chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided It was reported that first shipment was received on 15-March2021, and since they didn't know it was refrozen, they used it beyond April 14th
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-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 PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) 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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Shortness of Breath; weird chest feeling; Muscle pain inside the chest; 2nd dose beyond the recommended interval; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (weird chest feeling), MYALGIA (Muscle pain inside the chest) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond the recommended interval) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (weird chest feeling) and MYALGIA (Muscle pain inside the chest). 21-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond the recommended interval). At the time of the report, DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (weird chest feeling), MYALGIA (Muscle pain inside the chest) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose beyond the recommended interval) outcome was unknown.            Patient had reported that he was worried about Myocarditis and the pain he was experiencing.  Concomitant information was not reported. Treatment information was not reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose was administered to patients after the 30 days use by date.; patient was administered frst dose moderna without 30 days refrigeration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) and PRODUCT STORAGE ERROR (patient was administered frst dose moderna without 30 days refrigeration) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) and PRODUCT STORAGE ERROR (patient was administered frst dose moderna without 30 days refrigeration). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date.) and PRODUCT STORAGE ERROR (patient was administered frst dose moderna without 30 days refrigeration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided. Nurse stated that patient received the 1st dose of the Moderna COVID 19 vaccine on 20SEPT2021 between 8:10-9:10am. The dose was administered to patients after the 30 days use by date.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received on 23-Sep-2021 contains significant information, added reporter information and added an event or incorrect product storage.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain, Neck pain, Pain
Clinical narrative: there is a knot there; pain from my neck all the way down to my hand; really painful to touch; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (there is a knot there), NECK PAIN (pain from my neck all the way down to my hand), PAIN (really painful to touch) and INJECTION SITE PAIN (pain at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced INJECTION SITE DISCOMFORT (there is a knot there), NECK PAIN (pain from my neck all the way down to my hand), PAIN (really painful to touch) and INJECTION SITE PAIN (pain at the injection site). At the time of the report, INJECTION SITE DISCOMFORT (there is a knot there), NECK PAIN (pain from my neck all the way down to my hand), PAIN (really painful to touch) and INJECTION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes after 3 months of receiving second dose; 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 RASH (Rashes after 3 months of receiving second dose) 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.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rashes after 3 months of receiving second dose). At the time of the report, RASH (Rashes after 3 months of receiving second dose) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Left arm felt heavy; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left arm felt heavy) and PAIN IN EXTREMITY (Sore left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-935) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LIMB DISCOMFORT (Left arm felt heavy) and PAIN IN EXTREMITY (Sore left arm). At the time of the report, LIMB DISCOMFORT (Left arm felt heavy) and PAIN IN EXTREMITY (Sore left arm) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-326861 (Patient Link).   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Feeling abnormal, Headache
Clinical narrative: Feel weird; Kicked my butt/worse reaction than what I had with the flu shot; Temperature of 103; Headache; Blood pressure was high; Dizziness; Left hand was tingly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), FEELING ABNORMAL (Feel weird) and VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A, 017B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Immunization: Flu. Past adverse reactions to the above products included Weird feeling with Flu. Concurrent medical conditions included Raynaud's disease (immunocompromised with Reynaud's syndrome) and Immunocompromised. Concomitant products included PAROXETINE, BUSPIRONE, FOLIC ACID, METHOTREXATE from an unknown date to 03-Sep-2021 and OMEPRAZOLE for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), PYREXIA (Temperature of 103) and HEADACHE (Headache). 16-Sep-2021, the patient experienced VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot). On an unknown date, the patient experienced FEELING ABNORMAL (Feel weird). On 18-Sep-2021, HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), PYREXIA (Temperature of 103) and HEADACHE (Headache) had resolved. At the time of the report, FEELING ABNORMAL (Feel weird) had not resolved and VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood pressure measurement: high (High) High. On 16-Sep-2021, Body temperature: 103 (High) high. On 16-Sep-2021, Heart rate: 99 (High) high.         Other Concomitant medication included ceterone. No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypertension, Paraesthesia, Pyrexia, Vaccination complication
