chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Loss of appetite; Dizzy in the morning; Fatigue; Headache; Muscle ache; Waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle ache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2017 and COVID-19 in January 2021. Concomitant products included APIXABAN (ELIQUIS), LETROZOLE, CARVEDILOL, ATORVASTATIN, FAMOTIDINE, VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Waves of nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Waves of nausea) outcome was unknown.            Treatment for the event, headache included extra strength paracetamol as needed. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-060702, US-MODERNATX, INC.-MOD-2021-035381 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060702:crosslinked US-MODERNATX, INC.-MOD-2021-035381:crosslinked
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ACETAMINOPHEN, ATORVASTATIN, RISPERIDONE and TRAZODONE for an unknown indication.    On 22-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 EXTRA DOSE ADMINISTERED (first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February). At the time of the report, EXTRA DOSE ADMINISTERED (first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February) outcome was unknown. 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.   Concomitant medications included Dicyclomine, Colace, Donepezil.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Fatigue, Herpes zoster, Hypersensitivity
Clinical narrative: allergy; axillary lump; shingles; tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (tired). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). At the time of the report, HYPERSENSITIVITY (allergy) and FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were provided.Treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090139 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Followup was received and reporter contact information was updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Nasal congestion, Swelling face
Clinical narrative: Left side swollen 1 hr after the first dose; Stuffy Nose; Sinus Numb; Lymph nodes swollen; This spontaneous case was reported by a physician assistant and describes the occurrence of SWELLING FACE (Left side swollen 1 hr after the first dose), NASAL CONGESTION (Stuffy Nose), HYPOAESTHESIA (Sinus Numb) and LYMPHADENOPATHY (Lymph nodes swollen) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Cancer (Patient mentioned she is 3 times Cancer Survivor.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced SWELLING FACE (Left side swollen 1 hr after the first dose), NASAL CONGESTION (Stuffy Nose), HYPOAESTHESIA (Sinus Numb) and LYMPHADENOPATHY (Lymph nodes swollen). At the time of the report, SWELLING FACE (Left side swollen 1 hr after the first dose), NASAL CONGESTION (Stuffy Nose), HYPOAESTHESIA (Sinus Numb) and LYMPHADENOPATHY (Lymph nodes swollen) was resolving.        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.   Treatment medications includes acetaminophen and diphenhydramine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site pain, Injection site reaction, Swelling
Clinical narrative: Delayed injection site reaction; Redness; Injection site pain; Swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), ERYTHEMA (Redness), SWELLING (Swelling) and INJECTION SITE REACTION (Delayed injection site reaction) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) 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) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Headache) and SWELLING (Swelling). On 17-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) and ERYTHEMA (Redness). On 24-Apr-2021, the patient experienced INJECTION SITE REACTION (Delayed injection site reaction). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Injection site pain), HEADACHE (Headache), ERYTHEMA (Redness), SWELLING (Swelling) and INJECTION SITE REACTION (Delayed injection site reaction) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling hot, Headache, Myalgia, Nausea
Clinical narrative: Weird like metal taste in her mouth; Felt a little itchy; Rash from head to toe which spread out as well in the private area; Body ache; Headache; Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x; Nausea; Neck pain; Swelling of the right arm which felt like she was hit by a baseball bat; Feels so hot like searing hot; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Weird like metal taste in her mouth), NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot) and PRURITUS (Felt a little itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Fruit allergy (Allergic to Kiwi), Fruit allergy (Allergic to Mango) and Iodine allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and TOPIRAMATE for Antidepressant therapy.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot), RASH (Rash from head to toe which spread out as well in the private area), MYALGIA (Body ache), HEADACHE (Headache), VOMITING (Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x) and NAUSEA (Nausea). On 25-Apr-2021, the patient experienced DYSGEUSIA (Weird like metal taste in her mouth) and PRURITUS (Felt a little itchy). The patient was treated with IBUPROFEN on 24-Apr-2021 at a dose of 1 dosage form; PARACETAMOL (TYLENOL) on 24-Apr-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 24-Apr-2021, NAUSEA (Nausea) had resolved. At the time of the report, DYSGEUSIA (Weird like metal taste in her mouth), NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot), PRURITUS (Felt a little itchy), RASH (Rash from head to toe which spread out as well in the private area), MYALGIA (Body ache), HEADACHE (Headache) and VOMITING (Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pruritus, Rash, Swelling, Vomiting
