chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Dyspnoea, Erythema, Hypertension
Clinical narrative: tingling lips; tremors; dizziness; her throat was closing; voice seemed affected; her heart was racing; high blood pressure; swelling of her face; shortness of breath; hive on cheek; redness of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face) and PARAESTHESIA ORAL (tingling lips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 007m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy (Patient stated that she had in the past an anaphylactic allergic reaction to shellfish). Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNEA (shortness of breath), SWELLING FACE (swelling of her face), URTICARIA (hive on cheek) and ERYTHEMA (redness of face). On 06-Mar-2021, the patient experienced PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing) and DYSPHONIA (voice seemed affected). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In March 2021, DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing), DYSPHONIA (voice seemed affected), URTICARIA (hive on cheek) and ERYTHEMA (redness of face) had resolved. Not Provided          No concomitant medications reported.  Treatment of the events included (125mg Met prednisolone 50mg Benadryl) IV 40mg Prednisone 2 tablets per day until March the 22nd Benadryl capsules every 6 hours until march the 11th.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia oral, Pharyngeal swelling, Swelling face, Tremor
Clinical narrative: tingling lips; tremors; dizziness; her throat was closing; voice seemed affected; her heart was racing; high blood pressure; swelling of her face; shortness of breath; hive on cheek; redness of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face) and PARAESTHESIA ORAL (tingling lips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 007m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy (Patient stated that she had in the past an anaphylactic allergic reaction to shellfish). Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNEA (shortness of breath), SWELLING FACE (swelling of her face), URTICARIA (hive on cheek) and ERYTHEMA (redness of face). On 06-Mar-2021, the patient experienced PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing) and DYSPHONIA (voice seemed affected). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In March 2021, DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing), DYSPHONIA (voice seemed affected), URTICARIA (hive on cheek) and ERYTHEMA (redness of face) had resolved. Not Provided          No concomitant medications reported.  Treatment of the events included (125mg Met prednisolone 50mg Benadryl) IV 40mg Prednisone 2 tablets per day until March the 22nd Benadryl capsules every 6 hours until march the 11th.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: tingling lips; tremors; dizziness; her throat was closing; voice seemed affected; her heart was racing; high blood pressure; swelling of her face; shortness of breath; hive on cheek; redness of face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face) and PARAESTHESIA ORAL (tingling lips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 007m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy (Patient stated that she had in the past an anaphylactic allergic reaction to shellfish). Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNEA (shortness of breath), SWELLING FACE (swelling of her face), URTICARIA (hive on cheek) and ERYTHEMA (redness of face). On 06-Mar-2021, the patient experienced PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing) and DYSPHONIA (voice seemed affected). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. In March 2021, DYSPNEA (shortness of breath), PALPITATIONS (her heart was racing), HYPERTENSION (high blood pressure), SWELLING FACE (swelling of her face), PARAESTHESIA ORAL (tingling lips), TREMOR (tremors), DIZZINESS (dizziness), PHARYNGEAL SWELLING (her throat was closing), DYSPHONIA (voice seemed affected), URTICARIA (hive on cheek) and ERYTHEMA (redness of face) had resolved. Not Provided          No concomitant medications reported.  Treatment of the events included (125mg Met prednisolone 50mg Benadryl) IV 40mg Prednisone 2 tablets per day until March the 22nd Benadryl capsules every 6 hours until march the 11th.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Swelling face
Clinical narrative: tingling sensation in left cheek and lip; Lymph nodes under arm of injection are swelling/Lymph nodes under arm of injection are painfull; Swelling of left cheek; Swelling of face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of left cheek), PARAESTHESIA (tingling sensation in left cheek and lip), SWELLING FACE (Swelling of face) and LYMPHADENOPATHY (Lymph nodes under arm of injection are swelling/Lymph nodes under arm of injection are painfull) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE and HYDROXYCHLOROQUINE for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING FACE (Swelling of left cheek) and SWELLING FACE (Swelling of face). On 24-Mar-2021, the patient experienced PARAESTHESIA (tingling sensation in left cheek and lip) and LYMPHADENOPATHY (Lymph nodes under arm of injection are swelling/Lymph nodes under arm of injection are painfull). At the time of the report, SWELLING FACE (Swelling of left cheek), PARAESTHESIA (tingling sensation in left cheek and lip), SWELLING FACE (Swelling of face) and LYMPHADENOPATHY (Lymph nodes under arm of injection are swelling/Lymph nodes under arm of injection are painfull) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Benadryl 1 dose.