Age: 34.0
Sex: M
Vaccine: PNC20
Symptoms: Intentional product use issue, Intentional self-injury, Laboratory test normal, Medication error
Clinical narrative: Patient grabbed the syringe and injected into an IV (Intravenous) line; self harm attempt; This is a spontaneous report received from a Pharmacist from medical information team and product quality group.  A 34-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Dec2023 at 15:03 as dose 1, 0.5 ml, single (Batch/Lot number: unknown) at the age of 34 years intravenous for immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Schizoaffective disorder" (unspecified if ongoing); "Psychotic disorder" (unspecified if ongoing); "multiple suicide attempts" (unspecified if ongoing); "subtance abuse disorder" (unspecified if ongoing); "hemorrhage" (unspecified if ongoing); "admitted", start date: 07Dec2023 (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTENTIONAL PRODUCT USE ISSUE (medically significant) with onset 08Dec2023 at 15:50, outcome "unknown", described as "Patient grabbed the syringe and injected into an IV (Intravenous) line"; INTENTIONAL SELF-INJURY (medically significant) with onset 08Dec2023 at 15:50, outcome "unknown", described as "self harm attempt". The patient underwent the following laboratory tests and procedures: test: (08Dec2023) WNL/Baseline; Weight: (unspecified date) 62.4 kg. Therapeutic measures were not taken as a result of intentional product use issue, intentional self-injury.  The reporter considered "patient grabbed the syringe and injected into an iv (intravenous) line" and "self harm attempt" not related to pneumococcal 20-val conj vac (dipht CRM197 protein).  Additional information: Pharmacist calling about Prevnar 20. He is calling to report that a patient grabbed a Prevnar 20 syringe and injected it into his own IV (intravenous) line inadvertently. Patient is being monitored to make sure there is no adverse reaction. Occurred this afternoon around 350pm. Seriousness: would think not serious, does not have expectation of adverse events. Patient will have additional monitoring of vitals for a couple of hours. Dose: Prefilled syringe, believe the entire dose of the syringe was injected. Caller states the patient was already in the ICU prior to patient injecting his IV line with Prevnar 20. This was the first the patients first Prevnar 20 dose. This case was not serious. On 16Jan2024, it was reported that patient was admitted for trauma following involving multiple factors and hemorrhage. Patient was admitted to the hospital on 07Dec2023. While nurse was out of room to obtain an IM needle, patient grabbed vaccine syringe from computer wheels adjacent to the hospital bed. Patient reported attaching to peripheral IV connection and pushed contents via IV route. Patient attached and administered the prefilled vaccine dose into his active peripheral IV line. Nurse left med at computer station, labeled to med room to obtain IM needle, and returned to patient with the empty syringe. Poison control and health system drug information was consulted. Monitored patient for 24 hours inpatient via vital signs after self harm attempt. Routine measurement aligned with baseline values at admission obtained. No further active intervention performed. No reaction (s) recur on re-administration of product. A true IM vaccine dose of Prevnar 20 was administered successfully on the following day 09Dec2023. Patient was discharge on 01Jan2024. The product is not available to be sent to Pfizer for evaluation. The error was not noticed and intercepted before the product was supplied to the patient. The factor considered to be responsible for the medication error is deliberate incorrect use of the medication by the patient. The patient did not provide information regarding the reported adverse event(s) with the use of the product. The reporter does not consider the Pfizer product had a causal effect to the adverse event.   Investigational results received on 14Dec2023 concluded that this complaint reported "Patient grabbed the syringe and injected into an IV (Intravenous) line inadvertently" for Prevnar 20V Injectable. The lot number is unknown. As the Lot Number is unknown for this complaint the final scope was limited to a review of the trend profile for Complaint. Subclass Adverse Event MD/MDCP, Adverse Event/Negligible-Minor', 'Adverse Event/Serious/Unknown' for Prevnar 20V and similar products Prevenar20V and Apexxnar Injectable was performed over 36 months for all markets. Following review a trend was not identified. A review of the Prevnar 20V complaint Annual Product Record Reviews (APRR) for the previous period was performed. The review has determined that there has not been a clear medical safety signal arising from manufacturing concerns related to the batches/lots reviewed in the time period. Controls are in place to prevent/detect the reported adverse event complaint. Release testing including Sterility, Endotoxin and Antigenicity is performed for each drug product lot. All results must meet specification prior to batch disposition. A complaint sample was not available as the product was administered. A trend was not identified. No root cause or CAPA was identified. The complaint was not confirmed. No additional regulatory notification is required. No further action is required.  The information on the batch/lot number for [pneumococcal 20-val conj vac] has been requested and will be submitted if and when received.  Follow-up (14Dec2023 and 19Dec2023): This is a follow-up spontaneous report received from product quality group in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Added product quality investigation results.  Follow-up (16Jan2024): This is a spontaneous follow-up report received from a same pharmacist. Updated information included: added medical history, lab data, vaccination details, new event (self harm attempt); updated coding of event "Patient grabbed the syringe and injected into an IV (Intravenous) line inadvertently".  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The Intentional self-injurious behavior by the patient's grabbing the syringe and injecting into an Intravenous line is not due to the vaccine use but associated with the patient underlying psychiatric conditions including  Schizoaffective disorder, Psychotic disorder, multiple suicide attempts and substances abuse disorder