Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | RA |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | — | — |
stomach ache; redness spreading down arm; Swollen arm; nausea; pain in arm at site and down arm; pain in arm at site and down arm; lump; redness at injection site; loss of appetite; low grade fever; chills; tired; lethargic; back ache; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Aug2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in arm for immunisation; hepatitis B vaccine rhbsag (yeast) (ENGERIX B), on 12Aug2025 as dose 2, single, in right arm for immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: recovery; "Drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Engerix b (DOSE 1, SINGLE), for Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Aug2025, outcome "not recovered", described as "Swollen arm"; BACK PAIN (non-serious) with onset 13Aug2025, outcome "not recovered", described as "back ache"; CHILLS (non-serious) with onset 13Aug2025, outcome "not recovered"; LETHARGY (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lethargic"; DECREASED APPETITE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "loss of appetite"; PYREXIA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "low grade fever"; VACCINATION SITE MASS (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lump"; NAUSEA (non-serious) with onset 13Aug2025, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 13Aug2025, outcome "not recovered" and all described as "pain in arm at site and down arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "redness at injection site"; FATIGUE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "tired"; ERYTHEMA (non-serious) with onset 16Aug2025, outcome "not recovered", described as "redness spreading down arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Aug2025, outcome "not recovered", described as "stomach ache". Therapeutic measures were taken as a result of peripheral swelling, nausea, vaccination site pain, pain in extremity, vaccination site mass, vaccination site erythema, decreased appetite, pyrexia, chills, fatigue, lethargy, back pain, abdominal pain upper, erythema. Causality for "swollen arm", "nausea", "pain in arm at site and down arm", "lump", "redness at injection site", "loss of appetite", "low grade fever", "chills", "tired", "lethargic", "back ache", "stomach ache" and "redness spreading down arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: PREVNAR 20 was vaccinated on the upper arm. Swollen arm, nausea, pain in arm at site and down arm, lump, redness at injection site, loss of appetite, low grade fever, chills, tired, lethargic, back ache. Day 4 stomach ache, redness spreading down arm, back ache, chills. Antibiotic treatment received for the adverse events. It was reported that patient did not received any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The patient wasn't receiving any other medications within 2 weeks of the event starting. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. Amendment: This follow-up report is being submitted to amend previously reported information: case seriousness should be update to serious. Amendment: This follow-up report is being submitted to amend previously reported information: case seriousness should be downgraded to non-serious.
Medical History/Concurrent Conditions: Cancer (recovery); Drug allergy