Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
increased inflammation and pain in her shoulder/that the pneumococcal vaccine administration led to a nerve injury; Complex regional pain syndrome; Information has been received from a pharmacist regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On unspecified date in 2017, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis; on the same date (unclear which vaccination was administered first) the patient received a dose of Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid (BOOSTRIX) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis too. The vaccinations were received sequentially and administered so close to the same spot that there was only 1 visible skin puncture. Upon administration of the first vaccination, the patient told the pharmacist that she felt pain and that "something was wrong." During the next 2 days (unspecified date in december 2017), the patient experienced increased inflammation and pain in her shoulder. The patient sought medical follow-up and was diagnosed with complex regional pain syndrome. Initially, it was alleged through expert testimony that the administration of the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vaccine was outside the standard of care, and another expert concluded that the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vaccine administration led to a nerve injury. The Act was passed to create a vaccine injury compensation (VIC) program for specific vaccine-related injury claims. The VIC program covers injuries related to the Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid (BOOSTRIX) but did not cover injuries related to the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vaccine. In December 2020, the patient filed a lawsuit against the pharmacy alleging that negligent administration of the pneumococcal vaccine led to "painful and permanent" nerve injuries. At the reporting time, the outcome of both adverse events was unknown. The reporter considered both events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) The reporter considered both events to be disabling events.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : (withheld) , Index date : 2025-10-07 , MNSC number : , CLIC number : 938859 , ESTAR number : , IRMS number : PI1166104 , Central date : 2025-10-07 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :