chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt a very deep, stabbing pain in my lower right abdomen; I could barely move, or walk on my own; know I was ovulating around the time of this happening/I am ovulating and feeling a less painful; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 24-year-old female patient received bnt162b2 (Pfizer Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in arm left on 06May2021 12:00 (Batch/Lot Number: EW0187) as dose 1, single at the age of 24-year-old for covid-19 immunisation. There were no concomitant medications and medical history. The patient previously took amoxicillin and experienced drug allergy (reported as known allergies: Amoxcillian). Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. A week and a couple days after getting her first dose of the bnt162b2 (14May2021), she, all of a sudden (around 6pm) felt a very deep, stabbing pain in her lower right abdomen. She thought it might go away but the pain increased. She would say she had a pretty high pain tolerance but after 5 hours, she could barely move, or walk on her own. She spoke with a nurse over the phone and she suggested her go to the ER because how bad the pain was. She was worried that it might be her appendix, so she got a CT scan, blood tests, urine tests, everything, and the doctor said she looked healthy and fine (May2021). He prescribed two paracetamol (TYLENOL). She kept track of her menstrual cycle and she knew she was ovulating around the time of this happening. She was not on birth control and she had sometimes felt a weird sensation while ovulating but never, NEVER painful. Now, two months after getting the vaccine, she was ovulating and feeling a less painful version of what she felt after the vaccine. She was going to see a primary care provider to make sure. The adverse event result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment. The patient recovered with lasting effects. The outcome of event was recovered with sequelae. Serious reported as no.  Follow-up attempts are completed. No further information is expected.
Headache, neck pain, body aches, warmth at injection site, nausea, pain
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0763C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The information about allergies, acute illnesses, chronic or long standing health conditions, information about other medications (prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown.  The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit.  The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Cardiac Arrest; Ventricular Fibrillation; This is a spontaneous report from a contactable physician reporting for a patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) in two weeks. It was unknown if the patient received Other vaccine in four weeks, if patient had Covid prior vaccination, if Covid was tested post vaccination. Patient went for Running after returning home suffered Cardiac Arrest, Ventricular Fibrillation on 28Jan2021, CPR (Cardiopulmonary resuscitation) by Wife, Intubated by EMS (Emergency Medical Service) brought to the Hospital. The adverse events resulted in visiting Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of cardiac arrest and ventricular fibrillation which included CPR and Intubated. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac arrest and ventricular fibrillation cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Pt recvd 3 doses of Engerix-B 10APR90, 10MAY90 & 12NOV90 & it was determined that pt had an insufficient antibody response;
Injection site warm to touch but not itchy; 2-3 inches of raised hives; Solid raised rash around the injection site; Sore spot; Mild ache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to touch but not itchy), MYALGIA (Mild ache), VACCINATION SITE URTICARIA (2-3 inches of raised hives), VACCINATION SITE SWELLING (Solid raised rash around the injection site) and VACCINATION SITE PAIN (Sore spot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 29-Dec-2020, the patient experienced MYALGIA (Mild ache) and VACCINATION SITE PAIN (Sore spot). On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch but not itchy), VACCINATION SITE URTICARIA (2-3 inches of raised hives) and VACCINATION SITE SWELLING (Solid raised rash around the injection site). On 29-Dec-2020, MYALGIA (Mild ache) and VACCINATION SITE PAIN (Sore spot) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site warm to touch but not itchy) outcome was unknown and VACCINATION SITE URTICARIA (2-3 inches of raised hives) and VACCINATION SITE SWELLING (Solid raised rash around the injection site) 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 considered VACCINATION SITE WARMTH (Injection site warm to touch but not itchy), VACCINATION SITE URTICARIA (2-3 inches of raised hives), VACCINATION SITE SWELLING (Solid raised rash around the injection site) and VACCINATION SITE PAIN (Sore spot) to be related. No further causality assessment was provided for MYALGIA (Mild ache).    The patient did not take any concomitant medication at the time of vaccination.  The patient did not receive any treatment.  No reaction following the second dose. Reportedly, the patient had no known drug allergy (NKDA).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Action taken, event outcome, causality, and event description; Reporter's Comments: This case concerns a 68-year-old female who experienced NS events of unexpected urticaria, pain, Injection site warmth and expected injection site pain, injection site rash.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment not reported. 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.
Second shot.  At 3 am started  feeling body aches, muscle soreness, nausea, tiredness that is still present at 8:40 pm.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 17-NOV-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
dizziness; Fever off and on; bad nausea; light headache; Sore arm; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headache, fever off and on, sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced fever 99.8F coming and going, bad nausea, a light headache, dizziness, and an annoying sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), light headache, fever off and on, sore arm was unknown.
