chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Tooth disorder
Clinical narrative: rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May; Wisdom teeth Pulled; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May) and TOOTH DISORDER (Wisdom teeth Pulled) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-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 INTENTIONAL PRODUCT USE ISSUE (rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May) and TOOTH DISORDER (Wisdom teeth Pulled). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May) and TOOTH DISORDER (Wisdom teeth Pulled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue
Clinical narrative: Caller is past 35 days from first dose; Soreness to arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller is past 35 days from first dose) and MYALGIA (Soreness to arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-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 (Caller is past 35 days from first dose) and MYALGIA (Soreness to arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller is past 35 days from first dose) and MYALGIA (Soreness to arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaccination complication
Clinical narrative: COVID arm from both doses of the Moderna COVID-19; ever since 2nd vaccine, I haven't had a period; This spontaneous case was reported by a pharmacist and describes the occurrence of MENSTRUAL DISORDER (ever since 2nd vaccine, I haven't had a period   ) and VACCINATION COMPLICATION (COVID arm from both doses of the Moderna COVID-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE (REMERON) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENSTRUAL DISORDER (ever since 2nd vaccine, I haven't had a period   ). On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID arm from both doses of the Moderna COVID-19). At the time of the report, MENSTRUAL DISORDER (ever since 2nd vaccine, I haven't had a period   ) and VACCINATION COMPLICATION (COVID arm from both doses of the Moderna COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-233523 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009c21a and 46017821a) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) had resolved.            Blood thinners and blood pressure were used as concomitant medications. No treatment medication details was reported.   This case was linked to MOD-2021-231073 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up document received on 19-JUL-2021.Updated event outcome( Difficulty breathing)
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I got my first moderna shot and two days later i tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (I got my first moderna shot and two days later i tested positive for covid) 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 SARS-COV-2 TEST POSITIVE (I got my first moderna shot and two days later i tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (I got my first moderna shot and two days later i tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Negative(17 days after COVID positive).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node by his left clavicle got inflamed again; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node by his left clavicle got inflamed again) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (lymph node by his left clavicle got inflamed again). The patient was treated with IBUPROFEN (ADVILCAPS) at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (lymph node by his left clavicle got inflamed again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.   This case was linked to MOD-2021-230862 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a lot of pain on my left arm; a lot of pain on my left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of pain on my left arm) and PAIN IN EXTREMITY (a lot of pain on my left leg) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported by reporter.     On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced PAIN IN EXTREMITY (a lot of pain on my left arm) and PAIN IN EXTREMITY (a lot of pain on my left leg). On 22-Jun-2021, PAIN IN EXTREMITY (a lot of pain on my left arm) and PAIN IN EXTREMITY (a lot of pain on my left leg) 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 concomitant drugs was reported. No  treatment medications were  reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: late reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (late reaction) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (late reaction). At the time of the report, VACCINATION COMPLICATION (late reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.  Additionally it was reported that patient missed the second dose as vaccination site did not advise the patient of date for second dose.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Patient and suspect drug details updated.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with vaccines that were in the fridge for 33 days; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with vaccines that were in the fridge for 33 days) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with vaccines that were in the fridge for 33 days). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (vaccinated with vaccines that were in the fridge for 33 days) 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 concomitant medication details was reported. No treatment medication details was reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Headache, Lethargy
Clinical narrative: slight chest pain; Lethargy; weakness; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (slight chest pain), LETHARGY (Lethargy), ASTHENIA (weakness) and HEADACHE (Headache) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 022A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced CHEST PAIN (slight chest pain), LETHARGY (Lethargy), ASTHENIA (weakness) and HEADACHE (Headache). At the time of the report, CHEST PAIN (slight chest pain), LETHARGY (Lethargy), ASTHENIA (weakness) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided  Treatment medication was not reported Action taken mRNA-1273 in response to the event was not applicable
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009c21a and 46017821A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing). At the time of the report, DYSPNOEA (Difficulty breathing) had resolved.            Concomitant medication include blood thinner and blood pressure medications. No treatment medication was provided.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19 Jul 2021 contains no significant information
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hot flush
