chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Biopsy kidney, Blood albumin, Blood creatinine, Light chain analysis
Clinical narrative: a severe local reaction to the 2 vaccines she received in April 2021; This is a literature report for the following literature source(s):   A 66-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 DM" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LOCAL REACTION (medically significant) with onset Apr2021, outcome "unknown", described as "a severe local reaction to the 2 vaccines she received in April 2021". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) Negative; Biopsy kidney: (unspecified date) results pending; Blood albumin: (unspecified date) 2.2 g/dl; Blood creatinine: (unspecified date) 0.92 mg/dl; Light chain analysis: (unspecified date) negative; Serology test: (unspecified date) Negative; Urine albumin/creatinine ratio: (May2021) less than 30; (Apr2022) greater than 22000, notes: increased.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported event of local reaction and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202200130550 Same article/patient/drug; different event;
Sex: F
Vaccine: COVID19
Symptoms: Local reaction, Serology test, Urine albumin/creatinine ratio
Clinical narrative: a severe local reaction to the 2 vaccines she received in April 2021; This is a literature report for the following literature source(s):   A 66-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 DM" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LOCAL REACTION (medically significant) with onset Apr2021, outcome "unknown", described as "a severe local reaction to the 2 vaccines she received in April 2021". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) Negative; Biopsy kidney: (unspecified date) results pending; Blood albumin: (unspecified date) 2.2 g/dl; Blood creatinine: (unspecified date) 0.92 mg/dl; Light chain analysis: (unspecified date) negative; Serology test: (unspecified date) Negative; Urine albumin/creatinine ratio: (May2021) less than 30; (Apr2022) greater than 22000, notes: increased.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported event of local reaction and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202200130550 Same article/patient/drug; different event;
Sex: F
Vaccine: 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: COVID 19 Treatment (Paxlovid). Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Treatment start date: 09Dec2022, treatment stop date: 13Dec2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Off label use, Pain, Product use issue, Pyrexia
Clinical narrative: little aches; small fever; Pfizer Bivalent GH9693/ Flu shot injection; Pfizer Bivalent GH9693/ Flu shot injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 26Feb2021, Anatomical site of injection: Right arm, Lot# EN6200), administration date: 26Feb2021, for COVID-19 immunization; BNT162b2 (Dose: 2nd , Date: 19Mar2021, Anatomical site of injection: Left arm, Lot# EN6207), administration date: 19Mar2021, for COVID-19 immunization; BNT162b2 (Dose: 3rd , Date: 28Oct2021, Anatomical site of injection: Arm, Lot# FF2589), administration date: 28Oct2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "Pfizer Bivalent GH9693/ Flu shot injection"; PAIN (non-serious), outcome "unknown", described as "little aches"; PYREXIA (non-serious), outcome "unknown", described as "small fever".  Additional information: Vaccine was not administered at military facility. Dose 4 given at their clinic at the mall. Doses 1, 2, 3 was the worse. Dose 4 little aches, small fever. Not in bed all day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201232892 same patient/drug/event, different dose;US-PFIZER INC-202201233151 same patient/drug/event, different dose;US-PFIZER INC-202201233152 same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash
Clinical narrative: rash in her biceps; some allergic reactions to the vaccine to her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Cancer patient with lymphoma and leukemia; "lymphoma" (unspecified if ongoing); "leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "some allergic reactions to the vaccine to her arm"; RASH (non-serious), outcome "unknown", described as "rash in her biceps".  Additional information: She had her 2 shots vaccine from Pfizer and she had some allergic reactions to the vaccine to her arm.  The reporter reported that she had a rash in her biceps.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): UNT-2022-031105 (regulatory authority).  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), first regimen since 29Oct2020 (Batch/Lot number: unknown) and second regimen (Lot number: 2102219, Expiration Date: 30Nov2023) at 54 ug 4x/day (54 microgram (9 breaths), four times a day) for pulmonary arterial hypertension; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Secondary pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: OPSUMIT; SILDENAFIL CITRATE. The following information was reported: DIARRHOEA (non-serious) with onset 17Nov2022, outcome "unknown", described as "Diarrhea"; VOMITING (non-serious) with onset 17Nov2022, outcome "unknown". The events "vomiting" and "diarrhea" required emergency room visit. The action taken for treprostinil sodium was unknown.  Additional information: The patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 29Oct2020 for secondary pulmonary arterial hypertension. The current dose was reported as 54 microgram (9 breaths), four times a day (QID) via inhalation (IH) route. On 17Nov2022, 2 years and 20 days after initiating Tyvaso, the patient went to emergency room after receiving COVID [coronavirus disease] and flu shot as she had vomiting (vomiting) and diarrhea. Action taken with Tyvaso was not reported for the events of vomiting and diarrhoea. At the time of reporting, the outcome of vomiting and diarrhoea was unknown. The reporter did not provide causality for the events of vomiting and diarrhoea. The reporter's causality for the events of vomiting and diarrhoea with COVID-19 vaccine and influenza vaccine was considered to be possibly related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 20Dec2022, outcome "unknown" and all described as "COVID positive". The event "covid positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Positive. Additional information: Patient had COVID positive as per ER visit on 20Dec2022 now patient question was how was she able to get COVID when she had all them shots.