chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Upper arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Upper arm was sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Upper arm was sore). On 23-Feb-2021, PAIN IN EXTREMITY (Upper arm was sore) had resolved.            No concomitant medicine reported. Treatment medication was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: body aches; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (body aches), HEADACHE (headache) and CHILLS (chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history not included.  Relevant concomitant products usage were not reported by the reporter.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .  On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (body aches), HEADACHE (headache) and CHILLS (chills).  On 25-Mar-2021, CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (body aches) and HEADACHE (headache) outcome was unknown.     Treatment includes Tylenol.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Depressed mood
Clinical narrative: very heavy feeling in her chest; very sad; tight inside her chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (very heavy feeling in her chest), DEPRESSED MOOD (very sad) and CHEST DISCOMFORT (tight inside her chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (very heavy feeling in her chest), DEPRESSED MOOD (very sad) and CHEST DISCOMFORT (tight inside her chest). At the time of the report, CHEST DISCOMFORT (very heavy feeling in her chest), DEPRESSED MOOD (very sad) and CHEST DISCOMFORT (tight inside her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included .  relevant concomitant products usage were not reported by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .  On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain).  At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.    No treatment information was provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Flushing, Hyperhidrosis, Pain
Clinical narrative: Flushed Cheeks; Sweating; Chills; Fatigue; Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), PAIN (Aches), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 05-Mar-2021, the patient experienced PAIN (Aches) and VACCINATION SITE PAIN (Sore Arm). On 19-Mar-2021, the patient experienced FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue). On 07-Mar-2021, PAIN (Aches) and VACCINATION SITE PAIN (Sore Arm) had resolved.  At the time of the report, FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      No treatment information was provided. The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Flushed Cheeks; Sweating; Chills; Fatigue; Aches; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), PAIN (Aches), VACCINATION SITE PAIN (Sore Arm) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 05-Mar-2021, the patient experienced PAIN (Aches) and VACCINATION SITE PAIN (Sore Arm). On 19-Mar-2021, the patient experienced FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue). On 07-Mar-2021, PAIN (Aches) and VACCINATION SITE PAIN (Sore Arm) had resolved.  At the time of the report, FLUSHING (Flushed Cheeks), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      No treatment information was provided. The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus
Clinical narrative: Itching in the eyes; Pain in the eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Itching in the eyes) and EYE PAIN (Pain in the eyes) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised and Corneal defect. relevant concomitant products usage were not reported by the reporter Treatment included Pataday Eye Drops.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced EYE PRURITUS (Itching in the eyes) and EYE PAIN (Pain in the eyes). At the time of the report, EYE PRURITUS (Itching in the eyes) and EYE PAIN (Pain in the eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Covid Arm/Rash went all the way around her arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and RASH (Covid Arm/Rash went all the way around her arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 01-Mar-2021, the patient experienced PYREXIA (Fever). On 12-Mar-2021, the patient experienced RASH (Covid Arm/Rash went all the way around her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and RASH (Covid Arm/Rash went all the way around her arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment included Tylenol.   No concomitant medication is provided.    Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Unevaluable event
Clinical narrative: Arm is very sore; Arm is very swollen; tested two times negative and two times positive for this; Redness in arm is pretty large; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore), PERIPHERAL SWELLING (Arm is very swollen), UNEVALUABLE EVENT (tested two times negative and two times positive for this) and ERYTHEMA (Redness in arm is pretty large) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 13-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 (Arm is very sore), PERIPHERAL SWELLING (Arm is very swollen), UNEVALUABLE EVENT (tested two times negative and two times positive for this) and ERYTHEMA (Redness in arm is pretty large). At the time of the report, PAIN IN EXTREMITY (Arm is very sore), PERIPHERAL SWELLING (Arm is very swollen), UNEVALUABLE EVENT (tested two times negative and two times positive for this) and ERYTHEMA (Redness in arm is pretty large) 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure decreased, Flushing, Pallor, Pruritus
