chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Small fibre neuropathy, Vaccination complication
Clinical narrative: he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy; had all kinds of bad side effects/had so many problems; sirva injury; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had all kinds of bad side effects/had so many problems), LIMB INJURY (sirva injury) and SMALL FIBRE NEUROPATHY (he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (had all kinds of bad side effects/had so many problems) and LIMB INJURY (sirva injury). In November 2021, the patient experienced SMALL FIBRE NEUROPATHY (he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy). At the time of the report, VACCINATION COMPLICATION (had all kinds of bad side effects/had so many problems), LIMB INJURY (sirva injury) and SMALL FIBRE NEUROPATHY (he was diagnosed by clinic with a skin biopsy severe non linked dependent small fiber neuropathy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided. patient had neurological nightmare. Patient had not received his 2nd dose.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired  after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired  after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Malaria in 1970. Concurrent medical conditions included High cholesterol.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (Tired  after first dose). On 13-Feb-2021, FATIGUE (Tired  after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.    This case was linked to MOD-2021-412766 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 expired moderna doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 expired moderna doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 expired moderna doses administered). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 expired moderna doses administered) had resolved.        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. The vial was initially stored in the refrigerator on 08-Dec-2021. On 10-Dec-2021, the vial was first punctured and after dose administration, the vial was put back on the refrigerator. The vial was exposed to the room temperature range of 8 degree to 25 degree Celsius , not more than 20 to 30 minutes.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used/ Several patients vaccinated with expired vials; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Several patients vaccinated with expired vials) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Several patients vaccinated with expired vials). On 04-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ Several patients vaccinated with expired vials) had resolved.            No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: non-significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 26 patients received expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 patients received expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 EXPIRED PRODUCT ADMINISTERED (26 patients received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 patients received expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date(s) of administration of vaccine: 09Sep2021 and 10Dec2021  No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Influenza like illness, Malaise, Myalgia
Clinical narrative: Flu like symptoms; intense body aches; felt very worn down; ache; could not get comfortable; nor sleep solidly; Slight fever for 3-4 days; Joint pain was pretty intense; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache) and DISCOMFORT (could not get comfortable) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine allergy).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache), DISCOMFORT (could not get comfortable), SLEEP DISORDER (nor sleep solidly), PYREXIA (Slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache), DISCOMFORT (could not get comfortable), SLEEP DISORDER (nor sleep solidly), PYREXIA (Slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense) had resolved.        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.   It lasted for about 2 days intensely and then another 2 of milder symptoms. No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-395635, MOD-2021-413020 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: Flu like symptoms; intense body aches; felt very worn down; ache; could not get comfortable; nor sleep solidly; Slight fever for 3-4 days; Joint pain was pretty intense; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Dec-2021 and was forwarded to Moderna on 14-Dec-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache) and DISCOMFORT (could not get comfortable) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine allergy).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache), DISCOMFORT (could not get comfortable), SLEEP DISORDER (nor sleep solidly), PYREXIA (Slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (intense body aches), MALAISE (felt very worn down), PAIN (ache), DISCOMFORT (could not get comfortable), SLEEP DISORDER (nor sleep solidly), PYREXIA (Slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense) had resolved.        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.   It lasted for about 2 days intensely and then another 2 of milder symptoms. No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2021-395635, MOD-2021-413020 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received Moderna dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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. On 22-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna dose). On 22-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. No Treatment medication reported. The pharmacist stated that a 16-year-old was accidentally given a first dose. .
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Influenza like illness, Malaise, Pain
Clinical narrative: Flu like - intense body aches and slight fever for 3-4 days; Felt very worn down; Achy; Could not get comfortable; Nor sleep solidly; Fever/slight fever for 3-4 days; Joint pain was pretty intense; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable) and SLEEP DISORDER (Nor sleep solidly) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine Allergy).    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable), SLEEP DISORDER (Nor sleep solidly), PYREXIA (Fever/slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable), SLEEP DISORDER (Nor sleep solidly), PYREXIA (Fever/slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the symptoms lasted for about 2 days intensely and then another 2 of milder symptoms.  No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395635, MOD-2021-412957 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Flu like - intense body aches and slight fever for 3-4 days; Felt very worn down; Achy; Could not get comfortable; Nor sleep solidly; Fever/slight fever for 3-4 days; Joint pain was pretty intense; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable) and SLEEP DISORDER (Nor sleep solidly) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine Allergy).    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable), SLEEP DISORDER (Nor sleep solidly), PYREXIA (Fever/slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like - intense body aches and slight fever for 3-4 days), MALAISE (Felt very worn down), PAIN (Achy), DISCOMFORT (Could not get comfortable), SLEEP DISORDER (Nor sleep solidly), PYREXIA (Fever/slight fever for 3-4 days) and ARTHRALGIA (Joint pain was pretty intense) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the symptoms lasted for about 2 days intensely and then another 2 of milder symptoms.  No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395635, MOD-2021-412957 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lymph node pain, Paraesthesia, Photopsia
Clinical narrative: Tingling whole left leg after first shot; Numb whole left leg  after first shot; Light flashing vision after first shot; Headache on & off after first shot; Left arm hurt after first shot; Pain in the lymph node left armpit after first shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot) and VACCINATION SITE PAIN (Left arm hurt after first shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot), VACCINATION SITE PAIN (Left arm hurt after first shot) and LYMPH NODE PAIN (Pain in the lymph node left armpit after first shot). On 03-Apr-2021, PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot), VACCINATION SITE PAIN (Left arm hurt after first shot) and LYMPH NODE PAIN (Pain in the lymph node left armpit after first shot) had resolved.        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 treatment medication was provided by reporter.   This case was linked to MOD-2021-413029 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tingling whole left leg after first shot; Numb whole left leg  after first shot; Light flashing vision after first shot; Headache on & off after first shot; Left arm hurt after first shot; Pain in the lymph node left armpit after first shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot) and VACCINATION SITE PAIN (Left arm hurt after first shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot), VACCINATION SITE PAIN (Left arm hurt after first shot) and LYMPH NODE PAIN (Pain in the lymph node left armpit after first shot). On 03-Apr-2021, PARAESTHESIA (Tingling whole left leg after first shot), HYPOAESTHESIA (Numb whole left leg  after first shot), PHOTOPSIA (Light flashing vision after first shot), HEADACHE (Headache on & off after first shot), VACCINATION SITE PAIN (Left arm hurt after first shot) and LYMPH NODE PAIN (Pain in the lymph node left armpit after first shot) had resolved.        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 treatment medication was provided by reporter.   This case was linked to MOD-2021-413029 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: He got a fever from the booster shot which lasted 5 to 6 days and it reached 102.5F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He got a fever from the booster shot which lasted 5 to 6 days and it reached 102.5F) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (He got a fever from the booster shot which lasted 5 to 6 days and it reached 102.5F). At the time of the report, PYREXIA (He got a fever from the booster shot which lasted 5 to 6 days and it reached 102.5F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) 102.5F.         No concomitant medications were reported. No treatment mediations were reported. Patient mentioned he got a fever from the booster shot which lasted 5 to 6 days and it reached 102.5F.   Reporter did not allow further contact
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Sep-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-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 and treatment medication information were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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.   This case was linked to MOD-2021-413275, MOD-2021-411099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Follow up document contains non significant information.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered doses of a vial 4 days after the 30-day Use By Date/ Receiving expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered doses of a vial 4 days after the 30-day Use By Date/ Receiving expired doses) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered doses of a vial 4 days after the 30-day Use By Date/ Receiving expired doses). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered doses of a vial 4 days after the 30-day Use By Date/ Receiving expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The 4 patients were administered doses of a vial 4 days after the 30-day Use By Date.  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-411099, MOD-2021-413238, MOD-2021-413267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Follow-up received. Non-significant information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Nov-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-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 Moderna vial was removed from freezer to refrigerator on 24 NOV 2021. Concomitant and treatment medication was not reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   None of the reported symptom were experienced by patient. Concomitant product use was not provided by the reporter.   No treatment information provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patients did not experience symptoms.  No concomitant medication were provided.  No treatment information were given.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (after the expiration date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030B21A and 016B21A) for COVID-19 immunization. No medical history reported. On Aug 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 22, 2021, patient administered expired product (after the expiration date). On Sep 22, 2021, administered expired product (after the expiration date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: After the expiration date; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-413535, MOD-2021-413554 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: After months patient received the Moderna vac and got really sick both times; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (After months patient received the Moderna vac and got really sick both times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had a severe case of COVID).    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, the patient experienced ILLNESS (After months patient received the Moderna vac and got really sick both times). At the time of the report, ILLNESS (After months patient received the Moderna vac and got really sick both times) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-411091 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Pruritus, Rash pruritic, Swelling
Clinical narrative: Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose; It itches on the body; Like red spots; Swollen/sometimes it goes and sometimes it comes; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (It itches on the body), RASH PRURITIC (Like red spots) and SWELLING (Swollen/sometimes it goes and sometimes it comes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 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 MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (It itches on the body), RASH PRURITIC (Like red spots) and SWELLING (Swollen/sometimes it goes and sometimes it comes). At the time of the report, MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (It itches on the body), RASH PRURITIC (Like red spots) and SWELLING (Swollen/sometimes it goes and sometimes it comes) outcome was unknown.            No concomitant medication reported. No treatment medication reported. Reporter stated the village where I live a lot of people is suffering this.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Menstrual disorder, Product administered to patient of inappropriate age, Pruritus, Swelling
Clinical narrative: Sometimes it itches on the body; Like red spots; Swollen; Inappropriate age at vaccine administration; Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots), SWELLING (Swollen) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). In 2021, the patient experienced MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose). On an unknown date, the patient experienced PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (Swollen). In May 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, MENSTRUAL DISORDER (Menstruation problems/With the menstruation the problems appeared after 15 day from the second dose), PRURITUS (Sometimes it itches on the body), ERYTHEMA (Like red spots) and SWELLING (Swollen) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided. It was reported sometimes it itches on the body, like red spots and was swollen and that sometimes it goes and come. The menstruation problems appeared after 15 days from the second dose.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Nerve compression, Pain
Clinical narrative: sciatic nerve pinching; had sharp pain, and area affected is left side of neck to lower hip; started having pain on left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (sciatic nerve pinching), PAIN (had sharp pain, and area affected is left side of neck to lower hip) and NECK PAIN (started having pain on left side of neck) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 069F21A and 069F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced NERVE COMPRESSION (sciatic nerve pinching), PAIN (had sharp pain, and area affected is left side of neck to lower hip) and NECK PAIN (started having pain on left side of neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NERVE COMPRESSION (sciatic nerve pinching) had not resolved, PAIN (had sharp pain, and area affected is left side of neck to lower hip) outcome was unknown and NECK PAIN (started having pain on left side of neck) had resolved.            No medical history was provided by reporter.  No concomitant medication was reported.  The feeling on sciatic nerve pinching was still ongoing, it comes and goes while sitting. It was not resolved completely.   This case was linked to MOD-2021-413868 (Patient Link).
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose; patient was given booster dose instead of second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose) and INCORRECT DOSE ADMINISTERED (patient was given booster dose instead of second dose) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose) and INCORRECT DOSE ADMINISTERED (patient was given booster dose instead of second dose). On 14-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between first and second doses was greater than 35 days/the patient received the booster dose but did not receive the second dose) and INCORRECT DOSE ADMINISTERED (patient was given booster dose instead of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As second dose, the patient received a booster dose of Moderna COVID-19 Vaccine (second dose was not a full dose).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Going through stuff in her body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Going through stuff in her body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Going through stuff in her body). At the time of the report, FEELING ABNORMAL (Going through stuff in her body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication information was not reported  It was reported that the first dose date was  received on 26-Mar-2021 and next to the date, a barcode says Apr-2021. . The patient missed the second Moderna dose because she was "going through stuff in her body" and didn't want to receive the second dose until she "felt better in her body". The patient did get the 2nd dose of the Moderna vaccine.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow up received contained narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) 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.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) had not resolved.            Patient mentioned being with UTI and under antibiotics, her Urine test is negative but her doctor gave her more antibiotics..Patient received the two shot vaccination series of Moderna COVID-19 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Nausea, Oxygen saturation
Clinical narrative: flu like symptoms; chills; body aches; fever; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalisation) in January 2020, Hospitalisation from 05-Jan-2021 to 13-Jan-2021 and Limb hyperextension. Family history included Polycystic kidney.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Oxygen saturation: 20% (abnormal) 20%.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Family history included PKD. Patient remained negative.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-413845 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; chills; body aches; fever; nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalisation) in January 2020, Hospitalisation from 05-Jan-2021 to 13-Jan-2021 and Limb hyperextension. Family history included Polycystic kidney.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), MYALGIA (body aches), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Oxygen saturation: 20% (abnormal) 20%.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Family history included PKD. Patient remained negative.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-413845 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Pain
Clinical narrative: Can't eat; Still minor aches and pain; Feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Can't eat), PAIN (Still minor aches and pain) and NAUSEA (Feeling nauseous) 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 FEEDING DISORDER (Can't eat), PAIN (Still minor aches and pain) and NAUSEA (Feeling nauseous). At the time of the report, FEEDING DISORDER (Can't eat) and NAUSEA (Feeling nauseous) outcome was unknown and PAIN (Still minor aches and pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.