chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication was provided. no treatment details was included.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Tenderness
Clinical narrative: arm is tender; feel like they have at temperature; Head is hurting; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm is tender), FEELING ABNORMAL (feel like they have at temperature) and HEADACHE (Head is hurting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced TENDERNESS (arm is tender), FEELING ABNORMAL (feel like they have at temperature) and HEADACHE (Head is hurting). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, TENDERNESS (arm is tender), FEELING ABNORMAL (feel like they have at temperature) and HEADACHE (Head is hurting) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Some vaccine leaked onto arm of patient when administered; Some vaccine leaked onto arm of patient when administered; This spontaneous case was reported by a nurse and describes the occurrence of   in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. 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.   No Concomitant  information was  provided. Treatment information include HCP will administer a 2nd Dose in the opposite arm.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dysgeusia, Fatigue, Headache
Clinical narrative: fatigue; muscle pain; joint pain; Sore arm; headache; nausea; vomiting; dizziness; Metallic Taste; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DYSGEUSIA (Metallic Taste), DIZZINESS (light headedness), NAUSEA (nausea) and VOMITING (vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles in 2020.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (dizziness), DYSGEUSIA (Metallic Taste) and DIZZINESS (light headedness). On 06-Mar-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and INJECTION SITE PAIN (Sore arm). On 13-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (dizziness) and DYSGEUSIA (Metallic Taste) had resolved. At the time of the report, DIZZINESS (light headedness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headache) and INJECTION SITE PAIN (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Vomiting
Clinical narrative: fatigue; muscle pain; joint pain; Sore arm; headache; nausea; vomiting; dizziness; Metallic Taste; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DYSGEUSIA (Metallic Taste), DIZZINESS (light headedness), NAUSEA (nausea) and VOMITING (vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles in 2020.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (dizziness), DYSGEUSIA (Metallic Taste) and DIZZINESS (light headedness). On 06-Mar-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headache) and INJECTION SITE PAIN (Sore arm). On 13-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (dizziness) and DYSGEUSIA (Metallic Taste) had resolved. At the time of the report, DIZZINESS (light headedness), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headache) and INJECTION SITE PAIN (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Feeling abnormal, Pain
Clinical narrative: Dizziness; disoriented; Burning pain starting from the injection site upto her neck around ears head and all over the face; Brain fog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), CONFUSIONAL STATE (disoriented), PAIN (Burning pain starting from the injection site upto her neck around ears head and all over the face) and FEELING ABNORMAL (Brain fog) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was reported.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced CONFUSIONAL STATE (disoriented), PAIN (Burning pain starting from the injection site upto her neck around ears head and all over the face) and FEELING ABNORMAL (Brain fog). On 21-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 21-Mar-2021, DIZZINESS (Dizziness) and CONFUSIONAL STATE (disoriented) had resolved. At the time of the report, PAIN (Burning pain starting from the injection site upto her neck around ears head and all over the face) and FEELING ABNORMAL (Brain fog) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Myalgia, Pain in extremity, Somnolence
Clinical narrative: Muscle pain all over the body; Fell sleep on the chair /  Fell forward /Falling; Sleepy; Sore shoulder; Sore Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm Injection Site), FALL (Fell sleep on the chair /  Fell forward /Falling), SOMNOLENCE (Sleepy), ARTHRALGIA (Sore shoulder) and MYALGIA (Muscle pain all over the body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema. Concomitant products included PREDNISONE for Emphysema.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm Injection Site). On 04-Mar-2021, the patient experienced FALL (Fell sleep on the chair /  Fell forward /Falling), SOMNOLENCE (Sleepy) and ARTHRALGIA (Sore shoulder). On 04-Mar-2021 at 12:04 AM, the patient experienced MYALGIA (Muscle pain all over the body). On 06-Mar-2021, PAIN IN EXTREMITY (Sore Arm Injection Site), FALL (Fell sleep on the chair /  Fell forward /Falling) and SOMNOLENCE (Sleepy) had resolved. At the time of the report, ARTHRALGIA (Sore shoulder) and MYALGIA (Muscle pain all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site rash
Clinical narrative: sick; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and INJECTION SITE RASH (Rash at injection site) 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 ILLNESS (sick) and INJECTION SITE RASH (Rash at injection site). At the time of the report, ILLNESS (sick) and INJECTION SITE RASH (Rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness
Clinical narrative: Flu Like Symptoms; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like Symptoms), FATIGUE (Tiredness) and HEADACHE (Headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like Symptoms), FATIGUE (Tiredness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu Like Symptoms), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: felt dizzy; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy) and HEADACHE (headache) 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 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 DIZZINESS (felt dizzy) and HEADACHE (headache). The patient was treated with MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (felt dizzy) and HEADACHE (headache) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medication was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hypersomnia, Nausea
Clinical narrative: slept all day; dizzy like I was cae sick; slight headache; nauseated; vomited; chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), HEADACHE (slight headache), NAUSEA (nauseated) and VOMITING (vomited) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), HEADACHE (slight headache), NAUSEA (nauseated), VOMITING (vomited) and CHILLS (chills). At the time of the report, HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), NAUSEA (nauseated) and VOMITING (vomited) outcome was unknown and HEADACHE (slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: slept all day; dizzy like I was cae sick; slight headache; nauseated; vomited; chills; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), HEADACHE (slight headache), NAUSEA (nauseated) and VOMITING (vomited) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), HEADACHE (slight headache), NAUSEA (nauseated), VOMITING (vomited) and CHILLS (chills). At the time of the report, HYPERSOMNIA (slept all day), DIZZINESS (dizzy like I was cae sick), NAUSEA (nauseated) and VOMITING (vomited) outcome was unknown and HEADACHE (slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchiness at the injection site; rash at the injection site; swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20 (1 or 0) A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  Treatment information was not provided  The patient decided not to take second dose.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Conjunctivitis, Eye injury
Clinical narrative: Signs of pink eye; Bruising around eye; Loss of taste; Loss sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (Signs of pink eye), EYE INJURY (Bruising around eye), AGEUSIA (Loss of taste) and ANOSMIA (Loss sense of smell) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. t041L20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-Dec-2020 and Stroke (Stroke from COVID.) on 23-Dec-2020.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss sense of smell). On an unknown date, the patient experienced CONJUNCTIVITIS (Signs of pink eye) and EYE INJURY (Bruising around eye). At the time of the report, CONJUNCTIVITIS (Signs of pink eye), EYE INJURY (Bruising around eye), AGEUSIA (Loss of taste) and ANOSMIA (Loss sense of smell) outcome was unknown.            concomitant medication and treatment taken was not reported. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Sore Arm; Slight headache; Chills on/off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), HEADACHE (Slight headache) and CHILLS (Chills on/off) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     The patient's past medical history included Weight loss (chills with were with weight loss ( prior to vaccine).) and Chills (chills with were with weight loss ( prior to vaccine).).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), HEADACHE (Slight headache) and CHILLS (Chills on/off). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore Arm), HEADACHE (Slight headache) and CHILLS (Chills on/off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.    This case was linked to MOD21-063420 (E2B Linked Report).; Sender's Comments:  MOD21-063420:MOD-2021-059848 -1st Vaccine Dose of Husband
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Dysuria
Clinical narrative: Painful Urination; blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Painful Urination) and BLOOD URINE PRESENT (blood in urine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DYSURIA (Painful Urination) and BLOOD URINE PRESENT (blood in urine). At the time of the report, DYSURIA (Painful Urination) and BLOOD URINE PRESENT (blood in urine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.   No treatment details were provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; low grade fever of 99.6; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (low grade fever of 99.6) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (low grade fever of 99.6). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (low grade fever of 99.6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Uncomfortable; Arm Very Sore; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Uncomfortable) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LIMB DISCOMFORT (Uncomfortable). At the time of the report, LIMB DISCOMFORT (Uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Warmth at the injection site; Redness at the injection site; Little bit swelling at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Little bit swelling at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE WARMTH (Warmth at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Little bit swelling at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE WARMTH (Warmth at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (Redness at the injection site), INJECTION SITE SWELLING (Little bit swelling at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE WARMTH (Warmth at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sharp pains in her right calf; shoulder started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp pains in her right calf) and ARTHRALGIA (shoulder started to hurt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     No medical History reported by the reporter.    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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sharp pains in her right calf) and ARTHRALGIA (shoulder started to hurt). The patient was treated with MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sharp pains in her right calf) and ARTHRALGIA (shoulder started to hurt) had resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received outcome of event updated to Resolved and Patient declined further follow-up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Constipation
Clinical narrative: Constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included LEVOTHYROXINE, GLIPIZIDE, DULOXETINE HYDROCHLORIDE (CYMBALTA), CITRIC ACID, SODIUM CITRATE ACID (SODIUM CITRATE/CITRIC ACID), INSULIN ASPART (NOVOLOG), DOLUTEGRAVIR SODIUM, RILPIVIRINE HYDROCHLORIDE (JULUCA), GEMFIBROZIL, ROSUVASTATIN, FINASTERIDE, FOLIC ACID, LOSARTAN, ALLOPURINOL and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.    On 20-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 CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood glucose: 65 (Inconclusive) 65.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.    This case was linked to MOD-2021-059977 (E2B Linked Report).; Sender's Comments:  MOD-2021-059977:Second dose of Vaccine case of same patient.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Nov-2020 and the estimated date of delivery was 02-Sep-2021. On 25-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 25-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound antenatal screen: normal (normal) normal.     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.   On 25-Feb-2021 ultrasound genetic testing for chromosome 18,21,13 done, result negative. Past pregnancy included live birth on 19-Jun-2017.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Headache; Sore Arm; Numbness in Lips; Numbness in Cheeks; Numbness in Tongue; weird feeling in sore throat; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in Lips), HYPOAESTHESIA (Numbness in Cheeks), HYPOAESTHESIA (Numbness in Tongue), OROPHARYNGEAL PAIN (weird feeling in sore throat) and PAIN IN EXTREMITY (Sore Arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety and Headache. Concomitant products included BUSPIRONE from 16-Feb-2019 to an unknown date for Anxiety, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and CODEINE PHOSPHATE, PARACETAMOL (MIGRALEVE [CODEINE PHOSPHATE;PARACETAMOL]) for Headache, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness in Lips), HYPOAESTHESIA (Numbness in Cheeks), HYPOAESTHESIA (Numbness in Tongue) and OROPHARYNGEAL PAIN (weird feeling in sore throat). On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headache). On 20-Mar-2021, HYPOAESTHESIA (Numbness in Lips), HYPOAESTHESIA (Numbness in Cheeks), HYPOAESTHESIA (Numbness in Tongue) and OROPHARYNGEAL PAIN (weird feeling in sore throat) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) was resolving and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Information about Patient's demographics added.Stop date of event (Lip, cheek ,tongue, arm, throat numbness) addedProduct (Buspirone, Effexor and Migraleve )dosage information, route and indication  mentioned.Second dose not taken yet.Vaccine facility information added.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heart beat for 15 minutes; Heart rate increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart rate increased) and HEART RATE INCREASED (rapid heart beat for 15 minutes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included VERAPAMIL, AMIODARONE and FLECAINIDE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate increased). On 22-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heart beat for 15 minutes). On 19-Feb-2021, HEART RATE INCREASED (Heart rate increased) outcome was unknown. On 22-Mar-2021, HEART RATE INCREASED (rapid heart beat for 15 minutes) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included Verapamil.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: redness and swelling in her left arm; redness and swelling in her left arm; left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm soreness), ERYTHEMA (redness and swelling in her left arm) and PERIPHERAL SWELLING (redness and swelling in her left arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included VITAMIN D3, CALCIUM, VITAMIN C [ASCORBIC ACID], LISINOPRIL, HCTZ and ATORVASTATIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (left arm soreness). On 24-Mar-2021, the patient experienced ERYTHEMA (redness and swelling in her left arm) and PERIPHERAL SWELLING (redness and swelling in her left arm). At the time of the report, PAIN IN EXTREMITY (left arm soreness) outcome was unknown and ERYTHEMA (redness and swelling in her left arm) and PERIPHERAL SWELLING (redness and swelling in her left arm) had not resolved. Not Provided          Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Can't lift arm; Shoulder pain - right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Can't lift arm) and ARTHRALGIA (Shoulder pain - right arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can't lift arm) and ARTHRALGIA (Shoulder pain - right arm). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, INJECTED LIMB MOBILITY DECREASED (Can't lift arm) and ARTHRALGIA (Shoulder pain - right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood blister
Clinical narrative: Blood blister under his tongue the size of a pencil eraser where tongue connects to bottom of mouth; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (Blood blister under his tongue the size of a pencil eraser where tongue connects to bottom of mouth) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced BLOOD BLISTER (Blood blister under his tongue the size of a pencil eraser where tongue connects to bottom of mouth). At the time of the report, BLOOD BLISTER (Blood blister under his tongue the size of a pencil eraser where tongue connects to bottom of mouth) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Updated event outcome blood blister from Unknown to Recovered
