chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Illness, Myalgia, Nausea
Clinical narrative: got terribly sick; was feeling horrible; because of her compromised immune system she may have had a delayed reaction; Diarrhea; Loss of appetite; Headache; Nausea; Fatigue; Body aches; 103 fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS ("has a bunch of autoimmune disease since before the vaccination").   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills). On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown and ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible), HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that the patient's doctor advised her to get tested in case she picked up Covid or the flu. She was subsequently tested and both were negative.  The patient reported that her reactions ("terribly sick", 103 fever, chills, body aches, "feeling horrible" and "may have had a delayed reaction") lasted for 4-5 days and then stopped and she no longer has symptoms.   This case was linked to MOD-2021-035549, MOD-2021-035549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received: Additional events were added ("got terribly sick", "feeling horrible" and "may have had a delayed reaction"); outcome for fever, chills and body aches updated; reporter details updated; narrative updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: got terribly sick; was feeling horrible; because of her compromised immune system she may have had a delayed reaction; Diarrhea; Loss of appetite; Headache; Nausea; Fatigue; Body aches; 103 fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS ("has a bunch of autoimmune disease since before the vaccination").   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills). On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible) and HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown and ILLNESS (got terribly sick), FEELING ABNORMAL (was feeling horrible), HYPERSENSITIVITY (because of her compromised immune system she may have had a delayed reaction), MYALGIA (Body aches), PYREXIA (103 fever) and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that the patient's doctor advised her to get tested in case she picked up Covid or the flu. She was subsequently tested and both were negative.  The patient reported that her reactions ("terribly sick", 103 fever, chills, body aches, "feeling horrible" and "may have had a delayed reaction") lasted for 4-5 days and then stopped and she no longer has symptoms.   This case was linked to MOD-2021-035549, MOD-2021-035549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received: Additional events were added ("got terribly sick", "feeling horrible" and "may have had a delayed reaction"); outcome for fever, chills and body aches updated; reporter details updated; narrative updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: achy pain above right ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (achy pain above right ear) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027120A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced EAR PAIN (achy pain above right ear). At the time of the report, EAR PAIN (achy pain above right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2DA) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included NIFEDIPINE and METOPROLOL for Blood pressure management.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), GAIT INABILITY (could not stand up), PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 HYPERHIDROSIS (sweating), GAIT INABILITY (could not stand up), PYREXIA (fever) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweating), GAIT INABILITY (could not stand up), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Hypertension, Paraesthesia, Respiratory tract irritation, Throat irritation
Clinical narrative: prickly feeling was in her throat; dryness; felt like lungs were sticking together; prickly feeling on face; blood pressure was high 103/107; prickly feeling under eyelids; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (prickly feeling was in her throat), DRY THROAT (dryness), RESPIRATORY TRACT IRRITATION (felt like lungs were sticking together), PARAESTHESIA (prickly feeling on face) and HYPERTENSION (blood pressure was high 103/107) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced THROAT IRRITATION (prickly feeling was in her throat), DRY THROAT (dryness), RESPIRATORY TRACT IRRITATION (felt like lungs were sticking together), PARAESTHESIA (prickly feeling on face), HYPERTENSION (blood pressure was high 103/107) and PARAESTHESIA (prickly feeling under eyelids). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, THROAT IRRITATION (prickly feeling was in her throat), DRY THROAT (dryness), RESPIRATORY TRACT IRRITATION (felt like lungs were sticking together), PARAESTHESIA (prickly feeling on face), HYPERTENSION (blood pressure was high 103/107) and PARAESTHESIA (prickly feeling under eyelids) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Very Bad Chills; Fever; Fatigue; Nausea; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Very Bad Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027821A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 03-Mar-2021, the patient experienced CHILLS (Very Bad Chills), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Very Bad Chills), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pain in extremity
