chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Headache, Lethargy
Clinical narrative: Felt lethargic; Couldn't keep any food down; Felt tired; Felt achy; Nauseous; Felt tired - sleeping a lot; Felt very dizzy - everything was spinning; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt very dizzy - everything was spinning), HEADACHE (Very bad headache), LETHARGY (Felt lethargic), ABDOMINAL DISCOMFORT (Couldn't keep any food down) and FATIGUE (Felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 01-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) (Intramuscular) 1. On 01-Apr-2021, the patient experienced DIZZINESS (Felt very dizzy - everything was spinning) and HEADACHE (Very bad headache). On an unknown date, the patient experienced LETHARGY (Felt lethargic), ABDOMINAL DISCOMFORT (Couldn't keep any food down), FATIGUE (Felt tired), MYALGIA (Felt achy), NAUSEA (Nauseous) and SOMNOLENCE (Felt tired - sleeping a lot). At the time of the report, DIZZINESS (Felt very dizzy - everything was spinning), HEADACHE (Very bad headache), LETHARGY (Felt lethargic), ABDOMINAL DISCOMFORT (Couldn't keep any food down), FATIGUE (Felt tired), MYALGIA (Felt achy), NAUSEA (Nauseous) and SOMNOLENCE (Felt tired - sleeping a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Somnolence
Clinical narrative: Felt lethargic; Couldn't keep any food down; Felt tired; Felt achy; Nauseous; Felt tired - sleeping a lot; Felt very dizzy - everything was spinning; Very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt very dizzy - everything was spinning), HEADACHE (Very bad headache), LETHARGY (Felt lethargic), ABDOMINAL DISCOMFORT (Couldn't keep any food down) and FATIGUE (Felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 01-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) (Intramuscular) 1. On 01-Apr-2021, the patient experienced DIZZINESS (Felt very dizzy - everything was spinning) and HEADACHE (Very bad headache). On an unknown date, the patient experienced LETHARGY (Felt lethargic), ABDOMINAL DISCOMFORT (Couldn't keep any food down), FATIGUE (Felt tired), MYALGIA (Felt achy), NAUSEA (Nauseous) and SOMNOLENCE (Felt tired - sleeping a lot). At the time of the report, DIZZINESS (Felt very dizzy - everything was spinning), HEADACHE (Very bad headache), LETHARGY (Felt lethargic), ABDOMINAL DISCOMFORT (Couldn't keep any food down), FATIGUE (Felt tired), MYALGIA (Felt achy), NAUSEA (Nauseous) and SOMNOLENCE (Felt tired - sleeping a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: couldn't sleep; warm; swollen at the injection; Patient experiencing soreness; redness; feverish; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness) and VACCINATION SITE ERYTHEMA (redness) in a 42-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.     No Medical History information was reported.    On 06-Apr-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 INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness), VACCINATION SITE ERYTHEMA (redness), PYREXIA (feverish) and MYALGIA (muscle pain). At the time of the report, INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness), VACCINATION SITE ERYTHEMA (redness), PYREXIA (feverish) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: couldn't sleep; warm; swollen at the injection; Patient experiencing soreness; redness; feverish; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness) and VACCINATION SITE ERYTHEMA (redness) in a 42-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.     No Medical History information was reported.    On 06-Apr-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 INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness), VACCINATION SITE ERYTHEMA (redness), PYREXIA (feverish) and MYALGIA (muscle pain). At the time of the report, INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (warm), VACCINATION SITE SWELLING (swollen at the injection), VACCINATION SITE PAIN (Patient experiencing soreness), VACCINATION SITE ERYTHEMA (redness), PYREXIA (feverish) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Trigeminal neuralgia
Clinical narrative: Medical condition worsen; Trigeminal neuralgia; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Medical condition worsen) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Trigeminal neuralgia. Concomitant products included CARBAMAZEPINE for Trigeminal neuralgia.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1.    On 10-Apr-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 experienced CONDITION AGGRAVATED (Medical condition worsen) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia). At the time of the report, CONDITION AGGRAVATED (Medical condition worsen) and TRIGEMINAL NEURALGIA (Trigeminal neuralgia) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated reporter information. The outcome of the event changed from unknown to resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: Strong headache; 105.8 Fever; Fever; Body pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Strong headache), PYREXIA (Fever), MYALGIA (Body pain) and PYREXIA (105.8 Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, AMLODIPINE, LISINOPRIL and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body pain). On 19-Feb-2021, the patient experienced HEADACHE (Strong headache) and PYREXIA (105.8 Fever). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) ongoing since an unknown date at a dose of 1 dosage form; ANTIBIOTICS ongoing since an unknown date at a dose of 1 dosage form and PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HEADACHE (Strong headache), PYREXIA (Fever) and PYREXIA (105.8 Fever) outcome was unknown and MYALGIA (Body pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 105.8 (High) 105.8 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment medication was reported as some IV fluids.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Non-significant follow-up, document appended On 05-Aug-2021: The follow-up document was attached and had no new information.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose administered to a 17 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Pharmacist reported the patient was almost 18 years of age but not completely 18 years old yet.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-077679 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077679:Crosslinked (MOD21-076257)
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received shingles vaccine 7 day after getting the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received shingles vaccine 7 day after getting the Moderna Covid-19 vaccine) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received shingles vaccine 7 day after getting the Moderna Covid-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received shingles vaccine 7 day after getting the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Co-suspect product included non-company product Singles Vaccine for an unknown indication. No concomitant medications were reported No treatment drugs were reported
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pyrexia
Clinical narrative: injection site is sore; low-grade fever of 101 °F; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site is sore) and PYREXIA (low-grade fever of 101 °F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 15-Apr-2021, the patient experienced INJECTION SITE PAIN (injection site is sore) and PYREXIA (low-grade fever of 101 °F). At the time of the report, INJECTION SITE PAIN (injection site is sore) and PYREXIA (low-grade fever of 101 °F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 °f High.         Concomitant medication was not provided. Treatment medication reported included.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus, Pyrexia, Urticaria
Clinical narrative: fever; welts all over her body; itchy; a sore arm; a strong headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), URTICARIA (welts all over her body), PRURITUS (itchy), PAIN IN EXTREMITY (a sore arm) and HEADACHE (a strong headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 004M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, AMLODIPINE, LISINOPRIL and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), URTICARIA (welts all over her body), PRURITUS (itchy), PAIN IN EXTREMITY (a sore arm) and HEADACHE (a strong headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), URTICARIA (welts all over her body), PRURITUS (itchy), PAIN IN EXTREMITY (a sore arm) and HEADACHE (a strong headache) outcome was unknown. Not Provided          Treatment  information includes IV fluids, Benadryl pill and IV and antibiotics. Steroids (prednisone).  The action taken with the drug was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Non-significant follow document received on 09-JUN-2021 and does not contain any new infomation
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of Injection site pain (sore arm in the injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-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) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced Injection site pain (sore arm in the injection site). At the time of the report, Injection site pain (sore arm in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication included Ibuprofen
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Arthralgia, Burning sensation, Chills, Nasal congestion
Clinical narrative: leg pain which made difficult for her to move - leg was very heavy; pain in the shoulder and neck; pain in the shoulder and neck; rash in the shoulder and neck; rash burned when she put something on it; canker sores in her mouth and gums; body aches - like the flu; stuffy nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (rash burned when she put something on it), NASAL CONGESTION (stuffy nose), APHTHOUS ULCER (canker sores in her mouth and gums), PAIN (body aches - like the flu) and PAIN IN EXTREMITY (leg pain which made difficult for her to move - leg was very heavy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    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 NASAL CONGESTION (stuffy nose), PAIN (body aches - like the flu) and CHILLS (chills). On 27-Mar-2021, the patient experienced BURNING SENSATION (rash burned when she put something on it), APHTHOUS ULCER (canker sores in her mouth and gums), NECK PAIN (pain in the shoulder and neck), ARTHRALGIA (pain in the shoulder and neck) and RASH (rash in the shoulder and neck). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain which made difficult for her to move - leg was very heavy). On 21-Mar-2021, NASAL CONGESTION (stuffy nose) had resolved. On 24-Mar-2021, PAIN (body aches - like the flu) and CHILLS (chills) had resolved. At the time of the report, BURNING SENSATION (rash burned when she put something on it), APHTHOUS ULCER (canker sores in her mouth and gums), PAIN IN EXTREMITY (leg pain which made difficult for her to move - leg was very heavy), NECK PAIN (pain in the shoulder and neck), ARTHRALGIA (pain in the shoulder and neck) and RASH (rash in the shoulder and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: normal (normal) Ultrasound test came back clear.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medication was reported. Patient received Fluocinonide as treatment drug.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Rash, Ultrasound scan