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nausea; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and DIZZINESS (Dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event. Concomitant products included LORAZEPAM (ATIVAN) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced NAUSEA (nausea) and DIZZINESS (Dizziness). At the time of the report, NAUSEA (nausea) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over the back, legs, buttocks; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (all over the back, legs, buttocks) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINS, CALCIUM, and BIOTIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (all over the back, legs, buttocks). At the time of the report, PRURITUS (all over the back, legs, buttocks) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medicine has been reported by reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: rash which is like a cluster of mosquito bites; itchy; redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash which is like a cluster of mosquito bites), PRURITUS (itchy) and ERYTHEMA (redness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 RASH (rash which is like a cluster of mosquito bites), PRURITUS (itchy) and ERYTHEMA (redness). At the time of the report, RASH (rash which is like a cluster of mosquito bites), PRURITUS (itchy) and ERYTHEMA (redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications of the patient included Calahist lotion. No concomitant medications were reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pallor, Skin exfoliation, Vertigo
Clinical narrative: Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"; both palms started pilling; Blisters in those places that he was pilling - looks like leprosy; his thumbs are pilling too; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"), BLISTER (Blisters in those places that he was pilling - looks like leprosy) and SKIN EXFOLIATION (his thumbs are pilling too) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Overweight and Smoker.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VERTIGO (Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"), BLISTER (Blisters in those places that he was pilling - looks like leprosy) and SKIN EXFOLIATION (his thumbs are pilling too). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, VERTIGO (Woke up by extreme vertigo - felt like spinning 100 miles an hour and had to grab on to the bed since it felt like he was going to "fly off"), BLISTER (Blisters in those places that he was pilling - looks like leprosy) and SKIN EXFOLIATION (his thumbs are pilling too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. Treatment medications taken were readjustments for the "crystals" in his ears, Benadryl and 2 Aleve or Advil.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: no new information
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling hot, Nasopharyngitis, Nausea
Clinical narrative: extremely cold; I felt weak; Feeling hot; nauseated; still feel tired and weak; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot) and NAUSEA (nauseated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Mar-2021, the patient experienced NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot), NAUSEA (nauseated) and FATIGUE (still feel tired and weak). On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 08-Mar-2021, NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot) and NAUSEA (nauseated) had resolved. At the time of the report, FATIGUE (still feel tired and weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Hydration Fluids, Tylenol and Aspirin. Patient was also taken to emergency department on 08-Mar-2021 and left same day. Concomitant medication included senior vitamin.   This case was linked to MOD-2021-044677 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: extremely cold; I felt weak; Feeling hot; nauseated; still feel tired and weak; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot) and NAUSEA (nauseated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Mar-2021, the patient experienced NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot), NAUSEA (nauseated) and FATIGUE (still feel tired and weak). On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 08-Mar-2021, NASOPHARYNGITIS (extremely cold), ASTHENIA (I felt weak), FEELING HOT (Feeling hot) and NAUSEA (nauseated) had resolved. At the time of the report, FATIGUE (still feel tired and weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment include Hydration Fluids, Tylenol and Aspirin. Patient was also taken to emergency department on 08-Mar-2021 and left same day. Concomitant medication included senior vitamin.   This case was linked to MOD-2021-044677 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: TCR
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 100.5degree F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.5degree F) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included PRIMIDONE and ESOMEPRAZOLE for an unknown indication.    On 25-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 PYREXIA (Fever 100.5 degree F). At the time of the report, PYREXIA (Fever 100.5 degree F) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 100.5 F.     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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Myalgia, Nausea, Pain in extremity
Clinical narrative: Chest is painful and sore in the inside; Ended up not getting the 2nd one; Woke up in the middle of the night to rash; Nausea; Muscle Pain; Hives / Hives for a month; Woke up in the middle of the night to itching / itching all over the body; Sore arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest is painful and sore in the inside), URTICARIA (Hives / Hives for a month), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm) and DIZZINESS (Dizziness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-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 URTICARIA (Hives / Hives for a month), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), RASH (Woke up in the middle of the night to rash), NAUSEA (Nausea) and MYALGIA (Muscle Pain). On an unknown date, the patient experienced CHEST PAIN (Chest is painful and sore in the inside) and PRODUCT DOSE OMISSION ISSUE (Ended up not getting the 2nd one). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest is painful and sore in the inside), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), RASH (Woke up in the middle of the night to rash), NAUSEA (Nausea) and MYALGIA (Muscle Pain) outcome was unknown, URTICARIA (Hives / Hives for a month) had not resolved and PRODUCT DOSE OMISSION ISSUE (Ended up not getting the 2nd one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information include Diphenhydramine, Paracetamol and Naproxen.  Patient was not sure about getting her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow-up information received on 15-MAY-2021: New events added.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Rash, Urticaria
Clinical narrative: Chest is painful and sore in the inside; Ended up not getting the 2nd one; Woke up in the middle of the night to rash; Nausea; Muscle Pain; Hives / Hives for a month; Woke up in the middle of the night to itching / itching all over the body; Sore arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest is painful and sore in the inside), URTICARIA (Hives / Hives for a month), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm) and DIZZINESS (Dizziness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-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 URTICARIA (Hives / Hives for a month), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), RASH (Woke up in the middle of the night to rash), NAUSEA (Nausea) and MYALGIA (Muscle Pain). On an unknown date, the patient experienced CHEST PAIN (Chest is painful and sore in the inside) and PRODUCT DOSE OMISSION ISSUE (Ended up not getting the 2nd one). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest is painful and sore in the inside), PRURITUS (Woke up in the middle of the night to itching / itching all over the body), PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), RASH (Woke up in the middle of the night to rash), NAUSEA (Nausea) and MYALGIA (Muscle Pain) outcome was unknown, URTICARIA (Hives / Hives for a month) had not resolved and PRODUCT DOSE OMISSION ISSUE (Ended up not getting the 2nd one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information include Diphenhydramine, Paracetamol and Naproxen.  Patient was not sure about getting her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow-up information received on 15-MAY-2021: New events added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Pharyngitis; Hard area on the injection site; injection site redness; injection site swelling; injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGITIS, VACCINATION SITE INDURATION, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PRURITUS in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Influenza, Influenza vaccine in 2020; for Pneumonia, PNEUMOCOCCAL VACCINE in November 2020. Past adverse reactions to the above products included No adverse reaction with Influenza vaccine and PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Asthma.    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 PHARYNGITIS, VACCINATION SITE INDURATION, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PRURITUS. The patient was treated with ACETYLSALICYLIC ACID at an unspecified dose and frequency; BENADRYL at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PHARYNGITIS, VACCINATION SITE INDURATION, VACCINATION SITE ERYTHEMA, VACCINATION SITE SWELLING, and VACCINATION SITE PRURITUS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated medically confirm  from NO to YES. updated patient medical history, Re-challenge fields, added new event Pharyngitis, updated outcome of the events Vaccination site erythema, vaccination site swelling, vaccination site pruritus, vaccination site induration from unknown to Recovered. Patient declined to provide additional information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity
Clinical narrative: Muscle cramps; Pain on the back of the legs; pain on the front shins; very painful; Bad; Felt like Jumping up; Cramps on the left thumb; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps on the left thumb), MUSCLE SPASMS (Muscle cramps), PAIN IN EXTREMITY (Pain on the back of the legs), PAIN IN EXTREMITY (pain on the front shins) and PAIN (very painful) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LAMOTRIGINE, ZYRTEC LIQUID GEL CAPSULES, NAPROXEN SODIUM (ALEVE) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Mar-2021, the patient experienced MUSCLE SPASMS (Cramps on the left thumb). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle cramps), PAIN IN EXTREMITY (Pain on the back of the legs), PAIN IN EXTREMITY (pain on the front shins), PAIN (very painful), PAIN (Bad) and PAIN (Felt like Jumping up). At the time of the report, MUSCLE SPASMS (Cramps on the left thumb), MUSCLE SPASMS (Muscle cramps), PAIN IN EXTREMITY (Pain on the back of the legs), PAIN IN EXTREMITY (pain on the front shins), PAIN (very painful), PAIN (Bad) and PAIN (Felt like Jumping up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information was  provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: achy and cruddy; "I got real cold"; fever (101); felt really tired; slept long.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy and cruddy), NASOPHARYNGITIS ("I got real cold"), PYREXIA (fever (101)), FATIGUE (felt really tired) and HYPERSOMNIA (slept long.) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-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 PAIN (achy and cruddy), NASOPHARYNGITIS ("I got real cold"), PYREXIA (fever (101)), FATIGUE (felt really tired) and HYPERSOMNIA (slept long.). At the time of the report, PAIN (achy and cruddy), NASOPHARYNGITIS ("I got real cold"), PYREXIA (fever (101)), FATIGUE (felt really tired) and HYPERSOMNIA (slept long.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity, Palpitations, Temperature intolerance
Clinical narrative: 5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; 5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; 5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; soreness in the arm; 5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), TEMPERATURE INTOLERANCE (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), PALPITATIONS (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), DYSPNOEA (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) and CHEST DISCOMFORT (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    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 PAIN IN EXTREMITY (soreness in the arm) and TEMPERATURE INTOLERANCE (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that). On an unknown date, the patient experienced PALPITATIONS (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), DYSPNOEA (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) and CHEST DISCOMFORT (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that). On 25-Mar-2021, TEMPERATURE INTOLERANCE (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), PALPITATIONS (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), DYSPNOEA (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) and CHEST DISCOMFORT (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included LEVOTHYROXINE  and Antianxiety medication. Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity
Clinical narrative: soreness in her arm; shortness of breath and tightness in her chest; tightness in her chest and tightness in her chest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm), DYSPNOEA (shortness of breath and tightness in her chest) and CHEST DISCOMFORT (tightness in her chest and tightness in her chest) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination.     The patient's past medical history included no adverse drug effect. Concomitant products included "9 or 10 meds in the morning" and "4 meds in the afternoon".    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm), DYSPNOEA (shortness of breath and tightness in her chest) and CHEST DISCOMFORT (tightness in her chest and tightness in her chest). At the time of the report, PAIN IN EXTREMITY (soreness in her arm), DYSPNOEA (shortness of breath and tightness in her chest) and CHEST DISCOMFORT (tightness in her chest and tightness in her chest) outcome was unknown. Not Provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: sporadic rashes on both hands which have spread in tiny places all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (sporadic rashes on both hands which have spread in tiny places all over her body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (sporadic rashes on both hands which have spread in tiny places all over her body). At the time of the report, RASH (sporadic rashes on both hands which have spread in tiny places all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Redness like a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Redness like a rash) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 RASH ERYTHEMATOUS (Redness like a rash). At the time of the report, RASH ERYTHEMATOUS (Redness like a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose of Moderna COVID-19 vaccine on March 9th , 2021. Reports that is experiencing a redness , like a rash.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cleft palate, Ear infection, Eye disorder, Eye swelling, Muscle spasms
