Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complement factor C3, Complement factor C4, Dizziness, Double stranded DNA antibody, EGFR status assay
Clinical narrative: Generalized urticaria (hives); hypersensitivity; serum sickness; joint swelling; joint stiffness; pruritus; Generalized erythema; swelling/Swelling to skin/joints; vein disorder; swelling/Swelling to skin/joints; arthralgias; myalgias; multiple joints petechiae; sever sickness; tearful; knee swelling; red patches on skin; burning especially in the evenings; extreme pain; occasional fever of 100-100.5 with exacerbations; dizzy; vomited; beginning Fatigue; Hair loss; This is a spontaneous report from a contactable physician and other HCP. A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in arm left on 10Feb2021 12:00 (at the age of 69-year-old) as dose 2, single for COVID-19 immunization. Medical history included Right breast cancer (gene negative (in 2012) from 1992 to 2012 (treated with cytoxin/methotrexate/adrenomycin/5 FC), Osteopenia, Environmental allergies, Basal cell cancer (Basal cell cancer-face and thigh), R superficial phlebitis, bilateral knee degeneration, Dry eye, Kidney stones, Right leg venous ligation in 1986, right mastectomy in 1992, breast reconstruction (right breast reconstruction and left breast mastectomy/saline implant 1993), basal cell carcinoma removed (basal cell carcinoma removed from left side of nose and left upper thigh 2008, basal cell removed from left forehead 2010), small spot of diverttulosis (COLONOSCOPY, small spot of diverttulosis, polyps rec f/u q 3 year 2012), Knee surgery (right knee surgery for torn meniscus 2010, left knee surgery for torn meniscus 2011, Total right knee Nov2017), right knee arthroplasty/replacement (Right knee replacement 2017), ESWL (Extracorporeal shock wave lithotripsy) and Hypertension from 1992. Family History included Father had alcoholism, HTN, Mother had breast cancer age 40, colorectal cancer age 44, metastatic cancer to bone, liver and lung age 48, diagnosed with Cancer, brother (both) had alcoholism. Maternal cousins with breast cancer; mother with 10 sisters, 4 with breast cancer (alt between 40-50 years) and 3 with brain cancer; 3 sisters with colon cancer (3 brothers-no known cancer hx). The patient social history included marital Status (divorced in 2011, Committed Relationship with my ex-husband), Non-Smoker, Diet overall good, alcohol rare, Caffeine 2-3/day, Exercise 5 days a week, golfing; 5d/week; cycling/walking and weights, Occupation she retired since 2014, RN doing home health and directing that service, no Physical abuse, sexually active and no domestic Violence. The patient was allergic to most metal but nickel for sure, pine: respiratory, mold: respiratory, linen: rash, lactose: sick to stomach, peaches: rash, Allergies Palm oil, seafood/shellfish, Iodine: itching, rash, fever, confusion and verbal slurring, Allergies white/red whine. The patient received Histamine, codeine, morphine and had Allergic (morphine and codeine: vomit). Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN POTASSIUM AND HCTZ) 50mg/12.5mg tablet orally once a day; estradiol 0.0375mg transdermal patch 2x/week, 24HR patch via transdermal route; progesterone (PROMETRIUM [PROGESTERONE]) 8 days a month, discontinued; tretinoin 0.025% cream daily via transdermal route; clobetasol propionate (CLOBETA [CLOBETASOL PROPIONATE]) ointment; varicella zoster vaccine rge (cho) (SHINGRIX, Lot: P2J7E) from 16Apr2021 to 16Apr2021, all taken for an unspecified indication. The patient received Histamine, codeine, morphine and had Allergic (morphine and codeine: vomit). The patient received unspecified antihistamine for previous history of allergies. Historical vaccine included first dose of bnt162b2 on 14Jan2021 at 12.15 PM (Batch/lot number: EL3248, intramuscularly in Arm (Deltoid) (at the age of 69-year-old) for covid-19 immunisation and experienced arthritis, hairloss, hemoglobin leakage under skin, fever, rash, pruritus, skin burning sensation, fatigue. Historical vaccine included Tdap (Dose 1, Manufacturer: Sanofi, Lot: U5771AA) on 19Mar2018 (at the age of 66-year-old), Hepatitis A Hep A (adult) (Dose 1, Manufacturer: Glaxo, Lot: 595AS) on 26Feb2018 (at the age of 66-year-old), Seasonal Influenza Influenza IIV4 (P-Free Injection) (Dose 1, Manufacturer: Glaxo, Lot: 595AS) on 20Oct2017 (at the age of 66-year-old), Seasonal Influenza IIV3 High Dose from 29Nov2018 (Dose 2, Manufacturer: sanofi, Lot: UJ030AB)(at the age of 67-year-old), Influenza IIV3 High Dose on 21Oct2019 (Dose 3, Manufacturer: Sanofi, Lot: UJ274AB) (at the age of 68-year-old), Influenza IIV4 High Dose (FluZone HD Quad) on 12Oct2020 (Dose 4, Manufacturer: Sanofi, Lot: UJ510AB) (at the age of 69-year-old), Pneumocaccal Adult (PREVENAR 13) (Vaccine: Pneumocaccal Adult PCV13 (Prevenar13), Dose 1) on 17Nov2017 ((at the age of 68-year-old), PPSV23 (Pneumovax) on 26Feb2018 (Dose 2, Manufacturer: Merck, Lot: N023650) (at the age of 66-year-old), Typhoid Typhoid ViCPS on 26Feb2018 (dose 1, Lot: N1K90) (at the age of 66-year-old), Zoster ZVL (Zostavax) on 09Oct2012 (dose 1, Manufacturer : Merck, Lot: 0071AE) (at the age of 61-year-old), Zoster RZV (Shingrix) on 12Oct2020 (Dose 2, Manufacturer : Glaxo, Lot: 52B24) (at the age of 69-year-old). The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient was not treated with any other vaccines, immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient experienced generalized urticaria (hives), hypersensitivity, serum sickness, joint swelling, joint stiffness, pruritus, generalized erythema, swelling, vein disorder on an unspecified date in 2021. It was unknown if patient had Angioedema (not hereditary), generalized prickle sensation, Localized injection site urticaria or Red and itchy eyes. On an unspecified date in 2021, swelling to skin/joints, arthralgias, myalgias, multiple joints petechiae and sever sickness. The patient chooses not to get ashes because of fear of kneeling with difficulty. On 18Feb2021, the had appointment for specialist to discuss planned eyelid surgery. On 26Feb2021, 8 hour meeting the patient was taking Ibuprofen for joint and muscle in. That seemed to work and was thrilled as had gotten the vaccine and was experiencing some knee swelling still. On 03Mar2021, Annual physical Mentioned joint issues but patient think it was attributed to aging. Then that afternoon had appointment again for testing regarding surgery and exhibited swelling and pain with movement expressed concern with getting surgery because of general difficulty joints and obvious swelling of R leg veins. He suggested that she had Serum Sickness. Never heard of it, didn't ask any aid mention It to your physician. Decided to wait to get the eye surgery. Mammogram on the on 04Mar2021 which was ok. The patient very concerned about the distended veins in right leg and she made appointment with GR vein specialists for 10Mar2021 to R/O problem or clot. It was stated that the patient was continued doing vaccination shots for the month of Mar for Allegan, Co Noted distended veins in bilateral legs, worse in Right leg. Elbows, wrist and shoulders were inflamed and painful. Still going to the gym and biking and walking with ease as before Covid shots. On 10Mar2021, had appt. with Nurse Practitioner and made appt to follow up with physician. On 25Mar2021, Appt with physician. She measured, photo'd and manually examined legs and joints and confirmed that she thought serum sickness. She explained the reaction to foreign protein in the body and said she had seen a few cases. Explained that it could take weeks to months to get through. Explained how challenging it was the actual blood vessels in the body and by then exhibited leaking in the vessels red patches on skin, and along with swelling and pain and was tearful. On 12Apr2021, the patient walked to and had a lot of pain and difficulty with shoulders and knees. On 15Apr2021, Ultrasound for right leg and no abnormalities noted. Stopped taking any Ibuprofen. On 24Apr202, ate dinner and had one glass of wine. Woke up swollen and peppered with hives from the waist down. Started taking Benadryl 2x daily for the week. Wondered if it was food/histamine/general. On 28Apr2021, the patient had to be very careful with food choices and any ETOH (Meaning totally abstained from any ETOH going forward) By then any current allergy was exacerbated 3 fold. (Milk, preservatives, sugar, she made really good simple choices). Still swollen through month of Apr and May. On 13May2021, Appt with Allergist. Again, confirmed Serum Sickness and that it would go away but causes hypersensitivity to everything. No testing as it would exacerbate the symptoms and body was already pretty inflamed. It was stated that In the fourth week of May2021, the patient woke up one morning and the swelling was gone and patient was happy. In Jun2021, Swelling gone but joints still painful. Still very hypersensitive to food. Unable to drink a glass of wine w/o extreme pain, itching and swelling the next day. In Jul2021, noted the red blotching under the skin with itching and burning especially in the evenings. Everything the same all month, no more swelling, yes to itching and leaky vessels, yes to taking very good care of herself. On 28Jul2021, the patient had reaction on l r/t soup. Legs broke out with itching and swelling, leaking and pain within an hour. (Not a fish soup). Due to this the patient cancelled scheduled eye surgery. On 30Jul2021, received cortisone injection for knee. In Aug2021, the patient had trip and felt good. After returned home, she had Itching, burning and skin issues returned and Icing helped on that. 09Aug2021, the patient went on lunch with friends, and they noted how bad my legs. The patient was cancelled Aug2021 dental appt because she doesn't want any more issues. In Sep2021, Same issues. stung by a bee at the. L arm swelled immediately, dizzy, and vomited. it was weird. Took one week for swelling to resolve, very painful, took Benadryl for the event for 10 days. On 10Sep2021, Sclerotherapy R leg Spectrum. On 13Sep2021, Eye surgery (took 4 amoxicillin prior to the surgery as ordered by orthopaedic surgeon before any invasive surgery). One week prior to surgery tested me for any allergy to medication being used (except the PCN) including betadine. No reactions noted. Surgery successful. Tuesday rash and flush in lower R extremities. Extreme itching, leaking, pain and ugly. suggested Zyrtec and use Cerave cream liberally and a 12 day prednisone routine. On 20Sep2021, during follow up explained reaction to physician and noted that didn't think it had any connection to the eye surgery except timing and he thought about It and said the PCN derivatives and bee stings exacerbate the Serum Sickness. The patient continues to itch and look awful. The patient doesn't drink ETOH, but just want to be normal. The patient want more information about covid vaccine. The patient had Hair loss, beginning Fatigue, occasional fever of 100-100.5 with exacerbations on an unknown date. The patient was seen by vascular Surgery who basically stated that felt that this was a consistent diagnosis she stated that this was likely that was causing the vascular changes. The patient noticed black blotches on her skin as well as red patches and has pictures of urticaria areas she had an ultrasound on the leg in Apr2021 looking for more venous insufficiency she stated that she was affected by food especially alcohol and red Wine. She was then had an appointment with her allergist and confirmed serum sickness and he Stated that this was a hypersensitivity and this will go away unfortunately no treatment Was given he did not do any testing at that time due to the fact that he was concerned that she would react to everything. The practitioners treating the skin symptoms and trying prednisone which helps some but unfortunately she did have surgery in the past and because Of the surgery she had taken penicillin and this had caused an exacerbation as well so overall she talks about her fear of the future she was concerned about the vaccine itself and was there a database that has these reactions we discussed that it does sound like she has Serum sickness although will get blood work to help try to confirm this but by history she very much fits at diagnosis we discussed that these typically take time to settle down that treatment of long-term prednisone was advised. Patient presents with concerns that she feels were related to Pfizer COVID injections. She had on-going pain in multiple joints with stiffness. Also, with concerns about possible serum sickness. Swelling in BLE with large painful varicosities. Continues to have severe itching over her entire body. Tries not to itch- likely unintentionally itching in her sleep. Legs with ecchymotic areas and patches of redness. She feels the symptoms were unrelenting. She was complaining of broken blood vessels on arms and legs. swelling and pain of the extremities with pink splotches and bulging veins of the lower legs. Her plastic surgeon felt she had serum sickness, she also saw a vein specialist who said she has varicose veins, but she also agreed that there was an allergic component, and she was referred for allergy assessment, and will have testing in Oct2021. Had no other unusual bruising, bleeding, chest pain, shortness of breath, night sweats, fever, or weight changes. The patient did not display any clinical signs at rest indicative of severe systemic illness. The reporter consider the Pfizer product had a causal effect to the adverse events. The patient was not seen in the emergency department or intensive care unit. No hospitalization required. No dermatological/Mucosal, Cardiovascular organ involvement. Capillary refill time was more than 3 sec was Unknown and Reduced central pulse volume: Unknown. The patient did not had symptoms of gastrointestinal, diarrhea, abdominal pain, nausea or vomiting. No any new or worsened symptoms/signs noted during the COVID-19 illness. Diagnosis as per Allergists Vascular surgeon to have serum sickness. The patient vitals sign noted as BP 198/70 mmHg and Pulse sitting 72 on an unknown date. The patient general examinations was normal on an unknown date. Assessment of Serum sickness, initial encounter was T80.69XA and Dermatitis was L30.9. The patient underwent lab tests and procedures which included on 28Sep2021, included Complement activation test was Normal C3 and C4, Rheumatoid panel was normal. On 29Sep2021 included SARS-CoV-2 by PCR was Positive, SARS-CoV-2 IgG Ab was Reactive A (Reference range: Nonreactive), Rheumatoid Factor was 11.2 iu/ml (0 to 14), sed rate was 3 mm/hr (0 to 20), RBC 4.79 10e6/uL, Total protein 6.4 g/dl, Platelet count 239 10e3/uL, MCV 89.1 fl, MCHC 33 g/dl, MCH 29.4pg, OCP antibody 0.9 EliA U/mL, Hepatitis Interpretation (Unknown result), Hepatitis C Antibody Negative, Hepatitis Bs Ag Negative, Hepatitis B Core At), lgm was Negative, Hepatitis A Ab.,lgm Negative, Haemoglobin 14.1g/dl, Haematocrit 42.7 percent, Globulin 2.4 g/dl less than 60 mL/min/1.73m2, Double stranded DNA was 0.6 iu/ml, Complement C4 33.2 mg/dl, Complement activation test (C3) 121 mg/dl (Serum sickness, initial encounter was T80.69XA), Carbon dioxide 30 mmol/l, Uric acid 3.5 mg/dl, Bun 14 ,g/dl, RDW 14.3 percnet, High Sensitivity CRP was 0.8, ANA Symphony 0.20, ANA interpretation Negative, alanine aminotransferase: 27 iu/l, anion gap: 5 mmol/l, aspartate aminotransferase: 18 iu/l, blood albumin: 4.0 g/dl, blood alkaline phosphatase: 52 iu/l, blood bilirubin: 0.60 mg/dl, blood calcium: 9.3 mg/dl, blood chloride: 102 mmol/l, blood creatinine: 0.74 mg/dl, blood glucose: 102 mg/dl, Comprehensive Chemistry Panel Test: Glucose , blood potassium: 3.7 mmol/l, blood sodium: 137 mmol/l. On 30Spe2021, included Complement Total S was 73 u/ml (30 to 75). The patient received Corticosteroids, Antihistamine, Benadryl 25 mg 10 days, Zyrtec 10 mg and Prednisolone 12 days. It was stated that Addition of Benadryl prednisone/Zyrtec Benadryl was daily but too sedative than switched Zyrtec prednisone done least twice for 6-12 days. Therapeutic measures were taken as a result of events. The outcome of events generalized urticaria (hives), hypersensitivity, joint swelling, serum sickness, joint stiffness, pruritus, generalized erythema, vein disorder was recovering while outcome of other events was unknown.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101365226 same patient/reporter, different drug dose