chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose Apr2022, 2nd 31Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in April 2022).   On 31st January 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's Comments: The patient received their first dose of Twinrix vaccine in April 2022 and did not receive second dose until 31st January 2023.   Reporter declined to provide any patient information.  The reporter did not have the exact date of the first dose and did not have the lot number or expiration date of either dose. The consent to follow up was not obtained. Additional Supportive Information: The patient received 2nd dose of Twinrix on 31st January 2023, later than recommended schedule, which led to lengthening of vaccination schedule.
expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-350559 (Patient Link).
Suffered a Blood Clot that migrated from my Heart to my Cerebellum resulting in Massive Stroke
Woke up the 23rd at 6:00am, very tired, hard to move, arm swelled up like grapefruit very hot and red, used ice packs, no fever.   Tiredness let about 8:00 pm, swelling stayed for 2-3 days.
Modern a COVID-19 Vaccine EUA. Left arm where administered had about a Golf ball size bump starting about 8 hours after administration as well as a 7/10 pain by palpitation and 4/10 pain with movement. At about the 10 hour mark symptoms started with GI issues, fever and sweats, rapid heart rate and general malaise. Day 2 continued with the GI issues 5/10 arm pain with the golf ball size lump remaining but adding a second bump right at the injection site. GI issues subsided by day 3 but general malaise continued and finally subsiding and a 1/10 pain.
I woke up at 1:00 am , several hours after getting the shot. My body was freezing with chills coupled with  painful cramps throughout my body. i couldn't stop shaking with chills until my wife piled on several blankets, which warmed me up. The chills and the cramps went away after a 1/2 hour or so. Felt wiped out the next morning and throughout the day. Same exact adverse effect occurred on the following days when i got the next three shots: 3/21/2021 11/01/2021 06/23/2022
Patient described having fever, chills, and shooting needle like pain from head to foot for a day and a half following vaccine administration
Statement from health worker from Mobile Vax Team: "We arrived at the patient's home and daughter explained patient was on hospice, had difficulty breathing and was on fentanyl and morphine but they definitely wanted to go ahead with the vaccination. Nursing student, who gave the vaccine said she saw the patient breathing. She wasn't blinking from my observations. We left after 15 minutes. I left my purse there by mistake so about 40 minutes later we called and the daughter informed us that her mother had passed away. Death verified by hospice nurse."
ARM TISSUES AND BONES STILL BRUISED; MUSCLE TISSUE WERE DAMAGED; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm tissues and bones bruised and the doctor said that the patient's muscle tissues were damaged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm tissues and bones still bruised, and muscle tissue were damaged. This report was non-serious.
SOB on exertion; Retaining fluid; could not walk far (10-15 ft)  hindered walking; diarrhea; shortness of breath on exertion; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking) and FLUID RETENTION (Retaining fluid) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension, TADALAFIL for an unknown indication and MACITENTAN (OPSUMIT) for an unknown indication.    The patient's past medical history included Post procedural complication and Hip surgery on 20-Jan-2020. Concurrent medical conditions included Pulmonary arterial hypertension, Interstitial lung disease, Fibrosis and Chronic obstructive pulmonary disease.   On 24-Nov-2020, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to .6 milligram per millilitre. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-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 TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose On an unknown date, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to at an unspecified dose., TADALAFIL (unknown route) 40 milligram and MACITENTAN (OPSUMIT) (unknown route) 10 milligram once a day. In January 2021, the patient experienced DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion) and GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking). On an unknown date, the patient experienced DYSPNOEA EXERTIONAL (SOB on exertion) and FLUID RETENTION (Retaining fluid). At the time of the report, DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking) and FLUID RETENTION (Retaining fluid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown Unknown. On an unknown date, Electrocardiogram: unknown Unknown.         On 20 Jan 2020, the patient underwent a hip surgery, which also hindered his walking. The patient had shortness of breath upon exertion. The patient also had heavy oxygen around the neck which the patient also said that he needed to get something else that was lighter to carry.   No treatment information was reported.
I started with severe bloating and constipation. Then it progressed over a 12-15 hour period to vomiting and abdominal pain. I went to the emergency room of Hospital, and was diagnosed with appendicitis. I had an emergency appendectomy. I have never previously experienced constipation or symptoms related to appendicitis.   After reading about a possible increase in Bell's palsy and appendicitis in the clinic trials, I wanted to err on the side of caution and submit this incident for data purposes and tracking.
Fever, dizzy, nausea, vomiting, weakness, worsening in the morning (from around 9:30, could hardly move until about 3:30, now just feeling weak, feverish, unable to eat.
