Symptomtext
10/10 headache; Hypotensive; tachycardic; nausea and vomiting; nausea and vomiting; body shakes; shivers; hypertension; This is a spontaneous report from a contactable registered nurse. A 16 year-old female patient received meningococcal group b rlp2086 (TRUMENBA), administered in deltoid left, administration date 17Nov2021 12:09 (Lot number: ER2622, NDC number: 0005-0100-10, Expiration Date: Jan2024) at the age of 16 years as dose number unknown, 0.5 ml, single for immunisation; influenza vaccine (FLUZONE), intramuscular, administered in deltoid right, administration date 17Nov2021 (Lot number: UT7411KA, Expiration Date: 30Jun2022) as 0.5 ml, single; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), intramuscular, administered in deltoid right, administration date 17Nov2021 (Lot number: U7207AB, Expiration Date: 08Feb2023) as 0.5 ml, single. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. No prior vaccination within 4 weeks. No AE following prior vaccination. The following information was reported: HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "10/10 headache"; HYPOTENSION (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "Hypotensive"; TACHYCARDIA (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "tachycardic"; VOMITING (medically significant), NAUSEA (medically significant) all with onset 17Nov2021, outcome "recovered" (Nov2021) and all described as "nausea and vomiting"; TREMOR (non-serious) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "body shakes"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "shivers"; HYPERTENSION (non-serious) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "hypertension". Within an hour of receiving the vaccines, the patient had a 10 out of 10 headache, body shakes, shivers, nausea. Around 1:30PM, the patients' mom was calling about this and then the patient was taken to the ER. The patient was hypotensive, tachycardic and had nausea and vomiting, also had hypertension. The patient received a bolus of IV fluids and IV benadryl. Symptoms eventually resolved. No relevant test. Clarified that the patient was not admitted to the hospital, she was just in the emergency room. It all had subsided but the reporting nurse did not know how long this lasted. Seriousness of 10 out of 10 headache, hypotensive, tachycardic, nausea and vomiting: the reporting nurse stated she did not know how to classify it, stating that if she had not gone to the ER, it would have been life threatening. She stated that it was definitely medically significant. The doctors in the office don't want to continue using this Lot number so the reporting nurse called their specific Rep regarding getting a replacement for the product and she was told that she would have to call the Safety department about that.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect vaccine meningococcal group b rlp2086 may have contributed to the onset of reported serious events including headache, hypotensive, tachycardic, nausea and vomiting all of which occurred within an hour of receiving the vaccines. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate