chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.92
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered Menveo liquid component without the reconstitution of the lyophilized component.; administered Menveo liquid component without the reconstitution of the lyophilized component.; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 11-month-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 08-JAN-2024, the patient received the 1st dose of Menveo. On 08-JAN-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered Menveo liquid component without the reconstitution of the lyophilized component.) and inappropriate dose of vaccine administered (Verbatim: administered Menveo liquid component without the reconstitution of the lyophilized component.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-APR-2024 This report was submitted via the online direct entry reporting system.  The nurse reported that the patient was administered Menveo liquid component without the reconstitution of the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Nausea, Pyrexia
Clinical narrative: Temperature; Nauseated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: Temperature) and nausea (Verbatim: Nauseated). The outcome of the fever and nausea were not reported.   It was unknown if the reporter considered the fever and nausea to be related to Arexvy.     It was unknown if the company considered the fever and nausea to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-APR-2024 This case was reported via interactive digital media. The patient had temperature and was nauseated. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness; swelling; itchiness; painful; This non-serious case was reported by a consumer and described the occurrence of erythema of extremities in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (On 07-FEB-2024, the patient received 1st dose and experienced pain, refer case - US2024039814). Concurrent medical conditions included anxiety. Concomitant products included fluoxetine.   On 01-MAR-2024, the patient received the 2nd dose of Shingles vaccine. On 02-MAR-2024, 1 days after receiving Shingles vaccine, the patient experienced erythema of extremities (Verbatim: Redness), swelling arm (Verbatim: swelling), pruritus (Verbatim: itchiness) and pain (Verbatim: painful). Rechallenge with Shingles vaccine was positive. The outcome of the erythema of extremities, swelling arm, pruritus and pain were not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pruritus and pain to be related to Shingles vaccine.     It was unknown if the company considered the erythema of extremities, swelling arm, pruritus and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024039814   Additional Information: GSK Receipt Date: 28-MAR-2024 The reporter reported that the patient received a dose of Shingles vaccine. The patient would like to know if there was somewhere to file a claim. Second shot was still ongoing. The symptoms were not treated. The patient was receiving Fluoxetine from 1st January 2022 for anxiety.; Sender's Comments:  US-GSK-US2024039814:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st Februrary 2022).   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: hasn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-APR-2024 The pharmacist called and reported that the patient received the first dose of Shingrix and had not received the second dose yet. The reporter did not consent to follow-up. This was 1 of the 3 cases, reported by the same reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2024042176:SAME REPORTER US-GSK-US2024042175:SAME REPORTER
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered first dose of Engerix-B on 01Mar2024 and then was administered another dose on 08Mar2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old male patient who received HBV (Engerix B) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 08-MAR-2024, the patient received the 2nd dose of Engerix B. On 08-MAR-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: administered first dose of Engerix-B on 01Mar2024 and then was administered another dose on 08Mar2024). The outcome of the drug dose administration interval too short 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: 03-APR-2024 The clinical operations manager reported that during a chart review it was noted that a patient was administered a dose of Engerix-B on 01 March 2024 and then was administered another dose on 08 March 2024. The reporter stated that the nurse who administered the second shot did not review the patient's chart.  The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Engerix-B earlier than recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: patient received two doses of Rotateq and then received one dose of Rotarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included Rotavirus vaccine live reassort oral 5v (Rotateq) for prophylaxis.   Previously administered products included Rotateq (1st dose received on an unknown date).   On an unknown date, the patient received Rotarix lyophilized formulation and the 2nd dose of Rotateq. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced interchange of vaccine products (Verbatim: patient received two doses of Rotateq and then received one dose of Rotarix). The outcome of the interchange of vaccine products 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: 04-APR-2024 The nurse manager reported that a patient received two doses of Rotateq and then received one dose of Rotarix, which led to interchange of vaccine products. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not have the second dose because they have no record; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix vaccine on 21 July 2023.).   