chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave patient Moderna Spikevax 2023-2024 on left arm then gave Flucelvax on right arm. Immediately after giving flu shot to patient. Patient fell forward, hitting the curtain on her way down to the floor. She had a seizure for about 5-10 seconds. I ran back to call 911. While dialing, she got up and asked what had happened. I told her what had happened. She told me not to call 911 and that she was okay. She stated that she had severe menstral cramps and she gets lightheaded easily whenever she is on her period.   She stated she has never had a seizure before.  Patient was given water and ibuprofen per her request. Pharmacy managers, checked in on her as well. After sitting for about 30-40 minutes, she let us know she was feeling better and asked to get escorted to her car. Staff escorted her out to her car.
pt woke up 9AM felt warm,mom gave APAP,10 mins later pt had episode of stiffness w/some perioral cyanosis (similar to prev episode of febrile sx @ 2mos) mom began mouth to mouth & pt responded; total episode lasted 5-10mins mom not sure
Gout Mild Diarrhea  Skin rash Chills but no fever
Redness at injection site; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) 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 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            No concomitant and treatment medications were not provided.   Reporter did not allow further contact
On 1/1/2023, patient presented to the emergency department with concerns for weakness and speech difficulties. She was promptly tested for COVID-19 which came back positive. Patient did have a mild fever, but her other vital signs were normal, and she was not hypoxic. There was no evidence of viral or bacterial pneumonia on chest x-ray or upon examination. Chest x-ray showed no acute cardiopulmonary findings. Treatment included IV fluids for hydration and Tylenol for a low-grade temperature of 100.4F. Patient was noted to have a fall earlier in the day at her assisted living residence. Therefore, she was evaluated for hemorrhagic versus ischemic CVA due to weakness in the left arm. Her stat head CT was unremarkable and showed no intracranial hemorrhage. Treatment for Ischemic CVA with tPA was considered but was deferred given the uncertainty of a CVA and the anticoagulation medication that the patient takes. Due to the patient's increased overall weakness, weakness in her left arm and possibility of a CVA, she was admitted to the hospital on 1/2/2023 for further treatment and evaluation. Her admission diagnoses were COVID-19 Infection, Generalized Weakness, and Questionable Left Sided Weakness (likely chronic in LUE).  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
shortly after receiving COVID vaccine, patient complained of arm hurting with shooting pains down to her elbow and fingers. Patient started shivering, HR 129, BP 131/78 o2 sat 98%. continued to monitor employee. physician at side 800mg ibuprofen given. Patient hr down to 111 and bp 135/97. Patient refused evaluation in ED. was released and escorted by physician out of department.
HX of rash on neck and face 6 to 8 hours after shots. Developed upper lip swelling 10 hours after shots and lower lip swelling 16 hours after shots.
Next morning, got more sore at site of the injection. Vaccination site was hot, red (size of a little bigger than silver dollar), swollen and sore. Took Ibuprofen a couple of times but did not help. Did not call doctor or vaccine administrator since pharmacist warned her that everyone that had received the vaccine at the site so far had reported getting the problems. Patient wants vaccine manufacturer to know what is going on so that they will tweak it especially because she still needs to get the 2nd dose. In terms of recovery, the adverse events are about the same still.
COVID VACCINE TWO MADE SICK; Loose bowels; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (COVID VACCINE TWO MADE SICK) and DIARRHOEA (Loose bowels) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In September 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. 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 IMMUNISATION REACTION (COVID VACCINE TWO MADE SICK) and DIARRHOEA (Loose bowels). At the time of the report, IMMUNISATION REACTION (COVID VACCINE TWO MADE SICK) had resolved and DIARRHOEA (Loose bowels) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials.  No concomitant product reported by reporter. No treatment medication reported by reporter.  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.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # M039642, expiration date 03-JUL-2019; lot # N002913 expiration date 23-FEB-2019 and lot # M037248 expiration date 21-FEB-2019) dose and route of administration were not reported for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA002375: US-009507513-1704USA010672:
Patient accidentally received a second flu shot for2021. Patient had already received the seasonal flu shot in October 2021.
