Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Dizziness, Hypokalaemia, Injection site erythema, Injection site induration
Clinical narrative: This is a spontaneous report from a contactable nurse. A 71-year-old female patient of unspecified ethnicity received pneumococcal 13-val conj (dipht crm197 protein) (Lot # N05077; Exp: 30Sep2017), via an unspecified route of administration at single dose on 23Aug2016. Medical history included disorder of lipoid metabolism, essential hypertension, depressive disorder, not elsewhere classified, unspecified cerebral artery occlusion with cerebral infarction (HCC), osteoporosis unspecified, headache, Alzheimer's disease, esophageal reflux, obstructive sleep apnea (adult) (Paediatric), hypothyroidism, minimal facial droop, which has been there since CVA 4-5 years ago. Concomitant medication included BACTRIM DS oral 1DF, 2x/day on 29Aug2016, SEPTRA DS oral 1 DF, 2x/day on 29Aug2016, ROCEPHIN intramuscular 1 g, single on 29Aug2016. The patient previously took lisinopril and experienced drug allergy. Concern about worsening cellulitis and not responding to KEFLEX. Will tx with ceftriaxone and add BACTRIM to KEFLEX regimen. The patient passed out for 20 seconds/passing out episodes on an unspecified date with outcome of recovered, cellulitis of right upper extremity -primary on an unspecified date with outcome of recovering, hypokalaemia on an unspecified date with outcome of recovered, poor appetite on 24Aug2016 with outcome of unknown, fever/febrile on 24Aug2016 with outcome of recovered, rash on left upper arm where she got the vaccine/area of redness, warmth spread/left upper arm red, warm and indurated (approx 6 inch diameter tall) with demarcated border on 24Aug2016 with outcome of recovering, arm feels itchy on an unspecified date with outcome of unknown, fainting episodes on 24Aug2016 with outcome of unknown, slumped over while on the couch and became stiff on an unspecified date with outcome of unknown, feeling weak on an unspecified date with outcome of unknown, emesis episode on an unspecified date with outcome of recovered, elevated ANC 9.1, and neutrophil percentage 87.6% on an unspecified date with outcome of unknown, probably had a vasovagal reaction on an unspecified date with outcome of unknown, dizziness on an unspecified date with outcome of unknown, UTI/ urine culture grew out mixed flora on an unspecified date with outcome of unknown, allergies: pneumococcal vaccines/ should not receive this vaccine again on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included Blood potassium (K+): 2.9 on unknown date, 3.8 (normalized) on 29Aug2016; Blood pressure (BP) 122/60 mmHg, 130/85 mmHg on unknown date, 130/90 mmHg on 23Aug2016, 122/80 mmHg on 29Aug2016, 120/60 mmHg on 30Aug2016; Body mass index (BMI)(Calculated): 26.92kg/(m square) on unknown date, 27.3 on 23Aug2016, 26.8 on 29Aug2016, 26.9 on 30Aug2016; Body temperature: 101.6 degree F on unknown date, 97.9 degree F on 23Aug2016; 98.3 degree F on 29Aug2016, 97.5 degree F on 30Aug2016; Pulse: 23Aug2016: 68; 29Aug2016: 70; 30Aug2016; 70; Respiratory rate: 23AUG2016: 19; 29Aug2016: 18; 30Aug2016: 18; SpO2: 23Aug2016: 95%; Weight: 23Aug2016: 59.784 kg (131 lb 12.8 oz); 29Aug2016: 58.7 kg (129 lb 6.6 oz), 30Aug2016: 58.968 kg (130 lb). Chest xray was negative on 30Aug2016. Blood work shows normal WBC on 29Aug2016, but elevated ANC 9.1 on unknown date, and neutrophil percentage 87.6% on unknown date. Therapeutic measures were taken as a result of cellulitis of right upper extremity -primary, rash on left upper arm where she got the vaccine/area of redness, warmth spread/left upper arm red, warm and indurated (approx 6 inch diameter tall) with demarcated border. Pfizer is Marketing Authorization Holder Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val-conj vac (dipht crm197 protein) has been submitted the same report to the regulatory authorities.