Clinical narrative: Inflamed Injection Site; Hot Flashes; quite large hard knot at the vaccine area; Red Injection Site; Swollen Injection Site (> Golf Ball); Sore Injection Site; Joint Aches and Pain; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE MASS (quite large hard knot at the vaccine area), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-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 VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE MASS (quite large hard knot at the vaccine area), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)), VACCINATION SITE PAIN (Sore Injection Site), ARTHRALGIA (Joint Aches and Pain), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)), VACCINATION SITE PAIN (Sore Injection Site), ARTHRALGIA (Joint Aches and Pain), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved and VACCINATION SITE MASS (quite large hard knot at the vaccine area) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No Concomitant medication was reported. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional information was added on 22-Jun-2021. Reporter address, contact  information added, patient details was added, Information about 2 doses  along with other events like Sore at injection site,joint aches and pain, hot flashes, chills, Headache, fatigue were added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Inflamed Injection Site; Hot Flashes; quite large hard knot at the vaccine area; Red Injection Site; Swollen Injection Site (> Golf Ball); Sore Injection Site; Joint Aches and Pain; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE MASS (quite large hard knot at the vaccine area), VACCINATION SITE ERYTHEMA (Red Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-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 VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE MASS (quite large hard knot at the vaccine area), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)), VACCINATION SITE PAIN (Sore Injection Site), ARTHRALGIA (Joint Aches and Pain), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed Injection Site), HOT FLUSH (Hot Flashes), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site (> Golf Ball)), VACCINATION SITE PAIN (Sore Injection Site), ARTHRALGIA (Joint Aches and Pain), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved and VACCINATION SITE MASS (quite large hard knot at the vaccine area) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No Concomitant medication was reported. No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional information was added on 22-Jun-2021. Reporter address, contact  information added, patient details was added, Information about 2 doses  along with other events like Sore at injection site,joint aches and pain, hot flashes, chills, Headache, fatigue were added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Illness, Myalgia
Clinical narrative: Very sick; Swelling; Redness; Muscle Aches; Joint Aches; Fatigue; temperature; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches) and ARTHRALGIA (Joint Aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-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 ILLNESS (Very sick), SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches), FATIGUE (Fatigue), PYREXIA (temperature) and VOMITING (Throwing up). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, ILLNESS (Very sick), SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches), FATIGUE (Fatigue), PYREXIA (temperature) and VOMITING (Throwing up) 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.   This case was linked to MOD-2021-231095 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Very sick; Swelling; Redness; Muscle Aches; Joint Aches; Fatigue; temperature; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches) and ARTHRALGIA (Joint Aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-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 ILLNESS (Very sick), SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches), FATIGUE (Fatigue), PYREXIA (temperature) and VOMITING (Throwing up). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, ILLNESS (Very sick), SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches), FATIGUE (Fatigue), PYREXIA (temperature) and VOMITING (Throwing up) 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.   This case was linked to MOD-2021-231095 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated with vaccines that were in the fridge for 33 days; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacy received the vaccine box on 19-may-2021 and was put on refrigerator. The expiration date of vaccine box was till 18-jun-2021.Staff did not dispose the vaccine and continued to use the vaccine until  22-jun-2021 morning  for 5 patients. The reporter stated that remaining 25 doses were disposed. No side effect or prior medical history were reported. No concomitant medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Additional information received and First dose details were added
Sex: U
Vaccine: COVID19
Symptoms: Colonoscopy, Constipation
Clinical narrative: Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation). At the time of the report, CONSTIPATION (Ever since receiving the Moderna vaccine in February I have been having severe cycles of constipation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: severe (abnormal) Severe.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: achy arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (achy arm). The patient was treated with GLYCERYL TRINITRATE (NITROGLYCERINE) at a dose of 1 dosage form and MORPHINE at a dose of 1 dosage form. At the time of the report, MYALGIA (achy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vaccination site pain
Clinical narrative: diarrhea; after both vaccines she experienced a sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q29K20A) for COVID-19 vaccination.     Concomitant products included DOFETILIDE (TIKOSYN), METFORMIN, INSULIN GLARGINE (LANTUS), METOPROLOL SUCCINATE and APIXABAN (ELIQUIS) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-231100 (Patient Link).
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-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 (shoulder pain). The patient was treated with GABAPENTIN ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: TCR. added. NNI.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I received my 1st dose 7 wks ago on 05May2021.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my 1st dose 7 wks ago on 05May2021.) 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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my 1st dose 7 wks ago on 05May2021.). On 22-Jun-2021, PRODUCT DOSE OMISSION ISSUE (I received my 1st dose 7 wks ago on 05May2021.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Myalgia, Swelling
Clinical narrative: Swelling; Redness; Muscle Aches; Joint Aches; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 043B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-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 SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, SWELLING (Swelling), ERYTHEMA (Redness), MYALGIA (Muscle Aches), ARTHRALGIA (Joint Aches) and FATIGUE (Fatigue) outcome was unknown.            Treatment details were not provided.   This case was linked to MOD-2021-231082 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Computerised tomogram, Cough, Fall
Clinical narrative: Urinary tract problems; Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks; Started getting pain in back when urinating; Experiencing a cough; Last Friday I broke out in chills, went to Emergency Room; he collapsed to the floor from pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating), FALL (he collapsed to the floor from pain) and COUGH (Experiencing a cough) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and TAMSULOSIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FALL (he collapsed to the floor from pain). On 18-Jun-2021, the patient experienced CHILLS (Last Friday I broke out in chills, went to Emergency Room). On an unknown date, the patient experienced URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating) and COUGH (Experiencing a cough). The patient was treated with CEFALEXIN (CEPHALEXINE) for Bladder infection, at a dose of 1 dosage form. At the time of the report, URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating), FALL (he collapsed to the floor from pain), COUGH (Experiencing a cough) and CHILLS (Last Friday I broke out in chills, went to Emergency Room) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Computerised tomogram: inconclusive (Inconclusive) The patient claimed that 2 out of 3 doctors mentioned no kidney stone present..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by the reporter. The action taken with the suspect product was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated patient demographics. Added concomitant and treatment medicines. Added new events Back pain, Fall, Chills and Cough.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Urinary tract discomfort
