chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizures; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disabled child and Epilepsy.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 15-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant). At the time of the report, SEIZURE (Seizures) outcome was unknown.            The patient's seizures have been under control at the time of report. Concomitant product use was not reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Based on the 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.  However, the previous history of epilepsy is a confounder.; Sender's Comments: Based on the 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.  However, the previous history of epilepsy is a confounder.
This spontaneous case initially received on 26-Jan-2017, was reported by a Non-Health Professional and concerns a 46-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA (thiomersal-containing) from 12-JAN-2017 to 12-JAN-2017. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse event description: On 12-Jan-2017, the patient received vaccine following temperature excursion (outcome: unknown). Special circumstances: incorrect product storage without adverse event, drug administration error without adverse event.
Information has been received from a registered nurse concerning a female who on 29DEC2003 was vaccinated with varicella virus vaccine live. Concomitant therapy that day included measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, Hib conj vaccine (tet toxoid), pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine, diphtheria toxoid + pertussis acellular 5-component vaccine + tetanus toxoid. There was no other concomitant medication. On 07JAN2004 the patient developed chicken pox like lesions on the trunk. The patient developed approximately 200 lesions but did not develop blisters. The lesions were described as "just red." The patient sought unspecified medical attention. There was no treatment provided. The patient recovered. There was no product complaint involved. Additional information has been requested.
Information has been received from a consumer concerning her daughter (approximately 17 year old) with codeine allergy who had been experiencing headaches 6 month ago (approximately September 2008) after receiving a dose of GARDASIL. The patient received the third dose last month. She had been receiving the vaccine at a Healthcare Center. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
ATRIAL FIBRILLATION; DIZZINESS; FELT SHOT WENT STRAIGHT TO BRAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient is currently on anxiety pills and the patient's physician planned to start Lexapro for patient. On an unspecified date, during the vaccination the patient felt that the medicine in the vaccine went straight to her brain. The patient experienced dizziness. After 24 hours of vaccination the patient experienced atrial fibrillation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, feeling abnormal and atrial fibrillation. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210422259.; Sender's Comments: V0: 20210456944-covid-19 vaccine ad26.cov2.s -atrial fibrillation. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 14-JUN-2014 at 14:45 PM (same date tha thte patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2015 (dose was not reported). No adverse symptoms reported.  It ws reported that the vaccine storage temperature dropped to 0-1 degrees (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). This is one of several reports received from the same reporter. Additional information is not expected due to all follow ups requested to complete the case were received.
After receiving vaccination mid day Monday, I awoke Friday morning with slight swelling on right upper lip and surrounding cheek area. Thinking I had slept in an odd position, I went about my business. At noon, I realized that it had not gotten any better, By 3PM it was clearly more involved. I took 2 benedryl tablets.  By abour 6:30 swelling was increasing, Visited facility and Urgent Care where I was given Dexamethasone 10 mg injection IM. Prescribed Predisone 20 mg tablet x2 daily for 5 days. Most swelling resolved by Saturday morning, but slight swelling is presisting so far.
Shaking tremors throughout body started about one month after second dose of vaccine. Continually experiencing six weeks after starting.
Information has been received from a physician concerning an 8-month-old male who on 07-NOV-2007 was vaccinated with a 0.5mL dose of VAQTA (Lot # 659187/1259U) instead of a dose of hepatitis B vaccine, recomb (manufacturer unknown). The parents have not notified the office of any adverse effects. No additional information is available. Additional information has been requested.
Fever, dehydration, muscle soreness; all over almost 48 hours.  Symptoms still present.
After administration we realized the youth was under 16 yo.  We notified dad immediately.  Dad was not worried and Patient is a "big kid" but I informed him how to reach us if needed and called to let his dr know.
9 days after receiving vaccine,  she reports that arm was red, warm, swollen and itchy.  Called and made an appointment to come to the clinic
Patient did not complete primary series.  She received Moderna monovalent dose 1 on 8/25/22.  Patient came in 10/29 requesting a moderna BOOSTER. We failed to confirm completion of the PRIMARY SERIES as patient did not present her card and gave her a Moderna Bivalent booster as a second dose in the primary series.
