Age: 65.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Muscle spasms, Myalgia, Pain, Petechiae, Product administered at inappropriate site
Clinical narrative: Leg calf muscle became heavy; Cramps and severe muscle spams on / right leg; Small petechia rash on / lower legs; Petechia rash / started to burn; CPK was over 2400 when / admitted to the hospital; Dry skin; Itching; So much fatigue/ tired; So much / myalgia; So much / pain; She couldn't walk; Admitted to the hospital / Rhabdomyolysis was really bad; Inappropriate site of vaccine adminstration; This case was reported by a nurse via other manufacturer and described the occurrence of rhabdomyolysis in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and COVID 19 VACCINE PFIZER (batch number EL0140, expiry date unknown) for prophylaxis.   The patient's past medical history included osteoporosis (since 2011), osteoarthritis, knee replacement (one knee replaced in 2004 and other knee replaced in 2011), spinal compression fracture and vertebroplasty (spinal compression fracture was repaired by Vertebroplasty in 2011). Concurrent medical conditions included hyperthyroidism (since 1998 or 2000).   On 29th December 2020, the patient received Shingrix (intramuscular) and Hepatitis A vaccine (intramuscular). On 23rd December 2020, the patient received the 1st dose of COVID 19 VACCINE PFIZER. On 29th December 2020, unknown after receiving Shingrix and Hepatitis A vaccine, the patient experienced vaccine administered at inappropriate site. On 30th December 2020, the patient experienced fatigue (serious criteria hospitalization and clinically significant/intervention required), myalgia (serious criteria hospitalization and clinically significant/intervention required), pain (serious criteria hospitalization and clinically significant/intervention required) and walking difficulty (serious criteria hospitalization). On 6th February 2021, the patient experienced rhabdomyolysis (serious criteria hospitalization, disability and GSK medically significant), cpk increased (serious criteria hospitalization), petechial rash (serious criteria hospitalization and clinically significant/intervention required) and burning sensation (serious criteria hospitalization). In February 2021, the patient experienced dry skin (serious criteria hospitalization and clinically significant/intervention required) and pruritus (serious criteria hospitalization and clinically significant/intervention required). On 17th February 2021, the patient experienced cramp (serious criteria hospitalization and clinically significant/intervention required). On an unknown date, the patient experienced sensation of heaviness (serious criteria hospitalization). The patient was treated with sodium chloride (Normal Saline), naproxen, ibuprofen, paracetamol (Tylenol) and coconut oil. On an unknown date, the outcome of the rhabdomyolysis, fatigue, myalgia and pain were recovering/resolving and the outcome of the walking difficulty, cpk increased, burning sensation, sensation of heaviness and vaccine administered at inappropriate site were unknown and the outcome of the cramp, petechial rash, dry skin and pruritus were not recovered/not resolved.   The reporter considered the rhabdomyolysis, fatigue, myalgia, pain, walking difficulty, cpk increased, cramp, petechial rash, burning sensation, sensation of heaviness, dry skin and pruritus to be related to Shingrix and Hepatitis A vaccine.  Additional details were provided as follows: On 6th January 2021, the patient underwent blood work (BMP, CBC and thyroid level).  It was reported that the patient received hepatitis A booster dose and shingrix  in left deltoid. The patient was hospitalized on 6th February 2021 for rhabdomyolysis and rhabdomyolysis was very bad. The patient had so much fatigue, myalgia and pain she could not walk. The patient reported that she had given lot of fluid in hospitalization. The patient's CPK was over 2400 when she was admitted to hospital. The patient drank lot of water until diagnosis of rhabdomyolysis because her urine was colorless and her kidneys were not damaged. The patient kept putting her symptoms and took naproxen and Tylenol for whole month of January 2021. The patient's symptoms started brewing up from day 1. The patient stated that her symptoms were not really bad until 30th December 2021 and 31st December 2021. The patient took  naproxen, Tylenol and ibuprofen and nothing helped her. The patient knew her symptoms were not normal and went for whole month of January 2021 with her symptoms. The patient needed to check in hospital and took naproxen and Tylenol and felt little better and drove herself to hospital. The patient kept walking and taking medicines and while at work she diverted her mind from her symptoms but when she came home she felt tired and she could not do anymore. The patient did not know if she experienced adverse event from covid-19 vaccine but that definitely had reaction to hepatitis A booster dose and shingrix  or COVID-19 vaccine. The patient had read article that said vaccine could cause rhabdomyolysis. The patient received 11 bags of normal saline 1000ml/per bag. The patient stated that fluid resuscitation was only way to bring back her CPK down and to treat rhabdomyolysis. On 17th February 2021, the patient's CPK was 134. The patient had cramps and severe muscle spasm at right leg on 17th February 2021 and had cramps and muscle spasm in left leg on following day. The patient's cramps and severe muscle spasm not gone completely. The patient had small petechia rash on her lower leg. The patient reported that she would have muscle spasm in that area. The patient had 2 petechia rashes on lateral side of right ankle. The petechial rashes started to burn and her right leg calf muscle became heavy. The patient stated that her right leg calf muscle going to start spasm. So the patient applied some coconut oil on her right leg calf muscle and massaged her calf muscle. The immunologist told the patient that going forward if patient has to get flu o COVID 19 vaccine the patient would have to ordered CPK within 24 hrs of taking vaccine otherwise the patient would not be able to take vaccine. On 23rd February 2021, the patient had 2 areas of petechial rash and patient first noticed petechial on 6th February 2021. The patient stated that prior to hospitalization patient did not have dry skin or itching. The patient was using coconut oil to keep her skin moist. It was unknown if the reporter considered the rhabdomyolysis, fatigue, myalgia, pain, walking difficulty, cpk increased, cramp, petechial rash, burning sensation, sensation of heaviness, dry skin and pruritus to be related to COVID 19 vaccine.