Clinical narrative: Weird like metal taste in her mouth; Felt a little itchy; Rash from head to toe which spread out as well in the private area; Body ache; Headache; Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x; Nausea; Neck pain; Swelling of the right arm which felt like she was hit by a baseball bat; Feels so hot like searing hot; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Weird like metal taste in her mouth), NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot) and PRURITUS (Felt a little itchy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Fruit allergy (Allergic to Kiwi), Fruit allergy (Allergic to Mango) and Iodine allergy. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and TOPIRAMATE for Antidepressant therapy.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot), RASH (Rash from head to toe which spread out as well in the private area), MYALGIA (Body ache), HEADACHE (Headache), VOMITING (Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x) and NAUSEA (Nausea). On 25-Apr-2021, the patient experienced DYSGEUSIA (Weird like metal taste in her mouth) and PRURITUS (Felt a little itchy). The patient was treated with IBUPROFEN on 24-Apr-2021 at a dose of 1 dosage form; PARACETAMOL (TYLENOL) on 24-Apr-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 24-Apr-2021, NAUSEA (Nausea) had resolved. At the time of the report, DYSGEUSIA (Weird like metal taste in her mouth), NECK PAIN (Neck pain), SWELLING (Swelling of the right arm which felt like she was hit by a baseball bat), FEELING HOT (Feels so hot like searing hot), PRURITUS (Felt a little itchy), RASH (Rash from head to toe which spread out as well in the private area), MYALGIA (Body ache), HEADACHE (Headache) and VOMITING (Vomiting profusely of previously ingested food (in her case just water and gatorade) for about 5-6x) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness left side of their face, neck, ear, and back of head; Tingling of face, neck, ear, and back of the head; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness left side of their face, neck, ear, and back of head) and PARAESTHESIA (Tingling of face, neck, ear, and back of the head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness left side of their face, neck, ear, and back of head) and PARAESTHESIA (Tingling of face, neck, ear, and back of the head). At the time of the report, HYPOAESTHESIA (Numbness left side of their face, neck, ear, and back of head) and PARAESTHESIA (Tingling of face, neck, ear, and back of the head) outcome was unknown. Not Provided          Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure medications  Treatment information included Steroids.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Achy body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Achy body) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Achy body) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Achy body) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant medication use was unknown Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-090536, MOD-2021-090511 (Patient Link).   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for covid after receiving her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid after receiving her 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 (Tested positive for covid after receiving her 1st dose). At the time of the report, COVID-19 (Tested positive for covid after receiving her 1st dose) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy
Clinical narrative: chills; Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and LYMPHADENOPATHY (Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included METFORMIN and LISINOPRIL for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced CHILLS (chills) and LYMPHADENOPATHY (Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node). The patient was treated with PARACETAMOL (TYLENOL) on 22-Apr-2021 at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and LYMPHADENOPATHY (Swelling the size of a tennis ball under his arm (the vaccine was received) at the lymph node) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-090572 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-090572:cross linked; husband case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Feeling abnormal
Clinical narrative: Started to had cough; Lot of body pain; Temperature 104°F; A lot of headache; Chills; Felt bad; Sore arm; Little headache; Arm tired or heavy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), COUGH (Started to had cough), MYALGIA (Lot of body pain) and HEADACHE (Little headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Little headache) and FATIGUE (Arm tired or heavy). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (Felt bad). On 21-Apr-2021, the patient experienced CHILLS (Chills). On 22-Apr-2021, the patient experienced COUGH (Started to had cough), MYALGIA (Lot of body pain), PYREXIA (Temperature 104°F) and HEADACHE (A lot of headache). The patient was treated with PARACETAMOL (TYLENOL) for Migraine and Headache, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), COUGH (Started to had cough), MYALGIA (Lot of body pain), HEADACHE (Little headache), FATIGUE (Arm tired or heavy), CHILLS (Chills), PYREXIA (Temperature 104°F) and HEADACHE (A lot of headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 104 (High) temperature 104°F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also include Tylenol for migraine.  Patient used wet towels for fever.   This case was linked to US-MODERNATX, INC.-MOD-2021-090600 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090600:Case for husband
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Started to had cough; Lot of body pain; Temperature 104°F; A lot of headache; Chills; Felt bad; Sore arm; Little headache; Arm tired or heavy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), COUGH (Started to had cough), MYALGIA (Lot of body pain) and HEADACHE (Little headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032BZLA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (Little headache) and FATIGUE (Arm tired or heavy). On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (Felt bad). On 21-Apr-2021, the patient experienced CHILLS (Chills). On 22-Apr-2021, the patient experienced COUGH (Started to had cough), MYALGIA (Lot of body pain), PYREXIA (Temperature 104°F) and HEADACHE (A lot of headache). The patient was treated with PARACETAMOL (TYLENOL) for Migraine and Headache, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), COUGH (Started to had cough), MYALGIA (Lot of body pain), HEADACHE (Little headache), FATIGUE (Arm tired or heavy), CHILLS (Chills), PYREXIA (Temperature 104°F) and HEADACHE (A lot of headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 104 (High) temperature 104°F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also include Tylenol for migraine.  Patient used wet towels for fever.   This case was linked to US-MODERNATX, INC.-MOD-2021-090600 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090600:Case for husband
