chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: it was hot; it was very itchy; rash at the injection site that was quite large about 3 to 5 inches; it was red; it was swollen; typical soreness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (it was hot), VACCINATION SITE PRURITUS (it was very itchy), MYALGIA (typical soreness), VACCINATION SITE RASH (rash at the injection site that was quite large about 3 to 5 inches) and VACCINATION SITE ERYTHEMA (it was red) in a 73-year-old female patient who received COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy. Concomitant products included ESTRADIOL for HRT.   On 08-Jan-2021, the patient received first dose of COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form at an unspecified frequency. On an unknown date, the patient received first dose of COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) (Intramuscular) 1 dosage form at an unspecified frequency. On 08-Jan-2021,  after starting COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE), the patient experienced MYALGIA (typical soreness). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (it was hot), VACCINATION SITE PRURITUS (it was very itchy), VACCINATION SITE RASH (rash at the injection site that was quite large about 3 to 5 inches), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (it was swollen). On 31-Jan-2021, VACCINATION SITE WARMTH (it was hot) had resolved. At the time of the report, VACCINATION SITE PRURITUS (it was very itchy), MYALGIA (typical soreness), VACCINATION SITE RASH (rash at the injection site that was quite large about 3 to 5 inches), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (it was swollen) outcome was unknown.            con meds: Progesterone, 1mg, oral route, HRT-indication Patient have medication allergy, Ibuprofen allergy, Augmentin allergy, but not allergic to other penicillin's.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received: Please confirm NNI
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: it was hot; it was very itchy; rash at the injection site that was quite large about 3 to 5 inches; it was red; it was swollen; typical soreness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (it was hot), VACCINATION SITE PRURITUS (it was very itchy), MYALGIA (typical soreness), VACCINATION SITE RASH (rash at the injection site that was quite large about 3 to 5 inches) and VACCINATION SITE ERYTHEMA (it was red) in a 73-year-old female patient who received COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy. Concomitant products included ESTRADIOL for HRT.   On 08-Jan-2021, the patient received first dose of COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form at an unspecified frequency. On an unknown date, the patient received first dose of COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE) (Intramuscular) 1 dosage form at an unspecified frequency. On 08-Jan-2021,  after starting COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE), the patient experienced MYALGIA (typical soreness). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (it was hot), VACCINATION SITE PRURITUS (it was very itchy), VACCINATION SITE RASH (rash at the injection site that was quite large about 3 to 5 inches), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (it was swollen). On 31-Jan-2021, VACCINATION SITE WARMTH (it was hot) had resolved. At the time of the report, VACCINATION SITE PRURITUS (it was very itchy), MYALGIA (typical soreness), VACCINATION SITE RASH (rash at the injection site that was quite large about 3 to 5 inches), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE SWELLING (it was swollen) outcome was unknown.            con meds: Progesterone, 1mg, oral route, HRT-indication Patient have medication allergy, Ibuprofen allergy, Augmentin allergy, but not allergic to other penicillin's.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received: Please confirm NNI
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Swollen lymph node on the left side that the vaccine was administered; Inflamed; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on the left side that the vaccine was administered), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE SWELLING (swelling at the injection site) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node on the left side that the vaccine was administered), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE SWELLING (swelling at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and LORATADINE (CLARITIN [LORATADINE]) at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the left side that the vaccine was administered) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown and VACCINATION SITE INFLAMMATION (Inflamed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  According to the patient, the swelling at the injection site was still about the same, but had gone down a bit, at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DIZZINESS (Lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]), GABAPENTIN, LEVOTHYROXINE SODIUM (LEVOXYL), FOLIC ACID and KCL for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Dizziness) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymph node pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: lymph nodes of the side of the