Age: 68.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Abdominal discomfort, Culture stool, Diarrhoea, Full blood count, Metabolic function test
Clinical narrative: Stomach upset; Diarrhea; Tooth abscess; Tooth pain; This is a solicited report based on the information received by Pfizer from Regulatory Authority Number: EW0173) as DOSE 2, SINGLE for covid-19 immunisation; clindamycin HCL (CLINDAMYCIN HCL), oral from 22Oct2021 (Batch/Lot number was not reported) to 01Nov2021, at 300 mg (4 in 1 D) for tooth abscess; Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous from 14Apr2021 (Batch/Lot number was not reported) to 03Aug2021, at 150 mg (1 in 2 wk.) for moderate to severe chronic plaque psoriasis. Medical history included smoking (the patient stopped smoking three and a half years ago as of 08Nov2021), hearing problem (He had hearing problems and could not hear in one ear since childhood and had to wear a hearing aid.), alcohol use: mixed drinks or beer occasionally (started 1967), tobacco use: 20 cigarette sticks a day (started 1967), carpal tunnel, acid reflux, diabetes, high blood pressure and low thyroid hormones. The patient stopped smoking three and a half years ago as of 08Nov2021. He had hearing problems and could not hear in one ear since childhood and had to wear a hearing aid. No known allergy. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for gastrooesophageal reflux disease, start and stop date were not reported; metformin (METFORMIN) taken for diabetes mellitus, start and stop date were not reported; lisinopril taken for hypertension, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for hypothyroidism, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 via intramuscular on 31Mar2021 (Lot number: ER8730) for COVID-19 vaccination. In Oct2021, the patient experienced tooth pain. On 14Oct2021, the patient experienced tooth abscess. On 25Oct2021, the patient experienced stomach upset and diarrhea. On 01Nov2021, the tooth abscess resolved. in Nov2021, the tooth pain resolved. clindamycin was also considered suspect. The patient developed tooth pain three to four days before he was diagnosed with a tooth abscess and was on antibiotics at the time of report. On 27Oct2021, he had his tooth extracted due to the abscess. He was initially advised to use Clindamycin for seven days however since they were not able to do the tooth extraction right away, the doctor advised him to extend Clindamycin use for another week. He was brought to the emergency room last week due to diarrhea and stomach upset and had stool culture, complete blood count and complete metabolic panel done. Since the diarrhea had not resolved completely, he was advised to have unspecified laboratory tests in a couple of weeks from now. Reporter left the SKYRIZI pen in the freezer that was why he was not able to take it that day and then waiting for a replacement. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 31Mar2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 28Apr2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with PROBIOTIC. The patient underwent lab tests and procedures which included stool culture: result unknown in Nov2021, complete blood count: result unknown in Nov2021, metabolic panel: result unknown in Nov2021, x-ray: result unknown on 14Oct2021. The action taken in response to the events for clindamycin HCL and risankizumab was unknown. The outcome of stomach upset and diarrhea was recovering, outcome of tooth abscess was recovered on 01Nov2021 and tooth pain was recovered in Nov2021. Check all appropriate to adverse reaction for other medically important condition.  Causality for Skyrizi(Risankizumab): The reporter's causality for the events of tooth abscess, tooth pain, stomach upset and diarrhea with Skyrizi (Risankizumab) was no reasonable possibility.  Causality for clindamycin: The reporter's causality for the events of tooth abscess and tooth pain was not reported, of events stomach upset and diarrhea with clindamycin was probable.  The reporter's assessment of the causal relationship of all events with the suspect vaccine BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's assessment of the causal relationship of the events tooth abscess and tooth pain with clindamycin was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    Pfizer is a marketing authorization holder of clindamycin hcl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of clindamycin hcl has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the Company considers the events stomach upset and diarrhea were possibly related to clindamycin therapy. Considering the temporal gap between the vaccination and the event onset, stomach upset and diarrhea were unrelated to suspect vaccine BNT162B2. The events tooth pain and tooth abscess were intercurrent conditions and unrelated to clindamycin and BNT162B2.