Sex: F
Vaccine: FLU4, TDAP
Symptoms: Contusion, Erythema, Injection site pain, Insomnia, Limb mass
Clinical narrative: Initial information received on 04-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via sales rep. This case involves a 48 years old female patient who experienced, could not sleep all night, a grayish bruise like thing that is the size of a quarter and will not go away, indentation remaining that looks like a small pox vaccine, there was a huge lump inside, arm had gotten huge, hot, extremely red, pulsating, it was so painful, while she received vaccine ADACEL. The patients past medical history, concomitant medication and family history were not provided. Concomitant medications included injection of 0.5ml FLUZONE QUADRIVALENT in right deltoid. On 07-Nov-2018, Because the patient found a cat and got bit, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5898AA, expiry date 30-Mar-2020 via intramuscular route in the left deltoid. On 07-Nov-2018, the patient developed a non-serious there was a huge lump inside (mass) same day in evening following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On 07-Nov-2018, the patient developed a non-serious arm had gotten huge, hot, extremely red, pulsating, it was so painful (inflammation) same day in evening following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On 07-Nov-2018, the patient developed a non-serious arm had gotten huge, hot, extremely red, pulsating, it was so painful and there was a huge lump inside (vaccination site reaction) same day in evening following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On 08-Nov-2018, the patient developed a non-serious could not sleep all night (insomnia) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On unknown date, the patient developed a non-serious a grayish bruise like thing that is the size of a quarter and will not go away, indentation remaining that looks like a small pox vaccine (skin discolouration) with unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Because the patient works in a clinic with doctors, she did not have to go to the ER and was able to get medical care from the doctors as needed. Lab data was not provided. Final diagnosis was could not sleep all night, a grayish bruise like thing that is the size of a quarter and will not go away, indentation remaining that looks like a small pox vaccine, there was a huge lump inside, arm had gotten huge, hot, extremely red, pulsating, it was so painful. As a corrective treatment a doctor in the clinic where patient works, injected steroids directly into the huge lump in her left deltoid it helped a little, but it was still swollen some and very painful for 2 months. The patient outcome is reported as Recovered / Resolved on an unknown date for arm had gotten huge, hot, extremely red, pulsating, it was so painful and there was a huge lump inside, as Unknown for could not sleep all night and as Not Recovered / Not Resolved on an unknown date for a grayish bruise like thing that is the size of a quarter and will not go away, indentation remaining that looks like a small pox vaccine. List of documents held by sender- none.