chrisvoncsefalvay/vaers-outcomes huggingface dataset:
visual migraine; visual issues; saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes; experienced a fever 99.8; weakness; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (experienced a fever 99.8), ASTHENIA (weakness), HEADACHE (slight headache), VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (experienced a fever 99.8), ASTHENIA (weakness) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes). On 26-Apr-2021, the patient experienced RETINAL MIGRAINE (visual migraine). On 01-Apr-2021, PYREXIA (experienced a fever 99.8) and ASTHENIA (weakness) had resolved, HEADACHE (slight headache) outcome was unknown. On 03-Apr-2021, VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) had resolved. At the time of the report, RETINAL MIGRAINE (visual migraine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090202 (Patient Link).
pt presented w/redness & swelling from upper deltoid to anticubital space, lt arm;c/o 3 days s/s of weakness, body aches, fever & malaise;both vaccines given in lt arm d/t rt arm amputation;
experienced 40+ floaters in my left eye that hurt my vision; experienced 40+ floaters in my left eye that hurt my vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 19-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete, Manufacturer : Unknown, Dose number: Unknown), for COVID-19 immunization. The following information was reported: VITREOUS FLOATERS (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "experienced 40+ floaters in my left eye that hurt my vision". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Request Name: REQ-795287. Question: Hello, my name is (name-withheld). I am a 19 year old student and in late Jan i suddenly experienced 40+ floaters in my left eye that hurt my vision, and was tested for many serious things including different cancers and diseases. A few weeks prior to this happening, I had COVID and also received the pfizer booster shot around the exact same time. I am searching for answers related to what could be wrong with me, and I wanted to contact you to see if you know anything at all. Thank you. Agent: E-transmit only. Non-phone case, unable to gather additional demographics. Outbound call back placed 20May2022, at 2:47PM . Left VM with MI phone, hours of operation, and INT.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
noted rash on arm, redness into his armpit about 10 days after receipt of primary SPV  Symptom: Edema @ injection site >120 mm not beyond elbow Start: 12/10/2007  Symptom: Erythema Start: 12/10/2007  Symptom: Tenderness Start: 12/10/2007
Noticed slight swelling on evening of vax. In the morning, left thigh was quite swollen and red. By the next morning, swelling down past knee. Left thigh 33.5cm and right thigh 22cm noted per physician during office visit on 02/17.
Event occurred after 2nd dose. Patient was diagnosed with COVID 19 Remdesivir, Tylenol In-patient
my chem panel was off; my neutrophils went to 0.7; This case was reported by a consumer via patient support programs and described the occurrence of comprehensive metabolic panel in a 73-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and niraparib (Zejula) unknown (batch number 2054130, expiry date 31st March 2024) for malignant neoplasm of ovary.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season and the 2nd dose of COVID-19 VACCINE. On 2nd September 2021, the patient started Zejula (oral) 100 mg once daily (100 mg daily). On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and less than 4 months after starting Zejula, the patient experienced comprehensive metabolic panel and neutrophil count decreased. Zejula was continued with no change. On an unknown date, the outcome of the comprehensive metabolic panel and neutrophil count decreased were unknown.   It was unknown if the reporter considered the comprehensive metabolic panel to be related to Influenza vaccine Quadrivalent unspecified season and Zejula. It was unknown if the reporter considered the neutrophil count decreased to be related to Zejula.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was unknown. The reporter stated that, after the flu shot her chem panel was off. On an unknown date, unknown after receiving Covid vaccine, the patient experienced neutrophil count decreased (neutrophil went ot 0.7). The patient was taking Zejula from 2nd September 2021 for malignan neoplasm of unspecified ovary. The reporter stated that, her scan in November 2021 was clear. The reporter stated that she had seen the provider every two weeks and had blood work done monthly. The patient would have a scan in May 2022. It was unknown if the reporter considered the neutrophil count decreased to be related to Covid vaccine. The consent to follow up was granted.
