Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Arthralgia, Body temperature increased, Chills, Contusion, Hyperhidrosis
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 experienced body temperature of 99.5, sweaty, chills, shoulder hurt like a bruise, joint hurt, shortness of breath, all on an unspecified date with outcome of unknown. The reporter assessed the events as related to TRUMENBA. Follow up (09Aug2016): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported for 18-years-old male 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 Also shortness of breath during the night, requiring use of bronchodilator. 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: 18 years old well adolescent Start date: 22Jun2016 Stop date or duration of treatment: second dose due 22Dec2016 Time vaccination was given: 09:30 Anatomical location of the administration of the vaccine Left 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  Adverse Event Was the patient admitted to hospital: No Event Onset date: 22Jul2016 Causal Relationship: 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: Outcome of the event: Recovered Please add relevant date: 24Jun2016 Note: For reports of Lack of Effect please provide the following information in the Adverse Event section: N/A Adverse event following vaccination: N/A Please provide information  below (only for children 5 years and under): N/A Adverse event following prior vaccination: N/A As applicable, list all vaccine given on same date along with suspect vaccine Vaccine Name: GARDASIL 9 Manufacturer: Merck Lot#: M004116 Route: IM Site: LD No. of previous doses: 2 Vaccine Name: Hepatitis A Manufacturer: Merck Lot# L045713 Route: IM Site: RD No. of previous doses: 0 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 Were specific tests and/or treatment required: No If yes, please specify in Adverse Event section above: 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 include 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 Illness at time of vaccination (specify): N/A Have you reported this adverse event previously: No If yes, to : N/A Concomitant Medication: N/A Patient Medical History: Illness: Environmental allergies Onset Date: 2012 Stop Date: If ongoing at time of last observation, during, or at end of events tick box: Checked Pertinent Details: Intermittent, rare Illness: Exercise induced bronchospasm Onset Date: 2000 Stop Date: If ongoing at time of last observation, during, or at end of events tick box: Checked Pertinent Details: rare Illness: Osgood-Schlatter disease Onset Date; Feb2013 Stop Date: If ongoing at time of last observation, during, or at end of events tick box: Checked Pertinent Detail: painful intermittently May we contact you to request additional information if needed Yes Follow-up attempts completed. No further information expected.