chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 13:00 as dose 2, single (Lot number: FH9894) at the age of 77 years, in left arm and on 22Oct2021 as dose 1, single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Known allergies: sulpha" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course and investigation of conclusion: Patient did not receive any medications within two weeks. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Headache
Clinical narrative: I am feeling very weak.; headache; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (COMIRNATY), on 23May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer, Caller states that he did not have any side effects with his other Covid19 vaccines.), for COVID-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "I am feeling very weak."; HEADACHE (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Pfizer booster shot; after that shot, I developed an onset of tinnitus and its been with me ever since; it's a radiator is going on in my head; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 18Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete:, Unknown manufacturer), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 18Nov2021, outcome "unknown", described as "Pfizer booster shot; after that shot, I developed an onset of tinnitus and its been with me ever since; it's a radiator is going on in my head".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200759702 Same reporter and drug, different patient
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: the doctor who was the head of vaccine group, took a covid 19 vaccine; he developed tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "the doctor who was the head of vaccine group, took a covid 19 vaccine; he developed tinnitus".  Additional Information: Reporter called Pfizer earlier and  reported an adverse reaction because reporter think it's important if a patient has any adverse reaction to let the drug company know with the understanding that, you know, we were in middle of the pandemic. And that, you know, it was more important to, you know, try to protect ourselves from the virus and do something than not do anything so that you wouldn't get sick. But that being said where do reporter get medical information about the Pfizer booster (Covid-19 Vaccine). Further stated that event happened after the Pfizer, my Pfizer booster shot, 18Nov2021. After that shot, I developed an onset of tinnitus and its been with me ever since, it's a radiator is going on in my head. So, what I want to understand is, I understand this is happening with other patient's as well, ok. I just go even to my primary care, he has seen patients (further clarifications unknown) with the same type of situation, where they had the vaccine and they developed tinnitus in their ears. At the (Name) clinic the doctor who was the head of vaccine group, took a covid 19 vaccine, and he was involved in the research of it, and he developed tinnitus (hence, split made by (Name)). So, there is a small group of that, it is a rare side effect but I want to know what Pfizer knows about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200759687 Same reporter and drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for Covid-19 after receiving Covid-19 vaccines; She tested positive for Covid-19 after receiving Covid-19 vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm, as dose 2, single (Batch/Lot number: unknown), in arm, as dose 3 (booster), single (Batch/Lot number: unknown), in arm and as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. 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 "She tested positive for Covid-19 after receiving Covid-19 vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: diagnosed with Covid-19 with an at home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She said after the diarrhea she was sitting in the kitchen and she was wondering so she went on the web and she said she has had Pfizer's regular shot and two boosters. She said massive diarrhea is a sign of Covid and she took a test that was sent through the mail from the government and the test came up positive and she almost threw up. She called her pulmonologist and left a message and he called her back and she said she has heard there are a lot of false positives and the doctor told her there are not that many false positives and he said he is prescribing Paxlovid and to go get it. Patient's Medical History (including any illness at time of vaccination)? None or Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity Illness/AE: Onset Date: Stop Date: If no Stop Date, check box if ongoing at time of last observation during or at end of event(s) Pertinent Details: Include surgical procedures and dates: No.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: she was exhausted and she laid down; arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she was exhausted and she laid down"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2), for covid-19 immunization, reaction(s): "stomach was kid of queasy", "arm hurts"; Bnt162b2 (DOSE 1), for Covid-19 Immunization, reaction(s): "exhausted", "arm was sore". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: pooping blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hemorrhoids" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "pooping blood". Clinical course: The reported stated that the patient got the booster shot and pooping blood. The patient had hemorrhoids already and thought that this may just be from patient's aggressive wiping due to patient's stress of getting COVID. The patient queried if poopy blood was side effect from getting booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 after immunization; COVID 19 after immunization; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "recovering" and all described as "COVID 19 after immunization". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN, notes: Covid symptoms.Clinical course included anti viral details product COVID 19 Treatment, brand Paxlovid, treatment start date 10May2022, treatment stop date 14May2022, indication Treatment of COVID-19. Adverse event Five days after completing five day course of paxlovid, Covid symptoms returned, mild fever, malaise, cough, congestion.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pyrexia, Rash
