chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nasal congestion, Nasal pruritus, Oropharyngeal pain
Clinical narrative: Nasal congestion; she began experiencing head congestion; sore throat; muscle soreness; itchy nasal symptoms; she experienced pain at the site of injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-DEC-2023, the patient received the 1st dose of Shingrix (left arm). On 27-DEC-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: she experienced pain at the site of injection). On 29-DEC-2023, the patient experienced head discomfort (Verbatim: she began experiencing head congestion), sore throat (Verbatim: sore throat), muscle soreness (Verbatim: muscle soreness) and nasal itching (Verbatim: itchy nasal symptoms). On an unknown date, the patient experienced nasal congestion (Verbatim: Nasal congestion). The outcome of the injection site pain, head discomfort, sore throat, muscle soreness and nasal itching were resolved and the outcome of the nasal congestion was not resolved.   It was unknown if the reporter considered the injection site pain, head discomfort, sore throat, muscle soreness, nasal itching and nasal congestion to be related to Shingrix.     It was unknown if the company considered the injection site pain, head discomfort, sore throat, muscle soreness, nasal itching and nasal congestion to be related to Shingrix.   Additional Information: GSK Receipt Date:03-JAN-2024 The patient self-reported this case. The reporter stated that she had her first dose of Shingrix. The consumer stated that she experienced pain at the site of injection that began that evening and became worse by the next day. Then on 29-DEC-2023 through 31-DEC-2023 the patient began experiencing head congestion, sore throat, itchy nasal symptoms, and muscle soreness.  The consumer reported that as of 03-JAN-2024 only the nasal congestion remained, the other symptoms have resolved. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus congestion
Clinical narrative: Nasal congestion; she began experiencing head congestion; sore throat; muscle soreness; itchy nasal symptoms; she experienced pain at the site of injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-DEC-2023, the patient received the 1st dose of Shingrix (left arm). On 27-DEC-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: she experienced pain at the site of injection). On 29-DEC-2023, the patient experienced head discomfort (Verbatim: she began experiencing head congestion), sore throat (Verbatim: sore throat), muscle soreness (Verbatim: muscle soreness) and nasal itching (Verbatim: itchy nasal symptoms). On an unknown date, the patient experienced nasal congestion (Verbatim: Nasal congestion). The outcome of the injection site pain, head discomfort, sore throat, muscle soreness and nasal itching were resolved and the outcome of the nasal congestion was not resolved.   It was unknown if the reporter considered the injection site pain, head discomfort, sore throat, muscle soreness, nasal itching and nasal congestion to be related to Shingrix.     It was unknown if the company considered the injection site pain, head discomfort, sore throat, muscle soreness, nasal itching and nasal congestion to be related to Shingrix.   Additional Information: GSK Receipt Date:03-JAN-2024 The patient self-reported this case. The reporter stated that she had her first dose of Shingrix. The consumer stated that she experienced pain at the site of injection that began that evening and became worse by the next day. Then on 29-DEC-2023 through 31-DEC-2023 the patient began experiencing head congestion, sore throat, itchy nasal symptoms, and muscle soreness.  The consumer reported that as of 03-JAN-2024 only the nasal congestion remained, the other symptoms have resolved. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Injection site discharge, No adverse event, Underdose
Clinical narrative: received less than recommended volume of the Arexxy; leakage at site; leakage at site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 772LC, expiry date 23-JAN-2025) for prophylaxis.   On 03-DEC-2023, the patient received Arexvy. On 03-DEC-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: received less than recommended volume of the Arexxy), inadvertent exposure to vaccine (Verbatim: leakage at site) and exposure via skin contact (Verbatim: leakage at site). The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 03-JAN-2024 The healthcare professional reported that patient received less than recommended volume of the Arexxy after leakage at site which led to dose administered, inadvertent exposure to vaccine and exposure via skin contact. No reactions reported. The reporter did not consent to follow up.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Twinrix on 20DEC2023 and 10 days later received 2nd dose on 30DEC2023; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 30-DEC-2023, the patient received the 2nd dose of Twinrix adult. On 30-DEC-2023, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: 1st dose of Twinrix on 20DEC2023 and 10 days later received 2nd dose on 30DEC2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt date: 04-JAN-2024 Doctor of Medicine requested data for administration schedule for a patient who received 1st dose of Twinrix at their office and 10 days later received the 2nd dose at a local pharmacy. Patient was receiving accelerated dosing schedule. The reporter consented to follow-up. The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 40.0
Sex: F
Vaccine: RSV
Symptoms: Delivery, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: patient had already delivered the baby; a pregnant patient inadvertently received a dose of Arexvy instead of Avrysvo.; a pregnant patient inadvertently received a dose of Arexvy; a pregnant patient inadvertently received a dose of Arexvy instead of Avrysvo; This non-serious retrospective pregnancy case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 12-DEC-2023, the patient received Arexvy. On 12-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: a pregnant patient inadvertently received a dose of Arexvy) and wrong vaccine administered (Verbatim: a pregnant patient inadvertently received a dose of Arexvy instead of Avrysvo). On an unknown date, the patient experienced live birth (Verbatim: patient had already delivered the baby) and vaccine exposure during pregnancy (Verbatim: a pregnant patient inadvertently received a dose of Arexvy instead of Avrysvo.). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered, live birth and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK Receipt Date; 04-JAN-2024 The reporter called to inform that a pregnant patient inadvertently received a dose of Arexvy instead of Avrysvo, which led to wrong vaccine administered and vaccine exposure during pregnancy. The reporter informed that the patient read an article about the premature delivery risk after Arexvy and that considering that the patient's obstetrician decided to program the delivery at week 37 and 5 days.  At the moment of the call, the patient had already delivered the baby. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The patient received Arexvy vaccine below the recommended age schedule, which led to inappropriate age at vaccine administration.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: stored at minus 2.4 degrees Celsius for 4 hours 8 minutes; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS, expiry date 07-SEP-2025) for prophylaxis.   On 04-JAN-2024, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: stored at minus 2.4 degrees Celsius for 4 hours 8 minutes). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 4-JAN-2024 A registered nurse (RN) requested stability data on Bexsero, Menveo (1-vial), Menveo (2-vial), Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at minus 2.4 degrees Celsius for 4 hours 8 minutes on 29th December 2023. Infanrix, Kinrix, Bexsero, Menveo (1), Flulaval, Pediarix were administered to patients, which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of the 7 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2024001091:Same reporter/diferent product US-GSK-US2024001089:Same reporter/diferent product US-GSK-US2024001092:Same reporter/diferent product US-GSK-US2024001093:Same reporter/diferent product US-GSK-US2024001095:Same reporter/diferent product
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: a pediatric dose of Engerix-B was administered to an adult patient; a pediatric dose of Engerix-B was administered to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: a pediatric dose of Engerix-B was administered to an adult patient) and adult use of a child product (Verbatim: a pediatric dose of Engerix-B was administered to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 04-JAN-2024 The pharmacist reported a pediatric dose of Engerix-B was administered to an adult patient on an unknown date, which led to underdose and adult use of a child product. The Vaccine Administration Facility is the same as Primary Reporter. The health care professional (HCP) stated she was not in the pharmacy at the time of the call and had no adverse event (AE) information available to provide.  The HCP consented to safety team follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: storing Shingrix at a temperature outside the recommended range.; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product storage error in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: storing Shingrix at a temperature outside the recommended range.). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 05-JAN-2024 The customer reported storing Shingrix at a temperature around 55 to 60 Fahrenheit , outside the recommended range which led to intercepted product storage error. The reporter did not consent to follow up.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received a dose of Menveo 2 vial today that expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva764a, expiry date 31-DEC-2023) for prophylaxis.   On 05-JAN-2024, the patient received Menveo. On 05-JAN-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received a dose of Menveo 2 vial today that expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-JAN-2024 The practice manager called reporting a patient received a dose of Menveo 2 vial today that expired on 31-DEC-2023. The patient received Menveo beyond the expiration date, which led to expired vaccine used. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: eleven-year-old patient received a dose of Infanrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis.   On 05-JAN-2024, the patient received Infanrix. On 05-JAN-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: eleven-year-old patient received a dose of Infanrix.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt date: 05-JAN-2024 On reporting day a medical assistant called to inform that earlier on reporting day, patient received a dose of Infanrix. The patient was originally going to receive a dose of Boostrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient below recommended age received the Infanrix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never gotten a second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never gotten a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 05-JAN-2024 The reporter worked with the patient.  She stated that it had been more than 6 months since the patient received her first dose of SHINGRIX and had never gotten a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus
Clinical narrative: First dose on 16-Feb-2021 and second dose on 30-Mar-2021; Itching all over the body; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching all over the body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Feb-2021 and second dose on 30-Mar-2021) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 012M20A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Feb-2021 and second dose on 30-Mar-2021). In 2021, the patient experienced PRURITUS (Itching all over the body). At the time of the report, PRURITUS (Itching all over the body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Feb-2021 and second dose on 30-Mar-2021) outcome was unknown.            No concomitant medications were reported. The patient experienced itching all over body after about 2 weeks following both doses. It was reported that patient sought medical care. No treatment medications were reported.   This case was linked to MOD-2023-751620 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Syncope
Clinical narrative: faint; we tested positive; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (faint) in a 78-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032707) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 22-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (we tested positive). On 02-Jan-2024, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SYNCOPE (faint) and COVID-19 (we tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2023, SARS-CoV-2 test: Positive.         No concomitant medication was reported. Patient reported on 22-Dec-2023, symptoms were not bad, had a headache for a whole day, no fever, was blowing nose an awful lot, and coughing. On Saturday, 23-Dec-2023,was the worst day that he had. Patient reported, he was real tired, couldn't rest good, felt real bad, and went to bed early. From there it got better, except blowing nose and coughing. Symptoms were improving but still there. He stated that they contacted the HCP but have not heard back. Treatment include Cough syrup and Advil. Patient stated that they were not hospitalized.   Company Comment: This is a spontaneous case concerning a 78-year-old, male with no reported medical history, who experienced the serious (due to medically significant) unexpected event of syncope, and the non-serious event of COVID-19. The event Syncope occurred approximately 1 month after SPIKEVAX 2023-2024 PFS, administered as a 4th dose of COVID-19 vaccination schedule, and the event COVID-19 occurred almost 15 days after vaccination. Clinical course, supportive diagnostic tests, and context for this event were not provided. The outcome of the event was reported as not recovered. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-755549 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-755549:wife case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore; it is worsening; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 as dose 1, 0.3 ml, single (Lot number: 055F22B) at the age of 83 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; ZETIA; LEVOTHYROXINE; ELIQUIS. Vaccination history included: moderna vaccine (DOSE 1, Lot number: 02SJ20A), administration date: 08Jan2021, for COVID-19 immunisation; moderna vaccine (DOSE 2, Lot number: 025AJ20A), administration date: 05Feb2021, for COVID-19 immunisation; moderna vaccine (DOSE 3, Lot number: 005C21A), administration date: 07Sep2021, for COVID-19 immunisation; moderna vaccine (DOSE 4, Lot number: 002M21A), administration date: 23Apr2022, for COVID-19 immunisation; moderna vaccine (DOSE 5, Lot number:  055F22B), administration date: 22Oct2022, for COVID-19 immunisation; moderna vaccine (DOSE 6, Lot number:  A57184B), administration date: 30Jul2023, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Dec2023, outcome "not recovered", described as "Arm is still sore"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 23Dec2023, outcome "not recovered" and all described as "Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening"; CONDITION AGGRAVATED (non-serious) with onset 23Dec2023, outcome "not recovered", described as "it is worsening". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site pruritus, pain in extremity, condition aggravated.  Additional information: The patient stated, "I had the COVID Vaccine on Saturday and my arm is still sore and it is now very red. There is a patch of about 4 by 5 inches red, hot and it is itchy, just wondering if that is a reaction that it happens or that is a normal reaction just like to know it has been 4 days since I got it." When clarified if it is the Pfizer COVID-19 Vaccine, consumer stated, "Yes, the latest one, the 2023-24 vaccine (Clarified as Comirnaty)." Any Vaccine administered on the same date: Consumer stated, "No. I did not get any other vaccine, I just had this one."