Fever of 104.7 deg for 2 days which began the day he received the vaccinations.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No relevant concomitant medications were reported.  No treatment information was provided.
Nauseated,  Dizzy immediately after.   Headache and nausea continued 4 hours later
Patient hospitalized due to COVID-19. Patient is fully vaccinated. On supplemental O2, Rocephin, azithromycin, Decadron, Remdesivir, Lovenox
Rec'd 2nd COVID vaccine on 01/28/21. Positive pregnancy test on 2/14/21 with estimated due date 10/26/21. On 3/5/21 scant spotting noted. Contacted OBGYN on 3/8/21, seen in the office. Ultrasound confirmed intrauterine pregnancy with gestation sac, yolk sac and possible fetal pole although measuring smaller than estimated due date. HCG/Progesterone levels drawn. Repeat HCG/progesterone levels drawn on 3/10/21 showed decline. Started miscarrying 3/10/21 morning following blood work. Seen again in OBGYN office 3/16/21 which confirmed complete spontaneous miscarriage.
dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Sep2021 (Lot number: EW8177) as dose 1, single and administration date 03Nov2021 (Lot number: FF8841) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: medical history of underlying vertigo problem. The patient's concomitant medications were not reported.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: The patient who has a medical history of underlying vertigo problem and is calling about the gray and purple cap Pfizer Covid-19 vaccine. She received the first dose on 22SEP2021 (LotEW8177-did not come up in the system per Pfizer  and the second dose on 03NOV2021 (LotFF8841-purple cap formulation. She reported that she had complaints of dizziness after receiving both doses of the Pfizer Covid-19 vaccine but stated that she has "dizzy problems anyway". She asked if the potassium chloride or tromethamine in the Pfizer Covid-19 vaccines causes dizziness. She asked which of the Pfizer Covid-19 vaccines (gray and purple caps) does not have tromethamine and asked if the gray cap Pfizer Covid-19 vaccine is the one with potassium chloride.   No follow-up attempts are possible. No further information is expected.
high pitched screaming for >3hr on the day & following 4mo immunizations;child fell asleep & was back to nl upon awakening;
Patient developed bruising and epistaxis about 12 days after the first dose. His platelet count was 3K/cumm at PCP office on 6/28/2021. He was admitted to the pediatric hematology service on 6/29/21. His platelet count was 19K/cumm and other cell lines were normal. He was given two doses of IVIG  on 6/29 and 6/30/2021. As his platelet count dropped to 24K/cumm and started on dexamethasone for four days. He was discharged from the hospital on 7/1/2021 with platelet count of 31K/cumm. Follow up CBC showed Coombs negative drop in Hb and decline in platelet counts again on 7/21/21. He was started on steroid wean and thrombopoeitn receptor agonist. Recent platelet count was 101K/cumm on 8/4/2021 and continued to be foll. He continued to be followed with weekly CBC.
I'm not really sure about the timing in which this happened, but I know it happened in the winter of 2022. It probably took place in February or March. I began to feel weak at one point and like I had the flu. I had body aches, a fever, weakness, and achy eyes. I took both a rapid antigen and a PCR test at the the medical center, and the results on both were positive. I was prescribed a medication whose name I don't remember and then sent home. I stayed at home and had chicken noodle soup and orange juice for about three days or so. During my illness, I lost a little bit of my sense of smell and most of my sense of taste. The only thing I could taste was the chicken noodle soup. The loss of smell and taste lasted for maybe four days. After that, I started to feel better. I stayed at home from work for a week. When I went back to work, I felt fine, and I masked.
SPOKE WITH FATHER. HE STATES SYMPTOMS OF SCREAMING, BEING FUSSYAND GENERAL DISCOMFORT STARTED APPROXIMATELY 36 HOURS AFTER INJECTIONS.  TYLENOL WAS GIVEN DAY OF VACCINE - MAYBE 2 OR 3 TOTAL DOSES SINCE VACCINATIONS  SAW DOCTOR YESTERDAY.  HE HAS BEEN REFERRED TO GI.  MOTHER HAS BEEN WORKING ON GETTING REFERRAL UPFRADED TO URGENT - HAS NOT BEEN SEEN YET. HE STATES INFANT IS NOT GETTING WORSE, BUT NOT GETTING BETTER EITHER. FATHER AWARE REPORT BEING SENT IN TO THE STATE.
injection site pain; swelling (right deltoid); fatigue; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (injection site pain), VACCINATION SITE SWELLING (swelling (right deltoid)), FATIGUE (fatigue) and NAUSEA (Nausea) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site pain), VACCINATION SITE SWELLING (swelling (right deltoid)), FATIGUE (fatigue) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE PAIN (injection site pain), VACCINATION SITE SWELLING (swelling (right deltoid)), FATIGUE (fatigue) and NAUSEA (Nausea) outcome was unknown. Not Provided      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.   No concomitant medication was mentioned. No treatment medication was mentioned.