Clinical narrative: Fever; rash; vaccine given beyond expiration date; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4, (booster) single (Lot number: FK9729, Expiration Date: 23Mar2022) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (DOSE 3, Manufacturer unknown, Third shot: 29Sep2021, NDC: 59267-1000-1, LOT: EW0183, EXP: 30Nov2021), administration date: 29Sep2021, when the patient was 61-year-old, for COVID-19 Immunization; coviD-19 vaccine (DOSE: 2, Second Dose: 29Jan2021, LOT: EL0140, NDC, EXP: Unknown, Manufacturer unknown), administration date: 29Jan2021, when the patient was 60-year-old, for COVID-19 Immunization; covid-19 vaccine (DOSE: 1, First Dose: 8Jan2021, LOT: EL0140, NDC, EXP: Unknown, Manufacturer unknown), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 Immunization.  The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 18Apr2022, outcome "unknown", described as "vaccine given beyond expiration date"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; RASH (non-serious), outcome "unknown".  Additional information: She was notified yesterday (24May2022) by a health department that some doses of Pfizer-BioNTech COVID-19 Vaccine (orange cap) were expired. The original expiry date that they were told was 31May2022 and then they were notified that the real expiry date was 05May2022. The manufacture date of these vaccines printed on the vial was Sep2021.The vaccines were being stored in a refrigerator since 24Feb2022. According to the 10 week storage time and according to the caller, the expiry date would be 05May2022. Then, a dose of this vaccine was administered on 06May2022. Caller wanted to know if the vaccine could still be used. RA e-transmitting potential AE duplicate. She declined to be transferred this time, since she had no additional details to add. She also mentioned that she was among the patients that received the expired gray cap vaccine. She received a dose on 18Apr2022 and she had fever for 2 days. Suddenly during the call, caller was not able to hear me anymore. I could her hear but she could not.  Managed callback attempts as per attached "VR-Callback or Contact Attempts (v15.0)". Callback attempt #1: 25May2022, 10:22 AM. Able to reach (Name withheld) and continue the call. She was notified yesterday (24May2022) by a health department that some doses of Pfizer-BioNTech COVID-19 Vaccine (gray cap) were expired. The original expiry date that they were told was 31May2022 and then they were notified that the real expiry date was 23Mar2022.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose 4 (booster), single (Lot number: FH8027), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothryoid" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ARMOUR THYROID; SYNTHROID; NALTREXONE; TOPIRAMATE; BUSPIRONE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Four days after stopping Paxlovid and being symptom-free and testing negative on a home antigen test; Positive, notes: mild symptoms returned and a home antigen test showed positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral treatment for COVID 19 were started from 16May2022 to 21May2022. Patient reported symptom-free and testing negative on a home antigen test, mild symptoms returned, and a home antigen test showed positive for COVID. Adverse events start date: 25May2022, Known allergies: No.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient had Covid and got monoclonal antibodies and is asking "when should she have her Pfizer Covid19 booster vaccine; patient had Covid and got monoclonal antibodies and is asking "when should she have her Pfizer Covid19 booster vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient had Covid and got monoclonal antibodies and is asking "when should she have her Pfizer Covid19 booster vaccine".  Clinical Course: Reporter was calling on behalf of one of his female patients for information about the timing of the 4th dose of the Pfizer Covid19 vaccine. Caller states that his patient had COVID and got monoclonal antibodies and was asking when should she have her Pfizer Covid19 booster vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PT tested positive for a COVID-19 breakthrough infection-12 hours ago, Tuesday May 24th. Moderately ill and will require Doctor prescribed treatment.; PT tested positive for a COVID-19 breakthrough infection-12 hours ago, Tuesday May 24th. Moderately ill and will require Doctor prescribed treatment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022 at 13:00, outcome "recovering" and all described as "PT tested positive for a COVID-19 breakthrough infection-12 hours ago, Tuesday May 24th. Moderately ill and will require Doctor prescribed treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course-- Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Suspected COVID-19
Clinical narrative: positive for covid; positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (non-serious), DRUG INEFFECTIVE (non-serious), outcome "unknown" and all described as "positive for covid". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Feeling abnormal, Pain in extremity
