Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Malaise, Muscle spasms, Oxygen saturation, Pain in extremity
Clinical narrative: Fever; his confusion started at 4:00AM today; he had bad diarrhea from 4:00AM-5:30AM.; his dry eyes started around 12:00PM yesterday; his stomach started to hurt between 8:30-9:00PM last night; He had muscle spams last night; not feeling well; his first Pfizer BioNTech COVID-19 Vaccine shot was in his left deltoid, and his left upper arm hurt; he couldn't sleep last night; about 4:00PM yesterday (4-7 hours after getting his Pfizer BioNTech COVID-19 Vaccine), he was feeling weird, and it had gotten worse; his heart beat was fast and his heart rate was up to 120bpm last night; his blood pressure was 160/98; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 16Mar2021 09:30 (Batch/Lot Number: EU6204; Expiration Date: 30Jun2021) as dose 1, single (age at vaccination 23-year-old) for covid-19 immunisation. Medical history included ongoing attention deficit hyperactivity disorder Verbatim: ADHD , ongoing Blood pressure high ,anxiety, insomnia, muscle spasms, Panic attacks ,DUI accident , septorhinoplasty from 2020 to an unknown date. Reported he was prescribed Lyrica due to a DUI accident , rhinoplasty from 2020 to an unknown date  He said he had a septorhinoplasty a year ago. Concomitant medications included gabapentin, carisoprodol ,bisoprolol fumarate (ZEBETA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took trintellix for antidepressant therapy and experienced drug ineffective, trintellix for antidepressant therapy and experienced constipation, trintellix for antidepressant therapy and experienced nausea, clonazepam and experienced heart rate decreased. On16Mar2021, the patient experienced about 4:00pm yesterday (4-7 hours after getting his pfizer biontech covid-19 vaccine), he was feeling weird, and it had gotten worse, his heart beat was fast and his heart rate was up to 120bpm last night, his blood pressure was 160/98, his blood pressure was 160/98, his first Pfizer BioNTech COVID-19 Vaccine shot was in his left deltoid, and his left upper arm hurt, he couldn't sleep last night, his dry eyes started around 12:00PM yesterday, his stomach started to hurt between 8:30-9:00PM last night, Fever, He had muscle spasm last night and on 17Mar2021, patient experienced that his confusion started at 4:00AM today, he had bad diarrhea from 4:00AM-5:30AM. It was reported, He was diagnosed with ADHD between 2012-2014. He said he took a generic Adderall 20mg Immediate Release tablet, twice a day (20mg in the morning & 20mg at 2:00PM). He said he had been on Adderall for about 8 years. His muscles spasms were from a prior accident he had. He said he was hit by a car going 48mph while he was riding his bicycle. He got the Pfizer BioNTech COVID-19 Vaccine shot yesterday (16Mar2021). He said he was not feeling well. He said about 4:00PM yesterday (4-7 hours after getting his Pfizer BioNTech COVID-19 Vaccine), he was feeling weird, and it had gotten worse. He said his heart beat was fast, he had high blood pressure, his stomach hurt, he had muscle spasms, he could not sleep, he had diarrhea, a fever, dry eyes, and left upper arm pain. He said he was normally healthy, and did not have the COVID-19 Virus before. He said he wanted to report his symptoms to Pfizer. He had ADHD and high blood pressure. He clarified he took his blood pressure last night and his blood pressure was 160/98. He said he took his blood pressure medication, Zebeta, and his anxiety medicine, Clonazepam, at the same time last night. He said he takes Zebeta (Bisoprolol Fumarate) for his high blood pressure. He said he takes 1/2 of a Zebeta 5mg tablet (2.5mg) once a day, as needed, a few times a week when his blood pressure was high. He said the Zebeta was not like Propranolol. He said his blood pressure was fine. He said the Zebeta also lowered his heart rate. He clarified he takes Zebeta and all his other medications at the same time, and that his heart rate may have been lowered by the Clonazepam he took. He said he takes a Clonazepam 0.5mg tablet twice a day. He said he normally takes 1mg Clonazepam, but can take a Clonazepam 0.5mg tablet, as needed. He stated he had been taking the Clonazepam for as long as Adderall. He said he started taking Adderall first. He clarified he started