chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, Mobility decreased, Myalgia, Palpitations
Clinical narrative: trouble earing; lost domain little bit; some swollen on her hand, arm and feet's; couldn't do very much; Low energy; arm sore; chills; Fatigue; occasional headache; body ache; some swollen on her hand, arm and feet's; many strong palpitation/constant palpitation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (many strong palpitation/constant palpitation), HYPOACUSIS (trouble earing), DISSOCIATION (lost domain little bit), PERIPHERAL SWELLING (some swollen on her hand, arm and feet's) and MOBILITY DECREASED (couldn't do very much) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Coronary artery disease since 18-Jun-2019, Atrial fibrillation in 2009 and Primary progressive multiple sclerosis on 31-Mar-2016. Concurrent medical conditions included Hearing decreased and Hypertension. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, PRAVASTATIN for Cholesterol, AZILSARTAN KAMEDOXOMIL (EDARBI), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and HYDRALAZINE for Hypertension.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PALPITATIONS (many strong palpitation/constant palpitation), DISSOCIATION (lost domain little bit), PERIPHERAL SWELLING (some swollen on her hand, arm and feet's), MOBILITY DECREASED (couldn't do very much), ASTHENIA (Low energy), AXILLARY PAIN (arm sore), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (occasional headache), MYALGIA (body ache) and VACCINATION SITE SWELLING (some swollen on her hand, arm and feet's). On an unknown date, the patient experienced HYPOACUSIS (trouble earing). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, PERIPHERAL SWELLING (some swollen on her hand, arm and feet's), MOBILITY DECREASED (couldn't do very much), ASTHENIA (Low energy) and VACCINATION SITE SWELLING (some swollen on her hand, arm and feet's) had resolved. At the time of the report, PALPITATIONS (many strong palpitation/constant palpitation), DISSOCIATION (lost domain little bit), AXILLARY PAIN (arm sore), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (occasional headache) and MYALGIA (body ache) was resolving and HYPOACUSIS (trouble earing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient demographics were updated, Medical History information added, concomitant medications added, new events added and outcome of events updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: trouble earing; lost domain little bit; some swollen on her hand, arm and feet's; couldn't do very much; Low energy; arm sore; chills; Fatigue; occasional headache; body ache; some swollen on her hand, arm and feet's; many strong palpitation/constant palpitation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (many strong palpitation/constant palpitation), HYPOACUSIS (trouble earing), DISSOCIATION (lost domain little bit), PERIPHERAL SWELLING (some swollen on her hand, arm and feet's) and MOBILITY DECREASED (couldn't do very much) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Coronary artery disease since 18-Jun-2019, Atrial fibrillation in 2009 and Primary progressive multiple sclerosis on 31-Mar-2016. Concurrent medical conditions included Hearing decreased and Hypertension. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, PRAVASTATIN for Cholesterol, AZILSARTAN KAMEDOXOMIL (EDARBI), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and HYDRALAZINE for Hypertension.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PALPITATIONS (many strong palpitation/constant palpitation), DISSOCIATION (lost domain little bit), PERIPHERAL SWELLING (some swollen on her hand, arm and feet's), MOBILITY DECREASED (couldn't do very much), ASTHENIA (Low energy), AXILLARY PAIN (arm sore), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (occasional headache), MYALGIA (body ache) and VACCINATION SITE SWELLING (some swollen on her hand, arm and feet's). On an unknown date, the patient experienced HYPOACUSIS (trouble earing). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, PERIPHERAL SWELLING (some swollen on her hand, arm and feet's), MOBILITY DECREASED (couldn't do very much), ASTHENIA (Low energy) and VACCINATION SITE SWELLING (some swollen on her hand, arm and feet's) had resolved. At the time of the report, PALPITATIONS (many strong palpitation/constant palpitation), DISSOCIATION (lost domain little bit), AXILLARY PAIN (arm sore), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (occasional headache) and MYALGIA (body ache) was resolving and HYPOACUSIS (trouble earing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient demographics were updated, Medical History information added, concomitant medications added, new events added and outcome of events updated.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: left arm is swollen; itchy; very hard; painful; redness now it is going big; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm is swollen), PRURITUS (itchy), INDURATION (very hard), PAIN IN EXTREMITY (painful) and ERYTHEMA (redness now it is going big) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 (left arm is swollen), PRURITUS (itchy), INDURATION (very hard), PAIN IN EXTREMITY (painful) and ERYTHEMA (redness now it is going big). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (left arm is swollen), PRURITUS (itchy), INDURATION (very hard), PAIN IN EXTREMITY (painful) and ERYTHEMA (redness now it is going big) 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 product use was not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eating disorder, Nausea, Vomiting
Clinical narrative: stomach cramping; she cant eat; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramping), EATING DISORDER (she cant eat), NAUSEA (nausea) and VOMITING (vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramping), EATING DISORDER (she cant eat), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramping), EATING DISORDER (she cant eat), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient gave consent for Follow-up.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: fatigue; nausea; vomited; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), NAUSEA (nausea), VOMITING (vomited) and CHILLS (chills) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea), VOMITING (vomited) and CHILLS (chills). On 04-Mar-2021, CHILLS (chills) had resolved. At the time of the report, FATIGUE (fatigue), NAUSEA (nausea) and VOMITING (vomited) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Vaccination site pain
Clinical narrative: Hollow of heat behind her head; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Hollow of heat behind her head) and VACCINATION SITE PAIN (Soreness of arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) 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 04-Feb-2021, the patient experienced HEAD DISCOMFORT (Hollow of heat behind her head) and VACCINATION SITE PAIN (Soreness of arm). On 04-Feb-2021, HEAD DISCOMFORT (Hollow of heat behind her head) and VACCINATION SITE PAIN (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: vertigo; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), NAUSEA (nausea) and VOMITING (vomiting) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 04-Mar-2021, the patient experienced VERTIGO (vertigo), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, VERTIGO (vertigo), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Flushing, Headache, Inappropriate schedule of product administration
Clinical narrative: Red cheeks - Red Flush; Headache; 42 day difference between doses; tongue swelled; lips felt swelled; taste altered but not gone, everything tasted salty,Unusal Tatse; redness in throat; I did not feel well; sore throat; mouth broke out with sores; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores) and FLUSHING (Red cheeks - Red Flush) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 029L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), PROBIOTICS NOS, LOVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TRAMADOL, CORTISONE ACETATE and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores), SWOLLEN TONGUE (tongue swelled), LIP SWELLING (lips felt swelled), DYSGEUSIA (taste altered but not gone, everything tasted salty,Unusal Tatse) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 day difference between doses). On 01-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced FLUSHING (Red cheeks - Red Flush). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 22-Jan-2021, ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores), SWOLLEN TONGUE (tongue swelled), LIP SWELLING (lips felt swelled) and DYSGEUSIA (taste altered but not gone, everything tasted salty,Unusal Tatse) had resolved. On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 day difference between doses) had resolved. On 03-Mar-2021, FLUSHING (Red cheeks - Red Flush) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUN-2021 contains no significant information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Malaise, Oropharyngeal pain, Stomatitis, Swollen tongue
Clinical narrative: Red cheeks - Red Flush; Headache; 42 day difference between doses; tongue swelled; lips felt swelled; taste altered but not gone, everything tasted salty,Unusal Tatse; redness in throat; I did not feel well; sore throat; mouth broke out with sores; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores) and FLUSHING (Red cheeks - Red Flush) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 029L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), PROBIOTICS NOS, LOVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TRAMADOL, CORTISONE ACETATE and LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores), SWOLLEN TONGUE (tongue swelled), LIP SWELLING (lips felt swelled), DYSGEUSIA (taste altered but not gone, everything tasted salty,Unusal Tatse) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 day difference between doses). On 01-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced FLUSHING (Red cheeks - Red Flush). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 22-Jan-2021, ERYTHEMA (redness in throat), MALAISE (I did not feel well), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (mouth broke out with sores), SWOLLEN TONGUE (tongue swelled), LIP SWELLING (lips felt swelled) and DYSGEUSIA (taste altered but not gone, everything tasted salty,Unusal Tatse) had resolved. On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (42 day difference between doses) had resolved. On 03-Mar-2021, FLUSHING (Red cheeks - Red Flush) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUN-2021 contains no significant information.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site erythema, Vaccination site pain
Clinical narrative: Itchiness around the waist , head and arm; Hives; Rash around the waist; Pain at the injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness around the waist , head and arm), URTICARIA (Hives), RASH (Rash around the waist), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness around the waist , head and arm), URTICARIA (Hives), RASH (Rash around the waist), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, PRURITUS (Itchiness around the waist , head and arm), URTICARIA (Hives), RASH (Rash around the waist), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided. Patient received the 1st dose of Moderna COVID-19 vaccine on February 23rd , 2021. Reports rash and itchiness around the waist , head and arm, pain and redness at injection site and hives.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Illness, Night sweats, Oxygen saturation decreased
Clinical narrative: CHILLS LATE NIGHT; SWEATING ALL NIGHT; LEGS GOT WET / BED GOT WET; OXYGEN LEVEL DROPPED; SICK ALL DAY; sick overnight; FEVER 101.7; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick overnight), PYREXIA (FEVER 101.7), CHILLS (CHILLS LATE NIGHT), ILLNESS (SICK ALL DAY) and HYPERHIDROSIS (SWEATING ALL NIGHT) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0308217) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included FUROSEMIDE, ESCITALOPRAM, LEVOTHYROXINE, FINASTERIDE, preserdision, DABIGATRAN ETEXILATE MESILATE (PRADAXA), MEMANTINE HYDROCHLORIDE (MEMANTINA ACCORD), POTASSIUM, LEVODOPA, ENALAPRIL, TERAZOSIN and ALLOPURINOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (sick overnight), PYREXIA (FEVER 101.7) and ILLNESS (SICK ALL DAY). On 07-Mar-2021, the patient experienced CHILLS (CHILLS LATE NIGHT), HYPERHIDROSIS (SWEATING ALL NIGHT), NIGHT SWEATS (LEGS GOT WET / BED GOT WET) and OXYGEN SATURATION DECREASED (OXYGEN LEVEL DROPPED). At the time of the report, ILLNESS (sick overnight), PYREXIA (FEVER 101.7), CHILLS (CHILLS LATE NIGHT), ILLNESS (SICK ALL DAY), HYPERHIDROSIS (SWEATING ALL NIGHT), NIGHT SWEATS (LEGS GOT WET / BED GOT WET) and OXYGEN SATURATION DECREASED (OXYGEN LEVEL DROPPED) outcome was unknown.            No treatment information provided
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS LATE NIGHT; SWEATING ALL NIGHT; LEGS GOT WET / BED GOT WET; OXYGEN LEVEL DROPPED; SICK ALL DAY; sick overnight; FEVER 101.7; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick overnight), PYREXIA (FEVER 101.7), CHILLS (CHILLS LATE NIGHT), ILLNESS (SICK ALL DAY) and HYPERHIDROSIS (SWEATING ALL NIGHT) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0308217) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided.  Concomitant products included FUROSEMIDE, ESCITALOPRAM, LEVOTHYROXINE, FINASTERIDE, preserdision, DABIGATRAN ETEXILATE MESILATE (PRADAXA), MEMANTINE HYDROCHLORIDE (MEMANTINA ACCORD), POTASSIUM, LEVODOPA, ENALAPRIL, TERAZOSIN and ALLOPURINOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (sick overnight), PYREXIA (FEVER 101.7) and ILLNESS (SICK ALL DAY). On 07-Mar-2021, the patient experienced CHILLS (CHILLS LATE NIGHT), HYPERHIDROSIS (SWEATING ALL NIGHT), NIGHT SWEATS (LEGS GOT WET / BED GOT WET) and OXYGEN SATURATION DECREASED (OXYGEN LEVEL DROPPED). At the time of the report, ILLNESS (sick overnight), PYREXIA (FEVER 101.7), CHILLS (CHILLS LATE NIGHT), ILLNESS (SICK ALL DAY), HYPERHIDROSIS (SWEATING ALL NIGHT), NIGHT SWEATS (LEGS GOT WET / BED GOT WET) and OXYGEN SATURATION DECREASED (OXYGEN LEVEL DROPPED) outcome was unknown.            No treatment information provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Rash, Vomiting
Clinical narrative: Rash; headache; chill; Pain in extremity; vomiting; soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm). At the time of the report, PAIN IN EXTREMITY (soreness of 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 included took ibuprofen once   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Non-significant Follow Up appended. contact information updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Warm to Touch - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (Warm to Touch - Near Injection Site), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE SWELLING (Swelling - Near Injection Site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to Touch - Near Injection Site), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE SWELLING (Swelling - Near Injection Site). At the time of the report, INJECTION SITE WARMTH (Warm to Touch - Near Injection Site), INJECTION SITE PRURITUS (Itchy Sensation - Near Injection Site), INJECTION SITE ERYTHEMA (Redness - Near Injection Site) and INJECTION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) 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.  Treatment information was Antibiotics for UTI.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: nose ran so bad; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose ran so bad) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (nose ran so bad). At the time of the report, RHINORRHOEA (nose ran so bad) 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.   No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching at the injection site; Swelling at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Bone pain, Dizziness, Fatigue
