Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | LA |
Psoriasis/Psoriatic arthritis; Psoriasis/Psoriatic arthritis; legs that stopped working; It started with her legs, then, to the hands/She states that her hands were not working/She states that she "couldn't move my lower section; difficulty walking; Blood tests showed that her autoimmune system was "in overdrive."; Patient experienced lesions with a burning sensation; experienced severe allergies; lips turned black; bones were so inflamed, bones were hurting so bad; wrists swollen; cholesterol went way up; arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control.; Protein went way up; she "can barely talk."; lower extremities started having issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 53-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1222721171676634364, Expiration Date: 19Apr2026) for skin lesion. The patient's relevant medical history included: "NSAIDs" (unspecified if ongoing); "migraines" (unspecified if ongoing); "bee stings" (unspecified if ongoing); "steroids" (unspecified if ongoing). Concomitant medication(s) included: IRON; VITAMIN C [ASCORBIC ACID]. Past drug history included: Morphine, reaction(s): "allergic to a lot of pain"; Morphine, reaction(s): "allergic to a lot of pain"; Dilaudid, reaction(s): "allergic to a lot of pain"; Dilaudid, reaction(s): "allergic to a lot of pain"; Ibuprofens, reaction(s): "allergic to a lot of pain"; Ibuprofens, reaction(s): "allergic to a lot of pain". Vaccination history included: BNT162b2 (DOSE NUMBER 1, SINGLE), administration date: 31Mar2021, for Covid-19 immunization. The following information was reported: BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "Patient experienced lesions with a burning sensation"; PROTEIN TOTAL INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Protein went way up"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control."; BONE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "bones were so inflamed, bones were hurting so bad"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 2021, outcome "unknown", described as "cholesterol went way up"; GAIT DISTURBANCE (hospitalization) with onset 2021, outcome "unknown", described as "difficulty walking"; DRUG HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "experienced severe allergies"; MOVEMENT DISORDER (hospitalization) with onset 2021, outcome "not recovered", described as "legs that stopped working; It started with her legs, then, to the hands/She states that her hands were not working/She states that she "couldn't move my lower section"; LIP DISCOLOURATION (non-serious) with onset 2021, outcome "unknown", described as "lips turned black"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "lower extremities started having issues"; SPEECH DISORDER (non-serious) with onset 2021, outcome "unknown", described as "she "can barely talk.""; OEDEMA PERIPHERAL (non-serious) with onset 2021, outcome "unknown", described as "wrists swollen"; PSORIATIC ARTHROPATHY (hospitalization, medically significant), PSORIASIS (hospitalization) all with onset 2022, outcome "unknown" and all described as "Psoriasis/Psoriatic arthritis"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Blood tests showed that her autoimmune system was "in overdrive."". The event "blood tests showed that her autoimmune system was "in overdrive."" required emergency room visit. The event "psoriasis/psoriatic arthritis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood cholesterol: went way up; Blood test: autoimmune system was "in overdrive, notes: Blood tests showed that her autoimmune system was "in overdrive; arthritis sedimentation rate: 79, notes: arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control; went way up, notes: arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control; Lab work: Unknown results, notes: They did lab work for arthritis, sent her to arthritis specialist because, her bones were so inflamed, bones were hurting so bad; went sky high, notes: When looking at lab work, all her levels for labs, after she took shot; Protein total: went way up, notes: Protein went way up, rocketed up, everything went up, 3 months after the Covid shots; Weight: 195 pounds, notes: Height, Weight: just lost like 45 pounds, right now, is 5,5 and 195 pounds; 250 pounds, notes: Has been losing a lot of weight. At first, back then, when this started, was like 250 pounds. Therapeutic measures were taken as a result of psoriasis. Clinical course: Patient states that she received the Pfizer COVID-19 vaccine in 2021 and has since experienced many side effects since receiving the vaccine. Patient has many known allergies ("I'm allergic to everything") including NSAIDs and pain killers (caller did not specify which pain killers). Due to allergies, patient was originally hesitant to receive the vaccine but was urged to do so by her HCP to protect her mother who had lung cancer. Patient experienced side effects after the 2nd dose of the vaccine. She states that her hands were not working and she was unable to comb her hair or wipe herself. Upon consultation with a hand specialist, she did not receive treatment ("they couldn't do anything with my hand.") Patient recovered 1 week after. Patient also started to experience difficulty walking. She states that she transitioned from a cane, to a walker, to a wheelchair and was unable to get out of bed. She states that she "couldn't move my lower section." Patient was brought to the ER via ambulance. Blood tests showed that her autoimmune system was "in overdrive." Patient experienced lesions with a burning sensation. She states that she experiences "flare ups" and she "can barely talk." Caller states that "it's trying to kill me" and she just tries "to get through the day." In addition to aforementioned adverse effects involving her extremities, patient adds that she has since been diagnosed with Psoriasis and Psoriatic arthritis. Caller experienced lesions, was diagnosed with psoriatic arthritis and psoriasis and lips turned black, has lesions all over body and, the lesions burn, can hardly talk. There are flare ups, hard to get through the day. Thinks the vaccine was going to kill her, by the grace, she is still alive. She mentions that this affects her "all over" her body and her lips turned black. Despite independently seeking medical attention, HCPs are currently unable to help with her condition and have accused the patient of using illicit drugs. Patient states that she is not an illicit drug user. Due to difficulty receiving treatment, caller is attempting to seek treatment elsewhere and found a doctor who can potentially help her, but he (doctor) is not covered by her health insurance. Due to lack of coverage and lack of financial capability to fund treatment (caller is on retirement and disability), caller is seeking assistance in paying for medical expenses. Caller wants to know if it is possible to get reimbursement to help pay for the cost of treatment? They did lab work for arthritis, sent her to arthritis specialist because, her bones were so inflamed, bones were hurting so bad. When asked when her bones started hurting, she states, it just started hitting her. Clarified, she is still experiencing all of these experiences now, the legs and hands not working and the bone pain. It is all getting worse, that is why she was calling, to try and get help to get this out. When she picks up her grandbaby, her hands flare up. Can't really use her hands because, wrists swollen, having flare up. Whole body is flaring up now. If she does any extra movements if tries to use her hands, they hurt so bad. Like, when trying to cook, or turn key in car, is like, her body in flames. Has lesions all over her body. They said it is psoriasis, keeps scratching them. Never had pimple on body and now, these are all over. Can not even wear sundress, it is so bad. Clarified, the lesions started a year after the Covid shots. They just came popping out, like little nibbles. When putting lotion on, can feel them. Went to ER, thought it was blood clots because she never felt that before. Got mammogram, they said they could not do mammogram because of the bumps all over her breasts. They wanted her to go back to doctor, to get that cleared up before they would do mammogram. After that, the lesions started coming up black, was like a year later. They really got blacker and worse, when she took Rinvoq. Clarified, she took Rinvoq and the lesions started getting worse. They are itching really bad. They gave her Clobetasol, which was the only cream that helped. Is allergic to steroids so, they gave her Clobetasol which is a steroid, had to mix with diaper rash medicine, so it would not take the skin. It is the only thing that soothes it, tries to heal it but, it will come right back. Can't use steroids because they take the skin off her body, in her finger tips. Threw those away. They gave her pain medicine in hospital, they have those in her medical records. When looking at lab work, all her levels for labs, after she took shot, went sky high, cholesterol went way up, arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control. Protein went way up, rocketed up, everything went up, 3 months after the Covid shots. Asked doctor why they are not going back to normal. She does not drink or smoke, eats right. Asked doctor if she had cancer or AIDS. Has not been active since she had her son who is 15 years old. Was asking doctor to find out what this all is, he just said, it is long hauler's from the shots she took. Said it would take a year to get out of her blood. It is now going on 3 or 4 years. Seems like it is not getting better. Wants to get this shot out of her body. If they get this shot out of her body, she would be ok. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Allergy to NSAIDs; Bee sting hypersensitivity; Drug allergy; Migraine
IRON; VITAMIN C [ASCORBIC ACID]; RINVOQ
Test Name: cholesterol; Result Unstructured Data: Test Result:went way up; Test Name: Blood tests; Result Unstructured Data: Test Result:autoimmune system was "in overdrive; Comments: Blood tests showed that her autoimmune system was "in overdrive.; Test Name: arthritis sedimentation rate; Result Unstructured Data: Test Result:79; Comments: arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control.; Test Name: arthritis sedimentation rate; Result Unstructured Data: Test Result:went way up; Comments: arthritis sedimentation rate. Was supposed to be like 79, went way up, out of control.; Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results; Comments: They did lab work for arthritis, sent her to arthritis specialist because, her bones were so inflamed, bones were hurting so bad.; Test Name: Lab work; Result Unstructured Data: Test Result:went sky high; Comments: When looking at lab work, all her levels for labs, after she took shot; Test Name: Protein; Result Unstructured Data: Test Result:went way up; Comments: Protein went way up, rocketed up, everything went up, 3 months after the Covid shots.; Test Name: Weight; Result Unstructured Data: Test Result:195 pounds; Comments: Height, Weight: just lost like 45 pounds, right now, is 5,5 and 195 pounds.; Test Name: Weight; Result Unstructured Data: Test Result:250 pounds; Comments: Has been losing a lot of weight. At first, back then, when this started, was like 250 pounds.