Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; she could barely move or lift the arm; she could barely move or lift the arm; localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful; This spontaneous report was received from physician and refers to herself, an adult female.  The patient had no known allergies. Concomitant therapies were reported as: none - maybe thyroid medication. The patient's concurrent conditions were not reported.  On an unknown date (reported as "few years before that [14-SEP-2014]"), the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (reported as pneumococcal vaccine) (dose, lot #, expiry date, route of administration and vaccination site were not provided) administered for prophylaxis.  On an unspecified date (within one day after the injection), she experienced a significant localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful to the point where she could barely move or lift the arm (vaccination site erythema; vaccination site swelling; vaccination site warmth; vaccination site pain; injected limb mobility decreased).  On 14-SEP-2014, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (reported as pneumococcal vaccine) injection (dose, lot #, expiry date, route of administration and vaccination site were not provided) administered for prophylaxis.  On an unspecified date in September 2014 (within one day after the injection), she experienced a significant localized reaction in which the injection site and whole upper arm became red, swollen, hot, and painful to the point where she could barely move or lift the arm (vaccination site erythema; vaccination site swelling; vaccination site warmth; vaccination site pain; injected limb mobility decreased). An inquiry was noted. The inquiry regarded any information regarding ingredients in pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and whether or not there was a "hypoallergenic" vaccine option. The patient's own provider suggested she received pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) at her last visit, however, the health care professional (HCP) stated she received two prior pneumococcal vaccines (mentioned above). The HCP could not recall which vaccines she received, or any other information about the vaccines, but stated she would try to obtain more information which she would provide. The HCP stated she sought medical attention from her provider both times in which the only treatment she could recall was taking diphenhydramine (BENADRYL) to treat the reaction, which cleared up approximately 4 days later and never became systemic. Therefore, the outcome of all of the adverse events was reported as recovered. No other information was able to be provided by the HCP during the call. No additional adverse event (AE) was noted (no adverse event). No product quality complaint (PQC) was noted.  The causal relationship between the adverse events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Lot # is being requested and will be submitted if received.