The pt experienced a fever and lethargy beginning 8 hours following vax. The pt also experienced a runny nose, slight erythema. The throat was normal, chest normal, lungs normal.
Report received from a consumer on 27-OCT-2010 (received via Merck WAES 1010UA03406).  A 34 year old female patient received AFLURIA (batch number: M51507) on 20-OCT-2010. The patient had a medical history of sulfur allergies. On the morning of 21-OCT-2010, 12 hours after vaccination with the suspect drug, the patient woke up feeling the "typical aches and pains from the flu vaccine". She got up to urinate at about 6 p.m. and noticed blood in her urine. She also complained of having severe (10 out of 10) lower leg muscle cramps. She also reported that 20 hours later, she had intense tingling and numbness in the left side of her face and left arm. The patient thought what she experienced may be considered "transient renal involvement". The patient sought medical attention and attended the emergency department. She said the doctor thought that the events may be indicative of a vascular disorder. The events of intense tingling and numbness in the left side of her face and left arm were considered to have resolved and the other events were resolving. The patient stated that she continued to have blood in her urine but it was not visible any more. She thought that it was getting better. The reporter did not assess these events for seriousness or causality. The company considered this case as serious due to medical significance. The company considered events possibly related to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Information has been received from a nurse practitioner concerning a 47 month old (age estimated) female who in July 2007, was vaccinated with one dose of VARIVAX (Oka/Merck) 0.5 ml, SQ. There was no concomitant medication. The last couple of days, in February 2009, the patient had a possible breakthrough chicken pox. The patient's parent stated that there were scaly spots on several areas of her body. The patient did not recovered and sought medical attention as her parent spoke with the nurse. The patient had not been seen yet. This is one of several reports received from the same source. Additional information has been requested.
No additional AEs; Caller reported expired dose of MMR II  was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On 12-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, dose of 0.5 ml, administered subcutaneously, lot # T034389, expiration date 08-OCT-2022 (dose number, strength, and site of vaccination were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
On Saturday 6/26, I got the J&J vaccine at the clinic. That night I experienced whole body soreness/achiness, my entire left arm felt tingly and numb and restless, my back hurt a lot and I had a really bad headache. I felt dehydrated. I drank water but I still felt dehydrated. On Sunday 6/27, I was tired because I couldn't sleep well because my head hurt so bad the night before. My symptoms were the same as on Saturday night. On Monday 6/28 everything is the same except now I'm also throwing up, I'm not able to keep food or water down. I do not have a temperature.
H/A immed after vaccine; "tingling in brain; chills, fever of 102 degrees F after few hrs; sick in bed x 3 days with fever, chills, nausea, anorexia. Swollen, painful inj. site.
Delayed reaction: swollen, itchy, soreness, red/blistered skin which got worse over the corse of 4 days.
Extremely painful menstruation. Large clots.; Extremely painful menstruation; Severe cramping; Left arm pain; This is a spontaneous report from a contactable consumer (patient).   A 40-year-old female patient received the third dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 30Sep2021 19:00 (Batch/Lot Number: FF2589) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), ascorbic acid (VIT C), and multivitamins, taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 21Dec2020  (Batch/Lot Number: EK5731) as DOSE 1, SINGLE; the second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in the left arm  on 11Jan2021  (Batch/Lot Number: EL3249) as DOSE 2, SINGLE and experienced left arm pain with the second shot; both given  for COVID-19 immunization. The patient was not pregnant at time of vaccination. Facility where vaccine was administered was a pharmacy or dug store. There were no other medications received in two weeks. The patient did not have COVID-19 prior to vaccination. On 01Oct2021, the patient  experienced extremely painful menstruation. large clots, severe cramping, and left arm pain. The patient underwent lab tests and procedures which included COVID test nasal swab: negative  on 01Oct2021 Nasal Swab per test weekly. The events did not require treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Large red spot (about the size of a softball) surrounding injection site. Slightly raised, itchy, not painful
pt recv vax 5DEC97 & w/in 12hr of vax pt exp fever of 103, chills, severe intractable n/v, abd pain & loose stools to watery diarrhea;pt hosp for 3 days;