Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea, Body temperature, Carbon dioxide, Creatinine renal clearance, Dehydration
Clinical narrative: Major rash; itched and hurt a lot/ brokeout her arm; Dermatologist felt it had a system allergy; Dehydration/ Got too dehydrated; sick/ nausea; high fever/fever got up to 103/ fever set in; Booster; Felt pretty bad; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 15Nov2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from a contactable consumer for a Pfizer-sponsored program (159558). The reporter is the patient.  A 67 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm, administration date 07Oct2021 at noon (Lot number: EW0153) at the age of 67 years as dose 3 (booster), single for COVID-19 immunization. The vaccination facility type was reported as the doctor's office/urgent care. Relevant medical history included: "Extreme dry eyes", start date: 30Sep2021 (unspecified if ongoing); "Hashimoto's thyroid disease" (ongoing); "Type II diabetes" (ongoing); "Cholesterol" (ongoing); "High Blood Pressure" (ongoing); "Arrhythmia heart" (ongoing); "osteoporosis" (ongoing); "Osteopenia" (ongoing); "did have issues with potassium phosphate (intolerance)" (unspecified if ongoing); "Weakened immune system" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "bradycardia" (unspecified if ongoing); "patient was receiving numerous vaccines for a cruise and to update, but still got sick on cruise", start date: 07Dec2019 (unspecified if ongoing), notes: felt like all symptoms of COVID-19. Concomitant medications included: PREDNISOLONE ACETATE taken for extreme dry eyes, start date: 30Sep2021, stop date: 26Oct2021 [stopped due to blood pressure (BP) issues]; SYNTHROID taken for her thyroid (ongoing); METFORMIN taken for diabetes (ongoing); CRESTOR taken for her cholesterol (ongoing); TOPROL taken for high blood pressure (ongoing); LISIPRIL taken for high blood pressure (ongoing); FLECAINIDE ACETATE taken for arrhythmia heart (ongoing); XANAX (ongoing); CALCIUM + VIT D taken for osteopenia (ongoing); "Prolea" (Ongoing) every 6 months for osteoporosis; and "Prelasec" (Ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE, Batch/Lot number: EL9262, anatomical site of injection: arm), administration date: 22Jan2021 at noon, when the patient was 66 years old, for COVID-19 immunization, reaction "felt a little ill"; BNT162B2 (DOSE 2, SINGLE, Batch/Lot number: EM9809, anatomical site of injection: arm), administration date: 12Feb2021 at noon, when the patient was 66 years old, for COVID-19 immunization, reactions: "Dehydration", "dry heaves", "Nausea", and "very sick with high fever/fever got up to 103"; Flu shot (anatomical site of injection: arm, once a year), administration date: 20Sep2021, reaction: "No reaction"; Zoster recombinant, administration date: 10Sep2019, reaction: "fatigue", "fever", "felt like an infection" [very similar reaction, ended up in emergency room (ER) twice]; Flu vaccine, reactions: "very sick", "high fever/fever got up to 103"; Shingles vaccine, reactions: "very sick", "high fever/fever got up to 103"; German measles vaccine, reactions: "very sick", "high fever/fever got up to 103"; Zoster live, administration date: 2014, reaction: "No reaction" (no reaction at all to other vaccines on list even the Zoster live in 2014); German measles vaccine, administration date: 1978, reaction: "had a full case and was in hospital 2 weeks" (was told she was the only one who had a reaction). The following information was reported: IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "Booster"; DEHYDRATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "Dehydration/ Got too dehydrated"; NAUSEA (non-serious) with onset 08Oct2021, outcome "unknown", described as "sick/ nausea"; PYREXIA (non-serious) with onset 07Oct2021, outcome "unknown", described as "high fever/fever got up to 103/ fever set in"; FEELING ABNORMAL (non-serious) with onset Oct2021, outcome "unknown", described as "Felt pretty bad"; RASH PRURITIC (non-serious) with onset 11Oct2021, outcome "unknown", described as "Major rash; itched and hurt a lot/ brokeout her arm"; HYPERSENSITIVITY (non-serious) with onset 11Oct2021, outcome "unknown", described as "Dermatologist felt it had a system allergy". The events "booster", "dehydration/ got too dehydrated", "sick/ nausea", "high fever/fever got up to 103/ fever set in" were evaluated at the emergency room visit. The events "major rash; itched and hurt a lot/ brokeout her arm" and "dermatologist felt it had a system allergy" were evaluated at the physician office visit. The patient called, because she wanted to see if there was potassium phosphate in the three shots of the Pfizer Covid vaccine, with first dose she felt a little ill and with second dose and booster, she ended up in ER very sick with high fever, drank a lot of fluids, fever got up to 103, also reacted that way to flu vaccine and shingles vaccine and the German measles vaccine. She drank buttermilk once and ended up in ER for four hours, because it contained potassium phosphate. There was nothing out of ordinary regarding patient's medical history. The patient made sure it was well before getting vaccine and did not take it at same time as flu vaccine. For the adverse events, the patient reported on 2nd vaccine, the patient started to have dehydration, dry heaves, and nausea on 13Feb2021 at around 2AM, which required visit to ER and for which the patient was admitted to ICU for approximately 3hrs. The patient recovered after 3 days with treatment of intravenous (IV) Tylonol/moltrin/nausea medications in IV, 2 antibiotics in IV, and steroid. For the 3rd booster, the patient started to have event on 08Oct2021 at midnight close to 09Oct2021, which required visit to ER and for which the patient was admitted to ICU for approx. 3hrs. Treatment included IV mix, Tylenol+Moltrin, and anti-nausea medications. The reactions started later with arm breaking out also, for which the patient stayed in bed for 2 days. There were no major problems with 1st dose COVID-19 vaccine. There was brokeout on her arm on 11Oct2021 after vaccine on 07Oct2021; top to elbow, and was still feverish. Dermatologist felt it had a system allergy to 2nd and 3rd vaccine, but not sure. For Covid 19 vaccine #1 in Jan2021, it had only mild symptoms. For Covid 19 vaccine #2, about 8-10 hrs after vaccine, the patient had fever over 102, worked hard at reducing fever. The patient got dehydrated very easily. For Covid 19 vaccine #3, on 07Oct2021, the patient was fine for first 9-10 hrs then fever set in. The patient was in ER 24 hrs later, after working hard at reducing it on her own; got too dehydrated. The patient felt pretty bad for about a week. She rested as much as possible. There was major rash from vaccine on 11Oct2021; it itched and hurt a lot. The patient was not sure if preservatives or salts, but she did have issues with potassium phosphate (intolerance). Possibly, doses could be reduced to half after 1st vaccine to top off 1st vaccine felt like vaccine overload. The patient was asking if antibodies test would show if she was protected enough at the point they need another vaccine. The patient did want to stay protected and protect others. The patient underwent the following laboratory tests and procedures: adjusted calcium: 9 mg/dl; alanine aminotransferase: 61 IU/l, notes: Normal; anion gap: 9, notes: Normal; aspartate aminotransferase: 68 IU/l, notes: High (H); basophil count: 0 k, notes: Nornal; basophil percentage: 0.3 %, notes: Normal; blood albumin: 3.8 g/dl, notes: Normal; blood alkaline phosphatase: 73 IU/l, notes: Normal; blood bilirubin: 0.5 mg/dl; blood calcium: 8.8 mg/dl, notes: Low(L); blood chloride: 99 mEq/l, notes: Low (L); blood creatinine: 0.8 mg/dl, notes: Normal; blood glucose: 141 mg/dl, notes: High (H); blood potassium: 4.1 mEq/l, notes: Normal; blood sodium: 136 mEq/l; 135 mEq/l, notes: Low (L); blood urea: 15 mg/dl, notes: Normal; body temperature: 103, notes: fever got up to 103; carbon dioxide: 27 mEq/l, notes: Normal; creatinine renal clearance: 81.8 ml/min; 66.4 ml/min, notes: Normal; eosinophil count: 0 k, notes: Normal; eosinophil percentage: 0.5 %, notes: Normal; glomerular filtration rate: >60, notes: N/A; haematocrit: 39.7 %, notes: Normal; haemoglobin: 126 g/dl, notes: Normal; immature granulocyte count: 0.03 k, notes: Normal; immature granulocyte count: 0.5 %, notes: High (H); lymphocyte count: 0.5 k, notes: Normal; lymphocyte percentage: 7.5 %, notes: Low (L); mean cell haemoglobin: 27 pg, notes: Normal; mean cell haemoglobin concentration: 31.7 g/dl, notes: Low (L); mean cell volume: 85.2 fl, notes: Normal; mean platelet volume: 11.5 fl, notes: Normal; monocyte count: 0.7 k, notes: Normal; monocyte percentage: 11.9 %, notes: Normal; neutrophil count: 4.9 k, notes: Normal; neutrophil percentage: 79.3 %, notes: High (H); platelet count: 175k, notes: Normal; protein total normal: 7.5 g/dl, notes: Normal; red blood cell count normal: 4.66m, notes: Normal; red cell distribution width: 14.1 %, notes: Normal; red cell distribution width: 43.8 fl, notes: Normal; white blood cell count normal: 6.1 k, notes: Normal. Therapeutic measures were taken as a result of dehydration, nausea, pyrexia, feeling abnormal, rash pruritic, hypersensitivity.  Follow-up attempts are completed. No further information is expected.