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: swelling; redness; 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 SWELLING (swelling) and ERYTHEMA (redness) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SWELLING (swelling) and ERYTHEMA (redness). At the time of the report, SWELLING (swelling) and ERYTHEMA (redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications provided. No relevant treatment information provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Erythema, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: Redness reappeared 8 days later; itchiness reappeared 8 days later; Swollen glands on left side of body; Redness on arm; bad headache; Stiff neck; Constipation; hasnt felt herself; itchiness on arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands on left side of body), VACCINATION SITE ERYTHEMA (Redness on arm), ERYTHEMA (Redness reappeared 8 days later), HEADACHE (bad headache) and MUSCULOSKELETAL STIFFNESS (Stiff neck) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history provided by reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for COVID-19 vaccination.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen glands on left side of body), VACCINATION SITE ERYTHEMA (Redness on arm), HEADACHE (bad headache), MUSCULOSKELETAL STIFFNESS (Stiff neck), CONSTIPATION (Constipation), FEELING ABNORMAL (hasnt felt herself) and VACCINATION SITE PRURITUS (itchiness on arm). On 26-Mar-2021, the patient experienced ERYTHEMA (Redness reappeared 8 days later) and PRURITUS (itchiness reappeared 8 days later). At the time of the report, LYMPHADENOPATHY (Swollen glands on left side of body), VACCINATION SITE ERYTHEMA (Redness on arm), ERYTHEMA (Redness reappeared 8 days later), HEADACHE (bad headache), MUSCULOSKELETAL STIFFNESS (Stiff neck), CONSTIPATION (Constipation), FEELING ABNORMAL (hasnt felt herself), VACCINATION SITE PRURITUS (itchiness on arm) and PRURITUS (itchiness reappeared 8 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness reappeared 8 days later; itchiness reappeared 8 days later; Swollen glands on left side of body; Redness on arm; bad headache; Stiff neck; Constipation; hasnt felt herself; itchiness on arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands on left side of body), VACCINATION SITE ERYTHEMA (Redness on arm), ERYTHEMA (Redness reappeared 8 days later), HEADACHE (bad headache) and MUSCULOSKELETAL STIFFNESS (Stiff neck) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history provided by reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for COVID-19 vaccination.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen glands on left side of body), VACCINATION SITE ERYTHEMA (Redness on arm), HEADACHE (bad headache), MUSCULOSKELETAL STIFFNESS (Stiff neck), CONSTIPATION (Constipation), FEELING ABNORMAL (hasnt felt herself) and VACCINATION SITE PRURITUS (itchiness on arm). On 26-Mar-2021, the patient experienced ERYTHEMA (Redness reappeared 8 days later) and PRURITUS (itchiness reappeared 8 days later). At the time of the report, LYMPHADENOPATHY (Swollen glands on left side of body), VACCINATION SITE ERYTHEMA (Redness on arm), ERYTHEMA (Redness reappeared 8 days later), HEADACHE (bad headache), MUSCULOSKELETAL STIFFNESS (Stiff neck), CONSTIPATION (Constipation), FEELING ABNORMAL (hasnt felt herself), VACCINATION SITE PRURITUS (itchiness on arm) and PRURITUS (itchiness reappeared 8 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Area around injection site that is hot; Red area around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area around injection site that is hot) and VACCINATION SITE ERYTHEMA (Red area around injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Area around injection site that is hot) and VACCINATION SITE ERYTHEMA (Red area around injection site). At the time of the report, VACCINATION SITE WARMTH (Area around injection site that is hot) and VACCINATION SITE ERYTHEMA (Red area around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.    Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Neck pain; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain) in a 71-year-old female patient 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 NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain). At the time of the report, NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Limb operation, Rash
Clinical narrative: Severe rash, he was red from head to toe with no white spots on his body; Had surgery on his finger; Severe rash, he was red from head to toe with no white spots on his body; This spontaneous case was reported by a consumer and describes the occurrence of LIMB OPERATION (Had surgery on his finger), ERYTHEMA (Severe rash, he was red from head to toe with no white spots on his body) and RASH (Severe rash, he was red from head to toe with no white spots on his body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced LIMB OPERATION (Had surgery on his finger). On 10-Mar-2021, the patient experienced RASH (Severe rash, he was red from head to toe with no white spots on his body). In March 2021, the patient experienced ERYTHEMA (Severe rash, he was red from head to toe with no white spots on his body). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for Finger operation, at an unspecified dose and frequency and PREDNISONE for Rash generalised, at an unspecified dose and frequency. On 03-Mar-2021, LIMB OPERATION (Had surgery on his finger) had resolved. At the time of the report, ERYTHEMA (Severe rash, he was red from head to toe with no white spots on his body) and RASH (Severe rash, he was red from head to toe with no white spots on his body) had resolved.            On 03-Mar-2021, the patient had surgery on his finger and put sulfamethaxazole trimethoprim on it and due to the sulfas, it caused him a severe rash, he was red from head to toe with no white spots on his body. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Outcome of the events updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Less painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Less painful) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Quadruple vessel bypass graft in May 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Less painful). At the time of the report, VACCINATION SITE PAIN (Less painful) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-032413 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Has a big nod in the arm; It hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Has a big nod in the arm) and VACCINATION SITE PAIN (It hurts) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizures, Depression, Asthma, COPD, Blood pressure high and Acid reflux (esophageal).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE MASS (Has a big nod in the arm) and VACCINATION SITE PAIN (It hurts). At the time of the report, VACCINATION SITE MASS (Has a big nod in the arm) had not resolved and VACCINATION SITE PAIN (It hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included medications for seizures ,depression ,anxiety ,asthma ,COPD, high blood pressure and for acid reflux. Treatment information was not provided.