Age: 19.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Dizziness, Fatigue, Malaise, Nausea, Vision blurred
Clinical narrative: This is spontaneous report obtained from a contactable physician. A 19-year old healthy female patient of an unspecified ethnicity received, on 18Jan2016 at 12:00 PM, the second dose of TRUMENBA (Lot. M13066) intramuscular, in the left arm, single dose. The patient received also, on 18Jan2016, TDAP IPV (Lot. 45243AA) intramuscular, in the right arm, single dose. The vaccines was administered at the private physician's office/hospital and was purchased with private funds. Relevant medical history was unknown. Concomitants medications: none. The patient previously received the first dose of TRUMENBA (Lot. J29203, NDC number 0005-010-01), intramuscular in left arm on 25Nov2015 14:00 pm at single dose. After the first dose of TRUMENBA on 25Nov2015, the patient experienced chills, fatigue, dizziness, myalgia, generalized malaise and nausea, all resolved by 28Nov2015. These events did not require an emergency room or physician visit. On 18Jan2016, after the second dose of TRUMENBA, the patient experienced dizziness, fatigue, nausea, malaise, blurred vision and was feeling of faint. No treatment was received. The patient's condition gradually improved and she recovered from the events on 19Jan2016. No hospitalization was required. There was a reasonable possibility that the events were related to suspect products. Follow up (04Aug2016): This is a follow up spontaneous report from a contactable physician. This physician reported in response to the HCP letter sent that 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): No. SUSPECT VACCINE: Please provide below information. Suspect vaccine name and/or generic name: TRUMENBA. Batch/Lot # and expiration date: 25Nov2015 J29203, 18Jan2016 M13066. Prescribed dose, units, and frequency: 0 mo, 2mo, 6mo. Route of administration: IM. Start date (note dates for any subsequent dosing): 25Nov2015; 18Jan2016; 06Jun2016. Anatomical location of the administration of the vaccine: IM, LA. 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: 0 N/A. What was the final action taken with the product(s): Dose not changed. ADVERSE EVENT: please provide description of the course of events including body site and severity/seriousness criteria: Event(s): 25Nov2015; was the patient admitted to hospital: N; Event onset date: 25Nov2015; 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: J29203. Event(s): 18Jan2016; was the patient admitted to hospital: N; Event onset date: 18Jan2016; causal relationship: Is there a reasonable possibility that the event is related to suspect product(s): Yes, Suspect product name: TRUMENBA. 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 event(s) and seriousness criteria. Please circle the Outcome of each event: (add for each event). Outcome of Event (1): Recovered. Outcome of Event (2): Recovered. Adverse event following prior vaccination (check all applicable and specify): In patient: Adverse Event: Lethargy, fatigue. Onset Age: 19. Type Vaccine: TRUMENBA. Dose no in series: #1. In siblings: Adverse Event: Lethargy, fatigue, malaise, blurred vision. Onset Age: 19. Type Vaccine: TRUMENBA. Dose no in series: #2. As applicable, list all vaccines given on same date along with suspect vaccine: Vaccine name: Tdap. Manufacturer: SP. Lot#: 45243AA. Route: IM. Site: RA. No. of previous doses: 6. Dechallenge/Rechallenge? Did reaction(s) recur on re-administration: No. Were specific tests and/ or treatment required: No. Is patient deceased: No. Relationship to patient: vaccine provider; parent. Vaccinated at: Private Physician's office/hospital. Vaccine purchased with: Private funds. Have you reported this adverse event previously: Yes. If yes to: Manufacturer. 3rd dose of TRUMENBA given on 06Jun2016. No adverse events noted on 3rd dose. Reporter Information: May we contact you to request additional information if needed: No. Follow-up attempts completed. No further information expected.