Sex: M
Vaccine: COVID19, PPV
Symptoms: Arthralgia, Blood pressure measurement, Hypertension, Illness, Movement disorder
Clinical narrative: shock; blood pressure high; cannot move; joint pain; sickness; nerve damage; thinking abnormal; muscle pain; The previous case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on [17MAY2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-MYLANLABS-2023M1046618.  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; gabapentin (GABAPENTIN); pneumococcal vaccine polysacch 23v (PNEUMOVAX), (Batch/Lot number: unknown); tramadol hydrochloride (TRAMADOL [TRAMADOL HYDROCHLORIDE]), (Batch/Lot number: unknown); ibuprofen (IBUPROFEN), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid. The following information was reported: SHOCK (medically significant), outcome "unknown"; HYPERTENSION (non-serious), outcome "unknown", described as "blood pressure high"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "cannot move"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; ILLNESS (non-serious), outcome "unknown", described as "sickness"; NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage"; THINKING ABNORMAL (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. The action taken for gabapentin, tramadol hydrochloride and ibuprofen was unknown.  This serious spontaneous report was received on 28Apr2023. This initial case, received from consumer, non-health professional, involved unknown age male patient who reportedly experienced shock, hypertension, movement disorder, arthralgia, illness, nerve injury, thinking abnormal while receiving gabapentin. Medical history, concomitant medications and current conditions were not reported. Concomitant medications included COVID-19 vaccine and pneumonia vaccine (pneumovax). Non-company suspect medication included Tramadol (tramadol hydrochloride), Ibuprofen. The patient used Paxlovid previously. Unknown date: The patient-initiated ibuprofen at unknown dose and frequency via unknown route for unknown indication, tramadol hydrochloride at unknown dose and frequency via unknown route for unknown indication, COVID-19 vaccine at unknown dose and frequency via unknown route for unknown indication, gabapentin at unknown dose and frequency via unknown route for unknown indication. The patient experienced shock, thinking abnormal, blood pressure high, cannot move, joint pain, nerve damage and sickness. The event shock was considered medically significant. The patient initiated Paxlovid. Since Paxlovid did not do anything, the patient discontinued therapy with Paxlovid. The patient had gotten better for a week of Paxlovid but felt like it only killed 80 percent of the virus and there was still 20 percent left. After taking tramadol, the patient went into shock, and everything collapsed. The patient went into shock. The patient got sick after the COVID vaccine but did not specify manufacturer. After 2 months of completing 2 doses of the COVID vaccine, the patient received pneumonia vaccine. The patient also had high blood pressure and could not move. The patient had joint pain, muscle pain for over a year and nerve damage. The patient's every sickness increased. The patient had been taking gabapentin and ibuprofen for 3 or 4 months. The patient claimed that the patient was the boss of the President, had 2 spirits inside and owned the earth. The patient requested for a treatment that could kill the virus and help. Action taken with gabapentin, tramadol hydrochloride, ibuprofen was unknown. The outcome of events shock, hypertension, movement disorder, arthralgia, illness, nerve injury and thinking abnormal were unknown. Upon follow-up on 16May2023: Following internal review, significant correction was performed for the information received on 28Apr2023. The need for correction was identified on 15May2023: The events recoded to no adverse event as there was no event for gabapentin. Case downgraded from serious to non-serious. No valid events in this case, hence this case will assign for deletion. Upon follow-up on 17May2023: it is not reported the duration of therapy however, it seems that PAXLOVID discontinued prior. COVID-19 vaccine and pneumonia vaccine (pneumovax) were suspect products and the manufacturers were not reported. There is no event related to company suspect gabapentin hence case assigned for deletion. Caller mentioned that after taking tramadol, he went into shock and everything collapsed. Caller mentioned that it was like he went into stroke.  Comment: Serious: Shock, illness (non-serious) and nerve injury (non-serious) are unlisted events, whereas arthralgia (non-serious), movement disorder (non-serious),thinking abnormal (non-serious) and hypertension (non-serious) are listed events as per company of gabapentin. Causality has been assessed as possible for events shock, hypertension, movement disorder, arthralgia, illness, nerve injury, thinking abnormal, as contributory role of suspect drug cannot be completely excluded with available information.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Gabapentin is under agreement.; Sender's Comments: The reported events are likely intercurrent due to intercurrent condition and not related to gabapentin.