Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Malaise, Pain, Pain in extremity
Clinical narrative: she woke up every 2 hours last night; headache; feeling feverish; had a little upset stomach /her stomach felt "yucky"; itchy rash on her neck/ itchy rash on her throat; occasional chills,; feeling tired; having aches here and there; lack of energy; not feeling well/she thought she was getting sick; she had received the previous shingles vaccine prior to the 1st dose of the Shingrix.; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of poor sleep in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose recieved about 2 years ago of reporting date, refer case US2021AMR049697) and Shingles vaccine (received on an unknown date prior to the 1st Shingrix shot).   On 18th February 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 18th February 2021, the dose was an unknown dose. On 18th February 2021, less than a day after receiving Shingrix, the patient experienced poor sleep, headache, fever, upset stomach, itchy rash, chills, tiredness, pain, loss of energy, feeling unwell, extra dose administered and drug dose administration interval too long. The patient was treated with zinc, paracetamol (Tylenol Extra Strength) and melatonin. On an unknown date, the outcome of the poor sleep, upset stomach, tiredness, pain, loss of energy, feeling unwell, extra dose administered and drug dose administration interval too long were unknown and the outcome of the headache, itchy rash and chills were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the poor sleep, headache, fever, upset stomach, itchy rash, chills, tiredness, pain, loss of energy and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix and had experienced all the side effects. The patient stated that she woke up every 2 hours last night with the headache, felt feverish, had the little upset stomach, had an itchy rash on her neck, occasional chills, felt tired, had aches here and there and lack of energy. The patient stated that she thought she was getting sick, so she got up at the 3 am and took the Zinc, 2 Tylenol extra strengths and the Melatonin to try to go back to sleep, but then her stomach felt yucky. The patient reported that the headache and the itchy rash on her throat were till there on the day of reporting and she also got occasional chills, she did not think she was feverish that morning (on the day of reporting), she was unable to take her fever last night because she was not feeling well. The patient mentioned that she had received the previous shingles vaccine prior to the 1st dose of the Shingrix, which led to extra dose administered and lengthening of vaccination schedule. The patient was unable to provide the lot number or expiration of either doses for the vaccine. The patient gave permission to follow up with her health care professional and provided the contact information. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR049697:same reporter, same patient, same vaccine, different dose-1st dose