chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Included reporter information added, patient demographics added, dosage regimen updated and added for dose 1.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was called back to the clinic and vital signs were taken and were within normal limit. No signs and symptoms of any distress was present and when patient was asked if he had signs and symptoms he denied any at that time.  No concomitant medications was provided.  No treatment medications was provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: IRD of the follow up version is 19-Nov-2021 but taken as 23-Nov-2021 due to Argus limitations owing to the IRD being 23-Nov-2021 of the initial version. patient detail and dose number was updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient race was provided as W.  No concomitant medication information provided  No treatment medication information provided   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Included patient age and date of birth
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The patient vital signs were taken and within normal limits (WNL).It was reported that the patient denied any signs/symptoms of distress at the time of report. The patient was not diagnosed with COVID-19.This case was linked to MOD-2021-391981 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: included patient information and suspect details.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vital signs measurement
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal (normal) Within normal limits.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  It was reported that, the vial did not undergo any temperature excursions.  Date the vial was initially stored in the refrigerator: 19-Nov-2021   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up was received: Patient's demographics were updated.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Significant information received. The patient demographics were updated. The patients birthdate was added. The Race information was updated.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Additional reporter details, Patient demographics were updated.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No information was reported. Patient race was reported as B. It was reported that vital signs taken and were normal.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up version: Follow up contains race of the patient. Additional reporter added.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vital signs measurement
Clinical narrative: expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal (normal) vital signs normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient race reported.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Patient demographics updated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received: Reporter information was added, patient details and product details updated.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vital signs measurement
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.   On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: wnl (normal) WNL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-391981 (Patient Link)
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  It was reported that offender were called back to the clinic and vital signs were taken and were normal. No signs of any distress was present and when offender was asked if he had signs he denied any at that time.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Reporter added. Patient demographic updated.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No signs and symptoms of any distress was present and offender also denied signs and symptoms any at that time.It was unknown whether patient had any medical history or had any chronic conditions. It was unknown whether the patient had any allergic reactions to any medications, foods or other products. Concomitant product use was not provided by reporter. Treatment information was not provided. Patient's race was reported as B. This case was linked to MOD-2021-391981 (Patient Link). Most recent FOLLOW-UP information incorporated above includes:On 23-Nov-2021: Follow up received contains significant information: Patient initials updated and DOB added. Dose number updated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Date the vial was initially stored in the refrigerator: 19Nov2021  Patient experienced no signs or symptoms of any distress.  No Treatment information was reported.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received on 23-Nov-2021 and Reporter details  added and Patient demographics added.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 19-Nov-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.The patient experienced no signs or symptoms of any distress. No concomitant and treatment medications were reported.Most recent FOLLOW-UP information incorporated above includes:On 23-Nov-2021: Follow-up received: Secondary reporter details added. Patient date of birth added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: low-grade fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low-grade fever) and MYALGIA (body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (low-grade fever) and MYALGIA (body aches). On 16-Apr-2021, PYREXIA (low-grade fever) and MYALGIA (body aches) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395556 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: vaccinations to 5 patients after a temperature excursion; Expired Vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccinations to 5 patients after a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (vaccinations to 5 patients after a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccinations to 5 patients after a temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   5 Patients got vaccinated.  No concomitant medications were reported  No treatment medications were reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: left eye lid swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (left eye lid swollen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93909) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced SWELLING OF EYELID (left eye lid swollen). At the time of the report, SWELLING OF EYELID (left eye lid swollen) outcome was unknown.            No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2021-395554 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient that got their first dose from the expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient that got their first dose from the expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient that got their first dose from the expired vial). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient that got their first dose from the expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia
Clinical narrative: eye pain from movement,eye pain from light and light changes, eye ball pain; when he moved his eyes side to side and up and down he had eye pain; seeing red/black in the dark; eye pain from light and light changes; mild fever between 101.5 -102; very tired, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain from movement,eye pain from light and light changes, eye ball pain), EYE MOVEMENT DISORDER (when he moved his eyes side to side and up and down he had eye pain), CHROMATOPSIA (seeing red/black in the dark), PHOTOPHOBIA (eye pain from light and light changes) and PYREXIA (mild fever between 101.5 -102) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Patient had the first two doses of the Pfizer where he experienced fever, swollen lymph nodes, mild symptoms), Pfizer vaccine (Patient had the first two doses of the Pfizer where he experienced fever, swollen lymph nodes, mild symptoms), PFIZER BIONTECH COVID-19 VACCINE (Patient had the first two doses of the Pfizer where he experienced fever, swollen lymph nodes and mild symptoms). Past adverse reactions to the above products included Fever with Pfizer vaccine; Swollen lymph nodes with PFIZER BIONTECH COVID-19 VACCINE; and Vaccination adverse reaction with Pfizer vaccine. Concomitant products included OMEPRAZOLE, MAGNESIUM, FISH OIL, AZELASTINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PYREXIA (mild fever between 101.5 -102) and FATIGUE (very tired, fatigue). On 19-Nov-2021, the patient experienced EYE PAIN (eye pain from movement,eye pain from light and light changes, eye ball pain), EYE MOVEMENT DISORDER (when he moved his eyes side to side and up and down he had eye pain), CHROMATOPSIA (seeing red/black in the dark) and PHOTOPHOBIA (eye pain from light and light changes). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE PAIN (eye pain from movement,eye pain from light and light changes, eye ball pain) had resolved and EYE MOVEMENT DISORDER (when he moved his eyes side to side and up and down he had eye pain), CHROMATOPSIA (seeing red/black in the dark), PHOTOPHOBIA (eye pain from light and light changes), PYREXIA (mild fever between 101.5 -102) and FATIGUE (very tired, fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5-102 (High) Experiencing a mild fever.         Patient received Aleve for eye pain and treatment information for other reported events was not provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: had Bells Palsy for 7 months after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (had Bells Palsy for 7 months after the vaccine) 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 BELL'S PALSY (had Bells Palsy for 7 months after the vaccine). At the time of the report, BELL'S PALSY (had Bells Palsy for 7 months after the vaccine) outcome was unknown.            No Concomitants and Treatment medication were reported.  Company Comment; This case concerns a male patient of unknown age, with no relevant medical history, who experienced the non serious expected AESI of Bell's palsy. The event occurred at an unknown date after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age, with no relevant medical history, who experienced the non serious expected AESI of Bell's palsy. The event occurred at an unknown date after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Burning sensation, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: veins became very inflamed and like blood clots/inflammation; there appeared much more varicose veins; The soles of her feet started to burn; feet hurt a lot; her bones hurt; felt really bad; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn), PAIN IN EXTREMITY (feet hurt a lot) and BONE PAIN (her bones hurt) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Varicose veins in 2006, COVID-19 (She had had Covid before the vaccination) and Varicose vein operation NOS (he had various surgeries for Varicose veins).   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn), PAIN IN EXTREMITY (feet hurt a lot), BONE PAIN (her bones hurt), FEELING ABNORMAL (felt really bad), HEADACHE (headache) and PYREXIA (fever). In 2021, BONE PAIN (her bones hurt), FEELING ABNORMAL (felt really bad), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn) and PAIN IN EXTREMITY (feet hurt a lot) outcome was unknown.            No concomitant medication were provided.  After her second dose her veins became very inflamed and there appeared much more varicose veins and like blood clots. The soles of her feet started to burn. Also when she got the vaccine she felt really bad, she had headache, fever, her bones hurt. This lasted a few days. She had had COVID before the vaccination. Her feet hurt a lot. No treatment information were given.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Varicophlebitis, Varicose vein
Clinical narrative: veins became very inflamed and like blood clots/inflammation; there appeared much more varicose veins; The soles of her feet started to burn; feet hurt a lot; her bones hurt; felt really bad; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn), PAIN IN EXTREMITY (feet hurt a lot) and BONE PAIN (her bones hurt) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Varicose veins in 2006, COVID-19 (She had had Covid before the vaccination) and Varicose vein operation NOS (he had various surgeries for Varicose veins).   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn), PAIN IN EXTREMITY (feet hurt a lot), BONE PAIN (her bones hurt), FEELING ABNORMAL (felt really bad), HEADACHE (headache) and PYREXIA (fever). In 2021, BONE PAIN (her bones hurt), FEELING ABNORMAL (felt really bad), HEADACHE (headache) and PYREXIA (fever) had resolved. At the time of the report, VARICOPHLEBITIS (veins became very inflamed and like blood clots/inflammation), VARICOSE VEIN (there appeared much more varicose veins), BURNING SENSATION (The soles of her feet started to burn) and PAIN IN EXTREMITY (feet hurt a lot) outcome was unknown.            No concomitant medication were provided.  After her second dose her veins became very inflamed and there appeared much more varicose veins and like blood clots. The soles of her feet started to burn. Also when she got the vaccine she felt really bad, she had headache, fever, her bones hurt. This lasted a few days. She had had COVID before the vaccination. Her feet hurt a lot. No treatment information were given.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Fatigue, Mobility decreased, Pain