Clinical narrative: Feel weird; Kicked my butt/worse reaction than what I had with the flu shot; Temperature of 103; Headache; Blood pressure was high; Dizziness; Left hand was tingly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), FEELING ABNORMAL (Feel weird) and VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A, 017B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Immunization: Flu. Past adverse reactions to the above products included Weird feeling with Flu. Concurrent medical conditions included Raynaud's disease (immunocompromised with Reynaud's syndrome) and Immunocompromised. Concomitant products included PAROXETINE, BUSPIRONE, FOLIC ACID, METHOTREXATE from an unknown date to 03-Sep-2021 and OMEPRAZOLE for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), PYREXIA (Temperature of 103) and HEADACHE (Headache). 16-Sep-2021, the patient experienced VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot). On an unknown date, the patient experienced FEELING ABNORMAL (Feel weird). On 18-Sep-2021, HYPERTENSION (Blood pressure was high), DIZZINESS (Dizziness), PARAESTHESIA (Left hand was tingly), PYREXIA (Temperature of 103) and HEADACHE (Headache) had resolved. At the time of the report, FEELING ABNORMAL (Feel weird) had not resolved and VACCINATION COMPLICATION (Kicked my butt/worse reaction than what I had with the flu shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, Blood pressure measurement: high (High) High. On 16-Sep-2021, Body temperature: 103 (High) high. On 16-Sep-2021, Heart rate: 99 (High) high.         Other Concomitant medication included ceterone. No treatment medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I felt feverish for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (I felt feverish for 2 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-935) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (I felt feverish for 2 days). On 30-Apr-2021, PYREXIA (I felt feverish for 2 days) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-326837 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety level went through the roof; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety level went through the roof) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 013M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANXIETY (Anxiety level went through the roof). At the time of the report, ANXIETY (Anxiety level went through the roof) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of administered product to patient of inappropriate age (his son, who is 14 years of age, mistakenly given the Moderna COVID-19 vaccine) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 21, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 21, 2021, patient  administered product to patient of inappropriate age (his son, who is 14 years of age, mistakenly given the Moderna COVID-19 vaccine). At the time of the report,  administered product to patient of inappropriate age (his son, who is 14 years of age, mistakenly given the Moderna COVID-19 vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant product use or treatment information reported. Reporter stated he and his son went to receive the COVID-19 vaccine. His son (14 years of age) was mistakenly given the Moderna COVID-19 vaccine instead of the Pfizer vaccine. Reporter stated so far, his son seems fine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Illness, Myalgia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills) and MYALGIA (Aching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills), MYALGIA (Aching) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 24-Aug-2021, DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills), MYALGIA (Aching) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Body temperature: 101 f (High) Fever (max 101°F). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. It was reported that patient had to stay an extra 24hs fever-free for being able to go back to work. This case was linked to MOD-2021-326947.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills) and MYALGIA (Aching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills), MYALGIA (Aching) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 24-Aug-2021, DIARRHEA (Diarrhea), ILLNESS (Was sick), PYREXIA (Fever (101°F)), CHILLS (Chills), MYALGIA (Aching) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Body temperature: 101 f (High) Fever (max 101°F). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. It was reported that patient had to stay an extra 24hs fever-free for being able to go back to work. This case was linked to MOD-2021-326947.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Fatigue, Feeling abnormal, Headache
Clinical narrative: throat is dry; cannot fall asleep at night; Throat is itchy; fatigued; when I lay down at night it feels like I'm drowning; really dry cough; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night) and THROAT IRRITATION (Throat is itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (really bad headache). On 22-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (really dry cough). On an unknown date, the patient experienced FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 17-Aug-2021, HEADACHE (really bad headache) had resolved. At the time of the report, FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  The patient took other treatment medication include cough drops, cough syrup to relieve the symptoms.  It was reported that the day after receiving the vaccine she had a really bad headache which lasted for 2 days. Seven  days after receiving the vaccine she started to have a really dry cough that she could not get rid of. When she laid down at night it felt like she was drowning. Her throat was itchy and dry. She also felt fatigued and cannot sleep the whole night through.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Throat irritation
