Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | IM / LA |
shoulder injury related to vaccine administration/acute shoulder injury following Tdap vaccination; vaccine injection was administered higher than expected; This serious case was reported in a literature article and described the occurrence of shoulder injury related to vaccine administration in a 51-year-old female patient who received DTPa (DTPa vaccine) for prophylaxis. Literature Reference: Concurrent medical conditions included finger injury (to patient's finger). Additional patient notes included Patient with no significant medical history. Patient had no previous history of musculoskeletal or shoulder pathology and had tolerated previous vaccinations without incident. On 05-APR-2025, the patient received DTPa vaccine (intramuscular, left deltoid) .5 ml. On 05-APR-2025, less than a day after receiving DTPa vaccine, the patient experienced shoulder injury related to vaccine administration (Verbatim: shoulder injury related to vaccine administration/acute shoulder injury following Tdap vaccination) (serious criteria clinically significant/intervention required) and extra dose administered (Verbatim: vaccine injection was administered higher than expected). The patient was treated with ibuprofen and paracetamol (Acetaminophen). The outcome of the shoulder injury related to vaccine administration was resolving and the outcome of the extra dose administered was not applicable. The reporter considered the shoulder injury related to vaccine administration to be related to DTPa vaccine. The company considered the shoulder injury related to vaccine administration to be unrelated to DTPa vaccine. Additional Information: GSK receipt date: 03-NOV-2025 A 51-year-old female health professional with no significant medical history sustained a minor kitchen injury to finger on April 4, 2025. Patient received a Tdap vaccine in left (non-dominant) shoulder at an urgent care facility by a standing nurse while seated. The injection at a dose of 0.5ml was administered into the upper outer portion of deltoid muscle. As a healthcare professional, patient noticed immediately that the vaccine injection was administered higher than expected. Although patient did not initially experience severe discomfort, by evening patient developed progressive shoulder pain, reaching a severity of 8out of 10on the visual analog scale (VAS). The sharp, localized pain was aggravated by arm elevation and activities such as tying hair. There were no systemic symptoms like fever or chills,and patient did not experience numbness, tingling, or weakness. The contralateral arm was unaffected. Patient noted, It hurt so bad that I couldn't move or lie on the left side. Patient also said patient could barely sleep all night and awoke feeling fatigued and drained the next morning. Patient had no previous history of musculoskeletal or shoulder pathology and had tolerated previous vaccinations without incident. Initial self-management included ibuprofen 200 mg and acetaminophen 1000 mg taken three times daily for several days, resulting in partial relief. Patient began light self-guided physical therapy, reporting gradual improvement. No imaging was obtained, citing lack of time, and surgical opinion was not sought. As of May 3, 2025, which was 29 days after the initial injection, patient reported residual pain of 2/10 on the VAS but can perform moderate work duties. Physical Examination At approximately four weeks post-vaccination, a clinical evaluation was performed. The pain persisted at 2/10, but both active and passive range of motion (ROM) were preservedfully. Patient was able to raise both arms to shoulder height and overhead with proper form. Patient demonstrated full external and internal rotation, and a positive Apley Scratch test, indicating preserved shoulder mobility. No muscle atrophy or neurological deficits were identified. Sensation over the deltoid region was intact, and there was no cervical or thoracic spine involvement. Laboratory work, including complete blood count, basic metabolic panel, and lipid profile, was unremarkable. Vitamin D was mildly low but not thought to be contributory. The diagnosis of SIRVA was made based of the temporal relationship between vaccine administration and the onset of symptoms, absence of prior shoulder issues, and clinical findings. Patient was advised to continue conservative treatment, including physical therapy and as-needed NSAIDs. Should symptoms persist, patient might require further evaluation by the orthopaedic surgeons. Adverse events were reported to the Vaccine Adverse Event Reporting System (VAERS), and the patient was counselled on the expected recovery course. In this case, symptoms began within hours of Tdap administration, in the absence of other etiologies, supporting a diagnosis of SIRVA. Patient improved with conservative treatment but continued to experience mild discomfort. This case underscored the importance of proper vaccine administration to prevent SIRVA, a painful and potentially disabling condition. This article is not available for regulatory reporting purpose due to copyright restriction.; Sender's Comments: A case of Shoulder injury related to vaccine administration, less than a day after receiving a dose of DTPa vaccine in a 51-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (vaccine injection was administered higher than expected).
Finger injury (to patient's finger)
Comments: Patient with no significant medical history. Patient had no previous history of musculoskeletal or shoulder pathology and had tolerated previous vaccinations without incident.
Test Name: complete blood count; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: lipid profile; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: basic metabolic panel; Result Unstructured Data: (Test Result:unremarkable,Unit:unknown,Normal Low:,Normal High:); Test Name: visual analog scale; Result Unstructured Data: (Test Result:8/10,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250503; Test Name: visual analog scale; Result Unstructured Data: (Test Result:2/10,Unit:unknown,Normal Low:,Normal High:) after 29 days; Test Name: Vitamin D; Result Unstructured Data: (Test Result:mildly low but not thought to be contributory,Unit:unknown,Normal Low:,Normal High:); Comments: On an unknown date: Physical Examination- At approximately four weeks post-vaccination, a clinical evaluation was performed. The pain persisted at 2/10, but both active and passive range of motion (ROM) were preservedfully. Patient was able to raise both arms to shoulder height and overhead with proper form. Patient demonstrated full external and internal rotation, and a positive Apley scratch test, indicating preserved shoulder mobility. No muscle atrophy or neurological deficits were identified. Sensation over the deltoid region was intact, and there was no cervical or thoracic spine involvement