chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Joint stiffness, Mass, Swelling face
Clinical narrative: Swelling on one side of the jaw; Hardness on one side of the jaw; Warmth on one side of jaw; Redness with no swelling on the other jaw; huge mass on her chin noticed about a month ago; mass is warm to touch,one area on left jawline,4 raised areas on right jawline, one area on each upper cheekbone; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling on one side of the jaw), JOINT STIFFNESS (Hardness on one side of the jaw), FEELING HOT (Warmth on one side of jaw), ERYTHEMA (Redness with no swelling on the other jaw) and MASS (huge mass on her chin noticed about a month ago) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, INSULIN LISPRO (HUMALOG), INSULIN ASPART (NOVOLOG), DILTIAZEM HYDROCHLORIDE (CARTIA XT) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling on one side of the jaw), JOINT STIFFNESS (Hardness on one side of the jaw), FEELING HOT (Warmth on one side of jaw), ERYTHEMA (Redness with no swelling on the other jaw), MASS (huge mass on her chin noticed about a month ago) and FEELING HOT (mass is warm to touch,one area on left jawline,4 raised areas on right jawline, one area on each upper cheekbone). At the time of the report, SWELLING FACE (Swelling on one side of the jaw), JOINT STIFFNESS (Hardness on one side of the jaw), FEELING HOT (Warmth on one side of jaw), ERYTHEMA (Redness with no swelling on the other jaw), MASS (huge mass on her chin noticed about a month ago) and FEELING HOT (mass is warm to touch,one area on left jawline,4 raised areas on right jawline, one area on each upper cheekbone) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medicine :Zyrtec, Doxycycline , steroid injection   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: New AE added in Follow-up
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Poor quality sleep
Clinical narrative: she woke up every hour all night long; she couldn't lay on her arm; muscle pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (she woke up every hour all night long), LIMB DISCOMFORT (she couldn't lay on her arm) and MYALGIA (muscle pain in her arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced POOR QUALITY SLEEP (she woke up every hour all night long), LIMB DISCOMFORT (she couldn't lay on her arm) and MYALGIA (muscle pain in her arm). At the time of the report, POOR QUALITY SLEEP (she woke up every hour all night long), LIMB DISCOMFORT (she couldn't lay on her arm) and MYALGIA (muscle pain in her arm) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Diarrhea; feeling very weak; chills; fever; whole body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever) and MYALGIA (whole body aches) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever), MYALGIA (whole body aches) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever), MYALGIA (whole body aches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea; feeling very weak; chills; fever; whole body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever) and MYALGIA (whole body aches) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever), MYALGIA (whole body aches) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ASTHENIA (feeling very weak), CHILLS (chills), PYREXIA (fever), MYALGIA (whole body aches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Epistaxis, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: bleeding nose; Fever; Low energy; Vomiting; diareah; a runny nose this morning from my left nostril; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diareah), EPISTAXIS (bleeding nose), RHINORRHOEA (a runny nose this morning from my left nostril), PYREXIA (Fever) and FATIGUE (Low energy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Drug allergy (Percodan), Vegetable allergy (Tomatoes) and Fruit allergy (Strawberries). Concomitant products included PARACETAMOL (TYLENOL), ALPRAZOLAM, LAMOTRIGINE, METOPROLOL SUCCINATE (TOPROL XL), PREDNISONE, SIMVASTATIN, TRAMADOL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ZOLPIDEM TARTRATE (AMBIEN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced RHINORRHOEA (a runny nose this morning from my left nostril). On 24-May-2021, the patient experienced DIARRHOEA (diareah), PYREXIA (Fever), FATIGUE (Low energy) and VOMITING (Vomiting). On an unknown date, the patient experienced EPISTAXIS (bleeding nose). At the time of the report, DIARRHOEA (diareah), PYREXIA (Fever), FATIGUE (Low energy) and VOMITING (Vomiting) had not resolved, EPISTAXIS (bleeding nose) outcome was unknown and RHINORRHOEA (a runny nose this morning from my left nostril) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    In treatment details patient reported that she tilted her head up and used ice in order to stop the bleeding nose. She reported that she has not took any medications to help with the symptoms.   This case was linked to MOD-2021-223818 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Added medical history, allergies, facility information and events. Updated patient demographics.