injection site swollen; lymph nodes of the side of the injection site swollen painful; headache; chills; soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of the arm), HEADACHE (headache), CHILLS (chills), VACCINATION SITE SWELLING (lymph nodes of the side of the injection site swollen) and LYMPH NODE PAIN (lymph nodes of the side of the injection site swollen painful) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness of the arm). On 23-Jan-2021, the patient experienced HEADACHE (headache) and CHILLS (chills). On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (lymph nodes of the side of the injection site swollen) and LYMPH NODE PAIN (lymph nodes of the side of the injection site swollen painful). On 22-Jan-2021, VACCINATION SITE PAIN (soreness of the arm) had resolved. On 23-Jan-2021, HEADACHE (headache) and CHILLS (chills) had resolved. On 28-Jan-2021, VACCINATION SITE SWELLING (lymph nodes of the side of the injection site swollen) and LYMPH NODE PAIN (lymph nodes of the side of the injection site swollen painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Paraesthesia, Rash vesicular, Swelling face
Clinical narrative: her cheeks swollen; 1 circle on each of her cheeks; tingling sensation; numbness; redness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (her cheeks swollen), RASH VESICULAR (1 circle on each of her cheeks), PARAESTHESIA (tingling sensation), HYPOAESTHESIA (numbness) and ERYTHEMA (redness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SWELLING FACE (her cheeks swollen), RASH VESICULAR (1 circle on each of her cheeks), PARAESTHESIA (tingling sensation), HYPOAESTHESIA (numbness) and ERYTHEMA (redness). At the time of the report, SWELLING FACE (her cheeks swollen), RASH VESICULAR (1 circle on each of her cheeks), PARAESTHESIA (tingling sensation), HYPOAESTHESIA (numbness) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were provided as allergy medication No Treatment information provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN (Severe colon pain). On 03-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL PAIN (Severe colon pain) outcome was unknown. Not Provided          Patient's concomitant drugs included heart medications, thyroid medications and cholesterol medications.  No corrective treatment was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 62-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 recorded medical history).    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 22-Jan-2021, the patient experienced redness at the injection site that ended on 26-Jan-2021. On 29-Jan-2021, the patient reported that the injection site redness has came back.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Herpes zoster, Injection site erythema, Nervous system disorder, Pain in extremity
Clinical narrative: Vaccination site pain; TIGHT; injection site was red; itchy rash; red spot; shingles; eczema; psoriasis; itching; FEELS LIKE SHE IS LOSING HER MIND; sensitivity in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), HERPES ZOSTER (shingles) and ECZEMA (eczema) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Shingles.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sensitivity in her arm), HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching) and NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND). On 26-Jan-2021, the patient experienced RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red) was resolving and HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching), NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Added events
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Psoriasis, Rash macular, Rash pruritic, Vaccination site induration
Clinical narrative: Vaccination site pain; TIGHT; injection site was red; itchy rash; red spot; shingles; eczema; psoriasis; itching; FEELS LIKE SHE IS LOSING HER MIND; sensitivity in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), HERPES ZOSTER (shingles) and ECZEMA (eczema) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Shingles.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sensitivity in her arm), HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching) and NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND). On 26-Jan-2021, the patient experienced RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red) was resolving and HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching), NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Added events
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; TIGHT; injection site was red; itchy rash; red spot; shingles; eczema; psoriasis; itching; FEELS LIKE SHE IS LOSING HER MIND; sensitivity in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), HERPES ZOSTER (shingles) and ECZEMA (eczema) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Shingles.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sensitivity in her arm), HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching) and NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND). On 26-Jan-2021, the patient experienced RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN IN EXTREMITY (sensitivity in her arm), RASH PRURITIC (itchy rash), RASH MACULAR (red spot), VACCINATION SITE INDURATION (TIGHT) and INJECTION SITE ERYTHEMA (injection site was red) was resolving and HERPES ZOSTER (shingles), ECZEMA (eczema), PSORIASIS (psoriasis), PRURITUS (itching), NERVOUS SYSTEM DISORDER (FEELS LIKE SHE IS LOSING HER MIND) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Added events
