Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site warmth, Myalgia, Pain, Pruritus
Clinical narrative: Initial unsolicited report received from a nurse on 6 July 2015. A female patient (age not reported), whose medical history was none and concomitant medication was not reported, had received a dose of Adacel (batch number: U4998AA, expiration date: 25 March 2017, dose, dose number and route of administration were not reported) in left deltoid on 30 June 2015. On an unspecified date, six day post-vaccination, the patient developed firm lump, hot to touch, red, tender, painful, area around injection site and area right below injection site. The patient had required ER/doctor visit. Laboratory investigation and corrective treatment were not reported. At the time of this report, the patient was not recovered from the event. Documents held by sender: none. Follow-up information received from a physician on 31 August 2015. This case involves a 46-year-old female who presented with vaccine allergy after vaccination with Adacel. It was reported that after the shot symptoms progressed 6 days out which include pruritus, erythema, swelling, warmth and pain and do not include fever, chills, angioedema, wheezing and shortness of breath or seizure. The patient describes this as worsening. Associated symptoms include myalgias (Just in Left arm) and do not include malaise, irritability, drowsiness, arthralgias, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. As of 6 July 2015, patient had no known allergies and past medical history includes right sided pain (abdominal) off/on for four months not related to her periods, allergic rhinitis, cervical cancer screening, skin cancer screening, pelvic pain, well woman exam with routine gynecological exam, birth control, grieving, glaucoma screening, screening for cardiovascular condition of elevated triglycerides and diabetes mellitus screening. Family history includes brain cancer for maternal grandmother, diabetes mellitus for paternal grandmother, hypertension for paternal grandmother, mother and no other history of breast cancer and ovarian cancer. Social history included former smoker (social smoker) which patient had stopped at age 27 years 1995, no history of drug use, married and occasional alcohol use. Previous medication history prenatal (1 oral daily) active, calcium carbonate (600mg tablet, 1oral daily), zyrtec-d for allergy and congestion (5-120mg tablet 12 hour, oral) active. Microgestin 1/20 (1-20mg-mcg tablet, 1(one) oral daily, started taking on 7 April 2015) which were active. Medications reconciled for which patient verbally confirmed medications. Patient had Gravida 2, Para 2, 1c-section and 1 vaginal in which size baby of largest 6 lbs. Past Surgical included Cesarean Delivery on 1996 and Cholecystectomy on 1998. Loestrin 1/20 given for birth control which patient stopped in January and was only using condoms. Lab diagnostic studies on 16 October 2012, le arterial Dopplers was within normal limits and on 30 December 2013, lipid panel included Tc (total cholesterol 178, TG (thyroglobulin) 165, LDL 79, HDL 66). On 21 August 2013, mammogram screening was within normal limits on October 2011, Pap smear was within normal limits It was reported that patient had no chills, fever, and cardiovascular and edema (except at injection site). physical examinations include weight: 159 lb, 6.4 oz height: 62.5 in, body surface area:1.79 m2, body mass index: 28.69 kg/m2, pulse: 86 (regular) respiration 18 (unlabored) p. ox: 98 percent (room air), bp: 112/70 manual (sitting, right arm, standard) and also mental status- alert. General appearance was cooperative. Patient was not in acute distress or sick. Integumentary included normal coloration of skin and was with normal moisture. Left upper arm was laterally 9 cm diameter ill-defined mild erythema central 4.5 cm diameter and firm induration. Mild ttp. Neuropsychiatric examinations revealed that patient oriented thrice with appropriate mood and affect. It was also reported that patient had abnormal pap smears. With 3 year plan patient stated that each year she had female exam for female cancer screenings. It was reported that patient periods started at the age 13 and had regular menstruation (monthly) which lasted 3 to 4 days with a light flow. Patient received Bactrim DS 800-160mg, 1(one) tablet two times daily, loratadine 10mg, 1(one) tablet daily, diphenhydramine HCl 25mg, 1(one) to 2 (two) capsule for every six hours as needed, ibuprofen 200mg, 3 (three) to 4 (four) tablet for every eight hours as needed with no refill for all as corrective treatments. Patient was recovered from all the reported events. Reporter assessed the reactions as unlikely infection but possible. It was reported that follow-up checkup will be performed in 2 days. Follow up report received from a physician on 28 September 2015. On 1 July 2015, one day after vaccination the patient experienced events.