chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: Early 2nd dose; Rash; This non-serious case was reported by a nurse via call center representative and described the occurrence of rash in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 07-MAR-2024, the patient received the 2nd dose of Bexsero. On 07-MAR-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). In MAR-2024, the patient experienced rash (Verbatim: Rash). The outcome of the rash and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 08-MAR-2024 On reporting day, the reporter called to inform that the patient who received Bexsero, the vaccine was given too early. The 1st dose of Bexsero was given a week ago of 2nd dose of Bexsero. The patient had a reaction of a rash. According to the reporter the patient was prescribed Benadryl for the rash. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The reporter reported that the patient received 2nd dose of Bexsero earlier than the recommended interval, which led to drug dose administration interval too short.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; 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 3-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 05-MAR-2024, the patient received Infanrix. On 05-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used 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: 08-MAR-2024 A register nurse called to report the administration of an expired dose of Infanrix to a patient.  The health care professional (HCP) asked for guidance on this situation. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Genital herpes, Pain, Pyrexia, Vaccination failure
Clinical narrative: Suspected vaccination failure; two genital herpes outbreaks; outbreak of genital herpes,; shivering,; fever; generalized pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 03-DEC-2023, the patient received the 2nd dose of Shingrix. On 06-SEP-2023, the patient received the 1st dose of Shingrix. On 07-SEP-2023, not applicable after receiving Shingrix and 1 days after receiving Shingrix, the patient experienced shivers (Verbatim: shivering,), fever (Verbatim: fever) and generalized aching (Verbatim: generalized pain). On 26-DEC-2023, the patient experienced genital herpes (Verbatim: outbreak of genital herpes,). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and genital herpes (Verbatim: two genital herpes outbreaks). On 09-SEP-2023, the outcome of the shivers was resolved (duration 2 days). The outcome of the vaccination failure was unknown and the outcome of the genital herpes was not resolved and the outcome of the genital herpes was not reported and the outcome of the fever and generalized aching were resolved.   It was unknown if the reporter considered the vaccination failure, genital herpes and genital herpes to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, genital herpes, shivers, fever and generalized aching to be related to Shingrix.     It was unknown if the company considered the vaccination failure, genital herpes and genital herpes to be related to Shingrix. It was unknown if the company considered the vaccination failure, genital herpes, shivers, fever and generalized aching to be related to Shingrix.   Additional Information: GSK receipt date: 08-MAR-2024 The consumer reported that she received her first Shingrix dose and experienced two days of shivering, fever and generalized pain, which lasted for a couple of days. She received her 2nd dose on and she had an outbreak of genital herpes, which she stated she has never had before.   She has had a total of two genital herpes outbreaks since receiving the 2nd Shingrix.   She stated that she has never had genital herpes before.  She was requesting compensation and a returned call. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Genital herpes
Clinical narrative: Suspected vaccination failure; two genital herpes outbreaks; outbreak of genital herpes,; shivering,; fever; generalized pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 03-DEC-2023, the patient received the 2nd dose of Shingrix. On 06-SEP-2023, the patient received the 1st dose of Shingrix. On 07-SEP-2023, not applicable after receiving Shingrix and 1 days after receiving Shingrix, the patient experienced shivers (Verbatim: shivering,), fever (Verbatim: fever) and generalized aching (Verbatim: generalized pain). On 26-DEC-2023, the patient experienced genital herpes (Verbatim: outbreak of genital herpes,). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and genital herpes (Verbatim: two genital herpes outbreaks). On 09-SEP-2023, the outcome of the shivers was resolved (duration 2 days). The outcome of the vaccination failure was unknown and the outcome of the genital herpes was not resolved and the outcome of the genital herpes was not reported and the outcome of the fever and generalized aching were resolved.   