chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: allergic reaction; injection site hot to touch; injection site hard; injection site red; injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), VACCINATION SITE WARMTH (injection site hot to touch), VACCINATION SITE PRURITUS (injection site started itching), VACCINATION SITE INDURATION (injection site hard) and VACCINATION SITE ERYTHEMA (injection site red) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa), Lupus-like syndrome and Arthritis.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site started itching). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot to touch), VACCINATION SITE INDURATION (injection site hard) and VACCINATION SITE ERYTHEMA (injection site red). On 24-Feb-2021, the patient experienced HYPERSENSITIVITY (allergic reaction). On 25-Feb-2021, HYPERSENSITIVITY (allergic reaction) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site hot to touch), VACCINATION SITE PRURITUS (injection site started itching), VACCINATION SITE INDURATION (injection site hard) and VACCINATION SITE ERYTHEMA (injection site red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swollen upper arm; Warm upper arm; Itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen upper arm), SKIN WARM (Warm upper arm) and PRURITUS (Itchy arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen upper arm), SKIN WARM (Warm upper arm) and PRURITUS (Itchy arm). At the time of the report, PERIPHERAL SWELLING (Swollen upper arm), SKIN WARM (Warm upper arm) and PRURITUS (Itchy arm) outcome was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chemotherapy, Diarrhoea, Feeling abnormal, Nausea, Vaccination site erythema
Clinical narrative: Diarrhea; Nauseous; Red spot at the injection site; Feeling bad/ Felt like got hit by train; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Feeling bad/ Felt like got hit by train), DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (white blood cells are very low). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling bad/ Felt like got hit by train). On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad/ Felt like got hit by train), DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chemotherapy: unknown (Inconclusive) unknown. On an unknown date, White blood cell count decreased: low (Low) Low.     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 15-Apr-2021: Follow up received on 15-Apr-2021, no new information was recorded On 20-Apr-2021: Follow up received on 20-Apr-2021 included email address
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Diarrhea; Nauseous; Red spot at the injection site; Feeling bad/ Felt like got hit by train; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Feeling bad/ Felt like got hit by train), DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (white blood cells are very low). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling bad/ Felt like got hit by train). On 14-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling bad/ Felt like got hit by train), DIARRHOEA (Diarrhea), NAUSEA (Nauseous) and VACCINATION SITE ERYTHEMA (Red spot at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chemotherapy: unknown (Inconclusive) unknown. On an unknown date, White blood cell count decreased: low (Low) Low.     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 15-Apr-2021: Follow up received on 15-Apr-2021, no new information was recorded On 20-Apr-2021: Follow up received on 20-Apr-2021 included email address
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: worsening acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (worsening acid reflux) 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 Acid reflux (esophageal). Concomitant products included FAMOTIDINE (PEPCID AC) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid reflux (esophageal).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (worsening acid reflux). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (worsening acid reflux) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: skin reaction/delayed covid arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN REACTION (skin reaction/delayed covid arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to Compazine, Bactrim DF, morphine.) and Breast cancer female.    On 12-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 SKIN REACTION (skin reaction/delayed covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) at an unspecified dose and frequency. At the time of the report, SKIN REACTION (skin reaction/delayed covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in right shoulder (R) opposite arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in right shoulder (R) opposite arm) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ARTHRALGIA (Pain in right shoulder (R) opposite arm). At the time of the report, ARTHRALGIA (Pain in right shoulder (R) opposite arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: Tongue got very painful/ as if he bit his tongue; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Tongue got very painful/ as if he bit his tongue) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GLOSSODYNIA (Tongue got very painful/ as if he bit his tongue). At the time of the report, GLOSSODYNIA (Tongue got very painful/ as if he bit his tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Lymphocyte count increased
