Age: 77.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Dysuria, Fatigue, Fear, Hypersomnia
Clinical narrative: Initial unsolicited report received from a consumer, nurse via other company (Pfizer) (manufacturer report number 2016085125) on 14 June 2016. This case involves a 77-year-old male patient who was vaccinated with a fourth intramuscular dose of Flu Hd (batch number UI524AA, expiration date was not reported) in right deltoid and 0.5 ml intramuscular dose of PREVENAR 13 (batch number M27554, expiration date April 2017) in left deltoid on 12 November 2015. The patient had medical history of tobacco 1 pack x 60 years pack-year history and quitted smoking 15 years ago, had colon cancer, Gastroesophageal reflux disease, bronchopulmonary dysplasia, Chronic Obstructive Pulmonary Disease, bleeding. Patient did not have illness at time of vaccination. It was reported that patient had been testing blood every 3-4 months for colon cancer, he had removal and blood always tested at "18.4". The patient's current problems included abnormal glucose, actinic keratosis, acute bronchitis, acute sinusitis (unspecified), backache (unspecified), chronic airway obstruction, chronic kidney disease (unspecified), encounter for removal of sutures, esophageal reflux, essential hypertension, hematuria (unspecified), history of colonic polyps, hyperplasia of prostate (unspecified), urinary obstruction and other lower urinary symptoms (LUTS), hypertrophy Benign prostatic hyperplasia, major depression, single episode, neoplasm of unspecified nature: digestive tract, other hemoglobinopathy, unspecified visual disturbance. Concomitant medications included maxzide-25 mg 37.5 mg/25 mg tablet-half tablet by mouth daily for hypertension, Paxil 10 mg tablet- one tablets by mouth daily for depression, atenolol 25 mg for hypertension (half pill daily), Flonase allergy relief 50 mcg/ 1 actuation nasal spray 2 sprays each nostril before sleep, zantac 300 mg one tablet twice a day for Gastroesophageal reflux disease, Remeron 15 mg tablet one tablet by mouth daily, Flomax 0.4 mg one capsule at bedtime, Proto nix 40 mg tablets delayed release one tablets by mouth bid, Atrovent 0.03 percent nasal spray two sprays in right nostrils at before sleep, Xanax 0.25 mg tablet one at before sleep, amlodipine 5 mg tablet one at before sleep, Combivent 18 mcg/103 mcg per one inhalation oral inhaler 2 puffs qid, aspirin 325 mg tablet:1 tablet by mouth in morning, Cipro 500 mg: one mouth bid. On 12 November 2015, same day following vaccination, patient broke out with little sores first, trouble urinating, (pain)/pain getting worse, very weak, and lightheaded and not feeling well. On 13 November 2015, one day following vaccination little sores spread all over body. The patient went to physician and physician gave prescription for prostate. In November 2015, following vaccination, patient's blood marrow stops making blood. In December 2015, following vaccination, patient weight was down to 166 as he was 185 before he got sick. On 13 February 2016, three months following vaccination, patient got an infection in the blood from having a very low WBC, on 14 February 2016, three months following vaccination, patient had heart attack while in hospital. On an unspecified date in November 2015, following vaccination, patient was feeling weak, tired and very dizzy, he was afraid to do anything for fear he would fall/scary. On 23 November 2015, patient was seen to physician as reporter thought patient may had urinary tract infection and inner ear trouble but physician reported that patient had no any infection but gave him antibiotic. On an unspecified date, patient had inner car trouble, dizziness and was pale, scary, sleeps alot. It was reported that patient was needing transfusion every week because his body stopped making blood. Previously patient received flu shot without complications or side effects. The patient experienced adverse reaction after PREVENAR 13. On 13 February 2016, patient was hospitalized. Patient was advised not to take any aspirin. Patient's upcoming vaccination involves vaccination with Pneumococcal vaccine on 18 Sep 2012. Patient did not required emergency room or doctor visit. Lab data bone marrow test showed traces of myelodysplastic syndrome and "CT" and some blood work performed- platelet dropped to 62. The patient received corrective treatment with IV antibiotics and blood transfusion, platelet transfusion, blood pressure medication and chemotherapy. Patient wrapped a bond around his belly to help support the pain. On an unspecified date, patient was recovered from infection in blood. The patient was not recovered from blood marrow stops making blood, weigh was down to 166, he was 185 before he got sick after taking shot and broke out with little sores first, low wbc (1.4). Trouble urinating, pain, very weak and lightheaded. Outcome of other events was not reported. Upon internal review the case was considered as serious because of important medical event: had a heart attack while in the hospital, bone marrow shows a minute trace of MDS/ body stopped making blood/ blood marrow stops making blood. The reporter assessed the causal relationship as unknown. List of documents held by sender: none. Sender's Comments: The reported events heart attack and Myelodysplastic syndrome are unlisted for INFLUENZA VACCINE. Simultaneously patient also received PNEUMOCOCCAL POLYSACCHARIDE VACCINE. Patient had past history of colon cancer and an ongoing neoplasm of unspecified nature of digestive tract. Considering the medical history and nature of the events, the role of the vaccine can be excluded. Based on the available information patient's Myelodysplastic syndrome could be the alternative explanation for all other reported haematological disorders in this case, hence the causality for all the haematological disorders with INFLUENZA VACCINE can be excluded.