chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosis was Supraventricular Tachycardia; I got fast and irregular heartbeat.; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; This is a spontaneous report from a contactable consumer. A 64-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 29Jul2021 14:00 (Lot Number: FA7485) (Age at vaccination: 64-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included anxiety, GERD and fibromyalgia; all since from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besilate (Strength: 2.5 mg) at 2.5 mg unknown frequency; alprazolam at an unknown dose and frequency (0, 25) and calcium. The patient previously took Penicillin, Cipro and experienced drug hypersensitivity, Contrast dye and experienced allergy to chemicals. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 07:30, the patient experienced starting next day after vaccine, I got fast and irregular heartbeat. It did not go away, and since then I went to a cardiologist who did echocardiogram and a Holter monitor. Diagnosis was Supraventricular Tachycardia. I never had any heart problems before this event. Doctor prescribed metoprolol, 25 mg and irregular heartbeat is generally under control but not completely gone. I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw. I went to emergency room to be sure it was not a hear attack and they said it was not. The patient underwent lab tests and procedures which included echocardiogram: unknown on 30Jul2021 (I went to a cardiologist who did echocardiogram and a Holter monitor), Holter Monitor: unknown on 30Jul2021 (I went to a cardiologist who did echocardiogram and a Holter monitor), Rapid Test: negative on 31Aug2021 (Nasal Swab). Patient received treatment of Metoprolol 25 mg. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient presented to the ER with complaints of tingling and numbness in the left upper and lower extremities along with the left side of her face. She said this lasted 5 minutes the first time and then it happened again when she laid down to go to sleep, lasting about 3 minutes. She noted these same symptoms last month approximately 2 weeks after her first covid vaccine. She was admitted for observation to the facility to rule out stroke/TIA and had negative tests across the board. Physician attributes symptoms to covid vaccine. Pt was discharged in stable condition.
The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022; No adverse event; beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (beyond used date was on 24Sep2022 and they used it and made an error,Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25Aug2022 and administered on 26Sep2022).    No concomitant medication was reported.  On 25-Aug-2022, the vial was initially stored in the refrigerator. It was reported that one of the vials beyond used date was on 24-Sep-2022 and they used it and made an error yesterday. Four patients were given doses from that vial.   Vial size was reported as 2.5 mL.  The vial did not underwent any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-651820, US-MODERNATX, INC.-MOD-2022-651828, US-MODERNATX, INC.-MOD-2022-651830 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651820:same reporter US-MODERNATX, INC.-MOD-2022-651828:same reporter US-MODERNATX, INC.-MOD-2022-651830:same reporter
Patient reported light-headedness, fatigue, and racing heart rate 10 minutes after receiving his first dose of the Pfizer vaccine. Patient was advised to sit on the ground in the event that were to lose consciousness. This reporter attempted to check the patient's heart rate while an ambulance was contacted, but the patient's heart rate was hard to track as it was beating very repidly and seemed irregular. The ambulance arrived with 5 minutes of being contacted, and the patient was monitored and removed from the pharmacy. The patient never lost consciousness and was able to communicate the entire time, but he did state repeatedly that he felt as if he were going to pass out. Vaccine administered at 2:26, Patient reported symptoms to the pharmacy at 2:36. Ambulance arrives at 2:43, then Patient leaves in ambulance at 2:50.
Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 42-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
2 weeks post vaccine #1, red circular erythematous area noted at and just above injection site
chest, arm, leg pain; weakness; pallor afebrile w/nl vital signs, BP, exam x/as observed in office x 2 hrs until color & activity level improved;
sore arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm after the injection) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm after the injection). At the time of the report, VACCINATION SITE PAIN (sore arm after the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided   This case was linked to MOD-2021-039044 (Patient Link).   Reporter did not allow further contact
heart fludder once in awhile, makes me want to take a deep breath to make it go away.
Pt c/o dizziness with vertigo within 2 min of injection. He felt better after 5 min of resting and discharged from clinic.
