Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Loss of consciousness, Lumbar puncture, Magnetic resonance imaging, Seizure
Clinical narrative: breathing/unresponsive; seizures; blood sugar was 35/Blood sugar dropped into the 60's again; This is a spontaneous report from a contactable reporter. A 75-year-old female patient (reporter's mother) received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Mar2021 at single dose for covid-19 immunisation. Medical history included parkinson's disease from 2018 to an unknown date, the progressive type, covid-19 from Nov2020 to an unknown date (She had mild case of covid in November), she was not symptomatic, rheumatoid arthritis from 2018 to an unknown date, Heart failure from 2018 to an unknown date(which she was diagnosed in 2018 with and was being managed appropriately), spinal operation from an unknown date and unknown if ongoing PRESS (Posterior reversible encephalopathy syndrome) Complication, posterior reversible encephalopathy syndrome from an unknown date and unknown if ongoing (Complication after Back surgery). The patient's concomitant medications were not reported. The patient had the first dose of dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE) on 27Feb2021 for covid-19 immunisation. The patient experienced breathing/unresponsive but breathing on her bi-pap (hospitalization) on an unspecified date with outcome of unknown, seizures (hospitalization) on an unspecified date with outcome of recovered, blood sugar was 35/blood sugar dropped into the 60's again, blood sugar low (hospitalization) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included lumbar puncture: proteins and white blood cells on unknown date, Presence of proteins and white blood cells, magnetic resonance imaging(MRI): something that happened with brain on unknown date,  assault from something that happened with brain, white blood cell count: nothing crazy on unknown date. Therapeutic measures were taken as a result of seizures, blood sugar was 35/blood sugar dropped into the 60's again. The clinical course was reported as follows: She states, "Her mother was in a rehab facility up until the 26Mar2021, the CNA came in at noon and her mom wanted to keep sleeping. Thursday afternoon was the last time she got to talk to her. PT/OT came in at noon on Friday - found to be breathing/unresponsive. blood sugar was 35, gave her glucose, came up to 111. Still not responsive but breathing. Sent her to ER, she was breathing but still not responsive, then started she started having seizures. Blood sugar dropped into the 60's again, having seizures from Friday until Monday. managed it with Keppra and  another seizure medicine and now she is in ICU. Her mother is 75 years old with degenerative Parkinson's Disease, wheelchair bound, and a history of PRES (Posterior reversible encephalopathy syndrome). She was about to be discharged but then all of this happened. The only thing that was really different is the vaccine that she received. She had mild case of covid in November, she was not symptomatic. Waited 3 months to get the covid vaccine after she had covid. The caller states that her mother received the first dose of the Pfizer COVID-19 vaccine on 27Feb2021 and the second dose on 20Mar2021. The caller would like to know if there have been any reports of low blood sugar associated with receiving the Pfizer COVID-19 vaccine. The caller wants to know if anyone has reported seizures as a side effect from receiving the Pfizer COVID-19 vaccine. Responded per page 23 of the attached EUA Prescribing Information LAB-1457-6.0 Revised: 25Feb2021: "Throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuroinflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. 6.2 Post Authorization Experience: The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)". The caller has her best friend on the line with her  in case the caller forgets something. The caller's is calling on behalf of her mother who had both doses of the covid vaccine. The patient is currently in the Intensive Care Unit. The patient was supposed to go home from a rehabilitation facility on 27Mar2021 and staff found the patient on 26Feb2021 unresponsive but breathing on her bi-pap. Prior to the patient being found like this she was tired at noon and asked the staff to hold her lunch for her because she was tired and wanted to lay down because she had been up late the previous night. When physical therapy and occupational therapy came in a couple of hours later to do therapy they found the patient unresponsive and the patient's blood sugar was 35 so they gave her glucose and the blood sugar came up to 111. Emergency medical services came and took the patient to the emergency room and then she was put in the Intensive Care Unit, this was all within 30 minutes. The glucose dropped one more time and she started having seizures. The medical staff stabilized the patient with Keppra and another seizure medicine that starts with a V on a drip. The patient has been off her sedatives since Tuesday and she has eye movement under the eyes, she withdraws from pain, and when (name withheld) was talking to the patient on speakerphone the patient moved her head towards the phone. The caller mentions that the patient was not protecting her airway when the emergency medical service showed up and so the staff placed a king airway and then the patient moved to a normal ventilator. Wednesday the patient was being weaned on the ventilator and was able to breathe on her own for 7 hours. The caller was only able to breathe on her own on the ventilator for 2 hours yesterday, split up into 2 different trials. The medical team is pressuring the caller talking about tracheostomy and peg tubes and the medical staff wants to talk about that next week if the patient is not coming around. Investigations: MRI showed basically an assault from something that happened with the brain from having a low blood sugar. The patient has no history with diabetes or low blood sugars. Maybe the patient had a seizure prior? The patient had signs of infections, her white blood cell count is nothing crazy. The patient's lumbar puncture showed proteins and white blood cells present. The caller is trying to figure out what may have caused this incident. The patient had 4 strokes on her left side and has come back from that and has been driving and fine after. The patient's outpatient neuro person said it is from the seizures. The caller is trying to rule out if there is anything weird with this vaccine that may have caused this or been reported? PRESS is a rare complication after back surgery and the patient had that. If something is super weird and rare then the patient usually has it, she usually gets weird things. Is this related to the vaccine? The caller knows it may not be likely but it was the only thing she hadn't looked into yet.  Information on the lot/batch number has been requested.