chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Injection site rash; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Rash and Hives. Concomitant products included POTASSIUM for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were reported  as unknown medication for high blood pressure with diuretic.   The treatment information was not  reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Rash and Hives. Concomitant products included POTASSIUM for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were reported  as unknown medication for high blood pressure with diuretic.   The treatment information was not  reported.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Myalgia
Clinical narrative: cough; Achy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and MYALGIA (Achy) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COUGH (cough) and MYALGIA (Achy). At the time of the report, COUGH (cough) and MYALGIA (Achy) outcome was unknown. Not Provided      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.   Concomitant product use was not provided. Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and MYALGIA (Achy) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COUGH (cough) and MYALGIA (Achy). At the time of the report, COUGH (cough) and MYALGIA (Achy) outcome was unknown. Not Provided      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.   Concomitant product use was not provided. Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Night sweats, Peripheral swelling
Clinical narrative: got arm rash from both doses of the vaccine; Chills; Fever 101.9; Very tired and exhausted; Swollen  covid arm; Night sweat; Red; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm) and RASH (got arm rash from both doses of the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Colitis and Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, BUDESONIDE, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ESTRADIOL, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), BIOTIN and LIFITEGRAST (XIIDRA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted). On an unknown date, the patient experienced RASH (got arm rash from both doses of the vaccine). At the time of the report, PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), VACCINATION SITE REACTION (COVID arm), RASH (got arm rash from both doses of the vaccine), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted) had resolved and ERYTHEMA (Red) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Pyrexia: 101.9 (High) 101.9.         No treatment information for the event was provided.   This case was linked to MOD-2021-021462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated concomitant drugs and patient medical history.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site reaction
Clinical narrative: got arm rash from both doses of the vaccine; Chills; Fever 101.9; Very tired and exhausted; Swollen  covid arm; Night sweat; Red; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm) and RASH (got arm rash from both doses of the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Colitis and Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, BUDESONIDE, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ESTRADIOL, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), BIOTIN and LIFITEGRAST (XIIDRA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted). On an unknown date, the patient experienced RASH (got arm rash from both doses of the vaccine). At the time of the report, PERIPHERAL SWELLING (Swollen  covid arm), NIGHT SWEATS (Night sweat), VACCINATION SITE REACTION (COVID arm), RASH (got arm rash from both doses of the vaccine), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted) had resolved and ERYTHEMA (Red) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Pyrexia: 101.9 (High) 101.9.         No treatment information for the event was provided.   This case was linked to MOD-2021-021462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated concomitant drugs and patient medical history.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: nausea and vomiting; nausea and vomiting; having issues; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) had not resolved.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) had not resolved.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: red; Itching; hurting; like a sunburn /getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) 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 relevant concomitant medications were reported.  Treatment details included ice on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021:  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) 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 relevant concomitant medications were reported.  Treatment details included ice on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nasal congestion, Nasopharyngitis, Nausea, Oropharyngeal pain
Clinical narrative: Minor cold; Mild congestion; A little bit of a sore throat; Diarrhea; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up received on 05-MAY-2021, no new information
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Minor cold; Mild congestion; A little bit of a sore throat; Diarrhea; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up received on 05-MAY-2021, no new information
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain) 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 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body pain). At the time of the report, PAIN (Body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain) 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 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body pain). At the time of the report, PAIN (Body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Bone pain; Muscle spasms; Arm soreness; Joint pain; Headache; Fatigue; Fever; Chills; Vomiting; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness) and ARTHRALGIA (Joint pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (Nausea). On 03-Feb-2021 at 4:00 PM, the patient experienced DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Diarrhea; Bone pain; Muscle spasms; Arm soreness; Joint pain; Headache; Fatigue; Fever; Chills; Vomiting; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness) and ARTHRALGIA (Joint pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (Nausea). On 03-Feb-2021 at 4:00 PM, the patient experienced DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diarrhea; Bone pain; Muscle spasms; Arm soreness; Joint pain; Headache; Fatigue; Fever; Chills; Vomiting; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness) and ARTHRALGIA (Joint pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (Nausea). On 03-Feb-2021 at 4:00 PM, the patient experienced DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Throat irritation, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Itchy around mouth and nose; Flush in the face; itchy around IS; Redness around IS; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS) in a 70-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm). On 17-Feb-2021, the patient experienced THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Pain, Pyrexia
Clinical narrative: Asthma; Fever; Cough; Sore; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore). At the time of the report, ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Body aches; Fever; Couldn't sleep; Arm soreness; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 05-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness). On 09-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Arm felt sore; Redness 2x3 inches size; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness 2x3 inches size). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm felt sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPROFLO [CIPROFLOXACIN HYDROCHLORIDE]) for Adverse event, at a dose of 250 mg twice a day. On 02-Feb-2021, PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Received treatment including ice at vaccination site. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness 2x3 inches size). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm felt sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPROFLO [CIPROFLOXACIN HYDROCHLORIDE]) for Adverse event, at a dose of 250 mg twice a day. On 02-Feb-2021, PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Received treatment including ice at vaccination site.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Reported Treatment medication including antibiotics. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.   Reported Treatment medication including antibiotics.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient received both dose of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine) in a 36-year-old female patient (gravida 6) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage of pregnancy in January 2016, Miscarriage in July 2019 and Miscarriage in February 2020. Concurrent medical conditions included MS (Stable) since March 2016. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Jun-2020 and the estimated date of delivery was 27-Mar-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         The patient's date of positive pregnancy test was 15-Jul-2020 and estimated date of conception was 05-Jul-2020. No treatment information was provided by the reporter.; Reporter's Comments: This is a case of Vaccine exposure during pregnancy with no associated adverse events for this 36-year-old female. Patient will continue to be contacted for further monitoring of adverse events  during the pregnancy .
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: diagnosed with COVID; fever; headache; fatigue; a little cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ANASTROZOLE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced COUGH (a little cough), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 15-Jan-2021, the patient experienced COVID-19 (diagnosed with COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: diagnosed with COVID; fever; headache; fatigue; a little cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ANASTROZOLE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced COUGH (a little cough), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 15-Jan-2021, the patient experienced COVID-19 (diagnosed with COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Officially diagnosed with COVID-19). At the time of the report, COVID-19 (Officially diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of sore arm). In February 2021, PAIN IN EXTREMITY (A little bit of sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Pain at injection site (like bruised); Pain at injection site (like bruised); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Pain at injection site (like bruised)) and VACCINATION SITE PAIN (Pain at injection site (like bruised)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concomitant products included ISOSORBIDE NITRATE, PREDNISONE, ESTRADIOL, FAMOTIDINE (PEPCID [FAMOTIDINE]), VITAMIN D NOS and besacare for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Pain at injection site (like bruised)) and VACCINATION SITE PAIN (Pain at injection site (like bruised)). At the time of the report, VACCINATION SITE BRUISING (Pain at injection site (like bruised)) and VACCINATION SITE PAIN (Pain at injection site (like bruised)) 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 products included besacare.  Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccine reaction) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccine reaction). At the time of the report, VACCINATION SITE REACTION (Vaccine reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-021800 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site discomfort
Clinical narrative: Discomfort at the injection site; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: developed what she thinks its an UTI; lower back pain; chills; very sore arm (couldn't even lift her arm); low grade fever; body aches; feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain), PYREXIA (low grade fever) and MYALGIA (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (feel very tired). On 20-Feb-2021, the patient experienced URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) (oral) on 20-Feb-2021 for UTI, at a dose of UNK dosage form. On 12-Feb-2021, PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), MYALGIA (body aches) and FATIGUE (feel very tired) had resolved. At the time of the report, URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills) outcome was unknown and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.