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have some rashes in different area of my body; 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 (BNT162B2), as dose 4 (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 (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "not recovered", described as "I have some rashes in different area of my body".  Additional information: The reporter reported health issue that happened after getting 4th dose of COVID vaccine. Around last Aug the patient got 4th dose of vaccine. After couple weeks the patient realized that the patient have some rashes in different area of body. In the past months, the patient have been trying to find a suitable solution to improve this problem by referring to specialist doctors, but so far have not gotten any results and still in suffering because of rashes on body.  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: Arthralgia
Clinical narrative: sore shoulder; This is a spontaneous report received from a non-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: ARTHRALGIA (non-serious), outcome "recovered", described as "sore shoulder ".  Additional information: The patient had all my Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. I have never had a reaction to any of them except a sore shoulder for a day or two.  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-202201389812 same patient/vaccine/event, different dose;US-PFIZER INC-202201389813 same patient/vaccine/event, different dose;US-PFIZER INC-202201389811 same patient/vaccine/event, different dose.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Caller took Paxlovid; Caller took Paxlovid; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2022 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller took Paxlovid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I've had 2 shots but still contacted Covid; I've had 2 shots but still contacted Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A "27 (units not provided)" male patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I've had 2 shots but still contacted Covid".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient 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: ILLNESS (non-serious), outcome "unknown", described as "got sick".  Additional information: Caller stated that she received a Pfizer Covid-19 Vaccine and she was under the research study and she wanted to be connected to a specific facility. A second person took over the call and stated that the patient who got the shot got sick and wanted to get the number to get the money that was not put on the card.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19/states that her and her mom tested positive for Covid 19 on Saturday, but their symptoms started Friday night; tested positive for Covid 19/states that her and her mom tested positive for Covid 19 on Saturday, but their symptoms started Friday night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Blood pressure high" (ongoing), notes: has had for years, may have been 36 or 37 when she was diagnosed; "Obesity" (ongoing), notes: started when she stopped using drugs, that was 6 years ago. There were no concomitant medications. The patient did not receive any other vaccinations within four weeks prior to the last administration date of the Pfizer Covid 19 vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "recovering" and all described as "tested positive for Covid 19/states that her and her mom tested positive for Covid 19 on Saturday, but their symptoms started Friday night". The patient stated that her and her mom tested positive for Covid 19 on Saturday (17Dec2022), but their symptoms started Friday night (16Dec2022). Her brother also has Covid 19. Patient stated that they got it while working at the nursing home. Patient stated that they were feeling a lot better.  She had also been having diarrhea, but she did not know if it's from the PAXLOVID or Covid 19. The patient underwent the following laboratory tests and procedures: Covid 19 test: (17Dec2022) Positive. Therapeutic measures were taken as a result of 'drug ineffective, covid-19' which included PAXLOVID (Batch/lot number: GF3597, Expiry Date: Apr2023) which the patient started on 17Dec2022 at 300mg and 100mg, 3 tablets twice daily. The patient stated that her fever had been gone for 24 hours, and she was going to her job on 22Dec2022 to retest to see if she is still positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: He said he and his whole family got these vaccines and they were sick all the time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient 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: ILLNESS (non-serious), outcome "unknown", described as "He said he and his whole family got these vaccines and they were sick all the time".  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-PV202200130513 same reporter/drug/event, different patients;US-PFIZER INC-202201394111 same reporter/drug, different AE/patients.;
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: terrific headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient 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: HEADACHE (non-serious), outcome "unknown", described as "terrific headache".  Additional information: Patient had the new shot and had a terrific headache. Patient was asking if she can take tylenol.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he got vaccinated and he got sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A male patient 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: ILLNESS (non-serious), outcome "unknown", described as "he got vaccinated and he got sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Drug ineffective, Interchange of vaccine products, Stress, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; Stress/Felt stressed because lot going on; Moderna COVID-19 vaccine (Elasomeran)/Pfizer BioNTech COVID-19 vaccine; Low energy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4141712.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164826), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "Low energy"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown", described as "Moderna COVID-19 vaccine (Elasomeran)/Pfizer BioNTech COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19"; STRESS (non-serious), outcome "unknown", described as "Stress/Felt stressed because lot going on". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "moderna covid-19 vaccine (elasomeran)/pfizer biontech covid-19 vaccine", "covid-19" and "stress/felt stressed because lot going on" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "low energy" related to BNT162b2, BNT162b2 omi ba.4-5.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and on the compatibility with the drug's known safety profile, the company considers that a causal relationship between the reporter event-drug ineffective, suspected COVID-19,asthenia and stress  and suspect drug BNT162B2 cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a shipment which arrived yesterday of an entire lot ofthe Bivalent Covid-19 vaccines which had already expired; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received a shipment which arrived yesterday of an entire lot ofthe Bivalent Covid-19 vaccines which had already expired".  Additional information: The product was administered.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site pain
Clinical narrative: soreness in the arm and armpit of the left side where the vaccine was administered; soreness in the arm and armpit of the left side where the vaccine was administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An 11-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 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: VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2022, outcome "unknown" and all described as "soreness in the arm and armpit of the left side where the vaccine was administered".  Additional information: The soreness started the day after receiving the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: Effusive Constrictive Pericarditis After Covid-19 Vaccination; This is a literature report.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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. The following information was reported: PERICARDITIS CONSTRICTIVE (medically significant), 4 days after the suspect product(s) administration, outcome "recovering", described as "Effusive Constrictive Pericarditis After Covid-19 Vaccination". The event "effusive constrictive pericarditis after covid-19 vaccination" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102.7 Centigrade; Chest X-ray: noncontributory.; C-reactive protein: 17.18 mg/dl; Echocardiogram: Showed a small fibrinous circumferential pericardi, notes: effusion with no evidence of cardiac tamponade; however, there was an interventricular septal bounce suggestive of effusive-constrictive pericarditis; Electrocardiogram: revealed diffuse T wave inversions; autoimmune workup: Negative; Negative; Magnetic resonance imaging: This diastolic septal bounce was also seen, notes: along with a pericardial enhancement measuring up to 0.2 cm in thickness; Nucleic acid test: negative; Troponin: negative x2; White blood cell count: 13.6, notes: unit:Thou/uL. Therapeutic measures were taken as a result of pericarditis constrictive.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event Pericarditis constructive  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Magnetic resonance imaging, Nucleic acid test, Pericarditis constrictive, Troponin
Clinical narrative: Effusive Constrictive Pericarditis After Covid-19 Vaccination; This is a literature report.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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. The following information was reported: PERICARDITIS CONSTRICTIVE (medically significant), 4 days after the suspect product(s) administration, outcome "recovering", described as "Effusive Constrictive Pericarditis After Covid-19 Vaccination". The event "effusive constrictive pericarditis after covid-19 vaccination" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102.7 Centigrade; Chest X-ray: noncontributory.; C-reactive protein: 17.18 mg/dl; Echocardiogram: Showed a small fibrinous circumferential pericardi, notes: effusion with no evidence of cardiac tamponade; however, there was an interventricular septal bounce suggestive of effusive-constrictive pericarditis; Electrocardiogram: revealed diffuse T wave inversions; autoimmune workup: Negative; Negative; Magnetic resonance imaging: This diastolic septal bounce was also seen, notes: along with a pericardial enhancement measuring up to 0.2 cm in thickness; Nucleic acid test: negative; Troponin: negative x2; White blood cell count: 13.6, notes: unit:Thou/uL. Therapeutic measures were taken as a result of pericarditis constrictive.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event Pericarditis constructive  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Effusive Constrictive Pericarditis After Covid-19 Vaccination; This is a literature report.  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (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. The following information was reported: PERICARDITIS CONSTRICTIVE (medically significant), 4 days after the suspect product(s) administration, outcome "recovering", described as "Effusive Constrictive Pericarditis After Covid-19 Vaccination". The event "effusive constrictive pericarditis after covid-19 vaccination" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102.7 Centigrade; Chest X-ray: noncontributory.; C-reactive protein: 17.18 mg/dl; Echocardiogram: Showed a small fibrinous circumferential pericardi, notes: effusion with no evidence of cardiac tamponade; however, there was an interventricular septal bounce suggestive of effusive-constrictive pericarditis; Electrocardiogram: revealed diffuse T wave inversions; autoimmune workup: Negative; Negative; Magnetic resonance imaging: This diastolic septal bounce was also seen, notes: along with a pericardial enhancement measuring up to 0.2 cm in thickness; Nucleic acid test: negative; Troponin: negative x2; White blood cell count: 13.6, notes: unit:Thou/uL. Therapeutic measures were taken as a result of pericarditis constrictive.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported event Pericarditis constructive  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Headache, Pain, Pruritus
