Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Oropharyngeal pain, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received PREVNAR 13; (lot number and expiry date were unknown), via an unspecified route of administration on 10Jul2018 at a single dose for immunization given at the physician's office. The patient's medical history and concomitant medications were not reported. The patient previously received typhoid shot for immunization, 2 weeks prior on an unspecified date. Consumer said she had a serious anaphylactic reaction after being injected with the PREVNAR 13 on 10Jul2018. She had to go to the Emergency Room on Saturday and have an IVs. Consumer stated that she had pain on injection site on 10Jul2018 and a square red block that was a 2 inch by 2 inch square under the injection site that she noticed probably the next day on 11Jul2018. This was there for the next couple days and this has faded now. However, it was noticeable because people at work noticed it. She added that for the first couple of days on an unspecified date, her arm was extremely sore. She said this area was very painful and she jumped 10 feet when someone bumped into her and they barely touched her. She then experienced dry mouth on 10Jul2018. She said the symptoms gradually came on, little by little, until they exploded. On 12Jul2018, she also had tongue swelling and difficulty swallowing water. She said she still hadn't gone to Emergency Room at this point. She thought this was an initial side effect and it would wear off, she can rationalize very well. She didn't think this was severe. She didn't think it was that severe and thought it would go away. Again stated she didn't think it was severe enough, even though it probably was. Then she got rashes on her hands, face, forehead, neck, front of right leg, and she now has a rash on her lower back, but the rash on her lower back wasn't there originally, that probably came right around the time she was in the ER, it is still moving through her system. She now has the lower back rash that is bumpy. She also experienced itching. By Friday night she went to bed early and this is when the symptoms started getting bothersome. She thought she would go to a clinic to get something the next day. On 14Jul2018 reported as Saturday morning at 3 am, she woke up to go to the bathroom and her whole neck and all of those blotches that were rash, had turned to welts and severe hives. The whole neck was hives, the blotches on her hands were now hives and red. The front of her leg was hives. The swelling of her tongue was intense and she was itching everywhere. She said she got a shower and got dressed and drove herself to the Emergency Room. She arrived there around 5 am because she played around a bit. Probably the main reason she drove to the Emergency Room was it turned to hives and when she would drink a glass of water, because she still had that really dry mouth, she had trouble drinking water and she thought her throat was going to close up on her or something and that was a little scary. Consumer stated she was diagnosed with urticaria, tongue swelling, and rash in the Emergency Room. She said the itching became a nuisance, wasn't severe, but when she woke up in middle of the night the area was blown up ferocious. She stated that she is only itching in her lower back now. This was the last rash to come on and this started on Saturday or Sunday. She thinks it is still moving through her system. Itching has gone away in other areas. The neck, face and legs have stopped. She said her dry mouth started as soon as she got the drug, it was in the afternoon and she noticed it right away. Her tongue was swollen at first to double in size but has improved. She still has to drink a lot of water to get pills down, it is still swollen, but has lessened. Has to take a couple gulps to gets the pills down. She still has the rash on her neck, face, hands, back, forehead and everywhere, it is still red. She had an appointment this morning, a follow up, with her doctors office and the Nurse Practitioner said she was a mess. Originally stated the rash was improving because 70% is turning red it is improving, but it is still persisting actually, not improving because she thinks the medication is still going through her body, it is persisting. She further mentioned that for the event "hives", this started in morning of 14Jul2018. This changed from a rash to welts and hives that were thick, like an 1/8 of an inch thick and were fluidy, and looked fluid raised from the skin and this was also on her chin and neck. She said this area was puffy and was the size of a dime or nickel. There were like 6 or 7 of them up her neck and on her chin, she noticed this immediately when she went to the bathroom and saw it in the mirror. Her Right hand and leg were puffy. The worse welt was on her neck, chin, and lower face where her face was swollen. This was the lower jaw area. Her tongue was really swollen bad at this point. This was when she had the trouble sipping the water. Also on an unspecified date, the patient experienced high blood pressure and sore throat. She asked her if she knew what the ingredients were as she is obviously allergic to something in the PREVNAR13 but she did not have this information available. She would like to know if we have this so she can prevent this in the future. Therapeutic measures were taken as a result of rash, dry mouth, itchiness/itching, hives, and sore throat which included BENADRYL, Prednisone, REACTINE and PEPCID liquid. The outcome of the events "itchiness, hives, tongue swelling and square red block that was a 2 inch by 2 inch square under the injection site" was recovering; outcome of the events "rash, dry mouth and red rash" was not recovered; while the outcome of all other remaining events was unknown. Information regarding batch/lot number was requested.