Clinical narrative: Absolute number of lymphocytes came out high; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOCYTE COUNT INCREASED (Absolute number of lymphocytes came out high) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (Normal), Penicillin allergy (Penicillin allergy), Allergy (Allergic to Sulphur.), Anxiety since 2010, Hypercholesterolemia since 2010 and Hypertension since 2000. Concomitant products included DESVENLAFAXINE and ALPRAZOLAM for Anxiety, AMLODIPINE for Blood pressure, ROSUVASTATIN and EZETIMIBE for Cholesterol.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced LYMPHOCYTE COUNT INCREASED (Absolute number of lymphocytes came out high). At the time of the report, LYMPHOCYTE COUNT INCREASED (Absolute number of lymphocytes came out high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Lymphocyte count: 14857 (High) 14857. On 24-Jan-2021, Lymphocyte count: 11623 (High) 11623 H.         Concomitant medications DESVENLAFAXINE, ALPRAZOLAM, AMLODIPINE , ROSUVASTATIN , EZETIMIBE . Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Added patient demographics, medical history, lab tests and concomitant medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Swelling, Vaccination site erythema, Vaccination site induration
Clinical narrative: Sore arm,Pain to the touch; arms feels heavy like a weight is on it; swelling; fever around injection site; Hardness in arm; 6 inch of redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm,Pain to the touch), LIMB DISCOMFORT (arms feels heavy like a weight is on it), SWELLING (swelling), VACCINATION SITE WARMTH (fever around injection site) and VACCINATION SITE INDURATION (Hardness in arm) in a 34-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 13-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 PAIN IN EXTREMITY (Sore arm,Pain to the touch), LIMB DISCOMFORT (arms feels heavy like a weight is on it), SWELLING (swelling), VACCINATION SITE WARMTH (fever around injection site), VACCINATION SITE INDURATION (Hardness in arm) and VACCINATION SITE ERYTHEMA (6 inch of redness around injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm,Pain to the touch), LIMB DISCOMFORT (arms feels heavy like a weight is on it), SWELLING (swelling), VACCINATION SITE WARMTH (fever around injection site), VACCINATION SITE INDURATION (Hardness in arm) and VACCINATION SITE ERYTHEMA (6 inch of redness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Sore arm,Pain to the touch; arms feels heavy like a weight is on it; swelling; fever around injection site; Hardness in arm; 6 inch of redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm,Pain to the touch), LIMB DISCOMFORT (arms feels heavy like a weight is on it), SWELLING (swelling), VACCINATION SITE WARMTH (fever around injection site) and VACCINATION SITE INDURATION (Hardness in arm) in a 34-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 13-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 PAIN IN EXTREMITY (Sore arm,Pain to the touch), LIMB DISCOMFORT (arms feels heavy like a weight is on it), SWELLING (swelling), VACCINATION SITE WARMTH (fever around injection site), VACCINATION SITE INDURATION (Hardness in arm) and VACCINATION SITE ERYTHEMA (6 inch of redness around injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm,Pain to the touch), LIMB DISCOMFORT (arms feels heavy like a weight is on it), SWELLING (swelling), VACCINATION SITE WARMTH (fever around injection site), VACCINATION SITE INDURATION (Hardness in arm) and VACCINATION SITE ERYTHEMA (6 inch of redness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chills
Clinical narrative: Full feeling in abdomen; Chills; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL DISTENSION (Full feeling in abdomen) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (Full feeling in abdomen) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISTENSION (Full feeling in abdomen) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Arm Soreness; Low grade fever of 100; swollen lymph nodes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), PYREXIA (Low grade fever of 100) and LYMPHADENOPATHY (swollen lymph nodes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 041620A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness), PYREXIA (Low grade fever of 100) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Arm Soreness), PYREXIA (Low grade fever of 100) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 100 (High) low grade fever of 100.         No concomitant medication were provided  Treatment medication was not provided.  Lab tests included - some tests were conducted on the lymph nodes, no results were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021: Some tests were conducted on the lymph nodes.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Salivary hypersecretion