Strong metallic taste in mouth within 2 minutes and lasted about 3 hours, intense left wrist started a prickly tingle about 5 minutes and lasted about 3 hours, mild left palm and arm started a prickly tingle about 10 minutes after injection and lasted 1 hour, started feeling light headed about 10 minutes after and lasted about 1 hour with no blacking out, warm flush feeling started about 5 minutes after the injection and lasted for 32 hours (did not take temperature), my chest felt very heavy and breathing was a little diminished which lasted about 20 minutes.  The following morning I felt some nausea with mild dizziness that lasted about 4 hours.
itchy red spot; itchy red spot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy red spot) and ERYTHEMA (itchy red spot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PRURITUS (itchy red spot) and ERYTHEMA (itchy red spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy and Redness, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy red spot) was resolving and ERYTHEMA (itchy red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
patient had lightly red/pink, slightly swollen area about 0.5 to 1 in circumference from injection site.  patient reports warm to touch.  reports no fever.  reports has been getting slightly worse everyday since 3/12 (so for 3 days).  let patient know that injection site reactions are common with the vaccine and can commonly last 3 days (1-3 days median per trials).  also let patient know that if it continues to get worse over the next day or two, report to doctor.
Patient presented to emergency department on 10/7/2021 with shortness of breath and cough. She was found to be COVID-19 positive on 10/2/2021. Patient was admitted for further management and treated with steroids and supplemental oxygen. She was discharged home on 10/13/2021 with home oxygen.
The patient stated he did not feel well immediately after two vaccines were administered in succession.  He flailed his arms and legs, threw his head back and jerked for approx 5-10 seconds.  He remained on the chair "tired" and pale after this episode.
2 hrs p/DTP/OPV/HIB pt began crying a high pitched wierd cry; was inconsolable; cried in this way for over 1 hr;
Fever, chills, arthralgias, malaise - feels horrible, 1 day following Menactra immunization.  Did have nausea the day before vaccination.  When seen in office temperature 98.3, blood pressure 105/68, pulse 55.  No symptoms on 08/01/2005. Information from Annual Follow-up report states pt was recovered by 8/6/05.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date of refrigeration was 19 Aug 2021.
Headache; chills; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via Intramuscular on 20Jan2021 08:00 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number Left arm and Expiration Date unknown) via Intramuscular on 30Dec2020 08:00 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient experienced Headache and chills on 22Jan2021 06:00 AM, without treatment received. The outcome of events was unknown.  Information on the batch/Lot number has been requested.
Headache "Head so heavy, & I had the body ache & like shivering inside my body but no fever, it was 98.4*" Narrative:
Swollen, bruise, irritation, redness, inflamed, soreness. Pt given MOTRIN for local reaction
loss of taste; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: Feb2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious) with onset Mar2021, outcome "not recovered", described as "loss of taste". Therapeutic measures were not taken as a result of ageusia.  Additional Information: The patient has no other vaccine within 4 weeks. the patient has not had prior covid. The patient has not been tested for covid after vaccination. There were no known allergies. She had never had symptoms of Covid infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported). Concomitant therapy was not reported. It was reported that the patient was administered ZOSTAVAX with a one inch needle. No adverse symptoms reported. Additional information has been requested.
Tingling sensation; Numbness; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness). At the time of the report, PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up received on 18-MAY-2021 contains significant information includes, Event outcome.