Clinical narrative: started to get temperature; bone pain; strong headache; dizziness; very tired; has been having elevated blood pressure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BONE PAIN (bone pain), HEADACHE (strong headache), DIZZINESS (dizziness), FATIGUE (very tired) and HYPERTENSION (has been having elevated blood pressure) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetic. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE, METFORMIN and ATORVASTATIN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BONE PAIN (bone pain), HEADACHE (strong headache), DIZZINESS (dizziness), FATIGUE (very tired) and HYPERTENSION (has been having elevated blood pressure). On an unknown date, the patient experienced PYREXIA (started to get temperature). At the time of the report, BONE PAIN (bone pain), HEADACHE (strong headache), DIZZINESS (dizziness), FATIGUE (very tired) and HYPERTENSION (has been having elevated blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high. On an unknown date, Body temperature: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Pyrexia
Clinical narrative: started to get temperature; bone pain; strong headache; dizziness; very tired; has been having elevated blood pressure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BONE PAIN (bone pain), HEADACHE (strong headache), DIZZINESS (dizziness), FATIGUE (very tired) and HYPERTENSION (has been having elevated blood pressure) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetic. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), OMEPRAZOLE, METFORMIN and ATORVASTATIN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced BONE PAIN (bone pain), HEADACHE (strong headache), DIZZINESS (dizziness), FATIGUE (very tired) and HYPERTENSION (has been having elevated blood pressure). On an unknown date, the patient experienced PYREXIA (started to get temperature). At the time of the report, BONE PAIN (bone pain), HEADACHE (strong headache), DIZZINESS (dizziness), FATIGUE (very tired) and HYPERTENSION (has been having elevated blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) high. On an unknown date, Body temperature: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia, Vaccination site erythema
Clinical narrative: seriously red around the injection site and down her arm; Joint Pain; Extreme fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (seriously red around the injection site and down her arm), ARTHRALGIA (Joint Pain), FATIGUE (Extreme fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (seriously red around the injection site and down her arm), ARTHRALGIA (Joint Pain), FATIGUE (Extreme fatigue), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE ERYTHEMA (seriously red around the injection site and down her arm), ARTHRALGIA (Joint Pain), FATIGUE (Extreme fatigue), PYREXIA (Fever) and CHILLS (Chills) 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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Injection arm sore; Headache; Fatigue; Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)). On 06-Mar-2021, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 11-Mar-2021, PAIN (Body aches), PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.1 (High) High. On 06-Mar-2021, Body temperature: 100.2 (High) High. On 07-Mar-2021, Body temperature: 99.8 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information mentioned Ibuprofen. 05Mar2021 Received 1st Moderna Vaccination. Right arm(dominant) 05Mar2021 Developed fever 99.1F 06Mar2021 Developed a fever(100.2F), achy body, arm sore(injected arm), headache, fatigue. Treatment Ibuprofen 07Mar2021 Started feeling better, fever 99.8F 11Mar2021 Symptoms resolved. 07Feb2021 Patient has been breastfeeding her infant.   This case was linked to MOD21-051199 (Parent-Child Link).   See case MOD21-051199 for details regarding the child case.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Body aches; Injection arm sore; Headache; Fatigue; Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)). On 06-Mar-2021, the patient experienced PAIN (Body aches), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 11-Mar-2021, PAIN (Body aches), PYREXIA (Fever 99.1(F)/Fever 100.2(F)/Fever 99.8(F)), VACCINATION SITE PAIN (Injection arm sore), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.1 (High) High. On 06-Mar-2021, Body temperature: 100.2 (High) High. On 07-Mar-2021, Body temperature: 99.8 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information mentioned Ibuprofen. 05Mar2021 Received 1st Moderna Vaccination. Right arm(dominant) 05Mar2021 Developed fever 99.1F 06Mar2021 Developed a fever(100.2F), achy body, arm sore(injected arm), headache, fatigue. Treatment Ibuprofen 07Mar2021 Started feeling better, fever 99.8F 11Mar2021 Symptoms resolved. 07Feb2021 Patient has been breastfeeding her infant.   This case was linked to MOD21-051199 (Parent-Child Link).   See case MOD21-051199 for details regarding the child case.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Breast tenderness, Chills
