Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Fibromyalgia, Head discomfort, Headache, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) via a non-clinical study program Pfizer. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration as single dose on 08Apr2015. Relevant medical history included depression, insomnia, anxiety and low thyroid, all on unknown date in 2002; and immunosuppression, fibromyalgia, mental health problem (long standing but controlled) and chronic fatigue, all ongoing. Concomitant medications included ZOLOFT (tablet) oral from unknown date and ongoing at 12.5 mg, (cuts 25 mg in half) frequency unknown for depression; SEROQUEL (tablet) oral at 300 mg frequency unknown from unknown date and ongoing for insomnia; diazepam (manufacturer unknown, tablet) oral at 5 mg cyclic (Q5h and 15 mg pm) from unknown date and ongoing for anxiety; levothyroxine (manufacturer unknown) at 1 ug once daily from unknown date and ongoing for low thyroid; calcium (manufacturer unknown) from unknown date and ongoing for build up bone; Vitamin D (tablet) oral at 1000 IU frequency unknown from unknown date and ongoing for build up bone; magnesium (manufacturer unknown, tablet) oral at 500 IU frequency unknown from unknown date and ongoing for build up bone; boron (manufacturer unknown, tablet) oral at 3 mg from unknown date and ongoing; and Vitamin K (tablet) oral at 500 mg frequency unknown from unknown date and ongoing. Lab tests, done on 08Apr2015, showed cholesterol and thyroid both normal. On 15Apr2015, the patient got really sick from the drug and experienced malaise. The patient stated her doctor even agreed it was the shot that was making her sick. The patient experienced itching eyes, runny nose and she got really hot, severe headaches (sinus pressure headache) on 22Apr2015. On 30Apr2015 she had a really bad nasal congestion and she blew out a huge clot. She started getting blood out of her right nostril and her left nostril had green gunk and one of her Eustachian tubes was blocked. The drainage then traveled down her throat on unknown date. The patient had been on her back for a week because of this, she maybe was developing a viral sinus infection. On 05May2015, she was diagnosed with sinusitis and she was being treated with AUGMENTIN 875mg capsule, every twelve hours. She had a lot of chilling, fatigue, sore throat, and her head felt full. She had no lung involvement other than a few little coughs (not so bad as coughing with pneumonia). Moreover her fibromyalgia in neck flared due to cough. And she had to go to her chiropractor two extra times because of this (usually only goes once a month). The patient's sinusitis was scary with bloody discharge. She could not breathe in the middle of the night due to coughing and had to call the EMT's. Her cough lasted for a good month. The patient was treated with DELSYM 20mL as needed, twice a day by mouth for cough, sore throat, fever, nasal and chest congestion and headache; ALEVE for headache before starting the dextromethorphan hydrobromide but stopped as impossible to take them at the same time; ZYRTEC (lot 433411, Exp date: Sep2016, NDC: 50580776-36) to help her with side effects, but it did not work, it left her dry, as she felt like she needed to drink gallons and gallons of water. Treatments were also received for itching eyes, runny nose, Eustachian tube blocked, sinusitis, chills, fatigue, flare up of fibromyalgia. No treatments were administered in response to the events felt sick/malaise and got really hot. The patient was admitted to hospital on an unknown date due to itching eyes, really hot, severe headaches, runny nose, really bad nasal congestion, Eustachian tube blocked, sinusitis, chills, fatigue and cough. The patient recovered from all events (they lasted 1 month). The patient stated if her doctor would have asked her, she would have to say she didn't want the shot. She could believe this all happened from a pneumonia shot. Follow-up (05May2015 and 06May2015): New information received from a contactable consumer includes: vaccination date, medical history, events, course, treatments, lab test. Follow-up (06May2015): This follow-up report is being submitted to amend previously reported information: dosage for levothyroxine reported as 1ug, once daily for low thyroid. Formulation for concomitant medications Vitamin K, boron, magnesium, Vitamin D, diazepam, SEROQUEL and ZOLOFT reported as tablet. Follow-up (20Jul2015): New information received from a contactable consumer includes: concomitant medications details, clinical course, hospitalization added as seriousness criteria, 'could not breathe in the middle of the night due to coughing' added as event, outcome changed to recovered for all events.