chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Second shot was worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Second shot was worse) 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, 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 VACCINATION COMPLICATION (Second shot was worse). At the time of the report, VACCINATION COMPLICATION (Second shot was worse) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-351181, MOD-2021-351212 (Patient Link).   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heavy menstrual bleeding, Menstrual disorder, Myalgia
Clinical narrative: she has been having abnormal menstrual cycles; abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination; itchiness; fever after both shots, 102 degrees fahrenheit at first dose; chills; muscle ache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (she has been having abnormal menstrual cycles), HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination), PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 MENSTRUAL DISORDER (she has been having abnormal menstrual cycles), HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination), PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose), CHILLS (chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, MENSTRUAL DISORDER (she has been having abnormal menstrual cycles) and HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination) had not resolved and PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose), CHILLS (chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 Fahrenheit at first dose.     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 were provided. No treatment medications were provided.   This case was linked to MOD-2021-351073 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: she has been having abnormal menstrual cycles; abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination; itchiness; fever after both shots, 102 degrees fahrenheit at first dose; chills; muscle ache; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (she has been having abnormal menstrual cycles), HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination), PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-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 MENSTRUAL DISORDER (she has been having abnormal menstrual cycles), HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination), PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose), CHILLS (chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, MENSTRUAL DISORDER (she has been having abnormal menstrual cycles) and HEAVY MENSTRUAL BLEEDING (abnormal bleeding that is not stopping. The bleeding has occurred after each vaccination) had not resolved and PRURITUS (itchiness), PYREXIA (fever after both shots, 102 degrees fahrenheit at first dose), CHILLS (chills), MYALGIA (muscle ache) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 Fahrenheit at first dose.     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 were provided. No treatment medications were provided.   This case was linked to MOD-2021-351073 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: her first shot was bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (her first shot was bad) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (her first shot was bad). At the time of the report, VACCINATION COMPLICATION (her first shot was bad) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment drug details was reported.   This case was linked to MOD-2021-351181, MOD-2021-351210 (Patient Link).   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitants were reported. no treatment medications was provided
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chest pain, Cough, Erythema
Clinical narrative: pain in her brain and her chest/pain in his heart; pain in her back which disappeared over time; mental issues; stomach issues; cough; llaga roja; a non-painful red spot on her leg/2 red things on his armpits/llaga roja; pain in her brain and her chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in her brain and her chest/pain in his heart), BACK PAIN (pain in her back which disappeared over time), MENTAL DISORDER (mental issues), ABDOMINAL DISCOMFORT (stomach issues) and COUGH (cough) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04BbB2a/ and 021c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 CHEST PAIN (pain in her brain and her chest/pain in his heart), BACK PAIN (pain in her back which disappeared over time), MENTAL DISORDER (mental issues), ABDOMINAL DISCOMFORT (stomach issues), COUGH (cough), RASH ERYTHEMATOUS , ERYTHEMA (a non-painful red spot on her leg/2 red things on his armpits) and HEADACHE (pain in her brain and her chest). The patient was treated with VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency; VITAMIN B3 for Adverse event, at an unspecified dose and frequency; VITAMIN B COMPLEX ongoing since an unknown date at a dose of 1 dosage form; KETOCONAZOLE for Adverse event, at an unspecified dose and frequency and MICONAZOLE for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (pain in her brain and her chest/pain in his heart), MENTAL DISORDER (mental issues), ABDOMINAL DISCOMFORT (stomach issues), COUGH (cough), RASH ERYTHEMATOUS , ERYTHEMA (a non-painful red spot on her leg/2 red things on his armpits) and HEADACHE (pain in her brain and her chest) outcome was unknown and BACK PAIN (pain in her back which disappeared over time) had resolved.            Patient had a concomitant natural medicine and Treatment of essentials vitamins and pure equinacia,and HCP prescribed him clindamycin Ketoconazole and miconazole cream which not work and natural soap.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Mental disorder, Rash erythematous
Clinical narrative: pain in her brain and her chest/pain in his heart; pain in her back which disappeared over time; mental issues; stomach issues; cough; llaga roja; a non-painful red spot on her leg/2 red things on his armpits/llaga roja; pain in her brain and her chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (pain in her brain and her chest/pain in his heart), BACK PAIN (pain in her back which disappeared over time), MENTAL DISORDER (mental issues), ABDOMINAL DISCOMFORT (stomach issues) and COUGH (cough) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04BbB2a/ and 021c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 CHEST PAIN (pain in her brain and her chest/pain in his heart), BACK PAIN (pain in her back which disappeared over time), MENTAL DISORDER (mental issues), ABDOMINAL DISCOMFORT (stomach issues), COUGH (cough), RASH ERYTHEMATOUS , ERYTHEMA (a non-painful red spot on her leg/2 red things on his armpits) and HEADACHE (pain in her brain and her chest). The patient was treated with VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency; VITAMIN B3 for Adverse event, at an unspecified dose and frequency; VITAMIN B COMPLEX ongoing since an unknown date at a dose of 1 dosage form; KETOCONAZOLE for Adverse event, at an unspecified dose and frequency and MICONAZOLE for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (pain in her brain and her chest/pain in his heart), MENTAL DISORDER (mental issues), ABDOMINAL DISCOMFORT (stomach issues), COUGH (cough), RASH ERYTHEMATOUS , ERYTHEMA (a non-painful red spot on her leg/2 red things on his armpits) and HEADACHE (pain in her brain and her chest) outcome was unknown and BACK PAIN (pain in her back which disappeared over time) had resolved.            Patient had a concomitant natural medicine and Treatment of essentials vitamins and pure equinacia,and HCP prescribed him clindamycin Ketoconazole and miconazole cream which not work and natural soap.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a Moderna 2nd dose and the vaccine expired yesterday) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-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 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a Moderna 2nd dose and the vaccine expired yesterday). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna 2nd dose and the vaccine expired yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. It was reported that the vial was initially stored in the refrigerator on 08-Oct-2021 and did not undergo any temperature excursions. The reporter wasn't sure if they had concomitant medications but saw that they marked "no medical history" on the form
