Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 5R4CY | RA |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | MG7418 | LA |
red arm; pain, itching in the injection area; pain, itching in the injection area; arm has a red path where the liquid went through; Tiredness; loss of appetite; chills; headache; swelling of the arm; severe pain in the arm; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Oct2025 at 09:30 as dose 1, single (Lot number: MG7418) at the age of 53 years, in left arm for immunisation, Device Lot Number: MG7418; influenza vaccine (INFLUENZA VACCINE), on 28Oct2025 as dose 1, single (Lot number: 5R4CY), in right arm for immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). Concomitant medication(s) included: METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID], start date: 03Oct2025, stop date: 26Oct2025. The following information was reported: FATIGUE (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "Tiredness"; CHILLS (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering"; HEADACHE (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "loss of appetite"; PAIN IN EXTREMITY (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "severe pain in the arm"; PERIPHERAL SWELLING (non-serious) with onset 28Oct2025 at 14:30, outcome "recovering", described as "swelling of the arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 30Oct2025, outcome "recovering", described as "arm has a red path where the liquid went through"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 30Oct2025, outcome "recovering" and all described as "pain, itching in the injection area"; ERYTHEMA (non-serious) with onset 30Oct2025, outcome "recovering", described as "red arm". Therapeutic measures were taken as a result of fatigue, decreased appetite, chills, headache, peripheral swelling, pain in extremity, erythema, vaccination site pain, vaccination site pruritus, vaccination site erythema. Additional information: Reported event in the Evening: Tiredness and loss of appetite. At night: chills, headache, swelling of the arm, severe pain in the arm. In the morning: chills, headaches, nausea, tiredness, red arm, severe pain in the arm, loss of appetite. After 48 hours: red arm, pain, itching in the injection area, headache. Arm has a red path where the liquid went through. Treatment received for the adverse event: Tylenol, Advil, compress. No follow-up attempts are possible.
Medical History/Concurrent Conditions: Allergy
METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]