flu (FLU-BLOK) and almost immediately had burning and itching of the affected arm. Progressed to head congestion and headache and needed use of albuterol MDI. Arm was swollen, itchy, pain over injection site. Developed tingling distally. Saw PCP and given 6 day taper of steroids.
two hours after vaccines administered patient started to get a sore throat, runny nose, tiredness diarrhea  and achy arms. Patient took Ibuprofen and  Day quil. Provider stated to have him monitor symptoms due to it could be from shots or he could be coming down with something. Quarantine and  if symptoms don't improve may need to be tested for COVID.
PCR test/ Positive; PCR test/ Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "unknown" and all described as "PCR test/ Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events and suspect drug BNT162B2 cannot be excluded.
Information has been received from a medical assistant concerning a 15 month old pt who on 02/10/2003 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). One week later, on 02/17/2003 the mother said that the child had a fever of 103.5 that lasted about a day and then resolved. Unspecified medical attention was sought. Additional info has been requested.
Received booster 2/16/22 Left arm. By approx 3:15pm my neck chest and back were itchy and broke out in Red Rash. By 4pm had fever 101 orally. I am a  Nurse practitioner, so i took Liquid Benadryl Q 4-6 hours 2/16 PM until 2/17 pm. 2/18 rash subsided and i continue to take Claritin.
24hr post vax pt began w/fever, n/v, diarrhea;progressed to aphasia to rt side weakness;CVA confirmed w/MRI @ hosp;
Cannot smell anything. He rcvd a brochure stating he should report any issues after taking the vaccines.
Information has been received from a physician concerning a female who on 10-MAY-2008 was vaccinated with her first dose of GARDASIL (lot number unspecified). On 01-MAY-2008 the patient fainted immediately after receiving the dose. She hit the floor and hit her head and "it wasn't good".  The patient sough unspecified medical treatment in the office. No additional information at this time. Additional information has been requested.
Pt presented to hospital complaining of nausea, vomiting and cough, tested positive for covid. Pt treated with remdesivir and azithromycin, and dexamethasone. pt discharged home.
Fever around 101  for 3 days, hard/swollen knot at injection site, rash that broke out on right side of neck going down straight line to into my breast that was red/ itchy and eventually scabbed over and still have scars in placed
VS: 210/100-74-98.4-98%RA. Resident called front desk and reported she wasn't feeling good after receiving COVID-19 vaccine. Seen resident immediately in apartment around 1310 accompanied by CM sitting in chair. Alert and oriented to person, place, time, and situation. Verbal and able to make needs known. Speech clear and coherent. No slurred speech or facial drooping noted. Resident received the 1st dose of Moderna COVID-19 vaccine around 1200. She was observed for 30 min by ARR staff immediately after vaccine was administered. She then went to grab coffee and went to her apartment. She did not yet eat lunch. Resident c/o feeling "woozy" and eyes feeling heavy/"uncomfortable". Continued from above: Resident has a history of anaphylaxis  and several allergies. Called EMS around 1320. While waiting for EMS rechecked BP several times with SBP between 200-215. She denies any SOB, numbness, tingling, or indigestion. SpO2: 97-98%RA. Resident then stated she has slight tightness/discomfort to her left chest. EMS arrived and left ARR at 1414 and sent to Medical Center.
Information has been received from a certified medical assistant concerning a 21 year old female who was vaccinated with a dose of Gardasil. Subsequently two of three days after the vaccine the patient experienced "bleeding". Additional information has been requested. This is one of two reports from the same source.
This spontaneous report was received from a medical assistant regarding an 18 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On 28-OCT-2015, the patient was vaccinated with first does of VAQTA (lot # L028666, expiry date 04-NOV-2016) dosing details unknown. Concomitant medications were not reported. On 26-APR-2016, the patient was vaccinated with second dose of VAQTA (Lot # L023232, expiry date 25-FEB-2017) which was less than recommended 6 month interval (inappropriate schedule of vaccine administrated). No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Dizziness, headache, nausea started 12/19/20. Vomited on 12/20/20. Came in on 12/21/20 to be seen by provider.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Mild
I woke up really disoriented and felt weird. I ran to the bathroom and I started vomiting and had diarrhea at the same time. I also was running a fever of 101.6. I contacted my doctor and was told to increase fluids. I was taking TYLENOL and MOTRIN for the fever. The vomiting was the one time, but the diarrhea lasted a few days. I also experienced severe headaches that concentrated on the top of my head. I also had a softball size swelling at the injection site that lasted for a few weeks. I experienced these symptoms for about a month before they subsided and during this time, I ended up losing a total of 8 pounds. I did also end up having a breakthrough COVID-19 case on 01/20/2022. I experienced fever, headaches and breathing treatment. The cough was severe to the point I ended up losing my voice. That is when I got tested and it came back positive. I contacted my doctor and he prescribed steroids'. I had a reaction to steroids. I was taking MUCINEX and TYLENOL MOTRIN. These symptoms last about a month. I still experience heart rate issues, asthma and joint pain. I had been referred to see a Rheumatologist.
