Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Mouth swelling, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Medical assistant calling on behalf of their doctors, reporting for an female patient. An female patient of an unspecified age received TRUMENBA, lot # M37316, Expiry Date 30Apr2017) intramuscular at 0.5 ml, single on 15Jun2016. The patient medical history was not reported. There were no concomitant medications. On 16Jun2016, within 24 hours of being given the TRUMENBA vaccine, the patient experienced pain at the injection site, mouth swelling, headache, low grade fever, nausea, fatigue. No treatment received. The outcome of the events was not recovered. Follow up (01Aug2016): This is a follow up spontaneous report received from a contactable physician. This physician reported for the same 18 year old female patient in response to HCP Letter sent that included: Did the patient provide information to you regarding the reported adverse event(s) with the use of product? Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event? Yes Are you willing to be contacted again by Pfizer on the reported event(s)? Yes SUSPECT VACCINE: Suspect vaccine name and/or generic name: TRUMENBA Batch/Lot # and expiration date: M37316, Exp date: 30Apr2017. Prescribed daily dose, units, and frequency: 0.5 ml 1x injection Route of administration: Intramuscular Indication: Vaccine for meningitis B prevention Start date (note dates for any subsequent dosing): 15Jun2016 Stop date or duration of treatment: after 6 months, second dose Time vaccine was given (hour: minute - 24 hour clock): 09:00 Anatomical location of the administration of the vaccine: Left arm Did any of the AEs require an emergency room or physician visit?: No If the patient was hospitalized how many days was the hospital stay? N/A Please attach discharge summary if available and note any other relevant etiological factors: N/A What was the final action taken with the products(s)? Dose not changed Adverse event: please provide description of the course of event/s including body site and severity/ Seriousness Criteria. 1) Was the patient admitted to hospital? N - Pain, redness and mild swelling at injection site Event onset date (or time of onset): 16Jun2016 - about 24 hours after vaccine Causal Relationship: Is there a reasonable possibility that the event is related to suspect product/s: Yes Suspect product name: TRUMENBA Batch and /or Lot Number and expiration date?:M37316; Exp:30Apr2017 2) Was the patient admitted to hospital? N - Headache, low grade fever, fatigue, nausea Event onset date (or time of onset): 16Jun2016 - about 24 hours after vaccine Causal Relationship: Is there a reasonable possibility that the event is related to suspect product/s: Yes Suspect product name; TRUMENBA Batch and /or Lot Number and expiration date?:M37316; Exp: 30Apr2017 Please circle the outcome of the event for each event: (add for each event): Outcome of event 1: Recovered; Please add relevant date: within 2-3 days, 18Jun2016 or 19Jun2016 Outcome of event 2: Recovered; Please add relevant date: within 2-3 days, 18Jun2016 or 19Jun2016 Adverse event following prior vaccination (check all applicable and specify): In patient, Adverse Event: N/A In sibling, Adverse Event: N/A As applicable, list all vaccination within four weeks prior to date of vaccination: Vaccine name: GARDASIL HPV-9 Manufacturer: Merck and Co. Lot# M005714 Route: Intramuscular Site: Left arm No. of previous doses:1 Date: 31May2016 Dechallenge/Rechallenge? Did reaction(s) recur on re-administration: No Were specific tests and/or treatment required? Yes If yes, please specify in adverse event section above (Please provide Lab test date, Name, Results, and units): Conservative care only. Is patient deceased: No If available please include a copy of autopsy report or any other post-mortem findings: N/A Relationship to Patient: Vaccine provider Vaccinated at: Private Physician's office/hospital Vaccine purchased with: Private funds. Have you reported this adverse event previously? Yes If yes, to: Manufacturer Concomitant: Concomitant Drug; Ocella Start date: Apr2015 Indication: Elevated testosterone Most recent dose (daily dose and regimen): Ocella 3-0.03 mg oral tablet take 1 tablet daily Patient Medical History: Illness: Hirsutism (L68.0) Onset date: Dec2014 Stop date. If ongoing at time of last observation, during, at or end of events tick box: Checked Pertinent details: Taking Ocella daily for elevated testosterone Additional Comments Section: Symptoms clearly cumulated with vaccine administration however these resolved quickly with conservative care. May we contact you to request additional Information?: Yes