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening; Arm is still sore; it is worsening; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 as dose 1, 0.3 ml, single (Lot number: 055F22B) at the age of 83 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; ZETIA; LEVOTHYROXINE; ELIQUIS. Vaccination history included: moderna vaccine (DOSE 1, Lot number: 02SJ20A), administration date: 08Jan2021, for COVID-19 immunisation; moderna vaccine (DOSE 2, Lot number: 025AJ20A), administration date: 05Feb2021, for COVID-19 immunisation; moderna vaccine (DOSE 3, Lot number: 005C21A), administration date: 07Sep2021, for COVID-19 immunisation; moderna vaccine (DOSE 4, Lot number: 002M21A), administration date: 23Apr2022, for COVID-19 immunisation; moderna vaccine (DOSE 5, Lot number:  055F22B), administration date: 22Oct2022, for COVID-19 immunisation; moderna vaccine (DOSE 6, Lot number:  A57184B), administration date: 30Jul2023, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Dec2023, outcome "not recovered", described as "Arm is still sore"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 23Dec2023, outcome "not recovered" and all described as "Arm is still sore and it is now very red; a patch of about 4 by 5 inches red, hot and it is itchy; it is worsening"; CONDITION AGGRAVATED (non-serious) with onset 23Dec2023, outcome "not recovered", described as "it is worsening". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site pruritus, pain in extremity, condition aggravated.  Additional information: The patient stated, "I had the COVID Vaccine on Saturday and my arm is still sore and it is now very red. There is a patch of about 4 by 5 inches red, hot and it is itchy, just wondering if that is a reaction that it happens or that is a normal reaction just like to know it has been 4 days since I got it." When clarified if it is the Pfizer COVID-19 Vaccine, consumer stated, "Yes, the latest one, the 2023-24 vaccine (Clarified as Comirnaty)." Any Vaccine administered on the same date: Consumer stated, "No. I did not get any other vaccine, I just had this one."
Sex: M
Vaccine: RSV, HEP
Symptoms: Death, Product use issue
Clinical narrative: Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there; Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there; This is a spontaneous report received from a Consumer or other non HCP.  A 27-day-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.; Reported Cause(s) of Death: Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there
Sex: M
Vaccine: RSV, HEP
Symptoms: Death, Pulmonary oedema, Unresponsive to stimuli
Clinical narrative: Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there; Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there; This is a spontaneous report received from a Consumer or other non HCP.  A 27-day-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.; Reported Cause(s) of Death: Her son was only 27 days old and received the vaccine at doctor's office and he passed away right there
Age: 54.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Received High Heart Rate: 128 BPM; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Dec2023 at 13:30 as dose 1, single (Lot number: Unknown) at the age of 54 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 22Dec2023), in left arm. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Controlled; "Asthma" (unspecified if ongoing), notes: when I get a bad cold. Concomitant medication(s) included: BRIVIACT; VIMPAT; LEXAPRO; PROTONIX [OMEPRAZOLE]. Vaccination history included: pfizer (Dose Number: 5, Batch/Lot No: GJ6739, Route of Administration: Intramuscular), administration date: 16Nov2022, when the patient was 53-year-old, for COVID-19 Immunisation; pfizer (Dose Number: 4, Batch/Lot No: FP7141, Route of Administration: Intramuscular), administration date: 31Aug2022, when the patient was 53-year-old, for COVID-19 Immunisation; pfizer (Dose Number: 3, Batch/Lot No: FD0809, Route of Administration: Intramuscular), administration date: 14Dec2021, when the patient was 52-year-old, for COVID-19 Immunisation; pfizer (Dose Number: 2, Batch/Lot No: EP7534, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 52-year-old, for COVID-19 Immunisation; pfizer (Dose Number: 1, Batch/Lot No: EN6201, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 51-year-old, for COVID-19 Immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 23Dec2023, outcome "recovered", described as "Received High Heart Rate: 128 BPM". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased. Additional information: It was reported that the patient received High Heart Rate notification via watch. The patient was sleeping at the time and saw the notification the next day. 128 BPM. Five notifications between 12:10am - 12:55am. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient has reported no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: Received a dose two days after the used by date; Received a dose two days after the used by date; This is a spontaneous report received from a Consumer or other non HCP.  An 85-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Dec2023 as dose 1, single (Lot number: HF9300, Expiration Date: 31Jan2025) at the age of 85 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 27Dec2023, outcome "unknown" and all described as "Received a dose two days after the used by date".
