Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Oral discomfort, Oral mucosal blistering, Oral pain, Oropharyngeal discomfort
Clinical narrative: bolus purple blisters, with black dots around them that started popping up all in her mouth; left arm stopped working; felt claustrophobic; gums in her mouth were so swollen that she could hardly close her mouth; 10 sores that are not going away; For the first time since the vaccine, she was able to lift her left arm over her head but it's still sore; For the first time since the vaccine, she was able to lift her left arm over her head but it's still sore/left leg had a vicious pain going through it; burning sensation; Mouth had sores; Diarrhea; Nothing tastes right; Things formed in her mouth then go away and then come back; Her mouth is extremely swollen; patient fell; headaches daily that range from intense to dull; Fatigue; She was throwing up; her doctor advised her not to get the 2nd dose; shingles on her left side in the head and neck area.; Her tongue was swollen and numb; Intense pain in her shin; Lots of zaps in her head; left hand was numb/left toes felt numb; her tongue was swollen; throat felt like it was closing up; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (bolus purple blisters, with black dots around them that started popping up all in her mouth), MOBILITY DECREASED (left arm stopped working), OROPHARYNGEAL DISCOMFORT (throat felt like it was closing up), CLAUSTROPHOBIA (felt claustrophobic) and HYPOAESTHESIA (left hand was numb/left toes felt numb) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure high, LEVOTHYROXINE for Thyroid disorder, SPIRONOLACTONE, ACETYLSALICYLIC ACID (ASPIRINE), TRAZODONE and LOSARTAN for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt like it was closing up), HYPOAESTHESIA (left hand was numb/left toes felt numb), SWOLLEN TONGUE (her tongue was swollen), HYPOAESTHESIA ORAL (Her tongue was swollen and numb), BONE PAIN (Intense pain in her shin) and HEAD DISCOMFORT (Lots of zaps in her head). On an unknown date, the patient experienced ORAL MUCOSAL BLISTERING (bolus purple blisters, with black dots around them that started popping up all in her mouth), MOBILITY DECREASED (left arm stopped working), CLAUSTROPHOBIA (felt claustrophobic), HERPES ZOSTER (shingles on her left side in the head and neck area.), GINGIVAL SWELLING (gums in her mouth were so swollen that she could hardly close her mouth), STOMATITIS (10 sores that are not going away), LIMB DISCOMFORT (For the first time since the vaccine, she was able to lift her left arm over her head but it's still sore), PAIN IN EXTREMITY (For the first time since the vaccine, she was able to lift her left arm over her head but it's still sore/left leg had a vicious pain going through it), BURNING SENSATION (burning sensation), ORAL PAIN (Mouth had sores), DIARRHOEA (Diarrhea), TASTE DISORDER (Nothing tastes right), ORAL DISCOMFORT (Things formed in her mouth then go away and then come back), MOUTH SWELLING (Her mouth is extremely swollen), FALL (patient fell), HEADACHE (headaches daily that range from intense to dull), FATIGUE (Fatigue), VOMITING (She was throwing up) and OFF LABEL USE (her doctor advised her not to get the 2nd dose). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Shingles, at an unspecified dose and frequency; GABAPENTIN for Hypoaesthesia, at an unspecified dose and frequency and PENICILLIN NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, ORAL MUCOSAL BLISTERING (bolus purple blisters, with black dots around them that started popping up all in her mouth), HYPOAESTHESIA ORAL (Her tongue was swollen and numb), GINGIVAL SWELLING (gums in her mouth were so swollen that she could hardly close her mouth), ORAL PAIN (Mouth had sores), ORAL DISCOMFORT (Things formed in her mouth then go away and then come back) and MOUTH SWELLING (Her mouth is extremely swollen) was resolving, MOBILITY DECREASED (left arm stopped working), OROPHARYNGEAL DISCOMFORT (throat felt like it was closing up), CLAUSTROPHOBIA (felt claustrophobic), HYPOAESTHESIA (left hand was numb/left toes felt numb), SWOLLEN TONGUE (her tongue was swollen), STOMATITIS (10 sores that are not going away), LIMB DISCOMFORT (For the first time since the vaccine, she was able to lift her left arm over her head but it's still sore), PAIN IN EXTREMITY (For the first time since the vaccine, she was able to lift her left arm over her head but it's still sore/left leg had a vicious pain going through it), BURNING SENSATION (burning sensation), BONE PAIN (Intense pain in her shin), HEAD DISCOMFORT (Lots of zaps in her head), DIARRHOEA (Diarrhea), TASTE DISORDER (Nothing tastes right), FALL (patient fell), HEADACHE (headaches daily that range from intense to dull), FATIGUE (Fatigue), VOMITING (She was throwing up) and OFF LABEL USE (her doctor advised her not to get the 2nd dose) outcome was unknown and HERPES ZOSTER (shingles on her left side in the head and neck area.) had resolved.        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.   Company Comment   Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  Patient was prescribed medicine for diarrhea. Patient was also prescribed steroid, anti-inflammatory for swelling of mouth and magic mouthwash.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up document was received. It contains patient's date of birth, treatment medication and adverse events. It contains significant information. On 21-Jul-2021: Follow up document was received. It includes concomitant Medication, and events outcome. It contains significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.