chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Laboratory test, Pain in extremity, Pregnancy test, Ultrasound scan
Clinical narrative: Arm was sore; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Arm was sore) in a 25-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2 DRINKS/WEEK.) and Forceps delivery (Started out as a normal delivery and towards the end, it was a Forceps delivery.) on 26-Jan-2020. Concurrent medical conditions included Subchorionic hemorrhage (Last Monday 25MAR2021 had some bleeding and found out it was sub chorionic hemorrhage. Bleeding in another part of the ureters where baby is not.) on 25-Mar-2021 and Anxiety (STABLE.) since 01-Jan-2020. Concomitant products included FLUOXETINE for Anxiety, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Nov-2021. On 12-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 12-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Pregnancy test: Positive. In 2021, Ultrasound scan: Sub chorionic hemorrhage.. On an unknown date, Laboratory test: (normal) All prenatal lab and blood work, it was all normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-060711 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nausea, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Positive rapid COVID test; Nausea; Fever; Feeling COVID symptoms; Body aching; Slept all day; Food tasted terrible; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible) and SARS-COV-2 TEST POSITIVE (Positive rapid COVID test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Asthma (Patient is asthmatic and takes concomitant medication). Concomitant products included OXETORONE and DULOXETINE for an unknown indication.    On 06-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 COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible), NAUSEA (Nausea) and PYREXIA (Fever). On 13-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive rapid COVID test). The patient was treated with ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible), SARS-COV-2 TEST POSITIVE (Positive rapid COVID test), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test positive: Positive.     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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Taste disorder
Clinical narrative: Positive rapid COVID test; Nausea; Fever; Feeling COVID symptoms; Body aching; Slept all day; Food tasted terrible; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible) and SARS-COV-2 TEST POSITIVE (Positive rapid COVID test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Asthma (Patient is asthmatic and takes concomitant medication). Concomitant products included OXETORONE and DULOXETINE for an unknown indication.    On 06-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 COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible), NAUSEA (Nausea) and PYREXIA (Fever). On 13-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive rapid COVID test). The patient was treated with ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency and DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, COVID-19 (Feeling COVID symptoms), PAIN (Body aching), SOMNOLENCE (Slept all day), TASTE DISORDER (Food tasted terrible), SARS-COV-2 TEST POSITIVE (Positive rapid COVID test), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test positive: Positive.     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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy rash at injection site; itchy rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash at injection site) and VACCINATION SITE RASH (itchy rash at injection site) in a 42-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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at injection site) and VACCINATION SITE RASH (itchy rash at injection site). At the time of the report, VACCINATION SITE PRURITUS (itchy rash at injection site) and VACCINATION SITE RASH (itchy rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment included topical Benadryl.
Sex: U
Vaccine: COVID19
Symptoms: Nightmare, Sleep deficit
Clinical narrative: Nightmares and sleep deprivation; Nightmares and sleep deprivation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Nightmares and sleep deprivation) and SLEEP DEFICIT (Nightmares and sleep deprivation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced NIGHTMARE (Nightmares and sleep deprivation) and SLEEP DEFICIT (Nightmares and sleep deprivation). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NIGHTMARE (Nightmares and sleep deprivation) and SLEEP DEFICIT (Nightmares and sleep deprivation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Tremor
Clinical narrative: she was walking and was shaking, she had to sit down; low blood sugar; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (she was walking and was shaking, she had to sit down) and BLOOD GLUCOSE DECREASED (low blood sugar) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026A21A) for COVID-19 vaccination.     Concomitant products included FISH OIL, PARACETAMOL (TYLENOL), DEQUALINIUM CHLORIDE (HERPES) and VITAMINS NOS for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (she was walking and was shaking, she had to sit down) and BLOOD GLUCOSE DECREASED (low blood sugar). At the time of the report, TREMOR (she was walking and was shaking, she had to sit down) and BLOOD GLUCOSE DECREASED (low blood sugar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 treatment information was provided.   This case was linked to MOD-2021-060716 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Lump on the outside of her Left Elbow (Fluids in the lump); This spontaneous case was reported by a pharmacist and describes the occurrence of MASS (Lump on the outside of her Left Elbow (Fluids in the lump)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MASS (Lump on the outside of her Left Elbow (Fluids in the lump)). At the time of the report, MASS (Lump on the outside of her Left Elbow (Fluids in the lump)) 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.   No concomitant medications were reported. No treatment information was reported. It is reported that the lump was not related to Moderna vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Events outcome updated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Oropharyngeal pain
