Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Agitation, Alanine aminotransferase normal, Albumin globulin ratio, Aspartate aminotransferase normal, Asthenia
Clinical narrative: Information has been received from an investigator concerning an 84 year old female patient with anaemia, coronary artery disease, chronic obstructive pulmonary disease, gastrooesophageal reflux disease, hypertension, hypothyroidism and lipid disorder and a history of polymyalgia rheumatica who entered a study. On 26-JUN-2008 the patient was vaccinated SC with a first dose of ZOSTAVAX (Merck). Concomitant therapy included MICARDIS HCT, LEVOXYL, ezetimibe, iron (unspecified), VISION FORMULA tablets, stool softener (unspecified), calcium carbonate, ADVAIR, NEXIUM and SPIRIVA. On 11-JUL-2008 the patient began having facial and eye pain. The patient saw an ophthalmologist on 14-JUL-2008 and was started on TOBRADEX. The facial swelling and eye pain worsened. The patient was admitted to the hospital on 14-JUL-2008. Left facial shingles with corneal involvement was treated with IV acyclovir and hydromorphone in the hospital. The patient's left facial shingles with corneal involvement persisted. The reporting investigator felt that the adverse event was related to study therapy. The record for this patient was unblinded on 23-JUL-2008. The patient was treated with ZOSTAVAX (Merck). Follow up information received on 13-AUG-2008 from the investigator who added fibrocystic breast disease, hiatal hernia, macular degeneration and osteoporosis to concurrent conditions and coronary artery bypass graft, cholecysectomy and pneumothorax to medical history. On 05-AUG-2008, the patient experienced delirium and nausea, and on 09-AUG-2008 the patient experienced visual disturbance (all determined to be non-serious adverse events). On 09-AUG-2008 the patient experienced pneumonia and was hospitalized. A chest x-ray showed right upper lobe pneumonia. The patient was being treated with IV antibiotics (unspecified). The patient recovered from nausea on 06-AUG-2008. The outcome of for delirium, visual disturbance and pneumonia was not provided. The investigator felt that pneumonia was considered to be an event of clinical interest, and was not related to study therapy. Follow up information received on 14-AUG-2008 from the investigator who indicated that on 12-JUL-2008, the patient experienced nausea and headache. On 14-JUL-2008 the patient experienced vomiting and dizziness. On 15-JUL-2008 the patient experienced steroid induced hyperglycemia. Nausea, headache, vomiting, dizziness and steroid induced hyperglycemia were all considered to be non-serious adverse events. Centrum plus Vitamin D and vitamin C were added to concomitant medications. The patient recovered from vomiting and dizziness on 15-JUL-2008, from headache and steroid induced hyperglycemia on 16-JUL-2008, and from nausea on 17-JUL-2008. Treatment medications included: AVELOX for pneumonia, TOBRADEX from 14-JUL-2008 to 16-JUL-2008 1 drop, four times daily for facial shingles with corneal involvement, ZOFRAN from 14-JUL-2008 to 17-JUL-2008 4 mg, IV as needed for nausea, and hydromorphone from 14-JUL-2008 to 16-JUL-2008 0.5 mg, IV as needed for pain. The investigator felt that the events of vomiting, nausea, dizziness, headache, delirium, visual disturbance, nausea and steroid induced hyperglycemia were not related to study therapy. Follow up information received on 14-AUG-2008 from the investigator provided treatment medications as follows: FAMVIR 333.33 mg, PO, three times daily for facial shingles with corneal involvement from 14-JUL-2008 to 25-JUL-2008, prednisilone eye drops, 0.25 drops, four times daily for facial shingles with corneal involvement from 14-JUL-2008, NORVASC 10 mg, PO, once daily for hypertension from 14-JUL-2008, LYRICA 16.67 mg, PO, three times daily for pain from 14-JUL-2008, DURAGESIC patch 12 mcg, patch, every other day for pain from 14-JUL-2008, NEXIUM 40 mg, PO, once daily