Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Lyme disease, Malaise, Myalgia, Otitis media, Pyrexia
Clinical narrative: Information has been received from a 74 year old female registered nurse with cholesterol high who on 10-OCT-2008 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included (therapy unspecified - antihyperlipidemic agent) and vitamins (unspecified). On 12-OCT-2008, the patient experienced headache, muscle pain and low grade fever after she was vaccinated with ZOSTAVAX. The patient's headache, muscle pain and low grade fever persisted. The patient not had any laboratory test done. The patient did not seek medical attention. Additional information has been requested. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. Information has been received froma physician and an other health professional and a 74 year old female with carrots, strawberries and eggs allergies, cholesterol high and no illness at time of vaccination, and a history of GI upset while on erythromycin who on 10-OCT-2008 at 14:30 was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (Lot #662969/1206X) in the left deltoid. Concomitant therapy included (therapy unspecified-antihyperlipidemic agent) and vitamins (unspecified). On 10-OCT-2008 (previously reported as 12-OCT-2008), the patient experienced headache, muscle pain and low grade fever after she was vaccinated with ZOSTAVAX (Oka/Merck). On 10-OCT-2008, a physician's note stated that the patient was off of simvastatin (MSD) and/or pravastatin sodium. The patient's exam was negative for myalgia and shortness of breath and her pulses were equal. Her lungs were clear bilateral lower lobes and heart regular rhythm and rate. Her weight was 128.1 lbs. On 16-OCT-2008, the patient was at the physician's office and reported that, 9 days ago, on 07-OCT-2008, while landing in an airplane and the patient had bilateral ear pain and no further pain but bilateral ear congestion. She had a frontal headache, negative sinus congestion and non productive cough. The patient was concerned about her lymph nodes under arms. The patient's lungs were clear with negative rhonchi, ectopy and no murmur. Her R TM had no erythema and L TM with minimal erythema. Her lymph nodes were negative. The patient was diagnosed with sinusitis and otitis media. AUGMENTIN 875 mg oral, BID for 7 days and ALLEGRA every 12 hrs were prescribed. On that day, a chemistry blood panel and lipids were drawn (results not provided). On 20-OCT-2008, the patient phoned to complain of headache since ZOSTAVAX (Oka/Merck) and low grade fever. On 30-OCT-2008, a message was left of the patient's machine. Per the physician, the patient was told her that her LDL was increased and her chest x-ray was normal. She was told to watch her diet. On 03-NOV-2008 the patient was not feeling well after 4 weeks. She was on a cruise ship and an airplane and developed a cold. She saw a physician and was prescribed a decongestant and amoxicillin clavulanate. She complained of muscle aches and pain, lower back pain and headache. She took ALEVE for her symptoms. The symptoms started a few days after the vaccine. Now, more symptoms had resolved, but she did have mild occipital headache, complaints of light-headed feeling occasionally and felt weak. She was unable to do her usual activities like going to the gym, walk an 18 hole golf course or taking her grandkids to the water park. The patient was also seen by ENT and was put on a nasal spray. Her vitals were temperature 97.7, BP 130/70, pulse 70 and weight 125.1 lbs. Her heart was S1/S2 and regular, lungs clear to auscultation bilaterally, negative abdomen, and extremities with negative edema. The physician's assessment was fatigue, dizziness and weight loss. The patient was sick and then felt a little better. Later she had the ZOSTAVAX followed by headache, muscle pain and questionable reaction to the ZOSTAVAX. The plan included some bloodwork, CBC, thyroid profile, Epstein-Barr series titers and Lyme's test. The patient was to return to the clinic in 2 weeks for re-evaluation. The patient was scheduled for a colonoscopy on a Wednesday and would postpone it for later. She tried to a balanced diet to avoid extreme exhaustion. The lab results drawn on 03-NOV-2008 showed a her CBC was within normal limits except her RBC's of 3.75 mill/mcL, negative Epstein-Barr viral panel and negative Lyme's titers. On 06-NOV-2008, the laboratory results were discussed with the patient. Her thyroid profile and CBC were within normal limits. She had an old positive monospot. The patient would take a rest and was to observe her symptoms, and avoid exhaustion symptoms. Questionable reaction secondary to ZOSTAVAX (Oka/Merck). The headache appeared poor again. On 12-NOV-2008, the patient complained of cough for two weeks and post nasal drip. The patient stated that already had fexofenadine HCL for allergies and amoxicillin 500 mg. The patient had an appointed scheduled for 09-DEC-2008. Additional information is not available.