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: bleeding nose; Fever; Low energy; Vomiting; diareah; a runny nose this morning from my left nostril; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diareah), EPISTAXIS (bleeding nose), RHINORRHOEA (a runny nose this morning from my left nostril), PYREXIA (Fever) and FATIGUE (Low energy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Drug allergy (Percodan), Vegetable allergy (Tomatoes) and Fruit allergy (Strawberries). Concomitant products included PARACETAMOL (TYLENOL), ALPRAZOLAM, LAMOTRIGINE, METOPROLOL SUCCINATE (TOPROL XL), PREDNISONE, SIMVASTATIN, TRAMADOL, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ZOLPIDEM TARTRATE (AMBIEN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced RHINORRHOEA (a runny nose this morning from my left nostril). On 24-May-2021, the patient experienced DIARRHOEA (diareah), PYREXIA (Fever), FATIGUE (Low energy) and VOMITING (Vomiting). On an unknown date, the patient experienced EPISTAXIS (bleeding nose). At the time of the report, DIARRHOEA (diareah), PYREXIA (Fever), FATIGUE (Low energy) and VOMITING (Vomiting) had not resolved, EPISTAXIS (bleeding nose) outcome was unknown and RHINORRHOEA (a runny nose this morning from my left nostril) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    In treatment details patient reported that she tilted her head up and used ice in order to stop the bleeding nose. She reported that she has not took any medications to help with the symptoms.   This case was linked to MOD-2021-223818 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Added medical history, allergies, facility information and events. Updated patient demographics.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) 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 an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided   No concomitant and treatment details were provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-089519 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: muscle pain; chills; nausea; feeling all of the adverse events; fatigue; soreness; soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (soreness), the first episode of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and CLONAZEPAM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced the first episode of VACCINATION SITE PAIN (soreness) and the first episode of FATIGUE (fatigue). On 17-Apr-2021, the patient experienced MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), ADVERSE EVENT (feeling all of the adverse events), the second episode of FATIGUE (fatigue) and the second episode of VACCINATION SITE PAIN (soreness). On 19-Apr-2021, MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), the last episode of FATIGUE (fatigue) and the last episode of VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, ADVERSE EVENT (feeling all of the adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-089413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089413:1st dose
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle pain; chills; nausea; feeling all of the adverse events; fatigue; soreness; soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (soreness), the first episode of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) and CLONAZEPAM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced the first episode of VACCINATION SITE PAIN (soreness) and the first episode of FATIGUE (fatigue). On 17-Apr-2021, the patient experienced MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), ADVERSE EVENT (feeling all of the adverse events), the second episode of FATIGUE (fatigue) and the second episode of VACCINATION SITE PAIN (soreness). On 19-Apr-2021, MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), the last episode of FATIGUE (fatigue) and the last episode of VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, ADVERSE EVENT (feeling all of the adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-089413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089413:1st dose
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age patient inadvertently received 1st dose of the Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient inadvertently received 1st dose of the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient inadvertently received 1st dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age patient inadvertently received 1st dose of the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.    This case was linked to MOD21-081105 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 27 May 2021; Sender's Comments:  MOD21-081105:Case for patient 2
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Swelling face
Clinical narrative: he stated it felts like head is swelling; just didn't feel well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (he stated it felts like head is swelling) and MALAISE (just didn't feel well) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SWELLING FACE (he stated it felts like head is swelling) and MALAISE (just didn't feel well). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (he stated it felts like head is swelling) and MALAISE (just didn't feel well) outcome was unknown.            No Relevant concomitant medications was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Rash
