Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site pain, Vaccination site rash
Clinical narrative: episode of diarrhea; worsened left upper arm rash new burning and hurting; three inch rash on left upper arm, which worsened and spread down left arm to left wrist; really sore left arm/new burning and hurting; really severe chills, lasted for seven weeks; left hand rash 'jumped' to the right arm; hive like rash got bigger like 4 inches long; arm soreness; sudden tiredness/fatigue to beat the band; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), URTICARIA (hive like rash got bigger like 4 inches long), DIARRHOEA (episode of diarrhea), BURNING SENSATION (worsened left upper arm rash new burning and hurting) and FATIGUE (sudden tiredness/fatigue to beat the band) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  The patient's past medical history included Lung disease since an unknown date, Autoimmune disorder (Auto immune disease), Ulcer since an unknown date, Cystitis since an unknown date and Seizure since an unknown date. Concomitant products included PENTOSAN POLYSULFATE SODIUM (ELMIRON) for Cystitis, MONTELUKAST SODIUM (SINGULAIR) for Lung disease, PHENOBARBITAL for Seizure, RABEPRAZOLE SODIUM (ACIPHEX) for Ulcer, PREDNISONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (sudden tiredness/fatigue to beat the band). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 20-Feb-2021, the patient experienced URTICARIA (hive like rash got bigger like 4 inches long). On an unknown date, the patient experienced DIARRHOEA (episode of diarrhea), BURNING SENSATION (worsened left upper arm rash new burning and hurting), VACCINATION SITE RASH (three inch rash on left upper arm, which worsened and spread down left arm to left wrist), VACCINATION SITE PAIN (really sore left arm/new burning and hurting), CHILLS (really severe chills, lasted for seven weeks) and RASH (left hand rash 'jumped' to the right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Fatigue, at an unspecified dose and frequency; PREDNISONE for Itching, Rash and Burn, at a dose of 10 mg and PREDNISONE for Rash over arms, at a dose of 10 mg. At the time of the report, PAIN IN EXTREMITY (arm soreness), URTICARIA (hive like rash got bigger like 4 inches long), BURNING SENSATION (worsened left upper arm rash new burning and hurting), FATIGUE (sudden tiredness/fatigue to beat the band), VACCINATION SITE RASH (three inch rash on left upper arm, which worsened and spread down left arm to left wrist), VACCINATION SITE PAIN (really sore left arm/new burning and hurting), CHILLS (really severe chills, lasted for seven weeks) and RASH (left hand rash 'jumped' to the right arm) outcome was unknown and DIARRHOEA (episode of diarrhea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported additional treatment was steroid cream.    This case was linked to MOD-2021-095078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded. On 07-Jun-2021: follow-up received on 07 Jun 2021. Reporter details updated. Second dose details updated. Treatment details updated. This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Feb-2021. The most recent information was received on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), URTICARIA (hive like rash got bigger like 4 inches long), DIARRHOEA (episode of diarrhea), BURNING SENSATION (worsened left upper arm rash new burning and hurting) and FATIGUE (sudden tiredness/fatigue to beat the band) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  The patient's past medical history included Lung disease since an unknown date, Autoimmune disorder (Auto immune disease), Ulcer since an unknown date, Cystitis since an unknown date and Seizure since an unknown date. Concomitant products included PENTOSAN POLYSULFATE SODIUM (ELMIRON) for Cystitis, MONTELUKAST SODIUM (SINGULAIR) for Lung disease, PHENOBARBITAL for Seizure, RABEPRAZOLE SODIUM (ACIPHEX) for Ulcer, PREDNISONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (sudden tiredness/fatigue to beat the band). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 20-Feb-2021, the patient experienced URTICARIA (hive like rash got bigger like 4 inches long). On an unknown date, the patient experienced DIARRHOEA (episode of diarrhea), BURNING SENSATION (worsened left upper arm rash new burning and hurting), VACCINATION SITE RASH (three inch rash on left upper arm, which worsened and spread down left arm to left wrist), VACCINATION SITE PAIN (really sore left arm/new burning and hurting), CHILLS (really severe chills, lasted for seven weeks) and RASH (left hand rash 'jumped' to the right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Fatigue, at an unspecified dose and frequency; PREDNISONE for Itching, Rash and Burn, at a dose of 10 mg and PREDNISONE for Rash over arms, at a dose of 10 mg. At the time of the report, PAIN IN EXTREMITY (arm soreness), URTICARIA (hive like rash got bigger like 4 inches long), BURNING SENSATION (worsened left upper arm rash new burning and hurting), FATIGUE (sudden tiredness/fatigue to beat the band), VACCINATION SITE RASH (three inch rash on left upper arm, which worsened and spread down left arm to left wrist), VACCINATION SITE PAIN (really sore left arm/new burning and hurting), CHILLS (really severe chills, lasted for seven weeks) and RASH (left hand rash 'jumped' to the right arm) outcome was unknown and DIARRHOEA (episode of diarrhea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported additional treatment was steroid cream.    This case was linked to MOD-2021-095078 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: No specific follow-up information recorded. On 07-Jun-2021: follow-up received on 07 Jun 2021. Reporter details updated. Second dose details updated. Treatment details updated.