chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness after first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site soreness after first dose). At the time of the report, VACCINATION SITE PAIN (Injection site soreness after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-268129 (Patient Link).   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Only received one dose of the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Only received one dose of the moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 PRODUCT DOSE OMISSION ISSUE (Only received one dose of the moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Only received one dose of the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided.  The patient received only one dose of the Moderna vaccine, patient did not state why she did not get the second dose, but she was calling about getting it now.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Pruritus, Rash, Urticaria
Clinical narrative: Itching; Rash; Headache, severe headaches; Hives; Could not sit up because of pressure; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), MOBILITY DECREASED (Could not sit up because of pressure), PRURITUS (Itching), RASH (Rash) and HEADACHE (Headache, severe headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental exposure (Exposure to the roach spray.breathing issue,Hives) in 1997. Concomitant products included PROGESTERONE, THYROID, VITAMIN B COMPLEX (VIT B COMPLEX), VIT D [VITAMIN D NOS], DHEA, FISH OIL and COLECALCIFEROL, MAGNESIUM OXIDE, VITAMIN B1 NOS (MAGNESIUM 400) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced URTICARIA (Hives), MOBILITY DECREASED (Could not sit up because of pressure), RASH (Rash) and HEADACHE (Headache, severe headaches). On an unknown date, the patient experienced PRURITUS (Itching). On 26-May-2021, URTICARIA (Hives), MOBILITY DECREASED (Could not sit up because of pressure), RASH (Rash) and HEADACHE (Headache, severe headaches) had resolved. At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient didn't not go to the doctor treated symptoms at home.   This case was linked to MOD-2021-193704 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose of the vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose of the vaccine from an expired vial) 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.   Pharmacist stated that this morning, a couple doses of the Moderna Covid-19 vaccine was given from a bottle that was left out from yesterday. The vial was first punctured at 8:52 am yesterday 26/Jul/2021 and left at room temperature. It was administered today at 12:03 pm and 12:16 pm, 2 doses were given. Lot number is 091D21A, one vial. This lot number had not undergone any excursion. Upon inspection before administration, the vaccine was thawed, and it looked normal. it was the first doses for both patients that received the vaccine and caller stated that none of the patients had reported any adverse event.   This case was linked to US-MODERNATX, INC.-MOD-2021-268254 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-268254:Same reporter (CASE CROSSLINKED)
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the 1 month seocnd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the 1 month seocnd dose) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 PRODUCT DOSE OMISSION ISSUE (missed the 1 month seocnd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the 1 month seocnd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minimal soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minimal soreness at the injection site) 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 SITE PAIN (minimal soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (minimal soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) 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 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness
Clinical narrative: mild to moderate flu-like symptoms; joint pain; fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (mild to moderate flu-like symptoms), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 INFLUENZA LIKE ILLNESS (mild to moderate flu-like symptoms), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (mild to moderate flu-like symptoms), ARTHRALGIA (joint pain), FATIGUE (fatigue) and CHILLS (Chills) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-268098 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Other patients having similar side effects such as fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Other patients having similar side effects such as fast heart beat) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Other patients having similar side effects such as fast heart beat). At the time of the report, PALPITATIONS (Other patients having similar side effects such as fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Fatigue, Headache, Nausea
Clinical narrative: chest pains; alot of stomach pain; missed 2nd dose; pain below sternum; pain in left arm; pain in left thigh; tiredness; headaches; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum) and PAIN IN EXTREMITY (pain in left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum), PAIN IN EXTREMITY (pain in left arm), PAIN IN EXTREMITY (pain in left thigh), FATIGUE (tiredness), HEADACHE (headaches), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum), PAIN IN EXTREMITY (pain in left arm), PAIN IN EXTREMITY (pain in left thigh), FATIGUE (tiredness), HEADACHE (headaches), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported  No treatment medications were reported; Reporter's Comments: Caller and Husband both reporting adverse events during phone call through speakerphone or passing phone back and forth. Husband got the 1st dose of the vaccine on 12May2021 (Lot # 016C21A, expiration date not available) in left arm. Exact onset date and duration of AEs not provided. Consumer experienced chest pains, pain below sternum, a lot of stomach pain, headaches, vomiting, nausea, pain in left thigh, tiredness, and pain in left arm. Consumer states some of the adverse events are ongoing but getting better. Consumer gave safety consent to follow up via phone.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, Vomiting
