chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pressure in her head; sinus pressure; couldn't walk very good with her legs; epileptic reaction; swollen rash on left arm; swollen rash on left arm; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (epileptic reaction) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21, 046A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin-rash), Sulfonamide allergy (rash), Cancer and Diabetes (Not taking any Diabetic medication.). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced HEADACHE (really bad headache). On 30-Aug-2021, the patient experienced PERIPHERAL SWELLING (swollen rash on left arm) and RASH (swollen rash on left arm). On an unknown date, the patient experienced EPILEPSY (epileptic reaction) (seriousness criterion medically significant), HEAD DISCOMFORT (pressure in her head), PARANASAL SINUS DISCOMFORT (sinus pressure) and GAIT DISTURBANCE (couldn't walk very good with her legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 2 dosage form every four hours. At the time of the report, EPILEPSY (epileptic reaction), PERIPHERAL SWELLING (swollen rash on left arm), HEAD DISCOMFORT (pressure in her head), PARANASAL SINUS DISCOMFORT (sinus pressure), GAIT DISTURBANCE (couldn't walk very good with her legs), RASH (swollen rash on left arm) and HEADACHE (really bad headache) outcome was unknown.            Patient reported that she tried to go to urgent care for her rash and the doctor told her to take Benadryl (high doses) 2 tablets every 4 hours which she took for a week.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of diabetes and cancer are cofounder. The event was downgrade to non-serious, due the patient did not seek medical attention for the epileptic reaction, but she sought for medical attention for the rash.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of diabetes and cancer are cofounder. The event was downgrade to non-serious, due the patient did not seek medical attention for the epileptic reaction, but she sought for medical attention for the rash.
It happened the night of vaccination, I had a fever of 102-103 fever, with tired and achy. I was tired, fatigue, and felt bad the next day. This lasted one day. I called my doctor and he said to treat it with Aspirin, fluids, and bed rest.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaky legs) and FEELING ABNORMAL (it is very irritating) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Previously administered products included for an unreported indication: VACCINES (Received shingles vaccine) on 12-Mar-2021. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced TREMOR (Shaky legs) and FEELING ABNORMAL (it is very irritating). At the time of the report, TREMOR (Shaky legs) and FEELING ABNORMAL (it is very irritating) outcome was unknown. No treatment information was provided. This case concerns a 74-year-old female who reported having shingles vaccination and nonserious unexpected events of tremor and feeling abnormal. Event onset 36 days after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 74-year-old female who reported having shingles vaccination and nonserious unexpected events of tremor and feeling abnormal. Event onset 36 days after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Cleft lip and palate; My baby thrashed violently in my stomach most of the night; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus/baby. This is a baby report.   The mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 17Sep2021 13:00 (Batch/Lot Number: FF2587, expiration date: 30Dec2021) as dose 2, single for COVID-19 immunization. The patient received the drug via transplacental. The patient's medical history and concomitant medications were not reported. The baby thrashed violently in the mother's stomach most of the night on Sep2021. The patient had cleft lip and palate. The patient's father was 40 years old. No history of smoking, alcohol drinking and use of illicit drugs during the mother's pregnancy. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101227227 Mother/baby case
While administering vaccine, pt (5 years old) moved away and only half of the vaccine was administered. Pt's mother requested that the other half to be administered to the right arm.
FELT LIKE ALMOST LITERALLY BIT THE BULLET/INABILITY TO GET COMFORTABLE; UNABLE TO SLEEP; CONSTANT URGE TO STRETCH; NO APPETITE; SICK; ACHES; DISCOMFORT; UNCOMFORTABLE ACHY GUT; ENTIRE AREA WAS LIKE BAD MENSTRUAL CRAMPS; TIGHTNESS IN CHEST; MOSTLY BILE; LEGS WERE VERY WEAK; CHILLS; FEVER 99.5 TEMPERATURE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. 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, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like almost literally bit the bullet/inability to get comfortable. On AUG-2021, the patient experienced unable to sleep. On AUG-2021, the patient experienced constant urge to stretch. On AUG-2021, the patient experienced no appetite. On AUG-2021, the patient experienced sick. On AUG-2021, the patient experienced aches. On AUG-2021, the patient experienced discomfort. On AUG-2021, the patient experienced uncomfortable achy gut. On AUG-2021, the patient experienced entire area was like bad menstrual cramps. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced mostly bile. On AUG-2021, the patient experienced legs were very weak. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 99.5 temperature. On AUG-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like almost literally bit the bullet/inability to get comfortable, unable to sleep, constant urge to stretch, discomfort, uncomfortable achy gut, entire area was like bad menstrual cramps, tightness in chest, fever 99.5 temperature, headache, legs were very weak, chills, aches, sick, no appetite and mostly bile was not reported. This report was non-serious.
