chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: stuffy nose; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose) and OROPHARYNGEAL PAIN (sore throat) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced NASAL CONGESTION (stuffy nose) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, NASAL CONGESTION (stuffy nose) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not reported. Treatment information were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Throat irritation
Clinical narrative: itchiness all over left arm; swollen of lymph nodes; sensation of throat; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness all over left arm), LYMPHADENOPATHY (swollen of lymph nodes) and THROAT IRRITATION (sensation of throat) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (itchiness all over left arm), LYMPHADENOPATHY (swollen of lymph nodes) and THROAT IRRITATION (sensation of throat). On 19-Mar-2021, PRURITUS (itchiness all over left arm) had resolved and LYMPHADENOPATHY (swollen of lymph nodes) and THROAT IRRITATION (sensation of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient took Benadryl to treat his symptoms. no concomitant medication reported.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pyrexia
Clinical narrative: Aching body (After the Second Dose); Fever 101 F (After the Second Dose); lightheaded (After the Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aching body (After the Second Dose)), PYREXIA (Fever 101 F (After the Second Dose)) and DIZZINESS (lightheaded (After the Second Dose)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported).   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (Aching body (After the Second Dose)), PYREXIA (Fever 101 F (After the Second Dose)) and DIZZINESS (lightheaded (After the Second Dose)). At the time of the report, MYALGIA (Aching body (After the Second Dose)), PYREXIA (Fever 101 F (After the Second Dose)) and DIZZINESS (lightheaded (After the Second Dose)) outcome was unknown. Not Provided          no concomitant medication reported. treatment medication includes Tylenol for fever.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #019B21A and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, qd. At the time of the report, PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Swelling
Clinical narrative: arm was sore; huge, bright red lump on left arm; started as big bruise; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (started as big bruise), PAIN IN EXTREMITY (arm was sore) and SWELLING (huge, bright red lump on left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BZIA) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CONTUSION (started as big bruise) and SWELLING (huge, bright red lump on left arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, CONTUSION (started as big bruise), PAIN IN EXTREMITY (arm was sore) and SWELLING (huge, bright red lump on left arm) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Panic reaction
Clinical narrative: Panicing; Cracking of the joints; This spontaneous case was reported by an other caregiver and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Cracking of the joints) and PANIC REACTION (Panicing) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma (She has severe asthma from age of 18.) and Allergy (She has allergy from age of 18.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Cracking of the joints). On 16-Apr-2021, the patient experienced PANIC REACTION (Panicing). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Cracking of the joints) and PANIC REACTION (Panicing) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported    This case was linked to MOD-2021-079077 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Dyspnoea, Erythema, Influenza like illness
Clinical narrative: flu-like symptoms; felt like asthma or a seasonal allergy; felt like asthma or a seasonal allergy; some difficulty breathing; a little bit of cough; itchiness on her thighs; crazy red lines all over her thighs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs), ASTHMA (felt like asthma or a seasonal allergy) and SEASONAL ALLERGY (felt like asthma or a seasonal allergy). On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs), INFLUENZA LIKE ILLNESS (flu-like symptoms), ASTHMA (felt like asthma or a seasonal allergy) and SEASONAL ALLERGY (felt like asthma or a seasonal allergy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not reported. Treatment information were not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Seasonal allergy
Clinical narrative: flu-like symptoms; felt like asthma or a seasonal allergy; felt like asthma or a seasonal allergy; some difficulty breathing; a little bit of cough; itchiness on her thighs; crazy red lines all over her thighs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs), ASTHMA (felt like asthma or a seasonal allergy) and SEASONAL ALLERGY (felt like asthma or a seasonal allergy). On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, DYSPNOEA (some difficulty breathing), COUGH (a little bit of cough), PRURITUS (itchiness on her thighs), ERYTHEMA (crazy red lines all over her thighs), INFLUENZA LIKE ILLNESS (flu-like symptoms), ASTHMA (felt like asthma or a seasonal allergy) and SEASONAL ALLERGY (felt like asthma or a seasonal allergy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not reported. Treatment information were not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Nausea, Pyrexia