Clinical narrative: headache; sore throat; body aches; dizziness that got really bad with the fever; chills; felt like she had the flu; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), DIZZINESS (dizziness that got really bad with the fever), CHILLS (chills) and INFLUENZA LIKE ILLNESS (felt like she had the flu) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), DIZZINESS (dizziness that got really bad with the fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (felt like she had the flu) and PYREXIA (fever). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), DIZZINESS (dizziness that got really bad with the fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: headache; sore throat; body aches; dizziness that got really bad with the fever; chills; felt like she had the flu; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), DIZZINESS (dizziness that got really bad with the fever), CHILLS (chills) and INFLUENZA LIKE ILLNESS (felt like she had the flu) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), DIZZINESS (dizziness that got really bad with the fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (felt like she had the flu) and PYREXIA (fever). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), PAIN (body aches), DIZZINESS (dizziness that got really bad with the fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received the vaccine past the 6 hour vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine past the 6 hour vial puncture expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine past the 6 hour vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the vaccine past the 6 hour vial puncture expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Four male patients were receiving their first dose when the event occurred. No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 012A21A)  with no associated AEs.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red Rash at injection site 6 days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red Rash at injection site 6 days after vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01CA21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SPIRONOLACTONE for an unknown indication.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash at injection site 6 days after vaccination). At the time of the report, RASH ERYTHEMATOUS (Red Rash at injection site 6 days after vaccination) outcome was unknown. Not Provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Malaise, Myalgia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: hair loss; feeling unwell; Fever  (101°F); body ache; soreness of her arm; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss), PAIN IN EXTREMITY (soreness of her arm), MALAISE (feeling unwell), PYREXIA (Fever  (101°F)) and MYALGIA (body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 031B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included VITAMIN D NOS from 10-Jan-2020 to an unknown date for Deficiency vitamin, VITAMIN C [ASCORBIC ACID] 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of her arm). On 17-Mar-2021, the patient experienced MALAISE (feeling unwell), PYREXIA (Fever  (101°F)) and MYALGIA (body ache). On 25-Mar-2021, the patient experienced ALOPECIA (hair loss). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 18-Mar-2021, PAIN IN EXTREMITY (soreness of her arm) had resolved. On 20-Mar-2021, MALAISE (feeling unwell) and PYREXIA (Fever  (101°F)) had resolved. On 22-Mar-2021, MYALGIA (body ache) had resolved. At the time of the report, ALOPECIA (hair loss) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test positive: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added one additional event-body ache
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: hair loss; feeling unwell; Fever  (101°F); body ache; soreness of her arm; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss), PAIN IN EXTREMITY (soreness of her arm), MALAISE (feeling unwell), PYREXIA (Fever  (101°F)) and MYALGIA (body ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 031B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included VITAMIN D NOS from 10-Jan-2020 to an unknown date for Deficiency vitamin, VITAMIN C [ASCORBIC ACID] 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness of her arm). On 17-Mar-2021, the patient experienced MALAISE (feeling unwell), PYREXIA (Fever  (101°F)) and MYALGIA (body ache). On 25-Mar-2021, the patient experienced ALOPECIA (hair loss). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 18-Mar-2021, PAIN IN EXTREMITY (soreness of her arm) had resolved. On 20-Mar-2021, MALAISE (feeling unwell) and PYREXIA (Fever  (101°F)) had resolved. On 22-Mar-2021, MYALGIA (body ache) had resolved. At the time of the report, ALOPECIA (hair loss) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test positive: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added one additional event-body ache
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever; Headache; Body pain; Tingling and hot between legs and from the back to the head; Tingling and hot between legs and from the back to the head; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling and hot between legs and from the back to the head), FEELING HOT (Tingling and hot between legs and from the back to the head), PYREXIA (Fever), HEADACHE (Headache) and PAIN (Body pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included MIRTAZAPINE, FLUOXETINE, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] 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. On 17-Mar-2021, the patient experienced PARAESTHESIA (Tingling and hot between legs and from the back to the head) and FEELING HOT (Tingling and hot between legs and from the back to the head). On 18-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and PAIN (Body pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling and hot between legs and from the back to the head), FEELING HOT (Tingling and hot between legs and from the back to the head), PYREXIA (Fever), HEADACHE (Headache) and PAIN (Body pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Breath sounds, Delusion, Malaise, Pyrexia
Clinical narrative: vivid dreams; sound sleeping; vivid thoughts; delusions of flying; feeling "crappy"; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MALAISE (feeling "crappy"), STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams) and BREATH SOUNDS (sound sleeping) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (and hospitalization in November 2020 where he was admitted for 3-4 days and administered plasma and steroid therapies.). Concurrent medical conditions included Dementia (patient was currently having vivid thoughts and dreams, sleeps more soundly, and has delusions of flying airplanes). Concomitant products included MEMANTINE, DONEPEZIL and PRAVASTATIN for an unknown indication.   On 04-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) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever) and MALAISE (feeling "crappy"). On 29-Mar-2021, the patient experienced STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams), BREATH SOUNDS (sound sleeping) and DELUSION (delusions of flying). On 07-Mar-2021, PYREXIA (fever) and MALAISE (feeling "crappy") had resolved. At the time of the report, STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams), BREATH SOUNDS (sound sleeping) and DELUSION (delusions of flying) outcome was unknown.            No treatment information was provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: vivid dreams; sound sleeping; vivid thoughts; delusions of flying; feeling "crappy"; fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MALAISE (feeling "crappy"), STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams) and BREATH SOUNDS (sound sleeping) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (and hospitalization in November 2020 where he was admitted for 3-4 days and administered plasma and steroid therapies.). Concurrent medical conditions included Dementia (patient was currently having vivid thoughts and dreams, sleeps more soundly, and has delusions of flying airplanes). Concomitant products included MEMANTINE, DONEPEZIL and PRAVASTATIN for an unknown indication.   On 04-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) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever) and MALAISE (feeling "crappy"). On 29-Mar-2021, the patient experienced STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams), BREATH SOUNDS (sound sleeping) and DELUSION (delusions of flying). On 07-Mar-2021, PYREXIA (fever) and MALAISE (feeling "crappy") had resolved. At the time of the report, STRESS (vivid thoughts), ABNORMAL DREAMS (vivid dreams), BREATH SOUNDS (sound sleeping) and DELUSION (delusions of flying) outcome was unknown.            No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Dyspnoea, Rash, SARS-CoV-1 test, Urticaria
Clinical narrative: loss of smell; rash/hives back and neck; rash/hives back and neck; difficulty breating; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash/hives back and neck), URTICARIA (rash/hives back and neck), DYSPNOEA (difficulty breating) and ANOSMIA (loss of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMOXICILLIN and BUDESONIDE (NASOCORT) for an unknown indication.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash/hives back and neck), URTICARIA (rash/hives back and neck), DYSPNOEA (difficulty breating) and ANOSMIA (loss of smell). At the time of the report, RASH (rash/hives back and neck), URTICARIA (rash/hives back and neck), DYSPNOEA (difficulty breating) and ANOSMIA (loss of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) She has had three Covid19-test and they are all negative..         Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Postprandial hypoglycaemia, Pyrexia
Clinical narrative: Feels like having IPS: idiopathic postprandrial syndrome; shakiness after eating meals; She also feels she has less energy; slight headache; achy muscles; sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of POSTPRANDIAL HYPOGLYCAEMIA (Feels like having IPS: idiopathic postprandrial syndrome), TREMOR (shakiness after eating meals), ASTHENIA (She also feels she has less energy), HEADACHE (slight headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 007M20A) 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 FISH OIL, VITAMINS NOS and PARACETAMOL (TYLENOL) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced POSTPRANDIAL HYPOGLYCAEMIA (Feels like having IPS: idiopathic postprandrial syndrome), TREMOR (shakiness after eating meals), ASTHENIA (She also feels she has less energy), HEADACHE (slight headache) and MYALGIA (achy muscles). On 14-Mar-2021, PYREXIA (fever) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, POSTPRANDIAL HYPOGLYCAEMIA (Feels like having IPS: idiopathic postprandrial syndrome), TREMOR (shakiness after eating meals), ASTHENIA (She also feels she has less energy), HEADACHE (slight headache) and MYALGIA (achy muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Pyrexia: 100.4f (abnormal) Fever that reached 100.4F at 30 hours post second dose; the fever then went away. On 14-Mar-2021, Pyrexia: 100f (abnormal) reappeared the next day and was also over 100F..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included, NSAIDS occasionally (tylenol) and herpes medication. No treatment medication information was provided.   This case was linked to MOD-2021-060705 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-MAY-2021 contains non-significant information reporter contact details updated. On 07-Jul-2021: Follow up received on 07-JUL-2021 contains no new Information(NNI)
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: Feels like having IPS: idiopathic postprandrial syndrome; shakiness after eating meals; She also feels she has less energy; slight headache; achy muscles; sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of POSTPRANDIAL HYPOGLYCAEMIA (Feels like having IPS: idiopathic postprandrial syndrome), TREMOR (shakiness after eating meals), ASTHENIA (She also feels she has less energy), HEADACHE (slight headache) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 007M20A) 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 FISH OIL, VITAMINS NOS and PARACETAMOL (TYLENOL) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced POSTPRANDIAL HYPOGLYCAEMIA (Feels like having IPS: idiopathic postprandrial syndrome), TREMOR (shakiness after eating meals), ASTHENIA (She also feels she has less energy), HEADACHE (slight headache) and MYALGIA (achy muscles). On 14-Mar-2021, PYREXIA (fever) and VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, POSTPRANDIAL HYPOGLYCAEMIA (Feels like having IPS: idiopathic postprandrial syndrome), TREMOR (shakiness after eating meals), ASTHENIA (She also feels she has less energy), HEADACHE (slight headache) and MYALGIA (achy muscles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Pyrexia: 100.4f (abnormal) Fever that reached 100.4F at 30 hours post second dose; the fever then went away. On 14-Mar-2021, Pyrexia: 100f (abnormal) reappeared the next day and was also over 100F..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications included, NSAIDS occasionally (tylenol) and herpes medication. No treatment medication information was provided.   This case was linked to MOD-2021-060705 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-MAY-2021 contains non-significant information reporter contact details updated. On 07-Jul-2021: Follow up received on 07-JUL-2021 contains no new Information(NNI)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMINS NOS, VITAMIN D NOS and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) 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.   The patient's medical history was not provided.  The patient did not receive any treatment. Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060734:DOSE 2
