Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Paraplegia
Clinical narrative: he tried to get out of bed he could not move from the waist down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 4 (booster), 0.3 ml single (Lot number: FM0173, Expiration Date: 30Sep2022) at the age of 83 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Metastatic brain and lung cancer" (unspecified if ongoing), notes: My husband has metastatic brain and lung cancer.; "Metastatic brain and lung cancer" (unspecified if ongoing), notes: My husband has metastatic brain and lung cancer.; "Cholesterol" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing), notes: He has been on immunotherapy for two+ years with Opdivo. , He is immunocompromised and has been under immunotherapy for 2 years.; "Metastatic melanoma", start date: Aug2020 (unspecified if ongoing), notes: Metastatic melanoma Diagnosed latter part of Aug2020 had gamma knife treatment Sep2020. Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol abnormal; OPDIVO intravenous taken for immunodeficiency, start date: 2020, stop date: 2020. Vaccination history included: BNT162b2 (1st dose: Date: 09Feb2021. Time: Morning, she doesn't know specific time. , Anatomical Site of injection: arm, unknown which one. Route of Administration: intramuscular; Batch/Lot number: EK9231, EXP: Apr2021.), administration date: 09Feb2021, when the patient was 82-year-old, for COVID-19 immunization; BNT162b2 (2nd dose: Date: 02Mar2021, Time: Morning, unknown what time. , Anatomical Site of injection: unknown arm. , Route of Administration: intramuscular; Batch/Lot number: EL3246, EXP: Apr2021.), administration date: 02Mar2021, when the patient was 82-year-old, for COVID-19 immunization; BNT162b2 (he had the third dose in 26Aug2021., Time: Morning. Anatomical Site of injection: unknown arm. Route of Administration: intramuscular. , When he had the third, hours later when he tried to get out of bed he could not move from the waist down. In the morning he was fine.), administration date: 26Aug2021, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "he tried to get out of bed he could not move from the waist down"; Flu (He has had no other vaccines ever than typical Flu or pneumonia vaccines, which she can't remember when those were, they were not around the time of COVID-19 vaccines); Pneumonia vaccines (He got one of the pneumonia vaccines, she doesn't remember when.). The following information was reported: PARAPLEGIA (medically significant) with onset 19Jul2022, outcome "unknown", described as "he tried to get out of bed he could not move from the waist down". The patient underwent the following laboratory tests and procedures: Metastatic melanoma: (Aug2020) Metastatic melanoma.  Clinical course: Reporter husband had metastatic brain and lung cancer. He had been on immunotherapy for two+ years with Opdivo. He had the first two vaccines for COVID. His oncologist recommended additional vaccines. So when he had the third, hours later when he tried to get out of bed he could not move from the waist down. In the morning he was fine. It also happened when he had the fourth. It had us concerned as to whether he should continue with boosters if this was a possible side effect from the third and fourth. Calling on behalf of her husband's booster doses. "When he had the first and second dose there was no problem. He was immunocompromised and had been under immunotherapy for 2 years. When he had the third dose in 26Aug2021, when we've gotten them before it was before noon. In the middle of the night, he went to the restroom and from the waist down he couldn't move his legs. When he got up in the morning, he was fine." Reporter stated she "brushed it off" and didn't call anyone. In Jul2022 he got "the fourth booster with the same side effect, in the middle of the night." When he went to have his immunotherapy treatment last week, she mentioned it because "they want him to keep getting boosters" due to his immunosuppression. They suggested they call the CDC or Pfizer to see if he should continue to take boosters in the concern that he may have a worse reaction the next time. Reporter was uncertain if he received the bivalent booster as his 4th dose. Jul2022 dose: Lot #FM0173. Question: Patient was uncertain if he received the bivalent booster as his 4th dose. Reporter calling about Pfizer COVID-19 vaccine for her husband whose birthday was [DOB withheld]. He was immunocompromised, he had metastatic melanoma to the brain and lung. When the vaccine first came out they got the first two