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: severe pain comes in waves; tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Oct-2021 and was forwarded to Moderna on 13-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg) and PAIN (severe pain comes in waves) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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-May-2021, the patient experienced PARAESTHESIA (tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg). On an unknown date, the patient experienced PAIN (severe pain comes in waves). The patient was treated with PREDNISONE at an unspecified dose and frequency and GABAPENTIN (NEURONTIN) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingles in her left arm/ tingling spreading It moved to her left shoulder, between neck,shoulder, down her left side to her waist. It's also in her left shoulder blade, moving down her left leg) had not resolved and PAIN (severe pain comes in waves) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that, after receiving her 1st dose she started getting tingles in her left arm within a minute of it being administered. The tingling became more intense.  Patient scheduled for an EMG and was going to see a neurologist.   This case was linked to MOD-2021-351199 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: dose expired 08Aug2021; Inappropriate schedule of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose expired 08Aug2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose expired 08Aug2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose expired 08Aug2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine) had resolved.        For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Inappropriate schedule of product administration, Somnolence
Clinical narrative: Has continued to want to sleep all the time; Exhausted; 1st dose 12May2021; 2nd dose 25Jul2021; Got sick for 3 days, was in bed for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick for 3 days, was in bed for a week), SOMNOLENCE (Has continued to want to sleep all the time), FATIGUE (Exhausted) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 12May2021; 2nd dose 25Jul2021) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 12May2021; 2nd dose 25Jul2021). On an unknown date, the patient experienced ILLNESS (Got sick for 3 days, was in bed for a week), SOMNOLENCE (Has continued to want to sleep all the time) and FATIGUE (Exhausted). On 25-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 12May2021; 2nd dose 25Jul2021) had resolved. At the time of the report, ILLNESS (Got sick for 3 days, was in bed for a week), SOMNOLENCE (Has continued to want to sleep all the time) and FATIGUE (Exhausted) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient was reporting their experiences after receiving 2 doses of the Moderna Covid-19 Vaccine. The patient reported that post getting the 2nd dose the patient got sick for 3 days and was in bed for a week. The patient continued to want to sleep all the time and could stay up until a normal bedtime but was exhausted by the time the patient gets to bed. The patient also reported that they don't see a doctor regularly because they never used to get sick.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.  It was reported that, the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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 were reported.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        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.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Intentional dose omission
Clinical narrative: Hair loss, "shedding pretty bad", right side is thinner then left side of head hair; Refused to get 2nd dose due to continuous shedding; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss, "shedding pretty bad", right side is thinner then left side of head hair) and INTENTIONAL DOSE OMISSION (Refused to get 2nd dose due to continuous shedding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss, "shedding pretty bad", right side is thinner then left side of head hair) and INTENTIONAL DOSE OMISSION (Refused to get 2nd dose due to continuous shedding). At the time of the report, ALOPECIA (Hair loss, "shedding pretty bad", right side is thinner then left side of head hair) outcome was unknown and INTENTIONAL DOSE OMISSION (Refused to get 2nd dose due to continuous shedding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided  No treatment medication information was provided
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration where the vials did not undergo any temperature excursions.  No concomitant medication was reported. No treatment medication was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  The vials were stored in the freezer and taken out of the freezer and placed in refrigerator on the date of administration. The vials did not undergo any temperature excursions
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment drug was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication details was reported. No treatment medication details was reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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 concomitants were reported.  No treatment drugs  were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provided by the reporter. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) 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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that it was unknown if the doses was first, second or third for the patient. Reporter also reported that vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. Reporter also said that vials did not undergo any temperature excursion.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitants were reported No treatments were reported
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Dose administered after 12 hours of vial puncture.; Dose administered after being more than 24 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  On11-Oct-2021, the vial was stored in the refrigerator. On 12-Oct-2021, at 8AM they were taken to room temperature, and on 12-Oct-2021 at 10AM the vial was punctured. After puncture, the vial was stored at room temperature, and 5 doses were drawn and administered on 13-Oct-2021, first dose was administered at 10:40 AM EST of 13-Oct-2021, and 5th dose administered at 1:06PM EST of 13-Oct-2021.  Reporter stated that the total amount of time the vial was exposed to room temperature range was around 30 hours. Reporter assumed the patient was immunocompromised but didn't confirm it,