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: got a very strong reaction; had fever of 101ºF; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got a very strong reaction), PYREXIA (had fever of 101ºF), CHILLS (chills) and MYALGIA (body aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got a very strong reaction), PYREXIA (had fever of 101ºF), CHILLS (chills) and MYALGIA (body aches). At the time of the report, VACCINATION COMPLICATION (got a very strong reaction), PYREXIA (had fever of 101ºF), CHILLS (chills) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101ºF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated events outcome.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: Lethargic; Transitory loss of taste; Nausea; Stomach cramping; Fatigue; Didn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramping), LETHARGY (Lethargic), AGEUSIA (Transitory loss of taste), FEELING ABNORMAL (Didn't feel good) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma and Allergy (The patient was taking dizol as allergy pill.). Concomitant products included ATENOLOL, AMLODIPINE, LATANOPROST, CALCIUM and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Didn't feel good) and FATIGUE (Fatigue). On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping). On 28-Jan-2021, the patient experienced LETHARGY (Lethargic), AGEUSIA (Transitory loss of taste) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 28-Jan-2021, ABDOMINAL PAIN UPPER (Stomach cramping) and AGEUSIA (Transitory loss of taste) had resolved. At the time of the report, LETHARGY (Lethargic) and NAUSEA (Nausea) had not resolved and FEELING ABNORMAL (Didn't feel good) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included eye drops for glaucoma (unspecified) and Dizol as allergy pill.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Non-significant follow-up information received (consumer denied follow-up as she is doing fine).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Lethargic; Transitory loss of taste; Nausea; Stomach cramping; Fatigue; Didn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramping), LETHARGY (Lethargic), AGEUSIA (Transitory loss of taste), FEELING ABNORMAL (Didn't feel good) and NAUSEA (Nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma and Allergy (The patient was taking dizol as allergy pill.). Concomitant products included ATENOLOL, AMLODIPINE, LATANOPROST, CALCIUM and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING ABNORMAL (Didn't feel good) and FATIGUE (Fatigue). On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping). On 28-Jan-2021, the patient experienced LETHARGY (Lethargic), AGEUSIA (Transitory loss of taste) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 28-Jan-2021, ABDOMINAL PAIN UPPER (Stomach cramping) and AGEUSIA (Transitory loss of taste) had resolved. At the time of the report, LETHARGY (Lethargic) and NAUSEA (Nausea) had not resolved and FEELING ABNORMAL (Didn't feel good) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included eye drops for glaucoma (unspecified) and Dizol as allergy pill.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Non-significant follow-up information received (consumer denied follow-up as she is doing fine).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Asthenia, Burning sensation
Clinical narrative: Fever; Pain in the stomach; Burning head; Weakness; Felt very hot; Discomfort in the stomach; Not feeling hungry; Very weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), ASTHENIA (Weakness) and FEELING HOT (Felt very hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), ASTHENIA (Weakness), FEELING HOT (Felt very hot), ABDOMINAL DISCOMFORT (Discomfort in the stomach), ABDOMINAL DISTENSION (Not feeling hungry) and ASTHENIA (Very weak). The patient was treated with PARACETAMOL (ADVIL 6 PLUS) at an unspecified dose and frequency. On 25-Jan-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), FEELING HOT (Felt very hot), ABDOMINAL DISCOMFORT (Discomfort in the stomach) and ABDOMINAL DISTENSION (Not feeling hungry) had resolved. At the time of the report, ASTHENIA (Weakness) and ASTHENIA (Very weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pyrexia
Clinical narrative: Fever; Pain in the stomach; Burning head; Weakness; Felt very hot; Discomfort in the stomach; Not feeling hungry; Very weak; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), ASTHENIA (Weakness) and FEELING HOT (Felt very hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), ASTHENIA (Weakness), FEELING HOT (Felt very hot), ABDOMINAL DISCOMFORT (Discomfort in the stomach), ABDOMINAL DISTENSION (Not feeling hungry) and ASTHENIA (Very weak). The patient was treated with PARACETAMOL (ADVIL 6 PLUS) at an unspecified dose and frequency. On 25-Jan-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (Pain in the stomach), BURNING SENSATION (Burning head), FEELING HOT (Felt very hot), ABDOMINAL DISCOMFORT (Discomfort in the stomach) and ABDOMINAL DISTENSION (Not feeling hungry) had resolved. At the time of the report, ASTHENIA (Weakness) and ASTHENIA (Very weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Rash, Skin irritation