Clinical narrative: 110 heartbeat per minute; Fogginess; Nausea; Mild pain at injection site; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (110 heartbeat per minute), FEELING ABNORMAL (Fogginess), NAUSEA (Nausea), VACCINATION SITE PAIN (Mild pain at injection site) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (110 heartbeat per minute), FEELING ABNORMAL (Fogginess), NAUSEA (Nausea), VACCINATION SITE PAIN (Mild pain at injection site), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEART RATE INCREASED (110 heartbeat per minute), FEELING ABNORMAL (Fogginess), NAUSEA (Nausea), VACCINATION SITE PAIN (Mild pain at injection site), HEADACHE (Headache) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included:Beta Blocker meds,Blood pressure meds Thyroid meds   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: outcome reported and denied further follow up
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 110 heartbeat per minute; Fogginess; Nausea; Mild pain at injection site; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (110 heartbeat per minute), FEELING ABNORMAL (Fogginess), NAUSEA (Nausea), VACCINATION SITE PAIN (Mild pain at injection site) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (110 heartbeat per minute), FEELING ABNORMAL (Fogginess), NAUSEA (Nausea), VACCINATION SITE PAIN (Mild pain at injection site), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEART RATE INCREASED (110 heartbeat per minute), FEELING ABNORMAL (Fogginess), NAUSEA (Nausea), VACCINATION SITE PAIN (Mild pain at injection site), HEADACHE (Headache) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included:Beta Blocker meds,Blood pressure meds Thyroid meds   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: outcome reported and denied further follow up
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Throbbing headache; Arm throbbing; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Throbbing headache) and PAIN IN EXTREMITY (Arm throbbing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included OXYCODONE and AMOXICILLIN for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Throbbing headache) and PAIN IN EXTREMITY (Arm throbbing). At the time of the report, HEADACHE (Throbbing headache) and PAIN IN EXTREMITY (Arm throbbing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included aspirin. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079087 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079087:Son case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Dysstasia, Fatigue
Clinical narrative: dizzy; sweaty; lethargic; difficulty standing; brain fog; aches and pains; weak leg muscles; jittery; stomach ache; sore arm; chills; fatigue; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing) and FEELING ABNORMAL (brain fog) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 038A21A) 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 was provided.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever). At the time of the report, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever) had not resolved.            No concomitant medications were provided. Treatment medications included paracetamol, ibuprofen. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079068:1st dose vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling jittery, Hyperhidrosis, Lethargy, Muscular weakness
Clinical narrative: dizzy; sweaty; lethargic; difficulty standing; brain fog; aches and pains; weak leg muscles; jittery; stomach ache; sore arm; chills; fatigue; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing) and FEELING ABNORMAL (brain fog) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 038A21A) 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 was provided.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever). At the time of the report, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever) had not resolved.            No concomitant medications were provided. Treatment medications included paracetamol, ibuprofen. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079068:1st dose vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: dizzy; sweaty; lethargic; difficulty standing; brain fog; aches and pains; weak leg muscles; jittery; stomach ache; sore arm; chills; fatigue; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing) and FEELING ABNORMAL (brain fog) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 038A21A) 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 was provided.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever). At the time of the report, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), FEELING ABNORMAL (brain fog), PAIN (aches and pains), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (low grade fever) had not resolved.            No concomitant medications were provided. Treatment medications included paracetamol, ibuprofen. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079068:1st dose vaccine
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort
Clinical narrative: Icey feeling in the head; little weakness; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (Icey feeling in the head) and ASTHENIA (little weakness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U8B21-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced HEAD DISCOMFORT (Icey feeling in the head) and ASTHENIA (little weakness). On 22-Mar-2021, HEAD DISCOMFORT (Icey feeling in the head) and ASTHENIA (little weakness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: edema in the right leg; This spontaneous case was reported by a physician and describes the occurrence of OEDEMA PERIPHERAL (edema in the right leg) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) and DUPILUMAB (DUPIXENT) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced OEDEMA PERIPHERAL (edema in the right leg). At the time of the report, OEDEMA PERIPHERAL (edema in the right leg) 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-079122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079122:2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Migraine, Nausea, Pyrexia
