Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Vaccine positive rechallenge, Weight decreased
Clinical narrative: trouble in hands; shortness of breath; The caller took clonazepam for three days and was a nervous wreck; The caller states the Clonazepam made the tremors, anxiety and nervousness even worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; clonazepam (CLONAZEPAM) (Batch/Lot number: unknown) at 1 mg for anxiety, post-traumatic stress disorder. Relevant medical history included: "Anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "low blood pressure" (unspecified if ongoing); "nervousness" (unspecified if ongoing); "tremors" (unspecified if ongoing); "To control genetic cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). Past drug history included: Alprazolam, start date: 2003, stop date: 2019, for anxiety, reaction(s): "never had a single negative side effect from Alprazolam", notes: 1mg; Alprazolam, start date: 2003, stop date: 2019, for PTSD, reaction(s): "never had a single negative side effect from Alprazolam", notes: 1mg; Paroxetine, start date: 2014, stop date: 2014, for Anxiety and PTSD, reaction(s): "anxiety panic attack", notes: 1mg tablet. The caller states he took 1 tablet of Paroxetine and that was it and ended up in the emergency room; Paroxetine, start date: 2014, stop date: 2014, for Anxiety and PTSD, reaction(s): "anxiety panic attack", notes: 1mg tablet. The caller states he took 1 tablet of Paroxetine and that was it and ended up in the emergency room.; Paroxetine, start date: 2014, stop date: 2014, for Anxiety and PTSD, reaction(s): "blood pressure was 160/100 and normally the caller has a low blood pressure", notes: 1mg tablet. The caller states he took 1 tablet of Paroxetine and that was it and ended up in the emergency room.   The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "trouble in hands"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; NERVOUSNESS (non-serious), outcome "unknown", described as "The caller took clonazepam for three days and was a nervous wreck"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "The caller states the Clonazepam made the tremors, anxiety and nervousness even worse". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for clonazepam was dosage permanently withdrawn. Past drug notes: The caller has been taking Alprazolam since 2003, for 18 years the caller has been taking Alprazolam 1mg per day. The caller has never had a single negative side effect from Alprazolam. The medical facility, three times, has wanted the caller to try a new medication. Paroxetine: Diagnosed in emergency room with an anxiety panic attack: Starting in 2014, the (Withheld) wanted the caller to trying something else and switched the caller to Paroxetine 1mg, the generic for Paxil. The caller took one Paroxetine 1mg tablet and four hours later the caller started having side effects. The caller was diagnosed in the emergency room with an anxiety panic attack. The caller's blood pressure was 160/100 and normally the caller has a low blood pressure. Paroxetine: Dosage permanently discontinued. The emergency room wrote a report which was turned into the (Withheld) that said return patient original medication, Alprazolam 1mg. The caller had been taking Alprazolam since 2003. The medical facility said nobody could tell the (Withheld) what to do and transferred the patient to a mental health where the patient saw a mental health staff psychiatrist at local clinic. Starting in Sep2014, the Alprazolam 1mg was renewed and the psychiatrist said the only reason she would prescribe Alprazolam to the caller was because of the caller's history with the Alprazolam medication. The caller has never had a single adverse effect from Alprazolam. The caller continued on Alprazolam for about 5 years until 2019 when the psychiatrist left the (Withheld) completely. At that time, the nurse practitioner at clinic continued the 1mg of Alprazolam for the caller. Unknown medication: Was switched from Alprazolam to another medication, something for heart and blood pressure and the caller has no heart or blood pressure problems: Then the caller was transferred to a mental health specialist in Mar2021. The mental health specialist wanted to try something new. The caller was switched from Alprazolam to another medication, something for heart and blood pressure and the caller has no heart or blood pressure problems. The caller states he has no other medical issues, the only other thing the caller takes is Simvastatin to control genetic cholesterol. The caller states he was switched from Alprazolam to an unknown medication, the caller threw the medication away and does not know the name of the medication. Unknown medication: Caused to have a sudden drop in blood pressure and an attack of vertigo: The unknown medication caused the caller to have a sudden drop in blood pressure and an attack of vertigo. Unknown medication: NDC/lot/expiration: The caller does not have this information to provide.  