chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Nasal congestion, Nasopharyngitis
Clinical narrative: The expiration date written on the card says 5-9-21; severe cold; stuffed up nose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (severe cold), NASAL CONGESTION (stuffed up nose) and EXPIRED PRODUCT ADMINISTERED (The expiration date written on the card says 5-9-21) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE for an unknown indication.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 17-May-2021, the patient experienced NASOPHARYNGITIS (severe cold) and NASAL CONGESTION (stuffed up nose). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date written on the card says 5-9-21). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form. At the time of the report, NASOPHARYNGITIS (severe cold), NASAL CONGESTION (stuffed up nose) and EXPIRED PRODUCT ADMINISTERED (The expiration date written on the card says 5-9-21) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever 102.9) and HEADACHE (crazy headache/constant headache/brain is sick inside my head/bigger pressure) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. # 009C01A) for COVID-19 immunisation.     No Medical History information was reported.   On 14-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced PYREXIA (high fever 102.9) and HEADACHE (crazy headache/constant headache/brain is sick inside my head/bigger pressure). On 16-May-2021, PYREXIA (high fever 102.9) had resolved. At the time of the report, HEADACHE (crazy headache/constant headache/brain is sick inside my head/bigger pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Blood pressure measurement: 100/70 (normal) 100/70. On 14-May-2021, Body temperature: 102.9 (High) 102.9 degree.         No concomitant medications were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: Brought a really heavy period; Shortened their menstrual cycle; Had an earlier period; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period). At the time of the report, HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period) outcome was unknown.            Med Info Agent: name redacted.  Crosslinked with case number: MOD21-091759 Patient called because she wanted to report side effect that is not listed in the common side effects. She also mentioned that some women also had this with their menstrual cycle after vaccine.  Brought a really heavy period, shortened their menstrual cycle, had an earlier period.   This case was linked to US-MODERNATX, INC.-MOD-2021-148424, US-MODERNATX, INC.-MOD-2021-148762, US-MODERNATX, INC.-MOD-2021-149413, US-MODERNATX, INC.-MOD-2021-149360 (E2B Linked Report). This case was linked to MOD-2021-148821 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148424:Reporter as a patient-1st dose US-MODERNATX, INC.-MOD-2021-148762:Reporter as a patient-2nd dose US-MODERNATX, INC.-MOD-2021-149413:Cluster case-2nd dose US-MODERNATX, INC.-MOD-2021-149360:Cluster case-1st dose
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Product dose omission issue, Throat irritation, Throat tightness
Clinical narrative: Missed dose; Throat tightness; Itchy throat; Swallowing difficult; This spontaneous case was reported by a nurse and describes the occurrence of THROAT TIGHTNESS (Throat tightness), THROAT IRRITATION (Itchy throat), DYSPHAGIA (Swallowing difficult) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 42-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 09-Apr-2021, the patient experienced THROAT TIGHTNESS (Throat tightness), THROAT IRRITATION (Itchy throat) and DYSPHAGIA (Swallowing difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 10-Apr-2021, THROAT TIGHTNESS (Throat tightness), THROAT IRRITATION (Itchy throat) and DYSPHAGIA (Swallowing difficult) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Intentional dose omission
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of INTENTIONAL DOSE OMISSION (patient that doesn't want to have the second dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (patient that doesn't want to have the second dose of the vaccine). At the time of the report, INTENTIONAL DOSE OMISSION (patient that doesn't want to have the second dose of the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.Treatment information was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm for 2 days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, OMEPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), PROBIOTICS NOS and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm for 2 days). On 02-May-2021, VACCINATION SITE PAIN (Sore arm for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lip swelling, Throat tightness
Clinical narrative: first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021; lips were swollen; she felt like her throat was going to close; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021), THROAT TIGHTNESS (she felt like her throat was going to close) and LIP SWELLING (lips were swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypercholesterolemia. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN and GLIBENCLAMIDE (GLYBURIDE) for Diabetes.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 31-Mar-2021, the patient experienced THROAT TIGHTNESS (she felt like her throat was going to close). On 30-Apr-2021, the patient experienced LIP SWELLING (lips were swollen). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Swollen lips, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) (oral) for Throat swelling, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna Covid-19 on 31Mar2021, she received her second dose of Moderna covid-19 vaccine on 4Apr2021) outcome was unknown and THROAT TIGHTNESS (she felt like her throat was going to close) and LIP SWELLING (lips were swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-149672 (E2B Linked Report). This case was linked to MOD-2021-149232 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149672:Crosslink case for family member