Clinical narrative: Lump on the mouth; Eliminated a lot of saliva; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISORDER (Lump on the mouth) and SALIVARY HYPERSECRETION (Eliminated a lot of saliva) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 ORAL DISORDER (Lump on the mouth) and SALIVARY HYPERSECRETION (Eliminated a lot of saliva). At the time of the report, ORAL DISORDER (Lump on the mouth) and SALIVARY HYPERSECRETION (Eliminated a lot of saliva) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction to vaccine). At the time of the report, ADVERSE REACTION (Adverse reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Pyrexia
Clinical narrative: I've had like a burning in my spine ever since my second shot; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (I've had like a burning in my spine ever since my second shot), PYREXIA (Fever) and CHILLS (Chills) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus-like syndrome, Sjogren's, Myopathy and Fibromyalgia.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (I've had like a burning in my spine ever since my second shot), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, BURNING SENSATION (I've had like a burning in my spine ever since my second shot), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No treatment medications were reported by reporter. No concomitant medications were reported by reporter.  Fever and chills were gone after 24 hours but the burning sensation in spine lasted for three days. The patient found burning in spine to be abnormal.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Additional information was added: age group of patient, current condition and outcome of events were updated from unknown to recovered
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Nausea, Tinnitus
Clinical narrative: Hissing in his ear; Dizziness; Sweating; Nausea; Injection site soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Hissing in his ear), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Tiredness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were 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 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Tiredness). On 19-Feb-2021, the patient experienced TINNITUS (Hissing in his ear), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). At the time of the report, TINNITUS (Hissing in his ear) had not resolved and DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Injection site soreness), FATIGUE (Tiredness) and NAUSEA (Nausea) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: The outcome of the event(s) injection site soreness, tiredness, dizziness, sweating and nausea changed from unknown to recovered .The outcome of the event hissing in ear change from unknown to not resolved. On 04-Jun-2021: Non-Significant F/U Case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hissing in his ear; Dizziness; Sweating; Nausea; Injection site soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Hissing in his ear), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Tiredness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were 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 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Tiredness). On 19-Feb-2021, the patient experienced TINNITUS (Hissing in his ear), DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). At the time of the report, TINNITUS (Hissing in his ear) had not resolved and DIZZINESS (Dizziness), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Injection site soreness), FATIGUE (Tiredness) and NAUSEA (Nausea) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: The outcome of the event(s) injection site soreness, tiredness, dizziness, sweating and nausea changed from unknown to recovered .The outcome of the event hissing in ear change from unknown to not resolved. On 04-Jun-2021: Non-Significant F/U Case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination site pain
Clinical narrative: My arm did bother me the next day; a little bit of aches; I had a little bit of chills; A spontaneous report was received from a nurse who is a 74-year-old, female patient, that received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine site pain, arm soreness and chills.  The patient's medical history was not provided. Concomitant product included Apixaban.  On 19-FEB-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Feb 2021, after receiving vaccine the patient had a little bit of aches. Her arm did bother her  the next day after receiving the vaccine and she had some chills.   Treatment for the event included 1-2 Tylenol for symptoms.  Action taken with mRNA-1273 in response to the events was not provided.  The events, vaccine site pain, arm soreness and chills., was considered resolved on 21-Feb-2021.; Reporter'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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (excruciating pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 500 milligram. On 19-Jan-2021, VACCINATION SITE PAIN (excruciating pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.   This case was linked to MOD-2021-020922 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16 Apr 2021 included no new information (Patient mentioned she is feeling fine now and that she didn't experience any other events and has nothing else to report.)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Oral pain