It was unknown if the reporter considered the vaccination failure, genital herpes and genital herpes to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, genital herpes, shivers, fever and generalized aching to be related to Shingrix.     It was unknown if the company considered the vaccination failure, genital herpes and genital herpes to be related to Shingrix. It was unknown if the company considered the vaccination failure, genital herpes, shivers, fever and generalized aching to be related to Shingrix.   Additional Information: GSK receipt date: 08-MAR-2024 The consumer reported that she received her first Shingrix dose and experienced two days of shivering, fever and generalized pain, which lasted for a couple of days. She received her 2nd dose on and she had an outbreak of genital herpes, which she stated she has never had before.   She has had a total of two genital herpes outbreaks since receiving the 2nd Shingrix.   She stated that she has never had genital herpes before.  She was requesting compensation and a returned call. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; 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 25-month-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 08-MAR-2024, the patient received Infanrix. On 08-MAR-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used 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: 08-MAR-2024 Medical assistant reported that the patient was administered Infanrix vaccine that was expired, which led to expired vaccine used. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about 5 years ago).   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: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAR-2024 A pharmacist mentioned that he had a patient who received the first dose and the healthcare professional (HCP) was concerned if the patient needed to re-start the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. This case had been linked with US2024031105, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024031105:2nd patient case
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Administered a dose of Bexsero to 11 year old female patient that was meant to receive Gardasil.; This non-serious case was reported by a consumer via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Administered a dose of Bexsero to 11 year old female patient that was meant to receive Gardasil.). The outcome of the wrong vaccine administered 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: 08-Mar-2024 The reporter reported that they administered a dose of Bexsero vaccine to 11 year old female patient that was meant to receive Gardasil. The reporter reported that they did not had any further details. The reporter reported that, they were intending to administered Gardasil and inadvertently administered Bexsero instead of Gardasil, which led to wrong vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; Rebound COVID; This spontaneous report received from a consumer via another company (Pfizer) concerned a patient of unspecified age and sex. Initially received information processed along with additional information received on 11-MAR-2024 via Regulatory Authority. The patient's height, and weight were not reported. The patient's concurrent conditions included: IV dye allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211D21A) 0.5 ml (dose series 1), administered on 13-MAY-2021 to Left Arm, and dose was not reported, administered on 22-JAN-2022 (batch number: 201A21A, dose series 2)) 0.5 ml to Left Arm for covid-19 prophylaxis.  No concomitant medications were reported.  On 29-FEB-2024, the patient experienced suspected clinical vaccine failure, and rebound covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rebound covid, and the outcome of suspected clinical vaccine failure was not reported. This report is associated with product quality complaint: 90000316561 and 90000316930. The suspected product quality complaint has been confirmed to be Void. The PQC referral number 90000316930 for lot 201A21A is void (primary vaccine shot). Since lot 211D21A is the last Janssen COVID-19 vaccine administered prior to the consumer's rebound COVD-19, the efficacy of the booster shot with lot 211D21A would be evaluated instead of the primary shot with lot 201A21A. This report does not meet the definition of a product quality complaint or explicitly allege a potency issue for the initial vaccine injection. This record (90000316561) will be voided as no PQC based on the PQC evaluation/investigation performed. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Suspected clinical vaccine failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Giant cell arteritis
Clinical narrative: Giant cell arteritis; This spontaneous case was reported by a consumer and describes the occurrence of GIANT CELL ARTERITIS (Giant cell arteritis) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Cryptococcosis, Nocardia infection and Stress headache. Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GIANT CELL ARTERITIS (Giant cell arteritis). At the time of the report, GIANT CELL ARTERITIS (Giant cell arteritis) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bacterial infection, Biopsy skin abnormal, Blood test abnormal, Cryptococcosis, Cyst
Clinical narrative: Giant cell arteritis; This spontaneous case was reported by a consumer and describes the occurrence of GIANT CELL ARTERITIS (Giant cell arteritis) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Cryptococcosis, Nocardia infection and Stress headache. Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GIANT CELL ARTERITIS (Giant cell arteritis). At the time of the report, GIANT CELL ARTERITIS (Giant cell arteritis) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cyst removal, Dysstasia, Gait disturbance, Giant cell arteritis, Headache
Clinical narrative: Giant cell arteritis; This spontaneous case was reported by a consumer and describes the occurrence of GIANT CELL ARTERITIS (Giant cell arteritis) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Cryptococcosis, Nocardia infection and Stress headache. Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GIANT CELL ARTERITIS (Giant cell arteritis). At the time of the report, GIANT CELL ARTERITIS (Giant cell arteritis) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Migraine, Muscular weakness
Clinical narrative: Giant cell arteritis; This spontaneous case was reported by a consumer and describes the occurrence of GIANT CELL ARTERITIS (Giant cell arteritis) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Cryptococcosis, Nocardia infection and Stress headache. Concurrent medical conditions included Blood pressure high.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced GIANT CELL ARTERITIS (Giant cell arteritis). At the time of the report, GIANT CELL ARTERITIS (Giant cell arteritis) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hydrosalpinx, Ovarian cyst ruptured
Clinical narrative: Ovarian cyst with rupture 14 days after second dose/Pelvic pain during menstruation on periods following each vaccine; Ovarian cyst rupture led to hydrosalpinx; Excessive bleeding and pelvic pain during menstruation on periods following each vaccine; This spontaneous case was reported by a patient and describes the occurrence of OVARIAN CYST RUPTURED (Ovarian cyst with rupture 14 days after second dose/Pelvic pain during menstruation on periods following each vaccine) and HYDROSALPINX (Ovarian cyst rupture led to hydrosalpinx) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 043B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced OVARIAN CYST RUPTURED (Ovarian cyst with rupture 14 days after second dose/Pelvic pain during menstruation on periods following each vaccine) (seriousness criterion medically significant), HYDROSALPINX (Ovarian cyst rupture led to hydrosalpinx) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (Excessive bleeding and pelvic pain during menstruation on periods following each vaccine). The patient was treated with Surgery (bilateral salpingectomy) for Hydrosalpinx. On 26-Jun-2023, OVARIAN CYST RUPTURED (Ovarian cyst with rupture 14 days after second dose/Pelvic pain during menstruation on periods following each vaccine), HYDROSALPINX (Ovarian cyst rupture led to hydrosalpinx) and HEAVY MENSTRUAL BLEEDING (Excessive bleeding and pelvic pain during menstruation on periods following each vaccine) had resolved with sequelae.            It was unknown if the patient experienced any additional symptoms/events. Bilateral salpingectomy leading to infertility.   No concomitant medications was provided.  No treatment medications was provided.  Company comment:  This is a spontaneous case concerning a 41-year-old, female patient with no reported medical history, who experienced the unexpected serious (medically significant) events of Ovarian cyst ruptured and hydrosalpinx. The events occurred 14 days after the administration of the second dose of mRNA-1273 vaccine. An ovarian cyst ruptured 14 days following the second dose. There was heavy bleeding and significant pelvic pain during menstruation in the cycles after each vaccination. The rupture of the ovarian cyst resulted in hydrosalpinx, necessitating a bilateral salpingectomy, which caused infertility. Hydrosalpinx is assessed as not related as event is due to Ovarian cyst ruptured. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: Total of 11 Abrysvo Vaccines lure lock broke; This is a spontaneous report received from a Pharmacist from a sales representative and product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9851) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious) with onset Jan2024, outcome "unknown", described as "Total of 11 Abrysvo Vaccines lure lock broke". It was unknown if therapeutic measures were taken as a result of syringe issue.
Sex: U
Vaccine: PNC20
Symptoms: Product contamination physical
Clinical narrative: The product had "particulate matter found" once it was mixed; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 04Mar2024, this case now contains all required information to be considered valid.   This is a spontaneous report received from a pharmacist from product quality group.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), 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: PRODUCT CONTAMINATION PHYSICAL (non-serious), outcome "unknown", described as "The product had "particulate matter found" once it was mixed". Therapeutic measures were not taken as a result of product contamination physical. Additional information: This product was not given to a patient.   The reporter considered "the product had "particulate matter found" once it was mixed" as not related to pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein). Causality for "the product had "particulate matter found" once it was mixed" was determined associated to device constituent of neumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).  The information on the batch/lot number for neumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Nurse.  A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TEVA oral; ESCITALOPRAM oral; PANTOPRAZOLE MYLAN oral; SUMATRIPTAN AUROBINDO oral. Past drug history included: Hydrocodone, reaction(s): "known allergies". 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; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01Mar2024, outcome "not recovered", COVID-19 (medically significant) with onset 01Mar2024, outcome "unknown" and all described as "COVID-19". The patient started having symptoms (sore throat, body aches and nausea) on 01Mar2024. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID orally as COVID-19 treatment from 03Mar2024 to 07Mar2024.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202400064796 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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 4 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 64-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Lot number: HF9275) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, vaccine lot number=EN6207, vaccine location=Left arm), administration date: 18Mar2021, when the patient was 61-year-old, for COVID-19 immunization; comirnaty (DOSE 2, SINGLE, vaccine lot number=ER8729, vaccine location=Left arm), administration date: 08Apr2021, when the patient was 61-year-old, for COVID-19 immunization; comirnaty (DOSE 3 (BOOSTER), SINGLE, vaccine lot number=FH8020, vaccine location=Left arm), administration date: 23Oct2021, when the patient was 62-year-old, for COVID-19 immunization; pfizer / biontech (DOSE 4 (BOOSTER), SINGLE, vaccine lot number=FM9992), administration date: 22Apr2022, when the patient was 62-year-old, for COVID-19 immunization; comirnaty (DOSE 5 (BOOSTER), SINGLE, vaccine lot number=GH9702, vaccine location=Left arm), administration date: 19Sep2022, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient received other vaccine and did not receive other medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 02Mar2024 to 06Mar2024
Sex: F
Vaccine: COVID19
Symptoms: IgA nephropathy
Clinical narrative: IgA nephropathy; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: 159558.  A 32-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: May2021, when the patient was 29 years old, for Covid-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: IGA NEPHROPATHY (medically significant), outcome "unknown". Therapeutic measures were taken as a result of iga nephropathy.  Clinical course: The reporter stated that she is taking a medication called Tarpeyo which is a steriod. She wanted to know if by taking tarpeyo it will limit the effectiveness of covid vaccines or will it still be effective if she took the booster. She had a couple of the Pfizer covid vaccines and a couple of the Moderna covid vaccines in the past. After getting them, she was diagnosed with IgA nephropathy and has been given Tarpeyo which is a steroid. She would like to get a Pfizer covid booster and wants to know if the Tarpeyo will decrease its effectiveness. Consumer stated, "I had the vaccine in the September. I have definitely got more than that, but I am sure that I cannot remember them all, but I think 4 or 5 shots until. But the first one I had was of Pfizer that was in May2021."   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Aug2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from07Mar2024 to 11Mar2024  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Hypoxia, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Patient contracted RSV, needed oxygen/had hypoxia, and needed to be hospitalized for several days.  Patient was also given steroids.; Patient contracted RSV, needed oxygen/had hypoxia, and needed to be hospitalized for several days.  Patient was also given steroids.; This is a spontaneous report received from a Physician from a sales representative.  An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization) all with onset Mar2024, outcome "recovered" (Mar2024) and all described as "Patient contracted RSV, needed oxygen/had hypoxia, and needed to be hospitalized for several days.  Patient was also given steroids.". Therapeutic measures were taken as a result of vaccination failure, respiratory syncytial virus infection.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on the information currently available, a lack of efficacy with ABRYSVO in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Lot number: GJ2524) for COVID-19 immunisation; 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Vaccine brand other: Moderna/ Vaccine brand: Pfizer BioNTech; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Mar2021 at 10:00 as dose 1, single (Lot number: 045A21A), in left arm, on 16Apr2021 at 10:30 as dose 2, single (Lot number: 042B21A), in left arm, on 04Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 058H21A), in left arm, on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 033K21-2A), in left arm and on 28Oct2023 at 13:00 as dose 6 (booster), single (Lot number: 8058877), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "Allergies: Aspirin"; Oxycodone, reaction(s): "Allergies: oxycodone". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022 at 17:00, outcome "unknown", described as "Vaccine brand other: Moderna/ Vaccine brand: Pfizer BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 05Mar2024 to 09Mar2024).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Sharp pain at the site of the  Covid-19 injection. Sometimes hurts (sharp pain), sometimes not. Has not gone away yet after 3 years.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: sore arm, body aches, shivering
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain every few weeks for about 30 minutes at a time. It is becoming more frequent years later.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Seizure
Clinical narrative: Had Seizure ~12 hours after vaccine.  Pain in arm 12 hours after vaccine.  Not clear if vaccine was causation, correlated or pure coincidence, but it was first seizure for patient.  May have been a trigger or contributing factor.    Went to emergency room immediately following seizure.  Bloodwork was fine.  No further complications since.  Mother had childhood seizures.  Additional vaccine info: NDC#0069-2392-10.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a Pediarix vaccine and a Recombivax HB vaccine on the same day.  No reported adverse effects.
Age: 65.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Aphthous ulcer, Facial pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Approx 36 hours after getting the vaccine pt developed burning pain in cheeks and tender cervical lymphadenopathy. Exam showed large apthous ulcers on oral mucous on both cheeks. Will be treated with triancinolome past.
Age: 65.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Mouth ulceration
Clinical narrative: Approx 36 hours after getting the vaccine pt developed burning pain in cheeks and tender cervical lymphadenopathy. Exam showed large apthous ulcers on oral mucous on both cheeks. Will be treated with triancinolome past.
Age: 6.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: administered vaccine to patient on her right deltoid arm as soon as i administered vaccine and liquid went inside around vaccine it swelled up and got red with rashes around vaccine told parent i will call dr to check it out gave patient  time  to be in the room resting  to make sure everything was ok few minutes later patient  arm was better and dr took a look at it.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness and swelling that were severe for the first 3 days and are still affecting my ability to function
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Exposure during pregnancy, Fatigue, Injection site pain, Lethargy
Clinical narrative: severe pain at site of injection for 3 days. Diarrhea and nausea for 3 days starting on the day of injection. Lethargic and extreme fatigue.  This is my first pregnancy, estimated due date is 5/5/24.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Nausea
Clinical narrative: severe pain at site of injection for 3 days. Diarrhea and nausea for 3 days starting on the day of injection. Lethargic and extreme fatigue.  This is my first pregnancy, estimated due date is 5/5/24.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: 12hrs. after injection chills, fatique, vomiting, diahhrea, headache, passed out, loss of appetite ,  Felt just like I had Covid,again.  Very weak. drank a lot of water and Pedialyte.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Malaise, Vomiting
Clinical narrative: 12hrs. after injection chills, fatique, vomiting, diahhrea, headache, passed out, loss of appetite ,  Felt just like I had Covid,again.  Very weak. drank a lot of water and Pedialyte.
Age: 0.83
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: LVN identified that Covid vaccine was going to expire by thaw date of 03/07/2024, she did not remove the vaccine from the fridge, nor notify RN Ped dept Manager prior to her leaving her shift day. The LVN on duty next morning 03/08/2024 gave patient the vaccine in which she followed the correct administration process by scanning the barcode.  LVN gave the vaccine was able to scan vaccine barcode into the immunization record and able to print out the pt's copy of records that shows a manufacture expiration date of 07/31/2024, this allowing her to administer on the vaccine with no hard stop. However, the thaw expiration date was 03/07/2024, which LVN did not see on the packaging because the sticker was white and matched the box.  After vaccine was administered by the LVN on duty, LVN notified facility Pharmacy Service supervisor and was able to call Pfizer Manufacture to find out that it has a grace period of1-2days after the thaw expiration date.  Ordering Provide (MD), RN Dept Manager and parent was notified.  Information from Pfizer was forwarded to LVN (Coordinator) and attached the email to RN Dept Mgr. Notified also Pharmacy Manager. Dept of Ped Manager will ensure strict monitoring and administration of vaccines correctly. Learning and recommendations with the team given by Pharmacy Manager
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone abnormal
Clinical narrative: tsh labs were off the charts
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Received COVID shot 2 days ago in her L arm Began swelling yesterday, and got itchy/red
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Crying, Immediate post-injection reaction, Mobility decreased, Pallor, Slow speech
Clinical narrative: My son immediately started crying after the shot (probably not unusual), but did not stop crying for probably 45 minutes, so that would be 9:15 a.m. to about 10:00 a.m. He watched a show for the next 45 minutes and at about 10:45 began crying for water, laying on the ground asking to go to sleep, and lost all color in his face and lips. He could not lift his head. He speech was limited. When he spoke it was slow and difficult to speak. He was in fetal position on my wife. My wife immediately took him to the doctors office where the shot was administered. The doctor said it was not related to the vaccine because it was more than 15 minutes after the shot. He had no sickness prior to the shot and was not sick after the shot. I have no idea how it could not be related to the vaccine.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Somnolence, Thirst
Clinical narrative: My son immediately started crying after the shot (probably not unusual), but did not stop crying for probably 45 minutes, so that would be 9:15 a.m. to about 10:00 a.m. He watched a show for the next 45 minutes and at about 10:45 began crying for water, laying on the ground asking to go to sleep, and lost all color in his face and lips. He could not lift his head. He speech was limited. When he spoke it was slow and difficult to speak. He was in fetal position on my wife. My wife immediately took him to the doctors office where the shot was administered. The doctor said it was not related to the vaccine because it was more than 15 minutes after the shot. He had no sickness prior to the shot and was not sick after the shot. I have no idea how it could not be related to the vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: pain, redness, and swelling at the injection site, agitation and sleeplessness followed by headache, feeling feverish and chills, diarrhea, muscle aches lasted into the next day, weakness and tiredness lasted into the 3rd day, still soreness and now itching too in the 4th day
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, redness, and swelling at the injection site, agitation and sleeplessness followed by headache, feeling feverish and chills, diarrhea, muscle aches lasted into the next day, weakness and tiredness lasted into the 3rd day, still soreness and now itching too in the 4th day
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain, Pruritus
Clinical narrative: pain, redness, and swelling at the injection site, agitation and sleeplessness followed by headache, feeling feverish and chills, diarrhea, muscle aches lasted into the next day, weakness and tiredness lasted into the 3rd day, still soreness and now itching too in the 4th day
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Mass, Pain, Skin warm
Clinical narrative: painful lump of tissue that feels hot, some mild erythema
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: pt has a rash, red and swollen around the area, started the night vaccine was given. pt followed up on 2/22/24, was given antiobiotic. cephalexin, cetirizine, and orapred 15/5
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: staff member administered MMRV and VZV instead of MMR & VZV. Patient recieved 2 doses of varicella. Discovered 03/12/24 9 AM
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient received 0.3 ml IM of the COVID Pfizer 5-11 yr vaccine that was diluted with 1.1 ml of normal saline. The patient's mom was contacted on 3/5/24 and informed about the adverse event. Patient's mom stated that the patient had no side effects nor complications and is currently asymptomatic.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Epistaxis, Mouth haemorrhage, Pain, Petechiae, Platelet count decreased
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Thrombocytopenia, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.