Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Arthralgia, Cough, Diarrhoea, Feeling abnormal
Clinical narrative: DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVEL; SORE THROAT; PAIN IN LYMPH NODES; CONGESTION IN HER CHEST/ COUGH; CONGESTION IN HER CHEST/ COUGH; PAIN IN JOINT; LOSE BOWELS; PAIN IN STOMACH; NAUSEA; FELT BAD; This spontaneous case report was received from a consumer (PVX2019-524) on 25-Feb-2019. The report described a female consumer (weight: 150 pounds/ 68 kg and height: 5 feet 6 inch/ 167 cm) who felt bad and also experienced sore throat, pain in joints, pain in lymph nodes, pain in stomach, congestion in chest/ cough, nausea, and lose bowels following the intake of Vivotif (lot no: 3003239 and expiry date: Oct 2019) for vaccination. The consumer "did not complete immunization one week prior to travel".  The consumer's concurrent medical condition included high blood pressure for which she was taking Lisinopril (10 mg; once in a day).  It was reported that the consumer took the first dose of Vivotif on 21-Feb-2019, after that she felt bad. She took the second dose on 23-Feb-2019, and after that, she experienced sore throat, pains in her joints, lymph nodes, and stomach, congestion in her chest/ cough, nausea, and lose bowels. Her third dose was due today. She stated that the vaccine made her sick.  The consumer took Tylenol (paracetamol) for treatment and she also took OTC (over the counter) medicine for cold and cough on 25-Feb-2019.  The consumer had no laboratory test.  The action taken with Vivotif with respect to the events sore throat, pain in joints, pain in lymph nodes, pain in stomach, congestion in chest/ cough, nausea, and lose bowels was unknown, while with respect to the event felt bad was vaccine maintained and with respect to event "did not complete immunization one week prior to travel" was not applicable.  The clinical outcome of the events sore throat, felt bad, pain in joints, pain in lymph nodes, pain in stomach, nausea, lose bowels, and "did not complete immunization one week prior to travel" was unknown while with respect to the event congestion in chest/ cough was resolving.  Company's Comment: In this case, a female consumer experienced the event "felt bad" following the administration of Vivotif. She also experienced the following events "sore throat, pain in joints, pain in lymph nodes, pain in stomach, congestion in chest/ cough, nausea and lose bowels". Also the consumer "did not complete immunization one week prior to travel". The events were reported with reasonable time relationship to intake of the vaccine. The events sore throat, pain in joints, pain in lymph nodes, congestion in chest and cough are of infectious etiology and hence the causality of these events is assessed as unlikely to vivotif. The event "felt bad" can be attributed to the various events experienced by the consumer. The events "pain in stomach, nausea and lose bowels" can be due to the infectious etiology or the suspect vaccine as it has potential to cause these events. Hence, the causality of the events "pain in stomach, nausea and lose bowels" with Vivotif is assessed as possible. The causality of the event "did not complete immunization one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, a female consumer experienced the event "felt bad" following the administration of vivotif. She also experienced the following events "sore throat, pain in joints, pain in lymph nodes, pain in stomach, congestion in chest/ cough, nausea and lose bowels". Also the consumer "did not complete immunization one week prior to travel". The events were reported with reasonable time relationship to intake of the vaccine. The events sore throat, pain in joints, pain in lymph nodes, congestion in chest and cough are of infectious etiology and hence the causality of these events is assessed as unlikely to vivotif. The event "felt bad" can be attributed to the various events experienced by the consumer. The events "pain in stomach, nausea and lose bowels" can be due to the infectious etiology or the suspect vaccine as it has potential to cause these events. Hence, the causality of the events "pain in stomach, nausea and lose bowels" with Vivotif is assessed as possible. The causality of the event "did not complete immunization one week prior to travel" was considered as not applicable.