Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Headache, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema
Clinical narrative: skin bump/rash/pimple/red spots; skin bump/rash/pimple; black spots on skin like sun spots; headache; pain during injection; injection site reaction (red, painful, swollen and hot); injection site reaction (red, painful, swollen and hot); she couldn't mover her arm; injection site reaction (red, painful, swollen and hot); This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fungal infection. Previously administered products included flu shot (received on an unknown date for flu shot). Concurrent medical conditions included sarcoidosis, pancreatic cancer, penicillin allergy and iodine allergy.   On 27th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 27th December 2019, immediately after receiving Shingrix, the patient experienced injection site pain and headache. On an unknown date, the patient experienced injection site erythema, injection site swelling, injected limb mobility decreased, injection site warmth, red spotty rash, pimples and skin discoloration. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, headache, injection site erythema, injection site swelling, injected limb mobility decreased and injection site warmth were recovered/resolved and the outcome of the red spotty rash, pimples and skin discoloration were not recovered/not resolved.   The reporter considered the injection site pain, headache, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix. It was unknown if the reporter considered the injected limb mobility decreased, red spotty rash, pimples and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received a dose of Shingrix in an unknown arm.  She stated that the needle was very long therefore the injection was given intramuscularly (not subcutaneously) in the arm.  The patient did not have the lot number or expiration date of Shingrix because she called from her car and all her paperwork was at home.  She stated that it was painful during the actual injection.  The patient had a headache before she left the pharmacy on 27th December 2019.  She also stated that the injection site was red, painful, swollen and hot.  She was unable to move her arm nor could anyone touch her arm and she had to be careful not to lay on it.  Less than a day, the patient noticed some little bumps on her skin like a rash.  She said she had a couple of bumps that looked like a pimple on her skin in different parts of her body such as breast and legs.  They were red and some were black spots on the skin like sun spots.  She stated she stayed out of the sun due to her history of sarcoidosis.  Injection site reactions resolved after 5 days.  The reporter consented to follow up.