Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound breast, Vaccination failure
Clinical narrative: swelling and inflammation of the left side of her face: her left side of the forehead, chin and ear; allergic reaction; staph infection; scabies; The rashes are getting worse, the lesions are getting bigger/Bruising is getting worse; Bruising; rashes; dermatitis; Spongiotic dermatitis; Opening on her cheek, a lesion with like a little bit of yellow oozing/She has pus all over in her body; had a lesion on her left cheek with a yellow liquid coming out of it; swelling and inflammation of the left side of her face: her left side of the forehead, chin and ear; swelling and inflammation of the left side of her face: her left side of the forehead, chin and ear; Entire left half of her face literally from her chin to her forehead to her ear swollen, red and experiencing pain; Entire left half of her face literally from her chin to her forehead to her ear swollen, red and experiencing pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 03Jun2021 at 11:00 as dose 2, single (Lot number: ER8729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing); "Menopause" (unspecified if ongoing); "High allergies on multiple unknown medications" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Iron deficiency" (unspecified if ongoing); "c-section" (unspecified if ongoing), notes: Just the female stuff. 21 years ago and 23 years ago she had her 2 babies, they were c-section.; "she had her 2 babies" (unspecified if ongoing), notes: Just the female stuff. 21 years ago and 23 years ago she had her 2 babies, they were c-section. There were no concomitant medications. Past drug history included: Paxil, reaction(s): "she is allergic to: Paxle"; Paxil, reaction(s): "murmuring to her heart"; Paxil, reaction(s): "Weird heartbeat". Vaccination history included: BNT162b2 (Pfizer Covid Vaccine, 1st dose, Lot: EW0167), administration date: 13May2021, when the patient was 56-year-old, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious), PAIN (non-serious) all with onset 10Jun2021, outcome "recovered" (15Aug2021) and all described as "Entire left half of her face literally from her chin to her forehead to her ear swollen, red and experiencing pain"; FACIAL DISCOMFORT (non-serious) with onset 10Jun2021, outcome "recovered" (15Aug2021), described as "had a lesion on her left cheek with a yellow liquid coming out of it"; SWELLING FACE (non-serious), SWELLING (non-serious) all with onset 10Jun2021, outcome "recovered" (15Aug2021) and all described as "swelling and inflammation of the left side of her face: her left side of the forehead, chin and ear"; INFLAMMATION (non-serious), outcome "unknown", described as "swelling and inflammation of the left side of her face: her left side of the forehead, chin and ear"; SKIN LESION (non-serious) with onset 05Aug2021, outcome "recovered" (15Aug2021), described as "Opening on her cheek, a lesion with like a little bit of yellow oozing/She has pus all over in her body"; RASH (non-serious) with onset 09Jan2022, outcome "not recovered", described as "rashes"; CONTUSION (non-serious) with onset Feb2022, outcome "not recovered", described as "Bruising"; ECZEMA (non-serious) with onset 2022, outcome "not recovered", described as "Spongiotic dermatitis"; DERMATITIS (non-serious) with onset 2022, outcome "not recovered"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction"; STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown", described as "staph infection"; ACARODERMATITIS (non-serious), outcome "unknown", described as "scabies"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "The rashes are getting worse, the lesions are getting bigger/Bruising is getting worse". The events "had a lesion on her left cheek with a yellow liquid coming out of it", "swelling and inflammation of the left side of her face: her left side of the forehead, chin and ear", "dermatitis", "allergic reaction", "rashes", "entire left half of her face literally from her chin to her forehead to her ear swollen, red and experiencing pain", "opening on her cheek, a lesion with like a little bit of yellow oozing/she has pus all over in her body", "spongiotic dermatitis", "bruising", "staph infection" and "scabies" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of facial discomfort, swelling face, swelling, inflammation, dermatitis, hypersensitivity, rash, erythema, pain, skin lesion, eczema, contusion, staphylococcal infection, acarodermatitis.  Additional information: For First dose it was reported that had horrible handwriting on the CDC vaccine record card. Unknown number from CDC vaccine record card: 6426789. NDC/Expiry: Unknown, not on the CDC vaccine record card. Dose: Unknown strength/volume injection to left arm. For Second dose Pharmaceutical form (Dosage form) Injection. NDC/Expiry: Unknown, not on the CDC vaccine record card. Dose: Unknown strength/volume injection. Other Conditions: Yes. Vaccination Facility Type was Pharmacy inside the location. Vaccine was not Administered at Facility. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). AE(s) following prior vaccinations was None. There was a product complaint to report. Description of Product Complaint was Tested positive for COVID 02Jan2022 after 2 doses of Pfizer Covid Vaccine. Exposure to COVID positive family member. She explained that, after 1 week from receiving the second dose of the vaccine, she started developing symptoms such as swelling and inflammation of the left side of her face: her left side of the forehead, chin and ear. She explained that she went to the hospital and was prescribed antibiotics and anti-inflammatories. Her face went back to normal, but then, on 05Aug2021 she started developing the same symptoms again: swelling of the left side of the face. But this time, she had a lesion on her left cheek with a yellow liquid coming out of it. She went to the hospital once more and was treated. Then, on 02Jan2022, she got infected with COVID-19, probably the variant. After 1 week from the infection, she started developing rashes and now she has been diagnosed with some kind of dermatitis. Caller stated that she never had skin problems before. Also, her 85-year-old mother started developing the same symptoms (rashes) after her vaccination with the Moderna vaccine. Caller wanted to know if her symptoms had been reported before, what could she do about it. Caller asked what ingredient of the vaccine could be causing her allergic reaction. Relevant Medical History and Concurrent Conditions (not including reaction / event): Start Date: Jan2021. Comments: COVID Asymptomatic did not get any symptoms, she just did the test because her husband got tested positive for COVID. Menopause Comments: Menopause Started like 5-6 years ago. They put her on low dosage of hormone taking it for 5 years. Comments: High allergies on multiple unknown medications for this for about 10-12 years; condition has been since birth. Seasonal allergies which of course progressed with age so instead of 1 medication, started taking 2 then 3 to try to avoid the allergies. Not food allergies, like tree, grass, pollen. Iron deficiency, Comments: Iron deficiency Has had this pretty much her whole life. Been on iron pills for this for pretty much like 20-25 years since in her early 40s. Reaction / Event as Reported by the Primary Source for Translation: Entire left half of her face literally from her chin to her forehead to her ear swollen, red and experiencing pain. Date of start of reaction/event: 10Jun2021. Date of stop of reaction/event: 20Jun2021. Outcome of reaction/event at the time of last observation: recovered/Resolved. Reaction / Event as Reported by the Primary Source for Translation: COVID. Date of start of reaction/event: 02Jan2022. Outcome of reaction/event at the time of last observation: Unknown. This consumer was the patient who called because she needs some information about the side effects she had experienced since her second dose of Pfizer Covid Vaccine. She did not have any issues after her first dose of Pfizer Covid Vaccine. Side effects: Everything in her body changed since she took the second dose of Pfizer Covid Vaccine. On 10Jun2021 she woke up in the morning woke up with entire left half of her face literally from her chin to her forehead to her ear swollen, red and experiencing pain. At that time the doctor couldn't see anyone because they were having a covid scare. She had to go to the urgent care. At the urgent care they did not know what was going on, but put her on antibiotics and anti-inflammation steroid pills and within like 10 days it's gone, she had recovered completely. After that she went to see the doctor who didn't see anything, doctor ran some bloodwork but didn't see anything. 05Aug2021 she experienced the same thing again, entire left half of her face literally from her chin to her forehead to her ear swollen, red and experiencing pain. She went again to the urgent care but this time she had like an opening on her cheek, a lesion with like a little bit of yellow oozing from her face. The right side of her face was normal and other side was inflamed and her cheek the second time was red, with lesion oozing. The doctor at urgent care said it might be staph infection. They put her on steroids and antibiotic, and within 10 days event was gone, did not reoccur after that on her face. 02Jan2022 she got COVID. Her husband tested positive for COVID again, and she also tested positive for COVID. After a week, around 09Jan2022 she started experiencing rashes. Now it's been 3 plus months of rashes covering her with lesions oozing yellow liquid. She went to her doctor who sent her to her dermatologist. They did a biopsy on her and determined she has now developed Spongiotic dermatitis. She has never had this issue before, no one from her family had this, she never experienced anything horrible like what she is going through right now. With the rashes on her body the first time she went to the doctor with those rashes because it seems like she has 2 kinds: one is small and they look like liquid filled, have liquid in it; some are like dime-sized red and scaly or dry. So they thought she has scabies, even though she knows she did not have scabies; they gave her a scabies treatment which was horrible because it infected some of her lesions, so she has lesions that have been there for like 3 months that are still there still oozing fluid and just horrible. She has pus all over in her body. The rashes are getting worse, the lesions are getting bigger. The only time she feels some relief is when her doctor sends her another refill for her steroids. So far just steroid pills twice which she can't keep taking steroids and hormones. Bruising: it is not just the rashes and bumps, she also has weird looking bruises develop close to the lesions. So she has a few lesions on her breasts she didn't pay attention to the first time. The bruises came on her hips at first and she thought she had hit herself somewhere like bumped furniture; but when the bruises came up on her breast she thought ok how did she hit her breast? She noticed next to the big lesions she always develops a bruise. The bruises they are not like when you hit yourself where it's kind of red and becomes purple; the bruising comes right away like a purple bruise then just starts to fade and go. Now she has a few of them on her buttcheek and her side where the big new lesions are. Onset of bruising was about 1 month after onset of her having the rashes, so around Feb2022. Started just rashes and bumps, then start having like a dime size very red and painful lesions and they kind of keep oozing things and they get dry peels, then stay red and they left marks couple marks now they did not go away. Bruising is getting worse and she is getting more of the bigger lesions now. A month ago her mother in law called her, said she started getting some of the bumps and some of the lesions that caller has; and now within a month it progressed with her mother in law. Her mother in law's situation was after she took her booster from Moderna, not Pfizer. Her mother in law contacted Moderna and told them about this on 11Apr2022 because mother in law about 1 month ago started developing what caller developed. Caller declined to complete report for her mother in law or provide further details so Moderna booster product name/Lots/NDCs/Expiries: Not provided as caller unwilling to complete that report. Caller reported no relevant concomitant products or other medical conditions. Mentioned separately that she had COVID; Menopause; High allergies; Iron deficiency. She has had no new medications, no new living area, has been in same area for the last 12 years. No new products, no new lotions, nothing changed except lost her job because of COVID. She considered herself pretty healthy prior to these events. She does not take flu shots.Patient's Medical History (including any illness at time of vaccination) was She only has 1 medication that she is allergic to: Paxle she thinks is the spelling: Lot/NDC/Expiry: Unknown, that happened a while ago, like would say over 5-6 years ago. She was sick, doctors tried to give her unknown, it was some type of antibiotic, put her on Paxle and after the second pill she developed murmuring to her heart and weird heart beat. She went back to him and he checked her blood pressure and stopped the Paxle right away and put her on something else. No Family Medical History Relevant to AE. Relevant Tests: Just the normal things she usually gets like mammogram, ultrasound. Every year she goes through a mammogram, ultrasound because of a small lesion in her left breast and it has been same size for the last 10 years but they keep an eye on it. She does not have cancer in her family, but they try to keep an eye on it. Just the female stuff. 21 years ago and 23 years ago she had her 2 babies, they were c-section.