Sex: F
Vaccine: TYP
Symptoms: Chest discomfort, Condition aggravated, Feeling abnormal, Incomplete course of vaccination, Throat tightness
Clinical narrative: Chest tightness/ felt like she was having a heart attack and her chest "felt so bad"; Throat tightness; Felt like she was dying/ felt "weird"; Symptoms progressively got worse; Discarded her last/fourth dose of Vivotif; A spontaneous report was received from a patient on 13SEP2022. It described a female patient of unknown age who had "chest tightness/ felt like she was having a heart attack and her chest "felt so bad"" (PT: Chest discomfort), "throat tightness" (PT: Throat tightness), "felt like she was dying/ felt "weird"" (PT: Feeling abnormal), "symptoms progressively got worse" (PT: Condition aggravated) thus, "discarded her last/fourth dose of Vivotif" (PT: Incomplete course of vaccination). The patient received the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported that the patient took 3 doses of Vivotif. She felt chest and throat tightness right after taking the first dose of Vivotif and she felt "weird" like she was dying. Further, she mentioned that after taking the second and third pill (third pill was taken on Saturday- as per the reporting) of Vivotif her symptoms progressively got worse, felt like she was having a heart attack and her chest "felt so bad". Reportedly, after taking all three Vivotif pills her chest was not the same anymore and she still experienced the side effects and was massaging her chest. As stated, her blood pressure was in the normal range and not high rather it trended to be on the lower side, and her cholesterol was also normal. Reportedly, on the yearly basis she underwent complete check-up which included a heart check-up which revealed that her heart was good, and she was in good condition.   Additionally, it was reported that she did not get any treatment for her chest tightness and she has been massaging her chest, doing yoga, breathing exercises, and did a lot of walking but, she still was not 100 percent back to normal and she did not know when the effects of the medication would start wearing off. She further confirmed that she had not done any lab work since she experienced these symptoms.  Further, when she told her husband that she felt like she was dying, he proceeded to read the paperwork came with the medication which stated that "Vivotif may cause chest tightness" therefore, her husband discarded her last/fourth dose of Vivotif. Reportedly, she would be traveling on Thursday (as per the reporting) and wanted to make sure she would be ok.  The patient did not have any significant medical history. She was naturally healthy and had no health issues as she walks and runs, drinks a lot of water, and eats healthy. She did not take any medications other than supplements and vitamins.   Action taken with Vivotif with respect to the reported event "discarded her last/fourth dose of Vivotif" was not applicable and for the events "chest tightness/ felt like she was having a heart attack and her chest "felt so bad"", "throat tightness", "felt like she was dying/ felt weird", and "symptoms progressively got worse" it was withdrawn.  The patient had not recovered from the events "chest tightness/ felt like she was having a heart attack and her chest "felt so bad"", "throat tightness", "felt like she was dying/ felt weird", and "symptoms progressively got worse" and for the event "discarded her last/fourth dose of Vivotif", the outcome was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took 3 doses of Vivotif and she felt throat tightness, chest tightness/ felt like she was having a heart attack and her chest felt so bad (chest discomfort), felt like she was dying/ felt weird (feeling abnormal), symptoms progressively got worse (condition aggravated) and thus, she discarded her last/fourth dose of Vivotif (incomplete course of vaccination). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of chest discomfort, feeling abnormal and condition aggravated is assessed as possible with Vivotif. In addition, the causality of incomplete course of vaccination is assessed as not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took 3 doses of Vivotif and she felt throat tightness, chest tightness/ felt like she was having a heart attack and her chest felt so bad (chest discomfort), felt like she was dying/ felt weird (feeling abnormal), symptoms progressively got worse (condition aggravated) and thus, she discarded her last/fourth dose of Vivotif (incomplete course of vaccination). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of chest discomfort, feeling abnormal and condition aggravated is assessed as possible with Vivotif. In addition, the causality of incomplete course of vaccination is assessed as not applicable with Vivotif. The case is considered non serious as per medical assessment.