Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; recurrent RIME; soreness at back of left throat; redness at back of left throat; recurrence of pin point hemorrhages; lip swelling/bumpy texture to lip oral mucosa; small ulcer on the interior oral mucosa of left cheek; Prior vaccinations: 1st Dose: PFIZER BIONTECH COVID-19 VACCINE (07-APR-2021); 2nd Dose: PFIZER BIONTECH COVID-19 VACCINE (28-APR-2021); 3rd Dose: PFIZER BIONTECH COVID-19 VACCINE (18-NOV-2021); Prior vaccinations: 1st Dose: PFIZER BIONTECH COVID-19 VACCINE (07-APR-2021); 2nd Dose: PFIZER BIONTECH COVID-19 VACCINE (28-APR-2021); 3rd Dose: PFIZER BIONTECH COVID-19 VACCINE (18-NOV-2021); This spontaneous case was reported by a physician and describes the occurrence of HAEMORRHAGE (recurrence of pin point hemorrhages) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Burning lips (On August 13 I began experiencing a burning lip sensation while traveling), Nasal congestion (On August 13), Sore throat (On August 13), Cough (On August 13), COVID-19 (tested positive with at home COVID 19 antigen test on August 15 (day 1 of COVId 19 infection and tested positive with again on day 10 with final negative test on day 16)), Ulceration, Hemorrhage (pin point hemmorhages, vesicles that spontaneously hemorrhaged involving oral mucosa only), Oral mucosal eruption (mostly effecting lower lip, tongue, and gums diagnosed with reactive infectious mucocutaneous eruption (RIME)) and Sinus infection (Sinus infection on 11/25/2022 treated with 10 day course of Augmentin 825 mg p.o. bid.) on 25-Nov-2022. Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (dose 1 Pfizer lot#ER8729) on 07-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (dose 3 Pfizer lot # FH80JO) on 18-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE (dose 2. Pfizer lot # EW0169) until 28-Apr-2021; for COVID-19 prophylaxis: Spikevax (dose 4 Moderna Lot 014B22A) on 28-Jun-2022; for Sinus infection: AUGMENTINE PLUS (10 day course 825 mg p.o. bid.) on 25-Nov-2022 and VALACYCLOVIR MYLAN (500 mg p.o. bid and is still ongoing) on 28-Nov-2022; for Oral infection: TACROLIMUS (topical), PREDNISONE (40 mg prednisone with decreasing taper over two weeks) and CLOBETASOL E (topical). Past adverse reactions to the above products included No adverse event with AUGMENTINE PLUS, CLOBETASOL E, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PREDNISONE, Spikevax, TACROLIMUS and VALACYCLOVIR MYLAN. Concomitant products included AMOXICILLIN SODIUM, AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AUGMENTIN SR) for Bacterial infection and Sinus infection, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for an unknown indication.    On 02-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced COVID-19 IMMUNISATION (Prior vaccinations: 1st Dose: PFIZER BIONTECH COVID-19 VACCINE (07-APR-2021); 2nd Dose: PFIZER BIONTECH COVID-19 VACCINE (28-APR-2021); 3rd Dose: PFIZER BIONTECH COVID-19 VACCINE (18-NOV-2021)) and INTERCHANGE OF VACCINE PRODUCTS (Prior vaccinations: 1st Dose: PFIZER BIONTECH COVID-19 VACCINE (07-APR-2021); 2nd Dose: PFIZER BIONTECH COVID-19 VACCINE (28-APR-2021); 3rd Dose: PFIZER BIONTECH COVID-19 VACCINE (18-NOV-2021)). On 03-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced HAEMORRHAGE (recurrence of pin point hemorrhages) (seriousness criterion medically significant), LIP SWELLING (lip swelling/bumpy texture to lip oral mucosa) and MOUTH ULCERATION (small ulcer on the interior oral mucosa of left cheek). On 05-Dec-2022, the patient experienced OROPHARYNGEAL PAIN (soreness at back of left throat) and ERYTHEMA (redness at back of left throat). On an unknown date, the patient experienced SINUSITIS (sinus infection) and ORAL MUCOSAL ERUPTION (recurrent RIME). The patient was treated with PREDNISONE ongoing from 06-Dec-2022 at a dose of 40 milligram; TACROLIMUS (topical) ongoing from 03-Dec-2022 at an unspecified dose and frequency and CLOBETASOL (topical) ongoing from 03-Dec-2022 at an unspecified dose and frequency. At the time of the report, HAEMORRHAGE (recurrence of pin point hemorrhages), LIP SWELLING (lip swelling/bumpy texture to lip oral mucosa), MOUTH