Clinical narrative: Urinary tract problems; Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks; Started getting pain in back when urinating; Experiencing a cough; Last Friday I broke out in chills, went to Emergency Room; he collapsed to the floor from pain; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating), FALL (he collapsed to the floor from pain) and COUGH (Experiencing a cough) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE and TAMSULOSIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FALL (he collapsed to the floor from pain). On 18-Jun-2021, the patient experienced CHILLS (Last Friday I broke out in chills, went to Emergency Room). On an unknown date, the patient experienced URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating) and COUGH (Experiencing a cough). The patient was treated with CEFALEXIN (CEPHALEXINE) for Bladder infection, at a dose of 1 dosage form. At the time of the report, URINARY TRACT DISCOMFORT (Urinary tract problems), PAIN (Pain/Pain ranging from 3 to 8 out of 10 on a pain scale/The pain was on and off but kept getting worse after a couple of weeks), BACK PAIN (Started getting pain in back when urinating), FALL (he collapsed to the floor from pain), COUGH (Experiencing a cough) and CHILLS (Last Friday I broke out in chills, went to Emergency Room) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Computerised tomogram: inconclusive (Inconclusive) The patient claimed that 2 out of 3 doctors mentioned no kidney stone present..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by the reporter. The action taken with the suspect product was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Updated patient demographics. Added concomitant and treatment medicines. Added new events Back pain, Fall, Chills and Cough.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: developed two health problems/ side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (developed two health problems/ side effects) 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 VACCINATION COMPLICATION (developed two health problems/ side effects). At the time of the report, VACCINATION COMPLICATION (developed two health problems/ side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Diarrhoea, Nausea, Nightmare
Clinical narrative: feeling of panic; diarrhea; cold sweat; bad dream; chills; nausea/ slight nausea; after both vaccines she experienced a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream) and CHILLS (chills) in a 71-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 was provided by the reporter.  Concomitant products included DOFETILIDE (TIKOSYN), METFORMIN, INSULIN GLARGINE (LANTUS), METOPROLOL SUCCINATE and APIXABAN (ELIQUIS) for an unknown indication.    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 PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream), CHILLS (chills), NAUSEA (nausea/ slight nausea) and VACCINATION SITE PAIN (after both vaccines she experienced a sore arm). At the time of the report, PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream), CHILLS (chills), NAUSEA (nausea/ slight nausea) and VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) outcome was unknown.            Treatment included Tylenol and as well as coco-cola.     This case was linked to MOD-2021-231090 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Panic disorder, Vaccination site pain
Clinical narrative: feeling of panic; diarrhea; cold sweat; bad dream; chills; nausea/ slight nausea; after both vaccines she experienced a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream) and CHILLS (chills) in a 71-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 was provided by the reporter.  Concomitant products included DOFETILIDE (TIKOSYN), METFORMIN, INSULIN GLARGINE (LANTUS), METOPROLOL SUCCINATE and APIXABAN (ELIQUIS) for an unknown indication.    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 PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream), CHILLS (chills), NAUSEA (nausea/ slight nausea) and VACCINATION SITE PAIN (after both vaccines she experienced a sore arm). At the time of the report, PANIC DISORDER (feeling of panic), DIARRHOEA (diarrhea), COLD SWEAT (cold sweat), NIGHTMARE (bad dream), CHILLS (chills), NAUSEA (nausea/ slight nausea) and VACCINATION SITE PAIN (after both vaccines she experienced a sore arm) outcome was unknown.            Treatment included Tylenol and as well as coco-cola.     This case was linked to MOD-2021-231090 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated with vaccines that were in the fridge for 33 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-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 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with vaccines that were in the fridge for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose from vial that was opened on 18June2021 was administered on 21June2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose from vial that was opened on 18June2021 was administered on 21June2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose from vial that was opened on 18June2021 was administered on 21June2021). On 21-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose from vial that was opened on 18June2021 was administered on 21June2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 18June2021 a vial of Moderna vaccine was opened and didn't label with time or date and didn't discard. It was left refrigerated over the weekend. Concomitant product information was not provided Treatment information was not provided Action taken with mRNA-1273 in response to the events is not applicable
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Ear disorder
Clinical narrative: Terrible problem with her ears; Dizziness; 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 EAR DISORDER (Terrible problem with her ears) and DIZZINESS (Dizziness) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR DISORDER (Terrible problem with her ears) and DIZZINESS (Dizziness). At the time of the report, EAR DISORDER (Terrible problem with her ears) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with vaccines that were in the fridge for 33 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with vaccines that were in the fridge for 33 days) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) 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 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with vaccines that were in the fridge for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with vaccines that were in the fridge for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: What are the side effects when you get the 2nd vaccine?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are the side effects when you get the 2nd 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are the side effects when you get the 2nd vaccine?). At the time of the report, VACCINATION COMPLICATION (What are the side effects when you get the 2nd vaccine?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitants and treatment drugs were reported.