Clinical course: Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands. Caller clarifies he was not calling in regard to the Pfizer Covid 19 Vaccine and has no side effects to report regarding the Pfizer Covid 19 Vaccine. NDC/lot/expiration for Pfizer Covid 19 Vaccine doses not obtained. Caller clarifies the reason the caller is calling Pfizer is because he takes Alprazolam 1mg a day for anxiety and PTSD. The caller explained to the transfer agent that the medical facility writes the caller's prescription, and the caller picks up the prescription at a local pharmacy because it is cheaper than getting the prescription from the (Withheld) pharmacy. The caller states the new mental health specialist put the caller back on 1mg Alprazolam. Then about a week ago or so, for no reason the mental health specialists decided the caller should try a different medication. The caller was switched to Clonazepam 1mg. The caller took clonazepam for three days and was a nervous wreck. The caller states it was a 30-day prescription of Clonazepam with two refills. The caller states he did keep the Clonazepam but stopped taking the medication. The caller took Clonazepam for three days and couldn't continue taking Clonazepam because of the side effects. The caller states the Clonazepam did nothing for tremors or anxiety or nervousness. The caller states the Clonazepam made the tremors, anxiety and nervousness even worse. The caller told the mental health specialist the Clonazepam was making the tremors, anxiety and nervousness worse. The caller states the Clonazepam is in a bottle from the pharmacy. NDC: 43547-Q407-11. Lot: Caller states he does not see a lot to provide. Expiration: Unknown. The caller states there are 30 tablets, 1 a day. Paroxetine NDC/lot/expiration: The caller does not have this information to provide. The caller states he took 1 tablet of Paroxetine and that was it and ended up in the emergency room. The reason the caller contacted Pfizer is because now the mental health facility, (Withheld) and supervisor that put the caller on Clonazepam, the caller has told on a video that the caller can't take Clonazepam. The caller took Clonazepam for three days and caused the caller to have a breathing problem that the caller never had before. The caller states the breathing problem went away when the caller stopped taking the Clonazepam. The Clonazepam made the caller even more nervous than have ever been and did nothing for the caller's anxiety, just made things worse. The caller told the mental health person at the withheld at the Mental health department on Friday, 19Nov2021, that the caller can't take Clonazepam. At that point, the caller was no longer taking Clonazepam and does not have Alprazolam either. The doctor said doesn't know, should have been part of the same family, benzodiazepines. The reason the patient called Pfizer was it says in print out caller has that it is not known if Alprazolam is safe and effective when used to treat anxiety for longer than 4 months. The caller has not had a single negative event with Alprazolam. the caller states he can provide proof to Pfizer that Alprazolam is safe and effective when taking for longer than 4 months to treat anxiety because the caller has been taking Alprazolam since 2003. The caller doesn't know what the (Withheld) is going to do, (Withheld) said had to talk to supervisor. The (Withheld) may not prescribe that family of drugs to the caller, benzodiazepines. The caller does not wish to provide HCP address or email. The caller will provide the name of the mental health specialist in the (Withheld) who switched the caller from Alprazolam to Clonazepam. Pfizer can ask the mental health specialist why they switched the caller to Clonazepam. If Pfizer contacted the mental health specialist what would be the reason? Caller states if the mental health specialist is ticked off, could tell caller to find someone else, very sketchy at the (Withheld). The caller states to select no contact. The only reason the mental health specialist provided the caller for switching to Clonazepam was that it was longer lasting than Alprazolam, a lower dose for a longer period of time during the day. Since the caller can't take Clonazepam, the caller doesn't know what the (Withheld) will do about switching the caller back to 1mg Alprazolam or not. Caller clarified, he would like to select yes and grant Pfizer permission to contact HCP. The mental health specialist is in the (Withheld) mental health department. Dial number provided and hit zero for operator and ask for mental health because metal health is in a different building. At this point, the caller doesn't know what the (Withheld) will do. The main reason for calling Pfizer was because supposedly there is no evidence that Alprazolam is good for more than 4 months and the caller wanted to provide Pfizer evidence because the caller has been on Alprazolam for 18 years with no negative effects. Sample of the product was available to be returned, if requested. Caller informed may possibly receive a mailer in 3-10 business days. Paroxetine was not a Pfizer product (manufacturer: unspecified). Another concomitant medication included unknown medication (manufacturer: Unspecified; NDC number/ Lot number/ Expiry date: unknown) for heart and blood pressure when caller does not have heart or blood pressure problems from Mar2021 till unspecified date. Reason for no lot number of unknown medication stated as product discarded by complainant. Action taken on Unknown medication was dosage permanently discontinued. NDC number of Clonazepam was 43547-Q407-11. Reason for no lot number: of Clonazepam: Other: Caller states Clonazepam is in a bottle from the pharmacy and the caller does not see a lot to provide. Expiry Date of Clonazepam: Unknown. Clonazepam dosage permanently discontinued. Investigation assessment included none.   The lot number for bnt162b2 was not provided and will be requested during follow up.