Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue, Syncope, Tremor, Vision blurred
Clinical narrative: cold; fainting sensation; haziness in vision; anxiety; claustrophobia; headaches; shaky feeling; Impaired vision - everything is in a haize; faint shakiness; nervous and uncomfortable; light-headedness/dizziness; disoriented; feels foggy/cloudiness; the syringe being out there for a while (30 mins) before it was administered to him; the syringe being out there for a while (30 mins) before it was administered to him; This is a spontaneous report from a contactable consumer (patient).  A 53-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ZW0196 or BW0196 or GW0196; Expiration Date: 21Jul2021), via an unspecified route of administration, administered in Arm Left on 21Jul2021 18:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included muscular dystrophy from 1969, dyslexia Mentions he is dyslexic and has difficulty reading, predating the vaccine, claustrophobia, pulled muscle in his groin he had a CAT Scan for pulled muscle in his groin the day before the vaccine. The patient's concomitant medications were not reported. Prior vaccinations within 4 weeks was not provided. On 22Jul2021, the patient experienced fainting sensation, claustrophobia, haziness in vision, anxiety,  headaches. On 21Jul2021  disoriented, light headedness/dizziness, shaky feeling, impaired vision - everything is in a haize, faint shakiness, nervous and uncomfortable. On unspecified date, cold. On an unspecified date in 2021, the syringe being out there for a while (30 mins) before it was administered to him. After getting his 1st dose, the next day after that, he experienced haziness in vision that triggered his anxiety and his claustrophobia. He also reported, fainting sensation, light-headedness, headaches, cloudiness and dizziness right after getting the vaccine which became persistent as of the moment. He even attributed this side effect to something like smoking "weed/marijuana" but lighter than that. He also said that his head was cold, disoriented. He specified that it is not that grave.  He could still go to work but the feeling simply annoys him. He even reported that several people have also reported these side effects including to one of his colleague's (a forest ranger) brother having the side effect and not being resolved. In line with this, caller would like to know if this side effects were reported and if it will go away. For the haziness in vision- spoke as per VR-Consumer Inquiry Management (Off-Label or No Info), There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Referred to HCP for further clinical recommendations. Caller was speculating that the way the vaccine was given to him was probably one of the reason why he was experiencing side effects, when all his family members were not. He even mentioned that he got some conversation with the pharmacist and that the pharmacist explained that she/he had already had the diluent on it and that the vaccine was still good/stable. In line with this, caller would like to know if the vaccine administrator (pharmacist) did the right thing. Caller was persistent and wanted to know the stability of the vaccine given those conditions. Once vaccine is drawn on the syringe, it must be administered to the patient immediately. But After dilution, the vials can be stored between 2 degree C to 25 degree C (35 degree F to 77 degree F) and use within 6 hours from the time of dilution. Caller was allegedly saying that the dose given to him was an invalid one because of the improper storage and handling of the vaccine and would like to know as to what would possibly would happen to him if he was administered with an invalid vaccine, in terms of possible side effects. Caller was very persistent and would not accept this as an answer. Yet I still did the "broken record" and told him we do not have information about it as we don't recommend the use of the vaccine beyond what is described in the EUA PI. Beyond the proper storage and handling guidelines, we at, Pfizer cannot assure the potency, efficacy and even the safety of the vaccine. Beyond those point, some microbiological or physical instability may be considered. And with that, we refer them back to their HCP for further clinical recommendations and side effect management and are not able to give treatment recommendations to patients receiving the vaccine. Patient had a bad reaction. Caller confirmed information provided by transfer agent. Adds he was not comfortable and that was his worst fear; he is creeped out about the unknown. Everyone said you got to get it and now he wants to know what was wrong, was it gonna go away, was this a side effect, how long would it last. Adds he also gets a little  shaky feeling that comes and goes; it changes. He noticed every time somebody gets a shots on TV or in movies, they are sucking it out of the vial. This lady had an already filled syringe. He asked her wasn't it supposed to be cold, like Pfizer vaccine had to be kept in the cold. She said she had mixed it with the saline solution. He thought it had to go right out of the fridge. He would like to ask the USMI agent about if that was okay and was it supposed to be cold. When he first got the shot he felt dizzy and he waited around then he left. He still feels a little dizzy all the time. The next day after the shot he noticed his impaired vision. Adds he can see clearly but everything was hazy; the haze impairs his vision and adds to his claustrophobia. He already has to have glasses to do close up reading. Everything was like he was in a closed environment. If he was outside in the yard, it was not as bad, but he can still see a haze that is like everything is slightly out of focus. Adds the vision haze is like there is a delay in his vision; like a bad acid trip or smoking marijuana, just like if you only had a little bit of marijuana. The next day he also noticed, at night he feels a faint shakiness, like something was wrong and it was creeping him out. He tried to call his pharmacy to update them and they didn't answer so he called another pharmacy and the pharmacist said they knew exactly what he was going through but they didn't tell him if this would go away, he do not want to lose his vision. Not knowing was the worst. Added he went swimming; when he was at the ocean he almost felt normal. Like when he was swimming at Name. He noticed the haze right away the next day. The more nervous he gets the worse it got and he still has a slight dizziness. Adds he feels discombobulated. Adds hot and cold doesn't affect it; although swimming made him relax and seems to make it better. He is planning to go the optical doctor next, he is calling them next. Patient mentions he is 5 foot 5.5 or 5 foot 6 inches; mentions he has gained weight since COVID pandemic, he should be 160 pounds. Mentioned he ask his friends who said they got tired, body aches, warm chills but it went away. States he had one friend, Name who had side effects for two weeks but he seems fine now. Caller stated he do not have all the information to report about Name.  A clone report was created to document information provided for friend's side effects. Mentioned he told the other agent, he was concerned that might interfere with the vaccine; they told him to drink a lot of water and he told them he was getting the Pfizer shot the next day and they said sure go ahead. Caller mentioned he had a reaction but do not know if he was administered the covid vaccine that was past the 6-hour deadline. But he was planning to go to see the optical doctor. The patient underwent lab tests and procedures which included CAT Scan: unknown on 20Jul2021, CAT Scan for pulled muscle in his groin the day before the vaccine. Event fainting sensation was considered as serious (medically significant). The clinical outcome of events fainting sensation, haziness in vision, light-headedness/dizziness, headaches, shaky feeling, Impaired vision - everything is in a haize, faint shakiness, nervous and uncomfortable was not recovered and other events were unknown.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100952138 Same reporter/ drug/ AE, different patient;US-PFIZER INC-202100952137 Same reporter/ drug/ AE, different patient