Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004007 | PO / MO |
Patient started developing sore throat, positive on streptococcus (strep throat); Case reference number US-BN-2024-001979 is a spontaneous case report initially received from nurse via Med Communication (reference number: USBAV23-1233) on 03-Jun-2024 and concerns 18-year-old male patient. The patient's relevant medical history and concomitant medications were not provided. On 28-May-2024, the patient was vaccinated with first dose of Vivotif vaccine (batch number: 3004007, *expiry date: 31-Oct-2024), at a dose of one capsule,* orally, for typhoid immunization (immunization of adults and children against disease caused by Salmonella typhi). On 30-May-2024, two days after the first dose, the patient was vaccinated with second dose of Vivotif vaccine (batch number: 3004007, *expiry date: 31-Oct-2024), at a dose of one capsule,* orally. On 01-Jun-2024, reported as Saturday, two days after the second dose, the patient was vaccinated with third dose of Vivotif vaccine (batch number: 3004007, *expiry date: 31-Oct-2024), at a dose of one capsule,* orally. On the same day, patient started developing sore throat. On 02-Jun-2024, reported as yesterday on Sunday, patient throat was positive on streptococcus (strep throat) *and received antibiotics (brand name: unknown) as treatment for the event.* *On the same day, the patient recovered from the event 'Streptococcal sore throat'.* The reporter assessed the event 'Streptococcal sore throat' as non-serious, *and not related to Vivotif.* Additional information received on 03-Jun-2024 from Med Communication included additional reporter information, date of administration for three doses of Vivotif, patient information, events 'Streptococcal sore throat' added. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received form the reporter on 16-Jul-2024: New information included patient initials, Vivotif dosage information, event seriousness, intensity, stop date, treatment and updated outcome and causal relationship to Vivotif for the event of 'Streptococcal sore throat'.; Reporter's Comments: An 18-year-old male patient developing sore throat on the same day he was vaccinated with third dose of Vivotif vaccine. On the next day the patient was positive on streptococcus (strep throat). Pharyngitis streptococcal is unlisted and unexpected according to CCDS v8 and USPI for Vivotif. The outcome was resolved. The patient's relevant medical history and concomitant medications were not provided. Causality is conservatively assessed as related. The case is non-serious.; Sender's Comments: An 18-year-old male patient developing sore throat on the same day he was vaccinated with third dose of Vivotif vaccine. On the next day the patient was positive on streptococcus (strep throat). Pharyngitis streptococcal is unlisted and unexpected according to CCDS v8 and USPI for Vivotif. The outcome was resolved. The patient's relevant medical history and concomitant medications were not provided. Causality is conservatively assessed as related. The case is non-serious.
Test Date: 20240602; Test Name: Streptococcus test; Result Unstructured Data: patient throat was positive on streptococcus (strep throat); Comments: /