taking Clonazepam for bad nightmares. He said he had tried all other types of medications for his nightmares. He said he started the Clonazepam in 2014 for his bad nightmares, and now the Clonazepam was prescribed for anxiety and panic attacks. He said he sees a therapist once a week. He said he checked his "pulse ox" last night, and his pulse ox was good. He said his heart rate was up to 120bpm last night. He said he kept a watch on his heart rate, and his heart rate was around 100-110, which was higher than normal. He said his heart rate was still elevated while he was laying down, stating his current heart rate was 113bpm. He said when he exercised his heart rate normally goes up to between 140-160bpm. Clarified he woke up at 4:00AM this morning (17Mar2021) with diarrhea. He said he had bad diarrhea from 4:00AM-5:30AM. He said he ate something for breakfast and took a fiber gummie. He said the fiber gummie would help harden his stool, and he did not want to take anything to cause constipation.  He said he had not had diarrhea since about 5:30AM. He provided the fiber gummie product information as: Fiber Well Fit Supplement 5grams fiber. He had a fever. He stated he was going to check his temperature while he was speaking with the Pfizer agent, but did not provide his body temperature. He clarified a weird symptom he experienced after getting the Pfizer BioNTech COVID-19 Vaccine was dry eyes. He said his dry eyes started around 12:00PM yesterday (16Mar2021). He said he bought Liquid Tears eye drops that were either (Company name) brand or (Company name) brand. He said the Liquid Tears was a saline eye drop with no medication in it. His stomach started to hurt between 8:30-9:00PM last night. He said he had a normal dinner and had taken his daily medications at 6:00PM yesterday. He was confused, too. He clarified his confusion started at 4:00AM today (17Mar2021). He said he did not charge his phone overnight, which was not normal, and a lot of other weird things. He said he knows it was not his medications causing his confusion because he had not started any new medications. He said he had been taking the same medications for quite some time. He got everyone (his mother and father) signed up for the COVID-19 Vaccine, and he was the only one experiencing issues. He was prescribed Lyrica due to a DUI accident, saying he knows Lyrica was a Pfizer medication. He clarified he was on Gabapentin first. He said he was on the maximum dose of Gabapentin (either 2000mg or 6000mg) in 2016. He said he was then was put on Lyrica. He said the Lyrica did not work as well as the Gabapentin. He clarified the Lyrica 75mg was stronger than the Gabapentin, and he didnot like how tired he was while taking the Lyrica 75mg. He said he took the Lyrica 75mg for a month or 2, and then was put back on Gabapentin. He said he was no longer taking either the Gabapentin or Lyrica. He said it was 6-7 years ago that he had taken Lyrica 75mg. He said he knew beforehand what the COVID-19 Vaccine side effects were, like chills, but diarrhea was not on the list of COVID-19 Vaccine side effects. He was not immunosuppressed. He said he had a septorhinoplasty a year ago. He could not sleep last night. He said he had diarrhea. He said his arm (left) hurts, but he does not care about that. He clarified he had his first Pfizer BioNTech COVID-19 Vaccine shot in his left deltoid, and his left upper arm hurt. He said his left upper arm felt worse than getting a tetanus shot. He said he had really sensitive skin, and was white as a ghost. He said he did not have any swelling on his left upper arm and had put ice on his left upper arm earlier. He said he know, and intramuscular shot takes a few hours to get into the blood stream, and he did not know if the Pfizer BioNTech COVID-19 Vaccine passed through the blood brain barrier. He had muscle spams last night. He clarified he had the muscle spasms prior to the Pfizer BioNTech COVID-19 Vaccine. He said the muscles spasms were from a prior accident he had. He said he took one SOMA (Carisoprodol) last night (16Mar2021), clarifying the Carisoprodol was prescribed for his muscle spasms. He said he was prescribed a low dose of Carisoprodol for his muscle spasms. He said he usually takes Carisoprodol 250mg tablet up to twice a day (250mg at midday & 250mg at night). He said