Clinical narrative: she felt like her whole back was on fire; hands and palms were hot; having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (she felt like her whole back was on fire), FEELING HOT (hands and palms were hot) and RASH (having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced RASH (having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash). On 22-Apr-2021, the patient experienced BURNING SENSATION (she felt like her whole back was on fire) and FEELING HOT (hands and palms were hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (she felt like her whole back was on fire), FEELING HOT (hands and palms were hot) and RASH (having rash on her stomach, her groin area, bellow herbreast area, underneath her arm and her back towards her waist area, e rash on her arm were like welt rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia, Pruritus, Vaccination site erythema
Clinical narrative: Arm warm to the touch; A little bit of itching; Arm very sore; Redness larger, but lighter in color; redness on vaccination site; Soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness larger, but lighter in color), FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching), VACCINATION SITE PAIN (Soreness at vaccination site) and VACCINATION SITE ERYTHEMA (redness on vaccination site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), CARBIDOPA, LEVODOPA, ATORVASTATIN, LOSARTAN POTASSIUM, GABAPENTIN and LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at vaccination site). On 23-Apr-2021, the patient experienced ERYTHEMA (Redness larger, but lighter in color) and VACCINATION SITE ERYTHEMA (redness on vaccination site). On 24-Apr-2021, the patient experienced FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching) and MYALGIA (Arm very sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (Redness larger, but lighter in color), FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching), VACCINATION SITE PAIN (Soreness at vaccination site), VACCINATION SITE ERYTHEMA (redness on vaccination site) and MYALGIA (Arm very sore) had resolved.            It was reported that after 10-12 days her rash was completely gone and patient was fine at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and event outcome updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm warm to the touch; A little bit of itching; Arm very sore; Redness larger, but lighter in color; redness on vaccination site; Soreness at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness larger, but lighter in color), FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching), VACCINATION SITE PAIN (Soreness at vaccination site) and VACCINATION SITE ERYTHEMA (redness on vaccination site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), CARBIDOPA, LEVODOPA, ATORVASTATIN, LOSARTAN POTASSIUM, GABAPENTIN and LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at vaccination site). On 23-Apr-2021, the patient experienced ERYTHEMA (Redness larger, but lighter in color) and VACCINATION SITE ERYTHEMA (redness on vaccination site). On 24-Apr-2021, the patient experienced FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching) and MYALGIA (Arm very sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (Redness larger, but lighter in color), FEELING HOT (Arm warm to the touch), PRURITUS (A little bit of itching), VACCINATION SITE PAIN (Soreness at vaccination site), VACCINATION SITE ERYTHEMA (redness on vaccination site) and MYALGIA (Arm very sore) had resolved.            It was reported that after 10-12 days her rash was completely gone and patient was fine at the time of this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and event outcome updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Constipation, Dysuria, Feeling abnormal
Clinical narrative: Constipation; problem with urination; problem with back and front; feels miserable; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), DYSURIA (problem with urination), BACK PAIN (problem with back and front) and FEELING ABNORMAL (feels miserable) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M26A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), ALFUZOSIN, ABIRATERONE, WARFARIN SODIUM (COUMADIN), DILTIAZEM, METFORMIN and ROSUVASTATIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation), DYSURIA (problem with urination), BACK PAIN (problem with back and front) and FEELING ABNORMAL (feels miserable). At the time of the report, CONSTIPATION (Constipation), DYSURIA (problem with urination), BACK PAIN (problem with back and front) and FEELING ABNORMAL (feels miserable) outcome was unknown.            Treatment information included Liquid Dulcolax and Miralax.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: upper left leg muscle hurting since first dose. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (upper left leg muscle hurting since first dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (upper left leg muscle hurting since first dose). At the time of the report, MYALGIA (upper left leg muscle hurting since first dose) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Limb discomfort, Lymphadenopathy, Pain
