Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Pain, Skin warm
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative. A patient of unspecified age ethnicity an 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 a large area of redness like almost the whole top part of their arm or shoulder on an unspecified date with outcome of unknown, heat on an unspecified date with outcome of recovered, body ache on an unspecified date with outcome of unknown, shoulder hurt on an unspecified date with outcome of not recovered, headache on an unspecified date with outcome of recovered, low energy on an unspecified date with outcome of not recovered, fatigue on an unspecified date with outcome of not recovered. The reporter assessed the events as related to TRUMENBA. Follow up (08Aug2016): This is a follow-up spontaneous report from a contactable nurse. This nurse reported for a 19-years-old male patient on behalf of a physician in response to the HCP letter sent that included: Did the patient provide information to you regarding the reported adverse events with the use of product: Yes If yes above, do you consider the Pfizer product had causal effect to the adverse event: Yes Are you willing to be contacted again by Pfizer on the reported adverse events: Yes SUSPECT VACCINE: Please provide below information: Suspect vaccine name and/or generic name: TRUMENBA Batch/Lot# and expiration date: M95612, Exp: Jul2017 Prescribed dose, units, and frequency: 0.5 ml Route of administration: IM Indication: 19 year-old student Start Date (note dates for any subsequent dosing): 20Jun2016 Stop Date or duration of treatment: dose #2 due 20Dec2016 Time of vaccination was given (hour: minute-24 hour clock): 13:00 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 not any other relevant etiological factors: N/A What was the final action taken with the products? Please circle below: N/A Adverse event: Was the patient admitted to hospital: N Event Onset Date: 21Jun2016 Causal relationship: Is there a reasonable possibility that the event is related to suspect products: Yes Suspect product name: TRUMENBA Batch and/or lot number and expiration date: M95612, Exp: Jul2017 Were any of the events above considered serious due to being life-threatening, or due to persistent or significant disability/ incapacity or any other reason? If yes, note below which events and seriousness criteria: N/A Please circle the outcome of each event: Outcome of event (1): Recovered Please add relevant date: 26Jun2016 Note: for reports of lack of effect please provide the following information in the adverse event section: N/A Adverse event following prior vacation: N/A Please provide information below: N/A As applicable, list all vaccines 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 As applicable, list any other vaccinations within four weeks prior to date of vaccination: N/A Dechallenge/Rechallenge? Did reactions recur on re-administration: N/A Were specific tests and/or treatment required: No If event occurred after cessation of treatment, please provide the time lag from stop date: N/A Is patient deceased: No Relationship to patient: vaccine provider Vaccinated at: private physician's office/hospital. Vaccine purchased with: Private funds. Illness at time of vaccination: N/A Have you reported this adverse event previously? No If yes, to: N/A Concomitant medications: Concomitant drug: Naproxen; Start date: 19Nov2013; stop date: N/A; Duration of treatment: 2 years; Indication: headache; Most recent dose: 10May2016, takes as needed for headaches ZOLOFT; Start date: 2006; stop date: Jan2016; Duration of treatment: 10 years; Indication: TIC disorder, anxiety; Most recent dose: Jan2016 Patient medical history: Illness: Asthma; onset date: 1997; Stop date if ongoing at time of last observation, during, or at end of events tick box: checked; Pertinent details: intermittent last treated 2014 Illness: Allergic rhinitis; Onset Date: 2000; Stop date if ongoing at time of last observation, during, or at end of events tick box: checked; Pertinent details: intermittent. May we contact you to request additional information if needed: Yes