chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-357274, MOD-2021-357572, MOD-2021-356768 (Patient Link).
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered vaccine after 33 days in the refrigerator; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Daydreaming, Fatigue, Feeling abnormal, Thinking abnormal
Clinical narrative: 1 or 2 days of feeling crummy after 3rd dose; blurry mind stuff; can't think clearly at times; a lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (1 or 2 days of feeling crummy after 3rd dose), DAYDREAMING (blurry mind stuff), THINKING ABNORMAL (can't think clearly at times) and FATIGUE (a lot of fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ALPRAZOLAM, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), CLONAZEPAM (KLONOPIN), PITAVASTATIN CALCIUM (LIVALO) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced FEELING ABNORMAL (1 or 2 days of feeling crummy after 3rd dose), DAYDREAMING (blurry mind stuff), THINKING ABNORMAL (can't think clearly at times) and FATIGUE (a lot of fatigue). At the time of the report, FEELING ABNORMAL (1 or 2 days of feeling crummy after 3rd dose), DAYDREAMING (blurry mind stuff), THINKING ABNORMAL (can't think clearly at times) and FATIGUE (a lot of fatigue) outcome was unknown.            No treatment information was provided by the reporter. Other concomitant medications: acidophilus ,Airborne gummies   ,Aller-Flo nasal spray   ,doxapin , Move Free Daily, multivitamin  , Premarin cream, zolpidem 5mg   ,Prolia injection   This case was linked to MOD-2021-356901, MOD-2021-356856 (Patient Link).
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Injection site paraesthesia
Clinical narrative: Tingling sensation on the arm where injection was given; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (Tingling sensation on the arm where injection was given) 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 INJECTION SITE PARAESTHESIA (Tingling sensation on the arm where injection was given). At the time of the report, INJECTION SITE PARAESTHESIA (Tingling sensation on the arm where injection was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No Treatment information was reported.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  This is a case of expired product administered for this 64-year, male patient with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this 64-year, male patient with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after the second dose. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Totally 28 doses were administered on 18-OCT-2021 after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals. No relevant concomitant medications were reported. No treatment information was reported. This is a case of expired product administered for this 82-year old patient of an unknown gender, with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after third dose and no more dosing is expected. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a case of expired product administered for this 82-year old patient of an unknown gender, with no medical history reported, with no associated adverse events. The event expired product administered occurred same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event happened after third dose and no more dosing is expected. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Second dose after 38 days of first vaccine; Administered vaccine after 33 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose after 38 days of first vaccine) outcome was unknown.        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.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: "Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE ("Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) 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 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced DEVICE CONNECTION ISSUE ("Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage). On 28-Sep-2021, DEVICE CONNECTION ISSUE ("Patient did not feel as if he had received full dose as the vaccine was running down his arm/ the nurse administering the dose stated their was minimal leakage) 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaccination site erythema, Vaccination site irritation, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Irritated Injected Arm the first 24 hours; Localized allergic reaction on the vaccinated arm; Redness lasted a month/Red Injected Arm; Injected Arm got bigger and bigger the first 24 hours; Had an immediate reaction on my arm/that increased over that past 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours), VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours), ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm), VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours), ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm), VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours). In October 2021, the patient experienced VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours). On 10-Oct-2021, VACCINATION SITE IRRITATION (Irritated Injected Arm the first 24 hours) and VACCINATION SITE SWELLING (Injected Arm got bigger and bigger the first 24 hours) had resolved. In October 2021, VACCINATION SITE REACTION (Had an immediate reaction on my arm/that increased over that past 24 hours) had resolved. At the time of the report, ALLERGY TO VACCINE (Localized allergic reaction on the vaccinated arm) and VACCINATION SITE ERYTHEMA (Redness lasted a month/Red Injected Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: updated reporter details, patient age, vaccine start date and batch number and added new events and outcome.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Heart rate decreased, Hypertension
Clinical narrative: Serious palpitations; Lower number of blood pressure was high; Lower heart rate; Muscle ache; Headache; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Blood pressure measurement: high (High) lower number of blood pressure was high.. On 30-Sep-2021, Heart rate: 56 (Low) lower heart rate (56 bpm) for 2 weeks..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had serious palpitations, lower number of blood pressure was high, headache, muscle ache, and lower heart rate (56 bpm) for 2 weeks. The headache and muscle ache were coming and going. And all the symptoms started together the next day after first shot. No Concomitant medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations
Clinical narrative: Serious palpitations; Lower number of blood pressure was high; Lower heart rate; Muscle ache; Headache; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Serious palpitations), HYPERTENSION (Lower number of blood pressure was high), HEART RATE DECREASED (Lower heart rate), MYALGIA (Muscle ache) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Blood pressure measurement: high (High) lower number of blood pressure was high.. On 30-Sep-2021, Heart rate: 56 (Low) lower heart rate (56 bpm) for 2 weeks..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had serious palpitations, lower number of blood pressure was high, headache, muscle ache, and lower heart rate (56 bpm) for 2 weeks. The headache and muscle ache were coming and going. And all the symptoms started together the next day after first shot. No Concomitant medications were reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Peripheral swelling
