chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temp. excursion due to unknown reason, Max/low temperature reached: 9.3 C for 13 mins with no reported adverse event; puctured ipol was administered to patient post excursion with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 12 years old female patient who was administered with puctured Ipv (Vero) [Ipol] which was exposed to max/low temperature reached: 9.3 c for 13 mins, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) for Prophylactic vaccination.  On 18-Jan-2024, the patient received (0.5 ml once) dose of suspect Ipv (Vero), Suspension for injection, which was exposed to max/low temperature reached: 9.3 c for 13 mins, with no reported adverse event (product storage error) and (poor quality product administered) (strength: unknown) (lot: W1C751M, Expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  No lab data reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both the events.  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: 10.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: administration of punctured IPOL that was exposed to temperature excursion with Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 mins due to unknown reason with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 years old female patient who had administration of punctured IPV (VERO) [IPOL] that was exposed to temperature excursion with max/low temperature reached: 9.3 c for 13 mins 10 c for 10 mins due to unknown reason with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 22-Jan-2024, the patient received a dose of 0.5 ml of suspect IPV (VERO) (Suspension for injection) (lot: W1C751M; expiry date: 18-Nov-2025) via intramuscular route in the left deltoid for Prophylactic vaccination.  On 22-Jan-2024 the patient had administration of punctured ipol that was exposed to temperature excursion with max/low temperature reached: 9.3 c for 13 mins 10 c for 10 mins due to unknown reason with no reported adverse event (poor quality 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: COVID19, FLUC3
Symptoms: COVID-19, Nasal congestion, Product administration error, SARS-CoV-2 test
Clinical narrative: Nasal congestion; Tested Ag positive / Tested for COVID-19; Flucelvax Quadrivalent and Pfizer BioNTech COVID-19 vaccine administered in the same arm on the same date; This spontaneous case was received on 25-Jan-2024 from Pfizer, Inc. (reference number: US-PFIZER INC- 202400019627), reported by other healthcare professional (nurse) and concerned a patient of redacted age and gender.  The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  On 26-Oct-2023, the patient was vaccinated with a non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; dose: reported as '4'; route of administration: intramuscular; anatomical location: arm right, indication: not reported). The batch number reported was HF9275.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: right upper deltoid, dose, route of administration, and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 944457.  On 19-Jan-2024, at 08:00, two months and 24 days after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 vaccine, the patient got a nasal congestion.   On the same date, the patient was tested antigen (Ag) positive for COVID-19 from nasal swab.  The outcome of the events of COVID-19 and nasal congestion was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A patient of unreported age received the suspect product Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine on the same day and in the same anatomical location: right arm (explicitly coded as 'Product administration error'). The patient got a nasal congestion, and a COVID-19 nasal swab antigen (Ag) test was positive, two months and 24 days after vaccination. Based on biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A patient of unreported age received the suspect product Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine on the same day and in the same anatomical location: right arm (explicitly coded as 'Product administration error'). The patient got a nasal congestion, and a COVID-19 nasal swab antigen (Ag) test was positive, two months and 24 days after vaccination. Based on biological and chronological implausibility, causal role of the suspect vaccine is assessed as not related. Product administration error is assessed as unrelated per company's conventions.
Sex: U
Vaccine: FLUC3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis reactions; This spontaneous case was received on 24-Jan-2024 from a physician via Med Communications (reference number: SEQW24-00414) and concerned a patient of unreported gender or age (reported as a kid).   The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2017 or 2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported) The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced anaphylactic reaction.   The outcome of the event was not reported.   The reporter did not provide a causality assessment.   The event of 'anaphylaxis' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  This case is linked with the cases 202400598 and 202400599 (the same reporter).  Company comment: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent, on an unknown day. On unknown date and unknown amount of time following vaccination, patient experienced anaphylactic reaction. Considering the limited information provided, lack of information regarding the vaccination date and event onset date, and unclear temporal relationship, causality for reported event is unassessable.; Sender's Comments: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent, on an unknown day. On unknown date and unknown amount of time following vaccination, patient experienced anaphylactic reaction. Considering the limited information provided, lack of information regarding the vaccination date and event onset date, and unclear temporal relationship, causality for reported event is unassessable.
Sex: U
Vaccine: FLUC3
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis reactions; This spontaneous case was received on 24-Jan-2024 from a physician via Med Communications (reference number: SEQW24-00414) and concerned a patient of unreported age and gender (reported as a kid).  The patient's medical history and concomitant medications were not reported.  On an unspecified date in 2017 or 2018, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location, and indication: not reported) The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced anaphylactic reaction.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of 'anaphylaxis' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  This case is linked with the cases 202400597 and 202400599 (the same reporter).  Company comment: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent, on an unknown day. On unknown date and unknown amount of time following vaccination, patient experienced anaphylactic reaction. Considering the limited information provided, lack of information regarding the vaccination date and event onset date, and unclear temporal relationship, causality for reported event is unassessable.; Sender's Comments: A patient of unknown age and gender was vaccinated with Flucelvax Quadrivalent, on an unknown day. On unknown date and unknown amount of time following vaccination, patient experienced anaphylactic reaction. Considering the limited information provided, lack of information regarding the vaccination date and event onset date, and unclear temporal relationship, causality for reported event is unassessable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Pain, Pain in extremity
Clinical narrative: Severe bilateral leg pain with numbness and tingling. Burning pain when moving that takes up to 5 minutes to resolve when at rest. Burning pain noted in hips, gluteal, thigh and calf muscles. Tingling noted in feet and toes. No current loss of motor, superficial or deep pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Severe bilateral leg pain with numbness and tingling. Burning pain when moving that takes up to 5 minutes to resolve when at rest. Burning pain noted in hips, gluteal, thigh and calf muscles. Tingling noted in feet and toes. No current loss of motor, superficial or deep pain.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Chills, Dizziness, Nausea, Peripheral swelling
Clinical narrative: Sore arm, shivering, high temperature, dizziness/nausea, weakness
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Sore arm, shivering, high temperature, dizziness/nausea, weakness
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at injection site; swelling at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (Received first shot and felt pain, refer case US2024AMR013210).   On 23-JAN-2024, the patient received the 2nd dose of Shingrix (left arm). On 24-JAN-2024, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site) and injection site swelling (Verbatim: swelling at injection site). The outcome of the injection site erythema and injection site swelling were resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR013210   Additional Information: GSK Receipt Date: 26-JAN-2024 The patient self-reported this case. The patient received 2nd dose of shingrix and had redness and swelling at the injection site the next day. The patient reported that it was almost fully recovered. Referred to health care professional. No health care professional consent. The reporter did not consented to follow up.; Sender's Comments:  US-GSK-US2024AMR013210:Same patient/ Shot 1
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: She states it expired in 12Jan2024 and was administered by accident with no reported adverse event; Initial information received on 24-Jan-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] by accident with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jan-2024, the patient received 0.5 ml of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: U7271AA) (Expiry date: 12-Jan-2024) (strength: standard) (Frequency: Once) via unknown route in the left arm for immunisation.  On 16-Jan-2024, the patient was administered expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine by accident with no reported adverse event (expired product administered) (latency: same day).  It was reported, She states it expired in 12Jan2024 and was administered by accident on 16Jan2024. HCP wanted to know any information we have with regards to administering an expired vaccine and if ADACEL is considered a non-live vaccine.  This situation is pre-assessed as a medication error/an inappropriate use due to administering an expired vaccine to a patient.  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: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: some of vaccine "dribbled out" and the patient didn't receive the full dose with no reported adverse event; Initial information received on 24-Jan-2024 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case involves an unknown age and unknown gender patient where some of typhoid vi polysaccharide vaccine [Typhim VI] "dribbled out" and the patient didn't receive the full dose 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 received a dose of suspect typhoid vi polysaccharide vaccine Solution for injection lot number not reported via subcutaneous route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (incorrect dose 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: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blood pressure increased, Delivery, Exposure during pregnancy, Infusion, Liver function test increased
