chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/21: 5pm: arm pain started, got worse by evening, took tylenol, did not help. This pain lasted 3 days and now started to get better, after pain is better, injection site and around it started itching, did not treat this. This is similar to my reaction to the first shot of covid. 1/22: 3am: woke up with fever 102.5F, fatigue, chill and loss of appetite, treated with tylenol and ibuprofen. high fever for 18 hours, then better. 1/23: mild temp of 99.5F, no chill, no fatigue, appetite is back. Did not treat, temperature was normal by early afternoon. 1/24: by 5pm, mild soreness to the injection site, itchiness around injection is a little more intense, did not treat.
9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    No concomitant product use was reported.  Patient age was reported as 02 years and 11 months.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  No treatment information was provided.
patient reported stomach cramps and diarrhea the same night as receiving vaccine and the morning following. reported on 4/23 (2 days post-vaccine) still having bloody stool
low grade fever first 2 days, continued off and on nausea, dizziness and confusion
Intense migraines; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6199) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing), notes: on botox treatment every 3 months. Concomitant medication(s) included: BOTOX taken for migraine. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EL1283, Anatomical site: Left arm), administration date: 16Feb2021, when the patient was 26 years old, for COVID-19 immunisation, reaction(s): "Arm soreness". The following information was reported: MIGRAINE (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Intense migraines"; NAUSEA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "nausea". The events "intense migraines" and "nausea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, nausea.  Additional Information: It was reported that the patient's medical history chronic migraines was treated with botox every 3 months which largely eradicated it and typically only gets mild migraines as the botox wears off. 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 COVID vaccine. The treatment for event migraine included gabapentin for 5 days.  No follow-up attempts are possible. No further information is expected.
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
17 years old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). On 03-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 01A21A) with no associated AEs reported.
Potentially got the dose from a vial punctured longer than 12 hours ago; More than 36 days after the first dose receiving the second dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose receiving the second dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose receiving the second dose). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose receiving the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Felt extremely dizzy, fainted twice in the morning after receiving the vaccine. Heard a loud ringing in my ears for about 20 minutes (possibly from hitting my head after fainting and falling). Did not receive medical attention. An hour later, I felt completely fine and have not had any similar episodes since.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot number, route and site not reported) and recently got shingles. At the time of the report, the outcome was not reported. Unspecified medical attention was sought. Follow up information was received from the physician via a herpes zoster questionnaire. An 80 year old female who on 03-OCT-2008 was vaccinated with a single dose (0.65 ml) of ZOSTAVAX (Merck) (lot number: 662969/1206X) (route and site not reported). There was no a rash occurred at the site of injection or elsewhere within 42 days of the vaccination. On 09-JUL-2010 (also reported as 08-JUL-2010) the patient developed herpes zoster. The maximum temperature was unknown. The pain was at least grade 3. Other systemic symptoms included chest pain. At the time of the report, the patient recovered from got shingles. There was a history of chickenpox for the patient. There was no recent exposure to chickenpox or herpes zoster. A direct fluorescent antibody was not done and a specimen was not collected for polymerase chain reaction (PCR). Photo was not taken. The patient was admitted recently because of chest pain and chest pain was ruled out. Electrocardiography (EKG) and cardiac enzymes were negative. The patient was discharged to have out-patient exercise tolerance test (ETT). However, the night on 08-JUL-2010, she developed a rash on left chest, classic zoster. The patient would begin VALTREX along with NEURONTIN. The patient reassured. On 09-JUL-2010, EKG was completely unremarkable. The patient's hospital course and labs were all normal. The patient's head, eyes, ears, nose and throat were negative. neck was unremarkable. Lungs were clear. Cardiac exam was regular without murmur or gallop. There was the classic zostaform eruption midthorax. Abdomen was benign. Extremities were unremarkable. No skin rash. Peripheral pulses were excellent. Neuro was physiologic. No other skin rash other than as noted above. Additional information is not expected.
Hip dysplasia; Fetal exposure during pregnancy; The mother of the infant of unknown ethnic origin and unknown gender was participating in Moderna mRNA-1273 Observational Pregnancy Outcome Study and patient developed DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia). Additionally, the patient had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).  The subject's mother medical history provided by the reporter includes Mother did not had COVID-19 infection which was confirmed by negative test. Concurrent medical conditions included Caffeine consumption (caffeinated beverages less than 3 per day) and Alcoholic (Alcoholic drinks 1 to 9 drinks per week).  No medical history was reported for the subject. Concomitant medications reported included ACETYLSALICYLIC ACID, DIPYRIDAMOLE, LEVOTHYROXINE, ASCORBIC ACID, CALCIUM, CHOLECALCIFEROL, CYANOCOBALAMIN, FERROUS FUMARATE, FOLIC ACID, NIACIN, RIBOFLAVIN, THIAMINE, VITAMIN A NOS, VITAMIN E NOS, ZINC OXIDE, DOCONEXENT, ICOSAPENT and POLYETHYLENE GLYCOL 3350 for an unknown indication.  The subject received the first dose of mRNA-1273 for COVID-19 vaccination on an unknown date. On an unknown date, the subject experienced DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia) (seriousness criteria medically significant and congenital anomaly). Additionally, the subject had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The delivery occurred on 02-Feb-2022, which was reported as Abnormal Pregnancy Outcome. The outcome was reported as Term Birth with Cong Anomaly.  No treatment information was reported by the reporter.  The subject's last dose date prior to the event and the action taken with mRNA-1273 was unknown.  The outcome of the event DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia) was reported as unknown, and for the event FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) it was reported as resolved.  The reporter did not provide the causality for event DEVELOPMENTAL HIP DYSPLASIA (Hip dysplasia) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).; Sender's Comments: This Sponsored case concerning an infant patient of unknown gender, with no reported medical history and foetal exposure during pregnancy, who experienced the serious (due to medically important condition and congenital anomaly) unexpected, event of Developmental hip dysplasia, after the mRNA-1273 vaccine, dose number not provided, temporal association cannot be assessed due to lack of information on vaccination date. The outcome was reported as unknown. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Nausea, vomiting, abdominal pain, hypotension, anemia.
6JAN98 pt recv vax & itching, hot to touch, redness a few days p/vax;itching began in lt arm;14JAN98 lt arm deltoid area-hot to touch, tender, pale, pink rash extends from shoulder down underarm & sl forward;
Very hyper talkative & negative on way home. Got home had anxiety attack. Went to bed at 4:00pm couldnt sleep ..suicidal thoughts/OCD negative thoughts,very depressed... got up at 6pm.  Next day woke up with headache started to clean tired and depressed. Dizzy and tripping over my feet. Next day woke up with headache started to clean got very tense and lightheaded and weak. Had to sit. Husband took blood pressure and it was 70/50. took again diff arm same. Sat for 1/2 hr went to 100/74. Feeling weak all day. Very confused no memory. Went to bed took Seroquel to calm down and sleep. Add note: I have been depressed for a while but the drop in blood pressure, drop in mood(bad) and weakness and dizziness happened after shot. Im afraid to take the 2nd one because of how it affected my mood. and blood pressure.
I had a very good stress test in April with no Afib present. I developed Afib after not having any in over two years. I have been having night sweats waking soaking wet. I have been getting terrible night leg cramps. I have mast cell activation syndrome that is much, much worse, and I am very fatigued.
Information has been received from a medical student concerning one 10 year old patient who was vaccinated with a second 0.5mL subcutaneous dose varicella virus vaccine live (Oka/Merck) (Lot #656923/0451U). The patient developed injection site reaction with redness, swelling, warm and tender to touch that lasted 3-4 days. The patient was afebrile. This patient had a sibling who received the same lot number and did not have a reaction to the second dose. Unspecified medical attention was sought. This is one of three reports received from the same source. The physician is requesting a lot check. A review of the release testing lots revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the center for Biologics Evaluation and Research and was released. Additional information has been requested.
Pt was normally developing infant.  After 1st vaccination series 9/19/02 Pt became fussy and would not sleep or eat well.  He was followed by MD for possible colic.  After 2nd vaccination series on 11/22/02, fussiness increased and appetite decreased, along with decreased sleeping.  Pt was referred to a gastroenterologist; he diagnosed seizure activity and referred to neurologist, MD and to MD (cardiologist).  He was placed on ACTH and zonegram.  Childs condition worsened over the next several months and he expired on 3/18/03.  Dr. reportedly told family that he could not rule out an adverse reaction to immunizations as a cause of the seizure activity.
vaccine leaked out of the injection site; Accidental undersdose; Attempted administration of vaccine twice; Inadvertent exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix and Shingrix, the patient experienced injection site leaking, accidental underdose, wrong technique in drug usage process, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, accidental underdose, wrong technique in drug usage process, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A pharmacist reported that he attempted to administer Shingrix and the vaccine leaked out of the injection site after 2 attempts.  The pharmacist reported that the patient only received approximately 20% of both doses attempted.  The reporter consented to follow up. The pharmacist stated he did not have details.
According to the staff at the Hospital, the patient was treated in their emergency room for a stroke this morning at approximately 730AM
FIRST DOSE PATIENT WAS GIVEN A PFIZER DOSE ON 2/6/21. SECOND DOSE PATIENT WAS GIVEN A DOSE OF MODERNA ON 4/2/21.
Patient claims that he has a sensation or a sense of awareness of where the flu shot was given in his left arm. When he pushes on the spot of his arm he feels a weird sensation, almost like a nerve tingling. He says sometimes he feels the same sensation further down on his forearm, almost like a nerve pain. He is concerned since its been about 5 weeks since the shot. He is also a side sleeper, but doesn't feel that its that, because he notices it daily.
patient is fine. Confirmed no other symptoms or adverse events; administration of VARIVAX that was expired; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-OCT-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, once, lot #U030162 (lot number has been verified as valid for VARIVAX), expiration date: 28-SEP-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis. It was stated that the patient was fine. No adverse event was reported.
Patient had vaccine on 4/13/17. Had rash/itching/redness/swelling on 4/14/17. She said on 4/15/17 she had 103 fever and chills, continued swelling and redness. She went to the doctor on 4/18/17 and he said she had cellulitis. He gave her cephalexin. He tried to give her steroid - she refused. On 4/19 - she said it was much better.
The afternoon following the vaccine (5/7/21), he began to have a hard time breathing, at work, switching breathing between mouth and nose and felt warm. He is a dishwasher. By 5:00 pm, both of his arm muscles and stomach was cramping. He was having bigger problems breathing, and becoming woozy. The paramedics were called to his work,  and he was transported to the ER as they felt he was having an allergic reaction.  He had an IV, Tylenol for a fever, Atavan to relax, Benadryl for antihistamine as they could see his arms were red.  The ER did urine and blood tests as well as a Covid test. He was also given oxygen to bring his oxygen levels back up
pt recvd vax; Guillain barre synd; onset 1st wk of dec;
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Moderna vaccine (NDC--80777-0273-99, lot # 048C21A) was received at store on 7/16/2021 and placed under refrigerated temperature.  3 vials were transferred to another store where 20 doses were administered beyond use date.
Vaccine was expired at time of administration. Due to errors in store-to-store transfer we had zero knowledge that it was expired when given.
Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for the her sister. The age at the vaccination was not reported. The patient received Shingrix and experienced arm pain.  No details about the patients was available at time of report. The reporter did not consent to follow up. This case linked with US2020AMR084981, US2020084176 and US2020AMR084982, reported by same reporter.