Clinical narrative: leg pain which made difficult for her to move - leg was very heavy; pain in the shoulder and neck; pain in the shoulder and neck; rash in the shoulder and neck; rash burned when she put something on it; canker sores in her mouth and gums; body aches - like the flu; stuffy nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (rash burned when she put something on it), NASAL CONGESTION (stuffy nose), APHTHOUS ULCER (canker sores in her mouth and gums), PAIN (body aches - like the flu) and PAIN IN EXTREMITY (leg pain which made difficult for her to move - leg was very heavy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    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 NASAL CONGESTION (stuffy nose), PAIN (body aches - like the flu) and CHILLS (chills). On 27-Mar-2021, the patient experienced BURNING SENSATION (rash burned when she put something on it), APHTHOUS ULCER (canker sores in her mouth and gums), NECK PAIN (pain in the shoulder and neck), ARTHRALGIA (pain in the shoulder and neck) and RASH (rash in the shoulder and neck). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain which made difficult for her to move - leg was very heavy). On 21-Mar-2021, NASAL CONGESTION (stuffy nose) had resolved. On 24-Mar-2021, PAIN (body aches - like the flu) and CHILLS (chills) had resolved. At the time of the report, BURNING SENSATION (rash burned when she put something on it), APHTHOUS ULCER (canker sores in her mouth and gums), PAIN IN EXTREMITY (leg pain which made difficult for her to move - leg was very heavy), NECK PAIN (pain in the shoulder and neck), ARTHRALGIA (pain in the shoulder and neck) and RASH (rash in the shoulder and neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: normal (normal) Ultrasound test came back clear.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medication was reported. Patient received Fluocinonide as treatment drug.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Soreness in left arm; Injection site feels hot to touch; Developed a small lump at injection site (left arm); More soreness in left arm; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in left arm), VACCINATION SITE WARMTH (Injection site feels hot to touch), VACCINATION SITE MASS (Developed a small lump at injection site (left arm)), VACCINATION SITE PAIN (More soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in left arm), VACCINATION SITE WARMTH (Injection site feels hot to touch), VACCINATION SITE MASS (Developed a small lump at injection site (left arm)), VACCINATION SITE PAIN (More soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 06-Apr-2021, PAIN IN EXTREMITY (Soreness in left arm) had resolved. On 13-Apr-2021, VACCINATION SITE PAIN (More soreness in left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site feels hot to touch), VACCINATION SITE MASS (Developed a small lump at injection site (left arm)) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: injection site sore; low-grade fever of 101 °F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site sore) and PYREXIA (low-grade fever of 101 °F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-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) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (injection site sore) and PYREXIA (low-grade fever of 101 °F). At the time of the report, VACCINATION SITE PAIN (injection site sore) and PYREXIA (low-grade fever of 101 °F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: high (High) low-grade fever of 101 °F.         Concomitant medication not provided. Treatment medication included Ibuprofen    This case was linked to MOD-2021-077587 (E2B Linked Report).; Sender's Comments:  MOD-2021-077587:1st dose of vaccine
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: glands were swollen; glands was achy; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (glands were swollen) and AXILLARY PAIN (glands was achy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cellulitis of leg and Sleep disorder NOS. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder NOS, AMLODIPINE, METOPROLOL, APIXABAN (ELIQUIS), LORATADINE (CLARITIN [LORATADINE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and FUROSEMIDE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (glands were swollen) and AXILLARY PAIN (glands was achy). At the time of the report, LYMPHADENOPATHY (glands were swollen) and AXILLARY PAIN (glands was achy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Tylenol.   This case was linked to  INC.-MOD-2021-076653 (E2B Linked Report).; Sender's Comments:  , INC.-MOD-2021-076653:For second dose
