Sex: M
Vaccine: COVID19, FLUX
Symptoms: Agitation, Hypoaesthesia, Lymphadenopathy, Mass, Presyncope
Clinical narrative: Lump on the bone of the upper jaw on the inside, way above the cheek/Swollen lymph node or not; Lump on the bone of the upper jaw on the inside, way above the cheek/Swollen lymph node or not; His jaw went numb on the same side that he got the shot/Numb on his upper and lower jaw, shin and his ear/like getting Novocain; He almost passed out; He freaked himself out/Upset; Face went numb on the same side/Numbness in jaw; This spontaneous case from the Regulatory Authority was received on 08-Jun-2021 from other non-healthcare professional (patient's mother) with additional document received via Med Communication (reference number: SEQW21-01414) and concerned an adult, male patient. At the time of this report, the patient was 40-year-old.   The patient's medical history and concomitant medications were not reported.   On 28-Sep-2020, reported as last fall, the patient was vaccinated with Seqirus' influenza virus vaccine polyvalent (reported as quadrivalent influenza vaccine) (brand not specified; anatomical location, route of administration, dose and indication: not reported). The batch number reported was PLOOZZ9091 or PLOOZZ7091.  On the same day, after receiving influenza virus vaccine polyvalent, the patient's face went numb and had numbness in his jaw.   On an unknown date in Sep-2020, four to five hours later, the patient recovered from the event.   On 11-May-2021, around 06:00 p.m., the patient received first dose of non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; anatomical location: left side as reported; route of administration, dose and indication: not reported). The batch number was not reported.  On the same day, after an hour to an hour and a half of receiving first dose of non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient's chin, the left upper and lower jaw went numb as well as his left ear, which was on the same side as his injection. His hearing was okay. The patient said it was like getting Novocain (procaine). He went back to the emergency room (ER) and was told since the vaccine people were already gone, they could not help hum unless he wanted to be checked into the ER or he could go home. He hung out in the waiting room for three hours in case something else went wrong and then went home. The numbness was more intense after receiving Pfizer BioNTech COVID-19 vaccine.   On 12-May-2021, reported as this morning, the patient felt a lump on the bone of the upper jaw on the inside, was above the cheek and he was still numb. The patient stated that he almost passed out and the patient's mother reported that it was because he freaked himself out, not from the vaccine. The reporter was unable to determine if the lump he had on his jaw was a swollen lymph node or not and referred to health care professional (HCP) for evaluation.  Also, the reporter asked if this could be considered as bad allergic reaction. The patient reported adverse events to the day surgery unit ('DSU' as reported).   At the time of initial reporting on 08-Jun-2021, the patient had not recovered from the events of 'numbness', 'agitated', 'swollen lymph nodes' and 'mass'.   The outcome of event 'near fainting' was not reported.   The reporter did not provide causality assessment to influenza virus vaccine polyvalent. The reporter wanted to know what ingredients of vaccines could be causing this reaction. Also, the reporter stated that her son had a side effect after the first dose of the Pfizer BioNTech COVID-19 vaccine.  Case updated on 26-Apr-2022: Correction made to information received on 08-Jun-2021: Regulatory authority was deleted from Intermediary field and Report Sent to Regulatory Authority by Reporter was changed from 'Yes' to 'Unk'. No changes in the narrative.  Company comment: An adult, male patient was vaccinated with influenza virus vaccine polyvalent on 28-Sep-2020. On the same day, after receiving influenza virus vaccine polyvalent, the patient's face went numb and had numbness in his jaw. On 11-May-2021, the patient received first dose of non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. After an hour to an hour and a half of receiving COVID-19 vaccine, the patient's chin, the left upper and lower jaw went numb as well as his left ear, which was on the same side as his injection. The patient felt a lump on the bone of the upper jaw and he almost passed out and the patient's mother reported that it was because he freaked himself out, not from the vaccine. Causality is assessed as possibly related for first occurrence of hypoaesthesia, considering plausible chronology. All other events are assessed as not related, due to implausible chronology and alternative aetiology. (Covid 19 vaccine).; Reporter's Comments: The reporter wanted to know what ingredients of vaccines could be causing this reaction. Also, the reporter stated that her son had a side effect after the first dose of the Pfizer BioNTech COVID-19 vaccine.; Sender's Comments: An adult, male patient was vaccinated with influenza virus vaccine polyvalent on 28-Sep-2020. On the same day, after receiving influenza virus vaccine polyvalent, the patient's face went numb and had numbness in his jaw. On 11-May-2021, the patient received first dose of non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. After an hour to an hour and a half of receiving COVID-19 vaccine, the patient's chin, the left upper and lower jaw went numb as well as his left ear, which was on the same side as his injection. The patient felt a lump on the bone of the upper jaw and he almost passed out and the patient's mother reported that it was because he freaked himself out, not from the vaccine. Causality is assessed as possibly related for first occurrence of hypoaesthesia, considering plausible chronology. All other events are assessed as not related, due to implausible chronology and alternative aetiology. (Covid 19 vaccine).