Clinical narrative: Premature rupture of membranes and labor - pregnancy history had previously been uncomplicated.  This was my first pregnancy, and I was 35 weeks, 6 days along on the day that I got the vaccine; my estimated due date was Feb 12. 10 hours after receiving the vaccine, my water broke spontaneously without any apparent precipitating factor - I had not been having contractions and was not in labor.   I went to the hospital, where I was then found to have pre eclampsia with severe features. This had not been previously diagnoses in my pregnancy - I had been receiving regular prenatal care and my blood pressure and labs had been normal. However, when I presented to the hospital after receiving the vaccine, my blood pressure was up to 145/90, I had protein in my urine, and my liver function tests were elevated more than 5 times the upper limit of normal.  I received IV pitocin to accelerate my contractions and my son was born with a birth weight of 6 lb, 13 oz.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pre-eclampsia, Premature labour, Premature rupture of membranes, Protein urine present, Urine protein/creatinine ratio increased
Clinical narrative: Premature rupture of membranes and labor - pregnancy history had previously been uncomplicated.  This was my first pregnancy, and I was 35 weeks, 6 days along on the day that I got the vaccine; my estimated due date was Feb 12. 10 hours after receiving the vaccine, my water broke spontaneously without any apparent precipitating factor - I had not been having contractions and was not in labor.   I went to the hospital, where I was then found to have pre eclampsia with severe features. This had not been previously diagnoses in my pregnancy - I had been receiving regular prenatal care and my blood pressure and labs had been normal. However, when I presented to the hospital after receiving the vaccine, my blood pressure was up to 145/90, I had protein in my urine, and my liver function tests were elevated more than 5 times the upper limit of normal.  I received IV pitocin to accelerate my contractions and my son was born with a birth weight of 6 lb, 13 oz.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Uterine contractions during pregnancy
Clinical narrative: Premature rupture of membranes and labor - pregnancy history had previously been uncomplicated.  This was my first pregnancy, and I was 35 weeks, 6 days along on the day that I got the vaccine; my estimated due date was Feb 12. 10 hours after receiving the vaccine, my water broke spontaneously without any apparent precipitating factor - I had not been having contractions and was not in labor.   I went to the hospital, where I was then found to have pre eclampsia with severe features. This had not been previously diagnoses in my pregnancy - I had been receiving regular prenatal care and my blood pressure and labs had been normal. However, when I presented to the hospital after receiving the vaccine, my blood pressure was up to 145/90, I had protein in my urine, and my liver function tests were elevated more than 5 times the upper limit of normal.  I received IV pitocin to accelerate my contractions and my son was born with a birth weight of 6 lb, 13 oz.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blood pressure increased, Delivery, Exposure during pregnancy, Liver function test increased, Pre-eclampsia
Clinical narrative: Premature rupture of membranes and labor - pregnancy history had previously been uncomplicated.  This was my first pregnancy, and I was 35 weeks, 6 days along on the day that I got the vaccine; my estimated due date was Feb 12. 10 hours after receiving the vaccine, my water broke spontaneously without any apparent precipitating factor - I had not been having contractions and was not in labor.   I went to the hospital, where I was then found to have pre eclampsia with severe features. This had not been previously diagnoses in my pregnancy - I had been receiving regular prenatal care and my blood pressure and labs had been normal. However, when I presented to the hospital after receiving the vaccine, my blood pressure was up to 145/90, I had protein in my urine, and my liver function tests were elevated more than 5 times the upper limit of normal.  I received IV pitocin to accelerate my contractions and my son was born with a birth weight of 6 lb, 13 oz.
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Premature delivery, Premature labour, Premature rupture of membranes, Protein urine present, Urine protein/creatinine ratio increased
Clinical narrative: Premature rupture of membranes and labor - pregnancy history had previously been uncomplicated.  This was my first pregnancy, and I was 35 weeks, 6 days along on the day that I got the vaccine; my estimated due date was Feb 12. 10 hours after receiving the vaccine, my water broke spontaneously without any apparent precipitating factor - I had not been having contractions and was not in labor.   I went to the hospital, where I was then found to have pre eclampsia with severe features. This had not been previously diagnoses in my pregnancy - I had been receiving regular prenatal care and my blood pressure and labs had been normal. However, when I presented to the hospital after receiving the vaccine, my blood pressure was up to 145/90, I had protein in my urine, and my liver function tests were elevated more than 5 times the upper limit of normal.  I received IV pitocin to accelerate my contractions and my son was born with a birth weight of 6 lb, 13 oz.
Age: 0.83
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: my daughter got the first dose of Bexsero at 10 months old; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-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 inappropriate age at vaccine administration (Verbatim: my daughter got the first dose of Bexsero at 10 months old). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date: 26-JAN-2024 The patient was reporter's daughter. The patient got the first dose of Bexsero at 10 months old and missed the second one. The reporter stated that, in mid July and they missed the second dose schedule. The reporter asked, could they still give her (patient) the second dose and if not, what should they do. The patient received Bexsero below than the recommended age limit, which led to inappropriate age at vaccine administration.  The follow-up could not be possible as no contact details were available.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2023, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024012403   Additional Information: GSK Receipt Date: 26-JAN-2024 The patient self reported this case. The patient felt pain the next day after Shingrix vaccination that lasted a few days. The patient was referred to healthcare professional (HCP).  No HCP consent was provided. The reporter did not consent to follow-up. For tolerance of the 2nd dose refer case US2024012403.; Sender's Comments:  US-GSK-US2024012403:Same patient/ Shot 2
Sex: U
Vaccine: DTAP, HEP, MNQ
Symptoms: Product storage error
Clinical narrative: Engerix-B, Infanrix, and Menveo (1 vial formulation) had multiple excursions in December 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an specified number of patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Menveo, Infanrix and Engerix B. On an unknown date, an unknown time after receiving Menveo, Infanrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Engerix-B, Infanrix, and Menveo (1 vial formulation) had multiple excursions in December 2023). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-JAN-2024 The medical assistant reported in December 2023 Engerix-B, Infanrix, and Menveo (1 vial formulation) had multiple excursions. The above range total cumulative time was 43 hours 35 minutes, highest temperature 57.70 Fahrenheit and below range was 11 hours 3 minutes, lowest temperature 30.60 Fahrenheit.  The reporter stated the vaccines were administered following the excursions. The reporter estimated approximately 20 patients received at least one of the vaccines following the temperature excursions.  The reporter did not have patient information and date of administrations at the time of reporting was no available. The vaccine administration facility was the same as primary reporter. The patient received Engerix-B, Infanrix and Menveo had multiple excursions temperature excursion which led to incorrect storage of drug. The reporter consented to follow up.