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Intentional product use issue, SARS-CoV-2 test
Clinical narrative: Tested positive COVID 19 after 1st dose; Did not receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose) and COVID-19 (Tested positive COVID 19 after 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose). On 04-Mar-2021, the patient experienced COVID-19 (Tested positive COVID 19 after 1st dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose) had resolved and COVID-19 (Tested positive COVID 19 after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive for COVID -19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Products include Vaginal Steroid. Treatment received includes antibiotic medication and vitamins.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Immediate swelling at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE SWELLING (Immediate swelling at the injection site) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced INJECTION SITE SWELLING (Immediate swelling at the injection site). In April 2021, INJECTION SITE SWELLING (Immediate swelling at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that they did monitored the patient for 30min in the waiting area and it was subsided by then. No concomitant medication were given by the reporter. No treatment information were provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: low grade fever; Nausea; Fatigue; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-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 PYREXIA (low grade fever), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches). At the time of the report, PYREXIA (low grade fever), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided. No relevant concomitant medications were reported. No treatment information was provided
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Fatigue, Neck pain, SARS-CoV-2 test
Clinical narrative: PCR test result came back yesterday, 14APR2021, and it was positive for COVID; back pain; neck pain; slept a lot; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (PCR test result came back yesterday, 14APR2021, and it was positive for COVID), BACK PAIN (back pain), NECK PAIN (neck pain), SOMNOLENCE (slept a lot) and FATIGUE (tired) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and SPIRONOLACTONE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (neck pain), SOMNOLENCE (slept a lot) and FATIGUE (tired). On 14-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (PCR test result came back yesterday, 14APR2021, and it was positive for COVID). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (PCR test result came back yesterday, 14APR2021, and it was positive for COVID), BACK PAIN (back pain), NECK PAIN (neck pain), SOMNOLENCE (slept a lot) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, COVID-19: other Negative. On 14-Apr-2021, SARS-CoV-2 test: other (Positive) positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines include Dayquil, Nyquil   Patient's 2nd dose of the COVID-19 vaccine is scheduled on 17th of APRIL 2021
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Somnolence
Clinical narrative: PCR test result came back yesterday, 14APR2021, and it was positive for COVID; back pain; neck pain; slept a lot; tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (PCR test result came back yesterday, 14APR2021, and it was positive for COVID), BACK PAIN (back pain), NECK PAIN (neck pain), SOMNOLENCE (slept a lot) and FATIGUE (tired) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and SPIRONOLACTONE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (neck pain), SOMNOLENCE (slept a lot) and FATIGUE (tired). On 14-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (PCR test result came back yesterday, 14APR2021, and it was positive for COVID). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (PCR test result came back yesterday, 14APR2021, and it was positive for COVID), BACK PAIN (back pain), NECK PAIN (neck pain), SOMNOLENCE (slept a lot) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, COVID-19: other Negative. On 14-Apr-2021, SARS-CoV-2 test: other (Positive) positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines include Dayquil, Nyquil   Patient's 2nd dose of the COVID-19 vaccine is scheduled on 17th of APRIL 2021
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Vertigo
Clinical narrative: had severe vertigo that lasted for 5 or 6 days; legs and feet were numb; immediately after vaccination started feeling really tired for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (had severe vertigo that lasted for 5 or 6 days), HYPOAESTHESIA (legs and feet were numb) and FATIGUE (immediately after vaccination started feeling really tired for 2-3 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FATIGUE (immediately after vaccination started feeling really tired for 2-3 days). On an unknown date, the patient experienced VERTIGO (had severe vertigo that lasted for 5 or 6 days) and HYPOAESTHESIA (legs and feet were numb). At the time of the report, VERTIGO (had severe vertigo that lasted for 5 or 6 days), HYPOAESTHESIA (legs and feet were numb) and FATIGUE (immediately after vaccination started feeling really tired for 2-3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.  Follow-up received on 19 May 2021 included no new information.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 19-May-2021 contains non-significant information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vomiting
