Age: 89.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Anxiety, Blood test, Confusional state, Dysphonia
Clinical narrative: slight sore arm/sore arms; hoarseness in the throat; runny nose; strange dreams; tenderness in the left arm; confusion; anxiety; fast heart rate; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 89 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 13:30 (Lot number: EW0171) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (ongoing), notes: Verbatim: Osteoporosis; "Diverticulitis" (ongoing), notes: Verbatim: Diverticulitis; "changes in sleep habits" (ongoing), notes: Verbatim: changes in sleep habits. Concomitant medication(s) included: ALIGN taken for diverticulum, digestive enzyme abnormal (ongoing); CENTRUM SILVER WOMEN 50+ (ongoing); CALTRATE 600+D3 taken for osteoporosis (ongoing); VITAMIN D3; MIRALAX taken for digestive enzyme abnormal (ongoing); DOCUSATE SODIUM taken for digestive enzyme abnormal. Vaccination history included: Bnt162b2 (Dose number 1, Lot Number: EW0162, Anatomical location: left arm, Time the Vaccination was Given: between 14:00pm and 14:30pm), administration date: 20Apr2021, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: CONFUSIONAL STATE (non-serious) with onset 10May2021, outcome "not recovered", described as "confusion"; ANXIETY (non-serious) with onset 10May2021, outcome "not recovered", described as "anxiety"; HEART RATE INCREASED (non-serious) with onset 10May2021, outcome "not recovered", described as "fast heart rate"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slight sore arm/sore arms"; DYSPHONIA (non-serious) with onset 10May2021, outcome "not recovered", described as "hoarseness in the throat"; RHINORRHOEA (non-serious) with onset 10May2021, outcome "not recovered", described as "runny nose"; ABNORMAL DREAMS (non-serious) with onset 10May2021, outcome "not recovered", described as "strange dreams"; TENDERNESS (non-serious) with onset 10May2021, outcome "not recovered", described as "tenderness in the left arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Since receiving the second vaccine yesterday, patient (reporter's mother) has developed confusion, anxiety, a fast heart rate and was unable to sleep last night. The confusion and anxiety are continuing today. In addition, they both have had sore arms, a horse throat and a runny nose. Caller wanted to know if confusion and anxiety had been reported with the vaccine and how long this might last.   Patient has been taking Centrum Silver for years for general health. He says this is a calcium supplement with D3 included. He says she has been taking Caltrate 600 + D3 for years. He says she has been taking vitamin D3 for years. He says each miralax capsule is filled with osmotic laxative. He says she has been taking this for only for a few months. He says sometimes she might alternate Docusate Sodium with the Miralax. He says she has been taking Docusate Sodium for only for a few months. He says Osteoporosis has been downgraded to osteopenia because her bone density has improved. He says her bones are mildly brittle but not as bad as osteoporosis. He says she has had this condition for probably 20 years. He says Diverticulitis has been an ongoing issue for many years and she has had bowel problems there for quite a long time. He says she has had Diverticulitis at least maybe 20 years; within the last 20 years. He says with age within the last couple of years she has had changes in sleep habits. He says it might be Sun Down Syndrome. He says she is more awake in the night and sleeps more during the day. He says his mother seems to have had more of a reaction to second dose than he has. He says they both had a slight sore arm and hoarseness in the throat. He says his mother also experienced some fast heart beat and hoarseness of the voice. Regarding his mother he says the main thing he is concerned about was the confusion and anxiety cropping up since her shot yesterday afternoon. He says since yesterday afternoon and throughout the night she still has been having issues of confusion which is unusual for her. He says he just wanted to point that out and ask to see if there is anything else they should do for that. He says the pharmacist did mention to go to her primary care provider but to call Pfizer first. He says the pharmacist gave him the number as well, says the pamphlet for the vaccine the pharmacist gave him says to get the smart phone app but they do not have a smart phone. He says they were both run down for the next couple of days, rested, and it passed. He says it lasted maybe 3 or 4 days roughly. He says yesterday afternoon after he returned home they both have tenderness in the arm today. He says it is minor. He says they noticed that it is there but it is not impeding function. He says her fast heartbeat started last night and is still ongoing as far as he knows and that she did not mention it since he took her to the restroom recently. He is not sure regarding outcome. He says about the anxiety it started in the afternoon and she was trying to sleep during the night and kept waking up periodically after an hour every hour or so. He says she was waking up with her concerns and making statements out of the ordinary. He says she is resting right now, unless she gets on about something or has a strange dream or strange thought that has been about it. Clarifies she had strange dreams yesterday. For the Align Probiotics he says maybe some days she takes more than him. He says she possibly does 1 or 2 duo biotic gummies then in addition to or instead of she takes the Align probiotic once a day. He says she has been taking this for at least several years, at least 2 or 3 years. He says sometimes she may take also or instead the Align a duo-biotic which is a prebiotic plus probiotic digestive health. He says her last lab report was all within normal range. He mentions blood, urine, and says everything was in good condition considering. He says her last appointment with her doctor was back in Mar020. He says other than some additional weight loss because of the hours she is sleeping she is not eating as much so she has lost a little weight. He says her sleep habits are off. Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): None. He says not that she recalls. He says she usually has the annual flu shot and has had pneumonia vaccine in the past so she is up to date. He says she has had no unusual reaction that they know of. He says she was not not sick to his knowledge a the time of vaccination. He says her nose has been runny lately but they are in (withheld) with the air conditioning on a lot. He says they are going through high heat, high humidity and high pollen levels so they try to keep the air conditioning running, no fresh air or other irritating pollen. He says it is suffocating with the high humidity and high heat. He says not for what she is experiencing with the issue here on confusion and anxiety. He says not that he knows of. He says his mother experienced last night feeling like her heart was beating fast after the vaccine. He says he is not concerned about the hoarse voice, runny nose, or sore arm; that will pass. He says the fast heartbeat may pass as well. He says both he and his mother had the flu shot last Oct2020 done at one of the (withheld) as well. He says they had a sore arm and a little bit of tiredness within a day or two. NDC lot number, and expiration date for his mothers flu shot causing these AEs not provided.  No follow-up attempts are possible. No further information is expected.