Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Headache, Injection site discomfort, Myalgia
Clinical narrative: tiredness; headache; fever; upset stomach; He slept all day; Congestion in nose; cough/ lot of coughing; runny nose; can't smell; can't taste; congestion in his lungs; felt needle poking in his shoulder; Arm pain/sharp pains went down his arm; joint pain/ sharp pains went down into his joints, ankles and knees; muscle pain; Sore back; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2019, the patient received Shingrix (intramuscular). On 18th July 2019, less than a day after receiving Shingrix, the patient experienced tingling skin, pain in arm, joint pain, muscle pain and sore back. On 19th July 2019, the patient experienced lung congestion (serious criteria GSK medically significant), tiredness, headache, fever, upset stomach, sleepiness, nasal congestion, cough, runny nose, loss of smell and taste absent. The patient was treated with cough cold preparations nos (Cough Medication). On an unknown date, the outcome of the lung congestion, joint pain, muscle pain, upset stomach, nasal congestion, cough, runny nose, loss of smell and taste absent were not recovered/not resolved and the outcome of the tingling skin, pain in arm, sore back and headache were unknown and the outcome of the tiredness, fever and sleepiness were recovered/resolved.   It was unknown if the reporter considered the lung congestion, tingling skin, pain in arm, joint pain, muscle pain, sore back, tiredness, headache, fever, upset stomach, sleepiness, nasal congestion, cough, runny nose, loss of smell and taste absent to be related to Shingrix.  Additional details were received as follows: After getting the shot, the patient felt like there was still a needle poking in his shoulder.  Then sharp pains went down to his arm and into his joints, ankles and knees.  The patient's muscles and back became very sore.  The patient was tired with headaches, fever and upset stomach. He slept all day due to the tiredness and the headache went from his eyes all the way back into his head. The patient developed congestion in his lungs and nose and began having a lot of coughing and a runny nose.  The muscle pain and joint pain had gone away, though he did sometimes still get sharp pains in his ankles and muscles.  The patient was still congested and coughing though not as much as before, but he could not taste or smell anything.  The day before the reporting date, the patient visited his doctor and was given a stronger cough medication. Emergency room visit was required. The patient consented to follow up and provided his doctor's address. There was a discrepancy in the reported outcome of the event muscle pain and joint pain. In Agency, the outcome was mentioned as recovered/resolved and in the narrative, it was not recovered/not resolved. However outcome of the event is captured as per narrative. Also for the events upset stomach, cough, congestion, loss of smell and taste absent, the outcome was mentioned as recovering/ resolving in Agency but in Agency it was not recovered/not resolved. However outcome of the event is captured as per Agency.