Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Disease recurrence, Fatigue, Gait disturbance, Headache
Clinical narrative: Nauseous; Headache; Wobbly; There was a vice around my stomach; Malaise; Tiredness; Neuropathy for a fractured disc and that she felt like she was back to square one with regards to this treatment; Neuropathy for a fractured disc and that she felt like she was back to square one with regards to this treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 70 years for covid-19 immunisation; cortisone (CORTISONE), on 14Sep2022 (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "I had a ruptured disk and I had get surgery" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot no. - EL3249), administration date: 16Jan2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot no. - EL9269), administration date: 06Feb2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot no. - FF2588), administration date: 29Aug2021, when the patient was 68-year-old, for COVID-19 immunization; moderna (DOSE 1 (BOOSTER), SINGLE, Lot no. - GG5H214), administration date: 04Apr2022, when the patient was 69-year-old, for COVID-19 immunization; Flu shot, administration date: Sep2020, for Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Sep2022 at 18:00, outcome "unknown"; NEUROPATHY PERIPHERAL (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Neuropathy for a fractured disc and that she felt like she was back to square one with regards to this treatment"; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; HEADACHE (non-serious), outcome "recovering"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Wobbly"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "There was a vice around my stomach"; MALAISE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness". The action taken for cortisone was unknown. Therapeutic measures were taken as a result of headache. Clinical course: Patient mentioned last Wednesday evening she had a "terrible reaction" to the Pfizer-BioNTech COVID-19 Bivalent Vaccine, and is "still suffering from from symptoms". Patient asked if these are possible side effects. Patient mentioned she got the 4 vaccines already. The first and second dose was last Jan2021, the Pfizer-BioNTech COVID-19 Vaccine. 5 months later, patient got the Pfizer-BioNTech COVID-19 booster. By Apr2022, patient got the Moderna COVID-19 booster. And got he Pfizer-BioNTech COVID-19 Bivalent omicron variant Vaccine this Wednesday. Patient said that in the morning, she went to the orthopedic because her shoulder was "really bad" it needed surgery. Patient was given a cortisone shot in the shoulder but there was no problem encountered. By 6 in the evening, patient got her booster dose. Patient reported feeling nauseous and had a headache. Patient took Tylenol and went to bed. It became "10 times worse the next day", and described it as "pounding headache". Patient added that she has neuropathy from a fractured disc; "I felt like I'm back to square 1"; was "wobbly". Patient reported also that "there was a vice around my stomach"; "tightening". Patient also had malaise and tiredness which went on. By Saturday, the headache easing off. By Sunday, patient was "feeling a little better" but was still wobbly. Patient had neuropathy but claimed "I'm not diabetic". It was further reported by transferring agent as stated: "I have a patient on the line reporting an adverse event regarding the Pfizer BioNTech COVID-19 Vaccine, the Bivalent (COVID-19 Bivalent Vaccine) for the formulation with the, for the omicron variant. So, I have here a patient on the line, she declined to provide their name but only the initials. She is a non-healthcare provider she mentioned that she is a counselor for mental health. So, the patient mentioned that she received the booster dose of the Pfizer the bivalent formulation, she already had 4 shots, the first two were in Jan2021 both Pfizer's (Later consumer stated, "my first vaccination was 16Jan2021 and then the second one was 06Feb2021 and they were both Pfizer.") then 5 months later a Pfizer booster and then by April of this year 2022 she got a Moderna (COVID-19 Vaccine) booster and then she received this Pfizer (COVID-19 Vaccine) bivalent booster. So, the caller mentioned that this all happened last Wednesday evening she mentioned that she had a terrible reaction to it and is still suffering from the symptoms and let me provide how the caller shared it. In the morning she mentioned that she went to her ortho because her shoulder was really bad and it needed surgery (Intent: Medical History), she had a Cortisone shot in the shoulder but there wasn't any problems with the cortisone shot until 6 in the evening when she got the vaccine, the caller were then feeling nauseous, having some headache. She took Tylenol and went to bed but in the next day she mentioned that they were ten times worse and described it as a pounding headache and then she mentioned that she had neuropathy for a fractured disc and that she felt like she was back to square one with regards to this treatment. She described her condition as feeling wobbly furthermore, yes that's right wobbly, that was the term that the caller used and then the caller mentioned that there was a vice around her stomach some tightening and also reported some malaise tiredness and this went on. By Saturday the caller mentioned the headache was easing off and by Sunday she was feeling a little better but still wobbly. She also mentioned that she tried to research this possible side effect and found one case of a women which also had neuropathy and a week after the shot had flare-ups that lasted for two weeks and then lastly the caller added that she also experienced some numbness and tingling confirmed she also had neuropathy but she is not a diabetic and patient age is 70 years old and I was able to address her question regarding this." When clarified if received Moderna COVID-19 Vaccine after Pfizer COVID-19 Vaccine: Consumer stated, "So, last one was Moderna and this one was Pfizer." When clarified if received Cortisone shot before receiving the Pfizer COVID-19 Bivalent Vaccine: Consumer stated, "I did, I had that in morning." When clarified if headache got worse after taking Tylenol: Consumer stated, "Yes, the first two days, yes." For medical condition, the patient stated, "The only medical condition that I have is in Jul2020, I had a ruptured disk and I had get surgery and there was some damage done for my sciatic nerve and with that damage came neuropathy. So, I do had neuropathy so, I do have some of the symptoms that I am describing to you the numbness and the tingling and the wobbliness I do have those but I have been working really, really hard in physical therapy for the last couple of years to get stronger and I have been doing a lot better I am not back to where I was prior to having all this happened to me but I am much better but when I got this shot and all these symptoms last week, it got me right back to square one. All those symptoms that I had, my neuropathy symptoms are so bad right now and I am just nervous that they are not going to go away. My physical therapist who I saw yesterday says, I am just having a reaction and everything squared up right now and I am going to be okay he says, he promises me but I guess, I am just nervous because these symptoms are not gonna go away. I mean, I know people get long COVID and you know, I have a friend that had COVID and now she can only wear gym shoes and has to for physical therapy for her feet because she can't walk on them and its awful but I don't know if you can get long symptoms what I mean like the symptoms that can last from the vaccine I mean, I do have COVID (Further clarification unknown) but I have the vaccine and it affected me like this so, I need some reassurance that this is not gonna happen, that's all." Lab Test and Treatment: Consumer stated, "No, I just took Tylenol not that much of it and the headache went away by Saturday afternoon, the headache started to subside, the other symptoms were not but the headache." Consumer also stated, "Do you think that those people at Privacy Pharmacy or the women who gave me my Cortisone shot is spoken to doctors, she work with them all the time and I can trust her, if they knew that I was getting two shots in one day, do you think that they should have said something to me because when I talked to my Internist on Friday night because I didn't know what to do at this point because symptoms were just so bad and they weren't getting better then my Internist said to me, why did you take two shots in one day, I said well, nobody told me that I couldn't, the pharmacist didn't tell me? Well, how can I find, this is what I would like to find out okay, you can tell me, who I can contact in Pfizer for this, my Internist told me that because I got the Cortisone shot and the vaccine Pfizer (COVID-19 Bivalent Vaccine) booster in the same day that my Pfizer shot will not be as effective."