Received Nov 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); body ache/ body aches (back/knee pain, pre-existing, worsened in the past week); This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA103739 (Sanofi), AE-021514 (BioNTech). A 68-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 08Oct2025 (ongoing) at 300 mg (300 mg, every other week (eow) (300 mg/2 ml)), subcutaneous for chronic obstructive pulmonary disease; influenza vaccine (INFLUENZA VACCINE), on 08Oct2025 as dose number unknown, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LORATADINE taken for rhinorrhoea, start date: Oct2025 (ongoing). Past drug history included: Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "still experiencing red spots", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "dry skin", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "Restless occurred once during the past month", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "patient report difficulty sleeping, occurred once during the past month", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "bleeding sore", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "stinging", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "lesions develop and open", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "Itchy", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "decreased motivation to get up", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "worsened fatigue", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "lightheadedness", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "blood sugar was up", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "1/4 -3/4 inch, looked like eczema", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "skin tore when bandaid removed", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "headache", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "blurry vision/blurred vision", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "feels like he has small mosquito bites but less severe", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "spots on his arms that break open and have rashes", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "runny nose/drainage", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "fluctuations in weight over the last year 10 pounds", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "uncertain about balance", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "dry eyes", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "body ache/ body aches", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "back/knee pain", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously; Dupixent, start date: 26Mar2025, for Chronic obstructive pulmonary disease, reaction(s): "back/knee pain", notes: solution for injection; strength: 300mg/2ml;300mg QOW subcutaneously. The following information was reported: BACK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Oct2025, outcome "unknown" and all described as "body ache/ body aches (back/knee pain, pre-existing, worsened in the past week)". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for dupilumab was dosage not changed. Additional information: It was reported "he is still experiencing red spots and dry skin, but he just took his second dose today. Advised that the medication may take up to several weeks before he notices an improvement and to contact his doctor in a couple of months if he still sees no improvement. patient reports blood work done week of 28-Apr-2025 resulted 06-May-2025 showed blood sugar was up, md (medical doctor) aware; patient reports since start of therapy skin dryer, itchy, stinging, more red spots, "lesions" develop and open, bleeding sore noted. 06May2025, 1/4-3/4 inch, looked like eczema, applied bandaid, skin tore when bandaid removed, opened Page 10 of 12 another spot, reports since start of therapy: worsened fatigue, light headedness, body aches, decreased motivation to get up, noted 16May2025 to 20May2025, attributes to elevated blood sugar. patient reports difficulty sleeping, restless mentally active, occurred once during the past month, exact date unknown. titration dosing not applicable. Patient report body ache, headache, fatigue, dizziness, and blurry vision. Patient noted that "discussed with doctor to stop another medication concerning those symptoms." but no further information was available. Unknown exact date of adverse event. Patient reports a few days to a week before each dose is due he starts to feel like he has bugs crawling on him and feels like he has small mosquito bites but less severe, symptoms are "all over," patient reports symptoms come and go and he takes lots of baths to manage symptoms, md not aware, patient also states previously reported "spots" on his arms that break open and have rashes are ongoing, unknown if md not aware, patient also states previously reported dry skin is ongoing, reports skin is dryer than normal, unknown if md aware, patient states he now occasionally gets blurry vision and lightheaded with activity, states this is new. Patient states he has recently been monitoring his blood sugar at md instruction, unknown if md aware of new symptoms. No further details provided on dates, timeline, all unknown, last injection given yesterday 30Jul2025. Patient reported after start of therapy has dizziness/lightheadedness/"uncertain about balance," blurred vision, dry eyes, body aches (back/knee pain, pre-existing, worsened in the past week), runny nose/drainage (started loratadine last week Oct2025 - ongoing), fluctuations in weight over the last year (10 pounds). Received covid and flu vaccines on 08Oct2025, same day as Dupixent injection and stated has worsened body aches since then. MD aware". In Oct2025 the patient developed a non-serious event "body aches (back/knee pain, pre-existing, worsened in the past week)" (back pain) (latency: approximately 7 months) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB, COVID-19 VACCINE and Flu vaccine. Batch/lot number is not provided, and it cannot be obtained.
LORATADINE; DUPIXENT
Test Date: 20250428; Test Name: blood sugar; Result Unstructured Data: Test Result:blood sugar was up; Test Date: 20250506; Test Name: blood sugar; Result Unstructured Data: Test Result:elevated; Test Date: 2025; Test Name: Weight; Result Unstructured Data: Test Result:10; Comments: fluctuation in weight over the last year (10 pounds)