Stroke like symptoms; This is a spontaneous report from a non-contactable consumer reporting for father in law. An elderly male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stroke like symptoms in Jan2021 and was admitted to the hospital due to it. Outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Loss of motor skills; Loss of appetite/ Could not eat or drink; vomiting; bad diarrhea; Soreness at injection site; Swelling at injection site; not able to sleep and did not sleep for 7 to 8 days; not feeling well; This serious case was reported by a consumer via call center representative and described the occurrence of motor dysfunction in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 2nd dose of Shingrix. In AUG-2023, less than a day after receiving Shingrix, the patient experienced motor dysfunction (Verbatim: Loss of motor skills) (serious criteria hospitalization), appetite lost (Verbatim: Loss of appetite/ Could not eat or drink) (serious criteria hospitalization), vomiting (Verbatim: vomiting) (serious criteria hospitalization), diarrhea (Verbatim: bad diarrhea) (serious criteria hospitalization), injection site pain (Verbatim: Soreness at injection site), injection site swelling (Verbatim: Swelling at injection site), insomnia (Verbatim: not able to sleep and did not sleep for 7 to 8 days) and feeling unwell (Verbatim: not feeling well). The patient was treated with intravenous fluid (nos) (Intravenous Fluids). In AUG-2023, the outcome of the injection site pain, injection site swelling and insomnia were resolved. The outcome of the motor dysfunction, appetite lost, vomiting and diarrhea were unknown and the outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the motor dysfunction, appetite lost, vomiting, diarrhea, injection site pain, injection site swelling, insomnia and feeling unwell to be related to Shingrix.     It was unknown if the company considered the motor dysfunction, appetite lost, vomiting, diarrhea, injection site pain, injection site swelling, insomnia and feeling unwell to be related to Shingrix.   Additional Information: Receipt date: 10-Aug-2023 Patient's husband called to say his wife was hospitalized after the 2nd Shingrix Vaccine.  He said that she had swelling and soreness at the injection site for a few days, swelling and soreness had been resolved.   This vaccine was given approximately one week ago.  Patient was not feeling well after the vaccine and went to lay down.  She was not able to sleep and did not sleep for 7 to 8 days, then patient was taken to the emergency room and had multiple tests with no result.  Patient was given IV fluids.   Patient was released the same day but was readmitted yesterday (day before reporting) with a loss of motor skills, loss of  appetite, bad diarrhea and vomiting.  Patient was currently in the hospital.  Husband said the symptoms started within hours of the second vaccine.  Husband did not have a lot number or expiration date. The reporter consented to follow up
Onset of symptoms started Nov. 14, 2015 w/tingling and numbness in hands and feet, followed by full paralysis within 2 days. Treatment still continuing as of Aug. 21, 2016.
Fatigue, body aches, chills, sore throat, and ?injection site pain. Z-Pak- 5 days to recover.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-095360 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095360:
1 or 2 day p/vax pt exp redness,warmth,induration & swelling @inj site the size of a quarter or silver dollar.
Information was received from a claims examiner referring to a male patient, age unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX lot # J003357, expiration date 21Jun14. On 09-SEP-2013, the patient experienced an adverse reaction (no further specified) to the ZOSTAVAX vaccine. The outcome of the adverse reaction is unknown. Additional information has been requested.
non- occlusive dvt right leg; pain; rash; skin eruption in right leg; pityriasis rosea; swelling and rash with skin eruption in right leg; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0185), on 22Jul2021 as dose 2, single (Lot number: EW0186) and on 14Jan2022 as dose 3 (booster), single (Lot number: FJ582) for covid-19 immunisation. The patient's relevant medical history included: "patient has htn" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: TIZANIDINE; TRAMADOL; CLONAZEPAM; OLMESARTAN; FUROSEMIDE; AMITRIPTYLINE; PEPCID AC; TRIAMCINOLONE ACETONIDE; ABILIFY; HEMOCYTE PLUS; DISULFIRAM; XARELTO. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "non- occlusive dvt right leg"; PAIN (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "skin eruption in right leg"; PITYRIASIS ROSEA (non-serious), outcome "unknown"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling and rash with skin eruption in right leg". The clinical course reported as Patient experienced pain, swelling and rash with skin eruption in right leg and diagnosed with non- occlusive dvt right leg and pityriasis rosea 20Feb2022. Optional information: patient has htn (Hypertension), diabetes, obesity, hyperlipidemia. Pfizer covid vaccine 1st dose 30jun21 (EW0185), 2nd dose 22Jul2021(EW0186), Booster 14Jan2022 (FJ582). Event took place after use of product.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Deep vein thrombosis  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Information has been received from a healthcare worker concerning a 34 year old female who on 02-MAY-2008 was vaccinated with the first dose of MMR II. There was no concomitant medication. On 24-DEC-2008 the patient delivered a healthy newborn. Delivery was induced at 36 weeks gestation due to oligohydramnios. At the time of the report the patient was recovered. The patient sought unspecified medical attention. Induction of labor was considered to be an other important medical event by the healthcare worker. Additional information has been requested.