he had been taking Carisoprodol for 3 years. He said he took the 1 Carisoprodol 250mg tablet with the Zebeta (beta blocker) last night and he had no crazy muscle spasms. He said the Carisoprodol was dispensed in a pharmacy bottle and didn't have the NDC, Lot and Expiration Date listed. He had a complete blood panel a few months ago, and everything was fine. He had anxiety, ADHD and insomnia, saying that was why the takes his medications. He stated he did not take his Adderall this morning. He said he takes a generic Adderall 20mg Immediate Release tablet, twice a day (20mg in the morning & 20mg at 2:00PM). He said he had been on Adderall for about 8 years. He said the generic Adderall 20mg Immediate Release tablet was dispensed in a pharmacy bottle and had no NDC, Lot & Expiration Date listed. He does not drink coffee, and wanted to make sure that was noted on the report. He takes an Amitriptyline 50mg tablet at night. He stated he has been taking Amitriptyline 50mg for about 3-4 years. He said the Amitriptyline 50mg was dispensed in a pharmacy bottle, and he does not have the NDC, Lot, and Expiration Date. He said before the Amitriptyline, he used to take a Trintellix 20mg tablet once a day. He said the Trintellix 20mg was made by Takeda and was a terrible anti-depressant. He said he took Trintellix for about a year and a half, and the Trintellix did not do too much, he said the Trintellix was not working. He said the Trintellix gave him terrible constipation and nausea. He said he still had 4 Trintellix manufacturers bottles at his father house. He said the Trintellix 20mg was probably expired, and he had kept the Trintellix 20mg because it cost about $500 a bottle. He could not take SSRIs, like Paxil, Sertraline, and Lexapro. He said the SSRIs caused problems like sexual dysfunction. He said he does not have the NDC Number, Lot Numbers, and Expiration Dates for the SSRIs he used in the past. He said he was still with his pediatrician at the time he was taking SSRIs, and had since thrown out all his SSRI prescription bottles. He had some questions about the ingredients in the Pfizer BioNTech COVID-19 Vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 160/98 on 16Mar2021 , heart rate:100-110, heart rate:113, heart rate: 140 on an unknown date, heart rate: 120 on 16Mar2021 bpm , complete blood panel: everything was fine on an unknown date, oxygen saturation: good on 16Mar2021. Therapeutic measures were taken as a result of events includes Gabapentin, Carisoprodol, Clonazepam, Zebeta, Adderall. The clinical outcome for events his heart beat was fast and his heart rate was up to 120bpm last night, he had bad diarrhea from 4:00AM-5:30AM, his dry eyes started around 12:00PM yesterday was recovering and outcome for events hypertension, his stomach started to hurt between 8:30-9:00PM last night, Fever ,feeling unwell was unknown while rest of events was not recovered.   Description of Product Complaint: He was on Gabapentin, and then was put on Lyrica. He said the Lyrica did not work as well as the Gabapentin. He clarified the Lyrica 75mg was stronger than the Gabapentin, and he did not like how tired he was while taking the Lyrica 75mg. He said he took the Lyrica 75mg for a month or 2, and then was put back on Gabapentin. He said he was no longer taking either the Gabapentin or Lyrica. He said he had taken the Lyrica 75mg 6-7 years ago, and he no longer had the prescription to provide the Lyrica NDC, Lot, and Expiration Dates. He said in 2016 he was on the maximum dose of Gabapentin, and no longer had the Gabapentin NDC, Lot, and Expiration Date. He used to take a Trintellix 20mg tablet before he started taking Amitriptyline 50mg. He stated the Trintellix was a terrible anti-depressant. He said he took Trintellix for about a year and a half, and the Trintellix did not do too much. He said the Trintellix was not working. He said the Trintellix gave him terrible constipation and nausea. He said the Trintellix was dispensed in a manufacturer bottle, and he did not have the NDC, Lot, and Expiration Date to provide. He said he still had 4 Trintellix manufacturer bottles at his fathers house. He said the Trintellix was probably expired, and he had kept the Trintellix because it cost about $500 a bottle.  No follow-up attempts are possible. No further information is expected.