Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb mass, Mobility decreased, Nodule, Pain in extremity
Clinical narrative: her arm was swollen and red red with a lump the size of a golf ball, but not at the site of the injection, rather closer to the elbow region on the inner part of her right arm, about 4 inches below where the shot was given; her arm was swollen and red red with a lump the size of a golf ball, but not at the site of the injection, rather closer to the elbow region on the inner part of her right arm, about 4 inches below where the shot was given; she could hardly move her arm; her arm was swollen and red red with a lump the size of a golf ball, but not at the site of the injection, rather closer to the elbow region on the inner part of her right arm, about 4 inches below where the shot was given; muscle was swollen and hard; that she had difficulty sleeping on that side; her arm began to hurt in the eve; This spontaneous report was received from a pharmacist and a 75-year-old female patient referring to herself. The patient's concomitant therapies included influenza virus split virion 4v vaccine inactivated (FLUZONE) (vaccination in left arm). No information regarding her pertinent medical history, drug reactions or allergies was provided. On 22-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), intramuscularly in the right arm, lot # S026366, expiration date reported as September 2019 but upon internal review established as 17-SEP-2019 (dose was not reported) for prophylaxis. On 22-NOV-2019, the patient's arm began to hurt in the evening and she had difficulty sleeping on the right side. The pharmacist reported that on 23-NOV-2019, the patient's arm was swollen and red with a lump the size of a golf ball, but not at the site of the injection, rather closer to the elbow region on the inner part of her right arm, about 4 inches below where the shot was given. The patient could hardly move her arm. On 24-NOV-2019, it was visualized by the pharmacist as the swelling, redness and a nodule the size of a walnut on the inner part of the patient's arm, 3-4 inches below the band aid. The pharmacist reported that it was like the patient "got punched in that area" and that the boarders around the area were not defined. The swelling went down and the patient could move her arm more comparing to the day before. The pharmacist did a comparison to the other arm where the patient received the influenza virus split virion 4v vaccine inactivated (FLUZONE) vaccination and there was no swelling. The patient herself reported that from her elbow up about six inches towards her armpit, her arm was ''big and swollen, muscle was swollen and hard, and painful to the touch". She reported that the size of the lump in her arm was about the size of an orange. The patient was concerned but did not feel like she needed to seek medical attention and had only taken naproxen as a treatment. The outcome of the lump on vaccinated arm was reported as not recovered/not resolved. The outcome of difficulty sleeping, muscle hardness and arm pain was unknown. The outcome of redness and swelling of the vaccinated arm was reported as pretty much resolved on an unknown date in November 2019. The outcome of arm mobility decreased was reported as recovering/resolving. The causality assessment between the suspect vaccine and the events was not provided.