Clinical narrative: Irritation; Itchy; Rash; Red rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Irritation), PRURITUS (Itchy), RASH (Rash) and INJECTION SITE ERYTHEMA (Red rash on left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041l20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Many cold medicines---Heart race or pass out. Immediate reaction), Drug allergy (Vicodin ----Nausea and throwing up. Needed to take anti nausea med), Drug allergy (Oxycodone---Nausea and throwing up. Needed to take anti nausea med) and Drug allergy (Anesthesia- Nausea and throwing up.  Needed to take anti nausea med). Concomitant products included IBUPROFEN and PARACETAMOL (TYLENOL) for Back pain, MULTIVITAMIN & MINERAL and VIT D [VITAMIN D NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Jan-2021, the patient experienced SKIN IRRITATION (Irritation), PRURITUS (Itchy), RASH (Rash) and INJECTION SITE ERYTHEMA (Red rash on left arm). The patient was treated with CORTISONE at an unspecified dose and frequency. On 16-Feb-2021, SKIN IRRITATION (Irritation), PRURITUS (Itchy), RASH (Rash) and INJECTION SITE ERYTHEMA (Red rash on left arm) had resolved.            .   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received on 23 JUNE 2021, vaccine hypersensitivity form was added(date of second dose and outcome of event was added).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site swelling
Clinical narrative: Bad headache; Nausea; Left arm swollen at the injection site; A spontaneous report was received from a consumer concerning a 51-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bad headache, nausea, left arm swollen at the injection site, symptoms increased besides the tylenol he took.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided.) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event(s) bad headache, nausea, left arm swollen at the injection site. On 28 Jan 2021, the patient experienced the event(s) symptoms increased besides the tylenol he took.  Treatment details included Tylenol since 27Jan2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), bad headache, nausea, left arm swollen at the injection site, symptoms increased besides the tylenol he took was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: phlegm in his throat; This spontaneous case was reported by an other and describes the occurrence of PRODUCTIVE COUGH (phlegm in his throat) 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 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (phlegm in his throat). At the time of the report, PRODUCTIVE COUGH (phlegm in his throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Changed the outcome to resolved as patient is fine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Erythema, Feeling hot, Pain
Clinical narrative: Entire arm became red; hot to the touch; Low grade fever; Aches; Fever; Chills; Whole arm turned black and blue; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Whole arm turned black and blue), PAIN (Aches), ERYTHEMA (Entire arm became red), FEELING HOT (hot to the touch) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CONTUSION (Whole arm turned black and blue). On 21-Jan-2021, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). On 28-Jan-2021, the patient experienced ERYTHEMA (Entire arm became red), FEELING HOT (hot to the touch) and PYREXIA (Low grade fever). On 21-Jan-2021, CONTUSION (Whole arm turned black and blue) outcome was unknown, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, ERYTHEMA (Entire arm became red) and FEELING HOT (hot to the touch) had not resolved and PYREXIA (Low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Entire arm became red; hot to the touch; Low grade fever; Aches; Fever; Chills; Whole arm turned black and blue; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Whole arm turned black and blue), PAIN (Aches), ERYTHEMA (Entire arm became red), FEELING HOT (hot to the touch) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CONTUSION (Whole arm turned black and blue). On 21-Jan-2021, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). On 28-Jan-2021, the patient experienced ERYTHEMA (Entire arm became red), FEELING HOT (hot to the touch) and PYREXIA (Low grade fever). On 21-Jan-2021, CONTUSION (Whole arm turned black and blue) outcome was unknown, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, ERYTHEMA (Entire arm became red) and FEELING HOT (hot to the touch) had not resolved and PYREXIA (Low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Diarrhoea, Hyperhidrosis, Miliaria
