Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Muscle tightness, Photophobia, Pyrexia, Thermal burn, Urine odour abnormal
Clinical narrative: Case number# PHEH2014US020399, is an initial spontaneous report from a consumer (patient) received on 06 Oct 2014, with a follow up report received from a consumer (patient) on 18 Nov 2014, with a follow up report from a physician received on 09 Dec 2014. This report refers to a 66 year old female patient. Historical condition of the patient included broken back and neck, cervical spinal fusion, crushed ankle with broken right wrist, both rotator torn, lateral tendon severed with severe damage to right elbow, a bypass corrective bone surgery, surgeries to right foot, left knee, left ankle with an insertion of T wire, a pin and screw, which were later removed, 3 surgeries were done to cut a cyst from a bone out of left hip to make vertebrae wired into the neck of left shoulder bone, removal of cyst from left hand under the ring finger, left thumb surgery after severe CHT, bone regeneration due to which upper knuckle does not bend. Current condition included arthritis, osteoarthritis, high blood pressure, anxiety, panic attacks, nicotine use, chronic pain had trigger point injections for years all started in 1950, had insomnia and on wheels long time. Concomitant medications included hydrocodone (manufacturer unknown), Aspirin and acetaminophen (manufacturer unknown) for chronic pain and alprazolam (manufacturer unknown) for anxiety, panic attack and insomnia. The patient received DIOVAN for an unknown indication from an unknown date at an unknown dose. The patient also received DIOVAN HCT 80/12.5 mg (batch number 0078 0314 34) for high blood pressure/ hypertension from 1990 at a dose of 1 DF. Moreover, the patient received valsartan (manufacturer unknown) and valsartan HCT, prednisone (manufacturer unknown), sumatriptan (manufacturer unknown), VIOXX, CELEBREX, BEXTRA, FOSAMAX and arthritis medication (unspecified), all for an unknown indication from an unknown start date and dose. The patient was a disabled senior. On an unknown date, the patient got really, really sick. It was reported that the patient was very sensitive to a lot of medicines (drug hypersensitivity) so it was imperative that the patient stayed on the medication which she was taking earlier. On an unspecified date, the patient experienced burns; diverticulitis; headaches, stomach aches, bleeding and constipation. On an unspecified date, the patient had to go to the hospital (for unspecified reason) where the patient was checked up from throat till behind and received medication for it. The patient had a terrible reaction to a coating on a pill/sensitive to coating on a pill. The physician did not even have any sample to hold the patient over, so the patient was kind like in limbo. Some (unspecified) drugs (which she was taking from 1990, or 1996 or might be from 1997) were effective for the patient on which she wanted to remain stuck on. The patient did not want to end up in the hospital or with a stroke or a heart attack or something. On an unknown date, the patient was in the hospital, the patient was given medicine (unspecified) and the patient thought that she was having a heart attack. The patient took her own medicines (unspecified) with her and then the patient was given with a different pain pill (unspecified) and by the time she got home she was headed right back for another bout of diverticulitis. The patient went on to say that there were a lot of medications that she was sensitive to reactions. In Oct 2014, the patient received his follow up shot and also refilled DIOVAN. In Oct 2014 (second week), the patient felt feverish for a couple of days. Later on the patient took DIOVAN in that morning. On 07 Oct 2014, the influenza vaccine (manufacturer unknown) was received for an unknown indication at an unknown dose, once, intramuscularly. The fever continued for weeks. The patient had sweated like hot flushes, diarrhea for couple of weeks, muscle tightness and got dizzy. The patient urine became dark with strong odor and burning. The patient had joints hurt more cracking and popping even in the jaw and she was very tired often. The patient vision got worst and she was sensitive to light and the patient felt that her eyes would jump when she closed them. The patient received non drug treatment of cranberry juice, water less and sugar in diet. The patient thought that she had received a