Redness, raised, warm to touch, itchy- first two days after injection  Arm numbness/tingling  and cold sensation- three days after injection
After vaccine given about 30 min to an hour started to have pain in left arm. Went home at 1 pm and it was painful to lift arm. Arm was swollen and red and also had muscle spasms to left upper shoulder. Took Ibuprofen 800 mg twice on Monday, 2/1/21. On Tuesday did not go to work due to pain and spasms. Took one dose of Ibuprofen 800 mg once on Tuesday/ 2/2/21. Today. 2/3/21, still painful to touch at 7/10. Spasms if moved a certain way - like lifting to put on shirt. No Ibuprofen taken today. Site injection at 2-3 fingers from acromion bone. Site is slight warm, no swelling noted but very painful to touch.
This spontaneous report as received from a healthcare worker and refers to an unspecified number of patients. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of oral, ROTATEQ were given to unspecified patients on unspecified dates (Incorrect product storage). No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. This is one of several reports from the same reporter. Follow up has been received from a healthcare worker on 06-JUL-2015: It was reported that, on 02-JAN-2014 the patient of unknown age and gender was vaccinated with improperly stored oral, ROTATEQ (Lot number: H015715, expiry date: 15-MAR-2014). This is one of several reprots from the same reporter. Additional information has been requested.
Fever, chills, high blood pressure, headache, malaise, all lasting 10 hours, except for headache which persisted to 14+ hours
Rash 2 weeks after shot that got better, but hasn't gone away.  Have a little bit  on my eye.
RN was staffing a Covid clinic at HS. One of our other nurses gave her the 1st Moderna vaccine at 1:45 PM on 2/12/21. At 1:55 PM, the nurse who had given her shot noticed that patient was pale, and said she was not feeling well. Her BP was 179/110, and she said she usually has low BP. She c/o of "feeling hot and was having difficulty breathing." She was seen by our medical director. After 30 minutes, her BP was 120/82. She said she ?felt a little better and called her sister to pick her up.? Later that evening, patient texted me saying I didn?t feel well when I got home, had trouble focusing literally and had a crying jag and felt shaky on the inside. I kept hydrating, took 25 of Benadryl and slept for 2 hrs., now feel close to normal. It was definitely a reaction to the shot-just weird!? Patient texted me on 2/13/21 that ?the FDA thinks one vaccine may be enough for 80?90% effectiveness, so I might not get the 2nd dose? On 2/15/21 patient texted, ?My PCP thinks what I had was a side effect & recommends taking Benadryl, Zyrtec, or Tylenol before the 2nd injection, and doesn?t seem to be worried about it!?   On 2/19/21, I received a text from patient at 5:28 AM as she was scheduled to staff a Covid clinic that day, beginning at 7:30 AM. She said, ?I have been up for a couple hrs w/severe eye pain and can?t hardly open my eye but it hurts to close it too! At 10:37 AM she texted, ?I just got home from eye doctor and was prescribed drops 4X/day. Apparently, there are pin holes in my sclera & cornea which hurt so bad I had lavender cold pack on all day & couldn?t stand the light. It is a corneal abrasion & I have no idea why that would happen suddenly?. The following day, she texted me a picture of her L arm injection site which she said was ?very itchy and hot! Not painful-? It was about 6 inches in diameter, red, inflamed,  delayed cutaneous rx.
DEATH Narrative:  Son stated that patient was doing well, still working and driving places. He stated that he called his son and stated that he wasn't feeling well and died shortly after that.
Patient received bivalent booster only 1 month after completing primary series. Error with check-in and vaccinator.