Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pruritus, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of PREVNAR 13 (lot number and expiration date: unknown) intramuscular in the left deltoid on 08Feb2018 12:30 at a single dose for immunization (doctor suggested this because of her age). The patient medical history was not reported. The patient stated that she has some medical conditions, but nothing she feels is relevant and declined to provide more details. There were no concomitant medications. No vaccines were administered in the last 4 weeks. The patient previously received a tetanus vaccine shot and was allergic to tetanus. It was reported that when she was 3 years old she had a reaction to what her mother thought was a tetanus shot and she had to be hospitalized (she thinks it was a DTP vaccine). The patient received a shot on Thursday, 08Feb2018, she had a horrific experience with it. She couldn't move her left arm for 3 days and she was all swollen. She broke out in a rash from shoulder to elbow and around her arm. She took pictures of it. It was extremely painful. It was also itchy where she received the injection. She talked to her doctor and he told her to go to the emergency room. She didn't want to so she talked to a nurse and talked to their doctor line. They gave her some good advice and she had to take it easy over the weekend. On 11Feb2018, she had a knot in her left arm where she received the shot. On an unspecified date, it still hurt when she moves her arm. The swelling had gone down, but the pain and the knot in her shoulder had not. The events did not require a visit to the emergency room or physician office. She did not want to go to the doctor's office because they were going to charge her for it and she felt it was all their fault. She asked if the delivery system of this shot is a diphtheria serum because she read that it is. She has had it on her medical chart since she was 3 years old that she is allergic to tetanus. She asked if this was the same shot and if PREVNAR 13 has diphtheria in it. She was very upset with her doctor because they have known about her allergies all along. She stated that this was her first time ever receiving the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) vaccine. She had one in October that was the first vaccine of the series, but it had a different name and she could not remember the name of it. She did not have a reaction to that vaccine. Outcome of could not move her left arm was resolved with sequelae; the patient had recovered with lasting effects from not being able to move her arm. The event of left arm swollen was resolved on 13Feb2018. It still hurts when she moves her arm and she has a knot in her arm at the injection site. The itchiness described by the caller was persisting, but it comes and goes. The knot in her left arm, itchy where she received the injection and still hurts when she moves her arm were not recovered while the rash was recovering. The patient denied any medical testing. Information on batch and lot number has been requested.