Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: allergic reaction; Low grade fever; Swelling; I guess it would be referred to Urticaria;  primarily large well in one location; rash; angioedema again (same as in past); angioedema again (same as in past); The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 22Nov2021, this case contains serious adverse reaction(s) and all safety information is processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient.  A 62-year-old male patient received BNT162B2 (COMIRNATY), administered in arm right, administration date 29Oct2021 14:40 (Lot number: FD0809) at the age of 62 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease" (COPD), start date: 1992 (ongoing); "Chronic pain", start date: 1992 (ongoing), notes: Long term Pain Management; "Adrenalectomy", start date: 2005 (unspecified if ongoing); "cholesterol" (ongoing); "HBP" (high blood pressure), start date: 1992 (ongoing); "heart" (ongoing); "Reflux" (ongoing); "Prostate" (ongoing); "angioedema" (unspecified if ongoing), notes: same as in past. Concomitant medications included: fluticasone propionate (FLONASE); OXYCODONE and BACLOFEN taken for pain (ongoing); LIPITOR taken for Cholesterol (ongoing); TAMSULOSIN and PROSCAR taken for Prostate (ongoing); COZAAR taken for Heart/ BP (ongoing); albuterol [salbutamol] taken for COPD (ongoing); esomeprazole magnesium (NEXIUM MUPS) taken for Reflux (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Anatomical site of injection: left arm, Batch/lot number: FWQ182 or EWQ182), administration date: 13May2021 (3:30 PM), when the patient was 62 years old, for COVID-19 immunization, reaction(s): "Disequilibrium /proprioception issues" (for 10-12 weeks); Shingrix (about 2 years ago), administration date: 22Sep2020, when the patient was 61 years old, for immunization, reaction(s): "severe allergic reaction" - treated with omalizumab (XOLAIR) ending, 01Jul2021; also reported ended up having 6 months serious shot of ciclesonide;formoterol fumarate;tiotropium bromide (ZOVAIR). The following information was reported: ANGIOEDEMA and DISEASE RECURRENCE all (medically significant) with onset 31Oct2021 and described as "angioedema again (same as in past)"; HYPERSENSITIVITY (non-serious) described as "allergic reaction"; PYREXIA (non-serious) described as "Low grade fever"; SWELLING (non-serious) described as "Swelling"; URTICARIA (non-serious) described as "Urticaria" and RASH (non-serious) described as "rash" both with onset 31Oct2021; all outcome "not recovered". The patient guessed that had a delayed reaction to the second COVID vaccination Pfizer. It took about two days before he noticed anything and then he started noticing low grade fever (mild fever) and basically an allergic reaction, it would be referred to as urticaria and primarily large, well in one location and then started having swelling and well in another location and all of this was extremely similar to an auto immune or allergic reaction patient had the Shingrix Vaccine about 2 years ago. Patient got the shot on 29Oct2021 (Friday) and started noticing the rash on 31Oct2021 (Sunday) and was concerned that it may get worse. Patient just took an over-the-counter allergy medication. Patient was still experiencing issue and stated that started having the problem in other location. So it seems to be its slowly getting worse. It wasn't at the injection site and it wasn't immediate, but it definitely a reaction. Further reported that on 31Oct2021, started experiencing urticaria and angioedema again (same as in past). Have Since scheduled follow up with Allergist and resumption of XOLAIR treatment ASAP. Despite current treatment with Prednisone, symptoms were worsening daily.  Follow-up attempts are completed. No further information is expected.