Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Diarrhoea, Discomfort
Clinical narrative: diarrhea/loose stools; had neck; head pain; contractions and pressure in her hip; contractions and pressure in her hip and down her legs that kept coming and going; started to get cold; chilled in the evening; pain started / pain was so bad; layed in bed; body temperature was 99.2 which is usually 97 or 98; difficulty resting; had pressure pain in the muscle across the chest above the rib cage; oxygen level reading was 93 but usually 97 or 98; heart rate was 92 and usually in the 70s; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 48-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Tdap vaccine with an associated reaction of no adverse event (received 12 years ago with no issues).   On 5th March 2021, the patient received the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 5th March 2021, 7 hrs after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced feeling cold, chills, pain, movements reduced, body temperature increased, discomfort, myalgia, oxygen saturation decreased, heart rate increased, neck pain, headache, pain in hip and muscle contractions involuntary. On 6th March 2021, the patient experienced diarrhea. The patient was treated with ibuprofen. On an unknown date, the outcome of the feeling cold, chills, pain, movements reduced, body temperature increased, discomfort, myalgia, oxygen saturation decreased, heart rate increased, neck pain, headache, pain in hip and muscle contractions involuntary were recovered/resolved and the outcome of the diarrhea was not recovered/not resolved.   It was unknown if the reporter considered the feeling cold, chills, pain, movements reduced, body temperature increased, discomfort, myalgia, oxygen saturation decreased, heart rate increased, diarrhea, neck pain, headache, pain in hip and muscle contractions involuntary to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The patient took two Ibuprofen and after 30 minutes the pain started to let up. The patient received 1st dose of Boostrix and experienced cold and chilled in the evening and she got more clothes on and then layed in bed with blankets and then the pain and had pressure pain in the muscle across the chest above the rib cage. After eating dinner with no nausea, she had neck and head pain that was excruciating and she could not settle down and had contractions and pressure in her hip and down her legs that kept coming and going. The patient could not rest and settle down and her pain was so bad. On 5th March 2021, the patient underwent body temperature test which results 99.2 which is usually 97 or 98, heart rate was 92 and usually in the 70s and oxygen level reading was 93 but usually 97 or 98. She put a heating pad on her neck for 20 minutes and finally she fell asleep and when she awoke, she felt better. The next morning she was perfectly fine except she had loose stools and diarrhea which are both still unresolved. She claims that she did not know if she was having a heart attack. The side effects was so bad that she almost went to the emergency room. The reporter consent to follow up.