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received Hiberix that was reconstituted with MMR Varivax diluent; patient received Hiberix that was reconstituted with MMR Varivax diluent; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Hib (Hiberix) for prophylaxis.   On 25-JAN-2024, the patient received Hiberix. On 25-JAN-2024, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received Hiberix that was reconstituted with MMR Varivax diluent) and inappropriate dose of vaccine administered (Verbatim: patient received Hiberix that was reconstituted with MMR Varivax diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-JAN-2024 An assistant manager reported that a patient received Hiberix vaccine that was reconstituted with MMR Varivax diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal mail.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 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: not had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-JAN-2024 The consumer received 1st dose 2 years ago and not had the 2nd dose. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Reporter is the HCP (pharmacist) who states that 5 patients were administered only adjuvant component of AREXVY in error on 11 JAN 2024. This is report 4 of 5.; Reporter is the HCP (pharmacist) who states that 5 patients were administered only adjuvant component of AREXVY in error on 11 JAN 2024. This is report 4 of 5; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 45mg3, expiry date 10-JUL-2025) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. On 11-JAN-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Reporter is the HCP (pharmacist) who states that 5 patients were administered only adjuvant component of AREXY in error on 11 JAN 2024. This is report 4 of 5.) and inappropriate dose of vaccine administered (Verbatim: Reporter is the HCP (pharmacist) who states that 5 patients were administered only adjuvant component of AREXY in error on 11 JAN 2024. This is report 4 of 5). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JAN-2024 The reporter who stated that patient was administered only adjuvant component of Arexvy in error, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024013412:Same reporter US-GSK-US2024013413:4th patient US-GSK-US2024013410:Same reporter US-GSK-US2024013415:Same reporter
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: sore neck on the right side of her neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of neck pain in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JAN-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 mg. On 23-JAN-2024, 1 days after receiving Shingrix, the patient experienced neck pain (Verbatim: sore neck on the right side of her neck). The outcome of the neck pain was not resolved.   It was unknown if the reporter considered the neck pain to be related to Shingrix.     It was unknown if the company considered the neck pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2024 The patient reported that after receiving her second Shingrix vaccine on 22 January 2024, in the left arm, the next day she awoke with a sore neck on the right side of her neck. The patient reported that the neck was still sore on day of reporting. She will contact the doctor as she was unsure if this was related to the vaccine. The reporter did not consent to follow up.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/low temperature reached: 9.3 C for 13 mins/punctured IPOL was administered to patient with no reported AE; Max/low temperature reached: 9.3 C for 13 mins/punctured IPOL was administered to patient with no reported AE; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old female patient who received punctured Poliomyelitis Vaccine (Inactivated) IPV (VERO) (Ipol) reporter reported previously was administered to 50 patients/ max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hpv vaccine (hpv vaccine) for prophylactic vaccination; and varicella zoster vaccine (varicella vaccine) for prophylactic vaccination.  On 09-Jan-2024, the patient received 0.5 ml total of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: W1C751M) (Expiry date: 18-Nov-2025) (Strength: standard) (Frequency: once) via intramuscular route in the left deltoid for immunization.  On 09-Jan-2024, the patient received punctured Poliomyelitis Vaccine (Inactivated) IPV (VERO) (Ipol) reporter reported previously was administered to 50 patients/ max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no reported adverse event (product storage error, latency: unknown) (poor quality product administered; latency: same day).  It was reported, Nurse called back and added that the punctured IPOL she reported previously was administered to 50 patients. Nurse also asked for recommendations if the patients need revaccination. Product/s: Punctured IPOL Reason: Unknown Max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C Duration: As stated above Human error: Unknown Administered: Yes, it was administered to 50 patients. Does extended stability data cover the excursion :No. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  This situation is pre-assessed as a medication error/an inappropriate use due to administration of punctured IPOL that is not suitable for use.   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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Appendicitis perforated, Computerised tomogram abdomen abnormal, White blood cell count increased
Clinical narrative: appendicitis with 3 day hospitalization
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Musculoskeletal stiffness, Tachycardia
Clinical narrative: Patient requested that his vaccine reaction be reported from 02/11/2021. Reports the evening he received the COVID vaccine he had stiffness, difficulty moving, tachycardia, and chills. Symptoms were improving by the next morning.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, Retching, Vomiting
Clinical narrative: She did have good results overall with Repatha Sureclick until she became sick in October. She will be repeating labs in about a month and revisits with Cardiologist 03/11.  PT was hospitalized for 9 days in the middle to end of October, she was sick for 4-5 weeks before being hospitalized, stated she got a Covid shot and got very sick (fever, nausea, vomiting, dry heaving), subsided after 10 days then it came back. She followed up with GI and symptoms continued in 5 day cycle which lead to the hospitalization. She spent most of November in rehab since she lost about 20lbs being sick, went down to 100lbs and they had to increase her weight ASAP with unhealthy diet. She is now back to 120lbs.  In the last 6 months, have there been any recent changes in your mood that may be caused by your medication or condition? Y/N (If Y please transfer to RPh)- Y-due to condition of above hospitalization physichiatrist was brought it and became Anxious and Depressed. was giving Ativan and increased Lexapro to 15MG. She is no longer on Ativan and still on Lexapro 15MG.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: She did have good results overall with Repatha Sureclick until she became sick in October. She will be repeating labs in about a month and revisits with Cardiologist 03/11.  PT was hospitalized for 9 days in the middle to end of October, she was sick for 4-5 weeks before being hospitalized, stated she got a Covid shot and got very sick (fever, nausea, vomiting, dry heaving), subsided after 10 days then it came back. She followed up with GI and symptoms continued in 5 day cycle which lead to the hospitalization. She spent most of November in rehab since she lost about 20lbs being sick, went down to 100lbs and they had to increase her weight ASAP with unhealthy diet. She is now back to 120lbs.  In the last 6 months, have there been any recent changes in your mood that may be caused by your medication or condition? Y/N (If Y please transfer to RPh)- Y-due to condition of above hospitalization physichiatrist was brought it and became Anxious and Depressed. was giving Ativan and increased Lexapro to 15MG. She is no longer on Ativan and still on Lexapro 15MG.