Clinical narrative: cleft pallet; sinus; ear infections; Muscle spasms in the upper right cheek; Left eye is hurting inside the eye; Left eye is swollen; Muscle spams under the right eye; This spontaneous case was reported by a consumer and describes the occurrence of CLEFT PALATE (cleft pallet) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (diagnosed with cancer in 2017). Concurrent medical conditions included Diabetes, Hypertension and Reflux esophagitis.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle spams under the right eye). On 05-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle spasms in the upper right cheek), EYE DISORDER (Left eye is hurting inside the eye) and EYE SWELLING (Left eye is swollen). On an unknown date, the patient experienced CLEFT PALATE (cleft pallet) (seriousness criterion medically significant), SINUSITIS (sinus) and EAR INFECTION (ear infections). At the time of the report, MUSCLE SPASMS (Muscle spams under the right eye) had resolved and MUSCLE SPASMS (Muscle spasms in the upper right cheek), EYE DISORDER (Left eye is hurting inside the eye), EYE SWELLING (Left eye is swollen), CLEFT PALATE (cleft pallet), SINUSITIS (sinus) and EAR INFECTION (ear infections) outcome was unknown.            No concomitant medications were reported. Treatment medication include ciprofloxacin (500 mg) and doxycycline to treat sinus infection.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  She stated that it would be okay if the safety department contacts her if additional information is needed.   This case was linked to MOD-2021-036432 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: cleft pallet; sinus; ear infections; Muscle spasms in the upper right cheek; Left eye is hurting inside the eye; Left eye is swollen; Muscle spams under the right eye; This spontaneous case was reported by a consumer and describes the occurrence of CLEFT PALATE (cleft pallet) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (diagnosed with cancer in 2017). Concurrent medical conditions included Diabetes, Hypertension and Reflux esophagitis.   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle spams under the right eye). On 05-Mar-2021, the patient experienced MUSCLE SPASMS (Muscle spasms in the upper right cheek), EYE DISORDER (Left eye is hurting inside the eye) and EYE SWELLING (Left eye is swollen). On an unknown date, the patient experienced CLEFT PALATE (cleft pallet) (seriousness criterion medically significant), SINUSITIS (sinus) and EAR INFECTION (ear infections). At the time of the report, MUSCLE SPASMS (Muscle spams under the right eye) had resolved and MUSCLE SPASMS (Muscle spasms in the upper right cheek), EYE DISORDER (Left eye is hurting inside the eye), EYE SWELLING (Left eye is swollen), CLEFT PALATE (cleft pallet), SINUSITIS (sinus) and EAR INFECTION (ear infections) outcome was unknown.            No concomitant medications were reported. Treatment medication include ciprofloxacin (500 mg) and doxycycline to treat sinus infection.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.  She stated that it would be okay if the safety department contacts her if additional information is needed.   This case was linked to MOD-2021-036432 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Tested positive for Covid) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Hypothyroidism.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY), LISINOPRIL, ROPINIROLE, GABAPENTIN, PRAVASTATIN and NAPROXEN (NAPROSYN E) for an unknown indication.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Colitis, Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (gastrointestinal issues, diarrhea), DIARRHOEA (gastrointestinal issues, diarrhea) and COLITIS (Colitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021 at 3:00 AM, the patient experienced ABDOMINAL DISCOMFORT (gastrointestinal issues, diarrhea) and DIARRHOEA (gastrointestinal issues, diarrhea). On an unknown date, the patient experienced COLITIS (Colitis). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (gastrointestinal issues, diarrhea) and DIARRHOEA (gastrointestinal issues, diarrhea) had not resolved and COLITIS (Colitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient ended up with CDiff.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow-up received on 25-may-2021 included reporter email address. On 05-Aug-2021: Follow up received contains significant information: Events added: Colitis, CDiff
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid after first dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid after first dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid after first dose of vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: Positive.     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.   Concomitant medications were not reported. Treatment details not provided. Then the paitnet tested positive for Covid, Caller would like to know how to handle the second dose for the patient since she is outside the 36 day window.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema
Clinical narrative: redness reappeared; redness below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness reappeared) and VACCINATION SITE ERYTHEMA (redness below the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 ERYTHEMA (redness below the injection site). On 23-Mar-2021, the patient experienced ERYTHEMA (redness reappeared). On 16-Mar-2021, VACCINATION SITE ERYTHEMA (redness below the injection site) had resolved. At the time of the report, ERYTHEMA (redness reappeared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and Concomitant medicines were not reported   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-MAY-2021: Reporter details updated