Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pigmentation disorder, Pyrexia, Respiratory tract infection
Clinical narrative: Pain on gums; Body aches; High temperature (102F); Blistering on lips ("like a giant cold sore, but not a cold sore"); Brown coloration on mouth; Woke up in a puddle of sweat; Dryness on mouth; Soreness on mouth; Bad respiratory infection ("worse than before"); This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (ASPRIN), METOPROLOL, TRIMEBUTINE MALEATE (BUMETIN [TRIMEBUTINE MALEATE]), EZETIMIBE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR), MONTELUKAST SODIUM (MONTELUCAST), ALBUTEROL [SALBUTAMOL], AZELASTIN [AZELASTINE] and GLYCERYL TRINITRATE (NITROLINGUAL) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")) (seriousness criterion medically significant). On 24-Mar-2021, the patient experienced PIGMENTATION DISORDER (Brown coloration on mouth), HYPERHIDROSIS (Woke up in a puddle of sweat), DRY MOUTH (Dryness on mouth) and ORAL PAIN (Soreness on mouth). On 27-Mar-2021, the patient experienced LIP BLISTER (Blistering on lips ("like a giant cold sore, but not a cold sore")). On an unknown date, the patient experienced GINGIVAL PAIN (Pain on gums), PAIN (Body aches) and PYREXIA (High temperature (102F)). At the time of the report, RESPIRATORY TRACT INFECTION (Bad respiratory infection ("worse than before")), HYPERHIDROSIS (Woke up in a puddle of sweat), DRY MOUTH (Dryness on mouth), ORAL PAIN (Soreness on mouth), LIP BLISTER (Blistering on lips ("like a giant cold sore, but not a cold sore")), GINGIVAL PAIN (Pain on gums), PAIN (Body aches) and PYREXIA (High temperature (102F)) had resolved and PIGMENTATION DISORDER (Brown coloration on mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: high (High) 102 F.         Patient reported that patient did not seek medical attention for any of the reported symptoms. Patient reported that "patient received some Tylenol, at the beginning after symptoms following second dose". No additional information reported.  Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported event and positive rechallenge, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported event and positive rechallenge, a causal relationship cannot be excluded.