Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hypoaesthesia, Hypoaesthesia oral, Investigation
Clinical narrative: severe pain between her shoulder blades; sore throat; neck stiffness or sore/left side of her neck was very sore; tongue was swollen; tongue changing color to green and then to gray; roof of her mouth was like she had burned the roof of her mouth and was peeling and very red and very sore; burning sensation inside the mouth/was like she had burned the roof of her mouth and was peeling and very red and very sore; lips got like skin peeling off and very numb, no swelling; the tip of her tongue got very red like she had burned it; numbness on the tongue and lips/tongue, lips and mouth still numb and tingling; with her tongue, lips and mouth still numb and tingling; her lips were red and tingling and swelling; Chills; slight fever; sore arm; some other times the left cheek (tingling); left cheek was swelling; Her left cheek only will become numb/Her shoulder blades will get numb; This is a spontaneous report received from a Nurse from medical information team.  A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 as dose 1, single (Lot number: LM2216) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "latex allergy", start date: 2014 (unspecified if ongoing), notes: 10 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; IM right arm; Lot unknown), administration date: 10Jan2021, when the patient was 66-year-old, for COVID-19 immunisation, reaction(s): "sore arm", "chills", "feels a little blah"; BNT162b2 (Dose 2, single; IM she would guess probably right arm again; Lot unknown), administration date: 09Feb2021, when the patient was 67-year-old, for COVID-19 immunisation, reaction(s): "sore arm", "chills", "feels a little blah"; BNT162b2 (Dose 3 (booster), single; IM probably right arm again; Lot unknown), administration date: 10Sep2021, when the patient was 67-year-old, for COVID-19 immunisation, reaction(s): "sore arm", "chills", "feels a little blah"; BNT162b2 (Dose 4 (booster), single; IM right arm; Lot unknown), administration date: 01Apr2022, when the patient was 68-year-old, for COVID-19 immunisation, reaction(s): "sore arm", "chills", "feels a little blah"; moderna (Dose 5 (booster), single; probably right arm IM; Lot unknown; with the need of the installation of a heart pacer, the symptoms disappeared in about 4 months), administration date: 06Sep2022, when the patient was 68-year-old, for COVID-19 immunisation, reaction(s): "heart started skipping"; BNT162b2;BNT162b2 omi ba.4-5 (Dose 6 (booster), single; Lot unknown), administration date: 16May2023, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "sore arm", "chills", "feels a little blah", "pain at the injection site", "fever"; comirnaty (2023-2024 formula) (Dose 1, single; Lot number: HD9876; Arm Right), administration date: 17Nov2023, when the patient was 69-year-old, for COVID-19 immunisation, reaction(s): "sore arm", "chills", "feels a little blah", "pain at the injection site", "fever". The following information was reported: HYPOAESTHESIA (non-serious) with onset 2024, outcome "recovered with sequelae", described as "Her left cheek only will become numb/Her shoulder blades will get numb"; SWELLING FACE (non-serious) with onset 2024, outcome "recovered with sequelae", described as "left cheek was swelling"; PARAESTHESIA (non-serious) with onset 2024, outcome "not recovered", described as "some other times the left cheek (tingling)"; CHILLS (non-serious) with onset 05Sep2024, outcome "recovered" (06Sep2024); PYREXIA (non-serious) with onset 05Sep2024, outcome "recovered" (06Sep2024), described as "slight fever"; PAIN IN EXTREMITY (non-serious) with onset 05Sep2024, outcome "recovered" (Sep2024), described as "sore arm"; LIP SWELLING (non-serious) with onset 08Sep2024, outcome "recovered" (Sep2024), described as "her lips were red and tingling and swelling"; HYPOAESTHESIA ORAL (non-serious) with onset 08Sep2024, outcome "not recovered", described as "numbness on the tongue and lips/tongue, lips and mouth still numb and tingling"; PARAESTHESIA ORAL (non-serious) with onset 08Sep2024, outcome "not recovered", described as "with her tongue, lips and mouth still numb and tingling"; LIP EXFOLIATION (non-serious) with onset 09Sep2024, outcome "recovered" (Sep2024), described as "lips got like skin peeling off and very numb, no swelling"; TONGUE ERYTHEMA (non-serious) with onset 09Sep2024, outcome "recovered" (Sep2024), described as "the tip of her tongue got very red like she had burned it"; ORAL DISCOMFORT (non-serious) with onset 10Sep2024, outcome "recovered" (Sep2024), described as "burning sensation inside the mouth/was like she had burned the roof of her mouth and was peeling and very red and very sore"; ORAL MUCOSAL EXFOLIATION (non-serious) with onset 10Sep2024, outcome "recovered" (Sep2024), described as "roof of her mouth was like she had burned the roof of her mouth and was peeling and very red and very sore"; TONGUE DISCOLOURATION (non-serious) with onset 11Sep2024, outcome "recovered" (12Sep2024), described as "tongue changing color to green and then