Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal faeces, Constipation, Documented hypersensitivity to administered product, Faeces discoloured, Flatulence
Clinical narrative: bowel movement with darkened areas; bowel movement with very distinct smell; gas; itching/irritation on hands; hives all over body; severe constipation; latex allergy/ touch reaction/ over-sensitivity/ itching; itching/irritation on hands; Documented allergy to administered drug; This case was reported by a consumer via call center representative and described the occurrence of latex allergy in a 69-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.   Concurrent medical conditions included latex allergy.   On 19th August 2021, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. In August 2021, 24 hrs after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced latex allergy, itching both hands, skin irritation, generalized urticaria and documented allergy to administered drug. On 20th August 2021, the patient experienced constipation and gas. On 2nd September 2021, the patient experienced black stools and stool odor abnormal. The patient was treated with docusate sodium (Colace). On an unknown date, the outcome of the latex allergy, itching both hands, skin irritation, generalized urticaria, constipation, gas and documented allergy to administered drug were recovered/resolved and the outcome of the black stools and stool odor abnormal were not recovered/not resolved.   It was unknown if the reporter considered the latex allergy, itching both hands, skin irritation, generalized urticaria, constipation, gas, black stools, stool odor abnormal and documented allergy to administered drug 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 Information: GSK Receipt Date: 04-Aug-2022 Reporter's Comments: The patient reports she received her Boostrix vaccine on an unknown arm.  The reporter reported she was not told there was latex in the pre-filled syringe after reporting a latex allergy to the immunizer. The reporter reported about 24 hours later she experienced itching and irritation on her hands and hives all over her body. The symptoms resolved in about a week. The reporter also reported, at the same time, if she touched something with latex in it, she had an immediate reaction that she described as an over-sensitivity including itching. This resolved about 2 months after she received the Boostrix Vaccine. Also, in the first day or so after the Boostrix vaccine, the reporter reported severe constipation and gas. The reporter reported she took Colace to get over the constipation and that lasted about 2 weeks. At that time, she noticed her bowel movement sometimes have darkened areas on them and a very distinct smell which was still present a year later. 14 days after receiving the Boostrix, the patient experienced black stools and faeces abnormal smell of. 1 day after receiving Boostrix, the patient experienced latex allergy, constipation and gas. The duration for the events latex allergy, itching both hands was reported as 2 months and for the event constipation was reported as 2 weeks. The reporter would like to speak to safety concerning her reactions. The reporter did not consent to follow-up.