chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: Knocked out for 24-hours; Did a lot of sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Knocked out for 24-hours) and SOMNOLENCE (Did a lot of sleeping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-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 FEELING ABNORMAL (Knocked out for 24-hours) and SOMNOLENCE (Did a lot of sleeping). At the time of the report, FEELING ABNORMAL (Knocked out for 24-hours) and SOMNOLENCE (Did a lot of sleeping) outcome was unknown.            Patient experienced COVID before vaccination. Concomitant medications were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-374814, MOD-2021-374841 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Oral herpes
Clinical narrative: Headache; Bad chills (could not get warm); Tired; Fever of 99F; Cold sore in her mouth that seemed to be spreading; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore in her mouth that seemed to be spreading), HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 044A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ORAL HERPES (Cold sore in her mouth that seemed to be spreading). On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F). At the time of the report, ORAL HERPES (Cold sore in her mouth that seemed to be spreading), HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 99 (High) Fever of 99F..         No concomitant medications were reported.  Patient visited the dermatologist and they prescribed an ointment and pills as a treatment.   This case was linked to MOD-2021-374814, MOD-2021-374831, MOD-2021-374814 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Bad chills (could not get warm); Tired; Fever of 99F; Cold sore in her mouth that seemed to be spreading; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Cold sore in her mouth that seemed to be spreading), HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 044A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ORAL HERPES (Cold sore in her mouth that seemed to be spreading). On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F). At the time of the report, ORAL HERPES (Cold sore in her mouth that seemed to be spreading), HEADACHE (Headache), CHILLS (Bad chills (could not get warm)), FATIGUE (Tired) and PYREXIA (Fever of 99F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 99 (High) Fever of 99F..         No concomitant medications were reported.  Patient visited the dermatologist and they prescribed an ointment and pills as a treatment.   This case was linked to MOD-2021-374814, MOD-2021-374831, MOD-2021-374814 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: patient received a re frozen dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A / 23C21A) 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 PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine). At the time of the report, PRODUCT STORAGE ERROR (patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  There were two different lot numbers involved in the incident: 047C21A and 23C21A which were all booster doses. The patient received booster doses that were done from vaccine that was thawed, inadvertently refrozen, and then thawed again before administration.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up appended On 05-Nov-2021: Follow up contains significant information, Suspect batch number was added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Covid arm rash; sore arm at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Covid arm rash) and VACCINATION SITE PAIN (sore arm at vaccination site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chronic fatigue syndrome in 1985, Acute gastritis (Intestinal gastritis) in 1993, Hypertension in 2019, Chronic back pain in March 2003 and Arthritis in 2007. Previously administered products included for an unreported indication: INFLUENZA VACCINE (Innfluenza fluad (0.5ml)) on 07-Oct-2021. Concomitant products included HYDROXYZINE for Cystitis interstitial, PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Covid arm rash) and VACCINATION SITE PAIN (sore arm at vaccination site). At the time of the report, RASH (Covid arm rash) and VACCINATION SITE PAIN (sore arm at vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient have many drug sensitivities, but not "allergies" that are life threatening.  No treatment medications were provided by reporter.   This case was linked to MOD-2021-374828, MOD-2021-368330 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest constriction after 2nd dose for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest constriction after 2nd dose for 30 minutes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Shoulder pain and Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, CYCLOBENZAPRINE for Muscle relaxant, LEVOTHYROXINE and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (chest constriction after 2nd dose for 30 minutes). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN at a dose of Took before bed.. On 20-Mar-2021, CHEST PAIN (chest constriction after 2nd dose for 30 minutes) had resolved.            This case was linked to MOD-2021-374705 (Patient Link).
Age: 64.0
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 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Reporter had stated that the vial had been moved from frozen to refrigerated storage when they received them on 30Aug2021.
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: wrong dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (wrong dose administered) in an 88-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 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (wrong dose administered). On 27-Oct-2021, ACCIDENTAL OVERDOSE (wrong dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: received a booster dose out of a vial that had a needle left punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received a booster dose out of a vial that had a needle left punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received a booster dose out of a vial that had a needle left punctured). On 02-Nov-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (received a booster dose out of a vial that had a needle left punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Ankle redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Ankle redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Ankle redness). At the time of the report, ERYTHEMA (Ankle redness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant was reported. No Treatment medication was reported.   This case was linked to MOD-2021-374741, MOD-2021-374892 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Ankle Redness) and SWELLING (swelling after the 2nd shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Ankle Redness) and SWELLING (swelling after the 2nd shot). At the time of the report, ERYTHEMA (Ankle Redness) and SWELLING (swelling after the 2nd shot) had resolved.            Events resolved after one month later.  No concomitant medications was reported. No treatment was reported.   This case was linked to MOD-2021-374891, MOD-2021-374741 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Hypoaesthesia, Pain, Rash
Clinical narrative: Numbness; Pain; Swelling; skin discoloration; Left arm injection site swelled like a Popeye muscle and was down to elbow; Temperature; A rash; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling) and SKIN DISCOLOURATION (skin discoloration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included METOPROLOL, AMLODIPINE, EZETIMIBE (ZETIA), LEVOTHYROXINE, NITROFURANTOIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (PROAIR BRONQUIAL), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMINS NOS for an unknown indication.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature) and RASH (A rash). On 09-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling), SKIN DISCOLOURATION (skin discoloration) and VACCINATION SITE SWELLING (Left arm injection site swelled like a Popeye muscle and was down to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (Temperature), HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling), RASH (A rash) and VACCINATION SITE SWELLING (Left arm injection site swelled like a Popeye muscle and was down to elbow) had resolved and SKIN DISCOLOURATION (skin discoloration) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: abnormal (abnormal) abnormal.         The patient also took heating pad, and cold compress as treatment medication.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Swelling, Vaccination site swelling
Clinical narrative: Numbness; Pain; Swelling; skin discoloration; Left arm injection site swelled like a Popeye muscle and was down to elbow; Temperature; A rash; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling) and SKIN DISCOLOURATION (skin discoloration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included METOPROLOL, AMLODIPINE, EZETIMIBE (ZETIA), LEVOTHYROXINE, NITROFURANTOIN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (PROAIR BRONQUIAL), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMINS NOS for an unknown indication.   On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature) and RASH (A rash). On 09-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling), SKIN DISCOLOURATION (skin discoloration) and VACCINATION SITE SWELLING (Left arm injection site swelled like a Popeye muscle and was down to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (Temperature), HYPOAESTHESIA (Numbness), PAIN (Pain), SWELLING (Swelling), RASH (A rash) and VACCINATION SITE SWELLING (Left arm injection site swelled like a Popeye muscle and was down to elbow) had resolved and SKIN DISCOLOURATION (skin discoloration) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: abnormal (abnormal) abnormal.         The patient also took heating pad, and cold compress as treatment medication.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Rash, Skin discolouration
Clinical narrative: Arm hurts; Pinkish and in one area the look like dots and the other are they are is bigger; Raised bumps; Rash on my stomach also on my lower back/rib section; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), SKIN DISCOLOURATION (Pinkish and in one area the look like dots and the other are they are is bigger), MASS (Raised bumps) and RASH (Rash on my stomach also on my lower back/rib section) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), SKIN DISCOLOURATION (Pinkish and in one area the look like dots and the other are they are is bigger), MASS (Raised bumps) and RASH (Rash on my stomach also on my lower back/rib section). At the time of the report, PAIN IN EXTREMITY (Arm hurts), SKIN DISCOLOURATION (Pinkish and in one area the look like dots and the other are they are is bigger), MASS (Raised bumps) and RASH (Rash on my stomach also on my lower back/rib section) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment details were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Balance problems; Fever after booster; Chills after booster; Headache after booster; Fatigue after booster; Body aches after booster; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (Balance problems), PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster) and FATIGUE (Fatigue after booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster), FATIGUE (Fatigue after booster) and MYALGIA (Body aches after booster). On 01-Nov-2021, the patient experienced BALANCE DISORDER (Balance problems). On 27-Oct-2021, PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster), FATIGUE (Fatigue after booster) and MYALGIA (Body aches after booster) had resolved. At the time of the report, BALANCE DISORDER (Balance problems) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.    This case was linked to MOD-2021-374915 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Balance problems; Fever after booster; Chills after booster; Headache after booster; Fatigue after booster; Body aches after booster; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (Balance problems), PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster) and FATIGUE (Fatigue after booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster), FATIGUE (Fatigue after booster) and MYALGIA (Body aches after booster). On 01-Nov-2021, the patient experienced BALANCE DISORDER (Balance problems). On 27-Oct-2021, PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster), FATIGUE (Fatigue after booster) and MYALGIA (Body aches after booster) had resolved. At the time of the report, BALANCE DISORDER (Balance problems) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.    This case was linked to MOD-2021-374915 (Patient Link).
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Fatigue). On 04-Feb-2021, FATIGUE (Fatigue) 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.   After first dose patient had fatigue for a couple of days. Concomitant product information was not provided Treatment information was not provided   This case was linked to MOD-2021-374898, MOD-2021-374931 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: extreme headache. Her whole head feels very traumatic in her forehead and in back of head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extreme headache. Her whole head feels very traumatic in her forehead and in back of head) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F23A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Allergy to metals and Food allergy (Dairy products). Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for Cholesterol.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced HEADACHE (extreme headache. Her whole head feels very traumatic in her forehead and in back of head). At the time of the report, HEADACHE (extreme headache. Her whole head feels very traumatic in her forehead and in back of head) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.  Patient race was reported as black.  dose was given on 30-OCT-2021 12 PM.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant follow up was received and included vaccine facility information, contact address of health care professional, patient demographics (height, weight, race, and ethnicity), allergic and medical  history and concomitant medication.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was administered; 1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (1 vial of Moderna vaccine out of the Freezer on 23SEP2021 and placed it in the refrigerator. On 28OCT2021 they removed the unpunctured vial from the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants are provided No treatments are provided
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-374517 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue after 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Fatigue after 2nd dose). On 05-Mar-2021, FATIGUE (Fatigue after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided   This case was linked to MOD-2021-374898, MOD-2021-374915 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) 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.    This case was linked to MOD-2021-374517 (Patient Link).
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-374648, MOD-2021-374432, MOD-2021-374264 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization and medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.            No concomitant medications reported by reporter. Treatment medication not reported.  Company Comment: This case concerns a  55-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI  event of Appendicitis. The event occurred approximately 5 months after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-374276 (Patient Link).; Sender's Comments: This case concerns a  55-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI  event of Appendicitis. The event occurred approximately 5 months after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after the first dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after the first dose). At the time of the report, VACCINATION COMPLICATION (side effects after the first dose) outcome was unknown.        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-2021-374718 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: aching/achiness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aching/achiness) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 9399905) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage form. On an unknown date, the patient experienced MYALGIA (aching/achiness). At the time of the report, MYALGIA (aching/achiness) outcome was unknown.            No concomitant and treatment medications were provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SIMVASTATIN, SERTRALINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No Treatment medication was reported. Patient concomitant also included Rheumatoid arthritis weekly shots. Patient thinks they may have gotten another full dose instead of the booster half dose and will confirm with vaccination provider.   This case was linked to MOD-2021-374592 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: She was diagnosed with a "UTI" this morning; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (She was diagnosed with a "UTI" this morning) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URINARY TRACT INFECTION (She was diagnosed with a "UTI" this morning). At the time of the report, URINARY TRACT INFECTION (She was diagnosed with a "UTI" this morning) had not resolved.            No concomitant medication information was provided. Treatment medication include antibiotics for UTI. The patient took booster dose on 04Nov2021and had no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up includes booster dose information was added.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: ill; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) 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 ILLNESS (ill). At the time of the report, ILLNESS (ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial (lot # 046C21A) that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; arm soreness,body aches; headaches; 39°C fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), MYALGIA (arm soreness,body aches), HEADACHE (headaches), PYREXIA (39°C fever) and CHILLS (chills) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033f21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (lot# w0158) on 09-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (lot# eu00171) on 26-Apr-2021.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and MYALGIA (arm soreness,body aches). 02-Nov-2021, the patient experienced HEADACHE (headaches), PYREXIA (39°C fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (arm soreness), MYALGIA (arm soreness,body aches), HEADACHE (headaches), PYREXIA (39°C fever) and CHILLS (chills) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine that was given after the expiration date.) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 24-Sep-2021, the vial was initially stored in the refrigerator. The vaccine was administered between 24-Oct-2021 to 27-Oct-2021. The vial had not undergone any temperature excursions. Concomitant medication information not provided. Treatment information not provided.