chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Usual soreness at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0261.20A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Summer) in 2020. Concurrent medical conditions included Allergy NOS (Unspecified, takes eye drops), Chronic atrial fibrillation since 2011, Shellfish allergy, Hypothyroidism since 2010, Blood pressure high, Diabetes since 2020 and High cholesterol since 2020. Concomitant products included APIXABAN for Anticoagulant therapy, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism.    On 26-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Usual soreness at injection site). On 28-Jan-2021, VACCINATION SITE PAIN (Usual soreness at injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       There was no acute illness at the time of vaccination and up to one month before. Concomitant products also included unspecified eye drops for allergy. Treatment information was not reported.   This case was linked to MOD-2021-049777 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28-Apr-2021, Concurrent medications and medical history added. Concomitant medications added.Patient demographics updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Pain; FATIGUE; vision abnormal; Headache; muscle ache; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Migraine on 01-Dec-2010, Diverticulosis on 01-Mar-2007 and Osteoarthritis on 15-Apr-2001. Concurrent medical conditions included  (Sulfa  NSAID). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 21-Oct-2019 to an unknown date for Sleep deprivation, DIAZEPAM from 21-Oct-2019 to an unknown date.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced FATIGUE (FATIGUE) and PAIN (Pain). At the time of the report, VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown.            On 29apr2021, post vaccination, the patient stated that she experienced symptoms of fever, aches, body pains and migraines.   No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: No specific follow-up information recorded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Visual impairment
Clinical narrative: Pain; FATIGUE; vision abnormal; Headache; muscle ache; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  The patient's past medical history included Migraine on 01-Dec-2010, Diverticulosis on 01-Mar-2007 and Osteoarthritis on 15-Apr-2001. Concurrent medical conditions included  (Sulfa  NSAID). Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 21-Oct-2019 to an unknown date for Sleep deprivation, DIAZEPAM from 21-Oct-2019 to an unknown date.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced FATIGUE (FATIGUE) and PAIN (Pain). At the time of the report, VISUAL IMPAIRMENT (vision abnormal), HEADACHE (Headache), MYALGIA (muscle ache), PYREXIA (fever) and ARTHRALGIA (joint pain) outcome was unknown.            On 29apr2021, post vaccination, the patient stated that she experienced symptoms of fever, aches, body pains and migraines.   No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: No specific follow-up information recorded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced HEADACHE (HEADACHE). On 22-Mar-2021, HEADACHE (HEADACHE) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. No treatment information provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: lesion warm to touch; red mark on the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (lesion warm to touch) and ERYTHEMA (red mark on the area of the injection) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced FEELING HOT (lesion warm to touch) and ERYTHEMA (red mark on the area of the injection). At the time of the report, FEELING HOT (lesion warm to touch) and ERYTHEMA (red mark on the area of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose given at 17 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age). On 13-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given at 17 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Arm swelled up; A rash about 4 inches long and 3 inches wide; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING and RASH in a 50-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING and RASH. At the time of the report, PERIPHERAL SWELLING and RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 contains no significant information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose was after 37 days from the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was after 37 days from the 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was after 37 days from the 1st dose). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was after 37 days from the 1st dose) had resolved.            Action taken with mRNA-1273 in response to the event was Not Applicable  Concomitant medication and treatment information were not reported
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Burning sensation, Feeling abnormal, Pain in extremity