Clinical narrative: itching right where she got injected; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching right where she got injected) and PAIN IN EXTREMITY (arm is sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 04-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching right where she got injected). In March 2021, the patient experienced PAIN IN EXTREMITY (arm is sore). At the time of the report, INJECTION SITE PRURITUS (itching right where she got injected) and PAIN IN EXTREMITY (arm is sore) outcome was unknown.            Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site reaction, Pain in extremity, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), DIARRHOEA (upset stomach/ diarrhea), PALPITATIONS (heart palpitations) and TINNITUS (Tinnitus) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Blood pressure, ALENDRONATE SODIUM (FOSAMAX) for Bone injury, LATANOPROST for Glaucoma, LEVOTHYROXINE for Thyroid atrophy NOS.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (upset stomach/ diarrhea). On 02-Mar-2021, the patient experienced PALPITATIONS (heart palpitations), TINNITUS (Tinnitus) and INJECTION SITE REACTION (flash/current wave from injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form. On 28-Feb-2021, HEADACHE (headache), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (upset stomach/ diarrhea) had resolved. At the time of the report, PALPITATIONS (heart palpitations), TINNITUS (Tinnitus) and INJECTION SITE REACTION (flash/current wave from injection site) outcome was unknown.            Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (sore arm), DIARRHOEA (upset stomach/ diarrhea), PALPITATIONS (heart palpitations) and TINNITUS (Tinnitus) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Blood pressure, ALENDRONATE SODIUM (FOSAMAX) for Bone injury, LATANOPROST for Glaucoma, LEVOTHYROXINE for Thyroid atrophy NOS.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (upset stomach/ diarrhea). On 02-Mar-2021, the patient experienced PALPITATIONS (heart palpitations), TINNITUS (Tinnitus) and INJECTION SITE REACTION (flash/current wave from injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 1 dosage form. On 28-Feb-2021, HEADACHE (headache), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (upset stomach/ diarrhea) had resolved. At the time of the report, PALPITATIONS (heart palpitations), TINNITUS (Tinnitus) and INJECTION SITE REACTION (flash/current wave from injection site) outcome was unknown.            Reporter did not allow further contact
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My Son is 17 years got his 1st moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My Son is 17 years got his 1st moderna dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 03-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My Son is 17 years got his 1st moderna dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My Son is 17 years got his 1st moderna dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Reaction on Injection Site again with same symptoms; Itching Injection Site; Red Injection Site; Sore Injection Site; Swollen Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Sore Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE REACTION (Reaction on Injection Site again with same symptoms) and INJECTION SITE PRURITUS (Itching Injection Site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Sore Injection Site) and INJECTION SITE SWELLING (Swollen Injection Site). On 03-Mar-2021, the patient experienced INJECTION SITE REACTION (Reaction on Injection Site again with same symptoms) and INJECTION SITE PRURITUS (Itching Injection Site). At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PAIN (Sore Injection Site), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE REACTION (Reaction on Injection Site again with same symptoms) and INJECTION SITE PRURITUS (Itching Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle strain, Pain, Sensation of foreign body
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph that hurts when she takes a deep breath, cough, or laugh), PAIN (Sore), SENSATION OF FOREIGN BODY (Feels a small lump under the skin) and MUSCLE STRAIN (Feels like a muscle strain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph that hurts when she takes a deep breath, cough, or laugh), PAIN (Sore), SENSATION OF FOREIGN BODY (Feels a small lump under the skin) and MUSCLE STRAIN (Feels like a muscle strain). At the time of the report, LYMPHADENOPATHY (Swollen lymph that hurts when she takes a deep breath, cough, or laugh), PAIN (Sore), SENSATION OF FOREIGN BODY (Feels a small lump under the skin) and MUSCLE STRAIN (Feels like a muscle strain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. In March 2021, HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hypoaesthesia, Injection site rash, Limb discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck) and LIMB DISCOMFORT (heavy on her feet) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache). On 12-Feb-2021, the patient experienced INJECTION SITE RASH (Rash in form of blotches around the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck), LIMB DISCOMFORT (heavy on her feet), LIMB DISCOMFORT (wobbly) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck), LIMB DISCOMFORT (heavy on her feet), LIMB DISCOMFORT (wobbly), ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE RASH (Rash in form of blotches around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Antibiotics were used on 15-Feb-2021 for the rash.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck) and LIMB DISCOMFORT (heavy on her feet) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (headache). On 12-Feb-2021, the patient experienced INJECTION SITE RASH (Rash in form of blotches around the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck), LIMB DISCOMFORT (heavy on her feet), LIMB DISCOMFORT (wobbly) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (soreness on arm), PERIPHERAL SWELLING (swelling on arm), HYPOAESTHESIA (numbness all over her body), MUSCULOSKELETAL DISCOMFORT (heaviness on the back of her neck), LIMB DISCOMFORT (heavy on her feet), LIMB DISCOMFORT (wobbly), ASTHENIA (weakness), HEADACHE (headache) and INJECTION SITE RASH (Rash in form of blotches around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Antibiotics were used on 15-Feb-2021 for the rash.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pruritus