Clinical narrative: throat is dry; cannot fall asleep at night; Throat is itchy; fatigued; when I lay down at night it feels like I'm drowning; really dry cough; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night) and THROAT IRRITATION (Throat is itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced HEADACHE (really bad headache). On 22-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (really dry cough). On an unknown date, the patient experienced FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 17-Aug-2021, HEADACHE (really bad headache) had resolved. At the time of the report, FEELING ABNORMAL (when I lay down at night it feels like I'm drowning), COUGH (really dry cough), DRY THROAT (throat is dry), INSOMNIA (cannot fall asleep at night), THROAT IRRITATION (Throat is itchy) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  The patient took other treatment medication include cough drops, cough syrup to relieve the symptoms.  It was reported that the day after receiving the vaccine she had a really bad headache which lasted for 2 days. Seven  days after receiving the vaccine she started to have a really dry cough that she could not get rid of. When she laid down at night it felt like she was drowning. Her throat was itchy and dry. She also felt fatigued and cannot sleep the whole night through.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: myasthenia gravis; This spontaneous case was reported by a consumer and describes the occurrence of MYASTHENIA GRAVIS (myasthenia gravis) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Double vision. Concomitant products included AMLODIPINE, ATORVASTATIN, BUSPIRONE, FLUOXETINE, MELOXICAM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (myasthenia gravis) (seriousness criterion medically significant). The patient was treated with EPINASTINE for Adverse event, at a dose of UNK UNK, bid (1 drop in each eye twice daily); PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE [PYRIDOSTIGMINE BROMIDE]) for Adverse event, at a dose of UNK UNK, tid (60 mg half table) and MYCOPHENOLATE MOFETIL HCL for Adverse event, at a dose of 500 mg twice a day. At the time of the report, MYASTHENIA GRAVIS (myasthenia gravis) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include issued patient a pair of glasses to correct the double vision  It was reported that on 01 Feb 2021 patient went to the eye doctor. Patient had double vision for several months, left eye was drooping, left arm could not be raised above horizontal position. Patient was diagnosed with Myasthenia gravis in between June to July 2021.  Company comment: This case concerns a 79-year-old male patient with medical history of double vision, who experienced the unexpected, serious event of Myasthenia gravis. The event occurred approximately 1 day after first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Event myasthenia gravis was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.   This case was linked to MOD-2021-326977 (Patient Link).; Sender's Comments: This case concerns a 79-year-old male patient with medical history of double vision, who experienced the unexpected, serious event of Myasthenia gravis. The event occurred approximately 1 day after first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Event myasthenia gravis was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Myalgia, Nausea
Clinical narrative: body aches / same symptoms experienced by patient's boss; headache / same symptoms experienced by patient's boss; chills / same symptoms experienced by patient's boss; nausea; mini-flu / same symptoms experienced by patient's boss; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (mini-flu / same symptoms experienced by patient's boss), MYALGIA (body aches / same symptoms experienced by patient's boss), HEADACHE (headache / same symptoms experienced by patient's boss), CHILLS (chills / same symptoms experienced by patient's boss) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) 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 INFLUENZA (mini-flu / same symptoms experienced by patient's boss), MYALGIA (body aches / same symptoms experienced by patient's boss), HEADACHE (headache / same symptoms experienced by patient's boss), CHILLS (chills / same symptoms experienced by patient's boss) and NAUSEA (nausea). At the time of the report, INFLUENZA (mini-flu / same symptoms experienced by patient's boss), MYALGIA (body aches / same symptoms experienced by patient's boss), HEADACHE (headache / same symptoms experienced by patient's boss), CHILLS (chills / same symptoms experienced by patient's boss) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses given to 3 patients from a vial that has undergone a temperature excursion; Doses given to 3 patients from a vial that has undergone a temperature excursion; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given to 3 patients from a vial that has undergone a temperature excursion), EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and POOR QUALITY PRODUCT ADMINISTERED (Doses given to 3 patients from a vial that has undergone a temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given to 3 patients from a vial that has undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses given to 3 patients from a vial that has undergone a temperature excursion). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given to 3 patients from a vial that has undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses given to 3 patients from a vial that has undergone a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Pyrexia
Clinical narrative: Sick for couple days; Vey bad fever of 100.4°F; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for couple days), PYREXIA (Vey bad fever of 100.4°F) and HEADACHE (Very bad headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history provided by repoter.  Concomitant products included PREDNISONE and LEFLUNOMIDE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 ILLNESS (Sick for couple days), PYREXIA (Vey bad fever of 100.4°F) and HEADACHE (Very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick for couple days), PYREXIA (Vey bad fever of 100.4°F) and HEADACHE (Very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4°F.         This case was linked to MOD-2021-327066 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Bacterial infection, Rash
Clinical narrative: Rash on back and abdomen; Leg got bacterial infection; Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back and abdomen), BACTERIAL INFECTION (Leg got bacterial infection) and ALOPECIA (Hair loss) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination.     Concomitant products included LOSARTAN and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-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 RASH (Rash on back and abdomen), BACTERIAL INFECTION (Leg got bacterial infection) and ALOPECIA (Hair loss). The patient was treated with MUPIROCIN at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH (Rash on back and abdomen), BACTERIAL INFECTION (Leg got bacterial infection) and ALOPECIA (Hair loss) outcome was unknown.      Treatment medication also included antibiotics.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blepharospasm, Fatigue, Muscle twitching
Clinical narrative: weakness; left eye twitching/main twitching was on the eye & on the left side; left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), BLEPHAROSPASM (left eye twitching/main twitching was on the eye & on the left side), MUSCLE TWITCHING (left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg) and FATIGUE (fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058e21a) for COVID-19 vaccination.     The medical history information was not provided by the reporter.  Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GABAPENTIN and CLONAZEPAM for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced ASTHENIA (weakness), BLEPHAROSPASM (left eye twitching/main twitching was on the eye & on the left side), MUSCLE TWITCHING (left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), BLEPHAROSPASM (left eye twitching/main twitching was on the eye & on the left side), MUSCLE TWITCHING (left finger twitching then left arm twitching on the top all over/ random twitching on the stomach on the arm and on her leg) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The symptoms were ongoing, since every other minute.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: minor pain under my arm; vaccination site was red and swollen; vaccination site was red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor pain under my arm), VACCINATION SITE SWELLING (vaccination site was red and swollen) and VACCINATION SITE ERYTHEMA (vaccination site was red and swollen) 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.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PAIN IN EXTREMITY (minor pain under my arm), VACCINATION SITE SWELLING (vaccination site was red and swollen) and VACCINATION SITE ERYTHEMA (vaccination site was red and swollen). At the time of the report, PAIN IN EXTREMITY (minor pain under my arm), VACCINATION SITE SWELLING (vaccination site was red and swollen) and VACCINATION SITE ERYTHEMA (vaccination site was red and swollen) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.  Patient just received the booster shot on Monday at noon.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Headache, Influenza like illness, Malaise
Clinical narrative: feeling some pain in the injection site like it throbbes where he got the shot; no energy; feel sick/felt very sick; pain/pains were worse; headaches; aches/ache all over; quizzy; like a severe case of the flu, dry heat for like 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours), ASTHENIA (no energy), MALAISE (feel sick/felt very sick), PAIN (pain/pains were worse) and HEADACHE (headaches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 041L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, MONTELUKAST SODIUM (SINGULAIR), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), FAMOTIDINE and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours). On 19-Sep-2021, the patient experienced PAIN (pain/pains were worse), HEADACHE (headaches), MYALGIA (aches/ache all over) and NAUSEA (quizzy). On 21-Sep-2021, the patient experienced ASTHENIA (no energy) and MALAISE (feel sick/felt very sick). On 22-Sep-2021, the patient experienced VACCINATION SITE PAIN (feeling some pain in the injection site like it throbbes where he got the shot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like a severe case of the flu, dry heat for like 6 hours), ASTHENIA (no energy), MALAISE (feel sick/felt very sick), PAIN (pain/pains were worse), HEADACHE (headaches) and VACCINATION SITE PAIN (feeling some pain in the injection site like it throbbes where he got the shot) was resolving and MYALGIA (aches/ache all over) and NAUSEA (quizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2021, Body temperature: 100.6 (High) Degrees Fahrenheit. On 20-Sep-2021, Body temperature: 101.4 (High) Degrees Fahrenheit.         Patient  got the booster dose because he is travelling in October and that requires for them to get a booster shot.   This case was linked to MOD-2021-328256, MOD-2021-328226 (Patient Link).