Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia, Nausea, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. Concomitant products included Levothyroxine, Metformin, Pravastatin, hydrocodone and lisinopril. On 7th June 2018, the patient received the 1st dose of SHINGRIX and PNEUMOCOCCAL VACCINE. On 7th June 2018, several hours after receiving SHINGRIX and an unknown time after receiving PNEUMOCOCCAL VACCINE, the patient experienced nausea, injection site joint pain, injection site swelling and unable to eat. On 8th June 2018, the patient experienced headache. On 9th June 2018, the patient experienced bedridden. In June 2018, the patient experienced diarrhea, leg pain, general body pain, productive cough, skin warm, bone pain, sleeplessness, stomach pain, fever and frustration. The patient was treated with ibuprofen. In June 2018, the outcome of the skin warm was recovered/resolved. On an unknown date, the outcome of the headache, leg pain, injection site joint pain, general body pain, bone pain, unable to eat and stomach pain were not recovered/not resolved and the outcome of the nausea, injection site swelling, productive cough, bedridden and fever were recovered/resolved and the outcome of the diarrhea and frustration were unknown and the outcome of the sleeplessness was recovering/resolving. The reporter considered the headache, nausea, diarrhea, leg pain, injection site joint pain, injection site swelling, general body pain, productive cough, skin warm, bone pain, sleeplessness, bedridden, unable to eat, stomach pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the frustration to be related to SHINGRIX. Additional details were provided as follows:The patient had never before had any reactions to any prior vaccinations. Two to three hours prior to the SHINGRIX dose, the patient had a pneumococcal vaccine of unknown name and manufacturer administered into her left upper arm at her doctor's office. No dosing specifics or further details were known about the other vaccine. The patient described that the SHINGRIX dose was given into the right shoulder and later said it was administered into the upper right arm. The area of the patient's arm and shoulder where the dose had been administered hurt right away and for a week after the dose was administered and was swollen and still hurts upon being pressed. In the evening of vaccination day, several hours after receiving vaccination, the patient had feeling of being nauseated and she could not eat anything. On 8th June 2018, the patient was experiencing fevers daily since midnight of the day after the SHINGRIX dose up to 102 degrees and 103 degrees. The patient did not have a fever on the reporting date, but she thought it would return. In June 2018, since about the second or third day after the SHINGRIX, every day the whole day and night constantly the patient could not sleep or get out of bed to take a shower up until 2 days before the reporting date. On 11th June 2018, 4 days after receiving SHINGRIX, the coughing up of chest mucus and body aches was started. The patient's bones, specifically her butt bone, and legs were hurting so bad and she felt hot about 4 or 5 days after the SHINGRIX dose and were hurting and feeling hot off and on which frustrates her because she could not get comfortable. The patient's four year old and 12 year old granddaughters got sick too with the same symptoms of coughing with mucus and fever for about a week. She took them to the doctor, and the doctor said the younger one had a bug. On an unknown date in June 2018 by 03:00 pm, less than a month after receiving SHINGRIX, the patient nibbles on yogurt or strawberries, but then her stomach hurts so badly and had the runs. On 28th June 2018, the patient went to an urgent care facility due to all of the symptoms. The physician at urgent care told her that her symptoms were a reaction to the SHINGRIX, and she agreed. The patient had been taking ibuprofen which the urgent care physician ordered. All the symptoms did not begin until after the SHINGRIX was administered. On an unknown date in June 2018, the feeling of being nauseated had resolved because she had not been eating like she used to and only had a cup of coffee instead of eating breakfast. The patient gave permission to contact the prescribing healthcare physician (HCP), but she could not provide the name because the physician who ordered her to have the SHINGRIX was a team doctor and not her routine HCP. Upon listening back to the call, the caller reported that the patient mentioned at the beginning of call she was having the runs, so had added as symptom with no further details provided during the call. It was unclear during the call the exact site of administration on arm or possible shoulder for the SHINGRIX dose.