for GERD from 14-JUL-2008, "mycardis" 80 mg, PO, once daily for hypertension from 14-JUL-2008, SOLU-MEDROL 41.67 mg, IV, three times daily for COPD from 14-JUL-2008 to 15-JUL-2008, REGLAN 10 mg, IV, as needed for nausea from 15-JUL-2008 to 16-JUL-2008, trifluridine eye drops 0.25 drops, four times daily for facial shingles with corneal involvement from 15-JUL-2008, LASIX 20 mg, IV, as needed for high blood pressure from 15-JUL-2008 to 16-JUL-2008, NEURONTIN 75 mg, PO, four times daily for pain on 15-JUL-2008, TORADOL 3.75 mg, IV, four times daily for pain on 15-JUL-2008, "meclazine" 6.25 mg, PO, four times daily for dizziness on 15-JUL-2008, clindamycin 150 mg, IV, four times daily for facial shingles with corneal involvement from 15-JUL-2008 to 16-JUL-2008, LEVAQUIN 500 mg, IV, once daily for facial shingles from 15-JUL2008 to 16-JUL-2008, novalog insulin, injection, as needed for steroid induced hyperglycemia from 15-JUL-2008 to 16-JUL-2008, dexamethasone 3 mg, IV, four times daily for facial shingles with corneal involvement from 15-JUL-2008 to 16-JUL-2008, acyclovir 123.33 mg, IV, three times daily for facial singles with corneal involvement from 15-JUL-2008 to 16-JUL-2009, acetaminophen 162.5 mg PO, four times daily for headache on 16-JUL-2008, VIGAMOX eye drops 0.33, drops three times daily for facial shingles with corneal involvement from 21-JUL-2008 to 26-JUL-2008, NORCO 81.25 mg, PO, four times daily for pain from 21-JUL-2008 to 06-AUG-2008, DELTASONE 15 mg, PO, twice daily for facial shingles with corneal involvement from 21-JUL-2008, XOPENEX 1 puff, twice daily for COPD from 21-JUL-2008, PHENERGAN, PO, for nausea on 05-AUG-2008, oxygen, 2 liters for pneumonia from 09-AUG-2008, PREVACID 10 mg, PO, three times daily for prophylaxis from 09-AUG-2008, SURFAK 120 mg, PO, twice daily for prophylaxis from 09-AUG-2008, AVELOX 400 mg, IV, once daily for pneumonia from 10-AUG-2008, ferrous sulfate 325 mg, PO, once daily for anemia from 11-AUG-2008, aspirin 81 mg, PO, once daily for prophylaxis from 11-AUG-2008, and hydromorphone 1 mg, IV, as needed for pain from 12-AUG-2008. Follow up information received on 26-AUG-2008 from the investigator indicated that herpes simplex right lip (onset date not reported) was added as a non-serious adverse event. TOBRADEX continued (previously reported as stopped on 16-JUL-2008), AVELOX was taken from 09-AUG-2008 to 16-AUG-2008 (previously reported as 10-AUG-2008 & cont), PREVACID was discontinued on 16-AUG-2008 (previously reported as continued). Additional treatment medications included acyclovir cream, 2.5 twice daily for herpes simplex right lip (dates not reported), hydrocodone from 21-JUL-2008, prednisone 5 mg, PO, daily for facial shingles with corneal involvement from 13-AUG-2008, and SOLU-MEDROL from 14-AUG-2008 to 15-AUG-2008. On 11-AUG-2008 the events of delerium and visual disturbance were considered to be resolved. The investigator felt that the event of herpes simplex right lip was not related to study therapy. Follow up information was received on 25-SEP-2008 from the investigator. The patient was admitted to the hospital on 14-JUL-208 for left facial swelling and worsened eye pain. During the hospitalization, the patient experienced headache, nausea, vomiting, dizziness and intense pain. She had a CT scan which was unremarkable. The patient also had an ophthalmology consult during the hospitalization. The patient was treated with FAMVIR 333.33 mg, PO, TID for facial shingles with corneal involvement from 14-JUL-2008 to 25-JUL-2008, prednisilone eye drops, 0.25 drops, QID for facial shingles with corneal involvement from 14-JUL-2008, LYRICA 16.67 mg, PO, TID for pain from 14-JUL-2008, DURAGESIC patch 12 mcg, patch, every other day for pain from 14-JUL-2008, hydromorphone 0.5 mg, IV, PRN for pain from 14-JUL-2008 to 16-JUL-2008 for pain, acyclovir 123.33 mg, IV, TID for facial shingles with corneal involvement from 15-JUL-2008 to 16-JUL-2008, trifluridine eye drops 0.25 drops, QID for facial shingles with corneal involvement from 15-JUL-2008, VIGAMOX eye drops 0.33, drops TID for facial shingles with corneal involvement from 21-JUL-2008 to 26-JUL-2008, and NORCO 81.25 mg, PO, QID for pain from 21-JUL-2008 to 06-AUG-2008. The patient was discharged from the hospital on 21-JUL-2008 with a diagnosis of left eye zoster infection. The patient was considered to be not recovered from the event of left facial shingles with corneal involvement. The patient was admitted to the hospital on 09-AUG-2008 following a fall at home, confusion, nausea, pain on the left side of the head and visual disturbance. The patient received IV AVELOX, supplemental oxygen. The patient was treated with SOLU-MEDROL 187.5 mg, IV, BID from 14-AUG-2008 to 15-AUG-2008 for pneumonia. The patient responded nicely to AVELOX IV, and discharged home on 16-AUG-2008 with oxygen. Discharge diagnosis included right upper lobe pneumonia, acute left ophthalmic zoster infection with pain control, COPD, hypoxia, and right upper lip cold sore. The patient was considered to be recovering from the event of pneumonia. On 04-SEP-2008, the patient was admitted to hospital with weakness, needing strengthening and pain control. O2 sat was 81% on 2 L. On 14-SEP-2008, the patient began experiencing SOB and hypoxia. On 14-SEP-2008, a CT scan of the chest showed bilateral pulmonary emboli. The patient had a bilateral venous duplex ultrasound of LEs on 15-SEP-2008 that was positive for bilateral deep venous thrombosis. The events of bilateral deep venous thrombosis and pulmonary emboli secondary to DVT were previously reported with an onset date of 11-SEP-2008. The patient was treated with LOVENOX and COUMADIN (dose and duration not reported). The patient was considered to be recovering (previously reported as not recovered) from the events of b/l deep venous thrombosis and pulmonary emboli secondary to DVT. The investigator felt that the events of b/l deep venous thrombosis and pulmonary emboli secondary to DVT were not related to study therapy. The investigator believes that subject developed pneumonia, DVT and PE as a complication of having facial zoster and it's treatment. Indirectly these may be related, but the investigator does not feel there is a direct relationship between the vaccine and the pneumonia, DVT or PE. The investigator believes if the subject did not have facial zoster, it is likely that subject would not have had pneumonia, DVT, or PE. The investigator felt that the events of left facial shingles with corneal involvement and pneumonia were no longer considered to be events of clinical interest. This is a consolidation of two reports concerning the same patient. This is a correct report. The causality statement has been added to the report which stated that the investigator reported that deep vein thrombosis and pulmonary embolism were not related to study therapy. Follow up information has been received from the investigator on 03-OCT-2008. It is reported that the patient recovered from pneumonia on 04-SEP-2008. The patient was discharged from hospital and returned home from B/L deep venous thrombosis and pulmonary emboli secondary to DVT on 03-OCT-2008. Additional information added to treatment medications. LYRICA 16.67 mg oral TID, phenergan 50 mg as needed, and acyclovir cream 2.5 topical twice daily from 09-AUG-2008 to 19-AUG-2008 for herpes simplex rt lip. The patient was also treated with fish oil from AUG-2008 and ongoing, lidoderm patch 5% topical prn for pain from 19-AUG-2008 and ongoing, senna from 14-SEP-2008 and ongoing, LOVENOX 70 mg injection BID for DVT/PE from 14-SEP-2008 and ongoing, COUMADIN 5 mg daily for DVT/PE from 14-SEP-2008 to 23-SEP-2008, PROCTOFOAM cream topical PRN from 14-SEP-2008 and ongoing and LYRICA tab 150 mg po BID for pain from 14-SEP-2008 and ongoing. Lab tests on 15-JUL-2008 included unremarkable CT of head, CT scan of abdomen showing hiatal hernia, b/l small pleural effusions and CT scan