Sex: M
Vaccine: VARZOS
Symptoms: Tension headache
Clinical narrative: Fatigue; His scalp felt really tight, bruised, and kind of burned; His scalp felt really tight, bruised, and kind of burned; His scalp felt really tight, bruised, and kind of burned; He states his heartbeat was pretty fast; first dose in the left deltoid and had a very hard large lump; first dose in the left deltoid and had a very hard large lump that was/ He states he had a lump in his injected arm; It was raised, very red; It was raised, very red, and moderately sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin nodule in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included skin nodule (had a lump in his injected arm as well- it was on the same side, was the same duration,same everything), erythema, pain, fatigue, head tightness, bruise of head, burning sensation scalp, heartbeats increased and induration. Previously administered products included Flu vaccine (had a flu shot about 10 years ago).   On 25-OCT-2023, the patient received the 1st dose of Shingrix (left deltoid). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced skin nodule (Verbatim: first dose in the left deltoid and had a very hard large lump), induration (Verbatim: first dose in the left deltoid and had a very hard large lump that was/ He states he had a lump in his injected arm), erythema (Verbatim: It was raised, very red) and pain (Verbatim: It was raised, very red, and moderately sore). On 25-OCT-2023, the patient experienced fatigue (Verbatim: Fatigue), head tightness (Verbatim: His scalp felt really tight, bruised, and kind of burned), bruise of head (Verbatim: His scalp felt really tight, bruised, and kind of burned), burning sensation scalp (Verbatim: His scalp felt really tight, bruised, and kind of burned) and heartbeats increased (Verbatim: He states his heartbeat was pretty fast). On 25-OCT-2023, the outcome of the heartbeats increased was resolved. The outcome of the skin nodule, induration, fatigue, head tightness, bruise of head and burning sensation scalp were resolved and the outcome of the erythema and pain were resolved (duration 10 days).   It was unknown if the reporter considered the skin nodule, induration, erythema, pain, fatigue, head tightness, bruise of head, burning sensation scalp and heartbeats increased to be related to Shingrix.     It was unknown if the company considered the skin nodule, induration, erythema, pain, fatigue, head tightness, bruise of head, burning sensation scalp and heartbeats increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-NOV-2023 The patient had similar reaction to flu shot about 10 years ago. The patient received 1st dose of shingrix and had experienced a very hard large lump that was about 2 and a half inches. It was raised, very red, and moderately sore for about 10 days. The patient was not certain when it first started but thinks it may had started that night or the next morning. The patient stated he also had fatigue that started about 8 to 10 hours later.  His scalp felt really tight, bruised, and kind of burned and these also started about 8 to 10 hours later and lasted a day and a half. The patient stated that his heartbeat was pretty fast and started about 2 hours after receiving the vaccine and lasted about an hour and a half. All of the symptoms had since resolved.  The reporter mentioned that he had similar reaction to a flu shot about 10 years ago.  The patient's physician told him to never get the flu shot again. The reporter consented to follow up.