Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Insomnia, Mastication disorder, Muscle spasms
Clinical narrative: difficulty chewing and biting; Bilateral pain on ears; Pressure on both ears; difficulty talking; wasn´t able to sleep; difficulty swallowing; bronchitis; Stomach pain; Pain to chew, biting, talk, brush her teeth, swallowing, sneeze, eat; Arm sore after the vaccine; Trismus/ difficulty opening my mouth; Jaw pain; Site injection pain; Big nodule on the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number C7747, expiry date 20-JUN-2026) for prophylaxis.   Concomitant products included mefenamic acid (Advil).   On 28-JUN-2024, the patient received Boostrix (left deltoid). On 28-JUN-2024, less than a day after receiving Boostrix, the patient experienced injection site pain (Verbatim: Site injection pain) and injection site nodule (Verbatim: Big nodule on the injection site). On 01-JUL-2024, the patient experienced jaw pain (Verbatim: Jaw pain) and trismus (Verbatim: Trismus/ difficulty opening my mouth). On an unknown date, the patient experienced pain in arm (Verbatim: Arm sore after the vaccine), chewing difficulty (Verbatim: difficulty chewing and biting), ear pain (Verbatim: Bilateral pain on ears), sensation of pressure in ear (Verbatim: Pressure on both ears), speech disorder (Verbatim: difficulty talking), difficulty sleeping (Verbatim: wasn´t able to sleep), swallowing difficult (Verbatim: difficulty swallowing), bronchitis (Verbatim: bronchitis), stomach pain (Verbatim: Stomach pain) and oral pain (Verbatim: Pain to chew, biting, talk, brush her teeth, swallowing, sneeze, eat). In JUL-2024, the outcome of the injection site pain and injection site nodule were resolved. The outcome of the jaw pain was not resolved and the outcome of the pain in arm, trismus, ear pain, sensation of pressure in ear, difficulty sleeping, swallowing difficult, bronchitis, stomach pain and oral pain were unknown and the outcome of the chewing difficulty and speech disorder were not reported.   It was unknown if the reporter considered the injection site pain, injection site nodule, jaw pain, pain in arm, trismus, chewing difficulty, ear pain, sensation of pressure in ear, speech disorder, difficulty sleeping, swallowing difficult, bronchitis, stomach pain and oral pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site nodule, jaw pain, pain in arm, trismus, chewing difficulty, ear pain, sensation of pressure in ear, speech disorder, difficulty sleeping, swallowing difficult, bronchitis, stomach pain and oral pain 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: 17-JUL-2024 The patient had an adverse reaction to the Tdap vaccine, Boostrix, that received. And need to report it and needed some help So pretty much that was the Friday, so on Friday, Saturday and Sunday I was having like some cramp muscles aches, and a pretty large size nodule in the injection site, and I was told that that's normal, but that took about almost 2 weeks to disappear and the arm was pretty sore 1 entire week. But then, actually, on that Monday, started having left jaw pain, and mmm my husband was a dentist, so describe him what I was feeling, so basically had difficulty opening my mouth, and I was having a lot of pain in the muscle and difficulty chewing and biting, and he diagnosed with Trismus. The patient also been doing, like Invisalign, like orto, like teeth straining, but started that in February, so it was already 4 months without any issue, but currently out of the country.  They arrived on 16July2024, and so because the pain in jaw was pretty much 12 out of 10, was not able to sleep.  The patient could only eat very soft food, could not yawn or sneeze, have difficulty talking and brushing my teeth.  The patient have difficulty swallowing, and had bronchitis.  The patient also have bilateral ear pain, pain 10 out 10, and ear pressure. The patient was really scared that something was wrong, regular doctor was out on a patient, and actually had a chiropractor that is specialized in TMJ pain and they where shock of the muscles inside the mouth. The patient actually went for several appointments and had to stop the Invisalign, they remove everything in the mouth, the husband was trying adjust the smile, So been having a lot of difficult, pain and stuff, was starting having stomach pain for taking that. So the patient did not thought it was vaccine related, until at the airport was just googling and read that, this like lockjaw was a rare but possible side effect of the Tdap vaccine So it was not getting better, like same level pain, every couple hours had the patient, manually stretch out jaw muscles, before could even eat  So the patient was wondering if there was any patient case report, was scared, did not had fever, did not have much symptoms, but there was jaw pain and was not getting better since 01July2024, over 2 weeks. Consented to follow up.