Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Pyrexia, Rash, Rash erythematous, Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable Medical Assistant who reported from Physicians office, from a contactable consumer through Pfizer Medical Information and then from a contactable physician. A 71 year old female patient was administered PREVNAR 13, lot number H17427, expiration date APR2015 on 26SEP2013 9:45 AM single dose at right arm intramuscular. Relevant medical history included hyperlipidemia, impaired glucose tolerance, thyroid problem and blood pressure problem, all since an unknown duration. Relevant concomitant medication included pravastatin since an unknown date at 40 mg daily for hyperlipidemia, SYNTHROID since unknown duration at 0.05 mg daily for thyroid problem, Atenolol since an unknown date at 50 mg daily for blood pressure problem, MICARDIS since unknown duration at 40 mg daily for an unknown indication and baby aspirin since unknown duration at 81 mg daily as a blood thinner. The consumer reported that since 26SEP2013, she experienced shaking, weakness, redness at injection elaborated as "it was like one dollar paper bill" due to which she had to visit emergency room. She also reported that "the shot of PREVNAR 13, almost killed her" on 26SEP2013. The Medical Assistant reported that on the evening of 26SEP2013, the patient experienced fever, chills, flushing area at the injection site and psoriasis at injection site after which she went to emergency room. Relevant laboratory data was unknown. Consumer recovered from event "shaking", and was recovering from "redness at injection" site. Clinical outcome of the other reported events were unknown at the time of report. The patient was not hospitalized in response to the reported events and no other vaccine was administered to the patient on that day or 4 weeks prior to that. The vaccine was administered by the Medical Assistant at private doctors office. The reporter also mentioned that the patient was in good shape before the vaccination. The physician reported that the patient presented with rash on the right upper arm. IT was described as acute and erythematous noted in the evening of 26SEP2013 and had fever and chills that night prompting her to go to hospital for treatment and evaluation. She was not given any med's. The color is described as erythematous resolving. The symptom was resolving and ongoing. The complaint limits activity took off work or 2 days. The complaint was moderate prompting her to go to ER. Pertinent findings include fever chills, flushing area of the injection and pruritus. In addition, she presented with fever. At examination, the patient denied pathologies other then redness, skin discoloration (right upper arm), swelling and rash, but denied dry skin. On 01OCT2013 at 10:51 AM, vital signs were as follows: Weight: 159 lbs; Height: 5'2", BMI: 29.081; Temp: 97.9 F; HR: 66 bpm; BP: 112/80 mmHg. The patient appeared in good condition with a reaction described as erythematous and macule resolving erythematous to pinkish discoloration, warm to touch, slightly tender, much improved from 26SEP2013, resolving, slightly pruritic. Fever was resolving. According to physician this may just be a rare reaction to pneumonia vaccine and should be limited in duration but may still last up to one week. Treatment included: warm compresses for 30 minutes 2-3x/day. Patient didn't want an antibiotic medication. The reporting physician stated that the bigger erythema (2x3-4th) and she did not tell him/her shot almost killed her but yes she had  pronounced reaction with fever, chills. No psoriasis. the patient did provide information to the reporter regarding the reported adverse events with the use of the product and could confirm the occurrence of the events reported by the patient. The Pfizer Sales Representative informed that the physician had provided all the details in the follow up letters and there was no more information to provide, however, the physician as still receiving follow up letters. The physician does not want to receive any more letters from Pfizer.   Follow up attempts completed. No further information expected.  Follow-up (17OCT2013): New information received from a contactable consumer through Pfizer Medical Information includes: additional medical history, additional concomitants, additional events (shaking, weakness, redness at injection, injection site pain, feeling abnormal), outcome of some events.  Follow-up (04NOV2013): New information received from a contactable physician includes: confirmation of the events, product and reaction details,new event of pruritus, treatment.   Follow-up (02DEC2013): New information received from a contactable physician includes: reporter informed by patient about the event; reporter confirmed the events  reported by the patient.  Follow up (11DEC2013): New information received from a Pfizer Sales Representative calling on behalf of a contactable physician who reported for a patient, in response to the letter received by physician from Pfizer, includes: physician had provided all the details and has no more information to provide.