Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product complaint, Product preparation issue, Tendon injury, Tremor, Viral test negative
Clinical narrative: serious injury to her right foot; felt as if her legs were dissolving/muscle strength is not what it should be in her foot/decreased muscle strength; Sore throat; lost her voice and became "mute"; had a discomfort in her chest; coughing her head off; her arm is still sore; Limping/could barely walk at all/still "can't walk freely; had to use a wheelchair; weakness has caused her to be off balance / still can't walk freely; foot still hurts all the time; Unable to walk; Driving ability disturbed; she may have gotten a "bad batch" of the Shingrix vaccine or that it was not mixed properly at the time of administration. Agent filing related AE/PQC.; Inappropriate preparation of medication; Pharmaceutical product complaint; after taking the Shingrix injection, she had a fall/lie down/fall/fallen a few more; "global" headache; Vesicles on her chin, nose and hair; felt weak/she continued to get weaker/weakness; Vomiting; two serious tendon injuries that required custom inserts and braces and she said they may require surgery; uncontrollable shivering; uncontrollable shivering and shaking; This case was reported by a consumer via call center representative and described the occurrence of tendon injury in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3D57E, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax.   On 28th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than 3 months after receiving Shingrix, the patient experienced tendon injury (serious criteria other: serious per reporter), headache, vesicles, weakness, vomiting and fall. On an unknown date, the patient experienced foot injury (serious criteria other: serious per reporter), lower extremities weakness of, sore throat, loss of voice, chest discomfort, cough, shivering, tremor, pain, limping, wheelchair user, balance disorder, foot pain, unable to walk, driving ability disturbed, circumstance or information capable of leading to medication error, inappropriate preparation of medication and pharmaceutical product complaint. The patient was treated with medication unknown (Nebulizer (Name Unknown)) and cough cold preparations nos (Cough Syrup). On an unknown date, the outcome of the tendon injury, lower extremities weakness of, headache, vesicles, sore throat, chest discomfort, cough, wheelchair user, balance disorder, foot pain, unable to walk, driving ability disturbed, circumstance or information capable of leading to medication error, inappropriate preparation of medication and pharmaceutical product complaint were unknown and the outcome of the foot injury, weakness, pain and limping were not recovered/not resolved and the outcome of the vomiting, loss of voice, fall, shivering and tremor were recovered/resolved.   It was unknown if the reporter considered the tendon injury, foot injury, lower extremities weakness of, headache, vesicles, weakness, vomiting, sore throat, loss of voice, chest discomfort, cough, fall, shivering, tremor, pain, limping, wheelchair user, balance disorder, foot pain, unable to walk and driving ability disturbed to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and after eight hours later, she was at her son's house at the time, doing the dishes and she felt as if her legs were dissolving and felt weak and she had to lie down right away.  The patient woke up with global headache had vesicles on her chin, nose and hair. That day she was vomiting and had to miss dinner.  The patient also had a sore throat and lost her voice and became mute.  The patient continued to get weaker and had a discomfort in her chest as well as she was coughing her head off.  She stated that she continued to get weaker and that on the 9th day (after taking the Shingrix injection), she had a fall while she was taking a turn in her home and that the fall caused a serious injury to her right foot. on the 11th day, she had uncontrollable shivering and shaking that lasted less than 24 hours. She said she could barely walk at all that day. She stated she went to the hospital, was not admitted but had countless tests for every type of virus and was given nebulizer treatments and cough syrup.  She was also given a CAT scan. She said she was cleared of any potential viruses. She stated that the weakness continued and that she could not drive, which delayed a trip she was going to take. She stated that she was limping and had to use a wheelchair to get around the airport. She said she went for massages and got a personal trainer to build her muscle. She said she was examined to determine if her foot was broken and it was not but she has two serious tendon injuries that required custom inserts and braces and she said they may require surgery. She stated the weakness has caused her to be off balance.  The patient's arm was still sore and she still can't walk freely and foot still hurts all the time, her muscle strength is not what it should be in her foot and that she uses arch support. She says she has fallen a few more times. Also experienced bad batch of the Shingrix vaccine or that it was not mixed properly at the time of administration.      Lab Comments: Lab test performed on an unknown date