Clinical narrative: She had soreness in her left arm every time; She is loosing her mind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing); "She has compromised lungs" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR, start date: Nov2021; NORVASC, start date: Nov2021; PLAVIX, start date: Nov2021; LIPITOR, start date: Nov2021. Vaccination history included: BNT162b2 (DOSE 1, lot: EN6202, All given in left arm), administration date: 11Mar2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "no reaction"; BNT162b2 (DOSE 2, lot: ER2613, All given in left arm), administration date: 01Apr2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "didn't feel like herself", "Stroke". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had soreness in her left arm every time"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She is loosing her mind". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She is 74 years old. So she is over 50. She has compromised lungs. She was aware not to get Covid form the beginning and that was personal. The booster she got in Dec. She had been sick before that. She had 2 weeks of something she thinks she had omicron but tested too early. She had small stroke. She got booster in early Dec and was fine. She had soreness in her left arm every time and she expected that and it didn't bother her.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: Irritation of skin and rash around injection site within a few hours of injection.; Irritation of skin and rash around injection site within a few hours of injection.; Flu-like symptoms later, much worse the next day; Body ache; sweating; chills; extreme fatigue; low fever (99-100); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female (not pregnant) patient received BNT162b2 (BNT162B2), on 24May2022 at 09:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Reflux" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Second dose), administration date: 23Mar2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Third dose), administration date: 16Nov2021, when the patient was 49-year-old, for COVID-19 immunization; BNT162b2 (First dose), administration date: 01Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "Body ache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "Flu-like symptoms later, much worse the next day"; SKIN IRRITATION (non-serious), VACCINATION SITE RASH (non-serious) all with onset 24May2022 at 12:00, outcome "recovering" and all described as "Irritation of skin and rash around injection site within a few hours of injection."; CHILLS (non-serious) with onset 24May2022 at 12:00, outcome "recovering"; FATIGUE (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "extreme fatigue"; PYREXIA (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "low fever (99-100)"; HYPERHIDROSIS (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin irritation, vaccination site rash, influenza like illness, pain, hyperhidrosis, chills, fatigue, pyrexia.  Additional information: Irritation of skin and rash around injection site within a few hours of injection. Flu-like symptoms later, much worse the next day. Body ache, sweating, chills, extreme fatigue, low fever (99-100). The patient was tested COVID-19 positive prior to vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Skin irritation, Vaccination site rash
Clinical narrative: Irritation of skin and rash around injection site within a few hours of injection.; Irritation of skin and rash around injection site within a few hours of injection.; Flu-like symptoms later, much worse the next day; Body ache; sweating; chills; extreme fatigue; low fever (99-100); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female (not pregnant) patient received BNT162b2 (BNT162B2), on 24May2022 at 09:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Reflux" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy"; Levaquin, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Second dose), administration date: 23Mar2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Third dose), administration date: 16Nov2021, when the patient was 49-year-old, for COVID-19 immunization; BNT162b2 (First dose), administration date: 01Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "Body ache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "Flu-like symptoms later, much worse the next day"; SKIN IRRITATION (non-serious), VACCINATION SITE RASH (non-serious) all with onset 24May2022 at 12:00, outcome "recovering" and all described as "Irritation of skin and rash around injection site within a few hours of injection."; CHILLS (non-serious) with onset 24May2022 at 12:00, outcome "recovering"; FATIGUE (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "extreme fatigue"; PYREXIA (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "low fever (99-100)"; HYPERHIDROSIS (non-serious) with onset 24May2022 at 12:00, outcome "recovering", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin irritation, vaccination site rash, influenza like illness, pain, hyperhidrosis, chills, fatigue, pyrexia.  Additional information: Irritation of skin and rash around injection site within a few hours of injection. Flu-like symptoms later, much worse the next day. Body ache, sweating, chills, extreme fatigue, low fever (99-100). The patient was tested COVID-19 positive prior to vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing), notes: Mild asthma; "Known allergies: Sulfa based drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin antibiotics, reaction(s): "Known allergies: Drug allergy", notes: Augmentin Antibiotics. The following information was reported: COVID-19 (medically significant) with onset May2022, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: Reported event: red rash from head to chest, throat swelling while taking COVID symptoms were mild after taking first dose on 05May2022 and stopping the medication on 07May2022, COVID symptoms came back worse than before taking the medication. COVID symptoms started again on 10May2022. reaction from 07May2022 13:00 to 08May2022. Treatment was received for the adverse event BENADRYL.