Clinical narrative: warm to touch; itching; Vaccination site burning; Vaccination site swelling; Anxiety; flushing; blood pressure drop; pale as a ghost; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), VACCINATION SITE WARMTH (warm to touch), FLUSHING (flushing) and PRURITUS (itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (dyes and fillers, morphine, generic acetaminophen, zoloft). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Allergy.    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 BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), FLUSHING (flushing) and ANXIETY (Anxiety). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), PRURITUS (itching), VACCINATION SITE PAIN (Vaccination site burning) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), VACCINATION SITE WARMTH (warm to touch), FLUSHING (flushing), PRURITUS (itching), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE SWELLING (Vaccination site swelling) and ANXIETY (Anxiety) had not 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.   Patient reported after 20 mins  of vaccination events flushing, blood pressure decreased, pallor got resolved.  Concomitant product include steroid eye for allergy.  No treatment information was reported.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch; itching; Vaccination site burning; Vaccination site swelling; Anxiety; flushing; blood pressure drop; pale as a ghost; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), VACCINATION SITE WARMTH (warm to touch), FLUSHING (flushing) and PRURITUS (itching) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (dyes and fillers, morphine, generic acetaminophen, zoloft). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Allergy.    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 BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), FLUSHING (flushing) and ANXIETY (Anxiety). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), PRURITUS (itching), VACCINATION SITE PAIN (Vaccination site burning) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure drop), PALLOR (pale as a ghost), VACCINATION SITE WARMTH (warm to touch), FLUSHING (flushing), PRURITUS (itching), VACCINATION SITE PAIN (Vaccination site burning), VACCINATION SITE SWELLING (Vaccination site swelling) and ANXIETY (Anxiety) had not 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.   Patient reported after 20 mins  of vaccination events flushing, blood pressure decreased, pallor got resolved.  Concomitant product include steroid eye for allergy.  No treatment information was reported.   Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing for a week; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing for a week) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history not included.  Relevant concomitant products usage were not reported by the reporter.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (Coughing for a week). At the time of the report, COUGH (Coughing for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid-19) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Headaches; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headaches), MYALGIA (Body aches) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headaches), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headaches), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medicines reported. No treatment information reported. Action taken with the drug in response to events was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, Underdose
Clinical narrative: Approximately one quarter of vaccine given, followed by full dose in same arm; Vaccine Underdose; Syringe came off while injecting this patient; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Approximately one quarter of vaccine given, followed by full dose in same arm), UNDERDOSE (Vaccine Underdose) and DEVICE CONNECTION ISSUE (Syringe came off while injecting this patient) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Approximately one quarter of vaccine given, followed by full dose in same arm), UNDERDOSE (Vaccine Underdose) and DEVICE CONNECTION ISSUE (Syringe came off while injecting this patient). On 25-Mar-2021, INCORRECT DOSE ADMINISTERED (Approximately one quarter of vaccine given, followed by full dose in same arm), UNDERDOSE (Vaccine Underdose) and DEVICE CONNECTION ISSUE (Syringe came off while injecting this patient) 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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No new information was provided.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, lot # unknown with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: she suffers from chronic pain; Severe pain in arm and back; back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in arm and back), BACK PAIN (back pain) and PAIN (she suffers from chronic pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm and back) and BACK PAIN (back pain). On an unknown date, the patient experienced PAIN (she suffers from chronic pain). At the time of the report, PAIN IN EXTREMITY (Severe pain in arm and back), BACK PAIN (back pain) and PAIN (she suffers from chronic pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up information was received on 06-Aug-2021. Event outcome updated from  Unknown to Recovered and Anatomical location of vaccine administered updated and new event chronic pain added.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19 Positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 Positive) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 COVID-19 (Covid-19 Positive). At the time of the report, COVID-19 (Covid-19 Positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were provided. No Treatment History was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: he missed his 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (he missed his 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (he missed his 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (he missed his 2nd dose) 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.   concomitant medications were reported included Psychiatric medications.  No treatment information was provided.  Patient was due for second dose of Moderna COVID-19 Vaccine on 01 Mar 2021.Patient has not received dose as facility is not allowing patient to have vaccine from primary care physician.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Gait disturbance, Muscular weakness, Nausea
Clinical narrative: Muscles were tired; Hard to walk; Felt feverish; felt hot; Nausea; Arm with redness; Soreness in arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm). On 24-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), PYREXIA (Felt feverish), FEELING HOT (felt hot) and NAUSEA (Nausea). At the time of the report, MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), PYREXIA (Felt feverish), FEELING HOT (felt hot) and NAUSEA (Nausea) outcome was unknown and ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received contains non-significant information of reporter email address.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Muscles were tired; Hard to walk; Felt feverish; felt hot; Nausea; Arm with redness; Soreness in arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm). On 24-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), PYREXIA (Felt feverish), FEELING HOT (felt hot) and NAUSEA (Nausea). At the time of the report, MUSCULAR WEAKNESS (Muscles were tired), GAIT DISTURBANCE (Hard to walk), PYREXIA (Felt feverish), FEELING HOT (felt hot) and NAUSEA (Nausea) outcome was unknown and ERYTHEMA (Arm with redness), PAIN IN EXTREMITY (Soreness in arm) and PERIPHERAL SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received contains non-significant information of reporter email address.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: within a couple of hours of getting my first dose, I could feel the congestion breaking up and my sinus passages clearing; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (within a couple of hours of getting my first dose, I could feel the congestion breaking up and my sinus passages clearing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic sinusitis (decades long), Drug allergy (Atropine) and Congestion nasal (Nasal congestion). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), METFORMIN from 03-Feb-2017 to an unknown date and ATORVASTATIN for an unknown indication.    On 24-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 THERAPEUTIC RESPONSE UNEXPECTED (within a couple of hours of getting my first dose, I could feel the congestion breaking up and my sinus passages clearing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (within a couple of hours of getting my first dose, I could feel the congestion breaking up and my sinus passages clearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Patient had chronic sinus issues for years/decades long and within a couple of hours of getting his first dose, he could feel the congestion breaking up and his sinus passages clearing.  It was not 100% better, but noticably improved.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Concomitant medication added, event outcome change unknown to not recovered, event added, and narrative updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Feeling abnormal, Pain
Clinical narrative: She sometimes started to cry / Crying has gotten worse; Feeling abnormal; Pain; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (She sometimes started to cry / Crying has gotten worse), PAIN (Pain) and FEELING ABNORMAL (Feeling abnormal) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.  No Medical History information was reported.  On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced CRYING (She sometimes started to cry / Crying has gotten worse). On an unknown date, the patient experienced PAIN (Pain) and FEELING ABNORMAL (Feeling abnormal). The patient was treated with FLUOXETINE HYDROCHLORIDE at a dose of 10 milligram. At the time of the report, CRYING (She sometimes started to cry / Crying has gotten worse), PAIN (Pain) and FEELING ABNORMAL (Feeling abnormal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Additional treatment details included vurveroe XTL 5 mg. The patient tried it but not taking presently.   This case was linked to MOD-2021-057945 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: New event pain and feeling abnormal were added.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast mass, Mass, Peripheral swelling
Clinical narrative: Right arm swelling; 2 lumps in the armpit region (one in the center and the other near right breast); 2 lumps in the armpit region (one in the center and the other near right breast); Pain in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm swelling), MASS (2 lumps in the armpit region (one in the center and the other near right breast)), BREAST MASS (2 lumps in the armpit region (one in the center and the other near right breast)) and AXILLARY PAIN (Pain in the armpit) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Right arm swelling), MASS (2 lumps in the armpit region (one in the center and the other near right breast)), BREAST MASS (2 lumps in the armpit region (one in the center and the other near right breast)) and AXILLARY PAIN (Pain in the armpit). At the time of the report, PERIPHERAL SWELLING (Right arm swelling), MASS (2 lumps in the armpit region (one in the center and the other near right breast)), BREAST MASS (2 lumps in the armpit region (one in the center and the other near right breast)) and AXILLARY PAIN (Pain in the armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection site arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in injection site arm). At the time of the report, VACCINATION SITE PAIN (Soreness in injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain, Product dose omission issue
Clinical narrative: 47 days since first dose; Chest pain; Felt like a stabbing pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (47 days since first dose), CHEST PAIN (Chest pain) and PAIN (Felt like a stabbing pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHEST PAIN (Chest pain) and PAIN (Felt like a stabbing pain). On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (47 days since first dose). On 06-Feb-2021, CHEST PAIN (Chest pain) and PAIN (Felt like a stabbing pain) had resolved. On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (47 days since first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not provided by the reporter. No Treatment medications were provided by reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus, Rash papular