Clinical narrative: Itchy arm; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy arm), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, the patient experienced PRURITUS (Itchy arm) and FATIGUE (Fatigue). On 28-Feb-2021, NAUSEA (Nausea) had resolved. At the time of the report, PRURITUS (Itchy arm) and FATIGUE (Fatigue) outcome was unknown.            The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.  No treatment medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Injection site erythema, Injection site pain
Clinical narrative: Flu; redness in the right arm; pain in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness in the right arm), INJECTION SITE PAIN (pain in the right arm) and INFLUENZA (Flu) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness in the right arm) and INJECTION SITE PAIN (pain in the right arm). On an unknown date, the patient experienced INFLUENZA (Flu). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, INJECTION SITE ERYTHEMA (redness in the right arm), INJECTION SITE PAIN (pain in the right arm) and INFLUENZA (Flu) had resolved.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-MAY-2021 outcome updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: large red swollen area in the injection site; large red swollen area; itched; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (large red swollen area in the injection site), INJECTION SITE SWELLING (large red swollen area) and INJECTION SITE PRURITUS (itched) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ANASTROZOLE (ARIMIDEX) for Breast cancer.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (large red swollen area in the injection site), INJECTION SITE SWELLING (large red swollen area) and INJECTION SITE PRURITUS (itched). At the time of the report, INJECTION SITE ERYTHEMA (large red swollen area in the injection site), INJECTION SITE SWELLING (large red swollen area) and INJECTION SITE PRURITUS (itched) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.         No treatment medication was reported.   Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Micturition disorder, Nausea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MICTURITION DISORDER (About to pass out), PAIN IN EXTREMITY (Soreness in her arm), NAUSEA (Nauseous), FATIGUE (Feeling tired) and HEADACHE (headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm), NAUSEA (Nauseous), FATIGUE (Feeling tired) and HEADACHE (headache). On 02-Mar-2021, the patient experienced MICTURITION DISORDER (About to pass out). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. On 03-Mar-2021, NAUSEA (Nauseous) had resolved. At the time of the report, MICTURITION DISORDER (About to pass out), PAIN IN EXTREMITY (Soreness in her arm), FATIGUE (Feeling tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE PAIN (soreness at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE PAIN (soreness at injection site). At the time of the report, INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE PAIN (soreness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruised left arm injection site since day of vaccination, starting to fade) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruised left arm injection site since day of vaccination, starting to fade). At the time of the report, VACCINATION SITE BRUISING (bruised left arm injection site since day of vaccination, starting to fade) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: high temperature; headaches; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (high temperature) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cancer. Concomitant products included METFORMIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (headaches), NAUSEA (nausea) and FATIGUE (fatigue). On 03-Mar-2021, the patient experienced PYREXIA (high temperature). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 04-Mar-2021, PYREXIA (high temperature) had resolved. On 05-Mar-2021, HEADACHE (headaches), NAUSEA (nausea) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes blood pressure medication,diabetes medication, metformin.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TENDERNESS (Tenderness at injection site). On 05-Mar-2021, TENDERNESS (Tenderness at injection site) had resolved.            It was reported that patient taking Immunosuppressant medicine as concomitant medication.  No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-Up was received on 02-JUL-2021 and contain Non-Significant information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: 5 inch round red circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (5 inch round red circle around injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (5 inch round red circle around injection site). At the time of the report, INJECTION SITE ERYTHEMA (5 inch round red circle around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Doctor prescribed antibiotics to counteract reaction.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Fatigue, Feeling abnormal, Pain in extremity, Vaccination site nodule