Clinical narrative: burning sensation in both legs; painful in the bone; head feels funny.; both knees hurt; legs had funny pain; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in both legs), BONE PAIN (painful in the bone), ARTHRALGIA (both knees hurt), PAIN IN EXTREMITY (legs had funny pain) and FEELING ABNORMAL (head feels funny.) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced ARTHRALGIA (both knees hurt) and PAIN IN EXTREMITY (legs had funny pain). On 04-May-2021, the patient experienced BURNING SENSATION (burning sensation in both legs), BONE PAIN (painful in the bone) and FEELING ABNORMAL (head feels funny.). At the time of the report, BURNING SENSATION (burning sensation in both legs), BONE PAIN (painful in the bone), ARTHRALGIA (both knees hurt), PAIN IN EXTREMITY (legs had funny pain) and FEELING ABNORMAL (head feels funny.) outcome was unknown.            The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received on 05-May-2021 contains no new information.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got second shot today (7 days early); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second shot today (7 days early)) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 043B21A) for COVID-19 vaccination.     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 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second shot today (7 days early)). On 04-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second shot today (7 days early)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable  No concomitant details were provided No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-102912 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102912:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching in the area of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching in the area of the shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE PRURITUS (itching in the area of the shot). At the time of the report, VACCINATION SITE PRURITUS (itching in the area of the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: follow up received on 4-jun-2021:contains no new information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Itchy; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and PAIN (Pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA), MONTELUKAST, GLIMEPIRIDE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SIMVASTATIN and LISINOPRIL for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy) and PAIN (Pain). At the time of the report, PRURITUS (Itchy) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-103056 (E2B Linked Report). This case was linked to MOD-2021-041143 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-significant follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103056:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Depressed mood, Nasopharyngitis, Throat irritation
Clinical narrative: Feeling a little down; Caught a cold; Scratchy throat; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Feeling a little down), NASOPHARYNGITIS (Caught a cold), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (Feeling a little down), NASOPHARYNGITIS (Caught a cold), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing). At the time of the report, DEPRESSED MOOD (Feeling a little down), NASOPHARYNGITIS (Caught a cold), THROAT IRRITATION (Scratchy throat) and COUGH (Coughing) 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.       The patient said that she took the second dose of Moderna vaccine and that she did not had any adverse reactions. The patient said that she was feeling fine.  No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: No specific follow-up information recorded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Vaccination site bruising
Clinical narrative: stiffness; bruising at the site of injection size of a quarter; beyond the 35 days recommended interval; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the 35 days recommended interval) and VACCINATION SITE BRUISING (bruising at the site of injection size of a quarter) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the 35 days recommended interval). On 03-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE BRUISING (bruising at the site of injection size of a quarter). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (beyond the 35 days recommended interval) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness) and VACCINATION SITE BRUISING (bruising at the site of injection size of a quarter) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (taste buds are gone) and DYSGEUSIA (metallic taste in mouth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced AGEUSIA (taste buds are gone) and DYSGEUSIA (metallic taste in mouth). At the time of the report, AGEUSIA (taste buds are gone) and DYSGEUSIA (metallic taste in mouth) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: appetite lost; mild fever; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite lost), PYREXIA (mild fever), HEADACHE (headache) and FATIGUE (fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced DECREASED APPETITE (appetite lost), PYREXIA (mild fever), HEADACHE (headache) and FATIGUE (fatigue). On 03-May-2021, DECREASED APPETITE (appetite lost), PYREXIA (mild fever), HEADACHE (headache) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the concomitant medications were not provided. the Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Hot flush