Clinical narrative: gradually gotten worse; it hurt to even lift the arm; swollen lymph node; Felt pain in his right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt pain in his right arm), CONDITION AGGRAVATED (gradually gotten worse), LIMB DISCOMFORT (it hurt to even lift the arm) and LYMPHADENOPATHY (swollen lymph node) in a 64-year-old male 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) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (Felt pain in his right arm) and LYMPHADENOPATHY (swollen lymph node). On an unknown date, the patient experienced CONDITION AGGRAVATED (gradually gotten worse) and LIMB DISCOMFORT (it hurt to even lift the arm). At the time of the report, PAIN (Felt pain in his right arm), CONDITION AGGRAVATED (gradually gotten worse), LIMB DISCOMFORT (it hurt to even lift the arm) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown. Not Provided          Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Injection site itching; Redness at vaccination site; vaccination site swelling; 4-inches radius around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE REACTION (4-inches radius around the injection site), VACCINATION SITE ERYTHEMA (Redness at vaccination site) and VACCINATION SITE SWELLING (vaccination site swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI 24 FE) and Nexplanon insertion once every for Birth control.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE REACTION (4-inches radius around the injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Redness at vaccination site) and VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE REACTION (4-inches radius around the injection site), VACCINATION SITE ERYTHEMA (Redness at vaccination site) and VACCINATION SITE SWELLING (vaccination site swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm was sore at the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced INJECTION SITE PAIN (Arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (Arm was sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-089345 (E2B Linked Report).; Sender's Comments:  MOD-2021-089345:Wife case
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Pyrexia
Clinical narrative: Keeps getting hot and cold; Chills/Shivering really bad; Chills and fever back and forth; Slight headaches; Extremely tired; Chills and fever back and forth; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Keeps getting hot and cold), CHILLS (Chills/Shivering really bad), FATIGUE (Extremely tired), CHILLS (Chills and fever back and forth) and PYREXIA (Chills and fever back and forth) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ENALAPRIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced CHILLS (Chills and fever back and forth). On 23-Apr-2021, the patient experienced FATIGUE (Extremely tired). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Keeps getting hot and cold), CHILLS (Chills/Shivering really bad), PYREXIA (Chills and fever back and forth) and HEADACHE (Slight headaches). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Keeps getting hot and cold), CHILLS (Chills/Shivering really bad), FATIGUE (Extremely tired), CHILLS (Chills and fever back and forth), PYREXIA (Chills and fever back and forth) and HEADACHE (Slight headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include Tylenol. Concomitant product include vitamin supplementation.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches; fever 100 F; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (fever 100 F) and HEADACHE (mild headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (Body aches), PYREXIA (fever 100 F) and HEADACHE (mild headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Apr-2021, PAIN (Body aches), PYREXIA (fever 100 F) and HEADACHE (mild headache) had resolved.            No concomitant medications reported by investigator
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pyrexia, Rash, Swelling
Clinical narrative: redness; swelling; It was less severe; rash from shoulder to elbow; 101F temperature on the same right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling), FEELING ABNORMAL (It was less severe), RASH (rash from shoulder to elbow) and PYREXIA (101F temperature on the same right arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, OMEPRAZOLE, ESTRADIOL, CHORIONIC GONADOTROPHIN (PROVIGIL [CHORIONIC GONADOTROPHIN]), ATORVASTATIN, VITAMINS NOS, CALCIUM (CALCIUM Vitamin D3 magnesium), LORATADINE and LIPOIC ACID (alpha LIPOIC ACID) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced ERYTHEMA (redness), SWELLING (swelling), FEELING ABNORMAL (It was less severe), RASH (rash from shoulder to elbow) and PYREXIA (101F temperature on the same right arm). At the time of the report, ERYTHEMA (redness), SWELLING (swelling), FEELING ABNORMAL (It was less severe), RASH (rash from shoulder to elbow) and PYREXIA (101F temperature on the same right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information were not provided.   This case was linked to MOD-2021-089452 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Headache, Hypoaesthesia, Lymph node pain
