chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Neck pain
Clinical narrative: Muscle pain; finger joints had Burning sensation/extreme joint pain in fingers and knees; Fingers so stiff can not bend them; Horrible back pain; Severe headache; legs felt weak and shaky; Injection site swollen; Injection site sore; Fatigue; feeling hot/knees were warm to touch; burning sensation; neck pain; super congestion; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ARTHRALGIA (finger joints had Burning sensation/extreme joint pain in fingers and knees), MUSCULOSKELETAL STIFFNESS (Fingers so stiff can not bend them), BACK PAIN (Horrible back pain) and HEADACHE (Severe headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension, ASCORBIC ACID (VIT C), COLECALCIFEROL (VIT D3), ZINC, IRON, B-COMPLEX [CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE] and MULTI VIT for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (finger joints had Burning sensation/extreme joint pain in fingers and knees), MUSCULOSKELETAL STIFFNESS (Fingers so stiff can not bend them), BACK PAIN (Horrible back pain), HEADACHE (Severe headache), MUSCULAR WEAKNESS (legs felt weak and shaky), INJECTION SITE SWELLING (Injection site swollen), INJECTION SITE PAIN (Injection site sore), FATIGUE (Fatigue), FEELING HOT (feeling hot/knees were warm to touch), BURNING SENSATION (burning sensation), NECK PAIN (neck pain) and NASAL CONGESTION (super congestion). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. On 08-Feb-2021, MYALGIA (Muscle pain), BACK PAIN (Horrible back pain), HEADACHE (Severe headache), MUSCULAR WEAKNESS (legs felt weak and shaky), INJECTION SITE SWELLING (Injection site swollen), INJECTION SITE PAIN (Injection site sore), FATIGUE (Fatigue), FEELING HOT (feeling hot/knees were warm to touch), NECK PAIN (neck pain) and NASAL CONGESTION (super congestion) had resolved. On 15-Feb-2021, ARTHRALGIA (finger joints had Burning sensation/extreme joint pain in fingers and knees), MUSCULOSKELETAL STIFFNESS (Fingers so stiff can not bend them) and BURNING SENSATION (burning sensation) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: additional information included email, medical history, patient information, concomitant medications  and significant events.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: sore arm; hurt to move it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HYPOKINESIA (hurt to move it) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HYPOKINESIA (hurt to move it). At the time of the report, PAIN IN EXTREMITY (sore arm) and HYPOKINESIA (hurt to move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: No new information reported. No consent for further follow-up.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased activity, Fatigue, Feeling abnormal, Lethargy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ASTHENIA (Not feeling strong), FEELING ABNORMAL (Not feeling herself), DECREASED ACTIVITY (For 3-4 days not able to carry on normal activity) and FATIGUE (Fatigue) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Blood pressure). Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 LETHARGY (Lethargic), ASTHENIA (Not feeling strong), FEELING ABNORMAL (Not feeling herself), DECREASED ACTIVITY (For 3-4 days not able to carry on normal activity) and FATIGUE (Fatigue). At the time of the report, LETHARGY (Lethargic), ASTHENIA (Not feeling strong), FEELING ABNORMAL (Not feeling herself), DECREASED ACTIVITY (For 3-4 days not able to carry on normal activity) and FATIGUE (Fatigue) had not resolved. Not Provided          Treatment information was not provided.  Concomitant medication include pill for blood pressure
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased, Product dose omission issue, Spinal pain, Vaccination site pain
Clinical narrative: Has not received second dose; Vertigo; Could not get up; Sore spine; Dizziness/light headedness; Injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness/light headedness), MOBILITY DECREASED (Could not get up), SPINAL PAIN (Sore spine) and PRODUCT DOSE OMISSION ISSUE (Has not received second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness/light headedness) and VACCINATION SITE PAIN (Injection site is sore). On 14-Mar-2021, the patient experienced VERTIGO (Vertigo), MOBILITY DECREASED (Could not get up) and SPINAL PAIN (Sore spine). On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received second dose). On 05-May-2021, PRODUCT DOSE OMISSION ISSUE (Has not received second dose) had resolved. At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness/light headedness), MOBILITY DECREASED (Could not get up), SPINAL PAIN (Sore spine) and VACCINATION SITE PAIN (Injection site is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Significant follow up received on 5-May-2021.Updated reporter information, patient demographics. Added new event .The outcome of the events updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Has