ULCERATION (small ulcer on the interior oral mucosa of left cheek), OROPHARYNGEAL PAIN (soreness at back of left throat), ERYTHEMA (redness at back of left throat), SINUSITIS (sinus infection), ORAL MUCOSAL ERUPTION (recurrent RIME), COVID-19 IMMUNISATION (Prior vaccinations: 1st Dose: PFIZER BIONTECH COVID-19 VACCINE (07-APR-2021); 2nd Dose: PFIZER BIONTECH COVID-19 VACCINE (28-APR-2021); 3rd Dose: PFIZER BIONTECH COVID-19 VACCINE (18-NOV-2021)) and INTERCHANGE OF VACCINE PRODUCTS (Prior vaccinations: 1st Dose: PFIZER BIONTECH COVID-19 VACCINE (07-APR-2021); 2nd Dose: PFIZER BIONTECH COVID-19 VACCINE (28-APR-2021); 3rd Dose: PFIZER BIONTECH COVID-19 VACCINE (18-NOV-2021)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: Negative. On an unknown date, SARS-CoV-2 test: (Positive) tested positive with at home COVID 19 antigen test on August 15 day 1 of COVId 19 infection., (Positive) tested positive with again on day 10 and (Negative) final negative test on day 16.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient developed recurrent RIME that began 1 day after a fifth dose of COVID-19 vaccine. Initial symptoms on first day after vaccination included lip swelling, recurrence of pin point hemorrhages, bumpy texture to lip oral mucosa and a small ulcer on the interior oral mucosa of left cheek. Began topcial clobetasol and topical tacrolimus day one of vaccination and continuing. On morning of day 3, patient woke up with soreness and redness at back of left throat. Notified both dermatology and Dr. and started 40 mg of prednisone on day 4 after vaccination.  Company comment: This spontaneous case concerns a 58-year-old, female patient with medical history of COVID-19 infection, Reactive Infectious Mucocutaneous Eruption and Sinus infection, and past drug history of administration of three doses (doses 1, 2 and 3 in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine and a dose (dose 4 in the COVID-19 vaccination series) of the mRNA-1273 original vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products), who experienced the unexpected, serious (medically significant) event of haemorrhage (recurrence of pinpoint hemorrhages) and the unexpected, non-serious events of lip swelling, mouth ulceration, oropharyngeal pain, erythema, oral mucosal eruption and sinusitis. The events haemorrhage, lip swelling, mouth ulceration, oropharyngeal pain and erythema occurred beginning 1 day and up to 3 days after receiving a dose (dose 5 in the COVID-19 vaccination series) of the mRNA-1273 bivalent BA.4/BA.5 vaccine. The start dates of the other events were not provided, hence, the onset latency could not be assessed. It was reported that on August 13 (year not provided), the patient experienced a burning lip sensation while traveling. Upon returning home, she developed nasal congestion, sore throat and cough, and tested positive with a home COVID-19 Antigen test on August 15 (day 1 of COVID-19 infection). She again tested positive on day 10 with final negative test on day 16. During this time, the patient also developed ulcerations, pinpoint hemorrhages, vesicles that spontaneously hemorrhaged involving the oral mucosa only and mostly affecting the lower lip, tongue and gums. She was then diagnosed with Reactive Infectious Mucocutaneous Eruption (RIME). Treatment included prednisone 40 mg with tapering doses over 2 weeks, as well as topical tacrolimus and topical clobetasol. A swab for bacterial infection was negative. One week prior to vaccination, the patient had a sinus infection and was treated with a 10-day course of Augmentin (amoxicillin/clavulanate) 825 mg twice daily (bid). After 3 days, she was given valacyclovir 500 mg bid in preparation for the fifth dose of COVID-19 vaccine. One day after receiving the fifth dose of the mRNA-1273 bivalent BA.4/BA.5 vaccine, it was reported that the patient developed recurrent RIME. She experienced lip swelling, recurrence of pinpoint hemorrhages, bumpy texture of the lip oral mucosa, and a small ulcer on the interior oral mucosa of the left cheek. The patient used topcial clobetasol and topical tacrolimus. After 2 days, the patient woke up with soreness and redness at the back of left throat. The following day, the patient notified her doctors and she was started on 40 mg of prednisone. The outcomes of the events were unknown at the time of the report. The medical history of RIME remains a confounder for the events haemorrhage, lip swelling, mouth ulceration, oropharyngeal pain, erythema and oral mucosal eruption which are common symptoms of this reactive inflammatory mucositis. Of note, the history of COVID-19 infection may be a contributing factor to the development of RIME since there have been reports of multiple cutaneous manifestations of SARS-CoV-2 infection. The history of Sinus infection remains a confounder for the event sinusitis. The benefit-risk relationship of the mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 58-year-old, female patient with medical history of COVID-19 infection, Reactive Infectious Mucocutaneous Eruption and Sinus infection, and past drug history of administration of three doses (doses 1, 2 and 3 in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 mRNA vaccine and a dose (dose 4 in the COVID-19 vaccination series) of the mRNA-1273 original vaccine (revaccination with different COVID-19 vaccine and interchange of vaccine products), who experienced the unexpected, serious (medically significant) event of haemorrhage (recurrence of pinpoint hemorrhages) and the unexpected, non-serious events of lip swelling, mouth ulceration, oropharyngeal pain, erythema, oral mucosal eruption and sinusitis. The events haemorrhage, lip swelling, mouth ulceration, oropharyngeal pain and erythema occurred beginning 1 day and up to 3 days after receiving a dose (dose 5 in the COVID-19 vaccination series) of the mRNA-1273 bivalent BA.4/BA.5 vaccine. The start dates of the other events were not provided, hence, the onset latency could not be assessed. It was reported that on August 13 (year not provided), the patient experienced a burning lip sensation while traveling. Upon returning home, she developed nasal congestion, sore throat and cough, and tested positive with a home COVID-19 Antigen test on August 15 (day 1 of COVID-19 infection). She again tested positive on day 10 with final negative test on day 16. During this time, the patient also developed ulcerations, pinpoint hemorrhages, vesicles that spontaneously hemorrhaged involving the oral mucosa only and mostly affecting the lower lip, tongue and gums. She was then diagnosed with Reactive Infectious Mucocutaneous Eruption (RIME). Treatment included prednisone 40 mg with tapering doses over 2 weeks, as well as topical tacrolimus and topical clobetasol. A swab for bacterial infection was negative. One week prior to vaccination, the patient had a sinus infection and was treated with a 10-day course of Augmentin (amoxicillin/clavulanate) 825 mg twice daily (bid). After 3 days, she was given valacyclovir 500 mg bid in preparation for the fifth dose of COVID-19 vaccine. One day after receiving the fifth dose of the mRNA-1273 bivalent BA.4/BA.5 vaccine, it was reported that the patient developed recurrent RIME. She experienced lip swelling, recurrence of pinpoint hemorrhages, bumpy texture of the lip oral mucosa, and a small ulcer on the interior oral mucosa of the left cheek. The patient used topcial clobetasol and topical tacrolimus. After 2 days, the patient woke up with soreness and redness at the back of left throat. The following day, the patient notified her doctors and she was started on 40 mg of prednisone. The outcomes of the events were unknown at the time of the report. The medical history of RIME remains a confounder for the events haemorrhage, lip swelling, mouth ulceration, oropharyngeal pain, erythema and oral mucosal eruption which are common symptoms of this reactive inflammatory mucositis. Of note, the history of COVID-19 infection may be a contributing factor to the development of RIME since there have been reports of multiple cutaneous manifestations of SARS-CoV-2 infection. The history of Sinus infection remains a confounder for the event sinusitis. The benefit-risk relationship of the mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.