chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine administered past its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 2:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Vaccines went into 2-8 degree Celsius thaw state on or about 20-Dec-2021  No treatment medication information provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 3:39 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received booster dose.   Treatment medications were not reported.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 05 Feb 2022; The patient received vaccine past its 30 days of an expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 05 Feb 2022) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 1:54 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Feb-2022 at 1:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 05 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received vaccine past its 30 days of an expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 05 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had a census ethnicity of any race. The patient had received the vaccine dose number as  booster. No concomitant medications were reported. It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 12:52 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Mar-2022 at 12:52 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The patient received vaccine past its 30 days expiry date on 19-Mar-2022 at 12:52:43 PM. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 3:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.   This case was linked to MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  MOD-2022-542869:Master Case
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  The patient received vaccine past its 30 day expiry date on 02-Apr-2022 at 12:00:01, second booster. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment medications were provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 2:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Apr-2022 at 2:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient took the second booster dose on 01-Apr-2022 at 14:17:07
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 11:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 11:28 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had received booster dose. It was reported that patient had received lot 066H21A past its 30 days expiry date. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022 at 4:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had received booster dose. It was reported that patient had received lot 066H21A past its 30 days expiry date. No treatment drug information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 12:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 12:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022 at 1:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Mar-2022 at 1:29 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 07-Mar-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received vaccine past its 30 day expiry date The vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until it manufactured expiry date of 04-Apr-2022. The patient received booster dose.  No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022; Expired Vaccine Used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no known drug allergy or had no food and medication allergy patent had no acute illness.   On 20-Apr-2022 at 11:39 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:39 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and  date administered on 20 Apr 2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Dose administered past the 30 day storage on the refrigerator Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25-Feb-2022. The vial had not undergone any temperature excursion.  No treatment medications were reported
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood immunoglobulin M, General physical health deterioration, Immunisation, Off label use
Clinical narrative: The caller has received 4 shots; The caller has received 4 shots; She mentioned that she had some moderate diseases as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient 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, Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "The caller has received 4 shots"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "She mentioned that she had some moderate diseases as well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Transferring agent stated, "I have caller on the line she is a consumer. So, she mentioned after getting vaccinated she was travelling outside the company and she had some adverse events. She mentioned that she had some moderate diseases as well (no details available regarding the disease hence, captured as event as per the verbatim). She had some side effects after getting vaccinated so, she also wanted to reported this because she mentioned that even though that she got vaccinated she still experienced or she had some experiences for an adverse event".  QR Comment: As manufacturer name could not be probed over the call hence, is this a Pfizer product tab left unchecked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: updated event from Extra dose administered to "off label use' and booster". Updated dose description.  Follow-up (21Apr2022): This is a follow-up spontaneous report received from a contactable consumer (Patient) reported for herself that: Program ID: [159558]. Updated information: Classification added, Protect Confidentiality Unticked. New event She mentioned that she had some moderate diseases as well added, LRN added.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: The caller has received 4 shots; The caller has received 4 shots; She mentioned that she had some moderate diseases as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient 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, Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), outcome "unknown" and all described as "The caller has received 4 shots"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "She mentioned that she had some moderate diseases as well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Transferring agent stated, "I have caller on the line she is a consumer. So, she mentioned after getting vaccinated she was travelling outside the company and she had some adverse events. She mentioned that she had some moderate diseases as well (no details available regarding the disease hence, captured as event as per the verbatim). She had some side effects after getting vaccinated so, she also wanted to reported this because she mentioned that even though that she got vaccinated she still experienced or she had some experiences for an adverse event".  