Age: 27.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HIGHDOSE GIVEN TO 27 Y/O.  NO IMMEDIATE ISSUE; NO SUBSEQUENT ISSUE REPORTED
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash vesicular
Clinical narrative: THE GRANDMOTHER CALLED ME THE MORNING OF 2/2/24 TO TELL ME THE CHILD HAS A RASH ON HIS BODY , SOME WITH BLISTERS ON TOP. SHE STATED SHE KEPT HIM HOME FROM SCHOOL AND HE HAD A DOCTOR APPOINTMENT FOR LATER IN THE DAY. SHE STATED THE MOTHER OF THE CHILD HAD A SIMILAR REACTION
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus
Clinical narrative: Itchy skin beginning 02/01/2024, dermatographia beginning 02/02/2024
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Having on going R upper arm severe pain
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blepharitis, Body temperature increased, Fatigue, Headache
Clinical narrative: Headache,temperature,body ache, inflamed swollen and painful injection site,tiredness,upset stomach and nausea all which lasted for 3 days. Also small inflamed lump inside lower lid of left  eye which was there at time of writing for almost a week.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Mass, Nausea
Clinical narrative: Headache,temperature,body ache, inflamed swollen and painful injection site,tiredness,upset stomach and nausea all which lasted for 3 days. Also small inflamed lump inside lower lid of left  eye which was there at time of writing for almost a week.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Headache,temperature,body ache, inflamed swollen and painful injection site,tiredness,upset stomach and nausea all which lasted for 3 days. Also small inflamed lump inside lower lid of left  eye which was there at time of writing for almost a week.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given in L deltoid.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Decreased appetite, Dyspnoea, Nasopharyngitis, Pyrexia, Tongue coated
Clinical narrative: WHITE TONGUE , FEVER , SHORTNESS OF BREATH , COLD , NO APETITE
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Injection site pain, Pain
Clinical narrative: patient got HPV vaccine and developed a hard area of induration, L shoulder pain at site of injection, radiating down to hands, numbness in fingers. Was taking ibuprofen, I had her hold that and take steroid taper with Tylenol as needed and resume ibuprofen once steroids completed. She will FU with PCP in a week or two if no improvement
Age: 37.0
Sex: M
Vaccine: HEPA, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered Havrix Pediatric dose. There were no immediate adverse signs or symptoms from this. Patient was notified same day within 30 minutes of administration that he was given the pediatric dose of Havrix.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 88.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: 3 inch wide redness around inj site that was hot to touch.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Atrial fibrillation, Fear
Clinical narrative: Afflicted with atrial fibrillation symptoms several days after vaccine.  Note I had an EKG and chest XRay a week or so before the vaccine and results were normal.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Cough, Malaise, Nasal congestion
Clinical narrative: When I got the shot, I didnt say a word about it, I assumed it was going to be like years before. So that night, I started to get little chills and aches. By the next morning, I had runny nose and just faelt weak and no good. It progressed into coughing and sneezing with a lot of congestion in my nasal and sinuses I had to cough up a lot of phlem, a lot of gunk in it.  It got better after 5 days, but I still not a hundred percent.