Clinical narrative: Low grade Fever (99.3); Tired; chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade Fever (99.3)), FATIGUE (Tired), CHILLS (chills) and VOMITING (Vomiting) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Low grade Fever (99.3)), FATIGUE (Tired), CHILLS (chills) and VOMITING (Vomiting). At the time of the report, PYREXIA (Low grade Fever (99.3)), FATIGUE (Tired), CHILLS (chills) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site arm was very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 VACCINATION SITE PAIN (Injection site arm was very sore). At the time of the report, VACCINATION SITE PAIN (Injection site arm was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077891 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077891:Crosslinked with Mom's case (MOD21-076526)
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration
Clinical narrative: isn't going to receive the second dose in the series due to the dizziness; dizziness happens a lot a night while trying to sleep/dizziness is off and on/if she bends forward, she feels dizzy/dizziness happens a lot a night while trying to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (isn't going to receive the second dose in the series due to the dizziness) and DIZZINESS (dizziness happens a lot a night while trying to sleep/dizziness is off and on/if she bends forward, she feels dizzy/dizziness happens a lot a night while trying to sleep) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism, Hypertension and Stomach discomfort. Concomitant products included LEVOTHYROXINE, LOSARTAN, AMLODIPINE, METOPROLOL, OMEPRAZOLE, PRAVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (isn't going to receive the second dose in the series due to the dizziness) and DIZZINESS (dizziness happens a lot a night while trying to sleep/dizziness is off and on/if she bends forward, she feels dizzy/dizziness happens a lot a night while trying to sleep). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (isn't going to receive the second dose in the series due to the dizziness) and DIZZINESS (dizziness happens a lot a night while trying to sleep/dizziness is off and on/if she bends forward, she feels dizzy/dizziness happens a lot a night while trying to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: No new information was provided
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Intervertebral disc protrusion, Pyrexia
Clinical narrative: lower back pain/ back pain still present; herniated disks; chills; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), BACK PAIN (lower back pain/ back pain still present) and INTERVERTEBRAL DISC PROTRUSION (herniated disks) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On an unknown date, the patient experienced BACK PAIN (lower back pain/ back pain still present) and INTERVERTEBRAL DISC PROTRUSION (herniated disks). On 03-Apr-2021, CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) had resolved. At the time of the report, BACK PAIN (lower back pain/ back pain still present) outcome was unknown and INTERVERTEBRAL DISC PROTRUSION (herniated disks) had not resolved. Not Provided          The patient has herniated disks but now they aren't responding to normal treatment, stretches, yoga and movement.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non Significant Follow up
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a female 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose greater than 42 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose greater than 42 days) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Hyperlipidemia, Purified protein derivative skin test, Eczema and COPD. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, LISINOPRIL for Hypertension.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose greater than 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose greater than 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant follow-up (Added patient Age, medical history and concomitant medications)
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pyrexia
Clinical narrative: dizzy; feverish; tired and feel drained; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), PYREXIA (feverish), FATIGUE (tired and feel drained) and CHILLS (chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001b21A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concomitant products included LISINOPRIL, COLECALCIFEROL, UBIDECARENONE (COQ10 + D3), ACETYLSALICYLIC ACID (BABY ASPIRIN) and IBUPROFEN 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizzy), PYREXIA (feverish), FATIGUE (tired and feel drained) and CHILLS (chills). At the time of the report, DIZZINESS (dizzy), PYREXIA (feverish), FATIGUE (tired and feel drained) and CHILLS (chills) was resolving. Not Provided          Patient said he took his regular medications before he left to get the shot. Patient has been taking since he got his shoulder surgery a year ago.