Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Drug ineffective, Investigation, Oxygen saturation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EM9810), as dose 2, single (Batch/Lot number: unknown) and on 31May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "4 fusions in back" (unspecified if ongoing); "two hernias" (unspecified if ongoing); "hip replacements" (unspecified if ongoing); "States he thought it was allergies. States that the day before he cut the grass." (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "allergies" (unspecified if ongoing); "pneumonia" (unspecified if ongoing); "smoke marijuana" (unspecified if ongoing); "3 back surgeries" (unspecified if ongoing); "his joint socket was bone on bone" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller clarifies he got the Pfizer BioNTech Covid-19 vaccine/he has Covid"; RENAL DISORDER (non-serious), outcome "unknown", described as "He was told that his kidneys were a little weak when he went into the ER that Friday because he hadn't eaten or drank anything for two days"; PAIN (non-serious), outcome "unknown", described as "Then he thought it was allergies, the next day it got even worse, he was achy and he thought he had a bacterial infection"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "The next day he felt even worse in the chest from taking the Mucinex and he was told to go to urgent care". The events "he was told that his kidneys were a little weak when he went into the ER that Friday because he hadn't eaten or drank anything for two days" and "then he thought it was allergies, the next day it got even worse, he was achy and he thought he had a bacterial infection" required emergency room visit. The patient underwent the following laboratory tests and procedures: Flu test: Unknown results, notes: They tested for the flu and Covid; Unknown results, notes: States they tested him for flu or pneumonia and Covid: Oxygen saturation: 86 to 87, notes: His Pulse OX was 86 to 87 so they said he was able to go home and to start this medicine Paxlovid; SARS-CoV-2 test: Unknown results, notes: They tested for the flu and Covid. States they came back and said he has Covid; Positive, notes: States they came back and said he has Covid. Therapeutic measures were taken as a result of drug ineffective, Covid-19, renal disorder, pain, chest discomfort. Clinical Information: Caller male, aged 63, just finished taking the Paxlovid started on 13May2022 and ended the following Wednesday. He is concerned because in each dose that he received had one pink pill punched out. He isn't sure if it was tampered with or if maybe the nurses were saving it for themselves in case there's a shortage. On the paperwork from Pfizer it says to take two pink pills and one white pill two times a day for 5 days. It doesn't mention anything about lower doses or pills missing. It even talks about medicines not to take like blood pressure medicines, and lovastatin but not missing pills. He was told that his kidneys were a little weak when he went into the ER that because he hadn't eaten or drank anything for two days. His kidney levels were always fine but then after getting Covid shots he hears it can cause liver problems, heart problems, kidney problems, so maybe that's why his kidneys are having problems, after the vaccine. He still has a cough and tickle in his throat and is still blowing his nose and having green mucus. He isn't sure if because he didn't take the full amount of Paxlovid if he still has a little Covid left over or if its just allergies. He can't get a hold of anyone at the (withheld) to get Zyrtec, or what his brother takes which is Zyrtec D which has the decongestant too. He has a past medical history of 4 fusions in back, two hernias and hip replacements. He was told he'd be walking in two days but he crawled around for 2 weeks. Its all about money with the government, they don't want to do the surgery and then once they get paid you're just a number in the pickle barrel. He had to smoke marijuana for three years because they wouldn't give him pain medication even though his joint socket was bone on bone. Felt like he had pneumonia, feels like you're suffocating, anaconda around the throat, second dose felt better and better. Blow my nose and green stuff still coming out, infection somewhere, bronchitis somewhere. He believes he got Covid from going to the (name-withheld) that previous Sunday and initially just thought it was due to a long day and having a hip replacement 6 months ago. Then he thought it was allergies, the next day it got even worse, he was achy and he thought he had a bacterial infection. He called his doctor at the (withheld) and they told him its probably allergies and told him to take Mucinex and Tylenol. The next day he felt even worse in the chest from taking the Mucinex and he was told to go to urgent care. It was a four hour wait and he'd have to wait in his hot car so he went to the ER at the (withheld). They tested for the flu and Covid. His Pulse OX was 86 to 87 so they said he was able to go home and to start this medicine Paxlovid. It felt like he had pneumonia, like he was suffocating and an anaconda was wrapped around his throat. He was in the ER 4 hours and he took the first dose right away so he could start feeling better on the drive home. By the second dose he was feeling better and better. He stopped the medicine last Wednesday and now when he blows his nose green stuff is coming out which he thinks means the Covid is back which he doesn't think it is or there's another infection or its allergies. States he is not calling to get in trouble. States on the 13th he was getting sinus problems, he usually has allergies this time of year gets bad. States he thought it was allergies. States that the day before he cut the grass. States he has had 2 hip replacements and 3 back surgeries. States he called his doctor and they said probably sinus and to get Mucinex and Tylenol and he went and got that and took that for 1 day. States he felt worse and could tell his body started aching. Caller states he normally gets bronchitis with allergies, he had pneumonia as a kid. Caller states he can tell bacteria infection. Caller states he goes to the (withheld) and they said to come down and they would test him. States there is an emergency clinic and he had to wait outside for 4 hours and it was hot that day so he went to the (withheld) emergency. States they tested him for flu or pneumonia and Covid. States they came back and said he has Covid. Caller states he has all the vaccinations, he was lucky he didn't get it full blast. States they gave him the medication Paxlovid. Caller states that the paperwork says to take 2 pink ones and a white one, so 3 for each dose. Caller states they took out a pink one and he only had 1 pink one and 1 white one for 5 days. Caller states they took them out and didn't say anything, maybe there is a shortage that came up and they didn't have enough medication or they are storing them for themselves. Caller states he didn't know this and he read the thing that came with it. States that 90-95% is gone and he doesn't know if it is allergies but he still gets a cough in his chest. States he has not talked to the doctor yet. Caller would like to find out from us, should he had been taking 3 pills each dose. Caller states he might not have gotten the full effect and he wouldn't have to look for a decongestant. States he feels it in his chest. Caller is wondering about dosing, if they did take the medication. States they took 1 of the pink away so he took 2 in the morning and 2 at night. States the paper says it should have been 2 pink and 1 white with each dose. States he took 1 pink and 1 white with all the doses he did. Caller states when he called Monday he asked about Zyrtec D and asked about cough syrup and he has not gotten a call back yet. States before he calls them he is going to cross his dots. Caller states to him if we say to take 3 pills, they cut his dosage in half. That is what he doesn't understand. Caller is asking in call handlers opinion has the call handler ever gotten a medication from the pharmacy and they had already taken pills out. Caller states he was not thinking because he felt so bad, almost like the flu, like pneumonia. States he didn't care, he took the pills and went to bed and took two more later and felt better and read the information and it says you are supposed to take 3. States he doesn't want no one calling the (withheld) and cause a disturbance as he is the one that has to go back. Caller states he complained about his first doctor with the hip operation, they messed up with his insurance and he had his hip done and they changed the insurance and he got stuck with everything. States if you have a sore throat and they give you penicillin and tell you take 2 a day and you come back and read the paper and it says to take 3 a day, that is like him, it's like he took 3/4 of the medication. Caller states the one they removed probably killed the virus. Caller states he doesn't want to accuse them of anything. States they would probably say (name withheld) we never heard of anyone tampering and he trusts them. States when he calls back it's like it's his fault. States at night he still gets a whooping cough, sometimes he can't get the phlegm up out of his lungs and he thinks it's because he didn't take his medication. States the papers say to take 3 tablets in the morning and 3 at night and do no chew. States he should have been taking 3 and only got 2. Caller clarifies he got the Pfizer BioNTech Covid-19 vaccine. Caller states his card has a lot of dates on it. States he sees Jun2021 and EM9810 and sees 05Feb2021 and 26Feb2021 and the 3rd one he can't read, it looks like a 1 and then 18 and 2021, it's folded. States he also sees 30Jun2021 and the sticker says 31May2022. States he sees 31Jun2021 on the 1st one, 30Jun2021 on the 2nd and 31May2022 on the 3rd. States for dates he sees 05Feb2021, 26Feb2021 and he can't tell the last one, it's either 1 or x and then 18 and 2021. States the lot number provided was for his 1st dose. Caller states at his last hip check he was told we were coming out with another vaccine and that he should wait a few weeks since he was sick 3 weeks ago. Caller is thinking should he get another shot, if he gets it again and they don't have enough medication. States he finds it ironic that they would take medication out of his. States the paper says 3 tablets and he only took 1 pink and 1 white. Additional information: This is a notification generated from the system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes//Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: AE Ref No.(CC): # PR ID (CR): 7212220 Product-Description (CR): Compound BNT 162 Covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1.Lot-# (CR): EM9810. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 vaccine lot EM9810 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EM9810, fill lot EM9806, and the formulated drug product lot EM9808. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.