not received second dose; Vertigo; Could not get up; Sore spine; Dizziness/light headedness; Injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Dizziness/light headedness), MOBILITY DECREASED (Could not get up), SPINAL PAIN (Sore spine) and PRODUCT DOSE OMISSION ISSUE (Has not received second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness/light headedness) and VACCINATION SITE PAIN (Injection site is sore). On 14-Mar-2021, the patient experienced VERTIGO (Vertigo), MOBILITY DECREASED (Could not get up) and SPINAL PAIN (Sore spine). On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received second dose). On 05-May-2021, PRODUCT DOSE OMISSION ISSUE (Has not received second dose) had resolved. At the time of the report, VERTIGO (Vertigo), DIZZINESS (Dizziness/light headedness), MOBILITY DECREASED (Could not get up), SPINAL PAIN (Sore spine) and VACCINATION SITE PAIN (Injection site is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Significant follow up received on 5-May-2021.Updated reporter information, patient demographics. Added new event .The outcome of the events updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Pyrexia, Tongue discomfort, Tongue erythema
Clinical narrative: Pain across chest; Burning sensation on tongue; Red tongue; Cough; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain across chest), TONGUE DISCOMFORT (Burning sensation on tongue), TONGUE ERYTHEMA (Red tongue), COUGH (Cough) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHEST PAIN (Pain across chest), TONGUE DISCOMFORT (Burning sensation on tongue), TONGUE ERYTHEMA (Red tongue), COUGH (Cough) and PYREXIA (Fever). On 11-Mar-2021, CHEST PAIN (Pain across chest) had resolved. At the time of the report, TONGUE DISCOMFORT (Burning sensation on tongue), TONGUE ERYTHEMA (Red tongue), COUGH (Cough) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Peripheral swelling, Unevaluable event
Clinical narrative: swollen arm; chills; swollen arm that hurt; vaccine radiated to her neck; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (swollen arm that hurt), UNEVALUABLE EVENT (vaccine radiated to her neck) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (swollen arm that hurt) and UNEVALUABLE EVENT (vaccine radiated to her neck). On 03-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and CHILLS (chills). On 03-Feb-2021, PERIPHERAL SWELLING (swollen arm) and CHILLS (chills) had resolved. On 09-Feb-2021, PAIN IN EXTREMITY (swollen arm that hurt) had resolved. On 09-Mar-2021, UNEVALUABLE EVENT (vaccine radiated to her neck) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-058661 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Followup information was received and  contains no significant information
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to touch beneath injection site; Itchy beneath injection site; There was initial red mark was beneath injection site; Patient had a little red spot on left arm after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch beneath injection site), VACCINATION SITE PRURITUS (Itchy beneath injection site), VACCINATION SITE ERYTHEMA (There was initial red mark was beneath injection site) and VACCINATION SITE ERYTHEMA (Patient had a little red spot on left arm after receiving 1st dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included HYDROCORTISONE and DESMOPRESSIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Patient had a little red spot on left arm after receiving 1st dose). On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch beneath injection site), VACCINATION SITE PRURITUS (Itchy beneath injection site) and VACCINATION SITE ERYTHEMA (There was initial red mark was beneath injection site). The patient was treated with CORTISONE at an unspecified dose and frequency. On 09-Mar-2021, VACCINATION SITE ERYTHEMA (Patient had a little red spot on left arm after receiving 1st dose) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch beneath injection site), VACCINATION SITE PRURITUS (Itchy beneath injection site) and VACCINATION SITE ERYTHEMA (There was initial red mark was beneath injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Thyroid Medication. Treatment include ice pack and alcohol.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: Both upper and lower legs swollen; Had trouble bending his leg; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both upper and lower legs swollen) and LIMB DISCOMFORT (Had trouble bending his leg) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Both upper and lower legs swollen) and LIMB DISCOMFORT (Had trouble bending his leg). At the time of the report, PERIPHERAL SWELLING (Both upper and lower legs swollen) and LIMB DISCOMFORT (Had trouble bending his leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Pyrexia, Vaccination site pain
Clinical narrative: Diarrhea; Swelling - Near Injection site; Arm Pain - Near Injection Site; Chills; Fever - Temperature of 100.0F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 016M20A) 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 100.0 (High) Fever 100.0 F.         No concomitant medications were provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Diarrhea; Swelling - Near Injection site; Arm Pain - Near Injection Site; Chills; Fever - Temperature of 100.0F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 016M20A) 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling - Near Injection site), VACCINATION SITE PAIN (Arm Pain - Near Injection Site), CHILLS (Chills) and PYREXIA (Fever - Temperature of 100.0F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 100.0 (High) Fever 100.0 F.         No concomitant medications were provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Nausea; Dizzy; Flu-like symptoms; Slight fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slight fever), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slight fever) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slight fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DIZZINESS (dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RITUXIMAB, PREDNISONE, LISINOPRIL, CITALOPRAM and LORAZEPAM (ATIVAN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Mar-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypertension, Myalgia
Clinical narrative: feels like she is getting acupuncture; Blood pressure all over the place; Face tingling; Headaches; Muscle aches; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure all over the place), PARAESTHESIA (Face tingling), PAIN (feels like she is getting acupuncture), HEADACHE (Headaches) and MYALGIA (Muscle aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 04-Mar-2021, the patient experienced PARAESTHESIA (Face tingling), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (Tired). On 14-Mar-2021, the patient experienced HYPERTENSION (Blood pressure all over the place) and PAIN (feels like she is getting acupuncture). At the time of the report, HYPERTENSION (Blood pressure all over the place), PARAESTHESIA (Face tingling), PAIN (feels like she is getting acupuncture), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: contact details of the reporter was updated
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: feels like she is getting acupuncture; Blood pressure all over the place; Face tingling; Headaches; Muscle aches; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure all over the place), PARAESTHESIA (Face tingling), PAIN (feels like she is getting acupuncture), HEADACHE (Headaches) and MYALGIA (Muscle aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 04-Mar-2021, the patient experienced PARAESTHESIA (Face tingling), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (Tired). On 14-Mar-2021, the patient experienced HYPERTENSION (Blood pressure all over the place) and PAIN (feels like she is getting acupuncture). At the time of the report, HYPERTENSION (Blood pressure all over the place), PARAESTHESIA (Face tingling), PAIN (feels like she is getting acupuncture), HEADACHE (Headaches), MYALGIA (Muscle aches), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: contact details of the reporter was updated
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Palpitations
Clinical narrative: Heart raced; Allergic reaction; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart raced), HYPERSENSITIVITY (Allergic reaction) and HEADACHE (Bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PALPITATIONS (Heart raced), HYPERSENSITIVITY (Allergic reaction) and HEADACHE (Bad headache). At the time of the report, PALPITATIONS (Heart raced), HYPERSENSITIVITY (Allergic reaction) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
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 male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Report received on 21-05-2021 updated event onset .Event onset date added.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Sinusitis
Clinical narrative: you must wait 10 days after taking antibiotics to receive the vaccine; Sinus infection (March 3rd , 2021) after receiving the 1st dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUSITIS (Sinus infection (March 3rd , 2021) after receiving the 1st dose of Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (you must wait 10 days after taking antibiotics to receive the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-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 SINUSITIS (Sinus infection (March 3rd , 2021) after receiving the 1st dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (you must wait 10 days after taking antibiotics to receive the vaccine). At the time of the report, SINUSITIS (Sinus infection (March 3rd , 2021) after receiving the 1st dose of Moderna COVID-19 vaccine) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (you must wait 10 days after taking antibiotics to receive the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.  Treatment medication included antibiotics.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided. The patient refused further follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Influenza like illness, Nausea
