Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbness of tongue and lip; numbness of tongue and lip; change in sensation in right upper extremity, in hands; had a brief headache; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 5 (booster), 0.3ml single (Lot number: HH7595) at the age of 60 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "cardiovascular disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ATORVASTATIN taken for cardiovascular disorder (ongoing). Past drug history included: Amoxicillin, reaction(s): "rash"; Bactrim, reaction(s): "rash", notes: Sulfa antibiotics like Bactrim. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Date: 18Dec2020, LOT: EK5730, EXP: 31Mar2021), administration date: 18Dec2020, when the patient was 57-year-old, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE, manufacturer: Pfizer, Date: 08Jan2021, LOT: EL0142, EXP: 31Mar2021), administration date: 08Jan2021, when the patient was 57-year-old, for Covid-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Date: 28Sep2021, LOT:  EW0150, EXP: 31Oct2021), administration date: 28Sep2021, when the patient was 58-year-old, for Covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Date: 07Sep2022, LOT: GH9496, EXP: unknown), administration date: 07Sep2022, when the patient was 59-year-old, for Covid-19 immunization; flu vaccine (Route, Anatomical Location: left arm, Lot Number/ Expiry Date: unknown), administration date: 05Sep2023, when the patient was 60-year-old. The following information was reported: SENSORY DISTURBANCE (non-serious) with onset 21Sep2023, outcome "not recovered", described as "change in sensation in right upper extremity, in hands"; HEADACHE (non-serious) with onset 21Sep2023, outcome "recovered" (21Sep2023), described as "had a brief headache"; HYPOAESTHESIA ORAL (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 21Sep2023, outcome "not recovered" and all described as "numbness of tongue and lip".  Additional Information: Calling about the Covid Vaccine. Got shot this morning a little before 10AM. Caller clarified Covid Vaccine as Comirnaty. Got it in left deltoid. Has been doing fine until a little while ago. Having numbness of tongue and lip. Having a change in sensation in right upper extremity, in hands. It is mild. She is having no trouble swallowing and breathing. Her muscles seem fine. With her first dose she had arm pain. With second, third, and fourth doses it felt like they gave her saline. She was like really did they give her the shot.  This one she thought should she do anything different.  She hopes this doesn't stop her from getting further shots.  She had a brief headache for about 30 seconds just before the changes occurred then the headache went away. All her Covid vaccines have been manufactured by Pfizer. She got a flu shot a little more than 2 weeks ago. Flu shot name and manufacturer: unknown. Was given at the same (withheld) that she got Comirnaty at today. Specific Relevant Test: For Thromboembolic events with Thrombocytopenia: n/a .Treatment: she was thinking about taking half a Zyrtec of Benadryl, but if it would affect the efficacy she would hold off. It probably wouldn't hurt.  She would like to add that her headache returned just a tiny bit right now.  She gets side effect rash with Amoxicillin and Sulfa. Not a true allergic reaction but she longer takes them though. Clarified as Amoxicillin and Sulfa antibiotics like Bactrim.  Manufacturer of Amoxicillin and Sulfa antibiotics like Bactrim: unknown. She wouldn't have NDC/LOT/EXP to provide for those products she got the side effect rash from. That happened when she was 18 or 19 years old.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309866 Same patient, different vaccine dose and different event.;