Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Investigation, Nervousness, Pain in extremity
Clinical narrative: urinary tract infection; Thigh pain; hip pain; vomiting; shaky; weakness; Legs collapsed on her; Leg pain; fatigue; Severe headache; This is a spontaneous report from a contactable consumer. A 87-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 05Feb2021 10:00 as a single dose for COVID-19 immunization and received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 15Jan2021 16:00 as a single dose for COVID-19 immunization.  Medical history included allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergies to medications that contain dynacin; Allergic to Gabapentin; and has allergies to all antibiotics that end with 'cycline'. Pertinent Details Include surgical procedures and dates: She was given doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days. The pharmacy gave her about 5 other medications that end with 'cycline' and she was highly allergic to all of that so when she goes to the doctor she cannot take anything that has that in it. There were no concomitant medications. About a week after her second dose, she started having severe headache, pain in her legs, weakness, and fatigue. At one point, she collapsed because of weakness in her legs. Caller said they have gone to their HCP 6 times: 3 times with their urgent care doctor, 2 times with doctor, and 1 time in the emergency room. She wanted to know what to do with the adverse events. On 04Feb2021 she was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 14Feb2021 she saw her primary care doctor for severe headache. She was sent to the emergency room for the severe headache where she had a CAT scan in case she was having a brain bleed or stroke, but everything checked out just fine, they thought they were safe. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. On 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed Cyclobenzaprine as a muscle relaxer and Tramadol as pain medication. Before she took any of the Cyclobenzaprine or Tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again and he said to stop the Cyclobenzaprine and changed Tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the Tramadol and start taking Tylenol. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being real shaky and real weak. Each time they were seen by the doctor or at urgent care they drew blood and said everything was ok. On 02Mar2021 they started thinking maybe it's the Pfizer COVID-19 Vaccine. She called to ask if these events are side effects of the Pfizer COVID-19 Vaccine. Her bloodwork was fine, her urine tests since after 16Feb2021 are fine, the CAT scan showed her head is fine; but she still has severe weakness; she was walking with a cane now and before she was very active. The patient was treated with cyclobenzaprine: 5mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022; Tramadol: 50mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022. There are only 2 tablets missing from the bottle so caller believes patient took 1 whole tablet once, and then 1/2 tablet 2 different times and started vomiting so Tramadol was stopped; Tylenol 8 Hour Arthritis: 650mg strength. Lot: SBA002, Expiry: Dec2022; UPC: Unknown, there is no UPC or barcode on the bottle she has with her, but there is a little kind of icon with a stamp with some numbers above it; Phenazopyridine: 100mg strength tablets, Ciprofloxacin: 500mg strength, Cephalexin: 500mg strength. Outcome of the events was unknown.  Medications that contain dynacin: Lots/NDCs/Expiries: Unknown, they do not have products, this occurred in  before patient moved about 1 year ago. Gabapentin: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Doxycycline: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Antibiotics that end with 'cycline': Lots/NDCs/Expiries: Unknown, they do not have products, this occurred before patient moved to about 1 year ago. Reported patient was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. Urine tests since after 16Feb2021 are fine. Phenazopyridine: 100mg strength tablets. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC# Ciprofloxacin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #.Cephalexin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #.  No follow-up attempts are possible. No further information is expected.