No adverse effect reported; patient received improperly stored PROQUAD; Information has been received from a nurse concerning a 4 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and and drug reactions/allergies was not provided.   On 01-JUL-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number S002924 and expiration date 28-JUL-2020; dose, dose number, frequency and route of administration were not provided) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored sterile diluent. No adverse effect was reported. No product quality complaint (PQC) was involved.  The time frame: 6 Fahrenheit scale to 14 Fahrenheit scale (10.4 F) for 1 hour and 30 minutes. There was previous temperature excursion, total time in the range 6 Fahrenheit scale to 14 Fahrenheit scale (14 F) for 1 hour 56 minutes and total time in the range 15 Fahrenheit scale to 46 Fahrenheit scale (29 F) for 5 hours. Data logger was involved.  This is one of three linked cases received from the same reporter. ; Sender's Comments:  US-009507513-1907USA002200: US-009507513-1908USA000040:
May 2008-developed slight tinnitus in left ear prior to deployment. Respiratory infection after 7-10 days abroad, around 26 May 2008.  Night sweats x1, accompanied. Aug 2008- Knee joints felt on fire with pain. Some numbness, tingling in feet. Night sweats x1. Oct 2008 - Knee joints felt on fire with pain. Dec 2008 - Knee joints felt on fire with pain. Some numbness, tingling in feet. Night sweats x1. Jan 2 2009 (pm) Felt vertigo for 2 weeks, but this night I couldn't stand without fear of falling.  Drove to ER.  There is more....
excessive bleeding /clots after menstration. 13 days after first injection normal -menstration days were 09/8-09/15 ..excessive bleeding/clots from 09/19-09/27 and light spotting 09/16,09/17/09/18 09/28.    spotted 10/10-10/14 and then spotting/bleeding 10/20-10/22 then heavier bleeding 10/23-10/31 currently spotting /light/mild bleeding 11/22-current 12/7
Fever for 1 day 100.4F; chills; arthralgia; myalgia; arm soreness (at the injection site); This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on an unknown date (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 02Apr2021, the patient had experienced fever 100.4 degree fahrenheit for 1 day, chills, arthralgia, myalgia and arm soreness (at the injection site). The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the events fever for 1 day 100.4F, chills, arthralgia, myalgia and arm soreness (at the injection site) was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received PPSV23 at age 67 years, despite having received both the PCV13 and PPSV23 at age 65 and 66 respectively. Therefore, patient received an unnecessary extra dose of PPSV23. Pharmacy student intern provided this most recent vaccination, and did not look into patient's file to see that he had already completed the pneumococcal vaccination series. Patient received this extra vaccination because he could not recall that he had already completed the vaccine series.
upper arm became red, swollen, and very tender to the touch about 2 hours after vaccination, one day later it is still red and swollen but not tender to the touch
Weight gain, chronic migraines, plethora of cavaties in teeth, numbing of feet & hands, fatigue, personality changes (due to brain under impression of tumor)
Squishy cyst on left collarbone; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) as a single dose via unspecified route in left arm on 13Mar2021 at 13:15 PM (at the age of 60-year-old) for COVID-19 immunisation. Medical history and concomitant medication were not reported. It was reported that the patient has not had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, the patient had developed a squishy cyst on left collarbone. The patient never had a problem like this before. No treatment was received for the event. The clinical outcome of squishy cyst on left collarbone was not resolved at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. The concomitant history was not reported. The treatment history was not provided. patient received expired dose of moderna vaccine.
Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson (Batch/Lot number: Unknown. Expiration date: 23Jun2021. Route: A shot in her left arm (non-dominant) and she did not confirm that it was an intramuscular injection.) on 10-Apr-2021. Past adverse reactions to the above products included No adverse reaction with Johnson & Johnson. Concurrent medical conditions included Menopause (Patient was in menopause, and has been in menopause for a year and a half.).    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half). On 12-Jan-2022, POSTMENOPAUSAL HAEMORRHAGE (Signs of her period cycle for seven days/The period started light and then heavy/ she is in menopause, and has been in menopause for a year and a half) had resolved.            No concomitant medications were provided by reporter. On Wednesday she started to have signs of her period cycle for seven days. The period started light and then heavy and then it ended. Patient took Moderna Booster dose but does not confirm that it was an intramuscular injection. No treatment medications were provided by reporter.
No adverse event; First dose on 04-Aug-2022 and second dose on 13-Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04-Aug-2022 and second dose on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 19-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     The patient had no acute illness at the time of vaccination and up to one month before.  The patient's past medical history included COVID-19 on 21-Dec-2021. Concurrent medical conditions included Trisomy 21 (No recent changes in condition status.) since 17-Jan-2021. Concomitant products included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication.   On 04-Aug-2022 at 8:44 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 13-Sep-2022 at 3:38 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 13-Sep-2022 at 3:38 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04-Aug-2022 and second dose on 13-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04-Aug-2022 and second dose on 13-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04-Aug-2022 and second dose on 13-Sep-2022).    Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event were reported as none.  Patient received Moderna Bivalent dose on 06-Feb-2023 at 10:10 am. Dose number 3, route intramuscular, site Left Vastus Lateralis, dose 0.2ml, batch number 215K22A. No treatment medications were reported.   This case was linked to MOD-2023-713273 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug allergies were not reported. On 17-JUL-2017 the patient was vaccinated with both VARIVAX, 1 dose unit (Lot # M029918, Expiry date :28-SEP-2018) and PROQUAD 1 dose unit (Lot # N013865, Expiry date : 31-OCT-2018) for prophylaxis (inappropriate schedule of drug administration). Concomitant therapies included sterile diluent(STERILE DILUENT), lot # and expiry date was unknown. No adverse effects were reported. There was no product quality complaint involved. This is 1 of the 2 reports from the same reporter.; Sender's Comments:  US-009507513-1707USA008871: