chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Rash, Rash pruritic, Skin warm, Swelling
Clinical narrative: Fatigue; Rash was warm to the touch; Rash was the size of a softball; Rash on her left arm; Rash was itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm), RASH PRURITIC (Rash was itchy) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (Hives from  other sources.). Concurrent medical conditions included Iodine contrast media allergy (Hives from Iodine contrast dyes.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball) and RASH PRURITIC (Rash was itchy). 29-Oct-2021, the patient experienced RASH (Rash on her left arm). On an unknown date, the patient experienced FATIGUE (Fatigue). In November 2021, SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm) and RASH PRURITIC (Rash was itchy) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient received first booster on 27-Oct-2021.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-546786, MOD-2022-546924, MOD-2022-546935 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: Fatigue; Rash was warm to the touch; Rash was the size of a softball; Rash on her left arm; Rash was itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm), RASH PRURITIC (Rash was itchy) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (Hives from  other sources.). Concurrent medical conditions included Iodine contrast media allergy (Hives from Iodine contrast dyes.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball) and RASH PRURITIC (Rash was itchy). 29-Oct-2021, the patient experienced RASH (Rash on her left arm). On an unknown date, the patient experienced FATIGUE (Fatigue). In November 2021, SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm) and RASH PRURITIC (Rash was itchy) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient received first booster on 27-Oct-2021.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-546786, MOD-2022-546924, MOD-2022-546935 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Fatigue; Rash was warm to the touch; Rash was the size of a softball; Rash on her left arm; Rash was itchy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm), RASH PRURITIC (Rash was itchy) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 029K20A) for COVID-19 vaccination.     The patient's past medical history included Hives (Hives from  other sources.). Concurrent medical conditions included Iodine contrast media allergy (Hives from Iodine contrast dyes.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball) and RASH PRURITIC (Rash was itchy). 29-Oct-2021, the patient experienced RASH (Rash on her left arm). On an unknown date, the patient experienced FATIGUE (Fatigue). In November 2021, SKIN WARM (Rash was warm to the touch), SWELLING (Rash was the size of a softball), RASH (Rash on her left arm) and RASH PRURITIC (Rash was itchy) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Patient received first booster on 27-Oct-2021.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-546786, MOD-2022-546924, MOD-2022-546935 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 071F21A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Hives from other sources.) and Iodine contrast media allergy (Hives from Iodine contrast dyes.).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-546931, MOD-2022-546786, MOD-2022-546924, MOD-2022-546503 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, IRON and CLINDAMYCIN for an unknown indication.    On 01-Apr-2022 at 11:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 11:22 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 01-Apr- 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions. Patient was administered with booster dose. No treatment information was reported. Patient did not had COVID-19 preceding month of vaccination. Patient had no known allergies of medicines and food.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022; dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     BMI was reported as 40.0-44.9 Patient had no known drug allergies. Patient had morbid (severe). Patient not tested positive for COVID within last month.  The patient's past medical history included Tubal ligation. Concurrent medical conditions included Obesity, Hyperlipidemia, Acute atopic conjunctivitis, Visual disturbances, Acute nasopharyngitis, Tooth development disorder, Pain in knee, Cervical pain, Snoring, Pelvic pain, Perineal pain, Glucose abnormal, Vitamin D deficiency and Gastritis haemorrhagic. Concomitant products included FAMOTIDINE, SALBUTAMOL (VENTOLINE [SALBUTAMOL]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN D3 for an unknown indication.    On 30-Mar-2022 at 10:40 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Mar-2022 at 10:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-Mar-2022) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The product expiration date was 25-Mar-2022. It was reported that HCP confirmed the patients did not experience any side effects yet. On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022 and expired. The vial did not undergo any temperature excursions. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache
Clinical narrative: Cough; Headache; minor headache; Shortness of breath; This case was received via another Manufacturer (Reference number: UNT-2022-008175) on 21-Apr-2022 and was forwarded to Moderna on 21-Apr-2022.    This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (Shortness of breath), COUGH (Cough) and HEADACHE (Headache; minor headache) in a 69-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhaler for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 06-Apr-2022, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to 18 microgram four times per day. In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) 24 microgram four times per day. On 12-Apr-2022, the patient experienced COUGH (Cough) and HEADACHE (Headache; minor headache). In April 2022, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath), COUGH (Cough) and HEADACHE (Headache; minor headache) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered DYSPNOEA (Shortness of breath) to be related. No further causality assessments were provided for COUGH (Cough) and HEADACHE (Headache; minor headache).    No concomitant medications were reported. No treatment medications were reported.  The patient received co-suspect IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A) via inhalation route.  The patient reported cough and minor headache. The physician was aware.  On an unreported date in Apr-2022 (last week), the patient reported some shortness of breath (dyspnea) after getting first COVID (corona virus disease) vaccine.  The reporter did not provide causality for the events of cough, headache and dyspnea for Tyvaso. The reporter's causality for the event of dyspnea with IH Tyvaso was considered to be possibly related.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: Numbness in the right side of the face, right foot, leg , and right arm after 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Numbness in the right side of the face, right foot, leg , and right arm after 2nd booster) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A and 065F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (long before vaccination).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (Numbness in the right side of the face, right foot, leg , and right arm after 2nd booster). At the time of the report, HYPOAESTHESIA (Numbness in the right side of the face, right foot, leg , and right arm after 2nd booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Magnetic resonance imaging head: normal (normal) did not reveal anything..         No concomitant medications were reported. Patient reported as not having a medical history of Bell's Palsy. She stated that the vaccine did not affect her blood pressure.   Patient took first booster on 12 NOV 2021. After the 2nd booster on 13 APR 2022, the same symptoms came back. She visited a neurologist and did MRI of brain. She stated that she visited her cardiologist too and he did not find anything. No treatment details were reported.   This case was linked to MOD-2022-546579 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Have received an expired dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Have received an expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Have received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Have received an expired dose) outcome was unknown.            No concomitant medications were reported.  Patient received second dose of Moderna vaccine on 29-Nov-2021 with lot number 049E21A and expiry date 11-Oct-2021.  No treatment medications were reported.   This case was linked to MOD-2022-547112 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: No new information received.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Laryngitis
Clinical narrative: Laryngitis; coughing like there is something is in his thorat; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGITIS (Laryngitis) and COUGH (coughing like there is something is in his thorat) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Yearly intramuscular Flu vaccine) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high (No Recent change in status such as improvement or worsening.), Penicillin allergy and Drug allergy.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 05-Apr-2022, the patient experienced LARYNGITIS (Laryngitis) and COUGH (coughing like there is something is in his thorat). At the time of the report, LARYNGITIS (Laryngitis) and COUGH (coughing like there is something is in his thorat) had not resolved.            Relevant concomitant medications reported high Blood pressure medication of unknown brand.  Patient did not had COVID positive test or diagnosis.  No treatment information was provided.   This case was linked to MOD-2022-547050, MOD-2022-547043, MOD-2022-547048 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Loss of personal independence in daily activities, Malaise, Myalgia
Clinical narrative: she has not been the same since; still feels sick; Has not been able return to normal activities; Lack of energy; Intermitted muscle ache all over body; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy) and MYALGIA (Intermitted muscle ache all over body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy), MYALGIA (Intermitted muscle ache all over body) and NAUSEA (Nauseated). At the time of the report, FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy), MYALGIA (Intermitted muscle ache all over body) and NAUSEA (Nauseated) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-547047.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: she has not been the same since; still feels sick; Has not been able return to normal activities; Lack of energy; Intermitted muscle ache all over body; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy) and MYALGIA (Intermitted muscle ache all over body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy), MYALGIA (Intermitted muscle ache all over body) and NAUSEA (Nauseated). At the time of the report, FEELING ABNORMAL (she has not been the same since), MALAISE (still feels sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has not been able return to normal activities), ASTHENIA (Lack of energy), MYALGIA (Intermitted muscle ache all over body) and NAUSEA (Nauseated) had not resolved.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-547047.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain after the 1st booster dose) in a 71-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild injection site pain after the 1st booster dose). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain after the 1st booster dose) outcome was unknown. No concomitant medications were mentioned. No treatment details were reported. This case was linked to MOD-2022-547041 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm after second dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 030L20A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Yearly IM Flu vaccine fall) in 2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Penicillin allergy, Drug allergy (Unknown blood pressure medication) and Blood pressure high (No change reported).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In 2021, the patient experienced VACCINATION SITE PAIN (Sore left arm after second dose). At the time of the report, VACCINATION SITE PAIN (Sore left arm after second dose) had resolved.            Concomitant medications included unspecified high blood pressure medication. It was reported that the event did not cause patient to seek medical care. No treatment information was reported.   This case was linked to MOD-2022-547050, MOD-2022-547043, MOD-2022-547040, MOD-2022-548215 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A sore left arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 006M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Yearly IM Flu vaccine Fall 2021) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. In October 2021, the patient experienced VACCINATION SITE PAIN (A sore left arm). At the time of the report, VACCINATION SITE PAIN (A sore left arm) had resolved.   Concomitant medications included High Blood Pressure Medication (unknown brand). No treatment medications were reported. patient experienced a similar event in the past   This case was linked to MOD-2022-547040, MOD-2022-547043, MOD-2022-547048, MOD-2022-547048 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 (US) hours post puncture) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 (US) hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 (US) hours post puncture) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided. Moderna COVID-19 Vaccine was administrated on 22 APR 2022 from 10:30 AM to 12:00 PM. It was reported that vial was initially stored in the refrigerator on 20 APR 2022 and was first punctured on 21 APR 2022 at 8: 45 AM. Vial was stored at room Temperature post puncture and did not undergo temperature excursions. Vial was exposed to room temperature for more than 24 hours within the range 8 degree to 25 degree C which was equal to 46 degree to 77 degree F for 27 and half hours. No treatment medications were provided.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine; fatigue; headache; muscle pain; joint pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye injury (had a history of an eye injury (from a bad car accident several years ago).), Nerve damage (trigeminal nerve damage(and takes Botox)) and COVID-19 (Patient did have COVID two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma (had asthma but not a medical condition). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL [PARACETAMOL]) and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    On 04-Mar-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 SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine) had resolved and FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that about a week and a half later all the Botox were off.  Patient took three test at the times and came back negative (Dec 26/31/ Jan4)  The patient had to have a prosthetic lens in one eye   This case was linked to MOD-2022-547079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up received contains no newinformation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test, Swelling face
Clinical narrative: swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine; fatigue; headache; muscle pain; joint pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye injury (had a history of an eye injury (from a bad car accident several years ago).), Nerve damage (trigeminal nerve damage(and takes Botox)) and COVID-19 (Patient did have COVID two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma (had asthma but not a medical condition). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL [PARACETAMOL]) and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    On 04-Mar-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 SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine) had resolved and FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that about a week and a half later all the Botox were off.  Patient took three test at the times and came back negative (Dec 26/31/ Jan4)  The patient had to have a prosthetic lens in one eye   This case was linked to MOD-2022-547079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up received contains no newinformation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test, Visual impairment
Clinical narrative: swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine; fatigue; headache; muscle pain; joint pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye injury (had a history of an eye injury (from a bad car accident several years ago).), Nerve damage (trigeminal nerve damage(and takes Botox)) and COVID-19 (Patient did have COVID two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma (had asthma but not a medical condition). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL [PARACETAMOL]) and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    On 04-Mar-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 SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, SWELLING FACE (swelled up my left side of face that had the Botox ,Kind of like paralysis but I was fine) had resolved and FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, negative (Negative) Negative and negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that about a week and a half later all the Botox were off.  Patient took three test at the times and came back negative (Dec 26/31/ Jan4)  The patient had to have a prosthetic lens in one eye   This case was linked to MOD-2022-547079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up received contains no newinformation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: The Covid shot (also) messed with my vision; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye injury (Eye injury from a bad car accident several years ago and had to have a prosthetic lens in one eye.), Motor vehicle accident (bad car accident several years ago) and COVID-19 (two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma (Asthma but not a medical condition) and Injury to trigeminal nerve (trigeminal nerve damage takes Botox). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Injury to trigeminal nerve.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In 2021, the patient experienced VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2019, SARS-CoV-2 test: negative (Negative) Negative. On 31-Dec-2019, SARS-CoV-2 test: negative (Negative) Negative. On 04-Jan-2020, SARS-CoV-2 test: negative (Negative) Negative. On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive (two years ago).         The patient had COVID two years ago. She took three test at the times and came back negative (In Dec 26 and 31 and on 04-Jan) came Jan 21st positive (two years ago).  The patient had to wait two weeks after 2nd COVID shot to get botox shot. The Covid shot (also) messed with my vision.   This case was linked to MOD-2022-547056, MOD-2022-547082 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up received contains no new information received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test, Swelling face
Clinical narrative: The Covid shot (also) messed with my vision; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye injury (Eye injury from a bad car accident several years ago and had to have a prosthetic lens in one eye.), Motor vehicle accident (bad car accident several years ago) and COVID-19 (two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma (Asthma but not a medical condition) and Injury to trigeminal nerve (trigeminal nerve damage takes Botox). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Injury to trigeminal nerve.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In 2021, the patient experienced VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2019, SARS-CoV-2 test: negative (Negative) Negative. On 31-Dec-2019, SARS-CoV-2 test: negative (Negative) Negative. On 04-Jan-2020, SARS-CoV-2 test: negative (Negative) Negative. On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive (two years ago).         The patient had COVID two years ago. She took three test at the times and came back negative (In Dec 26 and 31 and on 04-Jan) came Jan 21st positive (two years ago).  The patient had to wait two weeks after 2nd COVID shot to get botox shot. The Covid shot (also) messed with my vision.   This case was linked to MOD-2022-547056, MOD-2022-547082 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up received contains no new information received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test, Visual impairment
Clinical narrative: The Covid shot (also) messed with my vision; Fatigue; Headache; Muscle pain; Joint pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye injury (Eye injury from a bad car accident several years ago and had to have a prosthetic lens in one eye.), Motor vehicle accident (bad car accident several years ago) and COVID-19 (two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma (Asthma but not a medical condition) and Injury to trigeminal nerve (trigeminal nerve damage takes Botox). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for Injury to trigeminal nerve.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In 2021, the patient experienced VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (The Covid shot (also) messed with my vision), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2019, SARS-CoV-2 test: negative (Negative) Negative. On 31-Dec-2019, SARS-CoV-2 test: negative (Negative) Negative. On 04-Jan-2020, SARS-CoV-2 test: negative (Negative) Negative. On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive (two years ago).         The patient had COVID two years ago. She took three test at the times and came back negative (In Dec 26 and 31 and on 04-Jan) came Jan 21st positive (two years ago).  The patient had to wait two weeks after 2nd COVID shot to get botox shot. The Covid shot (also) messed with my vision.   This case was linked to MOD-2022-547056, MOD-2022-547082 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up received contains no new information received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial exposed to room temperature for more than 24 hours and then administered; Expired Booster doses administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered >12 hours post puncture) and PRODUCT STORAGE ERROR (the vial exposed to room temperature for more than 24 hours and then administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial exposed to room temperature for more than 24 hours and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered >12 hours post puncture) and PRODUCT STORAGE ERROR (the vial exposed to room temperature for more than 24 hours and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The vial was initially stored in the refrigerator on 20-APR-2022. The vial was first punctured on 21-APR-2022 at 8:45AM. The vaccine on 22-APR-2022 from 10:30AM to 12:00PM. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 27 and half hours. No treatment information was provided by the reporter.