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Productive cough, Rhinorrhoea, Sinus congestion, Sneezing
Clinical narrative: When I got the shot, I didnt say a word about it, I assumed it was going to be like years before. So that night, I started to get little chills and aches. By the next morning, I had runny nose and just faelt weak and no good. It progressed into coughing and sneezing with a lot of congestion in my nasal and sinuses I had to cough up a lot of phlem, a lot of gunk in it.  It got better after 5 days, but I still not a hundred percent.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Chills, Feeling cold, Memory impairment
Clinical narrative: Starting that night, I could not get warm. I had bad chills. I put on many thick layers of clothes. I got up the next day and was in a total fog. I couldn't remember much. The next day I felt halfway better. The 3rd morning after the vaccine I was feeling more normal.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Rash, Rash pruritic
Clinical narrative: Unknown which type of RSV - received at pharmacy on 1/30/24 and on 2/2 began having an itchy rash on his right arm, then spread to itching and rash of entire body. No wheezing, no lip or mouth swelling.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Exposure during pregnancy, Fatigue, Heart rate increased, Myalgia
Clinical narrative: 36+6 weeks pregnant at time of vaccine. Woke up  next day (2/4) with common post-vaccine symptoms: muscle aches, joint pains, skin sensitivity, fatigue. In the afternoon felt heart rate was faster so put on watch to monitor, was 120-130s, blood pressure normal, no afib. Remained 120s into the night, no chest pain, shortness of breath or rapid breathing. Took nightly magnesium, one regular Tylenol, and had chamomile tea. Slept really well, but when woke up to pee could tell heart rate still fast, didn t measure and went back to sleep till morning. This morning (2/5) heart rate still low 100s (better), all other cold/flu symptoms have resolved. After some other vaccines I ve had cold/flu symptoms but never fast heart rate. I read on website it may be considered adverse vaccine reaction therefore I am reporting it.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Sensitive skin
Clinical narrative: 36+6 weeks pregnant at time of vaccine. Woke up  next day (2/4) with common post-vaccine symptoms: muscle aches, joint pains, skin sensitivity, fatigue. In the afternoon felt heart rate was faster so put on watch to monitor, was 120-130s, blood pressure normal, no afib. Remained 120s into the night, no chest pain, shortness of breath or rapid breathing. Took nightly magnesium, one regular Tylenol, and had chamomile tea. Slept really well, but when woke up to pee could tell heart rate still fast, didn t measure and went back to sleep till morning. This morning (2/5) heart rate still low 100s (better), all other cold/flu symptoms have resolved. After some other vaccines I ve had cold/flu symptoms but never fast heart rate. I read on website it may be considered adverse vaccine reaction therefore I am reporting it.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Chromaturia, Fatigue, Headache, Injection site pain
Clinical narrative: Paint at injection site, swollen and sore lymph node in armpit on injection side arm lasting for 5 days. Fever over 101, body aches, chills headache all starting the evening of dose one. Beginning the next day I experienced brown urine. This became lighter over the next three days before yellowish color returned. Severe red exhaustion lasted for 6 days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Paint at injection site, swollen and sore lymph node in armpit on injection side arm lasting for 5 days. Fever over 101, body aches, chills headache all starting the evening of dose one. Beginning the next day I experienced brown urine. This became lighter over the next three days before yellowish color returned. Severe red exhaustion lasted for 6 days.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Tremor
Clinical narrative: symptoms started overnight with major body shaking, headache, nausea ; lasted several hours; given ibuprofen and symptoms resolved
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was not discarded at the end of the previous day and was administered to patient after being diluted  and out of the refrigerator for >12 hours.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was not discarded at the end of the previous day and dose was administered to this patient after being reconstituted and in room temp for >12 hours.