The caregivers in their rounds indicates that resident was well, ate his meals and her vitals were taken. In their next 7:30 pm rounds they find that the resident was not breathing. Home physician certifies death as Congestive Heart Failure.
INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 68 year old female. 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: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. Age at time of vaccination 68 years old. No concomitant medications were reported. On 11-JAN-2022, the patient experienced vaccine administered after stored outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after stored outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558598, 20220558439, 20220558390, 20220558638 and 20220558823.
Started with leg swelling within 2 hours, much worse next am, right eye swollen next am as well. Left leg erythematous area 4cm x 2.25cm, right leg erythematous area 4.5cm x 7cm. Left thigh 25.5cm, right thigh 26.5cm, left foot diameter 13.5cm, right foot diameter 13cm.
Around 8PM, began feeling cold/chills. Began shaking / having seizures. Heart rate went up to 150. No loss of consciousness, however, was unable to control body.  Was taken to ER and was stabilized. With some pain medications and an IV, I was released. Had fever for 24 hours, reaching 104 F. By the third day my fever broke, but energy levels have remained low since the episode occurred.
Patient received full dose of FluMist.  She waited 15 minutes without incident and left the clinic area.  Approximately 20 minutes after leaving the clinic area, she returned c/o generalized pruritus, particularly on chest, arms, palms of hands.  Erythema and diffuse papules were present on her chest only, in the lower sternal area extending approximately to mid-clavicular area.  Dorsal thorax, stomach area, extremities negative for rash.  Patient denied all symptoms except pruritus.  Lungs and VS serially assessed over a period of 1/2 hour remained within normal limits (lungs clear, VS WNL).  50mg PO benadryl was administered. Phone consultation with primary care physician resulted in patient being transported to Emergency Dept. where she was assessed and released that day.  Rx was benadryl PRN and prednisone 20mg x 2D. Treated at hospital.
Sore throat; Nasal Drainage; Cough; scratchy throat; tiredness; Chillness; Soreness of the right arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Chillness), OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Nasal Drainage), COUGH (Cough) and THROAT IRRITATION (scratchy throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Mar-2021, the patient experienced FEELING COLD (Chillness) and VACCINATION SITE PAIN (Soreness of the right arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Nasal Drainage), COUGH (Cough), THROAT IRRITATION (scratchy throat) and FATIGUE (tiredness). The patient was treated with TRIAMCINOLONE ACETONIDE (NASACORT) for Nasal discharge, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Chillness), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PAIN (Soreness of the right arm) and FATIGUE (tiredness) had resolved, RHINORRHOEA (Nasal Drainage) had not resolved, COUGH (Cough) was resolving and THROAT IRRITATION (scratchy throat) outcome was unknown.        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.   Treatment:Nasal drip for scratchy throat, Nasacort for nasal drainage in addition to allergy medicine patient also took cough suppressant
After three weeks I had a test to determine if my anti rejection drugs allowed the shots to work.  The shots were rejected.
This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8737), at the age of 57, via an unspecified route of administration, in left arm, on Apr 2, 2021, at 12:45, single dose, for COVID-19 immunisation. Medical history included known allergies to sulfa drugs.  Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On Apr 16, 2021, patient experienced bursitis in the right elbow. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the events. The outcome of bursitis in the right elbow: unknown (at the time of this report). No follow-up attempts needed. No further information expected.
Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), on 10Mar2021 as dose 2, single (Lot number: EN6206) and on 15Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Aug2022, outcome "unknown" and all described as "Tested positive for Covid 19 after receiving 3 doses of the Pfizer Covid 19 Vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient use Paxlovid for the treatment of covid 19. Reporter stated that she originally tested positive for Covid 19 on Tuesday 23Aug2022, and she did not know if she was still testing positive or not, she had not retested. Caller also corrects that she started Paxlovid on Wednesday 24Aug2022.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided Refrigeration date of vaccine 07-May-2021.