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: did not have the second dose because they have no record). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The pharmacist reported that the patient received the first dose of Shingrix vaccine on 21 July 2023 and the patient thought that they had the second dose already back in October 2023 but the pharmacist reported that the patient did not have the second dose because they have no record of it but they could prove the first dose. The reporter asked the any guidance or information if the next dose be a late second dose or a potential third dose? The pharmacist mentioned they would not administer no shot until they get clear guidance or they are not going to do it. The reporter did not consent to follow up.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; adult patients were administered pediatric doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 63-year-old male patient who received HBV (Engerix B pediatric) (batch number FP9TJ, expiry date 24-MAR-2025) for prophylaxis.   On 29-FEB-2024, the patient received Engerix B pediatric. On 29-FEB-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: adult patients were administered pediatric doses). The outcome of the underdose and adult use of a child product were 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-05-APR-2024 The nurse reported that the adult patient received the pediatric dose of Engerix B vaccine which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. This case is 3 of the 3 cases reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024043624:Same reporter / different patient US-GSK-US2024043622:Same reporter / different patient
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Two adult patients were administered pediatric doses of Havrix; Administered pediatric doses of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 46-year-old male patient who received HAV (Havrix pediatric) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis.   On 26-OCT-2023, the patient received Havrix pediatric. On 26-OCT-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: Two adult patients were administered pediatric doses of Havrix) and adult use of a child product (Verbatim: Administered pediatric doses of Havrix). The outcome of the underdose and adult use of a child product were 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: 05-APR-2024 The nurse was reported that during vaccine record reconciliation, it was noted that two adult's patient was administered pediatric doses of Havrix vaccine, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. This was 2 of the 2 linked patients, reported by the same reporter. The reporter consent to follow up.; Sender's Comments:  US-GSK-US2024043626:Same reporter/Patient 1 of 2
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero was administered inadvertently instead of Menveo; This non-serious case was reported by a nurse via call center representative 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 the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero was administered inadvertently instead of Menveo). 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: 05-APR-2024 Nurse reported that a patient came for meningococci vaccine at 11 years old and got Bexsero and never got Menveo as a toddler, she wanted to know if it was allowed to give Bexsero as a first dose for meningococci virus.  Nurse wanted to know if she should continue with Menveo or Bexsero.  Nurse did not have any information on the vaccine or the patient and wanted to remain anonymous.  When nurse was transferred to second line for more information, she was asked if Bexsero was administered inadvertently instead of Menveo, and she confirmed this which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: did not get the 2nd yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received the first dose of Twinrix vaccine on 30 September 2023 with batch number 797F9 and expiration date 30 December 2025).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: did not get the 2nd yet). The outcome of the incomplete course of vaccination 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-APR-2024 The pharmacist reported that the patient received the first dose of Twinrix vaccine on 30th September 2023 and did not get the 2nd dose yet. If she got it right away when would she get the 3rd dose? Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This solicited report received from a consumer via regulatory authority concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. Reporter's dad was against the jab. He refused to take it. However, he required medical treatment and they were going to refuse to provide him with the care he needed unless he got the jab. He took it and two days later, he died (dose series 1). The cause of death was unknown. Autopsy performed was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and died was not related.  This report was serious (Death).; Sender's Comments: V0-Death. 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: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: They destroyed my life After I received this happened to me. shingles; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (They destroyed my life After I received this happened to me. shingles) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    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 HERPES ZOSTER (They destroyed my life After I received this happened to me. shingles). At the time of the report, HERPES ZOSTER (They destroyed my life After I received this happened to me. shingles) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.  RA ID was reported as 0049-22.