Clinical narrative: the loss of hair of half of her head; Unable to move/ could not move due to general fatigue; Slight body aches; General fatigue; Chills/ Shivers; High fever; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (the loss of hair of half of her head), MOBILITY DECREASED (Unable to move/ could not move due to general fatigue), PAIN (Slight body aches), FATIGUE (General fatigue) and CHILLS (Chills/ Shivers) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046G21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ALOPECIA (the loss of hair of half of her head), MOBILITY DECREASED (Unable to move/ could not move due to general fatigue), PAIN (Slight body aches), FATIGUE (General fatigue), CHILLS (Chills/ Shivers) and PYREXIA (High fever). At the time of the report, ALOPECIA (the loss of hair of half of her head), MOBILITY DECREASED (Unable to move/ could not move due to general fatigue), PAIN (Slight body aches), FATIGUE (General fatigue), CHILLS (Chills/ Shivers) and PYREXIA (High fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: the loss of hair of half of her head; Unable to move/ could not move due to general fatigue; Slight body aches; General fatigue; Chills/ Shivers; High fever; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (the loss of hair of half of her head), MOBILITY DECREASED (Unable to move/ could not move due to general fatigue), PAIN (Slight body aches), FATIGUE (General fatigue) and CHILLS (Chills/ Shivers) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046G21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ALOPECIA (the loss of hair of half of her head), MOBILITY DECREASED (Unable to move/ could not move due to general fatigue), PAIN (Slight body aches), FATIGUE (General fatigue), CHILLS (Chills/ Shivers) and PYREXIA (High fever). At the time of the report, ALOPECIA (the loss of hair of half of her head), MOBILITY DECREASED (Unable to move/ could not move due to general fatigue), PAIN (Slight body aches), FATIGUE (General fatigue), CHILLS (Chills/ Shivers) and PYREXIA (High fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received 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.        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 medication was not provided. Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Oligomenorrhoea
Clinical narrative: Menstrual cycle has been going on for many days,is longer than normal; has irregular start dates for her menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Menstrual cycle has been going on for many days,is longer than normal) and MENSTRUATION IRREGULAR (has irregular start dates for her menstrual cycle) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 021B21A-1) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OLIGOMENORRHOEA (Menstrual cycle has been going on for many days,is longer than normal) and MENSTRUATION IRREGULAR (has irregular start dates for her menstrual cycle). At the time of the report, OLIGOMENORRHOEA (Menstrual cycle has been going on for many days,is longer than normal) and MENSTRUATION IRREGULAR (has irregular start dates for her menstrual cycle) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache in temple; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache in temple) 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 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HEADACHE (Severe headache in temple). At the time of the report, HEADACHE (Severe headache in temple) outcome was unknown.            No concomitant medications were reported No treatment medications were reported It was reported that patient was asking if is it safe to take Tylenol for headache.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Illness, Myalgia, Oropharyngeal pain
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of illness (booster yesterday at 9:00 am, I've been sick ever since), oropharyngeal pain (sore throat), myalgia (major body aches) and fatigue in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Nov 22, 2021, at 9:00 am, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 22, 2021, patient experienced illness (booster yesterday at 9:00 am, I've been sick ever since), oropharyngeal pain (sore throat), myalgia (major body aches) and fatigue. At the time of the report, illness (booster yesterday at 9:00 am, I've been sick ever since), oropharyngeal pain (sore throat), myalgia (major body aches) and fatigue: not resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Headache, Myalgia
Clinical narrative: Vivid dreams; Muscle ache; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Vivid dreams), MYALGIA (Muscle ache), CHILLS (Chills) and HEADACHE (Headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ABNORMAL DREAMS (Vivid dreams), MYALGIA (Muscle ache), CHILLS (Chills) and HEADACHE (Headache). On 23-Nov-2021, MYALGIA (Muscle ache), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, ABNORMAL DREAMS (Vivid dreams) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Pruritus
Clinical narrative: itchiness; numb on right hand pinky; 1st dose of Johnson&Johnson vaccine and booster dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), HYPOAESTHESIA (numb on right hand pinky) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Johnson&Johnson vaccine and booster dose of Moderna) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OL19E21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson&Johnson vaccine (Received 1st dose of Johnson&Johnson vaccine in April by a doctor at a diagnostic hospital. Had Severe itchiness and which went away.) in April 2021. Past adverse reactions to the above products included Itching with Johnson&Johnson vaccine. Concurrent medical conditions included Acid reflux (oesophageal) and Knee swelling (Does not take any medications because of her kidneys.).    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced PRURITUS (itchiness), HYPOAESTHESIA (numb on right hand pinky) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Johnson&Johnson vaccine and booster dose of Moderna). On 22-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Johnson&Johnson vaccine and booster dose of Moderna) had resolved. At the time of the report, PRURITUS (itchiness) and HYPOAESTHESIA (numb on right hand pinky) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  Company Comment : This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine, who experienced non serious, unexpected events of Pruritus and Hypoaesthesia. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine remains a confounder for the event Pruritus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine, who experienced non serious, unexpected events of Pruritus and Hypoaesthesia. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine remains a confounder for the event Pruritus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Someone we know got both doses of the Moderna Covid-19 vaccine & died from Covid.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Someone we know got both doses of the Moderna Covid-19 vaccine & died from Covid.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced COVID-19 (Someone we know got both doses of the Moderna Covid-19 vaccine & died from Covid.) (seriousness criterion death). The patient died on 23-Nov-2021. The reported cause of death was covid-19. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported It was reported that patient took both doses of the Moderna Covid-19 vaccine and died from Covid.  Company Comment: This is a fatal case that concerns a patient of an unknown age and gender, with no relevant medical history reported, who experienced the unexpected fatal AESI event of COVID-19. The event occurred after an unknown time interval after both doses of the mRNA-1273. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a fatal case that concerns a patient of an unknown age and gender, with no relevant medical history reported, who experienced the unexpected fatal AESI event of COVID-19. The event occurred after an unknown time interval after both doses of the mRNA-1273. The rechallenge was not applicable as no additional dose is going to be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: COVID-19