Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Palpitations, Paraesthesia, Product use issue, SARS-CoV-2 test
Clinical narrative: headache; palpitations; fatigue; She gets a little out of breath; She is still having some tingling and paresthesias after taking a walk in her driveway but not as bad as before; She is still having some tingling and paresthesias after taking a walk in her driveway but not as bad as before; post exertional malaise; She was having a difficult time with just activities of daily living like washing dishes and mopping floors; feeling bad; she couldnt walk around; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID: Private. The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 23Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "She has a history of asthma" (unspecified if ongoing), notes: She has a history of asthma thats pretty significant.; "hypertension", start date: Jan2022 (unspecified if ongoing), notes: Starting in Jan she started to develop hypertension, headaches, and palpitations.; "headaches", start date: Jan2022 (unspecified if ongoing), notes: Starting in Jan she started to develop hypertension, headaches, and palpitations.; "palpitations", start date: Jan2022 (unspecified if ongoing), notes: Starting in Jan she started to develop hypertension, headaches, and palpitations.; "long covid", start date: Jan2022, stop date: Mar2022, notes: Shes been having covid since Jan to Mar2022; "tingling in the right foot", start date: Feb2022 (unspecified if ongoing), notes: In Feb and Mar, she developed tingling in the right foot; "she was having trouble with word finding", start date: Mar2022 (unspecified if ongoing), notes: By the end of Mar, she was having trouble with word finding. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 23Sep2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 23Sep2022, outcome "unknown"; GAIT INABILITY (disability), outcome "unknown", described as "she couldnt walk around"; HEADACHE (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering"; DYSPNOEA (non-serious), outcome "unknown", described as "She gets a little out of breath"; PARAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "recovering" and all described as "She is still having some tingling and paresthesias after taking a walk in her driveway but not as bad as before"; MALAISE (non-serious), outcome "unknown", described as "post exertional malaise"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "She was having a difficult time with just activities of daily living like washing dishes and mopping floors"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling bad". The patient underwent the following laboratory tests and procedures: Biopsy: (unspecified date) Unknown results; Echocardiogram: (unspecified date) Normal; Electrocardiogram: (unspecified date) Normal; Electrocardiogram ambulatory: (unspecified date) she was having supraectopic beats; a huge number of tests: (unspecified date) Unknown results; Lumbar puncture: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) Unknown results; (unspecified date) Unknown results; Nerve conduction studies: (unspecified date) Unknown results; SARS-CoV-2 test: (unspecified date) Negative, notes: she had a 4plex that came back negative, 24 hours after symptoms, the next day she still tested negative; (unspecified date) Negative, notes: she had a 4plex that came back negative, 24 hours after symptoms, the next day she still tested negative; (Feb2022) Positive; (09Dec2021) Negative, notes: On 09Dec2021 she sent a PCR to Pfizer, and she had a 4plex that came back negative; Spinal myelogram: (unspecified date) Unknown results.  Clinical information: Description of Event Outcome: Patient was pediatrician, Pfizer prior COVID-19 vaccine trial participant. And was a vaccine advocate and developed Long COVID in 2022. Patient was hesitant to get the bivalent booster. Patient did receive it 23Sep. Patient initially had an increase in headache, palpitations and fatigue, however, was three weeks out and had a significant improvement in symptoms and function. It is the only thing that has changed other than time. were there current trials assessing vaccine as treatment for long covid? She is calling in reference to the bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine. She received the bivalent vaccine on 23Sep2022 along with the flu vaccine. For the first few days she felt pretty bad, but the past 7 days she(s) felt better than she had in a long time. Its been a dramatic improvement, dramatic in a good way. Prior to this, she has been dealing with long Covid since Jan of this year. She(s) been having long covid since Jan2022 to Mar2022 and has been ongoing since then. She(s) had several hospital admissions. It(s) been a long road. Well with having this happen she was reading a retrospective study in which some patients with long covid received the bivalent formulation of the vaccine and reported their long covid symptoms improving. Some said there was no difference. She got the bivalent gray cap formulation on 23Sep2022 and at first it got a little worse, and then this week it(s) been a dramatic improvement in a good way. Having long covid, it almost feels like you were losing your mind, even with her doctor friends and having all these tests come back normal. She was having a difficult time with just activities of daily living like washing dishes and mopping floors. It(s) a noticeable improvement. She(s) not sure if its temporally associated, that the long Covid has run its course and she(s) finally getting better or if the improvement in symptoms was due to the bivalent vaccine that she received. On 09Dec2021 she sent a PCR to Pfizer, and she had a 4plex that came back negative, 24 hours after symptoms, the next day she still tested negative. It wasn't anything major, she had a sore throat, a fever, never went over 100.4, a cough, but it was a clearing your throat cough. She has a history of asthma that(s) pretty significant. Compared to the flu or enterovirus it was no big deal. Starting in Jan she started to develop hypertension, headaches, and palpitations. She went to PCP, regular doctor, and had testing done, she had an EKG, echo came back normal. She had a halter monitor and that found that she was having supraectopic beats. She was referred to a cardiologist in Apr. In Feb and Mar, she developed tingling in the right foot and she initially thought it was a disc problem. She heard back in Pfizer in Feb2022 that her sample came back positive for Covid. By the end of Mar, she was having trouble with word finding. She is a pediatrician and has to take quarterly maintenance certifications. She failed her first certification ever, and she graduated top 10 in her class. At that point she was referred to neurology and was admitted a few times. They initially thought she may have MS, they really downplayed the whole Covid illness. While admitted she had a lot of testing done including nerve conduction, nerve biopsy, MRI of the head and neck, a myelogram of her spine, a lumbar puncture, a huge number of tests done to rule out everything. She finally was able to go to a tertiary covid clinic and she has an appointment at (clinic name-withheld) on 19Dec2022. She also found an EP cardiologist that will see her. She has an appointment with them next week, where shell have a tilt table test done to assess for POTS. Last year she was skiing in (name-withheld) zones and hiking and biking, to not being able to walk her quarter mile long driveway. Since receiving the bivalent, after the initial few days of feeling bad, she(s)been able to walk her driveway every day this week except for today. She gets a little out of breath, but she isn't passing out on her bed afterwards like she was before. She(s) been able to drive this week which is a big deal, she wasn't able to before. She has been having full days at work, seeing 6 patients a day. Before she had to take off early for half days and take a nap everyday. This week she only had to take a nap today. Today was the only day that she kind of didn't feel so great. Initially after the bivalent vaccine she had a little post headache, fatigue and she couldn't walk around a museum in (name-withheld), her husband had to push her in a wheelchair and she was wearing compression stockings. But since then, she(s) felt better this past week than she has in a long time. She is still having some tingling and paresthesias after taking a walk in her driveway but not as bad as before. Her headaches are overall much better. She had a headache at the same level severity today. Before the bivalent shot the headaches would interrupt her whole day. She would have post exertional malaise and just headache after headache. Its just been such a noticeable difference. She was wondering if there was some type of inflammatory response from the Pfizer BioNTech Covid 19 vaccine bivalent gray cap formulation and/or the flu shot that helped clean up these long covid symptoms. Are there any current clinical trials looking at patients with long covid and the effects that the bivalent gray cap formulation of the Pfizer BioNTech Covid 19 vaccine had on their symptoms? She is very pro vaccine and was in some of the initial Covid studies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported serious event GAIT INABILITY and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.