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: experienced redness, tenderness, and swelling at her injection site recently; experienced redness, tenderness, and swelling at her injection site recently; experienced redness, tenderness, and swelling at her injection site recently; This is a spontaneous report received from a Nurse from medical information team.  An adult female patient (unknown if pregnant) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), 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: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "experienced redness, tenderness, and swelling at her injection site recently".  Additional information: The reporter asked for more data regarding local site reactions in adults that she can share with a patient who experienced redness, tenderness, and swelling at her injection site recently.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Injection site nodule
Clinical narrative: knots at the injection site; This is a spontaneous report received from a Physician from a sales representative.  An infant patient received pneumococcal 20-val conj vac (dipht 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: VACCINATION SITE NODULE (non-serious) with onset 11Apr2024 at 13:15, outcome "unknown", described as "knots at the injection site". It was unknown if therapeutic measures were taken as a result of vaccination site nodule.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Urinary tract infection
Clinical narrative: UTI; sick; flu like symptoms; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 11Apr2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP. Other Case identifier(s): LRN5145989.  A 44-year-old female patient 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 included: "Relapsing Remitting Multiple sclerosis" (unspecified if ongoing); "Severe anxiety" (unspecified if ongoing); "Allergy Mercury" (unspecified if ongoing); "Allergy Steroids/Allergy SSRI" (unspecified if ongoing); "Cavity" (unspecified if ongoing); "Serotonin Toxicity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization, reaction(s): "Sickness", "Flu like symptoms", "UTI". The following information was reported: URINARY TRACT INFECTION (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "UTI"; ILLNESS (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "sick"; INFLUENZA LIKE ILLNESS (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "flu like symptoms".  Additional information: The patient reported that a week after both vaccines she did feel sick and had flu like symptoms and UTI's.  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: Linked Report(s) : US-PFIZER INC-PV202400036304 same patient, vaccine and events, different dose number;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 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: "Asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sporanox, reaction(s): "Known allergies: Sporanox". Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; 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; Covid-19 vaccine (DOSE 6; UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 7; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Apr2024) Negative, notes: After 18 days finally seem to be negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received paxlovid from 25Mar2024 to 30Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of 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 (BNT162B2 NOS), on 26Sep2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 04Apr2024 to 09Apr2024.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: 13-year-old children died of heart attack after they got vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A 13-year-old female patient 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. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "13-year-old children died of heart attack after they got vaccine". The patient date of death was unknown. Reported cause of death: "13-year-old children died of heart attack after they got vaccine". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: 13-year-old children died of heart attack after they got vaccine
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; LOSARTAN taken for blood pressure abnormal. The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "unknown". Clinical course was reported as follows: patient took the vaccine on 08Nov202, and another one on the 08Dec2021. Patient saw an urologist, and he took sildenafil 50 milligram and tadalafil 5 milligram, but they didn't work so he stopped them in 2023 or 2022 . The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400086878 same patient/vaccine/event, diff doses;
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile dysfunction; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LOSARTAN. Vaccination history included: BNT162b2 (Dose 1), administration date: 08Nov2021, when the patient was 42-year-old, for Covid-19 Immunization, reaction(s): "erectile dysfunction". The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "unknown". The event "erectile dysfunction" required physician office visit. Therapeutic measures were taken as a result of erectile dysfunction. Clinical course: the patient took the vaccine on the 08Dec2021 and experienced erectile dysfunction; saw an urologist and took Sildenafil 50 milligram and Tadalafil 5 milligram but did not work so stopped taking it in 2023 or 2022.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400086617 same patient/vaccine/event, diff doses;
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Urinary tract infection
