chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nasal congestion, Tachycardia
Clinical narrative: flu like symptoms with increased heart rate; Muscle ache (like coming down with bad flu); Fast heart beat (103-109); Caller >35 days from first vaccination; Fatigue; Chills; Body ache; Stuffy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), NASAL CONGESTION (Stuffy) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), NASAL CONGESTION (Stuffy), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller >35 days from first vaccination). On 12-Mar-2021, the patient experienced TACHYCARDIA (Fast heart beat (103-109)). On 15-Mar-2021, the patient experienced MYALGIA (Muscle ache (like coming down with bad flu)). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms with increased heart rate). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), NASAL CONGESTION (Stuffy), HEADACHE (Headache), MYALGIA (Muscle ache (like coming down with bad flu)) and TACHYCARDIA (Fast heart beat (103-109)) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Heart rate: 103-109 (High) heart beating fast (103-109) for 20-30 minutes..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications reported by investigator  Water is the other treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14MAY2021, contains reporter details, additional events added Flu like symptoms and patient state that she didn't go back for 2nd dose and patient is due for 2nd dose i.e greater than 35days from first vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) 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 PAIN IN EXTREMITY (her arm was sore). At the time of the report, PAIN IN EXTREMITY (her arm was sore) 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 assessment.  No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-155051 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mouth injury, Paraesthesia, Pruritus
Clinical narrative: numbness on left side of her face; tingly on left side of her face; itching sensation; mouth feels crooked towards left side; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on left side of her face), PARAESTHESIA (tingly on left side of her face), PRURITUS (itching sensation) and MOUTH INJURY (mouth feels crooked towards left side) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-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 24-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on left side of her face), PARAESTHESIA (tingly on left side of her face), PRURITUS (itching sensation) and MOUTH INJURY (mouth feels crooked towards left side). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness on left side of her face), PARAESTHESIA (tingly on left side of her face), PRURITUS (itching sensation) and MOUTH INJURY (mouth feels crooked towards left side) outcome was unknown.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events were not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash, Sinusitis
Clinical narrative: sinuses; little bit of rash; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinuses), RASH (little bit of rash), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event in December 2020.    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 SINUSITIS (sinuses), RASH (little bit of rash), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, SINUSITIS (sinuses), RASH (little bit of rash), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient reported she had COVID-19 Virus back in December and she still has fatigue, headache, sinuses, little bit of rash, and she analyzed herself with long-term symptoms of COVID-19  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling down my arm; Sensation like pricking needle; Tingling numbness in left front section of my head; Progressed in left side my face; Sort of numbness not feeling anything lasted several hrs or half a day; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling down my arm), PARAESTHESIA (Sensation like pricking needle), HYPOAESTHESIA (Tingling numbness in left front section of my head), PARAESTHESIA (Progressed in left side my face) and HYPOAESTHESIA (Sort of numbness not feeling anything lasted several hrs or half a day) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Tingling and Numbness.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PARAESTHESIA (Tingling down my arm), PARAESTHESIA (Sensation like pricking needle), HYPOAESTHESIA (Tingling numbness in left front section of my head), PARAESTHESIA (Progressed in left side my face) and HYPOAESTHESIA (Sort of numbness not feeling anything lasted several hrs or half a day). On 03-Mar-2021, PARAESTHESIA (Tingling down my arm), PARAESTHESIA (Sensation like pricking needle), HYPOAESTHESIA (Tingling numbness in left front section of my head), PARAESTHESIA (Progressed in left side my face) and HYPOAESTHESIA (Sort of numbness not feeling anything lasted several hrs or half a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Lacrimation increased
Clinical narrative: Woke up with left eye pink; left eye has a little pinch of fluid; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (Woke up with left eye pink) and LACRIMATION INCREASED (left eye has a little pinch of fluid) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced CONJUNCTIVITIS (Woke up with left eye pink) and LACRIMATION INCREASED (left eye has a little pinch of fluid). At the time of the report, CONJUNCTIVITIS (Woke up with left eye pink) and LACRIMATION INCREASED (left eye has a little pinch of fluid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEART RATE INCREASED (Heartbeats increased ), PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (CHILLS) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIZZINESS (dizziness), HEART RATE INCREASED (Heartbeats increased ), PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (CHILLS). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), HEART RATE INCREASED (Heartbeats increased ), PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (CHILLS) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication provided was Tylenol. No concomitant medication were provided. Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: New events were added, treatment medication was added and event out come were updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on stomach; Rash on left side of the body; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on left side of the body) and RASH (Rash on stomach) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (Rash on left side of the body). On an unknown date, the patient experienced RASH (Rash on stomach). At the time of the report, RASH (Rash on left side of the body) and RASH (Rash on stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD21-061837 (E2B Linked Report).; Sender's Comments:  MOD21-061837:Link to Dose 2 with argus ID MOD-2021-056255
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue
Clinical narrative: Red area below the injection site that goes almost to her elbow; Feels chilly; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area below the injection site that goes almost to her elbow), FATIGUE (Extremely tired) and CHILLS (Feels chilly) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Extremely tired). On 19-Mar-2021, the patient experienced ERYTHEMA (Red area below the injection site that goes almost to her elbow) and CHILLS (Feels chilly). On 18-Mar-2021, FATIGUE (Extremely tired) had resolved. At the time of the report, ERYTHEMA (Red area below the injection site that goes almost to her elbow) and CHILLS (Feels chilly) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported Patient used ice on erythema site and it helped   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional document contains no new information
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      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.   Treatment information not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received dose of vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received dose of vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received dose of vaccine). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received dose of vaccine) had resolved. Not Provided      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.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 001B21A) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: excruciating pain in arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in arm) and HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PAIN IN EXTREMITY (excruciating pain in arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (excruciating pain in arm) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Migraine
Clinical narrative: Migraine; Shortness of breath; This spontaneous case was reported by a pharmacist and describes the occurrence of MIGRAINE (Migraine) and DYSPNOEA (Shortness of breath) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MIGRAINE (Migraine) and DYSPNOEA (Shortness of breath). In February 2021, MIGRAINE (Migraine) and DYSPNOEA (Shortness of breath) 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 product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: it has been 48 days since first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it has been 48 days since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT DOSE OMISSION ISSUE (it has been 48 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it has been 48 days since 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.   Treatment information not provided. List of concomitant medication were not given.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low grade fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (Diabetes at baseline).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Diabetes Medications.  The patient did not received any treatment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: noticed swelling under her right arm pit; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE SWELLING (noticed swelling under her right arm pit) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE SWELLING (noticed swelling under her right arm pit). At the time of the report, VACCINATION SITE SWELLING (noticed swelling under her right arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Injection site bleeding.; Warmth at the site of the injection on left arm; Body aches/Muscle pains; Chills; Joint pains; Fatigue; Pain at the site of the injection on left arm; Redness at the site of the injection on left arm; Swelling at the site of the injection on left arm; Itching at the site of the injection on left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: No specific follow-up information recorded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site haemorrhage, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Flu like symptoms; Injection site bleeding.; Warmth at the site of the injection on left arm; Body aches/Muscle pains; Chills; Joint pains; Fatigue; Pain at the site of the injection on left arm; Redness at the site of the injection on left arm; Swelling at the site of the injection on left arm; Itching at the site of the injection on left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: No specific follow-up information recorded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Flu like symptoms; Injection site bleeding.; Warmth at the site of the injection on left arm; Body aches/Muscle pains; Chills; Joint pains; Fatigue; Pain at the site of the injection on left arm; Redness at the site of the injection on left arm; Swelling at the site of the injection on left arm; Itching at the site of the injection on left arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE HAEMORRHAGE (Injection site bleeding.), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), MYALGIA (Body aches/Muscle pains), CHILLS (Chills), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), VACCINATION SITE PAIN (Pain at the site of the injection on left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection on left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) and VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2021: No specific follow-up information recorded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Fatigue; Headache; Muscle Pain; Joint Pain; Nausea; fever; Swelling of lymph nodes near arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (fever), LYMPHADENOPATHY (Swelling of lymph nodes near arm) and CHILLS (Chills). On 23-Mar-2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (fever), LYMPHADENOPATHY (Swelling of lymph nodes near arm) and CHILLS (Chills) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fatigue; Headache; Muscle Pain; Joint Pain; Nausea; fever; Swelling of lymph nodes near arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (fever), LYMPHADENOPATHY (Swelling of lymph nodes near arm) and CHILLS (Chills). On 23-Mar-2021, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (fever), LYMPHADENOPATHY (Swelling of lymph nodes near arm) and CHILLS (Chills) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Dizziness; Sore Arm; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headaches) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headaches). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-042810.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 : included No New Information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042810:sibling case (reporter)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Off label use
Clinical narrative: Got exposed to covid in school; Duration between 2 doses may exceed recommended; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got exposed to covid in school) and OFF LABEL USE (Duration between 2 doses may exceed recommended) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-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 COVID-19 (Got exposed to covid in school) and OFF LABEL USE (Duration between 2 doses may exceed recommended). At the time of the report, COVID-19 (Got exposed to covid in school) and OFF LABEL USE (Duration between 2 doses may exceed recommended) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Low grade temperature) and NAUSEA (Nausea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032L20A) for COVID-19 vaccination. The patient's past medical history included Migraine. Concurrent medical conditions included Diabetes and High cholesterol. Concomitant products included IBUPROFEN for Pyrexia and Nausea, FOLIC ACID for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Low grade temperature) and NAUSEA (Nausea). At the time of the report, PYREXIA (Low grade temperature) and NAUSEA (Nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concurrent product included medication for cholesterol. The action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD21-084754, MOD21-040476 (E2B Linked Report). This case was linked to MOD-2021-028092. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up document was received. Reporter's address and email id were added. It contains non significant information.; Sender's Comments:  MOD21-084754:follow up - contact information updated - last name , email , address of the reporter MOD21-040476:cross linked id
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test
Clinical narrative: Got tested for antibodies and he has none; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST (Got tested for antibodies and he has none) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L02A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant. Concomitant products included ANTIVIRALS for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-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 ANTIBODY TEST (Got tested for antibodies and he has none). At the time of the report, ANTIBODY TEST (Got tested for antibodies and he has none) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment were provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Labyrinthitis, Vertigo
Clinical narrative: developed vertigo; inner ear infection; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (developed vertigo) and LABYRINTHITIS (inner ear infection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VERTIGO (developed vertigo) and LABYRINTHITIS (inner ear infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, VERTIGO (developed vertigo) and LABYRINTHITIS (inner ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Slept for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN CR) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept for 24 hours). At the time of the report, SOMNOLENCE (Slept for 24 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that her arthritis pain has improved, she states she is used to have joint, knee, elbow, shoulder pain, but after taking the vaccine she got relaxed from the pain. Treatment details not included.   This case was linked to MOD21-061217 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizzy). On 24-Feb-2021, DIZZINESS (dizzy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on right side of the body; Rash in right armpit and waist area; rash in his right side of his body; Rash on stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (rash in his right side of his body), RASH (Rash on stomach), RASH (Rash on right side of the body) and RASH (Rash in right armpit and waist area) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (rash in his right side of his body) and RASH (Rash on stomach). On 24-Mar-2021, the patient experienced RASH (Rash on right side of the body) and RASH (Rash in right armpit and waist area). At the time of the report, RASH (rash in his right side of his body), RASH (Rash on stomach), RASH (Rash on right side of the body) and RASH (Rash in right armpit and waist area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-056232 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056232:Dose 1
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Insomnia, Sensitive skin
Clinical narrative: When I went to sleep it was like a ton of bricks; Backache; My skin was sensitive; Arm hurting at the injection site; Headache; Elbows hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache), SENSITIVE SKIN (My skin was sensitive), VACCINATION SITE PAIN (Arm hurting at the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007821A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache), SENSITIVE SKIN (My skin was sensitive), VACCINATION SITE PAIN (Arm hurting at the injection site), HEADACHE (Headache) and ARTHRALGIA (Elbows hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache) and HEADACHE (Headache) had resolved, ARTHRALGIA (Elbows hurt) outcome was unknown. At the time of the report, SENSITIVE SKIN (My skin was sensitive) and VACCINATION SITE PAIN (Arm hurting at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: When I went to sleep it was like a ton of bricks; Backache; My skin was sensitive; Arm hurting at the injection site; Headache; Elbows hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache), SENSITIVE SKIN (My skin was sensitive), VACCINATION SITE PAIN (Arm hurting at the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007821A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache), SENSITIVE SKIN (My skin was sensitive), VACCINATION SITE PAIN (Arm hurting at the injection site), HEADACHE (Headache) and ARTHRALGIA (Elbows hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, INSOMNIA (When I went to sleep it was like a ton of bricks), BACK PAIN (Backache) and HEADACHE (Headache) had resolved, ARTHRALGIA (Elbows hurt) outcome was unknown. At the time of the report, SENSITIVE SKIN (My skin was sensitive) and VACCINATION SITE PAIN (Arm hurting at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Delay getting second dose due to illness) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Delay getting second dose due to illness). At the time of the report, ILLNESS (Delay getting second dose due to illness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not feeling well so told to delay her second dose. No concomitant medications were reported. No treatment information was provided by reporter. Patient received the call and stated that she never had Moderna and hung up the phone.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-JUL-2021 and contains no new information
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Very bad headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included DENOSUMAB (PROLIA), LEVOTHYROXINE, CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Very bad headache). On 22-Mar-2021, HEADACHE (Very bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication for the event included Acetaminophen.