MA, drew up vaccine. Asked for assistant on giving immunizations. RN administered expired Tdap. Tdap was in a box that was transfered to Health Center from family Medicine. This specific Tdap vaccine was the only one in that box with that expiration date.
muscle weakness at site of injection; could not move the arm; extreme pain at the site of injection / extreme pain on left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MUSCLE WEAKNESS, JOINT RANGE OF MOTION DECREASED, and VACCINATION SITE PAIN in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Blood pressure high.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-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 experienced INJECTION SITE MUSCLE WEAKNESS, JOINT RANGE OF MOTION DECREASED, and VACCINATION SITE PAIN. At the time of the report, INJECTION SITE MUSCLE WEAKNESS, JOINT RANGE OF MOTION DECREASED, and VACCINATION SITE PAIN 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.   Concomitant medications reported were blood pressure medicine and asthma medicine. Treatment information were reported as patient went to the doctor and got a pain shot and took medicines.
had a rash on the right side of her face; rash on left side of face was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 65-year-old female patient received bnt162b2 (COMIRNATY), administration date 09Oct2021 (Lot number: FE3590) at the age of 65 years as dose 3 (booster), single for covid-19 immunization.   The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, Batch number: EP7334, Anatomical location: left arm), administration date: 19Mar2021, when the patient was 64 years old, for Covid-19 immunization; Bnt162b2 (dose 2, single, Batch number: EN0158, Anatomical location: left arm), administration date: 09Apr2021, when the patient was 64 years old, for Covid-19 immunization.  The following information was reported: RASH (non-serious) with onset 16Oct2021, outcome "not recovered", described as "had a rash on the right side of her face"; CONDITION AGGRAVATED (non-serious) with onset Oct2021, outcome "not recovered", described as "rash on left side of face was reported as worsened".  Additional information: Caller wanted to know if this was a reported side effect from the Pfizer Covid-19 vaccine. Caller received the Pfizer booster shot on 09Oct2021, she stated that she was out on vacations this week and about 4 days ago, clarified on the 16Oct2021 she noticed a rash on the right side of her face only, it was not the left side, she wanted to know if this was a side effect of the booster shot. Caller sated that it progressively got worse and in the last three days it has stayed the same and was not going away.  Follow-up attempts are completed. No further information is expected.
Patient presented to the ED on 1/26/22 with chest pain. She tested positive for COVID on 1/26/22. She is currently on 4L of nasal canula Oxygen.
Vomiting (for 6 hours), diarhea,  Chills where entire body shook, body aches for entire 72 hours, weakness,
Experienced burning to throat and lungs. Coughing and forceful. Felt like there was something caught in my throat. Almost constricted like sensation.
certain taste in my mouth just like egg stinks; I felt a little weird kind of like confusion; my breathing ability was little bit difficulty in breathing their for a while for two days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: TASTE DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "certain taste in my mouth just like egg stinks"; CONFUSIONAL STATE (non-serious) with onset Oct2021, outcome "unknown", described as "I felt a little weird kind of like confusion"; DYSPNOEA (non-serious) with onset Oct2021, outcome "unknown", described as "my breathing ability was little bit difficulty in breathing their for a while for two days". The events "certain taste in my mouth just like egg stinks", "i felt a little weird kind of like confusion" and "my breathing ability was little bit difficulty in breathing their for a while for two days" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of taste disorder, confusional state, dyspnoea.   Additional information: Patient reported that, had not taken any medication or any lab test. The patient felt a little weird kind of like confusion and certain taste in mouth just like egg stinks and breathing ability was little bit difficulty in breathing there for a while for two days but the slight confusion and the certain taste in mouth are still continued.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 17MAR97 pt devel a rash, felt to be a mild case of chickenpox;pt was not seen in MD office;pt mom noted that several other children in daycare devel a rash on same day;21MAR97 pt recovered;
DIED; SEVERE MEDICAL ISSUES; This spontaneous report received from a consumer via social media (RA) concerned multiple (unspecified numbers) patients of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced severe medical issues. On an unspecified date, the patients died from an unknown cause of death. It was unspecified if an autopsy was performed. It was reported as "I have friends-family members died and have severe medical issues from this Vaccine" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe medical issues was not reported. This report was serious (Death).; Sender's Comments: V0: 20230412578- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Headache, Myalgia, Arthralgia, Diarrhea & NauseaVomiting  Narrative:
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536: