Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2017US013944 is an initial spontaneous report received from consumer who is also a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 662377) website on 23 Jan 2017. This report refers to 76 year old female patient. Prior vaccination history included vaccination with varicella zoster vaccine (unknown whether seasonal or pandemic, other manufacturer) about 5 years before this report. It was reported that the patient arm got red, swollen and hot at the injection site for about 7 to 10 days and reported that the vaccine did not work for her because she had experienced shingles. Historical condition included old injuries and herpes zoster with shingles on her scalp and the back of her neck about 2 years before this report. Current condition included enlargement of left atrium (that was showed up in an electrocardiogram performed on an unknown date, but the cardiologist told her to not worry about it and that it was a very slight enlargement), vaginal itching, allergy, Barrett's oesophagus, blood pressure high and blood cholesterol increased. Concomitant medications included losartan, omeprazole, FLONASE, PREMARIN and atorvastatin calcium since 8 years. It was reported that on an unknown date, the patient also took supplement Super Beets for about 1 month to try and reported that it helped with her blood pressure and gave her more energy. On an unknown date in 2016, it caused her diastolic pressure to drop down to 51 and she stopped using it. It was also reported that the supplements helped her to lower her cholesterol however, on an unknown date in 2016, the lab test showed her blood cholesterol level of 240 before using the supplements and after using the supplement it was lowered to 150. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) into left arm on an unknown date in Sep 2016 (reported as 4 week prior to PREVNAR 13 vaccination). The patient was vaccinated with PREVNAR 13 (manufacturer unknown, batch number: not reported) into right arm on 05 Oct 2016. After vaccination on 08 Oct 2016 (three days after vaccination), the patient developed redness (a big, round, red spot right) and warmth at her injection site on her right arm. It was reported that the redness and warmth lasted about 5 days and recovered completely on an unknown date. On 13 Oct 2016 the patient experienced headaches, stomach pain, bloating, loss of appetite, pains in legs, wrist, knees, rotator cuffs, feeling feverish, stomach pain and loss of appetite. It was reported that the headaches would come and go and she recovered from headaches on an unknown date, but she occasionally felt a pressure in head. It was reported that the stomach pains lasted about 4 days and have gone away (recovered) on an unknown date and her loss of appetite was slowly improving, but she had lost 7 pounds. It was reported that the pains from her stomach seemed to radiate down her legs and she experienced muscle pains in either the front muscles of her legs or her feet. The pains in her legs and feet were mostly fine, but still come and go and it seemed like the pains were attacking her old injuries. The patient had pain in her shoulders from where she had rotator cuff injuries and pains in her knees and wrist that come and go, mostly at night and her pain in wrist was ongoing, but was very slight. Due to pains in her legs and joints the patient visited her physician and felt feverish, but did not have a fever and that feeling went away completely after about 2 to 3 days (complete recovery). It was reported that the patient was initially diagnosed with costochondritis on an unknown date (reported as when her symptoms first started). Patient was treated with NAPROSYN and was told to alternate with TYLENOL for the pains. It was reported that the patient assumed that her symptoms were due to atorvastatin calcium tablets, so she stopped without her physician knowledge on 13 Oct 2016. It was reported that the patient believed that the events were related to PREVNAR 13 vaccination. The outcome of the events abdominal pain upper, headache, pyrexia, skin warm and erythema was reported as complete recovery on an unknown date, for the events arthralgia, musculoskeletal pain and pain in extremity it was condition unchanged, for the event decreased appetite was condition improving and for the events abdominal distension, costochondritis, head discomfort, myalgia and weight decreased was not reported. Seriousness of the events were reported as non serious and causality was not reported.