Clinical narrative: raised mark; redness; hot and sore; hot and sore; itching from waist; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised mark), ERYTHEMA (redness), FEELING HOT (hot and sore), PAIN IN EXTREMITY (hot and sore) and PRURITUS (itching from waist) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds and Asthma. Concomitant products included ELDERBERRY [SAMBUCUS NIGRA], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    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 RASH PAPULAR (raised mark), ERYTHEMA (redness), FEELING HOT (hot and sore), PAIN IN EXTREMITY (hot and sore) and PRURITUS (itching from waist). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (raised mark), ERYTHEMA (redness), FEELING HOT (hot and sore), PAIN IN EXTREMITY (hot and sore) and PRURITUS (itching from waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the right arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included METHADONE, HYDROXYZINE, LISINOPRIL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), LORAZEPAM, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and BISACODYL (DULCOLAX [BISACODYL]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Soreness on the right arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Crying, Gait disturbance, Malaise, Muscle spasms
Clinical narrative: felt sick for 3 days/ gets sad; muscle cramps from her knees to her thighs; couldn't walk as much; feels heavy feeling in her chest, a burden, tightness; she sometimes started to cry/crying has gotten worse/ gets sad and cries every day; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CRYING (she sometimes started to cry/crying has gotten worse/ gets sad and cries every day), MALAISE (felt sick for 3 days/ gets sad), MUSCLE SPASMS (muscle cramps from her knees to her thighs), GAIT DISTURBANCE (couldn't walk as much) and CHEST DISCOMFORT (feels heavy feeling in her chest, a burden, tightness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 114M20A and 013M20A) for an unknown indication.     The patient's past medical history included No adverse event (No medical history was provided).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Feb-2021, the patient experienced CRYING (she sometimes started to cry/crying has gotten worse/ gets sad and cries every day). On 19-Mar-2021, the patient experienced MALAISE (felt sick for 3 days/ gets sad), MUSCLE SPASMS (muscle cramps from her knees to her thighs), GAIT DISTURBANCE (couldn't walk as much) and CHEST DISCOMFORT (feels heavy feeling in her chest, a burden, tightness). At the time of the report, CRYING (she sometimes started to cry/crying has gotten worse/ gets sad and cries every day), MALAISE (felt sick for 3 days/ gets sad), MUSCLE SPASMS (muscle cramps from her knees to her thighs), GAIT DISTURBANCE (couldn't walk as much) and CHEST DISCOMFORT (feels heavy feeling in her chest, a burden, tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient has been taking fluoxetine HCL 10 mg, levalbuterol (Vurveroe xtl) 5mg and ibuprofen (Advil) to treat symptoms.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder after first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 089L20A and 025A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder after first dose). At the time of the report, ARTHRALGIA (Sore shoulder after first dose) outcome was unknown. Not Provided          Relevant concomitant medications included amour thyroid and ketoconazole shampoo. Treatment information was not provided.  On 7 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 025A21A) intramuscularly for prophylaxis of COVID-19 infection.   This case was linked to US-MODERNATX, INC.-MOD-2021-057956 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057956:2nd dose case
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: sore arm - left arm; Muscle pain; Exhaustion; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm - left arm), PAIN (Muscle pain), FATIGUE (Exhaustion) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Muscle pain) and FATIGUE (Exhaustion). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm - left arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm - left arm), PAIN (Muscle pain), FATIGUE (Exhaustion) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included CAPSAICIN, MENTHOL (ALLEVESS), ACETYLSALICYLIC ACID (BABY ASPIRIN), INSULIN, METFORMIN, SIMVASTATIN and LISINOPRIL (LISOPRIL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: 0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe; 0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) and DEVICE CONNECTION ISSUE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) 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 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 24-Mar-2021, the patient experienced UNDERDOSE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) and DEVICE CONNECTION ISSUE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe). On 24-Mar-2021, UNDERDOSE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) and DEVICE CONNECTION ISSUE (0.5mL vaccine was drawn out and during administration some of the dose leaked out of the syringe) 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.   Reporter was not sure how much dose the patient received.  No relevant concomitant medications were reported. No treatment details were reported.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: Hives; Headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and HEADACHE (Headache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache). On 25-Mar-2021, the patient experienced URTICARIA (Hives). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 25-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Acetaminophen for headache. No relevant concomitant medications reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Anxiety. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, ATORVASTATIN for Cholesterol, AMLODIPINE for Hypertension, TACROLIMUS MONOHYDRATE (TACROLIMUS [TACROLIMUS MONOHYDRATE]) for Kidney transplant.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications reported were, second medication for anti rejection for kidney transplant, med for allergies.