Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Fatigue, Gait disturbance, Impaired driving ability
Clinical narrative: Off label use; Difficulty breathing; Pain; For the first week she was beyond tired; muscle cramps; she cant even drive or walk when it comes on; she cant even drive or walk when it comes on; severe pain especially in her back; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/ NDC number/ Expiry date was not reported) (Lot number: first digits were FC but the caller cannot read the next digit if it was a 7 or 8, then followed by 1F then 4 or 9. It was hand written and hard to read) via an unspecified route of administration, administered in left arm on 21Sep2021 15:30 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included osteoarthritis, metal in spine (Spinal fusion surgery: had for 5 years, done around 2005) and metal in both ankles (Joint injury: done 2014, she broke both ankles at the same time); all from an unknown date and unknown if ongoing. Patient had total left knee (knee arthroplasty: has not healed completely) on 29Oct2020. Concomitant medication was not reported. Historical vaccination included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot-EN5318, NDC/ Expiry date: unknown) on 27Jan2021 at 10:30 AM as DOSE 1, SINGLE and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot- EL9265, NDC/ Expiry date: unknown) on 14Feb2021 at 08:30 AM as DOSE 2, SINGLE; both doses (at the age of 61-year-old) via unspecified route of administration, administered in left arm for COVID-19 immunization. Previously patient had Zoster vaccine shot on 01Jul2021 (at the age of 61-year-old; the old shingles shot, it was given at her primary care, she has no NDC, Lot, or Expiry) and ended up in the emergency room on 04Jul, this was about 2 years ago. On 21Sep2021, patient had off label use of third dose as booster and on an unspecified date in Sep2021, patient had difficulty breathing, pain, for the first week she was beyond tired, muscle cramps, she cannot even drive or walk when it comes on and had severe pain especially in her back. It was reported that patient has nothing to report other than being tired for about a week after the previous shots. On 21Sep2021 she got the booster shot. For the first week she was beyond tired. The second week up till today she has had difficulty breathing and severe pain especially in her back that would stop her from walking. She will be ok then she cant move her legs and her husband has to help her back to bed. Patient did not had any ER visit but had been to Physician. She had a follow-up doctor appointment last Thursday where the doctor told her to give it another week to see if it gets better. She has also had muscle cramps, the doctor told her that was common. She informed the doctor that cannot even drive or walk when it comes on. Yesterday the breathing was really bad. Patient had the Pfizer vaccination at pharmacy facility. There were no additional vaccines administered on same date and no prior vaccinations were administered within 4 weeks of Pfizer suspect. The outcome of event difficulty breathing was not recovered and all others were of unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101351995 Same patient and drug, different event separated in time