chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report, as received from a registered nurse, refers to a patient of unknown gender and unknown age. No concurrent conditions or medical history were reported. On 10-FEB-2017, the patient was vaccinated with one dose of VARIVAX 1 dosage form (formulation, dosage and route of administration were not reported, lot number: L042265, expiration date: 26-OCT-2017) for prophylaxis. No concomitant therapies were reported. On unknown dates, prior to administration, the dose of the VARIVAX had been improperly stored, according to a digital data logger (DDL). The DDL indicated that the vaccine had been stored at 9 degrees Fahrenheit for 40 minutes; at more than 5 degrees Fahrenheit, but less than 14 degrees Fahrenheit for 6 minutes; at more than 14 degrees Fahrenheit, but less than 46 degrees Fahrenheit for 1 hour and 48 minutes; at more than 46 degrees Fahrenheit, but less than 77 degrees Fahrenheit for 2 hours and 42 minutes. No adverse events were reported. No product quality complaint was involved. Additional information has been requested.
Approximately 7:00 am on 1/13/2021 my Father was unable to walk.  He had previously gotten up that morning because the heat was already turned up.  I took his blood pressure and O2.  His blood pressure was 183/91 with pulse of 81.  His oxygen was 99%.  EMS was called and they arrived and took him to local Hospital.  He was diagnosed with a stroke (I believe that it was called a Lacunar infarct) after an MRI scan.    He was in the hospital for 7 days and then he was moved to a rehab facility on 1/20/2021 where he stayed until he was released home on 2/18/2021 with Health visits scheduled.    He was on Eliquis 2.5 mg every 12 hours due to his AFib.
Insomnia; Dizziness; Joint pain; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukemia.    Concurrent medical conditions included Hypothyroidism, Hypertension, Chronic lymphocytic leukemia, Diabetes and Chronic kidney disease. Concomitant products included INSULIN for an unknown indication.   On 01-Nov-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Insomnia), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue). At the time of the report, INSOMNIA (Insomnia), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had not resolved.            Patient's concomitant medications included thyroid and blood pressure medication.  The patient received booster dose.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.
Vaccination age < EUA age .  Patient age 17 and EUA is >18.  No adverse effects noted.
Soon after her shots she would get a high fever and would go into a febrile seizure.
Mild headache starting on 10/13/11 lasting until 10/17/11. Not relieved by NSAID. Headache both temples & brow area.
Spotting on arms and legs with some blood under skin which has disappeared since but spots still appearing; Spotting on arms and legs with some blood under skin which has disappeared since but spots still appearing; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 72-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL9262), via an unspecified route of administration, administered in Arm Right on 10Feb2021 08:30 as 2nddose, single for covid-19 immunisation (Age at Vaccination was 72 years). Patient was not pregnant at time of vaccination. Historical vaccination was a 72-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL3247), via an unspecified route of administration, administered in Arm Right on 20Jan2021 08:30 as 1stdose, single for covid-19 immunisation. Medical history included von willebrand's disease from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing (known allergies: Soy, mango). Concomitant medication(s) included clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took morphine and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation.  The patient experienced spotting on arms and legs with some blood under skin which has disappeared since but spots still appearing, spotting on arms and legs with some blood under skin which has disappeared since but spots still appearing on 25Feb2021 07:00. No other vaccine in four weeks was done. Covid prior vaccination was no, covid tested post vaccination was no. Physician office visit. No treatment was received. Outcome of the events was recovered with sequelae.    No follow-up attempts are possible. No further information is expected.
fever; This is a spontaneous report from a contactable other health professional. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) at the age of 61 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported stopping medication on 10Feb2021 due to receiving COVID-19 vaccination on 12Feb2021 and then resuming therapy on 15Feb2021. Patient reported fever for 2 days after vaccination on 14Feb2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.
all "common side effects"; got sick twice; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick twice) and VACCINATION COMPLICATION (all "common side effects") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick twice) and VACCINATION COMPLICATION (all "common side effects"). At the time of the report, ILLNESS (got sick twice) and VACCINATION COMPLICATION (all "common side effects") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.
Swollen, painful lymph node in armpit of arm that was injected. Pain lasted about 4 days.
Shortness of breath; wheezing cough; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 11:30 as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication included etanercept (ENBREL). After the 3rd day (31Mar2021 06:00 PM), patient developed increasing shortness of breath accompanied with a wheezing cough. The treatment was not received. No covid prior vaccination nor covid test post vaccination. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcomes of events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (dosing details were not reported) lot # M011116, expiry date:17-JUN-2016. There were no product quality complaints (PQC) involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
received dose 1 of Shingrix in June 2019, dose 2 in December 2019. He states he was diagnosed with shingles on August 1, 2020 / your vaccine, which didn't work in my case/ vaccination failure; shingles / having shingles; received 2nd dose after 1 month 24 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphoma (non Hodgkin lymphoma).   On 21st October 2019, the patient received the 1st dose of Shingrix. On 15th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 1st August 2020, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride). On 5th August 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the vaccination failure and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient received 2 doses of Shingrix and diagnosed with shingles on 1st August 2020. The patient started valcyclovir Hcl treatment and symptoms resolved on 5th August 2020. The date of the second vaccine was unknown, but the consumer thought it was 15th December 2019. The patient stated that vaccine did not work in his case. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortning of vaccination schedule. The reporter consented to follow up.
every time I got a flu shot I got sick; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via social media (comment ID: 623369078341234).  This case involves an adult patient who experienced every time I got a flu shot I got sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious every time I got a flu shot I got sick (illness) Unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case.
This spontaneous report as received from a registered nurse refers to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-MAY-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route or administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
1 of 3 pt's who exp swelling, erythema, & pain @ inject site beginning 24 hrs, postimmunization, & ending p/2 wks; tx APAP & ice packs;
Hives for 4 months; headache; Blurry vision; Double vision; dark area off the right side peripherally; This spontaneous case was reported by a patient and describes the occurrence of VISION BLURRED (Blurry vision), DIPLOPIA (Double vision), SKIN DISCOLOURATION (dark area off the right side peripherally), URTICARIA (Hives for 4 months) and HEADACHE (headache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 028A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concomitant products included MODAFINIL for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, 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 third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced VISION BLURRED (Blurry vision), DIPLOPIA (Double vision), SKIN DISCOLOURATION (dark area off the right side peripherally) and HEADACHE (headache). On an unknown date, the patient experienced URTICARIA (Hives for 4 months). At the time of the report, VISION BLURRED (Blurry vision), DIPLOPIA (Double vision), SKIN DISCOLOURATION (dark area off the right side peripherally), URTICARIA (Hives for 4 months) and HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication provided This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
CHRONIC HYPOTENSION 2/27/2022 FAILURE TO THRIVE SYNDROME, ADULT HYPOTENSION 6/30/2022 FAILURE TO THRIVE SYNDROME, ADULT CHRONIC HYPOTENSION 2/27/2022 FAILURE TO THRIVE SYNDROME, ADULT HYPOTENSION 6/30/2022 FAILURE TO THRIVE SYNDROME, ADULT CHRONIC HYPOTENSION 2/27/2022 FAILURE TO THRIVE SYNDROME, ADULT HYPOTENSION 6/30/2022 FAILURE TO THRIVE SYNDROME, ADULT CHRONIC HYPOTENSION 2/27/2022 UTI (URINARY TRACT INFECTION) HYPOTENSION 6/30/2022 UTI (URINARY TRACT INFECTION)
doses administered after excursion; No adverse event; received vaccine from vaccine that underwent a temperature excursion in the Freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (received vaccine from vaccine that underwent a temperature excursion in the Freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 (received vaccine from vaccine that underwent a temperature excursion in the Freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medication was provided.  The pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The excursion was found out in an audit.   No adverse events were reported.   Treatment medication was not provided by the reporter.
Patient called 6/1 to report that he had arm pain and irritation at the injection site around 8pm on 5/29. He reportts waking the next morning at 6am with clammy feeling and flu-like symptoms that persisted through the day on Thursday (5/31).
