Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blister infected, Immunisation, Respiratory disorder, Rhinorrhoea, Sinus congestion
Clinical narrative: he received booster dose; blister on his little toe of left foot, which later got infected and he had spent a week in the hospital; Respiratory disorder; runny nose; sinus congestion/stuffed up head; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4134747-00), from a contactable consumer (Patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE (at the age of 67 years) for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for colitis ulcerative. The patient medical history included ongoing ulcerative colitis and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 14Mar2021 and dose 2 on 21Apr2021 (both with age at vaccination: 67 years), both intramuscular for COVID-19 immunisation. Patient experienced events of Infection on little Toe on left Foot/ It started out as a blister and non-serious respiratory issues, Runny nose, and stuffed up head with Humira (Adalimumab). On an unknown date in 2021, the patient experienced infection on little toe on left Foot/ It started out as a blister. In 2021, the patient experienced Respiratory issues, Runny Nose and Stuffed up Head with HUMIRA (Adalimumab). The patient developed a blister on his little toe of left foot, which later got infected, and he had spent a week in hospital. In 2021, after his Covid booster dose he had runny nose, stuffed up head and respiratory issues. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 14Mar2021, he received 1st dose of COVID-19 vaccine manufactured by Pfizer BioNTech. On 21Apr2021, he received 2nd dose manufactured by Pfizer BioNTech. On 2021, he received booster dose of COVID-19 vaccine manufactured by Pfizer BioNTech. The action taken for adalimumab was unknown. The outcome of event Blister infected was not recovered while for other events was unknown.   Causality for Humira (ADALIMUMAB): The reporter's causality for the event(s) of INFECTION ON RESPIRATORY ISSUES, RUNNY NOSE and STUFFED up HEAD was not provided. opinion is that the events of INFECTION ON LITTLE TOE ON LEFT FOOT/IT STARTED OUT AS A BLISTER, RESPIRATORY ISSUES, RUNNY NOSE and STUFFED up HEAD are not assessable.  Causality for Pfizer Biontech Covid-19 Vaccine for event Blister infected: Causality as per reporter (Drug/Vaccine): Not Reported. Respiratory disorder (Respiratory disorder), Runny nose (Rhinorrhoea), Sinus congestion (Sinus congestion): Causality as per reporter (Drug/Vaccine): Not Related.  The reporter's assessment of the causal relationship of event Blister infected with the suspect product 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.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided the event blister infected is assessed as unrelated to the usage of the vaccine and considered as an intercurrent illness while the causal association for the events respiratory issues, sinus congestion and runny nose cannot be excluded with the usage of the vaccine as per the case reported. The case will reassessed once additional information is available.