Pt admitted 10/10 for etoh abuse, experiencing shakes and sweats. Pt COVID+ 10/10. 10/12 Patient A and O x 4, pt scoring 8 on CIWA. Patient wants to leave AMA. 10/12 Patient left AMA.
Information has been received from a pharmacist and a pharmacy technician referring to the 46 year old female pharmacy technician. The patient was allergic to cephalosporins. The patient had no pertinent medical history. On 19-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K012785 with expiration date 28-NOV-2015, 0.65 ml, subcutaneous) to prevent against shingles, which was outside of the recommendations in the ZOSTAVAX prescribing information. Concomitant therapies included bupropion, cyclobenzaprine, metoprolol tartrate, quetiapine fumarate and fluoxetine. On 20-JAN-2015 the patient developed red weepy blisters around the injection site after receiving ZOSTAVAX. The patient did not seek medical attention. No treatment was given for the event and no lab diagnostics performed. The patient stated that the red weepy blisters recovered on an unknown date of February 2015 (reported as took about 2-3 weeks to heal). The patient currently still had a scar where the blisters were located at. Causality was not reported. Additional information has been requested.
her arm stays really painful; inflammation; the first dose her injection spot was little sore; shoulders' joint and right hip joint continued to hurt; constant headache; upper respiratory problem; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (the first dose her injection spot was little sore), UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation) and PAIN IN EXTREMITY (her arm stays really painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem). On an unknown date, the patient experienced INJECTION SITE PAIN (the first dose her injection spot was little sore), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation), PAIN IN EXTREMITY (her arm stays really painful) and HEADACHE (constant headache). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500mg; MELOXICAM for Adverse event, at an unspecified dose and frequency and COLISTIMETHATE SODIUM, ERYTHROMYCIN GLUCOHEPTONATE (ANTIBIOTIC SIMPLEX) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (the first dose her injection spot was little sore), UPPER RESPIRATORY TRACT INFECTION (upper respiratory problem), ARTHRALGIA (shoulders' joint and right hip joint continued to hurt), INFLAMMATION (inflammation), PAIN IN EXTREMITY (her arm stays really painful) and HEADACHE (constant headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative. On an unknown date, X-ray: abnormal (abnormal) abnormal.         No concomitant medication was provided.Her injection spot was little sore
Swelling and soreness in the left armpit; Swelling and soreness in the left armpit; booster dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 18:30 (Lot number: FL3209) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 12May2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 19Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Jan2022 18:30, outcome "unknown", described as "booster dose"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 06Jan2022 08:00, outcome "recovering" and all described as "Swelling and soreness in the left armpit". Therapeutic measures were not taken as a result of swelling, axillary pain.  Additional information: There was no other vaccine in four weeks. No treatments for adverse events. Patient did not test covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Could not sleep; Hives which became progressive; Arms and leg itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives which became progressive), PRURITUS (Arms and leg itching) and INSOMNIA (Could not sleep) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE from 08-Jan-2017 to an unknown date and LISINOPRIL from 08-Jan-2017 to an unknown date for Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced URTICARIA (Hives which became progressive). 06-Jan-2021, the patient experienced PRURITUS (Arms and leg itching). On 08-Jan-2021, the patient experienced INSOMNIA (Could not sleep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 14-Jan-2021, URTICARIA (Hives which became progressive) was resolving. At the time of the report, PRURITUS (Arms and leg itching) and INSOMNIA (Could not sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient woke up around 4 am with arms and legs itching and noticed hives. These hives gradually became worse over the next 48 hours despite taking oral diphenhydramine for every 4 hours. These hives also began spreading to stomach, face, and ears. 48 hours later could not sleep and called a doctor and asked whether he would prescribed a solumedrol dose pack because she would otherwise end up in the Emergency room (ER). Doctor then collaborated with an ER physician who prescribed oral prednisone. 30mg the first day, 25mg the 2nd day, 20mg the 3rd day, 15mg the 4th day, 10mg the 3rd day, 5mg the 6th day. Around day 3 of taking these steroids hives became much better.  Company Comment - Based on the 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.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up received on 07-Apr-2021 included therapy start date , anatomical location, concomitant medication, onset date for event, additional events (Arms and leg itching and could not sleep) and outcome of the event was updated.; Sender's Comments: Based on the 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.
