Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Off label use, Pain, Pain in extremity, Product use issue
Clinical narrative: tiny nodules that are itching and burning; tiny nodules that are itching and burning; This rash is now spreading and it is almost following the accessory nerve or the branches of it; sunburn; sun stroke; develop achiness and itching all over his deltoid area and on his whole left upper extremity; look like shingles/herpes zoster; achiness and itching all over his deltoid; achiness and itching all over his deltoid/experiencing itchy left arm upper chest; Off label use; booster; Product use for unapproved combination; he had a hard time raising his left upper extremity; he hasn't slept for almost 10 nights.; he woke up with tenderness; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Sep2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 19Sep2021. Vaccination history included: Bnt162b2 (First Dose, Vaccine location: left arm), administration date: Dec2020, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Second Dose, Vaccine location: left arm), administration date: Jan2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 19Sep2021, outcome "unknown", described as "Off label use"; IMMUNISATION (non-serious) with onset 19Sep2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset Sep2021, outcome "not recovered", described as "pain at injection site"; PAIN (non-serious) with onset Nov2021, outcome "not recovered", described as "achiness and itching all over his deltoid"; PRURITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "achiness and itching all over his deltoid/experiencing itchy left arm upper chest"; NODULE (non-serious), BURNING SENSATION (non-serious) all with onset 08Nov2021, outcome "not recovered" and all described as "tiny nodules that are itching and burning"; HERPES ZOSTER (non-serious) with onset Nov2021, outcome "not recovered", described as "look like shingles/herpes zoster"; HEAT STROKE (non-serious) with onset Nov2021, outcome "unknown", described as "sun stroke"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "not recovered", described as "develop achiness and itching all over his deltoid area and on his whole left upper extremity"; RASH (non-serious) with onset 08Nov2021, outcome "not recovered", described as "This rash is now spreading and it is almost following the accessory nerve or the branches of it"; INSOMNIA (non-serious) with onset Sep2021, outcome "unknown", described as "he hasn't slept for almost 10 nights."; TENDERNESS (non-serious) with onset Sep2021, outcome "unknown", described as "he woke up with tenderness"; SUNBURN (non-serious) with onset Nov2021, outcome "unknown", described as "sunburn"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) with onset Sep2021, outcome "not recovered", described as "he had a hard time raising his left upper extremity"; PRODUCT USE ISSUE (non-serious) with onset 19Sep2021, outcome "unknown", described as "Product use for unapproved combination".  Additional information: The patient had the booster about 8 weeks ago and immediately afterwards nothing happened but after about 3 to 4 days he got pain in the site of injection and the pain won't go away. About 2 weeks ago he started to develop achiness and itching all over his deltoid area and on his whole left upper extremity. At that time, he was traveling and it was very hot, sunny and dry. The temperature ranged from 110 to 115 every day and he was seeing pyramids and going up and down and it was an exhausting type of trip. He was blaming what he was experiencing on sunburn because he had to wear a t-shirt and the arm was all open and he was getting more sun on his left side, so he was blaming it on sunburn. Then he finally got sun stroke and then he came back about 2 weeks ago. He started to notice some type of rash and the rash was almost like the rash you get with the herpes zoster, like vesicles. He then clarified and confirmed that the rash was more like solid nodules, not vesicles, and they were itching and burning. Now he had such bad pain and it was a really achy pain all over his arm and on the left side of his upper chest and things like that. This rash was then spreading and it was almost following the accessory nerve or the branches of it, he did not know, maybe sun stroke along the ulnar and medial side. It was like lots tiny nodules that were itching and burning look like shingles/herpes zoster of clusters of solid nodules that were itchy, burning and he had pain that was typical with the herpes zoster. He was a disabled person. Pain in the injection site: He said that he went 3 days without much of anything but then all of a sudden he woke up with tenderness and pain. He said it was much worse than what it was, it did not let him sleep and he hadn't slept for almost 10 nights. He said that he developed the achiness and the itching sometime in Nov2021. He said the rash began maybe a few days before the pain and all this became worse. He was exposed to the sun, so he was thinking it was from sunburn and then he noticed the clusters of tiny nodules. He said that he noticed those about 14 days ago, on 08Nov2021. He was going to get the vaccine for the herpes zoster but he did not know if he could take it. He might have to wait until everything resolved. The patient was taking some medications but he had been taking those for a long time and nothing has happened and he has never had side effects. He confirmed that he did have the flu shot the same day as his COVID vaccine booster. He provided that he only had his booster dose there but his 2 initial doses he took at the hospital where he used to work. Vaccination facility type was pharmacy. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient did not have medical history (including any illness at time of vaccination). The patient did not have family medical history. The patient did not have relevant tests. The patient did not visit emergency room or physician's office. Causality assessed by Global introspection method for events got pain in the site of injection and the pain won't go away, develop achiness and itching all over his deltoid area and on his whole left upper extremity, rash more like solid nodules and they were itching and burning and hasn't slept for almost 10 nights as related.  The lot number for bnt162b2 was not provided and will be requested during follow up.