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose given to patient under eighteen years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose given to patient under eighteen years old) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose given to patient under eighteen years old). On 18-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose given to patient under eighteen years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness) and FEELING ABNORMAL (brain fog) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 037K20A) for COVID-19 vaccination. No Medical History information was reported. 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) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (extreme dizziness) and FEELING ABNORMAL (brain fog). At the time of the report, DIZZINESS (extreme dizziness) and FEELING ABNORMAL (brain fog) outcome was unknown. No concomitant medications were reported. Treatment information included steroids. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip dry, Lip haemorrhage, Lip swelling
Clinical narrative: dry lips; chapped lips; bleeding lips; swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP DRY (dry lips), CHAPPED LIPS (chapped lips), LIP HAEMORRHAGE (bleeding lips) and LIP SWELLING (swollen lips) in a 48-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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced LIP DRY (dry lips), CHAPPED LIPS (chapped lips), LIP HAEMORRHAGE (bleeding lips) and LIP SWELLING (swollen lips). At the time of the report, LIP DRY (dry lips), CHAPPED LIPS (chapped lips) and LIP HAEMORRHAGE (bleeding lips) outcome was unknown and LIP SWELLING (swollen lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Bumps on forehead/bumps that were very itchy; Experiencing a rash and was itchy behind her ear; Experiencing a rash and was itchy behind her ear; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Experiencing a rash and was itchy behind her ear), RASH MACULAR (Bumps on forehead/bumps that were very itchy) and RASH (Experiencing a rash and was itchy behind her ear) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-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) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced RASH PRURITIC (Experiencing a rash and was itchy behind her ear) and RASH (Experiencing a rash and was itchy behind her ear). On an unknown date, the patient experienced RASH MACULAR (Bumps on forehead/bumps that were very itchy). At the time of the report, RASH PRURITIC (Experiencing a rash and was itchy behind her ear), RASH MACULAR (Bumps on forehead/bumps that were very itchy) and RASH (Experiencing a rash and was itchy behind her ear) outcome was unknown.            It was reported that, the patient started experiencing a rash and was itchy behind her ear. A couple of days later it got super itchy. Then it started traveling up to her forehead. There were bumps that were very itchy. She then went to urgent care and was prescribed a cream and an allergy medication. Her rash has now left her forehead and ears, but is traveling down chin, neck, chest and back. She says there are little bumps on those areas of the body.   This case was linked to MOD-2021-149687 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: dripping bloody nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (dripping bloody nose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced EPISTAXIS (dripping bloody nose). At the time of the report, EPISTAXIS (dripping bloody nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included METOPROLOL, LISINOPRIL and CLONIDINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events were not provided Patient visited emergency room with elevated blood pressure and was treated by Norvasc and hydralazine. Patient had previously High blood pressure and treated it by metoprolol and lisinopril but never had so unexpected elevations. Occasionally Patient had experienced nose bleeding after vaccination and Physician added clonidine to patient's daily medication to treat the symptoms.   Crosslinked with case MOD21-065683 Caller was returning call from safety, contact information was provided.  The caller does not have a computer, and has no way to receive e-mail.   This case was linked to MOD-2021-063092 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received on 14-MAY-2021, Included no new information
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: quite a lot of shoulder pain after the 1st Moderna Shot; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (quite a lot of shoulder pain after the 1st Moderna Shot) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041821A) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder. Concomitant products included PREDNISONE for an unknown indication.    On 20-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 ARTHRALGIA (quite a lot of shoulder pain after the 1st Moderna Shot). At the time of the report, ARTHRALGIA (quite a lot of shoulder pain after the 1st Moderna Shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included medications for Liver problem. Treatment information was not provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Throat tightness
Clinical narrative: Throat was closing up; Bones aching; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat was closing up) and BONE PAIN (Bones aching) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced THROAT TIGHTNESS (Throat was closing up) and BONE PAIN (Bones aching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Apr-2021, THROAT TIGHTNESS (Throat was closing up) and BONE PAIN (Bones aching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient took the first dose vaccine on 21-Apr-2021. He experienced the events 30 minutes after getting home and reported that the problems were resolved after 3 hours by taking Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-149408, US-MODERNATX, INC.-MOD-2021-149232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149408:Same Reporter US-MODERNATX, INC.-MOD-2021-149232:Crosslink case for family member
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Illness, Nausea
Clinical narrative: Really sick; Nauseous; stuck in bed all day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), NAUSEA (Nauseous) and BEDRIDDEN (stuck in bed all day) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALICYLIC ACID (CREAM 91) for an unknown indication.    On 30-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 ILLNESS (Really sick), NAUSEA (Nauseous) and BEDRIDDEN (stuck in bed all day). At the time of the report, ILLNESS (Really sick) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-149468 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nodule (Not verified if cancer), Stroke, Venous stenosis and Hypertension (For ten years.). Concomitant products included METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ADALIMUMAB (HUMIRA) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Feeling cold, Head discomfort