Mid June 2021 heart palpitations. Severe at first but improved with time. Slowly went away by mid Sept. 2021
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 18-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Jul2022, outcome "recovering", described as "This person had huge lymph nodes around her arm pit and upper breast tissue for 2 -3 days post 3rd dose". It was unknown if therapeutic measures were taken as a result of lymphadenopathy. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, patient did not diagnose with COVID-19 Prior to vaccination and Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been not tested for COVID. Device timestamp 25Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My face is swelling a little bit; My face was little fussy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Aug2021 (Lot number: EW0165) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset Aug2021, outcome "unknown", described as "My face is swelling a little bit"; FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "unknown", described as "My face was little fussy".  Follow-up (31Aug2021): Follow-up attempts are completed. No further information is expected.
5/4/15 developed quarter size area of induration with warmness, applied ice and took NSAID/ 5/5/15 increased to baseball size area of induration with warmness sent to PCP.
No adverse event; HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Patient had no known relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Feb-2023, 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 01-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.).    No concomitant medications were reported.  The health care professional stated that, the patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture. Patient did not reported any adverse event.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706846 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706846:Same reporter
Localized reaction to vaccine (IPV or Prevnar). Treatment: Atarax and warm compresses.
Case number PHEH2014US024307 is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a combine follow up information received from the nurse on 22 Jan 2015 and on 26 Jan 2015 respectively. This report refers to a 42 year old male patient. Historical conditions were not reported. No concomitant medication was reported.  The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly in left deltoid at a dose of 0.5 ml on 17 Nov 2014. The nurse reported that FLUVIRIN was stored at 49 F for one hour and 15 minutes before administration to the patient. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration (incorrect storage of drug). No adverse events occurred due to vaccine only there was a temperature fluctuation in storage. No further information was provided. Combined follow up information received from the nurse on 22 Jan 2015 and on 26 Jan 2015 respectively: Updated site of vaccination and reporter comment in narrative only.
The following morning I had a fever and felt achey overall. However later in the afternoon that day my fever had began to subside but my chest began to feel constricted.  There was a constant pressure in my chest and then waves of extreme construction and pain would come and go where I felt unable to breathe and felt intense pain all over my chest and upper body.
Tooth infection; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in arm right on 02Mar2021 at 18:45 (at the age of 62-years-old) as single for COVID-19 immunisation. Medical history included ongoing atrial fibrillation from 2012 (has had AFIB for 9 years now). There was no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not administer additional vaccines on same date of the Pfizer suspect and did not receive prior vaccinations within 4 weeks. The patient was not taking any concomitant medications. On 11Mar2021, the patient experienced tooth infection. On 13Mar2021, the patient started Amoxicilllin 500mg for 10 days with instructions to take 1 capsule every 8 hours. She was still taking the Amoxicillin as of 16Mar2021. She reported that she should finished with the Amoxicillin before she gets her second COVID-19 vaccine shot on 25Mar2021. She was scheduled for a root canal on 22Mar2021, and would be done with the Amoxicillin by that time. She asked if being on the Amoxicillin will effect her second COVID-19 vaccine dose. The patient did not visit emergency room or physician office due to the event. The outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Patient received vaccines 12 April 03.  12 days later had a grand mal seizure.  C/o subjective fever, headache, sore throat, myalgias x 2 days. Physical exam: T 37.5, + classic jennerian scab L deltoid c tender L axillary adenopathy.  Few macular lesions ant and post chest wall.  Remainder of physical including mental status, head CT, CSF studies wnl.