to gray"; SWOLLEN TONGUE (non-serious) with onset 11Sep2024, outcome "recovered" (12Sep2024), described as "tongue was swollen"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 12Sep2024, outcome "recovered with sequelae" (13Sep2024), described as "neck stiffness or sore/left side of her neck was very sore"; OROPHARYNGEAL PAIN (non-serious) with onset 12Sep2024, outcome "recovered" (13Sep2024), described as "sore throat"; ARTHRALGIA (non-serious) with onset 27Sep2024, outcome "recovered" (Sep2024), described as "severe pain between her shoulder blades". The events "numbness on the tongue and lips/tongue, lips and mouth still numb and tingling", "with her tongue, lips and mouth still numb and tingling", "some other times the left cheek (tingling)" and "her left cheek only will become numb/her shoulder blades will get numb" required physician office visit. The event "severe pain between her shoulder blades" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The chills and slight fever were on Thursday, 05Sep2024 and were gone by Friday 06Sep2024. She didn't check her temperature but had chills and her teeth were clattering, and she just went back to bed. Sore arm she would guess 2-3 days after it started it was better, gone. She woke in the middle of the night and also had a sore arm and that lasted a couple of days. Stated on Sunday (08Sep2024), she started the other symptoms. Tip of her tongue was numb, and her lips were red and tingling and swelling - was really weird on Sunday, 08Sep2024 after she went to the coffee shop for ice coffee and before she took a sip, she got in her car and looked at her face and said her tongue and lips were numb. That was like that the rest of Sunday. 09Sep2024 (Monday) the tip of her tongue got very red like she had burned it, and her lips got like skin peeling off and very numb, no swelling. Next day, Tuesday, 10Sep2024, was like she had burned the roof of her mouth and was peeling and very red and very sore. Then the roof of her mouth went back to normal overnight. On Wednesday, 11Sep2024, her tongue was swollen, and gray green and lips numb and by Thursday, 12Sep2024 was gone. On 12Sep2024 her throat became very sore and just the left side of her neck was very sore. These lasted overnight and on Friday 13Sep2024 they were gone. One week after these symptoms she was back into normal condition, except with her tongue, lips and mouth still numb and tingling, like "when Novocaine was administered at the dentist office". Stated her tongue and lips didn't go back to normal they stayed numb. The symptoms have been coming back and forth, sometimes is just the tongue, sometimes just the lips, some other times the left cheek, and the patient found it still manageable. Sometimes she feels numbness and swelling in lips and tongue. Her left cheek was swelling, it was manageable but annoying and repetitive. It was so strange because last week the roof of her mouth was very red and burned like. She has never lost numbness in tongue or lips, sometimes tongue has one spot that was not numb, or the tip was very red. Her left cheek only will become numb and that may last an hour or disappear in a day and be gone. Her neck will get sore every now and then really sore and then goes away. She doesn't do anything to it, it comes and goes. Her shoulder blades will get numb and can be a day or an hour or one can be numb and the other not. This started probably 2-3 weeks after the shot. Sometimes goes a week without any and then comes back. Last week (as reported), she had no shoulder anything and last night one shoulder was numb for about 30 minutes. She went to doctor last week. Stated she got the Flu shot on 27Sep2024 (Fluzone high dose PRIV 2024/25; Manufacturer: Sanofi Pasteur; lot: UT8409BA), 3 weeks after getting Covid shot. That night she ended up waking up with severe pain between her shoulder blades. She was very worried she might be having a heart attack and went to the ER. It lasted about 15 minutes at home and subsided on her way to the ER from very sharp pain. Nothing showed up and the pain went away. Her heart was good. Her daughter thinks this was long covid vaccination. She went to the doctor before to make sure anything he could think of she was missing and could this be from vaccine. He said before she gets another next fall, they have to revisit everything and see what the best thing for her was. She hopes she can get another; she would rather have this and feel safe than not have it. She appreciated Pfizer doing that and having vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400298947 Same reporter, patient / different AE, vaccine dose;US-PFIZER INC-202400298946 Same reporter, patient / different AE, vaccine dose;US-PFIZER INC-202400298948 Same reporter, patient / different AE, vaccine dose;US-PFIZER INC-202400299014 Same reporter, patient / different AE, vaccine dose;US-PFIZER INC-202400299015 Same reporter, patient / different AE, vaccine dose;US-PFIZER INC-202400299016 Same reporter, patient / different AE, vaccine dose;US-PFIZER INC-202400299017 Same reporter, patient / different AE, vaccine dose;