Clinical narrative: aching lower back; freezing cold; could not lift her head; terrible chills; fever; laid out for a day/ in and out of bed all day; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), VACCINATION SITE PAIN (Sore arm) and CHILLS (terrible chills) in a female patient of an unknown age 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), CHILLS (terrible chills), PYREXIA (fever) and FATIGUE (laid out for a day/ in and out of bed all day). At the time of the report, BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), VACCINATION SITE PAIN (Sore arm), CHILLS (terrible chills), PYREXIA (fever) and FATIGUE (laid out for a day/ in and out of bed all day) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-069621 (E2B Linked Report). This case was linked to MOD-2021-069621 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069621:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: aching lower back; freezing cold; could not lift her head; terrible chills; fever; laid out for a day/ in and out of bed all day; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), VACCINATION SITE PAIN (Sore arm) and CHILLS (terrible chills) in a female patient of an unknown age 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), CHILLS (terrible chills), PYREXIA (fever) and FATIGUE (laid out for a day/ in and out of bed all day). At the time of the report, BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), VACCINATION SITE PAIN (Sore arm), CHILLS (terrible chills), PYREXIA (fever) and FATIGUE (laid out for a day/ in and out of bed all day) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-069621 (E2B Linked Report). This case was linked to MOD-2021-069621 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069621:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (couldn't swallow), PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (lymph nodes swelled) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis, Stress, Depression, Itchy (Ears gets itchy), Arm discomfort (Arm Hurt), Swallowing difficult, Memory loss (Memory getting worse), Exacerbation of infection of skin, Drug hypersensitivity (Keflex), Drug hypersensitivity (Diflucan), Latex allergy, Gluten sensitivity, Reaction to coloring (artificial colors), Reaction to flavoring (artificial flavor), Milk allergy and Drug hypersensitivity (Suprex Allergy). Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPHAGIA (couldn't swallow), PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (lymph nodes swelled). At the time of the report, DYSPHAGIA (couldn't swallow) had not resolved, PAIN IN EXTREMITY (arm hurt) outcome was unknown and LYMPHADENOPATHY (lymph nodes swelled) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Headache, Nausea, Pruritus
Clinical narrative: Discomfort; bumps forming from these hives; Hives from her arms,going to the waist till her ankles / bumps forming from these hives; Vaginal spotting; Itchy all over; Throwing up; Nausea; Headache; Dizzy spells; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy spells), VAGINAL HAEMORRHAGE (Vaginal spotting), PRURITUS (Itchy all over), DISCOMFORT (Discomfort) and URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (codeine, Vicodin), Food allergy (coconut, seafood, shellfish: anaphylactic shock) and Asthma. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA HANDIHALER), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYDROCHLOROTHIAZIDE + LOSARTAN) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-May-2021, the patient experienced DIZZINESS (Dizzy spells), PRURITUS (Itchy all over), VOMITING (Throwing up), NAUSEA (Nausea) and HEADACHE (Headache). On 18-May-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal spotting). On 19-May-2021, the patient experienced URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives). On an unknown date, the patient experienced DISCOMFORT (Discomfort) and SKIN MASS (bumps forming from these hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy spells), VAGINAL HAEMORRHAGE (Vaginal spotting), PRURITUS (Itchy all over), DISCOMFORT (Discomfort), URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives), SKIN MASS (bumps forming from these hives), VOMITING (Throwing up), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Urticaria, Vaginal haemorrhage, Vomiting
Clinical narrative: Discomfort; bumps forming from these hives; Hives from her arms,going to the waist till her ankles / bumps forming from these hives; Vaginal spotting; Itchy all over; Throwing up; Nausea; Headache; Dizzy spells; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizzy spells), VAGINAL HAEMORRHAGE (Vaginal spotting), PRURITUS (Itchy all over), DISCOMFORT (Discomfort) and URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (codeine, Vicodin), Food allergy (coconut, seafood, shellfish: anaphylactic shock) and Asthma. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA HANDIHALER), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYDROCHLOROTHIAZIDE + LOSARTAN) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-May-2021, the patient experienced DIZZINESS (Dizzy spells), PRURITUS (Itchy all over), VOMITING (Throwing up), NAUSEA (Nausea) and HEADACHE (Headache). On 18-May-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal spotting). On 19-May-2021, the patient experienced URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives). On an unknown date, the patient experienced DISCOMFORT (Discomfort) and SKIN MASS (bumps forming from these hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy spells), VAGINAL HAEMORRHAGE (Vaginal spotting), PRURITUS (Itchy all over), DISCOMFORT (Discomfort), URTICARIA (Hives from her arms,going to the waist till her ankles / bumps forming from these hives), SKIN MASS (bumps forming from these hives), VOMITING (Throwing up), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles after first shot). At the time of the report, HERPES ZOSTER (Shingles after first shot) outcome was unknown.            No treatment and concomitant medications were reported.   This case was linked to MOD-2021-150441 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Fatigue, Feeling abnormal, Pain
Clinical narrative: Vaccine related malaise; Feels really bad; severe pain; Arthritis flare; fever of 103; Great fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare) and PYREXIA (fever of 103) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized for a week due to COVID-19 infection) from December 2020 to January 2021.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare), PYREXIA (fever of 103) and FATIGUE (Great fatigue). At the time of the report, VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare), PYREXIA (fever of 103) and FATIGUE (Great fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 fever.         Patient stated that second dose reactions are stronger than first dose reactions.  Concomitant medications were not provided.  Treatment medications were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-080493 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Added New event Vaccine related malaise
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Vaccine related malaise; Feels really bad; severe pain; Arthritis flare; fever of 103; Great fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare) and PYREXIA (fever of 103) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized for a week due to COVID-19 infection) from December 2020 to January 2021.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare), PYREXIA (fever of 103) and FATIGUE (Great fatigue). At the time of the report, VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare), PYREXIA (fever of 103) and FATIGUE (Great fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 fever.         Patient stated that second dose reactions are stronger than first dose reactions.  Concomitant medications were not provided.  Treatment medications were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-080493 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Added New event Vaccine related malaise
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after second dose; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles after second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles after second dose). Not Provided          This case was linked to MOD-2021-150332 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Pyrexia, Tremor
Clinical narrative: Uncontrolled shaking; Dizziness; Stomach ache; A little fever; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Uncontrolled shaking), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), PYREXIA (A little fever) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin) and Food allergy (Shrimp). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021 at 10:00 AM, the patient experienced TREMOR (Uncontrolled shaking), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), PYREXIA (A little fever) and FATIGUE (Tiredness). At the time of the report, TREMOR (Uncontrolled shaking), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomach ache), PYREXIA (A little fever) and FATIGUE (Tiredness) had resolved.            No treatment information was provided by the reporter.   This case was linked to MOD-2021-012995 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up was received on 26-JUN-2021 contains No new Information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: felt really super fatigue; Chills; Headache; arm was a little sore/there was tenderness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (arm was a little sore/there was tenderness at injection site), FATIGUE (felt really super fatigue), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE and VITAMINS NOS for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was a little sore/there was tenderness at injection site). On 26-Mar-2021, the patient experienced FATIGUE (felt really super fatigue), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 26-Mar-2021, FATIGUE (felt really super fatigue) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was a little sore/there was tenderness at injection site) was resolving and CHILLS (Chills) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021 contain no new information
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling to lymph nodes on right side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling to lymph nodes on right side) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced LYMPHADENOPATHY (Swelling to lymph nodes on right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swelling to lymph nodes on right side) outcome was unknown.             No concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity, Somnolence
Clinical narrative: sore arm; drowsy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SOMNOLENCE (drowsy) and FATIGUE (tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus disorder NOS (Reportedly there was none acute illness reported at the time of vaccination and upto one month before), Nasal allergy and Allergy. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (CORICIDIN HBP CHEST CONGESTION AND COLD) for Congestion nasal and Drainage, PARACETAMOL (TYLENOL) from 15-May-2021 to an unknown date for Pain and Headache.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), SOMNOLENCE (drowsy) and FATIGUE (tired). On 15-May-2021, PAIN IN EXTREMITY (sore arm), SOMNOLENCE (drowsy) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2020, COVID-19: nasal swab nasal swab test done for covid-19.         This case was linked to MOD-2021-078185 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: immunization was given within 12 hours of withdrawal/was drawn up and not given from vaccine clinic the night before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (immunization was given within 12 hours of withdrawal/was drawn up and not given from vaccine clinic the night before) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (immunization was given within 12 hours of withdrawal/was drawn up and not given from vaccine clinic the night before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (immunization was given within 12 hours of withdrawal/was drawn up and not given from vaccine clinic the night before) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter   Reporter did not allow further contact