generic. The patient had problems in the past with generic medications even some continues of medication wondered if the active ingredient had changed. Even though perhaps it was her follow up shot but the symptoms lasted too long. The patient was unsure if she received generic or brand name medications. All complaints was subjective, she was not seen in clinic or hospitalized and informed about her subjective symptoms. The patient had GI side effects to a lot of medication and GI evaluation was not done. The treatment with DIOVAN HCT was stopped in Nov 2014, with influenza vaccine was stopped on an unknown date while action taken with other suspect drugs was not reported. It was reported that the patient appeared to be somewhat getting better. In Nov 2014 (second week), pyrexia, hot flush, sweating, diarrhea, muscle tightness, dizziness, chromaturia, urine odour abnormal, dysuria, joint injury, crepitation, fatigue, visual acuity decreased, photophobia and exophthalmos were improved. The outcome of the other events was reported as unknown. Causality of pyrexia, hot flush, hyperhidrosis, diarrhea, chromaturia, urine odour abnormal, dysuria, joint injury, crepitation, fatigue, visual acute decreased, photophobia and exophthalmos, muscle tightness, dizziness was reported as suspected to DIOVAN HCT. The seriousness and causality of other events were not reported. Seriousness assessment of the events diverticulitis (medically significant) and feeling abnormal (hospitalization) was upgraded based on information available in the source document. Follow up report received from a consumer (patient) on 18 Nov 2014: Added co suspect drug Sumatriptan, events (constipation, hot flush, sweating, diarrhea, muscle tightness, dizziness, chromaturia, urine odour abnormal, dysuria. joint injury, crepitation, fatigue, visual acuity decreased, photophobia and exophthalmos), current condition and medical history. Updated suspect drug DIOVAN HCT details. Follow up report from physician received on 09 Dec 2014: Added co suspect drug influenza vaccine (manufacturer unknown), reporter comment and updated narrative.      Case number# PHEH2014US020399, is an initial spontaneous report from a consumer (patient) received on 06 Oct 2014, with a follow up report received from a consumer (patient) on 18 Nov 2014, with a follow up report from a physician received on 09 Dec 2014. This report refers to a 66 year old female patient. Historical condition of the patient included broken back and neck, cervical spinal fusion, crushed ankle with broken right wrist, both rotator torn, lateral tendon severed with severe damage to right elbow, a bypass corrective bone surgery, surgeries to right foot, left knee, left ankle with an insertion of T wire, a pin and screw, which were later removed, 3 surgeries were done to cut a cyst from a bone out of left hip to make vertebrae wired into the neck of left shoulder bone, removal of cyst from left hand under the ring finger, left thumb surgery after severe CHT, bone regeneration due to which upper knuckle does not bend. Current condition included arthritis, osteoarthritis, high blood pressure, anxiety, panic attacks, nicotine use, chronic pain had trigger point injections for years all started in 1950, had insomnia and on wheels long time. Concomitant medications included hydrocodone (manufacturer unknown), Aspirin and acetaminophen (manufacturer unknown) for chronic pain and alprazolam (manufacturer unknown) for anxiety, panic attack and insomnia. The patient received DIOVAN for an unknown indication from an unknown date at an unknown dose. The patient also received DIOVAN HCT 80/12.5 mg (batch number 0078 0314 34) for high blood pressure/hypertension from 1990 at a dose of 1 DF. Moreover, the patient received valsartan (manufacturer unknown) and valsartan HCT (hydrochlorothiazide), prednisone (manufacturer unkonwn), sumatriptan (manufacturer unknown), VIOXX, CELEBREX, BEXTRA, FOSAMAX and arthritis medication (unspecified), all for an unkonwn indication from an unknown start date and dose. The patient was a disabled senior. On an unknown date, the patient got really, really sick (malaise). It was reported that the patient was very sensitive to a lot of medicines (drug hypersensitivity) so it was imperative that the patient stayed on the medication which she was taking earlier. On an unspecified date, the patient experienced burns (thermal burn); diverticulitis; headaches, stomach aches (abdominal pain upper), bleeding (haemorrhage) and constipation. On an unspecified date, the patient had to go to the hospital (for unspecified reason) where the patient was checked up from throat till behind and received medication for it. The patient had a terrible reaction to a coating on a pill/sensitive to coating on a pill (reaction to drug excipients). The physician did not event have any sample to hold the patient over, so the patient was kind like in limbo. Some (unspecified) drugs (which she was taking from 1990, or 1996 or might be from 1997) were effective for the patient on which she wanted to remain stuck on. The   [Due to memory limitations, the remainder of this text could not be compared.]  k on. The patient did not want to end up in the hospital or with a stroke or a heart attack or something. On an unknown date, the patient was in the hospital, the patient was given a medicine (unspecified) and the patient thought that she was having a heart attack (feeling abnormal). The patient took her own medicines (unspecified) with her and then the patient was given with a different pain pill (unspecified) and by the time she got home she was headed right back for another bout of diverticulitis. The patient went on to say that there were a lot of medications that she was sensitive to reactions. In Oct 2014, the patient received his follow up shot and also refilled DIOVAN. In Oct 2014 (second week), the patient felt feverish for a couple of days (pyrexia). Later on the patient took DIOVAN in that morning. On 07 Oct 2014, the Influenza vaccine (manufacturer unknown) was received for an unknown indication at an unkonwn dose, once, intramuscularly. The fever continued for weeks. The patient had sweated like hot flushes, diarrhea for couple of weeks, muscle tightness and got dizzy. The patient urine became dark (chromaturia) with strong odor (urine odour abnormal) and burning (dysuria). The patient had joints hurt (joint injury) more with cracking and popping (crepitation) even in the jaw and she was very tired often (fatigue). The patient vision got worst (visual acuity decreased) and she was sensitive to light (photophobia) and the patient felt that her eyes would jump when she closed them (exophthalmos). The patient received non drug treatment of cranberry juice, water less and sugar in diet. The patient thought that she had received a generic. The patient had problems in the past with generic medications even some continues of medication wondered if the active ingredient had changed. Even though perhaps it was her follow up shot but the symptoms lasted too long. The patient was unsure if she received generic or brand name medications. All complaints was subject, she was not seen in clinic or hospitalized and informed about her subjective symptoms. The patient had GI side effects to a lot of medication and GI evaluation was not done. The treatment with DIOVAN HCT was stopped in Nov 2014, with Influenza vaccine was stopped on an unkonwn date while action taken with other suspect drugs was not reported. It was reported that the patient appeared to be somewhat getting better. In Nov 2014 (second week), pyrexia, hot flush, sweating, diarrhea, muscle tightness, dizziness, chromaturia, urine odour abnormal, dysuria, joint injury, crepitation, fatigue, visual acuity decreased, photophobia and exophthalmos were improved. The outcome of the other events was reported as unknown. Causality of pyrexia, hot flush, hyperhidrosis, diarrhea, chromaturia, urine odour abnormal, dysuria, joint injury, crepitation, fatigue, visual acuity decreased, photophobia and exophthalmos, muscle tightness, dizziness was reported as suspected to DIOVAN HCT. The seriousness and causality of other events were not reported. Seriousness assessment of the events diverticulitis (medically significant) and feeling abnormal (hospitalization) was upgraded based on information available in the source document. Follow up report received from a consumer (patient) on 18 Nov 2014: Added co suspect drug Sumatriptan, events (constipation hot flush, sweating, diarrhea, muscle tightness, dizziness, chromaturia, urine odour abnormal, dysuria, joint injury, crepitation, fatigue, visual acuity decreased, photophobia and exophthalmos), current condition and medical history. Updated suspect drug DIOVAN HCT details. Follow up report from physician received on 09 Dec 2014: Added co suspect drug Influenza vaccine (manufacturer unknown), reproter comment and updated narrative.