Clinical narrative: had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs; diarrhea; felt anxious; chills; sweating; body aches; felt like her body was prickly; A spontaneous report was received from a consumer concerning a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, sweating / hyperhidrosis, body aches /pain, felt like her body was prickly, had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs / rash, diarrhea, felt anxious/anxiety.  The patient's medical history include allergies, include mold, dust and dogs. Concomitant medications reported were  cetirizine hydrochloride, mometasone furoate, vitamins nos, fish oil, for drug use for unknown indication.  On 03 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 029L20A) (unknown route) in the left arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient experienced the event(s) chills, sweating, body aches, felt like her body was prickly. On 4 Feb 2021, the patient experienced the event(s) had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs, diarrhea, felt anxious.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable  The outcome of event(s), chills, sweating, body aches, felt like her body was prickly, had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs, diarrhea, felt anxious was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs; diarrhea; felt anxious; chills; sweating; body aches; felt like her body was prickly; A spontaneous report was received from a consumer concerning a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, sweating / hyperhidrosis, body aches /pain, felt like her body was prickly, had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs / rash, diarrhea, felt anxious/anxiety.  The patient's medical history include allergies, include mold, dust and dogs. Concomitant medications reported were  cetirizine hydrochloride, mometasone furoate, vitamins nos, fish oil, for drug use for unknown indication.  On 03 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 029L20A) (unknown route) in the left arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, the patient experienced the event(s) chills, sweating, body aches, felt like her body was prickly. On 4 Feb 2021, the patient experienced the event(s) had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs, diarrhea, felt anxious.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable  The outcome of event(s), chills, sweating, body aches, felt like her body was prickly, had a rash, started down the middle her chest, spread to left side of her stomach, spread a little bit on right arm, spread down all over her legs, diarrhea, felt anxious was unknown.
Age: 65.0
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 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (headache.). At the time of the report, HEADACHE (headache.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant product is not provided. Treatment is not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Redness; Small Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Small Rash) in a 66-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.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Small Rash). On 09-Jan-2021, VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Small Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       ICE used as treatment therapy.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Soreness; Chills; Tiredness; Temperature of 98 degress; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), CHILLS (Chills), FATIGUE (Tiredness) and PYREXIA (Temperature of 98 degress) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN (Soreness), CHILLS (Chills), FATIGUE (Tiredness) and PYREXIA (Temperature of 98 degress). At the time of the report, PAIN (Soreness), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown and PYREXIA (Temperature of 98 degress) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 98 (Inconclusive) 98 Degrees.         No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Hypersensitive reaction; Rash in her face and body; This spontaneous case was reported by a physician and describes the occurrence of HYPERSENSITIVITY (Hypersensitive reaction) and RASH (Rash in her face and body) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitive reaction) and RASH (Rash in her face and body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Hypersensitive reaction) and RASH (Rash in her face and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Palpitations
Clinical narrative: Felt warm; Felt like heart was going really fast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt warm) and PALPITATIONS (Felt like heart was going really fast) 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 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING HOT (Felt warm) and PALPITATIONS (Felt like heart was going really fast). At the time of the report, FEELING HOT (Felt warm) and PALPITATIONS (Felt like heart was going really fast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Middle insomnia
Clinical narrative: Did not sleep very well overnight; Achy; Headache; Nausea; Fatigue; Chills; Soreness at injection site; Flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIDDLE INSOMNIA (Did not sleep very well overnight), PAIN (Achy), HEADACHE (Headache) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 03-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) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Achy), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site). On 05-Feb-2021, the patient experienced MIDDLE INSOMNIA (Did not sleep very well overnight). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIDDLE INSOMNIA (Did not sleep very well overnight), PAIN (Achy), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at injection site) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product use was reported.  No treatment details were provided.