Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Discomfort, Herpes zoster, Injected limb mobility decreased, Injection site pain
Clinical narrative: Losing his strength and range of motion, cannot lift his hand above his head; Losing his strength and range of motion, cannot lift his hand above his head; Shingles/some complications as pain in left shoulder, neck and left arm which was the injection site; put on antibiotics,ultrasound showing acute density 3mm by 4mm x 3mm,may be infection fluid; This is a spontaneous report from two contactable Nurses.  A 66-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) Lot# AP2987, Expiration Date 31Jul2021, intramuscular in left deltoid on 10Sep2020 at 0.5 mL single dose for immunization. The documentation said 6:34, but the reporter was not unsure if it was given at that time. The patient medical history included generalized osteoarthritis, allergies due to pollen, Barrett's esophagus.  Concomitant medications included influenza vaccin on 27Aug2020 at 0.5ml on left deltoid for Immunization.  The patient previously took pneumococcal vaccine polysacch 23v (PNEUMOVAX VACCINE) on 29Nov2011 for immunisation. Patient received Prevnar 13 in September, he didn't get the vaccine in the office, got it done through a clinic. He had developed some complications as pain in left shoulder, neck and left arm which was the injection site in 2020. He received a pain medication acetaminophen;hydrocodone for it. So the doctor evaluated and determined the patient had shingles, shingles was diagnosed on 21Sep2020. The doctor put him on gabapentin (NEURONTIN), and it helped him. The patient was also put on Valaciclovir (VALTREX), for shingles, for 7 days.  But it came back and was still causing discomfort, he was also taking steroids; he was losing his strength and range motion since 17Sep2020, he cannot lift his hands above his head, they also did an ultrasound on 12Oct2020, it was showing a density, acute density, and the size was 3mm by 4mm x 3mm, so they will have to review further. He was also put on antibiotics in 2020, as it may be an infection fluid. She can give what they were calling the density on the ultrasound: it was a hypoechoic structure in the left upper extremity. Clarified shingles did not come back after gabapentin, shingles were not there, he was still experiencing pain, loss of strength, and loss of range of motion. He has recovered completely from shingles. The reporter was seeking further information. Lot was AP2987 and she wanted to report this and to see if there was anything wrong with the lot number. The patient called the facility with his first complaint on 17Sep2020. He said the neck pain was gone, but he was still having pain from his left shoulder to left elbow. The reporter stated she didn't think it required hospitalization, it was not life threatening, but it was serious, as the patient was losing strength and range of motion, so pain in his neck and shoulder and losing strength and range of motion was medically significant. ultrasound done on 21Sep2020; hypoechoic structure in the left upper extremity found. The density found on ultrasound was ongoing, she cannot provide if it was not there anymore, as there has not been another ultrasound done. Sample of the product was not available to be returned if requested as it was given at a clinic. The outcome of Infection was unknown, outcome for other events was not recovered. The reporter thought the events "pain in his neck and shoulder", "losing his strength" and "range motion, density, acute density" was related to the product.; Sender's Comments: Based on the information currently provided, the reported events more likely represent concurrent shingles with complications;  the device part of the suspect vaccine may also contribute to the vaccinated limb mobility decreased and abnormal ultrasound image showing small size fluid collection.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.