Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Expired product administered, Feeling abnormal, Headache, Lethargy
Clinical narrative: This is a spontaneous report from a contactable nurse. An 18-year-old female patient received TRUMENBA ( lot number, NDC number, expiration date not reported), via an unspecified route of administration at single dose in the right upper arm on 14Jul2016 08:38. Medical history included allergic rhinitis, menstrual cramps, tinea, dietary and exercise counseling. Concomitant medication included ergocalciferol (Vitamin D), ZYRTEC. On 14Jul2016, at 08:38 am the patient was administered expired TRUMENBA and then given a second dose. The morning, 15Jul2016, the patient feels like crap, headache, weakness and lethargic with outcome of not recovered. Follow-up (15Aug2016): This is a follow-up spontaneous report from a contactable Nurse. This nurse reported for the same patient that: Adverse events: Suspect products: TRUMENBA. Adverse events: expired vaccine administered patient, got two doses of vaccine TRUMENBA on the same day. Is it ok for us to contact you should we have further questions about this report: Yes. What Happened: Expired vaccine administered to patient. Got two doses of vaccine TRUMENBA on the same day. Products. Suspect products: TRUMENBA. Is this a Pfizer product: Yes. NDC number: Unknown. UPC number: Unknown. Lot Number: Unknown. Reason for no lot number: Other: LOT# not probed over the call. Expiry date: Unknown. Additional Context: (Name) transferred the call from Pfizer Medical Information (NT ID: (ID)). Transferring agent mentioned that nurse received a letter from Pfizer drug safety and they have some questions regarding the letter that they received. Transferring agent mentioned that Nurse was calling from Physician's office. Registered Nurse did not have an email address. Registered Nurse stated that she gave TRUMENBA vaccine to a patient, which was expired by about 4-5 days (however the exact expiration date not available over the call), that she checked by her provider. Registered Nurse stated that the patient got two doses of the vaccine TRUMENBA on the same day. Registered Nurse confirmed that expired vaccine administered to patient. Registered Nurse stated that vaccine was given to the patient back in Jul; however the exact date of vaccination not available over the call and she got the second letter today. Registered Nurse provided the MRN #. Registered Nurse stated the letter does not really address the situation because she does not believe it was the medication, the formulation of the medication, it was the fact the she got the two doses that she have the symptoms that she had. Registered Nurse stated the letter does not really address the situation of what happened. Limited information available over the call as nurse mentioned that there is some connection problem and she will call back tomorrow and hung up the call abruptly. Registered Nurse was provided with the number of Pfizer Drug Safety as (number) with IVR 1 followed by 1 with timings as 24x7. QR comment: LOT#, NDC#, UPC# and Expiration date not probed over the call. Probing to clarify the statement of "getting two doses of the vaccine TRUMENBA on the same day", not done on call. Causality was not available over the call; as it was not probed over the call.