Clinical narrative: Canker sore in mouth; Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts; The sore is all over her mouth; This spontaneous case was reported by a consumer and describes the occurrence of APHTHOUS ULCER (Canker sore in mouth), ORAL PAIN (Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts) and ORAL PAIN (The sore is all over her mouth) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN and AMLODIPINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced APHTHOUS ULCER (Canker sore in mouth), ORAL PAIN (Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts) and ORAL PAIN (The sore is all over her mouth). At the time of the report, APHTHOUS ULCER (Canker sore in mouth), ORAL PAIN (Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts) and ORAL PAIN (The sore is all over her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervousness
Clinical narrative: He is very nervous; Whole arm went numb (dead) for 5 min to the armpit; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Whole arm went numb (dead) for 5 min to the armpit) and NERVOUSNESS (He is very nervous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HYPOAESTHESIA (Whole arm went numb (dead) for 5 min to the armpit). On an unknown date, the patient experienced NERVOUSNESS (He is very nervous). On 09-Feb-2021, HYPOAESTHESIA (Whole arm went numb (dead) for 5 min to the armpit) had resolved. At the time of the report, NERVOUSNESS (He is very nervous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Event were updated to RESLOVED
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Nausea, Nervousness, Pain in extremity
Clinical narrative: Nervous; Jittery; Nauseated; Arm really hurts; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous), FEELING JITTERY (Jittery), PAIN IN EXTREMITY (Arm really hurts) and NAUSEA (Nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure management, CALCIUM for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm really hurts). On 28-Jan-2021, the patient experienced NERVOUSNESS (Nervous), FEELING JITTERY (Jittery) and NAUSEA (Nauseated). On 28-Jan-2021, PAIN IN EXTREMITY (Arm really hurts) had resolved. At the time of the report, NERVOUSNESS (Nervous), FEELING JITTERY (Jittery) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Feeling hot, Hyperglycaemia, Pain, Pain in extremity
Clinical narrative: Concurrent medical conditions included Diabetes mellitus. Concomitant products included PIOGLITAZONE, GLIMEPIRIDE and LISINOPRIL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little bit sore for a couple of days). On 21-Feb-2021, the patient experienced PAIN (It was really painful), FEELING HOT (It was real warm), HYPERGLYCAEMIA (181 blood sugar), PERIPHERAL SWELLING (Arm got swollen up) and VACCINATION SITE ERYTHEMA (Redness below vaccination site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Feb-2021, PAIN (It was really painful), FEELING HOT (It was real warm), HYPERGLYCAEMIA (181 blood sugar) and PERIPHERAL SWELLING (Arm got swollen up) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit sore for a couple of days) had resolved and VACCINATION SITE ERYTHEMA (Redness below vaccination site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood glucose fluctuation: 181 Inconclusive. On 22-Feb-2021, Blood glucose fluctuation: 115.4 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema
Clinical narrative: Concurrent medical conditions included Diabetes mellitus. Concomitant products included PIOGLITAZONE, GLIMEPIRIDE and LISINOPRIL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little bit sore for a couple of days). On 21-Feb-2021, the patient experienced PAIN (It was really painful), FEELING HOT (It was real warm), HYPERGLYCAEMIA (181 blood sugar), PERIPHERAL SWELLING (Arm got swollen up) and VACCINATION SITE ERYTHEMA (Redness below vaccination site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Feb-2021, PAIN (It was really painful), FEELING HOT (It was real warm), HYPERGLYCAEMIA (181 blood sugar) and PERIPHERAL SWELLING (Arm got swollen up) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit sore for a couple of days) had resolved and VACCINATION SITE ERYTHEMA (Redness below vaccination site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood glucose fluctuation: 181 Inconclusive. On 22-Feb-2021, Blood glucose fluctuation: 115.4 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swollen Injection site; Red injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE ERYTHEMA (Red injection site). At the time of the report, VACCINATION SITE SWELLING (Swollen Injection site) and VACCINATION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Ice.  No relevant concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Heart rate abnormal, Heart rate irregular
Clinical narrative: heart racing; heart skipping; dizziness; rise in blood pressure to 170; Pulse in the 70 S/erratic heart rhythm; erratic heart rythm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm) and PALPITATIONS (heart racing) in a 79-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.     The patient's past medical history included Allergy NOS since an unknown date. Concurrent medical conditions included Anaphylactic reaction (2 out of the three allergies are listed as anaphylactic). Concomitant products included CEFALEXIN (CEPHALEXIN AMEL), THIAMINE HYDROCHLORIDE (HYDROCHLORIDE B1), ATORVASTATIN CALCIUM (LIPITOR), PANTOPRAZOLE, FAMOTIDINE (PEPCID AC), CLOPIDOGREL BISULFATE (PLAVIX), DOXEPIN HYDROCHLORIDE (SILENOR), ATENOLOL (TENORMIN) and METFORMIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm) and HEART RATE IRREGULAR (heart skipping). On an unknown date, the patient experienced PALPITATIONS (heart racing). At the time of the report, DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm), PALPITATIONS (heart racing) and HEART RATE IRREGULAR (heart skipping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170 (High) 170. On an unknown date, Heart rate: 70 (Low) 70.         Information about treatment was not provided. Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021,the patient confirmed the first dose events and second dose related events given.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations, Pulse abnormal
Clinical narrative: heart racing; heart skipping; dizziness; rise in blood pressure to 170; Pulse in the 70 S/erratic heart rhythm; erratic heart rythm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm) and PALPITATIONS (heart racing) in a 79-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.     The patient's past medical history included Allergy NOS since an unknown date. Concurrent medical conditions included Anaphylactic reaction (2 out of the three allergies are listed as anaphylactic). Concomitant products included CEFALEXIN (CEPHALEXIN AMEL), THIAMINE HYDROCHLORIDE (HYDROCHLORIDE B1), ATORVASTATIN CALCIUM (LIPITOR), PANTOPRAZOLE, FAMOTIDINE (PEPCID AC), CLOPIDOGREL BISULFATE (PLAVIX), DOXEPIN HYDROCHLORIDE (SILENOR), ATENOLOL (TENORMIN) and METFORMIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm) and HEART RATE IRREGULAR (heart skipping). On an unknown date, the patient experienced PALPITATIONS (heart racing). At the time of the report, DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm), PALPITATIONS (heart racing) and HEART RATE IRREGULAR (heart skipping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170 (High) 170. On an unknown date, Heart rate: 70 (Low) 70.         Information about treatment was not provided. Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021,the patient confirmed the first dose events and second dose related events given.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Loose stool; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     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 14-Feb-2021, the patient experienced DIARRHOEA (Loose stool) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Loose stool) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Muscle aches and pain; Headaches; Chills; Muscle aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Muscle aches and pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle aches and pain) 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 21-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 PAIN (Muscle aches and pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle aches and pain). At the time of the report, PAIN (Muscle aches and pain), HEADACHE (Headaches), CHILLS (Chills) and MYALGIA (Muscle aches and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Itch; Stinging; Rash on back of neck, rash on front of shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of neck, rash on front of shoulder), PRURITUS (Itch) and PAIN (Stinging) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (Rash on back of neck, rash on front of shoulder). On an unknown date, the patient experienced PRURITUS (Itch) and PAIN (Stinging). At the time of the report, RASH (Rash on back of neck, rash on front of shoulder), PRURITUS (Itch) and PAIN (Stinging) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cold compress, oil and peach aesthetics.  No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Sore Mouth; "Foggy Brain"; Body Ache; Itchiness; Fever of 104 Degrees; Chills; Fatigue; Headache; Nausea; Injection site redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness) and PYREXIA (Fever of 104 Degrees) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ESZOPICLONE (LUNESTA), THYROID (ARMOUR THYROID) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness), PYREXIA (Fever of 104 Degrees), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency. At the time of the report, ORAL PAIN (Sore Mouth), FEELING ABNORMAL ("Foggy Brain"), PAIN (Body Ache), VACCINATION SITE PRURITUS (Itchiness), PYREXIA (Fever of 104 Degrees), CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 104 degree (plane angle) High.