Clinical narrative: chest pains; alot of stomach pain; missed 2nd dose; pain below sternum; pain in left arm; pain in left thigh; tiredness; headaches; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum) and PAIN IN EXTREMITY (pain in left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum), PAIN IN EXTREMITY (pain in left arm), PAIN IN EXTREMITY (pain in left thigh), FATIGUE (tiredness), HEADACHE (headaches), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum), PAIN IN EXTREMITY (pain in left arm), PAIN IN EXTREMITY (pain in left thigh), FATIGUE (tiredness), HEADACHE (headaches), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported  No treatment medications were reported; Reporter's Comments: Caller and Husband both reporting adverse events during phone call through speakerphone or passing phone back and forth. Husband got the 1st dose of the vaccine on 12May2021 (Lot # 016C21A, expiration date not available) in left arm. Exact onset date and duration of AEs not provided. Consumer experienced chest pains, pain below sternum, a lot of stomach pain, headaches, vomiting, nausea, pain in left thigh, tiredness, and pain in left arm. Consumer states some of the adverse events are ongoing but getting better. Consumer gave safety consent to follow up via phone.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Irritability, Pain in extremity, Throat irritation
Clinical narrative: Typical sore arm; scratchy throat; trouble sleeping; grumpiness; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Typical sore arm), THROAT IRRITATION (scratchy throat), INSOMNIA (trouble sleeping), IRRITABILITY (grumpiness) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027B21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MAGNESIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Typical sore arm), THROAT IRRITATION (scratchy throat), INSOMNIA (trouble sleeping), IRRITABILITY (grumpiness) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (Typical sore arm), THROAT IRRITATION (scratchy throat), INSOMNIA (trouble sleeping), IRRITABILITY (grumpiness) and FATIGUE (fatigue) outcome was unknown.            No treatment drug details was reported.   This case was linked to MOD-2021-268156 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Fatigue, Heart rate, Injection site pain
Clinical narrative: felt very fatigued; heart was erratic; a lot of pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart was erratic), INJECTION SITE PAIN (a lot of pain at the injection site) and FATIGUE (felt very fatigued) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021.    On 20-Jul-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021 at 7:30 PM, the patient experienced INJECTION SITE PAIN (a lot of pain at the injection site). On 21-Jul-2021, the patient experienced CARDIAC DISORDER (heart was erratic). On 21-Jul-2021 at 10:00 AM, the patient experienced FATIGUE (felt very fatigued). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jul-2021 at an unspecified dose and frequency. On 22-Jul-2021, CARDIAC DISORDER (heart was erratic), INJECTION SITE PAIN (a lot of pain at the injection site) and FATIGUE (felt very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Heart rate: 50-55 beats per minute (Low) his normal is around 70 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog) 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 FEELING ABNORMAL (Brain fog). At the time of the report, FEELING ABNORMAL (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was received by the patient  No Treatment was received by the patient.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Arthralgia, Burning sensation, Depression
Clinical narrative: depression - very dark thoughts (which were not her at all); anxiety; vivid dreams; Sore arm; She wasn't feeling good; constant scratchy throat; "ache-y" joints; days with deep fatigue (up to this day); headache; fever; body aches; lip or mouth is on fire; feeling flushed; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety) and ABNORMAL DREAMS (vivid dreams) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] and MAGNESIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 BURNING SENSATION (lip or mouth is on fire), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever). an unknown date, the patient experienced FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good), THROAT IRRITATION (constant scratchy throat), ARTHRALGIA ("ache-y" joints) and FATIGUE (days with deep fatigue (up to this day)). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), THROAT IRRITATION (constant scratchy throat), MYALGIA (body aches), ARTHRALGIA ("ache-y" joints), HEADACHE (headache) and PYREXIA (fever) had resolved and PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good) and FATIGUE (days with deep fatigue (up to this day)) outcome was unknown.            It was reported that the laboratory results of the patent indicated no sickness. She reported that her doctor ruled that the side effects were due to the vaccination   This case was linked to MOD-2021-268142 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up information included no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Headache, Malaise, Myalgia