Clinical narrative: Itchy; Headache; Body aches; She had no energy; A low grade fever; Diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis without rheumatoid factor, multiple sites" (unspecified if ongoing), notes: Rheumatoid arthritis without rheumatoid factor, multiple sites; "Pain" (unspecified if ongoing). Concomitant medication(s) included: MODERNA COVID-19 VACCINE taken for covid-19 immunisation; OXYCODONE. Past drug history included: Percocet, reaction(s): "Hurt her stomach". The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itchy"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; ASTHENIA (non-serious), outcome "unknown", described as "She had no energy"; PYREXIA (non-serious), outcome "unknown", described as "A low grade fever"; 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: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Itchy; Headache; Body aches; She had no energy; A low grade fever; Diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis without rheumatoid factor, multiple sites" (unspecified if ongoing), notes: Rheumatoid arthritis without rheumatoid factor, multiple sites; "Pain" (unspecified if ongoing). Concomitant medication(s) included: MODERNA COVID-19 VACCINE taken for covid-19 immunisation; OXYCODONE. Past drug history included: Percocet, reaction(s): "Hurt her stomach". The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itchy"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; ASTHENIA (non-serious), outcome "unknown", described as "She had no energy"; PYREXIA (non-serious), outcome "unknown", described as "A low grade fever"; 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: F
Vaccine: COVID19, FLUX
Symptoms: Guillain-Barre syndrome, Neurological symptom
Clinical narrative: Guillain-Barre syndrome; neurological symptoms; Initial information received on 21-Dec-2022 by health care professional regarding an unsolicited valid serious literature case.  This case involves a 39-year-old female patient who experienced Guillain-Barre syndrome (GBS) while receiving vaccines BNT162B2 (The Pfizer BioNTech vaccine against COVID-19 (corona virus 2019)) and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received the second dose of BNT162b2 and Fluzone® IIV4 INFLUENZA VACCINE (QUADRIVALENT) vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, and approximately 10 days later presented with neurological symptoms (neurological symptom) which required hospitalization for 21 days. Subsequently, the patient was discharged in stable and improved condition and met criteria for Brighton Level 2 diagnostic certainty for GBS.  Action taken: Not applicable Corrective treatment: unknown Outcome: Recovering / Resolving Seriousness criteria: Medically significant and hospitalization Reporter causality: Related; Sender's Comments: Sanofi company comment dated 27-DEC-2022: This case involves a 39-year-old female patient who experienced Guillain-Barre syndrome (GBS) while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based upon the reported information, the role of a vaccine cannot be assessed due to compatible temporal relationship of ADR to the vaccine. However, lack of information regarding the past medications, family history and medical history details precludes a comprehensive assessment in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: the senior flu shot in Oct. Got the flu first week in Dec; Initial information received on 15-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced the senior flu shot in oct. got the flu first week in Dec while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, dose, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious the senior flu shot in oct. got the flu first week in Dec (influenza) (unknown latency).  Lab data was not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (the senior flu shot in Oct. Got the flu first week in Dec).  At time of reporting, the outcome was Unknown for the event the senior flu shot in oct. got the flu first week in Dec.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information was received on 19-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age female patient who experienced flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with lot number, strength, formulation, dose not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.; Sender's Comments:  SanofiPVPortal20221220000617:
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 21-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age female patient who was sick after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient was sick (illness) (unknown latency) following the administration of influenza vaccine. Reportedly not getting it my mom got so sick after her shots not taking chance that will happen to me as for the boosters of covid they can stick it were the sun don't shine got it after first 2 shots.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got Type A flu anyway; Initial information received on 20-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got type A flu anyway after receiving vaccine Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation, route, expiry date and administration site not reported) for prophylactic vaccination.  On an unknown date the patient got type a flu anyway (influenza) (unknown latency) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event .  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: had flu; Initial information received on 20-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp (non healthcare professional)  This case involves an unknown age and unknown gender patient who had flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for flu (Influenza immunisation).  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Not Recovered / Not Resolved for the event had flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: just got over a 12 day flu bout; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who just got over a 12 day flu bout while receiving vaccine Influenza Vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number, expiry date, dose, strength, form, route, site was unknown) for Prophylactic vaccination.  On an unknown date the patient just got over a 12 day flu bout (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: got very sick from Flu; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who got very sick from Flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 1 DF (Dosage Form) dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, formulation, expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed got very sick from Flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.