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dose Number: 1, 2, 3, COVID 19 Treatment; Dose Number: 1, 2, 3, COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0173), in left arm and on 20Nov2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Fish allergy: Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Dose Number: 1, 2, 3, COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 31.6; SARS-CoV-2 test: (unspecified date) Negative; (May2022) mild covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 14Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient receive Paxlovid to treat drug ineffective, covid-19, treatment start date: 12May2022, treatment stop date: 16May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nucleic acid test, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "myositis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Nucleic acid test: Positive; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Confusional state, Facial paralysis, Fatigue, Herpes virus infection
Clinical narrative: COVID test result: Positive/30Dec2021; COVID test result: Positive/30Dec2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: WN6201), in left arm and on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "COVID test result: Positive/30Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive, notes: COVID test type post vaccination: Nasal swab.  Clinical course: Regular chills, fatigue, fever etc. from the first dose in February. Heightened response on 07Mar dose. On 27Mar experienced increasing and moderately severe trigeminal nerve pain on left side of face. Patient lid round this was reduced and affected slightly drooping, increasing fatigue and confusion. Reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose. Vision blurred on left eye and photosensitivity. Patient received Valcyclovir for treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Photosensitivity reaction, SARS-CoV-2 test, Trigeminal neuralgia, Vision blurred
Clinical narrative: COVID test result: Positive/30Dec2021; COVID test result: Positive/30Dec2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: WN6201), in left arm and on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "COVID test result: Positive/30Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive, notes: COVID test type post vaccination: Nasal swab.  Clinical course: Regular chills, fatigue, fever etc. from the first dose in February. Heightened response on 07Mar dose. On 27Mar experienced increasing and moderately severe trigeminal nerve pain on left side of face. Patient lid round this was reduced and affected slightly drooping, increasing fatigue and confusion. Reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose. Vision blurred on left eye and photosensitivity. Patient received Valcyclovir for treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID test result: Positive/30Dec2021; COVID test result: Positive/30Dec2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: WN6201), in left arm and on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "COVID test result: Positive/30Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) Positive, notes: COVID test type post vaccination: Nasal swab.  Clinical course: Regular chills, fatigue, fever etc. from the first dose in February. Heightened response on 07Mar dose. On 27Mar experienced increasing and moderately severe trigeminal nerve pain on left side of face. Patient lid round this was reduced and affected slightly drooping, increasing fatigue and confusion. Reactivation of herpes or shingles from centerline of chin completely around the right side of mouth all the way up to the bottom of the nose. Vision blurred on left eye and photosensitivity. Patient received Valcyclovir for treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 18Mar2021 as dose 2, single (Lot number: EN6204) and on 27Sep2021 as dose 3 (booster), single (Lot number: FC3181), in left arm for covid-19 immunisation. The patient relevant medical history included: "ADHD" (unspecified if ongoing), "depression" (unspecified if ongoing), "anxiety" (unspecified if ongoing), "migraines" (unspecified if ongoing), "chronic constipation" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE, MOTEGRITY, TROKENDI XR, TIZANIDINE, MAGNESIUM GLYCINATE, VITAMIN D3, B-COMPLEX [VITAMIN B COMPLEX], ZINC, NAPROXEN SODIUM, FLUOXETINE. Past drug history included: N/a, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive (Day 1) via rapid antigen test (RAT), Negative, notes: Symptoms were reduced, began testing negative on Day 6 via RAT. Tested negative via RAT from day 6-9, Positive, notes: bright red positive on RAT on Day 10, Positive, notes: I ended up testing positive via RAT from day 10 - 17, during which time I became symptomatic again with intense sinusitis like congestion. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical Course: Product was COVID 19 Treatment and brand was Paxlovid. Treatment was started 09May2022 and stopped 14May2022. Indication was Treatment of COVID-19.  Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6198, EN6204, FC3181 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 EN6198, fill lot EN5330, EN6204, fill lot EN5335, FC3181, fill lot EY0567 and the formulated drug product lot EN5319, EN5325, FE3195. 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.   SUSPECT PRODUCT is under agreement with SOCIETA PRODOTTI ANTIBIOTICI SPA.