Pt recvd 3 doses of series of Engerix-B & exp moderate fatigue 3-4 hrs p/each dose lasting 24-72 hrs; HBSAB test was negative p/3rd dose; Given booster dose of Engerix-B 03MAY91 & also exp fatigue; Pt has not been drawn for titer p/booster;
worse side effects than the previous side effects with the 1st and 2nd dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (worse side effects than the previous side effects with the 1st and 2nd dose.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient got treatment for the cancer months ago and the patient told that she currently does not have cancer.). Concomitant products included LOSARTAN, HCTZ and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (worse side effects than the previous side effects with the 1st and 2nd dose.). At the time of the report, VACCINATION COMPLICATION (worse side effects than the previous side effects with the 1st and 2nd dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitants medication also included Lexopril (5 mg 1 tablet once a day).   This case was linked to MOD-2021-335664, MOD-2021-335598 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Medical history, Concomitant medications and second dose date added.
Approx. 20 minues after receiving Moderna vaccine, patient complained of throat swelling, dizziness and feeling weak.  Benadryl 50 mg PO given and pateint was sent to the Ed for observation.  She was discharged after 1.5 hours.  No residual effects from the vaccine reported today.
Thrush on lips and tongue Dr. prescribed Mycostatin  (7/14) 2ml 4x day. He is improving. (never had thrush before!)
Information has been received from a RN concerning a 6 year old male pt with no allergies and no past medical history who on 02/04/98 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, the pt had a 'chickenpox break thru'. On 09/30/03, the pt presented to the doctor's office with an itchy rash, clear vesicles, approximately 20 lesions, but no fever. The pt was treated with Benadryl and calamine as needed. At the time of the report, the pt was improving and all lesions had crusted. A product quality complaint was not involved. The reporter also mentioned a second pt who developed chickenpox post vaccination with varicella virus vaccine live (WAES # 0310USA00574).  Additional information has been requested.
on 11/14/2021 -  cellulitis  in right foot,  it started early in the morning, over a series of days it progressed. I went to the urgent care. By the weekend I ended up in ER. They put me on Keflex then switched me Clindamycin, then added another prescription (I don't remember the name). The cellulitis was not responding to the clindamycin, so they added the 3rd prescription and it got better.
Arm hurt; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) 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 PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Temperatures 105; chills; confusion; unsteady walking needing, great assist; Severe pain in back and neck; Severe pain in back and neck; Not eating, taking water OK; Incontinent of urine and stool; Incontinent of urine and stool; This is a spontaneous report from a contactable (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:00 (at the age of 79-years-old), as single dose for COVID-19 immunisation. Medical history included aortic heart valve replaced, mild COPD, edema in legs, irregular heartbeat. Patient had no known allergy. Patient not diagnosed with COVID-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included MELOXICAM, LASIX and HCTZ. On 04Mar2021 at 14:00 (same day after vaccination), patient experienced temperatures 105, chills, confusion, unsteady walking needing, great assist, severe pain in back and neck, not eating, taking water OK, Incontinent of urine and stool. Patient did not receive any treatment for the events. Since vaccination patient not tested for COVID-19. The patient underwent lab tests and procedures which included Body Temperature: 105 on 04Mar2021. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a registered nurse referring to two boy patients of unknown age. The patients' medical history, concurrent condition and other concomitant medication were not reported. On 20-MAR-2018, the two patients were vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N017396 with expiration date 07-JUN-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA011818: US-009507513-1805USA011819: US-009507513-1805USA011820: US-009507513-1710USA004084: US-009507513-1805USA011822.
diarrhea; weakness; fatigue; malaise; This is a spontaneous report from a contactable nurse reported for herself. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 24Dec2020 08:00 AM at SINGLE DOSE for covid-19 immunisation. Medical history included childhood asthma, pancreatitis acute, allergies: sulfa and peanuts, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took ceclor and experienced drug allergy. On 24Dec2020 03:00 PM, the patient experienced diarrhea, weakness, fatigue and malaise for 2 days, all with outcome recovered. No treatment for these events. The patient has no covid prior vaccination. The patient has no covid tested post vaccination. The patient is not pregnant.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
1-2 hrs after ID FLUZONE 3" diameter baseball like lump - red warm to touch - called her 11/4 - no return call - spoke with her 11/15 - Redness and swelling gone - still a lump with soreness.