Clinical narrative: Little appetite; Extremely weak; Hot and cold flashes; Chills; Fever greater than 100 F; Injected arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills) and PYREXIA (Fever greater than 100 F) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills), PYREXIA (Fever greater than 100 F) and VACCINATION SITE PAIN (Injected arm is sore). At the time of the report, DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills), PYREXIA (Fever greater than 100 F) and VACCINATION SITE PAIN (Injected arm is sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Body temperature: 100 (High) Fever greater than 100 F.         Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Little appetite; Extremely weak; Hot and cold flashes; Chills; Fever greater than 100 F; Injected arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills) and PYREXIA (Fever greater than 100 F) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills), PYREXIA (Fever greater than 100 F) and VACCINATION SITE PAIN (Injected arm is sore). At the time of the report, DECREASED APPETITE (Little appetite), ASTHENIA (Extremely weak), HOT FLUSH (Hot and cold flashes), CHILLS (Chills), PYREXIA (Fever greater than 100 F) and VACCINATION SITE PAIN (Injected arm is sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Body temperature: 100 (High) Fever greater than 100 F.         Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: we were tested positive for corona; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (we were tested positive for corona) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (we were tested positive for corona). At the time of the report, COVID-19 (we were tested positive for corona) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-102947 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102947:Husband Case
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Vaccination site swelling
Clinical narrative: severe flu like symptoms, ("bad case of the flu"); swollen large area with fever in it at injection site; swollen large area with fever in it at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu like symptoms, ("bad case of the flu")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A27A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia.   On 30-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 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu like symptoms, ("bad case of the flu")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site). At the time of the report, INFLUENZA LIKE ILLNESS (severe flu like symptoms, ("bad case of the flu")), PYREXIA (swollen large area with fever in it at injection site) and VACCINATION SITE SWELLING (swollen large area with fever in it at injection site) had resolved. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Patient Reports swollen large area with fever in it at injection site and also reports that this also happens when bitten by a bug due to medical diagnosis and blood disorder. Also reports severe flu like symptoms, ("bad case of the flu").    .   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up information received on 01JUN2021, included outcome of events flu like symptoms, pyrexia and vaccination site swelling as recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Ear pain, Feeling hot, Headache
Clinical narrative: Night sweats; body temperature regulation issue; Pressure in ears results in her being able to hear her pulse; pain slowly shift across center of head and settling near ear; Feeling hot; Waking up with significant night sweats; Fever; Chills; Headache behind eye; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), TEMPERATURE REGULATION DISORDER (body temperature regulation issue), EAR DISCOMFORT (Pressure in ears results in her being able to hear her pulse), EAR PAIN (pain slowly shift across center of head and settling near ear) and FEELING HOT (Feeling hot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Factor V Leiden mutation and Migraine (migraines related to menstruation). Concomitant products included APIXABAN (ELIQUIS), SUMATRIPTAN, SERTRALINE HYDROCHLORIDE (ZOLOFT) and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), TEMPERATURE REGULATION DISORDER (body temperature regulation issue), EAR DISCOMFORT (Pressure in ears results in her being able to hear her pulse), EAR PAIN (pain slowly shift across center of head and settling near ear), FEELING HOT (Feeling hot), SLEEP DISORDER (Waking up with significant night sweats), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache behind eye). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at a dose of 50 mg every six hours. At the time of the report, NIGHT SWEATS (Night sweats), TEMPERATURE REGULATION DISORDER (body temperature regulation issue), EAR DISCOMFORT (Pressure in ears results in her being able to hear her pulse), EAR PAIN (pain slowly shift across center of head and settling near ear), FEELING HOT (Feeling hot), SLEEP DISORDER (Waking up with significant night sweats), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache behind eye) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Sleep disorder, Temperature regulation disorder