When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the vertigo was the debilitation factor.  I went to work because it was too late to call in sick, I managed to stay the whole day and then I was off some days due to the holidays. The nausea and vertigo lasted 11 days the headache lasted 2 days.  I decided to go to the walk in clinic (day 7 - 12/29) because the vertigo and nausea would not go away.  They run bloodwork all normal. They told me to take OTC meclizine.  It took the edge off helped a tiny bit. I woke up 01/01 symptom free.
Patient is an 82 y/o female with PMHx of HTN, HLD, COPD, CAD s/p CABG, AFlutter post CABG who presented to the  ED c/o generalized malaise, nausea, diaphoresis, dizziness, and a HA after her first Pfizer COVID vaccine on 4/22/21.She presented in Aflutter with RVR. She converted to sinus rhythm s/p IV Diltiazaem. She was evaluated by Cardiology and cleared for discharge on Multaq, diltiazem, carvedilol, ASA, and Eliquis. Echo showed LVEF 65%.  Mild MR. Moderate TR. Her symptoms resolved on the day of discharge. She is to follow up with Cardiology.
injection site was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was a little sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart failure (NOS).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site was a little sore). At the time of the report, VACCINATION SITE PAIN (injection site was a little sore) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment medication details was reported.   This case was linked to MOD-2021-082160 (Patient Link).
rash developed on stomach 11/23, then spread to neck, chest, on the 27th and on 11/30 it was over entire body. 2nd shot was given on 11/20.
COVID-19+, Symptoms include Lethargy, Headache, Congestion, Anosmia
This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (received more than 0.25 ml booster dose) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received more than 0.25 ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (received more than 0.25 ml booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided by reporter. No treatment information was provided by reporter.Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Non-Significant Follow-up appended, Email Address added.
Fever, chills, body aches , LLQ abdominal pain , one episode of diarrhea and is having constipation
large clotting discharge with period; period came earlier than usual and very heavy/clots are still present; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (lot number: Rw0186), via an unspecified route of administration in arm left on 13May2021 15:00 at single dose for COVID-19 immunisation. Medical history included no just bipolar. Concomitant medications included carbamazepine (TEGRETOL) for bipolar, and bupropion hydrochloride (WELLBUTRIN) for bipolar over 25 years daily with no unusual side effects. Patient previously received the first dose of BNT162B2 (lot: Ee0186) in arm left on 22Apr2021 15:00 for COVID-19 immunisation and experienced period came earlier than usual and very heavy. On 21May2021 13:00, the patient experienced large clotting discharge with period. This had never happened before and period had never been this heavy or early. Then it stopped but a few days later clots were still present. Looked it up and others had reported uterine lining shedding and heavy bleeding. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.
Patient called Health nurse -6/13/17, to report she developed "non-specific cellulitis at TDaP vaccination site." The patient saw personal MD, and stated she was prescribed antibiotics. Full ROM, RUE, has continued working.
Left thigh cellulitis.  Treated with Keflex and Tylenol.
Going to doctor tomorrow, went to UTC and ER. Throat felt swelling and felt hard to breathe, pressure on chest, right arm and right cheek/mouth numb, headache, felt like an out of body experience, today took benedryl-still itchy/scratchy throat. Started about 30-45 minutes after shot. Too tired to think of everything.
Patient presented to pharmacy 1.24.2020 to advise that she had what she believed to be a seizure 45 minutes following the administration of the vaccine.   Pt had traveled to Pharmacy and said she felt a "tremor" and left to quickly drive herself home. She stated she got to her back door and lost consciousness and then woke up shaking, or tremoring.  Did not report to any physician or HC provider until now.
Patient received Bivalent booster dose from another source on 09/23/2022.
Information has been received from a licensed vocational nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unspecified date between 01-SEP-2016 and 09-OCT-2016, the patient received improperly stored VARIVAX injection (lot # L037560, expiration date 29-SEP-2017; dose and route were unknown). No adverse effects were reported. The vaccine was stored under temperature 18.03 Fahrenheit degree for 16 hours. There was no prior temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA The evening after the shot, my arm was extremely sore.  Over the course of the next day, I developed a moderate to severe headache along with swelling in the lymph node under my right arm in the arm pit.  By the second day after the shot (March 3rd, 2021) all symptoms except some swelling in the lymph node had resolved.