QR Comment: As manufacturer name could not be probed over the call hence, is this a Pfizer product tab left unchecked.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: updated event from Extra dose administered to "off label use' and booster". Updated dose description.  Follow-up (21Apr2022): This is a follow-up spontaneous report received from a contactable consumer (Patient) reported for herself that: Program ID: [159558]. Updated information: Classification added, Protect Confidentiality Unticked. New event She mentioned that she had some moderate diseases as well added, LRN added.  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: Antibody test, Blood immunoglobulin M, General physical health deterioration, Immunisation, Off label use
Clinical narrative: got the Covid-19 Virus and had a moderate disease; got the Covid-19 Virus and had a moderate disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Jan2022 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "got the Covid-19 Virus and had a moderate disease".  Clinical Course: Verbatim and Event Description: Mentioned that she got her 4th booster shot last 05Jan and took a trip to withheld and got the Covid-19 Virus and had a moderate disease. She mentioned that she had a strong breakthrough case even though she had the four shots from Pfizer. Medical Information (MI): YES: Customer and/or medical inquiry forwarded or referred to MI  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: Drug ineffective, Suspected COVID-19
Clinical narrative: got the Covid-19 Virus and had a moderate disease; got the Covid-19 Virus and had a moderate disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 05Jan2022 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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "got the Covid-19 Virus and had a moderate disease".  Clinical Course: Verbatim and Event Description: Mentioned that she got her 4th booster shot last 05Jan and took a trip to withheld and got the Covid-19 Virus and had a moderate disease. She mentioned that she had a strong breakthrough case even though she had the four shots from Pfizer. Medical Information (MI): YES: Customer and/or medical inquiry forwarded or referred to MI  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: Antibody test, Blood immunoglobulin G, CD4 lymphocytes, COVID-19, Drug ineffective
Clinical narrative: This is a non-interventional study report received from a contactable reporter(s) (Other HCP) for the following literature source(s): A subject (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; Janssen Covid-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pcv13, for immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", described as "Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers and received an additional dose of mRNA vaccine on study"; COVID-19 (hospitalization, medically significant), outcome "unknown", described as "SARS-CoV-2 Infection". Clinical course: With a median follow-up of 263 days (interquartile range, 241-280) from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection, and all subjects are alive supplemental). Two subjects (1 previously treated and 1 active BTKi) required hospitalization and received dexamethasone (n 5 2), remdesivir (n 5 2) 6 casirivimab/imdevimab (n 5 1). Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers (,0.04 U/mL) and received an additional dose of mRNA vaccine on study (subsequent titers of ,0.04 and 1.39 U/mL). The patient underwent the following laboratory tests and procedures: Antibody test: unknown results; Blood immunoglobulin G: unknown results; CD4 lymphocytes: unknown results; SARS-CoV-2 antibody test: less than 0.04; less than 0.04, notes: after mRNA vaccine; Absolute CD3+ T-cell count: unknown results; unknown results; Lymphocyte count: unknown results. Therapeutic measures were taken as a result of Covid-19. The reporter considered "both hospitalized subjects were initially vaccinated with ad26.cov2.s with undetectable postvaccine titers and received an additional dose of mRNA vaccine on study" and "sars-cov-2 infection" related to COVID-19 Vaccine - Manufacturer Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.,Linked Report(s): US-PFIZER_INC-202200582228 Same article/ drug and different event/patient; US-PFIZER_INC-202200582229 Same article/ drug and different event/patient.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Lymphocyte count, SARS-CoV-2 antibody test
Clinical narrative: This is a non-interventional study report received from a contactable reporter(s) (Other HCP) for the following literature source(s): A subject (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; Janssen Covid-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pcv13, for immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", described as "Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers and received an additional dose of mRNA vaccine on study"; COVID-19 (hospitalization, medically significant), outcome "unknown", described as "SARS-CoV-2 Infection". Clinical course: With a median follow-up of 263 days (interquartile range, 241-280) from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection, and all subjects are alive supplemental). Two subjects (1 previously treated and 1 active BTKi) required hospitalization and received dexamethasone (n 5 2), remdesivir (n 5 2) 6 casirivimab/imdevimab (n 5 1). Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers (,0.04 U/mL) and received an additional dose of mRNA vaccine on study (subsequent titers of ,0.04 and 1.39 U/mL). The patient underwent the following laboratory tests and procedures: Antibody test: unknown results; Blood immunoglobulin G: unknown results; CD4 lymphocytes: unknown results; SARS-CoV-2 antibody test: less than 0.04; less than 0.04, notes: after mRNA vaccine; Absolute CD3+ T-cell count: unknown results; unknown results; Lymphocyte count: unknown results. Therapeutic measures were taken as a result of Covid-19. The reporter considered "both hospitalized subjects were initially vaccinated with ad26.cov2.s with undetectable postvaccine titers and received an additional dose of mRNA vaccine on study" and "sars-cov-2 infection" related to COVID-19 Vaccine - Manufacturer Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.,Linked Report(s): US-PFIZER_INC-202200582228 Same article/ drug and different event/patient; US-PFIZER_INC-202200582229 Same article/ drug and different event/patient.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood immunoglobulin G, CD4 lymphocytes, COVID-19, Drug ineffective
