chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: throat sore; Like sick; All body hurts; Horrible headache; fever; soreness arm; very shaky; dizzy; cold; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and OROPHARYNGEAL PAIN (throat sore) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included TMJ syndrome.    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 PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and PYREXIA (fever). On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (throat sore), ILLNESS (Like sick), PAIN (All body hurts) and HEADACHE (Horrible headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold), OROPHARYNGEAL PAIN (throat sore), ILLNESS (Like sick), PAIN (All body hurts), PYREXIA (fever) and HEADACHE (Horrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Pain medication for TMJ syndrome.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: throat sore; Like sick; All body hurts; Horrible headache; fever; soreness arm; very shaky; dizzy; cold; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and OROPHARYNGEAL PAIN (throat sore) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included TMJ syndrome.    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 PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold) and PYREXIA (fever). On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (throat sore), ILLNESS (Like sick), PAIN (All body hurts) and HEADACHE (Horrible headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness arm), TREMOR (very shaky), DIZZINESS (dizzy), NASOPHARYNGITIS (cold), OROPHARYNGEAL PAIN (throat sore), ILLNESS (Like sick), PAIN (All body hurts), PYREXIA (fever) and HEADACHE (Horrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Pain medication for TMJ syndrome.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: you know how many time I went to the toilet"; Sore and painful at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (you know how many time I went to the toilet") and VACCINATION SITE PAIN (Sore and painful at injection arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced DIARRHOEA (you know how many time I went to the toilet") and VACCINATION SITE PAIN (Sore and painful at injection arm). At the time of the report, DIARRHOEA (you know how many time I went to the toilet") and VACCINATION SITE PAIN (Sore and painful at injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 048A21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included AMLODIPINE BESILATE (NORVASC) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment information provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Induration, Nausea, Pain in extremity
Clinical narrative: Arm swollen after 1st dose; Arm hard after 1st dose; Dizziness after 1st dose; Arm sore and tender after 1st dose; Arm sore and tender after 1st dose; Headache after 1st dose; Nausea after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose) and TENDERNESS (Arm sore and tender after 1st dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030az1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose), TENDERNESS (Arm sore and tender after 1st dose), HEADACHE (Headache after 1st dose) and NAUSEA (Nausea after 1st dose). At the time of the report, PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose), TENDERNESS (Arm sore and tender after 1st dose), HEADACHE (Headache after 1st dose) and NAUSEA (Nausea after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Arm swollen after 1st dose; Arm hard after 1st dose; Dizziness after 1st dose; Arm sore and tender after 1st dose; Arm sore and tender after 1st dose; Headache after 1st dose; Nausea after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose) and TENDERNESS (Arm sore and tender after 1st dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030az1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose), TENDERNESS (Arm sore and tender after 1st dose), HEADACHE (Headache after 1st dose) and NAUSEA (Nausea after 1st dose). At the time of the report, PERIPHERAL SWELLING (Arm swollen after 1st dose), INDURATION (Arm hard after 1st dose), DIZZINESS (Dizziness after 1st dose), PAIN IN EXTREMITY (Arm sore and tender after 1st dose), TENDERNESS (Arm sore and tender after 1st dose), HEADACHE (Headache after 1st dose) and NAUSEA (Nausea after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache
Clinical narrative: Felt herself weak; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt herself weak), HEADACHE (Headache) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included RIVAROXABAN (XARELTO), CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) and POTASSIUM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On 13-Mar-2021, the patient experienced ASTHENIA (Felt herself weak). On 13-Mar-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, ASTHENIA (Felt herself weak) had not resolved.            The patient did not receive any treatment for the symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: hardness; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness) and VACCINATION SITE PAIN (pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M207) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, FAMOTIDINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness) and VACCINATION SITE PAIN (pain). At the time of the report, VACCINATION SITE INDURATION (hardness) and VACCINATION SITE PAIN (pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: extreme dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizzy spells) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (extreme dizzy spells). At the time of the report, DIZZINESS (extreme dizzy spells) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Malaise, Pain in extremity
Clinical narrative: Pain in  left arm same he received the vaccine in; Could  not move his left arm; No energy; Does not feel good; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in  left arm same he received the vaccine in), HYPOKINESIA (Could  not move his left arm), FATIGUE (No energy) and MALAISE (Does not feel good) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in  left arm same he received the vaccine in), HYPOKINESIA (Could  not move his left arm), FATIGUE (No energy) and MALAISE (Does not feel good). At the time of the report, PAIN IN EXTREMITY (Pain in  left arm same he received the vaccine in), HYPOKINESIA (Could  not move his left arm), FATIGUE (No energy) and MALAISE (Does not feel good) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included diabetes medications and blood thinner medication. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rash, Wheezing
