Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administration interrupted, Therapeutic response unexpected
Clinical narrative: switches between taking ibuprofen and Tylenol/Codeine; Teeth feel numb or like being paralyzed / not being able to feel his teeth/ upper quadrant of teeth area is numb.; unable to work physically; severally fatigued; migraine; felt different/ not normal; pain killers are helping him with numbness; This case was reported by a consumer via call center representative and described the occurrence of numbness oral in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included codeine unknown for dental implantation, ibuprofen for dental implantation and paracetamol (Tylenol) for dental implantation.   The patient's past medical history included dental implantation (about 4 weeks before the date of reporting, the patient had implants done for teeth.).   On 4th August 2021, the patient received the 1st dose of Shingrix. In July 2021, the patient started codeine at an unknown dose and frequency, ibuprofen at an unknown dose and frequency and Tylenol at an unknown dose and frequency. On 4th August 2021, 6 hrs after receiving Shingrix and less than a month after starting codeine, the patient experienced feeling abnormal. On 5th August 2021, the patient experienced numbness oral, inability to work, fatigue and migraine. In August 2021, the patient experienced therapeutic response unexpected. On an unknown date, the patient experienced product administration interrupted. The patient was treated with amoxicillin. The action taken with codeine was unknown. The action taken with ibuprofen was unknown. The action taken with Tylenol was unknown. On an unknown date, the outcome of the numbness oral was not recovered/not resolved and the outcome of the feeling abnormal, inability to work, fatigue, migraine, therapeutic response unexpected and product administration interrupted were unknown.   It was unknown if the reporter considered the numbness oral, feeling abnormal, inability to work, fatigue and migraine to be related to Shingrix and codeine. It was unknown if the reporter considered the therapeutic response unexpected to be related to codeine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. He has been prescribed antibiotic, Ibuprofen and Tylenol/Codeine for the implant. The patient stated that he switches between taking ibuprofen and Tylenol/Codeine. About 6 hours later, the patient noticed that he felt different, but not normal. Then next day, he stated that the right side of upper quadrant of teeth area was numb. The reporter termed numb as paralyzed. The patient was concerned because he does not want teeth to fall off. He stated that about 4 weeks ago, he had implants done for teeth. The patient also stated that next day, he was unable to work physically, severally fatigued, and had migraine. He stated that he visited his dentist after Shingrix side effects, and his dentist does not see any new infections present post implantation, but prescribed Amoxicillin to the reporter anyway. The pain killers are helping him with numbness. The date of reporting was day 5 of numbness. The reporter does not have a lot number or expiry date. He has NDC of Shingrix (58160-0823-11). The reporter refused to provide HCP contact information as well to answer the questions about adverse events. It was unknown if the reporter considered the numbness oral, feeling abnormal, inability to work, fatigue and migraine to be related to Ibuprofen and Tylenol. It was unknown if the reporter considered the therapeutic response unexpected to be related to Ibuprofen and Tylenol.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168415:Deleted duplicate case FU1