Clinical narrative: Pain in the injection arm/soreness in the injection arm; Upset Stomach; "Felt like I had the Flu"; Joint Pain/Joint Ache; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the injection arm/soreness in the injection arm), ABDOMINAL DISCOMFORT (Upset Stomach), INFLUENZA LIKE ILLNESS ("Felt like I had the Flu"), ARTHRALGIA (Joint Pain/Joint Ache) and FATIGUE (Tiredness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus infection (Received treatment for sinus infection before getting the vaccine.). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FLUTICASONE PROPIONATE (FLOVENT), SALBUTAMOL, CITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the injection arm/soreness in the injection arm), ABDOMINAL DISCOMFORT (Upset Stomach), INFLUENZA LIKE ILLNESS ("Felt like I had the Flu"), ARTHRALGIA (Joint Pain/Joint Ache), FATIGUE (Tiredness) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the injection arm/soreness in the injection arm), ABDOMINAL DISCOMFORT (Upset Stomach), INFLUENZA LIKE ILLNESS ("Felt like I had the Flu"), ARTHRALGIA (Joint Pain/Joint Ache), FATIGUE (Tiredness) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the injection arm/soreness in the injection arm; Upset Stomach; "Felt like I had the Flu"; Joint Pain/Joint Ache; Tiredness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the injection arm/soreness in the injection arm), ABDOMINAL DISCOMFORT (Upset Stomach), INFLUENZA LIKE ILLNESS ("Felt like I had the Flu"), ARTHRALGIA (Joint Pain/Joint Ache) and FATIGUE (Tiredness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus infection (Received treatment for sinus infection before getting the vaccine.). Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FLUTICASONE PROPIONATE (FLOVENT), SALBUTAMOL, CITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the injection arm/soreness in the injection arm), ABDOMINAL DISCOMFORT (Upset Stomach), INFLUENZA LIKE ILLNESS ("Felt like I had the Flu"), ARTHRALGIA (Joint Pain/Joint Ache), FATIGUE (Tiredness) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the injection arm/soreness in the injection arm), ABDOMINAL DISCOMFORT (Upset Stomach), INFLUENZA LIKE ILLNESS ("Felt like I had the Flu"), ARTHRALGIA (Joint Pain/Joint Ache), FATIGUE (Tiredness) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Rash, Throat irritation
Clinical narrative: Throat irritation; Rash on several parts of her body; Extreme stomach Cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Extreme stomach Cramps), DIARRHOEA (Diarrhea), THROAT IRRITATION (Throat irritation) and RASH (Rash on several parts of her body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included SEMAGLUTIDE (RYBELSUS), METFORMIN and LEVOTHYROXINE for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Extreme stomach Cramps) and DIARRHOEA (Diarrhea). On 15-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation) and RASH (Rash on several parts of her body). At the time of the report, ABDOMINAL PAIN UPPER (Extreme stomach Cramps), DIARRHOEA (Diarrhea), THROAT IRRITATION (Throat irritation) and RASH (Rash on several parts of her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Musculoskeletal discomfort, Pain in extremity, Pruritus
Clinical narrative: Shoulder area is hot; Shoulder area is bumpy; Shoulder area is a little itchy; Shoulder area is pink the size of a grapefruit; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Shoulder area is hot), VACCINATION SITE MASS (Shoulder area is bumpy), PAIN IN EXTREMITY (Arm was sore), PRURITUS (Shoulder area is a little itchy) and ERYTHEMA (Shoulder area is pink the size of a grapefruit) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 15-Mar-2021, the patient experienced FEELING HOT (Shoulder area is hot), VACCINATION SITE MASS (Shoulder area is bumpy), PRURITUS (Shoulder area is a little itchy) and ERYTHEMA (Shoulder area is pink the size of a grapefruit). On 07-Mar-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, FEELING HOT (Shoulder area is hot), VACCINATION SITE MASS (Shoulder area is bumpy), PRURITUS (Shoulder area is a little itchy) and ERYTHEMA (Shoulder area is pink the size of a grapefruit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; Sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN (Sore to touch) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (multiple shoulder surgeries) since an unknown date. Concomitant products included ATORVASTATIN and LOSARTAN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (Sore to touch). On 14-Mar-2021, PAIN IN EXTREMITY (Sore arm) and PAIN (Sore to touch) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site warmth, Rash pruritic