Clinical narrative: UTI; sick; flu like symptoms; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 11Apr2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from an Other HCP. Other Case identifier(s): LRN5145989.  An adult 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 included: "Relapsing Remitting Multiple sclerosis" (unspecified if ongoing); "Severe anxiety" (unspecified if ongoing); "Allergy Mercury" (unspecified if ongoing); "Allergy Steroids/Allergy SSRI" (unspecified if ongoing); "Cavity" (unspecified if ongoing); "Serotonin Toxicity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "UTI"; ILLNESS (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "sick"; INFLUENZA LIKE ILLNESS (non-serious), 1 week after the suspect product(s) administration, outcome "unknown", described as "flu like symptoms". Batch/lot number is not provided, and it cannot be obtained. Additional information: On unknown date, patient started therapy with Pfizer Covide-19 vaccine and Booster vaccine for vaccination. On unknown date, patient reported that a week after both vaccines she did feel sick and had flu like symptoms and UTI's.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400085518 same patient, vaccine and events, different dose number;
Sex: F
Vaccine: RSV
Symptoms: Cardiac disorder, Lung disorder
Clinical narrative: She has a heart and lung condition; She has a heart and lung condition; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female 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: CARDIAC DISORDER (non-serious), LUNG DISORDER (non-serious), outcome "unknown" and all described as "She has a heart and lung condition". Additional information: Caller the patient's daughter called on behalf of the patient seeking assistance with the Abrysvo vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC20
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Sensory loss, Spinal disorder
Clinical narrative: Guillain-Barre syndrome; Hypoaesthesia/legs and feet became numb; Sensory loss/lose feeling in both limbs; Spinal disorder; This is a spontaneous report received from an Other HCP.  A 52-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jan2024 as dose 1, single (Lot number: HG7760) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Acute sinus infection" (ongoing). The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 05Feb2024, outcome "not recovered"; HYPOAESTHESIA (hospitalization, medically significant) with onset 05Feb2024, outcome "not recovered", described as "Hypoaesthesia/legs and feet became numb"; SENSORY LOSS (hospitalization, medically significant) with onset 05Feb2024, outcome "not recovered", described as "Sensory loss/lose feeling in both limbs"; SPINAL DISORDER (hospitalization, medically significant) with onset 05Feb2024, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome, hypoaesthesia, sensory loss, spinal disorder (start date: 08Feb2024). The events "guillain-barre syndrome", "hypoaesthesia/legs and feet became numb", "sensory loss/lose feeling in both limbs" and "spinal disorder" required emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome, hypoaesthesia, sensory loss, spinal disorder. Additional information: Patient's legs and feet became numb and started to lose feeling in both limbs on 05Feb2024, so she went to the emergency room and they assumed it was something wrong with her spine and gave her a steroid to help with symptoms. She went back to the hospital on 08Feb2024 when the steroid did not help and her left breast and left side went numb also. They diagnosed her with Guillain-Barre and she has remained hospitalized ever since. She is still hospitalized. Medications At Time Of Vaccination was None.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; Fatigue; This is a spontaneous report received from a Consumer or other non-HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as DOSE NUMBER UNKNOWN, SINGLE (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness"; FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He's had Covid before and has all his Pfizer vaccines; He's had Covid before and has all his Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP.  A 78-year-old male patient 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. Past drug history included: Paxlovid for Covid-19, notes: He has had Paxlovid before. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He's had Covid before and has all his Pfizer vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Clinical course: Patient had COVID-19 and took Paxlovid. The reporter was a Caregiver. Caregiver stated that they needed financial assistance for Paxlovid since both had Covid. Patient was on his fifth day of Covid symptoms. He had Covid before and had all his Pfizer vaccines. He had Paxlovid before and made such a difference 'he thought they had both been prescribed Paxlovid'.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 28Feb2023; Covid 28Feb2023; This is a spontaneous report received from a Consumer or other non HCP.  An 88-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 87 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6199), on 20Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history included: "Afib", start date: 2007, stop date: 2011, notes: Pertinent details: Ablation; "Lymphoma", start date: 2019 (ongoing); "Skin disorder" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METOPROLOL SUCCINATE; ZETIA; ELIQUIS; BENZONATATE; METHOTREXATE; FOLIC ACID; TRIAMCINOLONE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; ATARAX [HYDROXYZINE]; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID]; ZINC taken for skin disorder; VITAMIN B-12; VITAMIN D NOS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Feb2023, outcome "unknown" and all described as "Covid 28Feb2023".  