Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Constipation, Musculoskeletal stiffness
Clinical narrative: constipation; Caller reported that the pain in her hips is not as bad as her back.; lower back stiffness; Hip pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm left on 22Feb2021 (at the age of 76-year-old) at dose 1, single for covid-19 immunisation. Time the Vaccination Was Given: 16:30 or 17:00. Medical history included cholesterol, Blood pressure, Diabetes, Depression. Patient did not have Prior Vaccinations within 4 weeks. Concomitant medications included simvastatin (SIMVASTATIN) taken for blood cholesterol from an unspecified start date to Feb2021 at 10 mg once daily at night; lisinopril (LISINOPRIL) taken for blood pressure abnormal from an unspecified start date to Feb2021 at 5 mg once daily; metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date to Feb2021 at 500 mg once daily in the evening; sertraline (SERTRALINE) taken for depression from an unspecified start date and ongoing at 25 mg in the evening. Reporter stated that she started taking simvastatin a few weeks before getting the Covid-19 vaccine and stopped. She reported that she got scared about cholesterol and restarted the medication. Reporter stated that she started taking Lisinopril about a year ago. Reporter stated that she takes Glucophage, clarified it is called metformin. She began taking this medication about a year ago. Reporter stated that she began taking Sertraline about a year ago. It is an antidepressant. Glucophage: Reporter reported that she takes this medication for diabetes, then stated that she is not sure if she is diabetic or pre-diabetic. She reported that she didn't get a prescription to check her blood. Reporter reported when this started she stopped her statin, blood pressure pill, and Glucophage as she needed to be clear on what the symptoms were. Clarified stop date with caller, and she reported that she stopped about a week before she received the Covid-19 vaccine. Patient previously received Sulfa medicine in the past which caused scaly and itchy skin but didn't cause these kinds of symptoms. Reporter stated that when she was very young, she received the smallpox vaccination which she said was a live virus. She stated that she scratched it open and gave herself a mild dose of smallpox. Queried on onset age, vaccine/brand name, and vaccination date but this information was unknown to her. She said that she didn't know at what age they gave the smallpox vaccine to children in the 1940's. On an unspecified date in Feb2021 the patient experienced hip pain, on 23Feb2021 lower back stiffness, caller reported that the pain in her hips is not as bad as her back, on 24Feb2021 constipation. Reporter is a 76 yo female consumer, asking if Hip pain, lower back stiffness and constipation are side effects of the vaccine. Asking does the vaccine have sulfa medicine in it. Additional Context: Reporter reported that she had the Pfizer vaccine, clarified as Covid-19 vaccine, on 22Feb2021. Caller reported that beginning 23Feb2021, her lower back has been getting worse and worse, it feels like she's getting close to crippled, and she can hardly get out of bed. She stated that both of her hips and bowels have been affected, that she has been constipated, and it's been awful. Reporter is inquiring if her back pain will get better and what should she do about the what she is experiencing. She stated that her second vaccine is scheduled for Monday, 15Mar2021, and she doesn't know if she should take it. Reporter later inquired if the side effects that she is experiencing have been reported before. Reporter second vaccination is scheduled for 15Mar2021. Weight: Reporter reported that her weight is about 125-130 lbs. Reporter stated that she hasn't been to the doctor in about a year but was thinking of contacting her Ob/Gyn as her female organs seem to be involved in all of these side effects. Lower back is very stiff: Caller stated that when she wakes up in the morning, it is horrific. She reported that it doesn't loosen up throughout the day. She reported that she has tried doing exercises to loosen up her back, and that she has taken Tylenol and aspirin, but the medications aren't touching it. She halved the Tylenol if she took it with aspirin. She stated that she just wants to scream that it hurts so much, that it feels like it's going to get stuck. She stated that it hasn't lightened up at all. Affecting hips, each step is painful: Caller reported that the pain in her hips is not as bad as her back. She stated that she noticed her back on 23Feb2021 and is unsure if her hip pain started at the same time. Constipation: Reporter reported that she did not have a bowel movement at all for the first couple days after receiving the Covid-19 vaccine. She reported that she took Metamucil, that she's been taking everything, and has eaten a lot of fiber and cabbage, anything she could think of to help her have a bowel movement. She stated that when she did have a bowel movement, her stool was the size of golf balls and that there were three. She stated that it's unreal, never ever has that happened to her. Reporter reported that today her stools were a little more back to normal, that they were loosely formed. Reporter stated that she waited in line to get the vaccine for 5 hours outside with no water and no bathroom that could be easily accessed. She stated there were hundreds and hundreds of people, that there were 80 year old's waiting in line. She states all of us old people acted very nice, no one was acting crazy. She reported that there was a lack of information provided and that when she reached the vaccine facility, it was all very disorganized inside. Reporter stated that she is attributing her side effects to the vaccine. She stated that she had attributed the lower back stiffness to standing in line because it was so bad the next day but stated that if it was just from standing that it should have been gone by now but it's not going away. She stated that she doesn't know if the vaccine hits the weak spot. Reporter also stated that she had attributed the back pain to the constipation she was experiencing as she couldn't go the first few days, that having all the stool backed up could cause back pain but reported that after she finally had a bowel movement the back pain wasn't lightening up at all. She reported that after taking Metamucil and eating a lot of fiber and cabbage, it has not been able to diminish the pain much. It wears on her since the pain has been there day after day. Reporter reported that she waited awhile to follow up regarding her symptoms because it didn't dawn on her that it could be from the Covid-19 vaccine, but now she's convinced that it is the cause. Reporter stated that she was asked her ethnicity when she registered to receive the Covid-19 vaccine. She stated that she doesn't understand, it's (the covid virus) killing population, it's just awful. She stated that she didn't have covid to begin with, but now with Pfizer if she's getting crippled, she would have taken her chances without getting the vaccine. Reporter reported that she is frightened, very frightened. She stated that it's difficult when there's no improvement, when day after day she's in the same degree of discomfort and pain, that it's wearing on her. Description of complaint: Aspirin and Tylenol didn't touch the pain. Metamucil took a few days to work and didn't provide any relief for pain originally attributed to constipation. Product strength and count size dispensed: Tylenol: Extra strength, 500 mg caplets, 50 caplets. Aspirin: 325 mg tablets, 100 tablets. Metamucil: Strength not listed, 23.3 ounces. Additional lot numbers: Tylenol: Lot: OSE3017B, Expiration Mar2022. Another number provided as 14847117F12. Aspirin: Lot: P119330, Expiration Feb2022. Metamucil: Lot: Caller unsure of lot, she said that the packaging said L0 [backward S] 761725A1. She was unsure of the third character in what she believed to be the lot number, at first stating that it could be a 2 and then stating that it looked like a backwards S. Expiration Jul2022. Reporter stated that they were not new bottles, that she had purchased and used prior to receiving the vaccination. Outcome of the event constipation was resolving and remaining other events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.