Age: 16.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. Medical history was not reported. There were no concomitant medications. The patient had pain at injection site, slight swelling, redness and heat at the site, all on an unspecified date with outcome of unknown. The reporter assessed the events as related to TRUMENBA. Follow up (12Aug2016): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported for 16 years old female patient in response to HCP letter sent to the Physician which included: Did the patient provide information to you regarding the reported adverse event(s) with the use of the 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 adverse event(s)? Yes SUSPECT VACCINE: Please provide below information. Suspect vaccine name and/or generic name: TRUMENBA Batch/Lot # expiration date: M95612, Jul2017 Prescribed dose, units, and frequency: 0.5 ml Route of administration: IM Indication: 16 Year-old student Start date (note dates for any subsequent dosing): 20Jun2016 Stop date or duration of treatment: N/A Time vaccination was given: 15:00 Anatomical location of the administration of the vaccine Right Deltoid 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 product(s)? Please circle below. N/A Adverse Event: Please provide description of the course of event/s including body site and severity/seriousness criteria. Was the patient admitted to hospital: N Event Onset date: 20Jul2016 Causal Relationship: Is there a reasonable possibility that the vent is related to suspect product/s: Yes Suspect Product Name: TRUMENBA Batch and or Lot Number and Expiration date: M95612, Jul2017 Were any of the events above considered serious due to being life-threatening, or due to persistent or significant disability/incapability or any other reason? If yes, note below which event/s and seriousness criteria: N/A Please circle the Outcome of each event: (add for each event) Outcome of the event (1): Recovered Please add relevant date: 25Jun2016 Note: For reports of Lack of Effect please provide the following information in the Adverse Event section: N/A Adverse event following prior vaccination (check all applicable and specify): N/A Please provide information below (only for children 5 years and under): N/A As applicable, list all vaccines given on same date along with suspect vaccine: Vaccine Name: Hepatitis A Manufacturer: Merck Lot# L045713 Route: IM Site: LD No. of previous doses: 0 Vaccine Name: MENACTRA Manufacturer: Pasteur Lot# U5180AA Route: IM Site: LD No. of previous doses: 1 As applicable, list any other vaccination within four weeks prior to date of vaccination: N/A Dechallenge/Rechallenge? Did reaction(s) recur on re-administration?: N/A If yes, please specify: Second dose due 20Dec2016 Were specific tests and/or treatment required: No If yes, please specify in Adverse Event section above (Please provide Lab Test date, Name, Results, and Units) N/A If event occurred after cessation of treatment, please provide the time lag from stop date: N/A Is patient deceased: No If available please provide Date of Death: N/A If available please include copy of autopsy report or any other post-mortem findings: Is patient deceased: No; If yes, please provide: N/A Relationship to patient: Vaccine provider Vaccinated at: Private Physician's office/hospital Vaccine purchased with: Private funds Illness at time of vaccination (specify): N/A Have you reported this adverse event previously: No If yes, to : N/A Concomitant Medications: Concomitant Drug: Albuterol inhaler Start Date: Jun2016 Duration of treatment: Ongoing Indication: RAD Most recent dose (daily dose regimen): 2 puffs every 4 hrs. as needed Patient Medical History: Illness: RAD; Onset date: 2001; Stop Date: (If ongoing at time of last observation, during, or at end of events tick box): Checked; Pertinent Details: Intermittent symptoms, ER for SOB 8Jun2016 Additional Comments Section: Allergic to Penicillin May we contact you to request additional information if needed Yes