DIAGNOSED AND HOSPITALIZED WITH COVID-19 AND PNEUMONIA ON 6/21/21 AFTER BEING VACCINATED WITH MODERNA VACCINE IN JAN/FEB. SHE HAS HAD INCREASING SHORTNESS OF BREATH FOR SEVERAL DAYS AND SAW HER PCP TODAY. SHE IS ON STEROID MEDS AND NEB TREATMENTS FREQUENTLY.
Woke up at 3 AM with moderate body aches. Slept off and on until 8 AM. At this time I had a low-grade fever, fatigue, body aches, moderate headache. Also lost my appetite and had a "sour" stomach. Not nauseus, but in the bathroom consistently throughout the day. These symptoms continued until 2 PM when the fever broke. Body aches lessened by 3 PM. Headache discomfort peaked around this time though. Worst headache I've had in as long as I can remember. Sour stomach was resolved by 8 PM and I ate a small meal. By 1030 PM, the only symptoms I'm dealing with now are a moderate headache and fatigue.
This case was reported by the mother of a consumer and described the occurrence of irritability in a 16-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent vaccination included MMR vaccine (manufacturer unspecified) and VARICELLA virus vaccine (manufacturer unspecified) both given on 3 March 2008.  Concurrent medications included Multivitamins (Multivitamin).  On 3 March 2008 at 11:00 the subject inadvertently received 4th dose of PEDIARIX (unknown).  On 3 March 2008, 2 hours after vaccination with PEDIARIX, the subject experienced irritability.  He was screaming at 18:00.  The mother reported that her child was not sleeping at night and had been uncontrollable throughout the day.  The subject experienced a systemic reaction.  The 4th dose of PEDIARIX was considered to be a maladministration (asymptomatic/extra dose given) as a 4th dose of PEDIARIX is not indicated.  At the time of reporting the events were improved.
Patient received her second dose of Shingrix on 5/22/2019 in her left arm. She returned to the pharmacy today on 5/24/2019 to show her reaction to the immunization. She said she developed a bright red rash on both arms. Her injection site was also red, swollen, and hot. She also reported 3 pustules; one on the right arm, one on the left arm, and one on the upper right thigh. Today the rash was gone on both arms and the pustules are gone but the injections site was still slightly red and warm to the touch. She said she didn't have any problem with the first dose.
Shortness of breath, chest pain. coughing, diffuse headache and some body aches, fever, chills, sweats. increased work of breathing, tachycardic, tachypnic,
pt recvd flu shot 22OCT93; 28OCT93 unable to move due to pain in neck, shoulder, behind eyes progressing to arms & legs; 5NOV93 unable to eat w/o dropping food, arms were like noodles; began w/resp problems, like an asthma attack;
Patient received the first COVID-19 vaccine on August 5, 2021. Approximately a week after injection, patient developed an itchy rash (AKA COVID arm). Patient took oral antihistamines and eventually the rash subsided. Patient presented to the pharmacy  on September 2, 2021 for the second COVID-19 vaccine dose. No additional symptoms or side effects were reported.
I received shingles and I was vaccinated for shingles and still got them after the shot.
Within 12 hours of my booster shot, I became extremely lethargic, had a bad headache, a slight fever, and extremely dizzy. I couldn?t eat anything and wanted to just lay in bed and not move. I felt like I had been hit by a truck. I started feeling better about 15 hours later but still had the headache.  By the next morning, I felt fine, just a little tired.
Vial of vaccine was not diluted prior to administration. Patient had no adverse affects from dose.
Information has been received from a RN concerning a pt who on 23Jan1996 was vaccinated with a dose of varicella virus vaccine live (lot 616337/1123B). Subsequently, on 27Oct00, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack/her other ear was burning, red, felt hot and started cracking again; right ear itching and burning and then the skin started to crack/her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Program. The report is first of four different patients.  A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had right ear itching and burning and then the skin started to crack. On an unspecified date, patient's other ear was burning, red, felt hot and started cracking again. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Diarrhea for 3 days, intense arm pain all the way up to the neck for 1 week.