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: tingling in 3 fingers of right hand/tingling in 3 of right toes; feels itching and burning; feels itching and burning; leg muscles are not as strong; fingers and toes are numb, achy and painful; fingers and toes are numb, achy and painful; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong) and HYPOAESTHESIA (fingers and toes are numb, achy and painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M201) 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong), HYPOAESTHESIA (fingers and toes are numb, achy and painful) and PAIN IN EXTREMITY (fingers and toes are numb, achy and painful). At the time of the report, PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong), HYPOAESTHESIA (fingers and toes are numb, achy and painful) and PAIN IN EXTREMITY (fingers and toes are numb, achy and painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. Doctor prescribed a steroid for 5 days patient states today is last day of steroid, aspirin because platelet numbers went up, vitamin b12
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: tingling in 3 fingers of right hand/tingling in 3 of right toes; feels itching and burning; feels itching and burning; leg muscles are not as strong; fingers and toes are numb, achy and painful; fingers and toes are numb, achy and painful; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong) and HYPOAESTHESIA (fingers and toes are numb, achy and painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M201) 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong), HYPOAESTHESIA (fingers and toes are numb, achy and painful) and PAIN IN EXTREMITY (fingers and toes are numb, achy and painful). At the time of the report, PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong), HYPOAESTHESIA (fingers and toes are numb, achy and painful) and PAIN IN EXTREMITY (fingers and toes are numb, achy and painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided. Doctor prescribed a steroid for 5 days patient states today is last day of steroid, aspirin because platelet numbers went up, vitamin b12
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Condition aggravated, Diarrhoea, Fatigue
Clinical narrative: Condition aggravated; Nausea; Vomiting; diarrhea; Headache; Weakness; Tiredness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), DIARRHOEA (diarrhea), HEADACHE (Headache), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No Adverse Event (No medical history reported). Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]), RIZATRIPTAN BENZOATE (MAXALT), ESTRADIOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) 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, the patient experienced HEADACHE (Headache), ASTHENIA (Weakness) and FATIGUE (Tiredness). On 11-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 12-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), DIARRHOEA (diarrhea), HEADACHE (Headache), ASTHENIA (Weakness), FATIGUE (Tiredness), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, COVID-19: negative (Negative) negative.         Patient received intravenous hydration and ibuprofen, acetaminophen, naproxen, ascorbic acid, air borne and oxymetazoline hydrochloride to help relieve symptoms in emergency room.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Condition aggravated; Nausea; Vomiting; diarrhea; Headache; Weakness; Tiredness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), DIARRHOEA (diarrhea), HEADACHE (Headache), ASTHENIA (Weakness) and FATIGUE (Tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No Adverse Event (No medical history reported). Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]), RIZATRIPTAN BENZOATE (MAXALT), ESTRADIOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) 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, the patient experienced HEADACHE (Headache), ASTHENIA (Weakness) and FATIGUE (Tiredness). On 11-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 12-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), DIARRHOEA (diarrhea), HEADACHE (Headache), ASTHENIA (Weakness), FATIGUE (Tiredness), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, COVID-19: negative (Negative) negative.         Patient received intravenous hydration and ibuprofen, acetaminophen, naproxen, ascorbic acid, air borne and oxymetazoline hydrochloride to help relieve symptoms in emergency room.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: More than 36 days after first dose without receiving 2nd dose; swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after first dose without receiving 2nd dose) and LYMPHADENOPATHY (swollen lymph nodes ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after first dose without receiving 2nd dose) and LYMPHADENOPATHY (swollen lymph nodes ). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after first dose without receiving 2nd dose) and LYMPHADENOPATHY (swollen lymph nodes ) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Aches and pains; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN (Aches and pains), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches and pains), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Vomiting
Clinical narrative: tight chest; difficulty breathing; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tight chest), DYSPNOEA (difficulty breathing) and VOMITING (Throwing up) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Penicillin allergy.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHEST DISCOMFORT (tight chest), DYSPNOEA (difficulty breathing) and VOMITING (Throwing up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (tight chest), DYSPNOEA (difficulty breathing) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product included sometimes painkillers for her knee.