Clinical narrative: arm  tingly and numb (started then came back); Lymph nodes really sore; extremely depressed; nausea; exhausted; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm  tingly and numb (started then came back)), LYMPH NODE PAIN (Lymph nodes really sore), DEPRESSION (extremely depressed), NAUSEA (nausea) and FATIGUE (exhausted) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HYPOAESTHESIA (arm  tingly and numb (started then came back)), LYMPH NODE PAIN (Lymph nodes really sore), DEPRESSION (extremely depressed), NAUSEA (nausea), FATIGUE (exhausted) and HEADACHE (headache). On 18-Apr-2021, DEPRESSION (extremely depressed), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, HYPOAESTHESIA (arm  tingly and numb (started then came back)), LYMPH NODE PAIN (Lymph nodes really sore) and FATIGUE (exhausted) 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.   Concomitant medication was not provided. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: arm  tingly and numb (started then came back); Lymph nodes really sore; extremely depressed; nausea; exhausted; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm  tingly and numb (started then came back)), LYMPH NODE PAIN (Lymph nodes really sore), DEPRESSION (extremely depressed), NAUSEA (nausea) and FATIGUE (exhausted) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HYPOAESTHESIA (arm  tingly and numb (started then came back)), LYMPH NODE PAIN (Lymph nodes really sore), DEPRESSION (extremely depressed), NAUSEA (nausea), FATIGUE (exhausted) and HEADACHE (headache). On 18-Apr-2021, DEPRESSION (extremely depressed), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, HYPOAESTHESIA (arm  tingly and numb (started then came back)), LYMPH NODE PAIN (Lymph nodes really sore) and FATIGUE (exhausted) 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.   Concomitant medication was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Rash
Clinical narrative: rash; painful ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and ARTHRALGIA (painful ankle) 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 an unknown date, the patient experienced RASH (rash) and ARTHRALGIA (painful ankle). At the time of the report, RASH (rash) and ARTHRALGIA (painful ankle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Invalid Dose; noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Invalid Dose) and DEVICE CONNECTION ISSUE (noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021 at 4:30 PM, the patient experienced UNDERDOSE (Invalid Dose) and DEVICE CONNECTION ISSUE (noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration). On 25-Apr-2021 at 4:30 PM, UNDERDOSE (Invalid Dose) and DEVICE CONNECTION ISSUE (noticed that a little amount of vaccine dripped/Caller mentioned that almost 0.45ml was administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. No treatment information was provided by reporter.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itchy; swelling/hardness; swelling/hardness; redness; hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling/hardness), VACCINATION SITE INDURATION (swelling/hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (hot) and PRURITUS (itchy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling/hardness), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE WARMTH (hot). On 21-Apr-2021, the patient experienced PRURITUS (itchy). On an unknown date, the patient experienced VACCINATION SITE INDURATION (swelling/hardness). At the time of the report, VACCINATION SITE SWELLING (swelling/hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE WARMTH (hot) and PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Neck pain
Clinical narrative: chills; pain in her neck to the top of her head; pain in her neck to the top of her head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in her neck to the top of her head), CHILLS (chills) and HEADACHE (pain in her neck to the top of her head) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced NECK PAIN (pain in her neck to the top of her head) and HEADACHE (pain in her neck to the top of her head). On 18-Apr-2021, the patient experienced CHILLS (chills). At the time of the report, NECK PAIN (pain in her neck to the top of her head), CHILLS (chills) and HEADACHE (pain in her neck to the top of her head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No Treatment medication information was provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Discomfort, Gait disturbance, Malaise
Clinical narrative: not feeling so well; did not feel like she had a good balance; discomfort in her left upper arm; Could not walk straight and confidently; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling so well), BALANCE DISORDER (did not feel like she had a good balance), DISCOMFORT (discomfort in her left upper arm) and GAIT DISTURBANCE (Could not walk straight and confidently) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (not feeling so well), BALANCE DISORDER (did not feel like she had a good balance), DISCOMFORT (discomfort in her left upper arm) and GAIT DISTURBANCE (Could not walk straight and confidently). At the time of the report, MALAISE (not feeling so well), BALANCE DISORDER (did not feel like she had a good balance), DISCOMFORT (discomfort in her left upper arm) and GAIT DISTURBANCE (Could not walk straight and confidently) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she is on regular medications and takes 15 pills that she takes every day. Treatment medication information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received contains no new information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: very tired; asleep for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired) and SOMNOLENCE (asleep for 24 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B214) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (very tired) and SOMNOLENCE (asleep for 24 hours). On 23-Apr-2021, SOMNOLENCE (asleep for 24 hours) had resolved. At the time of the report, FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.