Clinical narrative: Both legs became swollen; Skin on legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both legs became swollen) and PAIN OF SKIN (Skin on legs hurt) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced PERIPHERAL SWELLING (Both legs became swollen) and PAIN OF SKIN (Skin on legs hurt). The patient was treated with SODIUM CHLORIDE for Swelling of legs, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Both legs became swollen) was resolving and PAIN OF SKIN (Skin on legs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   Treatment included sodium chloride, for the adverse event and then the patient was feeling better.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow-up included treatment medication sodium chloride and Event swelling of legs outcome  were updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a dose of the vaccine from a vial that was left 30 hs out of the fridge; received a dose of the vaccine from a vial that was left 30 hs out of the fridge; 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 EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) 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-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) 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.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products were reported. No Treatment medication were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-357526, MOD-2021-357788, MOD-2021-357978, MOD-2021-357980, MOD-2021-358415 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Migraine, Myalgia, Nausea
Clinical narrative: I am currently under the care of my doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.; headaches but now in the form of extreme pressure.; 102 temp; Nausea; Muscle pain; extreme crushing headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (I am currently under the care of my Doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache). In April 2021, the patient experienced HEAD DISCOMFORT (headaches but now in the form of extreme pressure.). On an unknown date, the patient experienced MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) (seriousness criterion hospitalization). On 18-Mar-2021, PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache) had resolved. At the time of the report, MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) and HEAD DISCOMFORT (headaches but now in the form of extreme pressure.) had not resolved.            No concomitant medication information was provided. No treatment product information was provided.  patient had MRI of brain, cervical spine x-ray and numerous blood tests.; Sender's Comments: This case concerns a 63-year-old patient of an unknown gender with no medical history who experienced the unexpected event of migraine. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as the event occurred after the second dose. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting due to hospitalization.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I am currently under the care of my doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.; headaches but now in the form of extreme pressure.; 102 temp; Nausea; Muscle pain; extreme crushing headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (I am currently under the care of my Doctor with the neurology department at the Hospital who has diagnosed my headaches as chronic migraines.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache). In April 2021, the patient experienced HEAD DISCOMFORT (headaches but now in the form of extreme pressure.). On an unknown date, the patient experienced MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) (seriousness criterion hospitalization). On 18-Mar-2021, PYREXIA (102 temp), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (extreme crushing headache) had resolved. At the time of the report, MIGRAINE (I am currently under the care of the doctor with the neurology department at Hospital who has diagnosed my headaches as chronic migraines.) and HEAD DISCOMFORT (headaches but now in the form of extreme pressure.) had not resolved.            No concomitant medication information was provided. No treatment product information was provided.  patient had MRI of brain, cervical spine x-ray and numerous blood tests.; Sender's Comments: This case concerns a 63-year-old patient of an unknown gender with no medical history who experienced the unexpected event of migraine. The event occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable as the event occurred after the second dose. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event was assessed as serious per regulatory authority reporting due to hospitalization.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Hemiplegic migraine, Migraine, Oxygen saturation
Clinical narrative: scarring in her lungs; hemiplegic migraines; severe breathing problems / she struggles to breath when doing anything; pleural effusion; migraines; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-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 DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion) and MIGRAINE (migraines). In August 2021, the patient experienced SCAR (scarring in her lungs) and HEMIPLEGIC MIGRAINE (hemiplegic migraines). At the time of the report, SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: but nothing was found then (normal) but nothing was found then. In May 2021, X-ray: but nothing was found then (normal) but nothing was found then. In 2021, Oxygen saturation: low (Low) oxygen level got low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment included Oral steroids & steroid inhalers.  The patient developed scarring in her lungs in August-2021 after visiting the ER and getting x-rays & CT scans.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pleural effusion, Scar, X-ray
Clinical narrative: scarring in her lungs; hemiplegic migraines; severe breathing problems / she struggles to breath when doing anything; pleural effusion; migraines; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-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 DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion) and MIGRAINE (migraines). In August 2021, the patient experienced SCAR (scarring in her lungs) and HEMIPLEGIC MIGRAINE (hemiplegic migraines). At the time of the report, SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: but nothing was found then (normal) but nothing was found then. In May 2021, X-ray: but nothing was found then (normal) but nothing was found then. In 2021, Oxygen saturation: low (Low) oxygen level got low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment included Oral steroids & steroid inhalers.  The patient developed scarring in her lungs in August-2021 after visiting the ER and getting x-rays & CT scans.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The dose was administered to the patient after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided The vaccine was administered after being stored in a refrigerator for 33 days.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) 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
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   28 doses of vaccine were administered  (18OCT2021) after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals. All doses were administered by intramuscular injection from lot number 005C21A. None of these patients had reported symptoms to the contact or received any known treatments. 2 doses 20SEP2021 18OCT2021 Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Pain
Clinical narrative: He stated 2 patients reported being tired, fatigue and had ache and pain; He stated 2 patients reported being tired, fatigue and had ache and pain; Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female; This spontaneous case was reported by a physician and describes the occurrence of PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain), FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain), FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female). At the time of the report, PAIN (He stated 2 patients reported being tired, fatigue and had ache and pain) and FATIGUE (He stated 2 patients reported being tired, fatigue and had ache and pain) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients/  He stated 2 patients reported being tired, fatigue and had ache and pai/ The patients were male and female) 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 concomitant products were reported. No treatment information was reported by the reporter.