Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bone pain, Erythema, Interchange of vaccine products, Pain in extremity, Peripheral swelling
Clinical narrative: Had Moderna and ended up getting Pfizer because they didn't have anything but the Pfizer.; probably gained weight.; got splotches on upper arm around where the shot was given.; started swelling, whole upper part arm got really, really, red; started swelling, whole upper part arm got really, really, red; It hurt all the way to the bones.; Arm night have gotten a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Immune system is a little weak" (unspecified if ongoing); "cholesterol" (unspecified if ongoing), notes: Doctor has her on cholesterol medicine and blood pressure medicine.; "blood pressure" (unspecified if ongoing), notes: Doctor has her on cholesterol medicine and blood pressure medicine. Concomitant medication(s) included: HUMIRA. Vaccination history included: moderna (First Dose Covid vaccine, Moderna: 05Apr2021), administration date: 05Apr2021, when the patient was 62-year-old, for COVID-19 immunization; moderna (Second Dose Covid vaccine, Moderna: 03May2021), administration date: 03May2021, when the patient was 62-year-old, for COVID-19 immunization; moderna (Third Dose Covid vaccine, Moderna: 08Dec2021), administration date: 08Dec2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Fourth Dose Covid vaccine, Pfizer: think it was 16May2022, LOT: PP4554 or FF4554, Assuming it is P, could be F, NDC, EXP: Unknown), administration date: 16May2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16May2022, outcome "unknown", described as "Had Moderna and ended up getting Pfizer because they didn't have anything but the Pfizer."; PAIN IN EXTREMITY (non-serious) with onset 21Dec2022, outcome "unknown", described as "Arm night have gotten a little sore"; BONE PAIN (non-serious) with onset 21Dec2022, outcome "unknown", described as "It hurt all the way to the bones."; RASH MACULAR (non-serious) with onset 21Dec2022, outcome "unknown", described as "got splotches on upper arm around where the shot was given."; PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 21Dec2022, outcome "unknown" and all described as "started swelling, whole upper part arm got really, really, red"; WEIGHT INCREASED (non-serious), outcome "unknown", described as, probably gained weight.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash macular, peripheral swelling, erythema. Additional information: Got Pfizer booster for Covid and had severe reaction. Didn't want to go to doctor, because she would have to pay out of pocket for it. Just had some steroid cream and rubbed it on her arm. It did start calming it down had to do several applications of it to get it to calm down. This was the second Pfizer. Had Moderna and ended up getting Pfizer because they didn't have anything but the Pfizer. They told her it wouldn't hurt to mix them. Went ahead and got Pfizer so, this was second Pfizer shot, the booster. Never had reaction from all the other shots she got. This time, had a severe reaction. Calling because she just thought Pfizer needed to know. Also wanted to be sure if they tell her to get another booster sometime, that she will be able to do it. Details of the patient: Weight: probably gained weight. Didn't go to this doctor. Usually, if something was major, didn't go to him because he never usually has what she needs. Goes to Walk in clink. Doctor has her on cholesterol medicine and blood pressure medicine. He doesn't know about this. Severe reaction: Got shot last Wednesday and it escalated from then. After she got the shot, it started, got splotches on upper arm around where the shot was given. It started swelling, whole upper part arm got really, really, red. Has a picture of it. It was in her left arm. was right-handed and thank goodnes she got this in her left arm. It hurt all the way to the bones. Clarified this occurred last Wednesday, 21Dec2022. Outcome: Had some steroid cream that she always calls her miracle cream. Uses for booboos and she would put the cream on there and make them go away. Put some of that on and rubbed on her arm and it started getting a little better. Then, the next day put more on it got a little better again but, still got some redness and splotches. Provided name of steroid cream as Triamcinolone Acetonide, manufactured by Qualitest pharmaceuticals. Indication: Wanted booster before. Was going to go to friend's house an didn't want to be around people and get sick. Immune system was a little weak because she takes Humira. The last shot before this was Pfizer too and didn't have any reaction to that at all either. Arm night have gotten a little sore but, that was it. Concomitant Products/Medical Conditions: No, the same things she takes every day. 1st dose of Pfizer Covid vaccine was her fourth total dose of Covid vaccine. Had 3 doses Moderna Covid vaccine prior to this dose. 2nd Pfizer Covid vaccine was her fifth total dose Covid vaccine. Complete if a 3rd or Subsequent dose was administered. Immune system was a little weak because she takes Humira. Prior Vaccinations (within 4 weeks): No. Family Medical History Relevant to Adverse Events (AEs): No, not that she knows of. Neighbor was nurse, told caller if it persisted like it was doing, she would need to have it checked out. Caller didn't want to go back to pay doctor bill. Really didn't want to go because. That was why she put the steroid cream on it. Just wanted Pfizer to be aware because it was really bad. Daughter told her she needed to call Pfizer. Appreciates medications and believes in vaccinations. A lot of her friends didn't and, they all had Covid, she hasn't. Is there a product complaint to report? Yes. Description of Product Complaint: Description of complaint: Never had a reaction to any of the other shots she got. Had first 3 Moderna and fourth shot was Pfizer. Only had severe reaction to this Pfizer shot. Product strength and count size dispensed: not provided. Additional lot numbers: First 3 Covid shots: Moderna Fourth Covid shot (1st Pfizer shot: PP4554 or FF4554). Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided. 2nd PC not Pfizer product: Description of complaint: Steroid cream, Triamcinolone Acetonide got a little better again but, still got some redness and splotches. Manufacturer: Qualitest pharmaceuticals Product strength and count size dispensed: Additional lot numbers: Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact? not provided.