Clinical narrative: a lot of coughing; wheezing a lot; rash in Stomach and back; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a lot of coughing), WHEEZING (wheezing a lot) and RASH (rash in Stomach and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis on 27-Feb-2021.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced COUGH (a lot of coughing), WHEEZING (wheezing a lot) and RASH (rash in Stomach and back). At the time of the report, COUGH (a lot of coughing), WHEEZING (wheezing a lot) and RASH (rash in Stomach and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medications was provided.  No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Migraine, White blood cell count
Clinical narrative: migraine; intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) and HEADACHE (intense headaches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bone marrow depression.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HEADACHE (intense headaches). On an unknown date, the patient experienced MIGRAINE (migraine). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine) and HEADACHE (intense headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Body temperature: 102.4 (Inconclusive) temperature of 102.4°F after the second shot.. In November 2020, White blood cell count: 17000 High.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-017346 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: Headache after first dose; Slight fatigue after first dose; Vaccine exposure during pregnancy; Sore arm after first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), VACCINATION SITE PAIN (Sore arm after first dose), HEADACHE (Headache after first dose) and FATIGUE (Slight fatigue after first dose) in a 30-year-old female patient (para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm after first dose). On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache after first dose) and FATIGUE (Slight fatigue after first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 12-Feb-2021, VACCINATION SITE PAIN (Sore arm after first dose) and FATIGUE (Slight fatigue after first dose) had resolved. On 13-Feb-2021, HEADACHE (Headache after first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Oct-2020, Pregnancy test: positive (Positive) Positive.         No concomitant medications provided. Treatment information mentioned Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-048165 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048165:Second dose case
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Feeling of despair
Clinical narrative: Very drawn energy/weak; back of their leg hurts; Not able to eat; feel dizzy; Body aches; Feeling heavy; nauseous; Vomits; Tired; low grade fever; their jaw locked; This spontaneous case was reported by a consumer and describes the occurrence of TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat) and DIZZINESS (feel dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced TRISMUS (their jaw locked). On an unknown date, the patient experienced ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever). At the time of the report, TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever) outcome was unknown.            Concomitant medication was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No specific follow-up information recorded. On 05-Aug-2021: Non-significant follow up updated
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Trismus
Clinical narrative: Very drawn energy/weak; back of their leg hurts; Not able to eat; feel dizzy; Body aches; Feeling heavy; nauseous; Vomits; Tired; low grade fever; their jaw locked; This spontaneous case was reported by a consumer and describes the occurrence of TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat) and DIZZINESS (feel dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced TRISMUS (their jaw locked). On an unknown date, the patient experienced ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever). At the time of the report, TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever) outcome was unknown.            Concomitant medication was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No specific follow-up information recorded. On 05-Aug-2021: Non-significant follow up updated
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very drawn energy/weak; back of their leg hurts; Not able to eat; feel dizzy; Body aches; Feeling heavy; nauseous; Vomits; Tired; low grade fever; their jaw locked; This spontaneous case was reported by a consumer and describes the occurrence of TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat) and DIZZINESS (feel dizzy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced TRISMUS (their jaw locked). On an unknown date, the patient experienced ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever). At the time of the report, TRISMUS (their jaw locked), ASTHENIA (Very drawn energy/weak), PAIN IN EXTREMITY (back of their leg hurts), DECREASED APPETITE (Not able to eat), DIZZINESS (feel dizzy), PAIN (Body aches), FEELING OF DESPAIR (Feeling heavy), NAUSEA (nauseous), VOMITING (Vomits), FATIGUE (Tired) and PYREXIA (low grade fever) outcome was unknown.            Concomitant medication was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No specific follow-up information recorded. On 05-Aug-2021: Non-significant follow up updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Painful L arm; Pain at injection site (L arm); Itchiness at injection site (L arm); Swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful L arm), VACCINATION SITE PAIN (Pain at injection site (L arm)), VACCINATION SITE PRURITUS (Itchiness at injection site (L arm)) and VACCINATION SITE SWELLING (Swollen at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management. Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and PARACETAMOL (TYLENOL) for an unknown indication.    On 18-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 PAIN IN EXTREMITY (Painful L arm), VACCINATION SITE PAIN (Pain at injection site (L arm)), VACCINATION SITE PRURITUS (Itchiness at injection site (L arm)) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, PAIN IN EXTREMITY (Painful L arm) and VACCINATION SITE PRURITUS (Itchiness at injection site (L arm)) outcome was unknown and VACCINATION SITE PAIN (Pain at injection site (L arm)) and VACCINATION SITE SWELLING (Swollen at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication includes compound of water pill and blood pressure pill.   This case was linked to MOD-2021-048256 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: very sick after her second shot; aches and pain in body; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick after her second shot) and PAIN (aches and pain in body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ILLNESS (very sick after her second shot) and PAIN (aches and pain in body). At the time of the report, ILLNESS (very sick after her second shot) and PAIN (aches and pain in body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported.  No Treatment information was reported.   This case was linked to MOD-2021-048221 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, X-ray
Clinical narrative: experienced tired and diarrhea; experienced tired and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (experienced tired and diarrhea) and DIARRHOEA (experienced tired and diarrhea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (experienced tired and diarrhea) and DIARRHOEA (experienced tired and diarrhea). At the time of the report, FATIGUE (experienced tired and diarrhea) and DIARRHOEA (experienced tired and diarrhea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: X-ray showed that in the left AC joint there is degeneration.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Doctor recommended physical therapy  and cortisone shots   This case was linked to MOD-2021-035210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and added concomitant medication. Adverse events, added outcome of the events On 03-Aug-2021: Non significant follow up
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Joint swelling, Peripheral swelling
Clinical narrative: ankle is very swollen; Chills; a nagging headache for several days; upper arm is swollen; hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site; hot to touch, itchy hard; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch, itchy hard), JOINT SWELLING (ankle is very swollen), PERIPHERAL SWELLING (upper arm is swollen), VACCINATION SITE DISCOLOURATION (reddish brown circle the size of a quarter around the injection site) and VACCINATION SITE INDURATION (hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.     On 08-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 WARMTH (hot to touch, itchy hard), JOINT SWELLING (ankle is very swollen), PERIPHERAL SWELLING (upper arm is swollen), VACCINATION SITE DISCOLOURATION (reddish brown circle the size of a quarter around the injection site), VACCINATION SITE INDURATION (hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site), VACCINATION SITE PRURITUS (hot to touch, itchy hard), VACCINATION SITE SWELLING (injection site is swollen), CHILLS (chills) and HEADACHE (a nagging headache for several days). The patient was treated with CORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to touch, itchy hard), JOINT SWELLING (ankle is very swollen), PERIPHERAL SWELLING (upper arm is swollen), VACCINATION SITE DISCOLOURATION (reddish brown circle the size of a quarter around the injection site), VACCINATION SITE INDURATION (hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site), VACCINATION SITE PRURITUS (hot to touch, itchy hard), VACCINATION SITE SWELLING (injection site is swollen) and HEADACHE (a nagging headache for several days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 96.4 (Low) Patient reported that her temperature was normally 97.7 but it was around 96.4 for several days after the vaccination..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: ankle is very swollen; Chills; a nagging headache for several days; upper arm is swollen; hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site; hot to touch, itchy hard; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch, itchy hard), JOINT SWELLING (ankle is very swollen), PERIPHERAL SWELLING (upper arm is swollen), VACCINATION SITE DISCOLOURATION (reddish brown circle the size of a quarter around the injection site) and VACCINATION SITE INDURATION (hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.     On 08-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 WARMTH (hot to touch, itchy hard), JOINT SWELLING (ankle is very swollen), PERIPHERAL SWELLING (upper arm is swollen), VACCINATION SITE DISCOLOURATION (reddish brown circle the size of a quarter around the injection site), VACCINATION SITE INDURATION (hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site), VACCINATION SITE PRURITUS (hot to touch, itchy hard), VACCINATION SITE SWELLING (injection site is swollen), CHILLS (chills) and HEADACHE (a nagging headache for several days). The patient was treated with CORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to touch, itchy hard), JOINT SWELLING (ankle is very swollen), PERIPHERAL SWELLING (upper arm is swollen), VACCINATION SITE DISCOLOURATION (reddish brown circle the size of a quarter around the injection site), VACCINATION SITE INDURATION (hard, there is a red spot at the injection site and that there is a reddish brown circle the size of a quarter around the injection site), VACCINATION SITE PRURITUS (hot to touch, itchy hard), VACCINATION SITE SWELLING (injection site is swollen) and HEADACHE (a nagging headache for several days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 96.4 (Low) Patient reported that her temperature was normally 97.7 but it was around 96.4 for several days after the vaccination..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Painful arm; chronic pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and PAIN (chronic pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 010M20A) for an unknown indication.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (chronic pain). On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) and PAIN (chronic pain) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medication were reported.  No Treatment was reported.   This case was linked to -MODERNATX, INC.-MOD-2021-048422 (E2B Linked Report).; Sender's Comments:  -MODERNATX, INC.-MOD-2021-048422:Crosslinked with dose 2
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 010M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ESTROGENS CONJUGATED (PREMARIN), THYROID, MONTELUKAST SODIUM (SINGULAIR), FOLIC ACID, DEXLANSOPRAZOLE (DEXILANT), NADOLOL, ATORVASTATIN and CLOZAPINE for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 53/0 mmHg (Low) low BP. On an unknown date, Blood pressure measurement: 43/31 mmHg (Low) low BP.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Cardizem and Flonase.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  As per client, MI error in DOB capture   This case was linked to MOD-2021-043689 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative, Pain in extremity
Clinical narrative: negative antibody test; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ANTIBODY TEST NEGATIVE (negative antibody test) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 12-Jan-2021, the patient experienced ANTIBODY TEST NEGATIVE (negative antibody test). At the time of the report, PAIN IN EXTREMITY (sore arm) and ANTIBODY TEST NEGATIVE (negative antibody test) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Antibody test: negative (Negative) Negative. On 25-Jan-2021, Antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Eliquis, blood pressure medication. Treatment medication was not provided.   This case was linked to MOD21-14815, MOD21-04383, MOD21-14815 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-14815: MOD21-04383: MOD21-14815:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Tenderness, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Sore arm; Rash was 2 inches wide, 3 inches long and very red; Itches every once in a while and is not painful but a little tender underneath; Itching at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Rash was 2 inches wide, 3 inches long and very red), TENDERNESS (Itches every once in a while and is not painful but a little tender underneath), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ), EZETIMIBE, DILTIAZEM, FLUVASTATIN and METOPROLOL for an unknown indication.    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 PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Rash was 2 inches wide, 3 inches long and very red), TENDERNESS (Itches every once in a while and is not painful but a little tender underneath), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE RASH (Rash at the injection site). On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash was 2 inches wide, 3 inches long and very red) and VACCINATION SITE RASH (Rash at the injection site) had not resolved and TENDERNESS (Itches every once in a while and is not painful but a little tender underneath) and VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Low BP, patient was taken to the ER due to hypotension; diarrhea; fast HR; low appetite; HA; fatigue; 101.3 fever which rose 102.4; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low BP, patient was taken to the ER due to hypotension), DIARRHOEA (diarrhea), HEART RATE INCREASED (fast HR), DECREASED APPETITE (low appetite) and HEADACHE (HA) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LOSARTAN, CLOPIDOGREL BISULFATE (PLAVIX) and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (Low BP, patient was taken to the ER due to hypotension), DIARRHOEA (diarrhea), HEART RATE INCREASED (fast HR), DECREASED APPETITE (low appetite), HEADACHE (HA), FATIGUE (fatigue) and PYREXIA (101.3 fever which rose 102.4). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NORMAL SALINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOTENSION (Low BP, patient was taken to the ER due to hypotension), DIARRHOEA (diarrhea), HEART RATE INCREASED (fast HR), DECREASED APPETITE (low appetite), HEADACHE (HA), FATIGUE (fatigue) and PYREXIA (101.3 fever which rose 102.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101.3 (High) 101.3 fever which rose 102.4.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypotension, Pyrexia
Clinical narrative: Low BP, patient was taken to the ER due to hypotension; diarrhea; fast HR; low appetite; HA; fatigue; 101.3 fever which rose 102.4; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low BP, patient was taken to the ER due to hypotension), DIARRHOEA (diarrhea), HEART RATE INCREASED (fast HR), DECREASED APPETITE (low appetite) and HEADACHE (HA) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LOSARTAN, CLOPIDOGREL BISULFATE (PLAVIX) and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (Low BP, patient was taken to the ER due to hypotension), DIARRHOEA (diarrhea), HEART RATE INCREASED (fast HR), DECREASED APPETITE (low appetite), HEADACHE (HA), FATIGUE (fatigue) and PYREXIA (101.3 fever which rose 102.4). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NORMAL SALINE for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOTENSION (Low BP, patient was taken to the ER due to hypotension), DIARRHOEA (diarrhea), HEART RATE INCREASED (fast HR), DECREASED APPETITE (low appetite), HEADACHE (HA), FATIGUE (fatigue) and PYREXIA (101.3 fever which rose 102.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 101.3 (High) 101.3 fever which rose 102.4.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms and legs nightly; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on arms and legs nightly) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced URTICARIA (Hives on arms and legs nightly). At the time of the report, URTICARIA (Hives on arms and legs nightly) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: Follow-up received on 13 Jul 2021, contains patient demographic details, patient visited doctors office for reported event.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: nauseated; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nauseated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) for Adverse event, LORAZEPAM and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 16-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 HEADACHE (headache). On 18-Mar-2021, the patient experienced NAUSEA (nauseated). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include blood pressure medications and thyroid medications.