Additional information: Patient reported that booster dose given due to a weakened immune system. Patient currently or recently had cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas)-yes. No prior Vaccinations (within 4 weeks). Afib after 29Feb2024, subsided after 21Feb pulse still high. Also had reaction of (unclear) covid 28Feb2023. Pfizer Bivalent was administered on 04May2023 with lot no GJ3270.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400025614 same patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Biontech Vaccine Lack of efficacy; Suspected COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) 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. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Biontech Vaccine Lack of efficacy"; SUSPECTED COVID-19 (medically significant), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of Efficacy; Lack of Efficacy; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Lack of Efficacy".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RAB
Symptoms: Exposure to communicable disease
Clinical narrative: possible rabies exposure; Initial information received on 10-Apr-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced possible rabies exposure after receiving Rabies (Hdc) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Post exposure immunization (immunization). Information on the batch number was requested.  On an unknown date the patient developed possible rabies exposure (exposure to communicable disease) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event..  At time of reporting, the outcome was Unknown for the event.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: reported that they administered an expired TENIVAC to a patient and the caller wanted to know the recommendations with no reported adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 36 years old female patient who reported that they administered an expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] to a patient and the caller wanted to know the recommendations with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 05-Apr-2024, the patient received a dose 1 of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) lot C5965A,Expiry date :02-Mar-2024 , strength was unknown via intramuscular route in the left arm for prophylactic vaccination (Immunization) and reported that they administered an expired tenivac to a patient and the caller wanted to know the recommendations with no reported adverse event (expired product administered) (latency : same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given with an expired DAPTACEL today with no adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who received with an expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] today with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine Inact (Vaqta) for Immunisation.  On 11-Apr-2024, the patient received a dose 4 of 0.5 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) (lot C5980AB ,Expiry date: 06-Apr-2024, strength was unknown) via intramuscular route in the left thigh for Prophylactic vaccination (Immunization) and patient was given with an expired daptacel today with no adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: An expired dose of TYPHIM-VI was inadvertently administered to a patient with no reported adverse event; Initial information received on 11-Apr-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was inadvertently administered with an expired Typhoid VI Polysaccharide Vaccine [Typhim VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient had inadvertently received expired 0.5ml of suspect Typhoid VI Polysaccharide Vaccine (Solution for injection) (Frequency = once) (Strength = standard) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day). Batch number was requested for this case.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: Spoke with mom and informed me that baby has a Low Grade fever.
Age: 36.0
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy, Paraesthesia
Clinical narrative: Client called office on 4/9/2024 to report that after he was done lifting weights on 4/7/2024, he had tingling in his palms, that felt like pins and needles in the arm that he received the vaccine in. Also in the arm he received vaccine in he stated that he had swollen lymph nodes in his armpits. Saw client again in office on 4/12/2024, client stated that the tingling in his palms has resolved and his lymph nodes were no longer swollen. Client stated that symptoms resolved by 4/10/2024.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: INFORM FATHER TO BE ALERT TO FEVERS OR REACTIONS. IF SXS OUTGROW PLEASE TO TAKE TO ER OR URGENT CARE, CALL PCP
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event noted. Administered COVID 12 year old dose to patient <12 years old.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Blood in stool, diarrhea
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: Woke up 1 morning and couldn't move my right arm
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Eye pruritus
Clinical narrative: Patient came to receive the third dose engerix b. After an hour of vaccination, she called that her face was red and her eyes itched, that it could be from the vaccine. I told him to take Benadryl if he had access but he told me he was going to the emergency room. I instructed him to call back to check if there had been a reaction to the vaccine, but so far he has not done so. A call will be made tomorrow to verify the patient's condition.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient presented today for another Covid vaccine dose, he presented his left arm and said that the rash on his arm was itchy and appeared after his covid vaccine on 9/23/23. Told him he should have that looked at by his provider and I would not give him another dose at this time. Should be done in a clinic