Numbness; Trouble moving his legs; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness) and LIMB DISCOMFORT (Trouble moving his legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness) and LIMB DISCOMFORT (Trouble moving his legs). At the time of the report, HYPOAESTHESIA (Numbness) and LIMB DISCOMFORT (Trouble moving his legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided
Sensation of throat irritation and tightness. Benadryl 50 mg was administered with symptom resolution. Waiting for allergist to approve second vaccine dose.
8/14/2021 COVID pos and began feeling ill  8/19/2021 - present to ED with cough and SOB started on dexamethasone, remdesivir and O2 discharged on 8/27/2021 9/2/2021 returns to ED with SOB but no change in O2 needs - discharged on 9/3/2021 continued on O2
On 3/27/21 this patient came to a COVID vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the\saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the State reported there was a diluent shortage at the time. Under the direction of the stage the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state, as they later questioned their original desecion.  The were 30 to 36 doses drawn with this person is 1 of 72 others who may have had a dose of this mix
Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Missed second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Missed second dose). The patient was treated with Surgery (Knee surgery) for Intentional product use issue. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Missed second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications were provided. Treatment medications were unknown.  The patient had knee surgery after the first dose.
very weak; Diarrhea and went to the bathroom for 6-7 time; vomiting and has vomited 6-7 times; chills; a fever of 100.3 deg F.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), DIARRHOEA (Diarrhea and went to the bathroom for 6-7 time), VOMITING (vomiting and has vomited 6-7 times), CHILLS (chills) and PYREXIA (a fever of 100.3 deg F.) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (very weak), DIARRHOEA (Diarrhea and went to the bathroom for 6-7 time), VOMITING (vomiting and has vomited 6-7 times), CHILLS (chills) and PYREXIA (a fever of 100.3 deg F.). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (very weak), DIARRHOEA (Diarrhea and went to the bathroom for 6-7 time), VOMITING (vomiting and has vomited 6-7 times), CHILLS (chills) and PYREXIA (a fever of 100.3 deg F.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Pyrexia: 100.3 Farad (High) 100.3 deg F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported birth control medication.  Treatment included Gatorade and water.
Headache a short time after receiving the vaccine. 'Hives" and nausea at 5 AM. Pt took BENADRYL 25 mg at 5 A. Hives resolved. Came to Health Services at 940 AM. No hives present. Still slight nausea and headache. Vital signs stable. Given ZYRTEC on tab PO and Acetaminophen 2 tabs PO.
TDAP was given inadvertently.  DTAP should have been given.  No reaction was reported.
patient reports tremor in right arm-went to ER and they thought it was related to the vaccine, they ruled out stroke
Ended up having a rash or allergies; Ended up having a rash or allergies; This is a spontaneous report from a contactable other health professional (patient) via a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization, doxycycline hyclate; methylprednisolone; methylprednisolone sodium succinate (SOLU-MEDROL); amoxicillin via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got his first dose on 23Dec2020, due on Tuesday for 2nd dose. No reactions when he took the first shot. The caller was taking different medicines on 10Jan2021 and ended up having a rash or allergies. Gave allergic reaction Amoxicillin, Solu Medrol injection, Doxycycline, Methylprednisolone. The patient wanted to know if he can still be able to get the 2nd dose of vaccine on Tuesday. The action taken in response to the events for doxycycline hyclate was unknown, for methylprednisolone was unknown, for methylprednisolone sodium succinate was unknown, for amoxicillin was unknown. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Information has been received from a health professional concerning a 38 year old female nurse who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child. Subsequently the patient was not showing seroconversion. No product quality complaint was involved. No other information was provided. Additional information has been requested.
One hour after vaccination temp 101 and breaking then fever 104F about 1 1/5 hour after immunization out with hives.  Went to ER then went to hospital. Hives and was told reaction was reaction to immunization. Observation for 6 hours. Received Tylenol infant dose 1-2 doses.
Acitretin (Soriatane), 25 mg. daily, was prescribed and used for several months and then discontinued. The Rx was for pustular psoriasis developed from the Pfizer COVID-19 vaccine. The use Acitretin caused loss of skin layers and bleeding on arms, chest, and legs. The skin has yet to recover even though the use of Acitretin has been discontinued.