Age: 40.0
Sex: M
Vaccine: HEPAB, RAB, TDAP, TYP, YF
Symptoms: Dizziness, Feeling cold, Hyperaesthesia, Lymphadenopathy, Pain
Clinical narrative: Initial solicited report received 19 April 2018 from an investigator participating in the below mentioned study. This case involves a 40-year-old male subject who had body aches, light headed, swollen neck glands, woke up cold during the study participation. The subject had medical history of hypertension. The subject received concomitant medication with metoprolol tartrate (Metoprolol) 50 mg orally QD for hypertension from an unknown date and ongoing. On 18 April 2018, five days after receiving 0.5 ml single subcutaneous dose of STAMARIL (batch number: M53121V exp date 31 May 2018) in left arm on 13 April 2018, first dose of TWINRIX-DOSE 1-ACCELERATED) (batch number: 3HG77 exp. Date 03 July 2020) intramuscularly in right deltoid on 13 April 2018 (booster due 20 April 2018), first intramuscularly dose of RABAVERT) (batch number: 589011A exp. Date 30 April 2019) in left deltoid on 13 April 2018 (booster due 20 April 2018), BOOSTRIX) (batch number: 9PD92 exp. Date 30 May 2020) intramuscularly in left deltoid  on 13 April 2018, TYPHOID (TYPHIM VI))(batch number: N1K121M exp date 10 October 2019) intramuscularly in right deltoid on 13 April 2018, the subject had body aches, light headed, swollen neck glands, woke up cold. Subject called today stating that starting last night he was feeling achy, lightheaded, neck glands are swollen and woke up feeling cold during the night. Investigator explained that it was possible that it was from the vaccines but these are also symptoms of several illnesses that he should be tested for and possibly need treatment. He would contact his doctor and was thankful for the discussion. The subject stated that he could not get in to a doctor yesterday so he went to sleep early. He woke up this morning feeling great except for a little skin sensitivity on his back. Stated he felt good and was at work. He still wants to come in for follow up vaccines. In the afternoon and he stated that he was back to normal. The subject's lab data was not reported. The subject did not receive corrective treatment, no medical care. The events of body aches, light headed, swollen neck glands, woke up cold were resolved on 20 April 2018. According to the investigator, the event was not related to the STAMARIL vaccine and TWINRIX-dose 1-accelerated, (RABAVERT), (BOOSTRIX), (TYPHIM VI) were not reported. Relationship to investigational product (stamaril vaccine) according to company: not reportable with event of woke up cold, of body aches, light headed and swollen neck glands. For hepatitis a&b (twinrix)-dose 1-accelerated vaccine: associated with woke up cold, light headed, swollen neck glands and associated with body aches. For rabies (rabavert) vaccine: not associated with woke up cold, associated with body aches, light headed and swollen neck glands. For tetanus/diphtheria/pertussis (boostrix): not associated with woke up cold, light headed, swollen neck glands and associated body aches. For typhoid (typhim vi): not associated with woke up cold, light headed, swollen neck glands associated with body aches. List of documents held by sender: none Follow up information received on 27 April 2018. Narrative description was updated. Event outcome was updated. Follow up information received on 02 May 2018. Event stop date was updated. Follow up information received 11 July 2018. Details of corrective treatment was updated. Reporter causality was reported.; Sender's Comments: Follow up information received 11 July 2018. A 40-year-old male subject developed body aches, light headed, swollen neck glands and he woke up cold, five days after receiving a dose of Stamaril vaccine. The subject also received dose of hepatitis A&B (Twinrix)-dose 1-accelerated, rabies (Rabavert), tetanus/diphtheria/pertussis (Boostrix) and typhoid (Typhim Vi) same day of the vaccination with the dose of stamaril vaccine. Based on infective nature of the event the sponsor assesses the event "cold" as not related and based on time to onset the sponsor assesses the events body aches, light headed and swollen neck glands not related to the study vaccine. The events could also be related to the other vaccines given.