Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: cellulitis; COVID-19/anosmia/taste is altered/constant coughing/fever/headache; bug bite on his forearm; he started getting diarrhea and assumed it was from doxycycline and the diarrhea began 1-2 days after starting Doxycycline; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (cellulitis) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Asthma (diagnosed with asthma about 10 years ago. Albuterol inhaler,uses it 2-3 times a year.). Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, ATORVASTATIN and APIXABAN (ELIQUIS) for an unknown indication.   On 19-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). In July 2022, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant), COVID-19 (COVID-19/anosmia/taste is altered/constant coughing/fever/headache), ARTHROPOD BITE (bug bite on his forearm) and DIARRHOEA (he started getting diarrhea and assumed it was from doxycycline and the diarrhea began 1-2 days after starting Doxycycline). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Jul-2022 to 29-Jul-2022 for COVID-19 treatment, at an unspecified dose and frequency; ACETYLSALICYLIC ACID, CAFFEINE (ANACIN [ACETYLSALICYLIC ACID;CAFFEINE]) at a dose of took 2 tablets once or twice and DOXYCYCLINE on 21-Jul-2022 at a dose of 100 milligram. At the time of the report, CELLULITIS (cellulitis), ARTHROPOD BITE (bug bite on his forearm), DIARRHOEA (he started getting diarrhea and assumed it was from doxycycline and the diarrhea began 1-2 days after starting Doxycycline), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown and COVID-19 (COVID-19/anosmia/taste is altered/constant coughing/fever/headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2022, SARS-CoV-2 test: (Negative) Negative. On 07-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Body temperature: 101.3 degree Celsius. On an unknown date, SARS-CoV-2 test: (Negative) Negative, (Negative) Negative and (Positive) PCR came back Positive.         NDC number of Paxlovid was reported as 0069-1085-30.  Patient had a bug bite on his forearm and thought it was a mosquito bite and  a couple days later this got bigger and redder and was not going away and lasted a couple weeks so then he went to the doctor and was diagnosed with cellulitis and does not know if it was a spider bite and he was then put on doxycycline from 21-Jul-2022.The patient was with a group of people that had Covid the week before so he thought he was exposed to them and better get tested and it was a negative PCR test on 21Jul2022 at 11:30am. On 24-Jul-2022, Patient had a positive home test, took a photo of home test, and was sent to the doctor. Doctor prescribed Paxlovid. Patient took Paxlovid for 5 days of the regimen and felt better. After 3 days after stopping Paxlovid, the rebound came worse than it was before and was tested positive on 07-Aug-2022..The most concerning thing to the caller was through out the entire course of Paxlovid, the patient had no adverse events, but had anosmia and symptoms of food tasted a little bit different after completing Paxlovid. Patient noticed that he could not smell anything. He noticed that somethings are not tasted quite right. Paxlovid medication affected his taste. After a day or so Paxlovid was over, patient was not paying attention to the things that did not taste quite right and did not notice anything.Patient started getting diarrhea after 1-2 days of doxycycline. After he got most recent PCR positive, he decided to get more home test kits, and was negative for two days. At the same time, he got the results from the PCR came back positive. Patient reported that, had no side effects and had zero side effects from all covid vaccines.  Company Comment This is a spontaneous case reported by a patient concerning an 82-year-old male patient with no relevant medical history, who experienced the unexpected, serious, medically significant event of Cellulitis and the unexpected, non-serious AESI of COVID-19, which occurred on an unknown date on the next month after the fourth dose of mRNA-1273 vaccination schedule, used as the second booster dose, previously vaccinated with three doses of Pfizer COVID-19 vaccine. The patient experienced symptoms and potential positive self home test several days ago and called his doctor who prescribed Paxlovid, which he took for five days and felt better. About three days after he stopped the medication, he rebounded and it came back worse than before. The patient tested positive about a week after he stopped Paxlovid. He was concerned about anosmia and and taste disorder but had also headache (began two days after he stopped Paxlovid) and pyrexia. When the patient started Paxlovid, he had a bug bite on his forearm that turned into a cellulitis, that was treated with Doxycycline by a doctor. The non-serious event of bug bite could be due to Arthropod bite, however, since the outcome and the exact date onset of the events are unknown, Authority was conservatively retained as related. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a patient concerning an 82-year-old male patient with no relevant medical history, who experienced the unexpected, serious, medically significant event of Cellulitis and the unexpected, non-serious AESI of COVID-19, which occurred on an unknown date on the next month after the fourth dose of mRNA-1273 vaccination schedule, used as the second booster dose, previously vaccinated with three doses of Pfizer COVID-19 vaccine. The patient experienced symptoms and potential positive self home test several days ago and called his doctor who prescribed Paxlovid, which he took for five days and felt better. About three days after he stopped the medication, he rebounded and it came back worse than before. The patient tested positive about a week after he stopped Paxlovid. He was concerned about anosmia and and taste disorder but had also headache (began two days after he stopped Paxlovid) and pyrexia. When the patient started Paxlovid, he had a bug bite on his forearm that turned into a cellulitis, that was treated with Doxycycline by a doctor. The non-serious event of bug bite could be due to Arthropod bite, however, since the outcome and the exact date onset of the events are unknown, Authority was conservatively retained as related. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.