doses in 2021, and then he had the third dose in Aug2021 per recommendation of his oncologist. For the third dose which they both got in the morning, in the middle of the night he got up to go to the rest room and he couldn't move his legs from the waist down, which put her in a panic mode. When he woke up the next day he was fine. Then in Jul this year he had another Pfizer booster and had the same effects on the fourth one. A little over a week ago they casually mentioned this to his oncologist and she said it was too coincidental for him to do that both times, and they should call Pfizer and find out if this is a possible side effect, and if it was, if he should get any more boosters. On his birthday, 09Feb2021, her husband had his first dose of the Pfizer COVID-19 vaccine. His legs didn't work after his third dose booster he got 26Aug2021, which he was 82, clarified to 81 years old. She clarified that it was the last two booster doses that he had the same side effects, which his oncologist suggested they contact Pfizer since she couldn't make that call if he should have any more boosters or not. She would hate for him to have another booster and have another side effect. They did no treatment, it was just that he wanted to get up to go to the restroom and he couldn't get out of bed. When he tried he almost fell, and she got him back in bed and they went back to sleep. When he woke up in the morning he was fine and walked to the kitchen and had breakfast. When she asked him that day how he was doing he said he was fine. This happened again after his fourth dose booster, the same. He tried to get up in the wee hours of the night and couldn't, then in the morning there was no problem when he got up, which they always get up between 7:30- 8:00AM. He walked to the kitchen and had breakfast and was his normal self the rest of the day, he was fine. Pfizer COVID-19 vaccine Indication: He was immunocompromised, and his oncologist wanted to make sure he was protected. She suggested since they are husband and wife and live together that she have it as well, so they both have been boostered. Concomitant Medications: The only prescription her husband took was Atorvastatin, which he had been on at least ten years. He also had immunotherapy, for a little over two years he had been on Opdivo immunotherapy. It was Sep or Oct2020 when he started Opdivo. He has had no other vaccines ever than typical flu or pneumonia vaccines, which she couldn't remember when those were, they were not around the time of COVID-19 vaccines. He got one of the pneumonia vaccines, she didn't remember when. He got the flu or pneumonia vaccines at [pharmacy name withheld]. She Could not read HCP or site name for his third dose, she wanted to say it might have been (pharmacy name withheld) because one time they went to (pharmacy name withheld) since they didn't have to make an appointment. His third dose information on the vaccine card only has the LOT number provided on the handwritten card. LOT Look like FE3181. Pfizer/BioNTech COVID-19 Vaccine Follow-up Questionnaire: Pfizer/BioNTech COVID-19 Vaccine Details: 1st dose: Date: 09Feb2021. Time: Morning, she doesn't know specific time, all boosters were in the morning. Anatomical Site of injection: arm, unknown which one. Route of Administration: intramuscular; Batch/Lot number: EK9231, EXP: Apr2021. HCP clinic site said (facility name withheld), this could be (facility name withheld). 2nd dose: Date: 02Mar2021, Time: Morning, unknown what time. Anatomical Site of injection: unknown arm. Route of Administration: intramuscular; Batch/Lot number: EL3246, EXP: Apr2021. HCP clinic site said [facility name withheld], this could be [facility name withheld] Cancer Specialists. 3rd dose: Date: Time: Morning. Anatomical Site of injection: unknown arm. Route of Administration: intramuscular. 4th dose: Date: 19Jul2022. He had it at [pharmacy name withheld], information for it printed a label put on the back of the vaccine card. NDC: LOT: FM0173. EXP: 30Sep2022. Dose: quantity 0.3mL, injected into his unknown arm. Complete if a 3rd or Subsequent dose was administered. Booster dose due to a weakened immune system: if the reason is a weakened immune system, please select one of the conditions below: Current or recent cancer. Prior Vaccinations (within 4 weeks): None. Her husband got no other vaccines the same day or the four weeks prior to his booster doses. Family Medical History Relevant to Adverse Events (AEs): None, she didn't have any side effects to the vaccines, she didn't even have a sore arm.