Clinical narrative: legs ache; lumpy area on injection site; dry skin round the area; feels there is a hole; extreme fattigue; rediculously exhausted; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (legs ache), VACCINATION SITE NODULE (lumpy area on injection site), DRY SKIN (dry skin round the area), FEELING ABNORMAL (feels there is a hole) and FATIGUE (extreme fattigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (legs ache), VACCINATION SITE NODULE (lumpy area on injection site), DRY SKIN (dry skin round the area), FEELING ABNORMAL (feels there is a hole), FATIGUE (extreme fattigue) and FATIGUE (rediculously exhausted). At the time of the report, PAIN IN EXTREMITY (legs ache), VACCINATION SITE NODULE (lumpy area on injection site), DRY SKIN (dry skin round the area), FEELING ABNORMAL (feels there is a hole), FATIGUE (extreme fattigue) and FATIGUE (rediculously exhausted) had not 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.   No relevant concomitant medications were provided. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Hair loss; Hives; Fever; Chills; Headache; Muscle ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of (Hair loss), (Hives), (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 21-Feb-2021, the patient experienced  (Hair loss),  (Hives), (Fever), CHILLS (Chills), HEADACHE (Headache) and  (Muscle ache). The patient was treated with CORTICOSTEROID NOS at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, ALOPECIA (Hair loss),  (Hives),  (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hair loss; Hives; Fever; Chills; Headache; Muscle ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of (Hair loss), (Hives), (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 21-Feb-2021, the patient experienced  (Hair loss),  (Hives), (Fever), CHILLS (Chills), HEADACHE (Headache) and  (Muscle ache). The patient was treated with CORTICOSTEROID NOS at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, ALOPECIA (Hair loss),  (Hives),  (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Nausea, Neck pain
Clinical narrative: really bad headache down to jaw and neck; really bad headache down to jaw and neck; chest feels uncomfortable; really bad headache down to jaw and neck; chills; nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (really bad headache down to jaw and neck), NECK PAIN (really bad headache down to jaw and neck), CHEST DISCOMFORT (chest feels uncomfortable), HEADACHE (really bad headache down to jaw and neck) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025A21A) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (really bad headache down to jaw and neck), NECK PAIN (really bad headache down to jaw and neck), CHEST DISCOMFORT (chest feels uncomfortable), HEADACHE (really bad headache down to jaw and neck), CHILLS (chills) and NAUSEA (nauseous). At the time of the report, PAIN IN JAW (really bad headache down to jaw and neck), NECK PAIN (really bad headache down to jaw and neck), CHEST DISCOMFORT (chest feels uncomfortable), HEADACHE (really bad headache down to jaw and neck), CHILLS (chills) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: really bad headache down to jaw and neck; really bad headache down to jaw and neck; chest feels uncomfortable; really bad headache down to jaw and neck; chills; nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (really bad headache down to jaw and neck), NECK PAIN (really bad headache down to jaw and neck), CHEST DISCOMFORT (chest feels uncomfortable), HEADACHE (really bad headache down to jaw and neck) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025A21A) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (really bad headache down to jaw and neck), NECK PAIN (really bad headache down to jaw and neck), CHEST DISCOMFORT (chest feels uncomfortable), HEADACHE (really bad headache down to jaw and neck), CHILLS (chills) and NAUSEA (nauseous). At the time of the report, PAIN IN JAW (really bad headache down to jaw and neck), NECK PAIN (really bad headache down to jaw and neck), CHEST DISCOMFORT (chest feels uncomfortable), HEADACHE (really bad headache down to jaw and neck), CHILLS (chills) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: arm was sore; temperature of 99.6F/temperature was 101.5F/temperature was 100.6F; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PYREXIA (temperature of 99.6F/temperature was 101.5F/temperature was 100.6F) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A12A and 012M20A) for COVID-19 vaccination.     No medical history was reported by the reported.  Concomitant products included LEVOTHYROXINE, LOSARTAN, GEMFIBROZIL, ESTROGENS CONJUGATED (PREMARIN), FLECAINIDE, DILTIAZEM, ZOLPIDEM, CYCLOBENZAPRINE and LUBIPROSTONE (AMITIZA) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), PYREXIA (temperature of 99.6F/temperature was 101.5F/temperature was 100.6F) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), PYREXIA (temperature of 99.6F/temperature was 101.5F/temperature was 100.6F) and FATIGUE (tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (Inconclusive) woke up with temperature of 99.6F, 101.5 (Inconclusive) during day she states that her temperature was 101.5F and 100.6 (Inconclusive) during night her temperature was 100.6F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.