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "seasonal, allergies" (unspecified if ongoing); "allergies, to mold and dust" (unspecified if ongoing); "allergies, to mold and dust" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID, start date: 10Jun2019; XYZAL, start date: 05Feb2018; LEXAPRO, start date: 08Aug2023; OLLY DAILY ENERGY, start date: 02Oct2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: within 24-72 hours; (unspecified date) Negative, notes: within 24-72 hours; (28Dec2023) Positive, notes: time: 07:00 PM. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid from 19Dec2023 to 23Dec2023 as a COVID 19 Treatment. Known allergies: Sulfa drugs. Other medical history: Hypothyroidism, seasonal, allergies, allergies, to mold and dust, and anxiety.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NYQUIL, start date: 01Oct2023, stop date: 29Dec2023. 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as covid 19 treatment from 20Dec2023 to 26Dec2023  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300458080 Same patient, different drug and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) (reported vaccine administration date on "01Sep2020" at 12:00 PM), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 20Dec2023 to 24Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (25Dec2023) and all described as "COVID". The clinical course was reported as follows:  The patient tested negative on 25Dec2023 for COVID 2 days after completing 5-day course of nirmatrelvir, ritonavir (PAXLOVID). The patient was given nirmatrelvir, ritonavir as treatment of COVID-19 starting on 18Dec2023 until 23Dec2023. The patient underwent laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's 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; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as covid 19 treatment from 22Dec2023 to 26Dec2023  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300458087 Same patient, different drug and event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 18Dec2023 until 25Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: FLUX, RSV
Symptoms: Cardioversion, Dyspnoea, Insomnia
Clinical narrative: almost lost his breath; could not sleep; cardioversion procedure; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 79-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), on 08Oct2023 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOVERSION (medically significant) with onset 26Oct2023, outcome "unknown", described as "cardioversion procedure"; INSOMNIA (non-serious) with onset 28Oct2023, outcome "unknown", described as "could not sleep"; DYSPNOEA (hospitalization), outcome "unknown", described as "almost lost his breath". Additional information: Patient advised he had the Abrysvo shot along with the flu shot on 08Oct2023. He then had cardioversion procedure on 26Oct2023 and could not sleep 2 days after and almost lost his breath and went to the hospital himself. Patient would like to know if the side effects were related to the his shots. Patient mentioned his HCP has reported said incident.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization completed, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose 3, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose 4, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (Dose 5, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Positive; (Dec2023) negative; (Dec2023) negative. Therapeutic measures, Paxlovid from 18Dec2023 to 22Dec2023, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative twice since finishing paxlovid; (unspecified date) Negative, notes: Tested negative twice since finishing paxlovid; (28Dec2023) Positive, notes: I just got another positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid taken from 19Dec2023 to 24Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 treatment (Paxlovid); COVID-19 treatment (Paxlovid); This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1, single at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "heart palpitations" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "COVID-19 treatment (Paxlovid)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative; (27Dec2023) Positive, notes: rebound symptoms and tested positive. Therapeutic measures, Paxlovid from 18Dec2023 to 22Dec2023, were taken as a result of vaccination failure, covid-19. Clinical course: The patient was vaccinated with two boosters and 5 days of Paxlovid from 18Dec2023 to 22Dec2023, tested negative then 5 days later rebound symptoms and tested positive.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.