Clinical narrative: breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning; Soreness on the right side, under the arm; The whole breast center where the mammillary glands are located were itching; breast is still tender; Soreness on the right side, toward the collar bone; body aches; little sore arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (little sore arm), BREAST TENDERNESS (breast is still tender), BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning) and AXILLARY PAIN (Soreness on the right side, under the arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (little sore arm) and CHILLS (chills). On 04-Mar-2021, the patient experienced BREAST TENDERNESS (breast is still tender), AXILLARY PAIN (Soreness on the right side, under the arm), PRURITUS (The whole breast center where the mammillary glands are located were itching) and ARTHRALGIA (Soreness on the right side, toward the collar bone). On an unknown date, the patient experienced BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (little sore arm), BREAST TENDERNESS (breast is still tender), BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning), AXILLARY PAIN (Soreness on the right side, under the arm), PRURITUS (The whole breast center where the mammillary glands are located were itching), CHILLS (chills) and ARTHRALGIA (Soreness on the right side, toward the collar bone) 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.   No concomitant medications reported. Treatment information not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus
Clinical narrative: breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning; Soreness on the right side, under the arm; The whole breast center where the mammillary glands are located were itching; breast is still tender; Soreness on the right side, toward the collar bone; body aches; little sore arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PAIN IN EXTREMITY (little sore arm), BREAST TENDERNESS (breast is still tender), BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning) and AXILLARY PAIN (Soreness on the right side, under the arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (body aches), PAIN IN EXTREMITY (little sore arm) and CHILLS (chills). On 04-Mar-2021, the patient experienced BREAST TENDERNESS (breast is still tender), AXILLARY PAIN (Soreness on the right side, under the arm), PRURITUS (The whole breast center where the mammillary glands are located were itching) and ARTHRALGIA (Soreness on the right side, toward the collar bone). On an unknown date, the patient experienced BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning). At the time of the report, PAIN (body aches), PAIN IN EXTREMITY (little sore arm), BREAST TENDERNESS (breast is still tender), BREAST PAIN (breasts were so sore, especially the right side, same side of shot/The whole breast center where the mammillary glands are located were burning), AXILLARY PAIN (Soreness on the right side, under the arm), PRURITUS (The whole breast center where the mammillary glands are located were itching), CHILLS (chills) and ARTHRALGIA (Soreness on the right side, toward the collar bone) 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.   No concomitant medications reported. Treatment information not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Line of Soreness from arm to neck to below the ear; Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Line of Soreness from arm to neck to below the ear) and LYMPHADENOPATHY (Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FUROSEMIDE, AMLODIPINE, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE]), APIXABAN (ELIQUIS), TIOTROPIUM BROMIDE (SPIRIVA), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX), POTASSIUM CHLORIDE, EZETIMIBE (ZETIA) and SIMVASTATIN for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Line of Soreness from arm to neck to below the ear) and LYMPHADENOPATHY (Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine). The patient was treated with AMOXICILLIN in March 2021 for Swollen lymph nodes, at a dose of 1 dosage form. At the time of the report, PAIN (Line of Soreness from arm to neck to below the ear) and LYMPHADENOPATHY (Huge painful Swelling just below the ear/ swollen lymph nodes which were likely a late reaction of the vaccine) outcome was unknown.            Other concomitant products include Respimat.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-JUN-2021 contains non significant information. Patient's contact details were updated.