Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Mouth ulceration, Oral herpes
Clinical narrative: 100.2 degrees F fever; 83% oxygen saturation dropped.; mouth ulcers; huge cold sore; headache; joint pain; she could not get up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), MOUTH ULCERATION (mouth ulcers), ARTHRALGIA (joint pain), ORAL HERPES (huge cold sore) and PYREXIA (100.2 degrees F fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date, Autoimmune arthritis since an unknown date and Tinnitus since an unknown date. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), MONTELUKAST SODIUM (SINGULAIR), GABAPENTIN, CELECOXIB (CELEBREX), HYDROCHLOROTHIAZIDE, COLECALCIFEROL (VITAMIN D 3), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA), LOSARTAN, SALBUTAMOL (ALBUTEROL HFA), ZOLPIDEM TARTRATE (AMBIEN), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), MAGNESIUM, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 24 HOUR), GUAIFENESIN (MUCINEX) and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.    On 31-Mar-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache), ARTHRALGIA (joint pain) and ASTHENIA (she could not get up). On 02-Apr-2021, the patient experienced MOUTH ULCERATION (mouth ulcers) and ORAL HERPES (huge cold sore). On 04-Apr-2021, the patient experienced PYREXIA (100.2 degrees F fever) and OXYGEN SATURATION DECREASED (83% oxygen saturation dropped.). At the time of the report, HEADACHE (headache), MOUTH ULCERATION (mouth ulcers), ARTHRALGIA (joint pain), ORAL HERPES (huge cold sore), PYREXIA (100.2 degrees F fever), OXYGEN SATURATION DECREASED (83% oxygen saturation dropped.) and ASTHENIA (she could not get up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Pyrexia: 100.2 degrees F.         Reported Treatment: "Hydrocodone for chronic pain that I am already prescribed, Benadryl, acyclovir 500 mg and ointment for cold sore." Concomitant Medication: Lipo-Flavonoid for Tinnitus Patient stated that she has contacted and followed up with her healthcare provider and dentist regarding these symptoms experienced.    This case was linked to MOD21-071120 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), MOUTH ULCERATION (mouth ulcers), ARTHRALGIA (joint pain), ORAL HERPES (huge cold sore) and PYREXIA (100.2 degrees F fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date, Autoimmune arthritis since an unknown date and Tinnitus since an unknown date. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), MONTELUKAST SODIUM (SINGULAIR), GABAPENTIN, CELECOXIB (CELEBREX), HYDROCHLOROTHIAZIDE, COLECALCIFEROL (VITAMIN D 3), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR HFA), LOSARTAN, SALBUTAMOL (ALBUTEROL HFA), ZOLPIDEM TARTRATE (AMBIEN), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), MAGNESIUM, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 24 HOUR), GUAIFENESIN (MUCINEX) and ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) for an unknown indication.    On 31-Mar-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache), ARTHRALGIA (joint pain) and ASTHENIA (she could not get up). On 02-Apr-2021, the patient experienced MOUTH ULCERATION (mouth ulcers) and ORAL HERPES (huge cold sore). On 04-Apr-2021, the patient experienced PYREXIA (100.2 degrees F fever) and OXYGEN SATURATION DECREASED (83% oxygen saturation dropped.). At the time of the report, HEADACHE (headache), MOUTH ULCERATION (mouth ulcers), ARTHRALGIA (joint pain), ORAL HERPES (huge cold sore), PYREXIA (100.2 degrees F fever), OXYGEN SATURATION DECREASED (83% oxygen saturation dropped.) and ASTHENIA (she could not get up) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Pyrexia: 100.2 degrees F.         Reported Treatment: "Hydrocodone for chronic pain that I am already prescribed, Benadryl, acyclovir 500 mg and ointment for cold sore." Concomitant Medication: Lipo-Flavonoid for Tinnitus Patient stated that she has contacted and followed up with her healthcare provider and dentist regarding these symptoms experienced.    This case was linked to MOD21-071120 (E2B Linked Report).; Sender's Comments:  MOD21-071120:MOD-2021-069855  1st dose case