Clinical narrative: Raised hives like rash; Extremely itchy rash; Injection site is itchy; Injection site redness (4inch diameter); Injection site is raised; Injection site has a rash; Injection site is warm to the touch; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)), RASH PRURITIC (Extremely itchy rash) and URTICARIA (Raised hives like rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy, Allergy to metals and Atrial fibrillation. Concomitant products included METOPROLOL for Atrial fibrillation, ROSUVASTATIN from 10-May-2020 to 06-Feb-2021 for Cholesterol, ACETYLSALICYLIC ACID (ASPRIN) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills). On 13-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)), VACCINATION SITE SWELLING (Injection site is raised) and VACCINATION SITE RASH (Injection site has a rash). On an unknown date, the patient experienced RASH PRURITIC (Extremely itchy rash) and URTICARIA (Raised hives like rash). On 28-Feb-2021, CHILLS (chills) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), RASH PRURITIC (Extremely itchy rash), URTICARIA (Raised hives like rash) and VACCINATION SITE RASH (Injection site has a rash) had not resolved and INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)) and VACCINATION SITE SWELLING (Injection site is raised) outcome was unknown.            No treatment medication details was reported. action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27 May 2021 included: Updated reporter address and email. On 28-Jul-2021: Event added itchy rash, age updated,events outcome changed.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site rash, Vaccination site swelling
Clinical narrative: Raised hives like rash; Extremely itchy rash; Injection site is itchy; Injection site redness (4inch diameter); Injection site is raised; Injection site has a rash; Injection site is warm to the touch; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)), RASH PRURITIC (Extremely itchy rash) and URTICARIA (Raised hives like rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019b21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy, Allergy to metals and Atrial fibrillation. Concomitant products included METOPROLOL for Atrial fibrillation, ROSUVASTATIN from 10-May-2020 to 06-Feb-2021 for Cholesterol, ACETYLSALICYLIC ACID (ASPRIN) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills). On 13-Mar-2021, the patient experienced INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)), VACCINATION SITE SWELLING (Injection site is raised) and VACCINATION SITE RASH (Injection site has a rash). On an unknown date, the patient experienced RASH PRURITIC (Extremely itchy rash) and URTICARIA (Raised hives like rash). On 28-Feb-2021, CHILLS (chills) had resolved. At the time of the report, INJECTION SITE WARMTH (Injection site is warm to the touch), INJECTION SITE PRURITUS (Injection site is itchy), RASH PRURITIC (Extremely itchy rash), URTICARIA (Raised hives like rash) and VACCINATION SITE RASH (Injection site has a rash) had not resolved and INJECTION SITE ERYTHEMA (Injection site redness (4inch diameter)) and VACCINATION SITE SWELLING (Injection site is raised) outcome was unknown.            No treatment medication details was reported. action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27 May 2021 included: Updated reporter address and email. On 28-Jul-2021: Event added itchy rash, age updated,events outcome changed.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash papular
Clinical narrative: Itchy arm; Red arm; Raised oval shape on arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy arm), ERYTHEMA (Red arm) and RASH PAPULAR (Raised oval shape on arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Mar-2021, the patient experienced PRURITUS (Itchy arm), ERYTHEMA (Red arm) and RASH PAPULAR (Raised oval shape on arm). On 26-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 07-Mar-2021, PRURITUS (Itchy arm), ERYTHEMA (Red arm) and RASH PAPULAR (Raised oval shape on arm) had resolved. Not Provided          No concomitant medication details was reported.  No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25 May 2021 included: Reporter's email updated, patient demographics updated, second dose details updated and changed action taken from unknown to no change On 25-May-2021: Follow-up received on 25 May 2021: contain no new information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had a sore arm at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (Had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (Had a sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-May-2021: contains non-significant information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity
Clinical narrative: Back pain; Sore arm; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer and Surgery since an unknown date. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced BACK PAIN (Back pain), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain), PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  also applied ice to help with the symptoms.