Clinical narrative: Night sweats; body temperature regulation issue; Pressure in ears results in her being able to hear her pulse; pain slowly shift across center of head and settling near ear; Feeling hot; Waking up with significant night sweats; Fever; Chills; Headache behind eye; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), TEMPERATURE REGULATION DISORDER (body temperature regulation issue), EAR DISCOMFORT (Pressure in ears results in her being able to hear her pulse), EAR PAIN (pain slowly shift across center of head and settling near ear) and FEELING HOT (Feeling hot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Factor V Leiden mutation and Migraine (migraines related to menstruation). Concomitant products included APIXABAN (ELIQUIS), SUMATRIPTAN, SERTRALINE HYDROCHLORIDE (ZOLOFT) and LEVOTHYROXINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), TEMPERATURE REGULATION DISORDER (body temperature regulation issue), EAR DISCOMFORT (Pressure in ears results in her being able to hear her pulse), EAR PAIN (pain slowly shift across center of head and settling near ear), FEELING HOT (Feeling hot), SLEEP DISORDER (Waking up with significant night sweats), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache behind eye). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at a dose of 50 mg every six hours. At the time of the report, NIGHT SWEATS (Night sweats), TEMPERATURE REGULATION DISORDER (body temperature regulation issue), EAR DISCOMFORT (Pressure in ears results in her being able to hear her pulse), EAR PAIN (pain slowly shift across center of head and settling near ear), FEELING HOT (Feeling hot), SLEEP DISORDER (Waking up with significant night sweats), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache behind eye) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus, Vertigo
Clinical narrative: severe vertigo; bad tinnitus/Left ear become full feeling; Left ear become full feeling; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (severe vertigo), TINNITUS (bad tinnitus/Left ear become full feeling) and EAR DISCOMFORT (Left ear become full feeling) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030A21A) for COVID-19 vaccination.  No medical history was provided by the reporter. Concomitant products included TRIAMTERENE, METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VERTIGO (severe vertigo), TINNITUS (bad tinnitus/Left ear become full feeling) and EAR DISCOMFORT (Left ear become full feeling). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, VERTIGO (severe vertigo), TINNITUS (bad tinnitus/Left ear become full feeling) and EAR DISCOMFORT (Left ear become full feeling) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Hypoaesthesia oral, Influenza like illness
Clinical narrative: Flu like symptoms; Whole-body aches; Fatigue; Warm pressure sensation; leg pain, waist, back and glute region; Very Sleepy; Vomits; Headache; Nausea; Heart palpitations; swollen tongue; Numb tongue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue) and SOMNOLENCE (Very Sleepy) in a female patient of an unknown age 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue), NAUSEA (Nausea) and HEADACHE (Headache). On 09-Apr-2021, the patient experienced SOMNOLENCE (Very Sleepy) and VOMITING (Vomits). On 12-Apr-2021, the patient experienced FEELING HOT (Warm pressure sensation) and MYALGIA (leg pain, waist, back and glute region). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Whole-body aches) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue), SOMNOLENCE (Very Sleepy), FEELING HOT (Warm pressure sensation), MYALGIA (leg pain, waist, back and glute region), FATIGUE (Fatigue) and VOMITING (Vomits) had resolved and MYALGIA (Whole-body aches), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations, Somnolence, Swollen tongue
Clinical narrative: Flu like symptoms; Whole-body aches; Fatigue; Warm pressure sensation; leg pain, waist, back and glute region; Very Sleepy; Vomits; Headache; Nausea; Heart palpitations; swollen tongue; Numb tongue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue) and SOMNOLENCE (Very Sleepy) in a female patient of an unknown age 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue), NAUSEA (Nausea) and HEADACHE (Headache). On 09-Apr-2021, the patient experienced SOMNOLENCE (Very Sleepy) and VOMITING (Vomits). On 12-Apr-2021, the patient experienced FEELING HOT (Warm pressure sensation) and MYALGIA (leg pain, waist, back and glute region). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Whole-body aches) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue), SOMNOLENCE (Very Sleepy), FEELING HOT (Warm pressure sensation), MYALGIA (leg pain, waist, back and glute region), FATIGUE (Fatigue) and VOMITING (Vomits) had resolved and MYALGIA (Whole-body aches), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flu like symptoms; Whole-body aches; Fatigue; Warm pressure sensation; leg pain, waist, back and glute region; Very Sleepy; Vomits; Headache; Nausea; Heart palpitations; swollen tongue; Numb tongue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue) and SOMNOLENCE (Very Sleepy) in a female patient of an unknown age 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue), NAUSEA (Nausea) and HEADACHE (Headache). On 09-Apr-2021, the patient experienced SOMNOLENCE (Very Sleepy) and VOMITING (Vomits). On 12-Apr-2021, the patient experienced FEELING HOT (Warm pressure sensation) and MYALGIA (leg pain, waist, back and glute region). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Whole-body aches) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PALPITATIONS (Heart palpitations), SWOLLEN TONGUE (swollen tongue), HYPOAESTHESIA ORAL (Numb tongue), SOMNOLENCE (Very Sleepy), FEELING HOT (Warm pressure sensation), MYALGIA (leg pain, waist, back and glute region), FATIGUE (Fatigue) and VOMITING (Vomits) had resolved and MYALGIA (Whole-body aches), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of taste disorder (bad taste in the mouth), pain in extremity (arm pain to the point he can't move it), diarrhea, pyrexia (fever 99ºF to 103ºF) and fatigue (he is tired) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On May 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, patient experienced taste disorder (bad taste in the mouth), pain in extremity (arm pain to the point he can't move it), diarrhea, pyrexia (fever 99ºF to 103ºF), fatigue (he is tired), myalgia (body pain) and nausea. The patient treated with Tylenol (paracetamol); unspecified dose and frequency. At the time of the report, taste disorder (bad taste in the mouth), pain in extremity (arm pain to the point he can't move it), diarrhea, pyrexia (fever 99ºF to 103ºF), fatigue (he is tired), myalgia (body pain) and nausea outcome: unknown. Diagnostic results: On May 4, 2021, body temperature: 99-103ºF (high). No concomitant medication reported. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Taste disorder
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of taste disorder (bad taste in the mouth), pain in extremity (arm pain to the point he can't move it), diarrhea, pyrexia (fever 99ºF to 103ºF) and fatigue (he is tired) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On May 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, patient experienced taste disorder (bad taste in the mouth), pain in extremity (arm pain to the point he can't move it), diarrhea, pyrexia (fever 99ºF to 103ºF), fatigue (he is tired), myalgia (body pain) and nausea. The patient treated with Tylenol (paracetamol); unspecified dose and frequency. At the time of the report, taste disorder (bad taste in the mouth), pain in extremity (arm pain to the point he can't move it), diarrhea, pyrexia (fever 99ºF to 103ºF), fatigue (he is tired), myalgia (body pain) and nausea outcome: unknown. Diagnostic results: On May 4, 2021, body temperature: 99-103ºF (high). No concomitant medication reported. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Feeling hot, Myalgia
Clinical narrative: Arm swelling and warm; Warm; Chest pain; Dizzy; Tinnitus; Chills; Nausea; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Arm swelling and warm), FEELING HOT (Warm), CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and TINNITUS (Tinnitus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced SWELLING (Arm swelling and warm), FEELING HOT (Warm), CHEST PAIN (Chest pain), DIZZINESS (Dizzy), TINNITUS (Tinnitus), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body ache). On 29-Apr-2021, SWELLING (Arm swelling and warm), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body ache) had resolved. At the time of the report, FEELING HOT (Warm) had resolved and CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and TINNITUS (Tinnitus) was resolving.            No relevant concomitant medications were reported. No treatment information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Swelling, Tinnitus
Clinical narrative: Arm swelling and warm; Warm; Chest pain; Dizzy; Tinnitus; Chills; Nausea; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Arm swelling and warm), FEELING HOT (Warm), CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and TINNITUS (Tinnitus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced SWELLING (Arm swelling and warm), FEELING HOT (Warm), CHEST PAIN (Chest pain), DIZZINESS (Dizzy), TINNITUS (Tinnitus), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body ache). On 29-Apr-2021, SWELLING (Arm swelling and warm), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and MYALGIA (Body ache) had resolved. At the time of the report, FEELING HOT (Warm) had resolved and CHEST PAIN (Chest pain), DIZZINESS (Dizzy) and TINNITUS (Tinnitus) was resolving.            No relevant concomitant medications were reported. No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 and was symptomatic; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for Covid-19 and was symptomatic) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Apr-2021, the patient experienced COVID-19 (tested positive for Covid-19 and was symptomatic). On 29-Apr-2021, COVID-19 (tested positive for Covid-19 and was symptomatic) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive (Positive) was symptomatic.. On 29-Apr-2021, SARS-CoV-2 test: negative (Negative) Normal.     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 medication were reported. No treatment medication were reported.