Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a 64-year-old female patient via Pfizer Inc. (manufacturer control # 2016485579) refers to herself. The patient's concurrent conditions included rapid heartbeat, high blood pressure, acid reflux and low vitamin D numbers. The patient did not have any medical history or family medical history. On an unknown date in June 2016, the patient was vaccinated with a one time dose of ZOSTAVAX injection, in the left arm, lot # M005727 (dose, route of administration and expiry date were not reported). Concomitant therapies included atenolol, ranitidine, vitamins and vitamin D. On an unknown date in June 2016, after receiving the ZOSTAVAX, the patient broke out with cellulitis, described as "bad case of it", which started at the injection site. The patient thought at first that it was a normal reaction but the redness and heat got bigger and bigger. It grew and was spreading more and more. The patient received unspecified antibiotics, which cleared up the cellulitis. The patient recovered from the event of cellulitis which started at the injection site on an unknown date in June 2016. On 27-SEP-2016 in the morning, the patient was vaccinated with a 0.5 (unit not provided) dose of FLUZONE HIGH DOSE product, injection, in right arm, lot # NI6515 with expiry date in October 2017 (route of administration was not reported) and with a 0.5 (unit not provided) dose of PREVNAR 13 injection in right arm, lot # UI659AA with expiry date on 29-MAR-2017 (route of administration was not reported) at the pharmacy. The patient used to receive the FLUZONE annually every fall but she was not sure if it was this particular brand of shot before, however, she received one for years. The patient did not remember when she started to receive the FLUZONE. On 27-SEP-2016, after receiving the FLUZONE and PREVNAR 13, the patient's arm was really painful. The patient thought that her arm was really painful because she received both shots in one arm, therefore she did not pay as much attention on this experience. On 29-SEP-2016 (reported as "two days after receiving the shots"), while putting on a shirt, the patient realized her arm was huge. The area covered too much and was getting really big. On 29-SEP-2016, the patient went to the doctor, who recognized the patient's experience as cellulitis, which started fairly soon after she got the vaccines. It was reported as a worse case of the cellulitis. On the same day in the evening, the patient started her antibiotics (unspecified). On 30-SEP-2016 in the afternoon, her friend drew a circle around the area. On 01-OCT-2016 in the morning, most of the area was out of the circle. On the same day in the morning, the patient went to emergency room (ER) and was told "to give it time" and was sent home. On the same day at night, the patient took a shower and realized that the area doubled in size and it was darker red, therefore she went to the ER to get unspecified intravenous (IV) antibiotics. The patient confirmed that she was not admitted to the hospital. It took a while for the cellulitis to resolve. The cellulitis (reported as "it"), kept growing for six days with heavy doses of two unspecified antibiotics. It took longer for the cellulitis to go away that time than before. The cellulitis stopped growing on an unspecified date in October 2016 (reported as "by the next Tuesday"). The feeling of the really painful arm stopped in September or October 2016 (reported as "four or five days after receiving the product"). On 01-OCT-2016, the blood test and unspecified culture were performed. The blood work came back fine and the results of culture had never came back. The patient did not know what kind of culture was drawn but she thought that everything was fine. The patient reported, that she would stop using the FLUZONE if it caused the cellulitis and if she was allergic to something in that product. The patient did not know if she would continue to receive that product. It was also reported, that she would receive a different pneumonia vaccine later but she is not sure if she would. The patient believed that whether she got the cellulitis again, it would get worse. She used an example of someone, who had a reaction to drug and was given the drug again, the reaction would be worse. The patient was concerned that the cellulitis might get progressively worse. She was supposed to have another pneumonia shot, however she did not want to receive it. The patient wanted to figure out if it was an immune reaction and if there was something in the product (unspecified, which product was meant) that was causing this reaction. She was concerned with what the products contained. The patient wanted to make sure that if she took another product it would not contain what these products did. The patient explained the situation to another doctor, who told her that maybe it was not the cellulitis but an immune response. The patient would stop using the product if it was cellulitis and if she was allergic to something in the product. She did not feel like she could safely get another vaccine. The relatedness between the events and the ZOSTAVAX, FLUZONE and PREVNAR 13 was not reported. Upon internal review, the events of cellulitis which started at the injection site and cellulitis were considered to be medically significant. Additional information has been requested.