Clinical narrative: depression - very dark thoughts (which were not her at all); anxiety; vivid dreams; Sore arm; She wasn't feeling good; constant scratchy throat; "ache-y" joints; days with deep fatigue (up to this day); headache; fever; body aches; lip or mouth is on fire; feeling flushed; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety) and ABNORMAL DREAMS (vivid dreams) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] and MAGNESIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 BURNING SENSATION (lip or mouth is on fire), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever). an unknown date, the patient experienced FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good), THROAT IRRITATION (constant scratchy throat), ARTHRALGIA ("ache-y" joints) and FATIGUE (days with deep fatigue (up to this day)). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), THROAT IRRITATION (constant scratchy throat), MYALGIA (body aches), ARTHRALGIA ("ache-y" joints), HEADACHE (headache) and PYREXIA (fever) had resolved and PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good) and FATIGUE (days with deep fatigue (up to this day)) outcome was unknown.            It was reported that the laboratory results of the patent indicated no sickness. She reported that her doctor ruled that the side effects were due to the vaccination   This case was linked to MOD-2021-268142 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up information included no new information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Throat irritation
Clinical narrative: depression - very dark thoughts (which were not her at all); anxiety; vivid dreams; Sore arm; She wasn't feeling good; constant scratchy throat; "ache-y" joints; days with deep fatigue (up to this day); headache; fever; body aches; lip or mouth is on fire; feeling flushed; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety) and ABNORMAL DREAMS (vivid dreams) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] and MAGNESIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 BURNING SENSATION (lip or mouth is on fire), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever). an unknown date, the patient experienced FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good), THROAT IRRITATION (constant scratchy throat), ARTHRALGIA ("ache-y" joints) and FATIGUE (days with deep fatigue (up to this day)). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (lip or mouth is on fire), FLUSHING (feeling flushed), DEPRESSION (depression - very dark thoughts (which were not her at all)), ANXIETY (anxiety), ABNORMAL DREAMS (vivid dreams), THROAT IRRITATION (constant scratchy throat), MYALGIA (body aches), ARTHRALGIA ("ache-y" joints), HEADACHE (headache) and PYREXIA (fever) had resolved and PAIN IN EXTREMITY (Sore arm), MALAISE (She wasn't feeling good) and FATIGUE (days with deep fatigue (up to this day)) outcome was unknown.            It was reported that the laboratory results of the patent indicated no sickness. She reported that her doctor ruled that the side effects were due to the vaccination   This case was linked to MOD-2021-268142 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-123715 ) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog) 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 FEELING ABNORMAL (Brain fog). At the time of the report, FEELING ABNORMAL (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by reporter
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Product dose omission issue
Clinical narrative: not receiving the 2nd dose; cramps on his legs, feet and toes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps on his legs, feet and toes) and PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033b21a) for COVID-19 vaccination.     Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced MUSCLE SPASMS (cramps on his legs, feet and toes). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose). At the time of the report, MUSCLE SPASMS (cramps on his legs, feet and toes) and PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received 1st dose of the Moderna COVID19 on May the 25th 2021 on his left arm. On the 25th of June patient started to experience cramps on his legs, feet and toes mostly at night because of the heat or the vaccine. Also patient should have received the 2nd dose on June the 22nd but he lost the appointment.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Hypoaesthesia
Clinical narrative: bad chest pain; left arm was numb; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (bad chest pain) and HYPOAESTHESIA (left arm was numb) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced CHEST PAIN (bad chest pain) and HYPOAESTHESIA (left arm was numb). At the time of the report, CHEST PAIN (bad chest pain) and HYPOAESTHESIA (left arm was numb) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Heart rate: high (High) Fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information reported. No treatment medications were reported.  Patient experienced fast heartbeats and almost felt like she had a heart attack but 36 hours later, it was manageable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes; arm pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No medical history information was reported.   Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and CHILLS (chills). On 23-Jul-2021, the patient experienced HEADACHE (headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and MAGNESIUM at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain) and CHILLS (chills) outcome was unknown and HEADACHE (headache/ really bad headache/ (headache) moves from one side to the other/ (headache) comes and goes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter was not sure about the lot number and did not know if it was a 2 or a Z, if it was a 1 or an L. Expiration date was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not receive a second dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive a second dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 (did not receive a second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive a second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment Medications were reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the large spacing between the 1st and 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the large spacing between the 1st and 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the large spacing between the 1st and 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the large spacing between the 1st and 2nd dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No Treatment information was provided by the reporter. Patient did not have an adverse reaction to the vaccine, nor was the vaccine expired.  Patient simply did not receive the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.  Patient did not had any adverse reactions, and he was informed that due to the large spacing between the 1st and 2nd dose, there was no need to repeat the series but getting the 2nd dose could lead to decreased efficacy of the vaccine overall.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Product administered to patient of inappropriate age, Psychomotor hyperactivity
Clinical narrative: Running back and forth all day; Stomach hurts; Product administered to patient of inappropriate age (16 years old); This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Running back and forth all day), ABDOMINAL PAIN UPPER (Stomach hurts) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age (16 years old)) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included ADHD.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PSYCHOMOTOR HYPERACTIVITY (Running back and forth all day), ABDOMINAL PAIN UPPER (Stomach hurts) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age (16 years old)). At the time of the report, PSYCHOMOTOR HYPERACTIVITY (Running back and forth all day) and ABDOMINAL PAIN UPPER (Stomach hurts) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age (16 years old)) had resolved.            No concomitant drug details were reported.   Patient was running back in fourth all day and now he said stomach hurt.   No treatment details were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.            No concomitant medications were reported..  No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Headache, Illness
Clinical narrative: Never received 2th Moderna shot; Diarrhea; felt incoherent for 5 days; bad reaction; It morphed into a cold in 24 hours; dizzy; I felt sick again; stomach issues; body aches on top of that; swelling in the injection site; Nassau; headache; it was red; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (It morphed into a cold in 24 hours) in a 43-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.     Concurrent medical conditions included Arthritis and Immunosuppression.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up appended: Added patient details (DOB), dosage details of vaccine, new events
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incoherent, Myalgia, Nasopharyngitis, Nausea, Product dose omission issue
Clinical narrative: Never received 2th Moderna shot; Diarrhea; felt incoherent for 5 days; bad reaction; It morphed into a cold in 24 hours; dizzy; I felt sick again; stomach issues; body aches on top of that; swelling in the injection site; Nassau; headache; it was red; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (It morphed into a cold in 24 hours) in a 43-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.     Concurrent medical conditions included Arthritis and Immunosuppression.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up appended: Added patient details (DOB), dosage details of vaccine, new events
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Never received 2th Moderna shot; Diarrhea; felt incoherent for 5 days; bad reaction; It morphed into a cold in 24 hours; dizzy; I felt sick again; stomach issues; body aches on top of that; swelling in the injection site; Nassau; headache; it was red; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction) and NASOPHARYNGITIS (It morphed into a cold in 24 hours) in a 43-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.     Concurrent medical conditions included Arthritis and Immunosuppression.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never received 2th Moderna shot), DIARRHOEA (Diarrhea), INCOHERENT (felt incoherent for 5 days), VACCINATION COMPLICATION (bad reaction), NASOPHARYNGITIS (It morphed into a cold in 24 hours), DIZZINESS (dizzy), ILLNESS (I felt sick again), ABDOMINAL DISCOMFORT (stomach issues), MYALGIA (body aches on top of that), VACCINATION SITE SWELLING (swelling in the injection site), NAUSEA (Nassau), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (it was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up appended: Added patient details (DOB), dosage details of vaccine, new events
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: The patient missed their second scheduled Moderna COVID-19 dose/> 42 days since the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient missed their second scheduled Moderna COVID-19 dose/> 42 days since the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-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 (The patient missed their second scheduled Moderna COVID-19 dose/> 42 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient missed their second scheduled Moderna COVID-19 dose/> 42 days since the first dose) 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 relevant concomitant medication was reported. Treatment information were not provided.    Reporter did not allow further contact