Received Apr 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
idiopathic pleural effusion; This is a spontaneous report and received from Consumer or other non HCPs from medical information team. A 77-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, anatomical location Arm.), administration date: 03Jan2021, for Covid-19 immunization. The following information was reported: PLEURAL EFFUSION (medically significant) with onset 07Apr2021, outcome "not recovered", described as "idiopathic pleural effusion". The event "idiopathic pleural effusion" required physician office visit. Therapeutic measures were taken as a result of pleural effusion. Clinical course: Caller stated that his wife has been suffering from pleural effusion over the years. She has seen doctors and they don't know what the cause was so they consider it idiopathic. It started in April 2021 and so the caller was trying to figure out what had occurred about the time she was diagnosed and the only thing he found was that she took inoculation of Pfizer's covid vaccine. The first was 03Jan2021, the second 05Feb2021 and the third was 03Sep2021. She developed the pleural effusion between the second and third dose. He did some further research and found info f that there was a rare correlation between the covid vaccine and pleural effusion. He wanted to know if we had more information and what could be done about it. Reporter stated, they are calling for patient) Reporter stated, patient suffers from pleural effusion. She developed pleural effusion back in April of 2021. The pleural effusion that she has, has been with her at varying degrees requiring Thoracentesis from time to time, left her for a while, but it was back. The pleural effusion has been diagnosed as idiopathic. In other words, she has been through many different tests to determine whether it was a disease related, whether it was cancer related, whether it was blood related and it all came back negative. So, Patient husband trying to research what might be the cause. Patient husband tried to look back at what happened at the time that she was diagnosed with the pleural effusion. Again, that was on April 2021, to be exact, 07Apr2021 was when she was diagnosed initially. Care giver looked at what was going on in her life at that time and she had been inoculated for Covid-19 with the Pfizer vaccine (Hence, suspect captured as Covid-19 vaccine). The first vaccine was given on 03Jan2021, the second was on 05Feb2021, the third one was on 23Sep2021 and I will go as far as the fourth one, she has had many, the fourth one was on 23Mar2022. The information that reporter found was after trying to search to see if there was a correlation between pleural effusion and the Pfizer vaccine said that it was a very very rare case, but it does exist. It says that the correlation was rare in the word they used and it usually occurs between the second and third inoculation. Her pleural effusion occurred was diagnosed right in between the second and third inoculation. So, it gives me reason to investigate further and therefore the call. Reporter want to find out what Pfizer experience was with a correlation between pleural effusion and their vaccine." Reporter stated, "The drug name that was given. Whatever you were giving at the time for a Covid-19. The vaccination, I do not have it specifically handy, but I can find it because we were given cards. It says Pfizer EL2348, that might have been the batch. What I am reading from the card, it looks like it might have been the batch number. It says EL3249. Then second dose, it says 4264. It does not say specifically what the drug was." When probed to clarify the concern, reporter stated, Patient husband concern was they want to know if the Pfizer drug (vaccine) was the corporate that caused the pleural effusion. So, that was why he was asking if there was a correlation that you may have between your vaccination for Covid-19 that you were giving at that time and pleural effusion. he want to know if the drug affected his wife and caused possibly her Pleural effusion. So, he was asking if Pfizer has any data see if there was a correlation between the Pfizer the vaccination for Covid-19 and illness called plural effusion. Reporter stated patient still experiencing. Reporter stated regarding treatment There was none that you can take. There was none that we are aware of that you can take. When clarified if patient takes any other medications (Concomitant medications) Reporter stated, "She takes other medication, but he do not think she would permit me to tell you what they are. Reporter stated regarding facility details Well the first time she had it at a vaccination center which was down at and it was in Redacted facility because they were doing mass vaccinations and that was first and second one. I do not remember the name of the facility. It's a football facility in Redacted. The third and fourth vaccination were done at pharmacy and he believe it was done in the pharmacy in town. he believe it was on one street, and I do not know what the other cross street was. Reporter stated, She had the vaccine in her upper arm close to her shoulder, probably in her right side. he cannot be certain whether it was right or left. he mean, it depends upon when she got the inoculation. Sometimes she might have been right side, sometimes left side. Reporter stated, No. he already talked to your medical department. They gave me their number so that her doctor can get in touch with them directly and make a request for information in your data bank. there was a medical information request. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.