Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Hypoaesthesia, Interchange of vaccine products
Clinical narrative: Whole body is sore; I have body ache all over, including my wrist, my knuckles, my hands, my arms, the back of my legs; I have body ache all over, including my wrist, my knuckles, my hands, my arms, the back of my legs; I have body ache all over; my lower back, upper back; Feels like an intense workout that won't go away. Can't lift her baby; Numb to right arm and hand/Numb to right arm and hand; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 16:30 as dose 4 (booster), single (Lot number: GJ3275) at the age of 38 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 18Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna vaccine (Dose 3 (Booster), Single, Manufacturer: Moderna, Date: 24Nov2021, LOT: 066F21A, NDC/EXPIRY/Formulation/Dose: Unknown), administration date: 24Nov2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "No reaction"; moderna vaccine (Dose 2, Single, Manufacturer: Moderna, Date: 17May2021, LOT: 026C21A, NDC/EXPIRY/Formulation/Dose: Unknown), administration date: 17May2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "No reaction"; moderna vaccine (Dose 1, Single , Manufacturer: Moderna, Date: 19Apr2021, LOT: 038B21A, NDC/EXPIRY/Formulation/Dose: Unknown), administration date: 19Apr2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "No reaction"; Flu vaccine (Received flu vaccines the last 5 to 8 years, once a year), for immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 24Oct2022, outcome "unknown"; ASTHENIA (non-serious) with onset 26Oct2022, outcome "unknown", described as "Feels like an intense workout that won't go away. Can't lift her baby"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Oct2022, outcome "unknown" and all described as "I have body ache all over, including my wrist, my knuckles, my hands, my arms, the back of my legs"; BACK PAIN (non-serious) with onset 26Oct2022, outcome "unknown", described as "I have body ache all over; my lower back, upper back"; HYPOAESTHESIA (non-serious) with onset 26Oct2022, outcome "not recovered", described as "Numb to right arm and hand/Numb to right arm and hand"; PAIN (non-serious) with onset 26Oct2022, outcome "not recovered", described as "Whole body is sore". Therapeutic measures were taken as a result of pain, arthralgia, pain in extremity, back pain, asthenia, hypoaesthesia, interchange of vaccine products.  Additional information: Consumer stated that she thinks she had adverse reaction to the Pfizer booster. So, she was getting, she had body ache all over, including her wrist, knuckles, hands, arms, the back of legs, lower back, upper back. NDC number, Expiry Date and UPC number of Covid Vaccine Booster was Unknown. She got the vaccine on Monday which she thought if she had the body ache, it will be Monday and tuesday but she did not feel anything until Wednesday in the AM. And she was still having reactions from it. She wanted to know if this was a common side effect. Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department and telephone was shared as (phone number withheld), option 3, 8 AM to 9 PM, Monday to Friday, as per EST. Product details, Pharmacy details and other details could not be probed as consumer was unwilling to complete the report. Hence further probing could not be done. Limited information available over the call. Upon follow-up 31Oct2022, updated Reporter 1 salutation. Patient Ethnicity updated. Vaccination date and Lot number updated. Caller wanted to know if the Pfizer BionTech Covid-19 Bivalent Vaccine (was unable to specify if orange or gray) has an effect to breastfeeding. As per DSU agent, caller got her Pfizer BionTech Covid-19 Bivalent Vaccine (was unable to specify if orange or gray) last Monday 24Oct2022. She said that the lot number was GJ3275 while DSU agent was endorsing the call. Age was 38 Years Old. Gender was Female. She received a booster dose with a Pfizer Biontech COVID 19 vaccine (no formulation was specified by the caller). She received the booster last Monday at did not have any side effects until 2-3 days later. She mentioned her whole body was sore, and it has been sore since Wednesday, for 5 days already. Caller asked if this might be a delayed side effect to the vaccine. She also stated that all of her previous vaccines have been from Moderna, with no reaction to any of them. This was her second booster dose. Caller also asked how long do the side effects last. Whole body was sore from Around midnight 26Oct2022 and Ongoing. Numb to right arm and hand from 26Oct2022 and Ongoing. No other conditions, Investigations and other products. Reporting a side effect to Pfizer COVID-19 Vaccine Booster dose. Transfer agent not able to confirm if the Booster dose was Pfizer COVID-19 Vaccine Bivalent or not, caller just said Pfizer's. The caller clarified the information provided by the transfer agent. Took the Pfizer COVID-19 Vaccine Booster on Monday, 24Oct2022, and didn't feel it until Wednesday, 26Oct2022, in the morning. It was a delayed reaction. Patient Height was about 5 feet 2 inches tall and weight about probably about 95 pounds. Doesn't feel like it worsened. Today was first day she was feeling better. Only place not sore was her feet. Feels like an intense workout that won't go away. Can't lift her baby. Took flu shot recently. May have been given on 18Oct2022. Specific product name, manufacturer, NDC/LOT/EXPIRY/Formulation/Dose was Unknown. Concerned because she was breastfeeding and hopes it doesn't effect anything, requested transfer back to Pfizer Medical Information for guidance. Pfizer/BioNtech COVID-19 Vaccine 1st dose at 4:30pm and Anatomical Site of injection: Right Arm. Injection, not sure just a needle to arm to muscle. Does get numb in that arm and that hand. Numb to right arm and hand. Vaccination Facility Type was Hospital. Prior Vaccinations (within 4 weeks) was Flu Vaccine. Route, Anatomical Location was Left Arm Muscle. No. of Previous Doses and Dates was for this year just that one. Received flu vaccines the last 5 to 8 years, once a year. Patient medical history (including any illness at time of vaccination), Family Medical History Relevant to Adverse Events (AEs), Relevant Tests was None. Surgical procedures and dates were None. The event does not require the initiation of new medication/other treatment/ procedure. Her doctor recommend she take 650mg but doesn't have time to grab that medicine. Aware this was discrepant as caller previously provided, she has to take Tylenol to function. Product clarified from Pfizer COVID-19 Vaccine Booster to Pfizer Bivalent COVID-19 Vaccine. Aware this was discrepant as caller previously provided and referred to product as Pfizer COVID-19 Vaccine Booster multiple times in the call. Updated suspect product as clarified by caller. Caller provided LOT: GJ3275. Seriousness Criteria that caller provided was moderate to severe. AE does not require visit to ER or physician office. Have to take Tylenol to function to get through the day. Tylenol Dose: 500mg per tablet and takes two tablets, Expiry was May2025.