Clinical narrative: SARS-CoV-2 Infection; SARS-CoV-2 Infection; VACCINE RESPONSIVENESS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA  This is a non-interventional study report received from a contactable reporter(s) (Other HCP).  A subject (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pvc13, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "SARS-CoV-2 Infection". Clinical course: With a median follow-up of 263 days (interquartile range, 241-280) from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection, and all subjects are alive upplemental). Two subjects (1 previously treated and 1 active BTKi) required hospitalization and received dexamethasone (n 5 2), remdesivir (n 5 2) 6 casirivimab/imdevimab (n 5 1). Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers (,0.04 U/mL) and received an additional dose of mRNA vaccine on study (subsequent titers of ,0.04 and 1.39 U/mL). The subject underwent the following laboratory tests and procedures: Antibody test: unknown result; Blood immunoglobulin G: unknown result; CD4 lymphocytes: unknown result; Absolute CD3+ T-cell count: unknown result; unknown result; Lymphocyte count: unknown result; SARS-CoV-2 antibody test: less than 0.04; 1.39 IU/ml, notes: after additional dose.  The reporter considered "sars-cov-2 infection" related to COVID-19 Vaccine - Manufacturer Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : US-PFIZER_INC-202200582227 same article/ suspect/event but different patient.;US-PFIZER_INC-202200582229 same article/ suspect/event but different patient.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Investigation, Lymphocyte count, SARS-CoV-2 antibody test
Clinical narrative: SARS-CoV-2 Infection; SARS-CoV-2 Infection; VACCINE RESPONSIVENESS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA  This is a non-interventional study report received from a contactable reporter(s) (Other HCP).  A subject (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pvc13, for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "SARS-CoV-2 Infection". Clinical course: With a median follow-up of 263 days (interquartile range, 241-280) from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection, and all subjects are alive upplemental). Two subjects (1 previously treated and 1 active BTKi) required hospitalization and received dexamethasone (n 5 2), remdesivir (n 5 2) 6 casirivimab/imdevimab (n 5 1). Both hospitalized subjects were initially vaccinated with Ad26.COV2.S with undetectable postvaccine titers (,0.04 U/mL) and received an additional dose of mRNA vaccine on study (subsequent titers of ,0.04 and 1.39 U/mL). The subject underwent the following laboratory tests and procedures: Antibody test: unknown result; Blood immunoglobulin G: unknown result; CD4 lymphocytes: unknown result; Absolute CD3+ T-cell count: unknown result; unknown result; Lymphocyte count: unknown result; SARS-CoV-2 antibody test: less than 0.04; 1.39 IU/ml, notes: after additional dose.  The reporter considered "sars-cov-2 infection" related to COVID-19 Vaccine - Manufacturer Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.,Linked Report(s) : US-PFIZER_INC-202200582227 same article/ suspect/event but different patient.;US-PFIZER_INC-202200582229 same article/ suspect/event but different patient.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, CD4 lymphocytes, COVID-19, Investigation
Clinical narrative: This is a non-interventional study report. A subject (no qualifiers provided) received 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 subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pcv13, for immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "follow-up of 263 days from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection/Upper respiratory symptoms". Clinical course: A third subject had mild upper respiratory symptoms and convalesced at home. This subject had received 3 doses of BNT162b2 with undetectable titers before and after the third dose. The subject underwent the following laboratory tests and procedures: Antibody test: unknown results; Blood immunoglobulin G: unknown results; CD4 lymphocytes: UNKNOWN RESULTS; Absolute CD3+ T-cell count: unknown results; unknown results; Lymphocyte count: unknown results. The reporter considered "follow-up of 263 days from first sars-cov-2 vaccine, 3 subjects developed sars-cov-2 infection/upper respiratory symptoms" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events. Case will be reviewed further on receipt of FU information. 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-202200582227 same article/drug/event; different patient; US-PFIZER_INC-202200582228 same article/drug/event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Lymphocyte count, Vaccination failure
Clinical narrative: This is a non-interventional study report. A subject (no qualifiers provided) received 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 subject's relevant medical history included: "Chronic lymphocytic leukemia" (ongoing). The subject's concomitant medications were not reported. Vaccination history included: Pcv13, for immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "follow-up of 263 days from first SARS-CoV-2 vaccine, 3 subjects developed SARS-CoV-2 infection/Upper respiratory symptoms". Clinical course: A third subject had mild upper respiratory symptoms and convalesced at home. This subject had received 3 doses of BNT162b2 with undetectable titers before and after the third dose. The subject underwent the following laboratory tests and procedures: Antibody test: unknown results; Blood immunoglobulin G: unknown results; CD4 lymphocytes: UNKNOWN RESULTS; Absolute CD3+ T-cell count: unknown results; unknown results; Lymphocyte count: unknown results. The reporter considered "follow-up of 263 days from first sars-cov-2 vaccine, 3 subjects developed sars-cov-2 infection/upper respiratory symptoms" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events. Case will be reviewed further on receipt of FU information. 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-202200582227 same article/drug/event; different patient; US-PFIZER_INC-202200582228 same article/drug/event; different patient.