Clinical narrative: pain in injection site; fatigue; migraine; joint pain; extreme nausea; extreme vomiting; fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site), FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain) and NAUSEA (extreme nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain), NAUSEA (extreme nausea), VOMITING (extreme vomiting) and PYREXIA (fever of 103). On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). At the time of the report, VACCINATION SITE PAIN (pain in injection site), FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain), NAUSEA (extreme nausea), VOMITING (extreme vomiting) and PYREXIA (fever of 103) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-079130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079130:second dose
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: pain in injection site; fatigue; migraine; joint pain; extreme nausea; extreme vomiting; fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site), FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain) and NAUSEA (extreme nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain), NAUSEA (extreme nausea), VOMITING (extreme vomiting) and PYREXIA (fever of 103). On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site). At the time of the report, VACCINATION SITE PAIN (pain in injection site), FATIGUE (fatigue), MIGRAINE (migraine), ARTHRALGIA (joint pain), NAUSEA (extreme nausea), VOMITING (extreme vomiting) and PYREXIA (fever of 103) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-079130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079130:second dose
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: Missed the correct time window; Covid + between doses; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid + between doses) and PRODUCT DOSE OMISSION ISSUE (Missed the correct time window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid + between doses). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the correct time window). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid + between doses) and PRODUCT DOSE OMISSION ISSUE (Missed the correct time window) 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Eye pain, Feeling abnormal, Headache
Clinical narrative: pain in  eye; headaches; injection site pain; Watering eyes; mouth felt funny; nauseous; pain inside of ear; palpitation; light headed; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed) and EYE PAIN (pain in  eye) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed), INJECTION SITE PAIN (injection site pain), LACRIMATION INCREASED (Watering eyes) and FEELING ABNORMAL (mouth felt funny). On 15-Apr-2021, the patient experienced EYE PAIN (pain in  eye) and HEADACHE (headaches). On 14-Apr-2021, NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed), INJECTION SITE PAIN (injection site pain), LACRIMATION INCREASED (Watering eyes) and FEELING ABNORMAL (mouth felt funny) had resolved. On 16-Apr-2021, EYE PAIN (pain in  eye) and HEADACHE (headaches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lacrimation increased, Nausea, Palpitations
Clinical narrative: pain in  eye; headaches; injection site pain; Watering eyes; mouth felt funny; nauseous; pain inside of ear; palpitation; light headed; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed) and EYE PAIN (pain in  eye) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed), INJECTION SITE PAIN (injection site pain), LACRIMATION INCREASED (Watering eyes) and FEELING ABNORMAL (mouth felt funny). On 15-Apr-2021, the patient experienced EYE PAIN (pain in  eye) and HEADACHE (headaches). On 14-Apr-2021, NAUSEA (nauseous), EAR PAIN (pain inside of ear), PALPITATIONS (palpitation), DIZZINESS (light headed), INJECTION SITE PAIN (injection site pain), LACRIMATION INCREASED (Watering eyes) and FEELING ABNORMAL (mouth felt funny) had resolved. On 16-Apr-2021, EYE PAIN (pain in  eye) and HEADACHE (headaches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Illness, Product dose omission issue
Clinical narrative: This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of illness (did not feel well) and product dose omission issue (did not get 2nd dose on scheduled date) and vaccine exposure during pregnancy in a female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014M20A) for COVID-19 immunization. No medical history reported. On Mar 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. Last menstrual period and estimated date of delivery not provided. On an unknown date, patient experienced illness (did not feel well), product dose omission issue (did not get 2nd dose on scheduled date) and vaccine exposure during pregnancy. At the time of the report, illness (did not feel well) and product dose omission issue (did not get 2nd dose on scheduled date) outcome: unknown; and vaccine  exposure during pregnancy resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant products and treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy; rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy; rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy; rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy; rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE RASH (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE ERYTHEMA (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE INDURATION (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy) and VACCINATION SITE PRURITUS (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE RASH (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE ERYTHEMA (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE INDURATION (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy) and VACCINATION SITE PRURITUS (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy). At the time of the report, VACCINATION SITE WARMTH (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE RASH (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE ERYTHEMA (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy), VACCINATION SITE INDURATION (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy) and VACCINATION SITE PRURITUS (rash at the injection site that looks like an infected mosquito bite, red, hard, hot and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: itchiness; slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and PAIN IN EXTREMITY (slightly sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU in 1962. Concurrent medical conditions included High cholesterol since January 2021.    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 PRURITUS (itchiness) and PAIN IN EXTREMITY (slightly sore arm). At the time of the report, PRURITUS (itchiness) and PAIN IN EXTREMITY (slightly sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-079118 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: TCR - no email or fax available for follow up.; Sender's Comments:  MODERNATX, INC.-MOD-2021-079118:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Testicular pain
Clinical narrative: testicules crumps; little pain most in sitting position in his both testicules; left side testicule still hurt; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (testicules crumps), TESTICULAR PAIN (little pain most in sitting position in his both testicules) and TESTICULAR PAIN (left side testicule still hurt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE SPASMS (testicules crumps), TESTICULAR PAIN (little pain most in sitting position in his both testicules) and TESTICULAR PAIN (left side testicule still hurt). On 15-Apr-2021, MUSCLE SPASMS (testicules crumps) and TESTICULAR PAIN (little pain most in sitting position in his both testicules) had resolved. At the time of the report, TESTICULAR PAIN (left side testicule still hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported. Upon in internal review on 04-AUG-2021, the age was corrected to 35 years
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Colonoscopy, Computerised tomogram abdomen, Decreased appetite, Diarrhoea
Clinical narrative: Watery diarrhea; has not had a regular bowel movement; lost about 35-40 pounds; does not have appetite to eat; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat). At the time of the report, DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: Negative. In 2021, Computerised tomogram abdomen: (Negative) no inflammation or diverticulitis. In 2021, Endoscopy: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Omeprazole and Pepcid.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Endoscopy, Weight decreased
Clinical narrative: Watery diarrhea; has not had a regular bowel movement; lost about 35-40 pounds; does not have appetite to eat; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat). At the time of the report, DIARRHOEA (Watery diarrhea), BOWEL MOVEMENT IRREGULARITY (has not had a regular bowel movement), WEIGHT DECREASED (lost about 35-40 pounds) and DECREASED APPETITE (does not have appetite to eat) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: Negative. In 2021, Computerised tomogram abdomen: (Negative) no inflammation or diverticulitis. In 2021, Endoscopy: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Omeprazole and Pepcid.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: Bad headache; Not feeling very well; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) and MALAISE (Not feeling very well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Bad headache) and MALAISE (Not feeling very well). At the time of the report, HEADACHE (Bad headache) and MALAISE (Not feeling very well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and TRIGLYCERIDES.    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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was given Sleeping Pill as concomitant medication.   This case was linked to MOD-2021-079363 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: A rash on left side of the chest; A rash in the arm pit; Headache; A rash on the left thigh; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RASH (A rash on the left thigh), RASH (A rash on left side of the chest) and RASH (A rash in the arm pit) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 10-Apr-2021, the patient experienced HEADACHE (Headache), RASH (A rash on the left thigh) and RASH (A rash in the arm pit). On an unknown date, the patient experienced RASH (A rash on left side of the chest). At the time of the report, HEADACHE (Headache), RASH (A rash on the left thigh), RASH (A rash on left side of the chest) and RASH (A rash in the arm pit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were given to the patient.