Initial and follow-up information has been received from a physician and a certified nurse midwife concerning an 18 year old female who on 13-APR-2007 was vaccinated intramuscularly with a first dose of Gardasil (655324/0089U). Concomitant therapy included ORTHO TRI CYCLEN. On 13-APR-2007 the patient, "felt her throat closing and tightening". It was reported by the physician that the patient is not going to finish the series. The patient did not seek medical attention. Subsequently, the patient recovered. On 13-JUL-2007 the patient was vaccinated with a second dose of Gardasil. Two hours after vaccination the patient started "feeling funny", and her throat was constricted. On 14-JUL-2007 the next day the patient took BENADRYL and one hour later the symptoms subsided. Additional information has been requested.
On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was accompanied by a sharp soreness under my left arm and 12 hours of  iritis in my right eye. Both symptoms were mild. For my second Coivd vaccine in my right arm on Friday, 5/28/2021, my symptoms included a headache and fatigue which lasted for Friday and Saturday. I also had a bad night on Saturday. I had trouble sleeping, was achy and may have been running a slight fever. I have been slightly more sweaty than normal. Today, 5/31/2021, I had some blood in my urine.
Swelling, still there a little bit; Really strong reaction/long lasting reaction; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling, still there a little bit) and VACCINATION COMPLICATION (Really strong reaction/long lasting reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 045B21A and 046B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (in late September - left arm) in September 2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling, still there a little bit) and VACCINATION COMPLICATION (Really strong reaction/long lasting reaction). At the time of the report, SWELLING (Swelling, still there a little bit) had not resolved and VACCINATION COMPLICATION (Really strong reaction/long lasting reaction) outcome was unknown.            No medical history information was reported. No concomitant medication was provided.  There was nothing to worry about. The blood work was fine. Swelling never went away. Skipped mammogram in 2021 last because of the pain. The patient had not been exposed to COVID at all, be overly cautious.  No treatment medication was provided.   This case was linked to MOD-2022-513832, MOD-2022-513823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Non Significant follow-Up - No new pertinent information was added.
APPROX 10 DAY AFTER VACCINE I WOKE UP BARLEY ABLE TO MOVE.  I HAD EXTREME JAW PAIN, RIB PAIN, KNEE, SHOULDER, ANKLE, WRIST AND FINGER PAIN.  MY JOINTS WERE SWOLLEN AND DIFFICULT TO MOVE.  MY FINGERS WERE IN A CLAW.  MY THIGHS WERE EXTREMELY PAINFUL.  I HAVE ARTHRITIS BUT HAVE NEVER HAD ANYTHING LIKE THIS.  I STARTED PREDNISONE WHICH HELPED AFTER A FEW DAYS.  I EVENTUALLY SAW A RHEUMATOLOGIST.   INFLAMMATORY MARKERS WERE ALL HIGH.  I WAS DIAGNOSED WITH INFLAMMATORY ARTHRITIS AND NOW TAKE METHOTREXATE.  THIS HELPS SOMEWHAT..
Initial itchiness upon injection of vaccine; Chills within an hour of receiving the vaccine; Swelling of lymph nodes noticed one week after injection; This is a spontaneous report received from a non-contactable health care professional, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: Ep7534), via unspecified route of administration on 17Mar2021 at 13:00 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. The patient medical history included depression, seasonal allergies, obesity, asthma. The patient was allergic to bananas and latex. The patient past drug history was not reported. The concomitant medication included Fluoxetine (PROZAC), FLONASE (fluticasone propionate and birth control (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not have any symptoms associated with COVID-19 prior to vaccination. Since the vaccination, the patient had not tested for COVID-19. On 17Mar2021 at 13:00, the patient experienced itchiness. The patient experienced chills within an hour of receiving the vaccine. On an unknown date in Mar2021, the patient experienced swelling of lymph nodes which was noticed one week after injection. Treatment received for the adverse events was reported as no. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itchiness, chills and swelling of lymph node were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
3x5 inch area on arm-swollen, pink, hard. Her PCP said it was not cellulitis- but should be reported.
Severe headache; Elevated temperature 100.0; This is a spontaneous case from a Patient. A 69-years-old non- pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9269) via an unspecified route of administration, administered in Arm Left on 17Feb2021 15:00 (at the age of 69-years-old) as dose number unknown, single for covid-19 immunisation. The patient Medical history included type 2 diabetes mellitus, hypertension, asthma, and Drug hypersensitivity. Concomitant medications included Metformin, Lisinopril, VITAMIN B12, and Multivitamin all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. On 18Feb2021, 02:00 the patient experienced severe headache and elevated temperature 100.0. No treatment was received in response to the adverse events. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
pt became gazing rigid then blue emesis-unresponsive momentarily-2 episodes;no convuls activity-PE;dx hypotonic episode;