Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Mass, Myalgia, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient of an unspecified ethnicity received the 2nd dose of PREVNAR 13 (Lot # R70446, Expiry date: Apr2018, NDC # 0005197102) intramuscular at 0.5mL at right arm on 05Jun2017 11:20 for immunization, because of her age and for her preexisting conditions, at Pharmacy. Medical history included ongoing diabetes mellitus ongoing fibromyalgia ongoing osteoarthritis, ongoing chronic obstructive pulmonary disease (COPD), pain. Concomitant medication included hydrocodone bitartrate, ibuprofen (HYDROCODONE/IBUPROFEN) 7.5/200mg tablet one twice a day for pain and other regular unspecified medications, all prescribed by her doctor. The patient previously received the 1st dose of PREVNAR 13, ZOSTAVAX, and several flu vaccines for immunization. No additional vaccines administered on same date of the suspect. Patient started to experience symptoms on 08Jun2017. On 08Jun2017 the patient experienced fever, was having some chills, headaches on 08Jun2017, and  in Jun2017 she experienced increased bone and joint pain and all over muscle aches, all with  outcome not recovered. The patient previously received an dose of PREVNAR 13 in Mar2016 resulting the dose of 05Jun2017 an extradose. The patient also experienced 4 to 5 lumps on her head, lumps were painful but not very large and they do not itch, when she blows her nose in the morning there was blood in her sputum on an unspecified date all with outcome unknown. It was unsure if lumps started at the same time as other symptoms. As treatment, she is already on pain medication and she felt like she had to take more of her pain medication because of the reported events. She was taking two tablets twice a day at report time. No investigations performed. She has not gone to the hospital or doctor yet. No event required a visit to Emergency Room nor Physician Office.  The reporter mentioned Fever, chills, Headaches with seriousness criteria as Medically significant,  Increased bone and joint pain, all over muscle aches with seriousness criteria as Disabling,  4 to 5 painful lumps on her head was not serious.  No seriousness reported for blood in her sputum. The reporter considered there was a reasonable possibility that the events  fever, having some chills, headaches, increased bone and joint pain, all over muscle aches, 4 to 5 painful lumps on her head related to PREVNAR 13, and that the causality for blood in her sputum was unknown.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of serious events including fever, having some chills, headaches, increased bone and joint pain, all over muscle aches cannot be fully excluded, assuming a plausible temporal association and the known adverse event profile of the suspect product.  Headache, chills, fever, joint pain and muscle pain are known risks for the suspect vaccine.  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.