Age: 50.0
Sex: F
Vaccine: FLUR4, PNC13, TDAP, FLUR4, PNC13, TDAP
Symptoms: Chills, Erythema, Induration, Limb mass, Pain
Clinical narrative: cellulitis; very sore arms; body aches; chills; fever; golf ball sized lump in right arm and two smaller lumps in left arm; golf ball sized lumps in both arms and one of which was both hot and red, mild to touch; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional via Medical Information (Reference number: 2020404150) and transmitted to Sanofi on 21-Oct-2020.  This case involves a 50-years-old female patient [height:175 cm and weight: 210 (unit not specified)] who experienced cellulitis, very sore arms (pain in extremity), body aches (pain), chills, fever (pyrexia), golf ball sized lumps in both arms and one of which was both hot and red and one was spreading and mild to touch, while she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13]  The patient's past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing inflammatory bowel disease from 1998 and arthritis from 2018  Concomitant medications included CELECOXIB (CELEBREX) (100 mg capsule, twice a day) for Arthritis; LORATADINE (10 mg tablet, once a day) for Rhinitis allergic; SERTRALINE (100 mg tablet) for Anxiety; TOFACITINIB CITRATE (XELJANZ) (10mg tablet twice a day); METHOTREXATE for 20mg, every 7 day, 2.5mg tablet take 8 of them and patient take it one time every 7 day on Monday and FOLIC ACID (1 mg tablet).  On 14-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (injection, lot UJ497AA, expiry date: 03-May-2021) via an unknown route in the left deltoid, a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (injection, lot U6807BB, expiry date: 10-Sep-2022) via an unknown route in the right deltoid and also a 0.5 mL dose of suspect PREVNAR 13 not produced by Sanofi Pasteur (injection, lot DF1306, expiry date: 31-Aug-2022) via an unknown route in the left deltoid for prophylactic vaccination respectively.   On 15-Oct-2020, the patient developed a serious cellulitis one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and PREVNAR 13. This event was assessed as medically significant.  On 15-Oct-2020, the patient developed a non-serious very sore arms (pain in extremity), body aches (pain), chills, fever (pyrexia), golf ball sized lumps in both arms and one of which was both hot and red and one was spreading and mild to touch (vaccination site mass and vaccination site inflammation) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and PREVNAR 13.  Laboratory details were not reported.   No corrective treatment was received.  The event outcome was unknown for cellulitis, chills and pain.  The patient was not recovered from pain in extremity, vaccination site mass and vaccination site inflammation.  On 15-Oct-2020, the patient recovered from pyrexia.; Sender's Comments: A 50-years-old female patient presented with cellulitis, chills, pain in extremity, body pain, pyrexia, vaccination site mass and vaccination site inflammation one day following vaccination with ADACEL, FLUBLOK QIV, PREVNAR 13 (unknown manufacturer). The time to onset is compatible with the role of the vaccine. Medical history include arthritis and inflammatory bowel disease. Concomitant medication include CELEBREX, LORATADINE, SERTRALINE, METHOTREXATE. Lab data ruling out alternative etiologies and information on safety of the vaccination procedure would be needed for complete assessment of the case. Based upon reported information role of vaccine cannot be assessed.