Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: woke up with unbelievable chills; joint swelling and pain; joint swelling and pain; fever of 103 degrees Fahrenheit; Caller could barely hold anything he was shaking so bad; has had really severe fatigue, been sleeping 1 or 2 hours, feels the need, almost no choice, needs to lie down and sleep in the middle of the day; has had really severe fatigue, been sleeping 1 or 2 hours, feels the need, almost no choice, needs to lie down and sleep in the middle of the day; Patient was literally dreaming that he was being physically tortured which is unique, woke from that dream very ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (not ongoing), notes: had ulcerative colitis prior to getting any of the vaccines. There were no concomitant medications. Past drug history included: Levofloxacin, reaction(s): "Drug allergy", notes: Brand name Levaquin; allergic to whatever is active in both the generic and brand name of the medication. Vaccination history included: BNT162b2 (Dose 1, single, Only says Pfizer COVID-19 vaccine purple cap., Date: 23Mar2021, NDC number, lot number, expiration date: Unknown. , Dose, route: Injection, dose unknown, upper left arm), administration date: 23Mar2021, when the patient was 47-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Only says Pfizer COVID-19 vaccine purple cap., Date: 13Apr2021, NDC number, lot number, expiration date: Unknown. , Dose, route: Injection, dose unknown, upper left arm), administration date: 13Apr2021, when the patient was 47-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 (booster), single, Unknown color of cap for this dose., Date: 30Sep2021, NDC number, lot number, expiration date: Unknown. , Dose, route: Injection, dose unknown, upper left arm), administration date: 30Sep2021, when the patient was 47-year-old, for COVID-19 immunization, reaction(s): "Had a headache, pretty severe headache". The following information was reported: TREMOR (non-serious) with onset 03Jun2022, outcome "unknown", described as "Caller could barely hold anything he was shaking so bad"; ABNORMAL DREAMS (non-serious) with onset 03Jun2022, outcome "unknown", described as "Patient was literally dreaming that he was being physically tortured which is unique, woke from that dream very ill"; PYREXIA (non-serious) with onset 03Jun2022, outcome "unknown", described as "fever of 103 degrees Fahrenheit"; FATIGUE (non-serious), SOMNOLENCE (non-serious) all with onset 03Jun2022, outcome "not recovered" and all described as "has had really severe fatigue, been sleeping 1 or 2 hours, feels the need, almost no choice, needs to lie down and sleep in the middle of the day"; JOINT SWELLING (non-serious), ARTHRALGIA (non-serious) all with onset 03Jun2022, outcome "unknown" and all described as "joint swelling and pain"; CHILLS (non-serious) with onset 03Jun2022, outcome "unknown", described as "woke up with unbelievable chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, tremor.  Additional information: Other conditions was noted as no. For the first and second boosters patient received, the reason for those doses was because patient had ulcerative colitis, which is an autoimmune condition. It was confirmed that patient had ulcerative colitis prior to getting any of the vaccines. Family medical history relevant to adverse event was noted as no. Patient only had one known drug allergy, that was to an antibiotic with the generic name levofloxacin, brand name Levaquin, patient was allergic to whatever was active in both the generic and brand name of the medication. Anatomical location of suspect dose was noted as upper left arm. Vaccination facility type was noted as other (medical facility). Vaccine administered at military facility was noted as no. Other products was noted as no. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was noted as no. List all vaccines administered on same date with the Pfizer vaccine considered as suspect noted as no. Patient woke up at 06:00 AM the following morning, 03Jun2022, almost impossible to put in words, woke up with unbelievable chills, joint swelling and pain, and a fever of 103 degrees Fahrenheit. Patient could barely hold anything he was shaking so bad, pretty quickly after waking up patient took 1000mg of acetaminophen, took 2 hours for the fever to break. Then fever returned approximately 2 hours later, once fever reached 101.5 degrees Fahrenheit, patient took 1000mg of acetaminophen again, and that time the fever broke within in hour. Patient took the acetaminophen one more time that day and took once again the following day (captured as 04Jun2022), the fever reached 101 degrees Fahrenheit, took acetaminophen and the fever broke within an hour each time. Patient even had joint swelling and paint in finger and toe joints, lasted about 48 hours. Never had a sore toe joint before, that was unique. It was also reported that patient was literally dreaming that he was being physically tortured which was unique, woke from that dream very ill. Unknown when the actual onset began, but was in the process when patient woke up at 06:00 AM. For the second booster, since when patient woke up, so maybe even 3 weeks later, patient has had really severe fatigue, been sleeping 1 or 2 hours, feels the need, almost no choice, patient needs to lie down and sleep in the middle of the day. Treatment medication included, Acetaminophen, softgels. Patient took 1000mg, which was 2 500mg liquid gel or gel capsules, clarified the formulation was softgels, which are liquid filled capsules, by mouth, as needed. Felt like he was taking the medication scheduled. Took 2 hours for patient to see any effect from the initial dose of 1000mg, for the fever to break. Lot number was noted as S200802. Another number, 960109 was also reported which was not clarified by patient. It was further clarified by patient that for the subsequent doses after the first dose that patient took of acetaminophen, the doses were 500mg each and that acetaminophen was different, that was a powder form, and was a Tylenol brand and was much faster acting than the other brand, the softgels. Product strength and count size dispensed was noted as 500mg softgels, 40 count size. Additional lot numbers was noted as no. The event did not required emergency room or physician office visit. Investigations was noted as no. Relevant tests was noted as none.  The lot number for BNT162b2 was not provided and will be requested during follow up.