Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She could not get out of the bed because she was feeling sick; She could not get out of the bed because she was feeling sick; And her face is like, just a burning sensation like frostbite down to her eyes; I have swollen glands on my left side of my neck; I have like frostbite on my face down, my 2 cheeks, one is healed now but they were fiery yesterday; I am not feeling good; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown, Expiry date: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Single, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset May2022, outcome "recovering", described as "I am not feeling good"; FATIGUE (non-serious) with onset May2022, outcome "recovering", described as "Tiredness"; BURNING SENSATION (non-serious) with onset 19May2022, outcome "recovering", described as "And her face is like, just a burning sensation like frostbite down to her eyes"; FROSTBITE (non-serious) with onset 19May2022, outcome "not recovered", described as "I have like frostbite on my face down, my 2 cheeks, one is healed now but they were fiery yesterday"; LYMPHADENOPATHY (non-serious) with onset 19May2022, outcome "recovering", described as "I have swollen glands on my left side of my neck"; MALAISE (non-serious), BEDRIDDEN (non-serious) all with onset 19May2022, outcome "recovering" and all described as "She could not get out of the bed because she was feeling sick". The events "she could not get out of the bed because she was feeling sick", "and her face is like, just a burning sensation like frostbite down to her eyes", "i have swollen glands on my left side of my neck", "i have like frostbite on my face down, my 2 cheeks, one is healed now but they were fiery yesterday", "i am not feeling good" and "tiredness" required emergency room visit.  Additional Information: Reporter (Patient) stated, "Terrible reactions, the patient can't spend a lot of time talking to you. She had already spent a lot of time talking and she was not feeling good. She got the vaccine last Wednesday, the fourth booster and she felt alright. On Thursday morning, she couldn't get out of the bed, she was so sick and she had barely left bed and was Sunday. She have barely left other than to go to the bathroom and she was 90-year-old so it had just been a terrible challenge but she got something that was strange, she have like frostbite on my face down, her 2 cheeks, one was healed now but they were fiery yesterday and she had swollen glands on her left side of her neck now. She did have a reaction from one of the shot before (Further not clarified. Hence, captured suspect (unspecified medication) and event captured conservatively), she was not sure which one but it was nothing at all like this, it was like a extreme tiredness. This was so scary, so scary." When asked permission to file a safety report, Consumer stated, "Who was going to talk to me? As long as she can stay, she was ready to go back to bed with tiredness and whole thing, she was going to take the shower but she don't feel up to it and at 90-year-old, she can't spend that length of time. She was only conveying what has happened to me." But I wonder if there is something I should be doing, I haven't called my primary doctor, I was going to the emergency room at the hospital last night but I said I would wait till morning, I feel a lot better this morning really, I would lie if I say I wasn't feeling. I could not do this yesterday, I could not even talk to you yesterday so I don't know. I am just reporting a side effect I had you know and to see if there could be, my left cheek is still like frostbites." I also give this information to you, I gave this information 10 minutes ago while I was still on the phone that same number to call, if I needed any information. I think I am getting a lot of repeat information that I am not up to taking at the moment that's bothering me. There is a lot of waste of time, there is a lot of talk telling me about the vaccine that I don't need to know about all the vaccine. I only want to know if this side effect has been reported or is it unusual?" Consumer was unwilling to complete the report. Thus, further probing could not be done and product details (NDC#, UPC#, LOT#, Expiration date) and purchase details were unknown. Hence, limited information available over the call. LOT#: Patient stated, "Not now, I can't."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.