Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Nausea, Pain, SARS-CoV-2 test, Skin burning sensation
Clinical narrative: internal tremors; Nausea; internal tremors/Anxiety had been present before vaccination; Has lost 16 lbs/ lost 20lbs since getting the vaccine; Anxiety; Hot/cold flashes; Hot/cold flashes; trouble eating food; Body aches; Interchange of vaccine products; Burning sensation on his skin/ skin has been burning; 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 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose 4 (booster), 30 ug single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Tremor" (unspecified if ongoing); "sleep" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: QUADRIVALENT INFLUENZA VACCINE taken for immunisation, on 01Nov2022 as dose number unknown, single; HYDROXYZINE taken for sleep disorder, anxiety (ongoing); GABAPENTIN taken for tremor (ongoing). Past drug history included: Vitamins, notes: he takes some vitamins. Vaccination history included: coviD-19 vaccine moderna (Dose: 01, Lot: 014M20A,, printed sticker is really small, not hard to read, just small. , Expiry: 12Aug2021), administration date: 09Mar2021, when the patient was 40-year-old, for COVID-19 Immunization; coviD-19 vaccine moderna (Dose: 02, Lot: 038B21A, Expiry: 25Sep2021), administration date: 08Apr2021, when the patient was 40-year-old, for COVID-19 Immunization; coviD-19 vaccine moderna (Dose: 03, Lot: 078921A, 9 could be the letter T.), administration date: 23Dec2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: SKIN BURNING SENSATION (non-serious) with onset 30Nov2022, outcome "not recovered", described as "Burning sensation on his skin/ skin has been burning"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Nov2022, outcome "unknown"; PAIN (non-serious) with onset 01Dec2022, outcome "recovered" (03Dec2022), described as "Body aches"; ANXIETY (non-serious) with onset 03Dec2022, outcome "not recovered"; HOT FLUSH (non-serious), FEELING COLD (non-serious) all with onset 03Dec2022, outcome "recovering" and all described as "Hot/cold flashes"; EATING DISORDER (non-serious) with onset 03Dec2022, outcome "not recovered", described as "trouble eating food"; WEIGHT DECREASED (medically significant) with onset 10Dec2022, outcome "not recovered", described as "Has lost 16 lbs/ lost 20lbs since getting the vaccine"; TREMOR (non-serious), outcome "unknown", described as "internal tremors"; NAUSEA (non-serious), outcome "not recovered"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "internal tremors/Anxiety had been present before vaccination". The event "nausea" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2021) Positive, notes: he got Covid on 29Dec2021; Weight: (unspecified date) lost over 20 lbs, notes: has lost over 20 lbs since getting the vaccine; (17Oct2022) 199 lbs; (10Nov2022) weight up, notes: was gaining weight up until 10Nov2022, has now lost 16 lbs; (30Nov2022) 205 lbs; (10Dec2022) 197 lbs. Therapeutic measures were taken as a result of nausea.  Clinical information : Caller received his Pfizer Bivalent vaccine and since then he had a burning sensation on his skin, which started on 30Nov2022. This sensation lasted for over 5 weeks. He had also had lots of trouble eating food, and had lost over 20 lbs since getting the vaccine. Caller verified the contact information provided by the transferring agent. Weight: provided his current weight. Event details:  Stated that the burning sensation on his skin started a couple days after he got the Bivalent vaccine on 30Nov2022. 1-2Dec2022 he had body aches. On 03Dec2022 he ate some ice cream, got anxiety and tried to walk it off. Later he ate some Brisket fried rice, and woke up in the middle of the night with massive anxiety, internal tremors, and hot/cold flashes. Clarifies that the burning sensation on his skin was part of the hot/cold flashes. Some days it's bad and some days it's not so bad, but it's generally always there. On good days he only notices it if he scratches his skin, then he will have the lingering burning sensation. When food hits his small intestine, he had a chance of experiencing a lot of anxiety and it's been like that since getting the vaccine. He had the tremors since he got covid the first time. Stated he gets full body rumbling and tremors on the inside when his body was in stress. Permanent jaw chattering began on 03Jan2022, so not related to the bivalent vaccine. Body tremors started 2 weeks after the jaw chattering. Hot/cold flashes: The only thing that happens now, was he will get cold feet. When he gets stressed or had a flare, the temperature on the bottom of his feet goes below 93 degrees, and then his skin feels like it's burning. If his skin gets too hot or too cold, he had difficulty tolerating temperature changes. Trouble eating food, got a little better, but now was a lot worse. Weight: was gaining weight up until 10Nov2022, had now lost 16 lbs. 17Oct2022-199lbs. On 30Nov2022-205lbs. 10Dec2022-197lbs. Stated he sees in infectious disease doctor for long covid because he continues to have symptoms. It's actually called post viral syndrome, which began when he got Covid on 29Dec2021. The infectious disease doctor recommended he get the bivalent booster. His 3rd dose of Moderna was really close to when he started getting symptoms of Covid on 29Dec2021. History: Stated he takes some vitamins, but they weren't prescribed. No further details provided. Pfizer/BioNTech COVID-19 Vaccine Follow-up Questionnaire. 3. Complete if a 3rd or Subsequent dose was administered was none, 4. Vaccination Facility Type: other. Vaccine was not Administered at Facility, 5. Prior Vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): He got a flu shot, Influenza injectable quadrivalent, on 01Nov2022. No manufacturer/Lot/NDC/expiry to provide. 8. Family Medical History Relevant to Adverse Events (AEs) was none, 11. Adverse Events: Nausea when he would try to eat. Term/Date/Time: AE Term: Onset Date: Not provided. Seriousness Criteria: Not Serious. AE required visit to: Emergency Room. AE Outcome: Not Recovered. Treatment: Did the event require the initiation of new medication/other treatment/ procedure? Yes. if yes Details: He went to the ER, and had seen multiple doctors, and had several notes between his doctors. The only treatment he received was Zofran because he got very nauseous after getting the vaccine and couldn't eat without nausea. Zofran, was prescribed 4mg tablets, but had 8mg tablets. He only took it twice and then the nausea resolved. States that his symptoms got better so he went on vacation, but since coming back from vacation his symptoms are worse again. Description of Product Complaint: Description of complaint: Symptoms of Covid began on Covid on 29Dec2021. Prior to getting Covid he had 3 doses of the Moderna Covid 19 Vaccine. The 3rd dose was received on 23Dec2021. Product strength and count size dispensed was unknown.  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.