Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Middle ear effusion, Product administered at inappropriate site
Clinical narrative: Ear ache/fluid in the ear/drainage on the left side of head. 2 weeks and still not cleared up; Fluid in the ear/drainage on the left side of head; headache; throat drainage; fatigue; left ear feeling clogged; lymph node swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 31Mar2021 10:30 (Lot number: ER8734) at the age of 42 years as dose 2,single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, intramuscular, Lot number: EN4199, timings: 13:30, Anatomical site of injection: Shoulder), administration date: 03Mar2021, when the patient was 42 years old, for covid-19 immunisation, reaction(s): "The patient had no side effects after first dose.".  The following information was reported: EAR PAIN (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Ear ache/fluid in the ear/drainage on the left side of head. 2 weeks and still not cleared up"; OTORRHOEA (non-serious) with onset 01Apr2021 05:30, outcome "not recovered", described as "Fluid in the ear/drainage on the left side of head"; HEADACHE (non-serious) with onset 31Mar2021 22:30, outcome "unknown", described as "headache"; UPPER-AIRWAY COUGH SYNDROME (non-serious) with onset 31Mar2021 22:30, outcome "unknown", described as "throat drainage"; FATIGUE (non-serious) with onset 31Mar2021 22:30, outcome "unknown", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 31Mar2021, outcome "not recovered", described as "lymph node swelling"; EAR DISCOMFORT (non-serious) with onset 31Mar2021 22:30, outcome "not recovered", described as "left ear feeling clogged". The events "ear ache/fluid in the ear/drainage on the left side of head. 2 weeks and still not cleared up", "fluid in the ear/drainage on the left side of head", "lymph node swelling" and "left ear feeling clogged" were evaluated at the physician office visit. Therapeutic measures were taken as a result of ear pain, otorrhoea, ear discomfort.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No, other medications the patient received within 2 weeks of vaccination. Anatomical site of injection for both dose was shoulder. The patient experienced headache, left ear feeling clogged, throat drainage, fatigue, began 12 hrs post vaccine dose of 2nd dose. Left ear pain plus lymph node swelling continued for 2 weeks until the patient went to ENT specialist, ENT did not recognize any issue. Left ear still felt full of fluid/ water in ear as of 23Feb2022. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has been tested for COVID-19. No, Allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.   Amendment: This follow-up report is being submitted to amend previous information: added event "Fluid in the ear/drainage on the left side of head".  Follow up(01Mar2022): This is a follow up-spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported in response to consumer letter sent via follow-up letter which included that:  Updated information: Relevant medical history was added as none. Historical vaccine for first dose added route of administration, site of administration (shoulder) was added. For second dose route of administration, site of administration (shoulder) and Lot umber was added. New events headache, throat drainage, fatigue and lymph node swelling, ear feels clogged were added.