of orbits showing soft tissue swelling left orbit space. Lab results on 09-AUG-2008 included CT of head showing no change from 15-JUL-2008 CT had and chest x-ray showing new infiltrate RUL, small B/L pleural effusion. Chest x-ray on 11-AUG-2008 showed resolving RUL pneumonia. Chest x-ray on 04-SEP-2008 showed residual pneumonia. On 14-SEP-2008 chest x-ray showed hiatal hernia, L pleural effusion, scarring as previous and CT scan of chest showing b/l pulmonary emboli. On 15-SEP-2008, b/l venous duplex ultrasound LE showed positive for DVT's. Follow up information received from investigator on 09-OCT-2008 and 10-OCT-2008. Additional concomitant therapy includes prednisone. Additional treatment medications include centrum plus VD tablet 1200 mg daily for prophylaxis from 03-OCT-2008 and ongoing, MARCAINE liquid 0.5 % injection for nerve bloc, lidocaine liquid 4% injection for nerve block, triamcinolone liquid 10 mg for nerve block, fentanyl liquid 50 mcg IV for anesthetic and VERSED liquid 1 mg IV for anesthetic all given as one dose on 26-AUG-2008, PREVACID tab 30 mg daily for prophylaxis from 19-SEP-2008 to 03-OCT-2008, COUMADIN tab 5 mg PRN for DVT/PE from 26-SEP-2008 and ongoing and COUMADIN tab 2.5 mg PRN for DVT/PE from 26-SEP-2008 and ongoing. Stop dates added to treatment medications: prednisilone eye drops were stopped on 01-OCT-2008, DURAGESIC PATCH on 19-AUG-2008, DELTASONE on 11-AUG-2008, oxygen on 01-OCT-2008, aspirin on 19-AUG-2008 and LOVENOX on 18-SEP-2008. It was reported that patient recovered with sequelae from left facial shingles with corneal involvement on 25-JUL-2008. On 25-JUL-2008 the patient developed post herpetic neuralgia (NSAE). The patient has not yet recovered at the time of reporting. On 20-AUG-2008, the patient experienced agitation (NSAE) and is recovering. The reporting investigator felt that post herpetic neuralgia is related to study therapy. The reporting investigator felt that agitation is not related to study therapy. On 26-AUG-2008 the patient had occipital nerve block with results of pain relief. Follow up information received from investigator on 20-OCT-2008. Please see lab/diagnostic section. Follow up information received from investigator on 21-OCT-2008. See lab/diagnostic section. Follow up information received from the investigator on 04-DEC-2008. On 11-AUG-2008, laboratory results included: BUM/CR ratio 12.7, calcium 8.2 mg/dl, chloride 103 mmol/l, CO2 28 mmol/l, creatinine .9 mg/dl, EOS .12 TH/UL, EOS 1.6%, glucose 85 mg/dl, hematocrit 27.5%, hemoglobin 9.1 G/DL, lymphocyte 1.25 TH/UL, lymphocyte 16%, MCH 32.7 PG, MCHC 33 G/DL, monocyte .72 TH/UL, monocyte 9.3 % MPV 6.4 FL, neutrophil 5.66 TH/UL, neutrophil 72.6 %, platelet 288 K/UL, K 4.3 mmol/l and WBC 7.8 TH/UL. Follow up information received from investigator on 16-DEC-2008. Onset date for b/l deep venous thrombosis (previously reported as 15-SEP-2008) and pulmonary emboli 2nd to DVT (previously reported as 14-SEP-2008) have been updated to 03-OCT-2008. The patient was reported to have recovered with sequelae from b/l deep venous thrombosis and recovered from pulmonary emboli 2nd to DVT. Follow up information received from the investigator on 18-DEC-2008. The patient's b/L DVT resolved w/ sequelae due to still being on COUMADIN at last contact with site. Follow up information received from the investigator on 11-FEB-2009. Additional concurrent conditions included allergy to albuterol, CEFZIL, demerol and penicillin. The SAE term of "pulmonary emboli secondary to DVT" was updated to "pulmonary emboli", which started on 14-SEP-2008 and ended on 03-OCT-2008. Follow up information received from the investigator, who reported that the patient was treated with prednisone 15 mg QD PO (from 02-APR-2008 to 14-JUL-2008). On 25-JUL-2008, per phone call to subject she was able to open her eye and see fine. Concomitant therapy, MH/concurrent conditions, Labs and narrative have been updated. Additional information is not expected.