Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: severe left side neck spasms; severe left side neck spasms/Very very bad spasms. Came and went; little bit of a sore arm; Severe neck pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose 4 (booster), single (Lot number: GJ6796) at the age of 71 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing), notes: he takes a blood pressure pill and a tablet for urinating; "urinating" (unspecified if ongoing), notes: he takes a blood pressure pill and a tablet for urinating. Concomitant medication(s) included: SERTRALINE taken for urinary incontinence. Vaccination history included: BNT162b2 (Dose 1, Route of Administration: intramuscular, Lot number: EL9269), administration date: 13Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots"; BNT162b2 (Dose 2, Route of Administration: intramuscular, Lot number: EL9262), administration date: 07Mar2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots"; BNT162b2 (Dose 3/first booster, Route of Administration: intramuscular, Batch/Lot number: FF8841), administration date: 28Oct2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots". The following information was reported: NECK PAIN (non-serious) with onset 2022, outcome "unknown", described as "Severe neck pain"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2022, outcome "unknown", described as "little bit of a sore arm"; CONDITION AGGRAVATED (non-serious) with onset 01Dec2022, outcome "not recovered", described as "severe left side neck spasms/Very very bad spasms. Came and went"; MUSCLE SPASMS (non-serious) with onset 01Dec2022 at 02:00, outcome "unknown", described as "severe left side neck spasms". The events "little bit of a sore arm", "severe left side neck spasms", "severe left side neck spasms/very very bad spasms. came and went" and "severe neck pain" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, muscle spasms, condition aggravated, neck pain.  Additional information:Patient had a very weird side effect. he figured should speak to someone. he trying to understand if what he experiencing may be a side effect. he had the Pfizer COVID bivalent vaccine (Lot: 6J6796) this Wednesday 30Nov2022 a little before noon. he had a little bit of a sore arm, like he had on the other Pfizer shots, but nothing major. he woke up 2 AM in the morning on Thursday 01Dec2022 with severe left side neck spasms. On a scale of 1-10, he would say 11. Very very bad spasms. Came and went. Went to the doctor and they prescribed Diazepam 5mg twice a day. Also, Diclofenac Sodium 75 mg for neck spasms. Patient assessed as non serious. Started taking those, and just struggled all day Thursday. Can only sleep for a couple hours at a time. these spasms were coming and going erratically. When they did come, they were 11 out of scale of 10. Managed to get a couple hours of sleep at a time. Last night, went to bed, then woke up about 3 AM Friday 02Dec2022. The entire spasm has moved from left side of his neck to his right side of his neck, but worse. Had the shot in the right arm. he feel like he never expected this. Severe neck pain out of the blue for no reason at all just threw him for a loop. his HCP didn't think it had anything to do with the shot, but he never experienced that in 7 years. he had a sore back/sore neck when you over exercise, but nothing like this out of nowhere. his spasm lasts 3-4 seconds to 10 seconds, very severe, and then they go away." Caller had four shots total. He had the bivalent COVID-19 vaccine on 30Nov2022. He had the neck spasms after the bivalent, and had pain to the left side of his neck starting at about 14 hours after getting it. Spasm Treatment: He didn't get the Diazepam or the Diclofenac until 05:00-06:00pm on 01Dec22, and he took them right away, at 6:30pm. Spasm outcome: Since he has been talking to call handler and agent he has had not one spasm. Prior to that he had spasms from about 02:00 to 03:00am this morning and he didn't count them, but there were at least 20 of them. While they were happening the spasms stayed about the same. He says he has a handwritten vaccine card, and it looks like the LOT is 6J6796, but if it is not supposed to be a six that could be a G. It looks like a six but then the other two sixes are different from it, so he thinks it is actually a G. NDC/EXP not provided on handwritten vaccine card. He clarifies that he got the bivalent COVID vaccine between 11:30AM and noon. He got dose one and two from Pfizer then had one booster which was shot number three, but he didn't have booster four, and then he had the bivalent. He asks, is that considered a booster or a shot? He had shot number five but didn't have number four, he skipped that one and didn't want to do it. Indication: The reason he got the bivalent vaccine was it was the latest shot and a booster that also covers COVID symptoms and latest Omicron. Historical AE: little bit of a sore arm: When he had sore arm he took some Tylenol and Ibuprofen, which was 500 mg for Tylenol, which he took a couple of times as needed. For the Ibuprofen dose would have been 200mg, which he took the same as the Tylenol, a couple of times as needed. Ibuprofen was taken at same time as Tylenol. His sore arm got better. Concomitant Medications: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating, and he takes Sertraline. Caller says he doesn't feel those are relevant, he has been taking all of them for 4-5 years and didn't have neck spasms. AE Outcome: They did tell him that if it doesn't clear up in a week to come back for some kind of CT Scan or x-ray, and maybe do physical therapy, but they were guessing and have no idea where this come from. They didn't believe it had nothing to do with the shot. He tended to agree with her at the time, but he totally does not agree now after Thursday night and then it went over to the right side. He thinks it is in direct relation to the shot; he is retired and has done nothing in the last couple days that would cause muscle spasms. He didn't have a sore neck or have one before. He thinks the chance that this is a side effect of the shot is very high in his opinion.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201350178 same patient, different vaccine dose number/event;US-PFIZER INC-202201350179 same patient, different vaccine dose number/event;