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy Rash on neck, back and upper chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy Rash on neck, back and upper chest) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL, AMLODIPINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 29-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 RASH PRURITIC (Itchy Rash on neck, back and upper chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy Rash on neck, back and upper chest) outcome was unknown. 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.   Treatment medications provided by the reporter included  anti-itch ointment.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen spot at the injection site; red spot at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (swollen spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No patient medical history was provided.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swollen spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site). At the time of the report, VACCINATION SITE SWELLING (swollen spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator. No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-090662 (E2B Linked Report). This case was linked to MOD21-081731, MOD21-081735 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090662:Same reporter
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Influenza, Nausea, Peripheral swelling
Clinical narrative: flu-like thing; stomach cramps; diarrhea; swollen arm; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PERIPHERAL SWELLING (swollen arm) and PYREXIA (fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (sulfa). Concomitant products included COLLAGEN and VITAMIN B NOS for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever) and NAUSEA (nausea). On 25-Apr-2021, INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Patient had not taken anything to relieve reactions, patient said just wanted to sleep.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu-like thing; stomach cramps; diarrhea; swollen arm; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PERIPHERAL SWELLING (swollen arm) and PYREXIA (fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (sulfa). Concomitant products included COLLAGEN and VITAMIN B NOS for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever) and NAUSEA (nausea). On 25-Apr-2021, INFLUENZA (flu-like thing), ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Patient had not taken anything to relieve reactions, patient said just wanted to sleep.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Its hot to touch; Arm started itching; I developed a really big rash around the Vaccine area; Burns to touch; Spreading and going down and towards the inside of the arm. ,I still have the rash today; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Its hot to touch), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE RASH (I developed a really big rash around the Vaccine area), VACCINATION SITE PAIN (Burns to touch) and RASH (Spreading and going down and towards the inside of the arm. ,I still have the rash today) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Its hot to touch), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE RASH (I developed a really big rash around the Vaccine area), VACCINATION SITE PAIN (Burns to touch) and RASH (Spreading and going down and towards the inside of the arm. ,I still have the rash today). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Its hot to touch), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE RASH (I developed a really big rash around the Vaccine area), VACCINATION SITE PAIN (Burns to touch) and RASH (Spreading and going down and towards the inside of the arm. ,I still have the rash today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Pain in arm; achy body; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), MYALGIA (achy body) and HEADACHE (headache) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), MYALGIA (achy body) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm), MYALGIA (achy body) and HEADACHE (headache) outcome was unknown. Not Provided          The concomitant medications were not provided. The treatment provided is unknown.  Action taken with the outcome of event is not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090511, US-MODERNATX, INC.-MOD-2021-090536 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090536:cross linked case US-MODERNATX, INC.-MOD-2021-090511:cross linked case
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: Some people's arms hurt after receiving a dose; In bed sick like the flu; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some people's arms hurt after receiving a dose) and ILLNESS (In bed sick like the flu) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Some people's arms hurt after receiving a dose) and ILLNESS (In bed sick like the flu). At the time of the report, PAIN IN EXTREMITY (Some people's arms hurt after receiving a dose) and ILLNESS (In bed sick like the flu) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: burning; tingling; This spontaneous case was reported by a pharmacist and describes the occurrence of BURNING SENSATION (burning) and PARAESTHESIA (tingling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No patients medical history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning) and PARAESTHESIA (tingling). At the time of the report, BURNING SENSATION (burning) and PARAESTHESIA (tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications provided by the reporter.   This case was linked to MOD21-081833, US-MODERNATX, INC.-MOD-2021-090391, US-MODERNATX, INC.-MOD-2021-090401 (E2B Linked Report).; Sender's Comments:  MOD21-081833:crosslinked US-MODERNATX, INC.-MOD-2021-090401:Same reporter US-MODERNATX, INC.-MOD-2021-090391:Same reporter
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation normal, Premenstrual syndrome, Psoriasis
Clinical narrative: Psoriasis; Period; Premenstrual syndrome; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PSORIASIS (Psoriasis), PREMENSTRUAL SYNDROME (Premenstrual syndrome) and MENSTRUATION NORMAL (Period) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 20-Apr-2021, the patient experienced PREMENSTRUAL SYNDROME (Premenstrual syndrome). On an unknown date, the patient experienced PSORIASIS (Psoriasis) and MENSTRUATION NORMAL (Period). At the time of the report, PSORIASIS (Psoriasis), PREMENSTRUAL SYNDROME (Premenstrual syndrome) and MENSTRUATION NORMAL (Period) outcome was unknown. Unknown          No concomitant medication details were provided. No treatment medication details were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17yr old received Moderna vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine.) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine.). On 26-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17yr old received Moderna vaccine.) 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.   Concomitant medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Wrong technique in device usage process
Clinical narrative: Needle went into the fluid sack and made it painful; needle went into the fluid sack and made it painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle went into the fluid sack and made it painful) and PAIN (needle went into the fluid sack and made it painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-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 20-Apr-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle went into the fluid sack and made it painful) and PAIN (needle went into the fluid sack and made it painful). On 20-Apr-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Needle went into the fluid sack and made it painful) had resolved. At the time of the report, PAIN (needle went into the fluid sack and made it painful) outcome was unknown.            Concomitant medication was not reported. Treatment medication reported included steroids. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide causality assessment.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal tenderness, Feeling abnormal, Nausea, Somnolence
Clinical narrative: hard to figure out what to eat; stomach tenderness; nausea; slept a lot first couple of days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (hard to figure out what to eat), SOMNOLENCE (slept a lot first couple of days), ABDOMINAL TENDERNESS (stomach tenderness) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included TRAMADOL, TRAZODONE, OMEPRAZOLE, METHOCARBAMOL and DULOXETINE for an unknown indication.   On 16-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced SOMNOLENCE (slept a lot first couple of days). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (hard to figure out what to eat), ABDOMINAL TENDERNESS (stomach tenderness) and NAUSEA (nausea). On 18-Apr-2021, SOMNOLENCE (slept a lot first couple of days) had resolved. At the time of the report, FEELING ABNORMAL (hard to figure out what to eat), ABDOMINAL TENDERNESS (stomach tenderness) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment includes Bland deit.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (felt like she had a lump in throat) and VACCINATION SITE RASH (rash below injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SENSATION OF FOREIGN BODY (felt like she had a lump in throat) and VACCINATION SITE RASH (rash below injection site). At the time of the report, SENSATION OF FOREIGN BODY (felt like she had a lump in throat) and VACCINATION SITE RASH (rash below injection site) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.    This case was linked to MOD-2021-018467 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood pressure increased, Diarrhoea, Oropharyngeal pain, Pain
Clinical narrative: Throat hurts; blood pressure increased; general body ache; back pain; diarrhoea; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), DIARRHOEA (diarrhoea), PAIN IN EXTREMITY (pain in arm), OROPHARYNGEAL PAIN (Throat hurts) and BLOOD PRESSURE INCREASED (blood pressure increased) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (high blood pressure) and Hyperglycemia. Concomitant products included ATENOLOL for Hypertension, CLONAZEPAM for an unknown indication.    On 24-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 BACK PAIN (back pain), DIARRHOEA (diarrhoea) and PAIN IN EXTREMITY (pain in arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat hurts), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN (general body ache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain), DIARRHOEA (diarrhoea), PAIN IN EXTREMITY (pain in arm), OROPHARYNGEAL PAIN (Throat hurts), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN (general body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Throat hurts; blood pressure increased; general body ache; back pain; diarrhoea; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), DIARRHOEA (diarrhoea), PAIN IN EXTREMITY (pain in arm), OROPHARYNGEAL PAIN (Throat hurts) and BLOOD PRESSURE INCREASED (blood pressure increased) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (high blood pressure) and Hyperglycemia. Concomitant products included ATENOLOL for Hypertension, CLONAZEPAM for an unknown indication.    On 24-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 BACK PAIN (back pain), DIARRHOEA (diarrhoea) and PAIN IN EXTREMITY (pain in arm). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat hurts), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN (general body ache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain), DIARRHOEA (diarrhoea), PAIN IN EXTREMITY (pain in arm), OROPHARYNGEAL PAIN (Throat hurts), BLOOD PRESSURE INCREASED (blood pressure increased) and PAIN (general body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: slept the next day; headache; arm was sore; felt unwell/ felt like she had chemicals thru her whole body and felt unwell; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept the next day), MALAISE (felt unwell/ felt like she had chemicals thru her whole body and felt unwell), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (felt unwell/ felt like she had chemicals thru her whole body and felt unwell), CHILLS (chills), PYREXIA (fever) and MYALGIA (arm was sore). On 06-Apr-2021, the patient experienced SOMNOLENCE (slept the next day) and HEADACHE (headache). On 06-Apr-2021, SOMNOLENCE (slept the next day) and PYREXIA (fever) had resolved. On 07-Apr-2021, CHILLS (chills) had resolved. On 11-Apr-2021, MYALGIA (arm was sore) outcome was unknown. On 12-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, MALAISE (felt unwell/ felt like she had chemicals thru her whole body and felt unwell) 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   This case was linked to US-MODERNATX, INC.-MOD-2021-090255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090255: