chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: punctured IPOL was administered to patient that is not suitable for use with no reported adverse event; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 2 years old male patient who was administered punctured IPV (VERO) [IPOL] that is not suitable for use 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 Hepatitis A vaccine and HIB vaccine, both for Immunisation.  On 05-Jan-2024, the patient received 0.5 ml dose of suspect IPV (Vero) (punctured; frequency: total) Suspension for injection of lot W1C751M and expiry: 18-Nov-2025 via intramuscular route in the right vastus lateralis for immunization, that is not suitable for use with no reported adverse event (poor quality product administered).  Reportedly, 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.  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: 11.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administration of punctured ipol that is not suitable for use with no reported ae; Initial information received From Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old male patient who had administration of punctured IPV (Vero) [IPOL] that is not suitable for use 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); MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI); DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 11-Jan-2024, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection (strength: standard, frequency: once, expiry date: 18-NOV-2025 and lot W1C751M) via intramuscular route in the left deltoid as Immunization punctured ipol that is not suitable for use with no reported ae (poor quality product administered) (latency: same day).   Reportedly: 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. Max/low temperature reached: 9.3 Celsius for 13 mins.   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: 13.0
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; Initial information was received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient of max/low temperature reached: 9.3 c for 13 mins/punctured IPV (VERO) [IMOVAX POLIO] was administered to patient 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; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 17-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 strength was unknown) via intramuscular route in the left deltoid for Immunization and max/low temperature reached: 9.3 c for 13 mins/punctured ipol was administered to patient with no reported ae (poor quality product administered) (latency : same day) following the administration of IPV (VERO).  Reportedly "Human error? Unknown Administered? Yes, it was administered to 50 patients. Does extended stability data cover the excursion? No Nurse verbally consented for a follow up in case Safety team wants additional information. See Transfer Screen for the details of patient 46. 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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administration of acthib, that was reconstituted with sterile water with no reported ae; Initial information received from Regulatory Authority on 30-Jan-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient who had administration of HIB (PRP/T) vaccine [ACT-HIB], that was reconstituted with sterile water 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 an unknown dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UJ867AA; expiry date: 24-Mar-2026) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had administration of HIB (PRP/T) vaccine, that was reconstituted with sterile water with no reported ae (product preparation error) (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: 7.0
Sex: M
Vaccine: FLUC3
Symptoms: Swelling, Urticaria
Clinical narrative: Swelling the size of an orange; Hives; This spontaneous case was received on 26-Jan-2024 from other healthcare professional (nurse) (reference number SEQW24-00403) and concerned a 7-year-old, male patient.   The patient had no relevant medical history and was not taking any concomitant medications. The patient's historical vaccines included unspecified vaccines and influenza vaccines (brand not specified), on an unspecified dates, for unreported indications after which the patient experienced swelling the size of an orange and hives (see case 202400555).   On 11-Oct-2024, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4V; route of administration: intramuscular, anatomical location: right arm, dose and indication: not reported. The batch number was not reported.   On the same date, after receiving Flucelvax Quadrivalent, the patient broke out with swelling the size of an orange, registered nurse (RN) gave cool compress, Benadryl (diphenhydramine hydrochloride) and cortisone cream, waited 30 minutes and it stayed the same.  On unspecified dates in Oct-2024, two to three days, the patient's mom watched outline of hives, administered Zyrtec (cetirizine hydrochloride) and Benadryl and symptoms got worse before they got better.   The outcome of the events of selling and hives was not reported.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  This case is linked with case 202400555 (the same patient).  Company comment: A 7-year-old, male patient experienced swelling and urticaria on the same day after being vaccinated with Flucelvax Quadrivalent. The patient was treated with cool compress, Benadryl, and cortisone cream. Additionally, the patient was treated with Zyrtec. Causality for both events is assessed as possibly related, due to chronological plausibility.; Sender's Comments: A 7-year-old, male patient experienced swelling and urticaria on the same day after being vaccinated with Flucelvax Quadrivalent. The patient was treated with cool compress, Benadryl, and cortisone cream. Additionally, the patient was treated with Zyrtec. Causality for both events is assessed as possibly related, due to chronological plausibility.
Sex: M
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Swelling the size of an orange; Hives; This spontaneous case was received on 26-Jan-2024 from other healthcare professional (nurse) via Med Communications (reference number: SEQW24-00403) and concerned a male patient of unspecified age (the patient was a 7-year-old at the time of initial reporting).  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine (brand not specified; 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 the influenza vaccine, the patient experienced hives and broke out with swelling the size of an orange.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A male patient was vaccinated with influenza virus vaccine, on unknown date. On unknown day and unknown amount of time following vaccination, patient experienced swelling and urticaria. Considering the limited information provided, lack of information regarding the vaccination date and events onset dates, and unclear temporal relationship, causality for reported events is unassessable.; Sender's Comments: A male patient was vaccinated with influenza virus vaccine, on unknown date. On unknown day and unknown amount of time following vaccination, patient experienced swelling and urticaria. Considering the limited information provided, lack of information regarding the vaccination date and events onset dates, and unclear temporal relationship, causality for reported events is unassessable.
Sex: F
Vaccine: FLUC3
Symptoms: Allergy to vaccine
Clinical narrative: Allergy to Flucelvax; This spontaneous case was received on 29-Jan-2024 from other healthcare professional (nurse) via Med Communications (reference number: SEQW24-00433) and concerned a 67-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (dose, route of administration, anatomical location: not reported) as active immunization against influenza disease. The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient had an allergy to Flucelvax, as reported. No further follow-up was anticipated.  The outcome of the event was not reported.  The reporter did not provide a casualty assessment.  The case was assessed as non-serious.  Company comment: The event of 'allergy to vaccine' is unassessable to Fluad Quadrivalent due to unclear temporal relationship..; Sender's Comments: The event of 'allergy to vaccine' is unassessable to Fluad Quadrivalent due to unclear temporal relationship.
Age: 48.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS TOO YOUNG TO RECEIVE DOSAGE. PHARMACIST FELT THAT BECAUSE PATIENT HAD COME DOWN WITH RSV BEFORE, IT WOULD BE OKAY TO ADMINISTER
Age: 24.0
Sex: M
Vaccine: UNK
Symptoms: Alopecia areata
Clinical narrative: I currently do not have my vaccine info but this can be obtained. I was vaccinated at the university as a student there due to their vaccine mandate and immediately developed alopecia areata. Without a family history and due to the subsequent development after the vaccine it is pretty clear what the cause is.
Age: 20.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Arthralgia, Asthenia, Back pain, C-reactive protein increased, Chills
Clinical narrative: symptoms: left arm numbness and left sided neck numbness at first. Led to left side body numbness and weakness. I had tachycardia and trouble breathing. My left hand was stuck in a clenched fist position. About 17 hours after shots, I developed a low grade fever and chills. My heart rate rapidly increased to 180 bpm, my whole body developed paralysis, I had double vision, and my lips went numb so I couldn?t open my mouth and couldn?t breathe. This developed into waist down paralysis, bladder retention, and constipation that lasted 11 days. The paralysis in legs turned into weakness that would get worse the more I attempted to walk. When I stood up, I experienced my heart rate going up to 180 bpm and blood pressure would go up to around 150/100. I developed numbness frequently in my left foot and toes. My left lower back hurts and knee hurts while I walk. I developed left foot drop. When I rest completely in bed, my legs get less weak. Once, I try to walk a bit, my legs decline in strength. I?m currently in the hospital and have been here for 2 1/2 weeks since the day I got the shots. I have had a ton of imaging and labs done. Currently my legs are declining again. When I try to walk with the walker, I can?t make steps, my feet drag, and I shake a lot. It did get better once I was in bed rest for 2 days. Currently awaiting an acute rehab bed for physical therapy. We have not tried any treatments.
Age: 20.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Computerised tomogram head abnormal, Computerised tomogram normal, Constipation, Diplegia, Diplopia
Clinical narrative: symptoms: left arm numbness and left sided neck numbness at first. Led to left side body numbness and weakness. I had tachycardia and trouble breathing. My left hand was stuck in a clenched fist position. About 17 hours after shots, I developed a low grade fever and chills. My heart rate rapidly increased to 180 bpm, my whole body developed paralysis, I had double vision, and my lips went numb so I couldn?t open my mouth and couldn?t breathe. This developed into waist down paralysis, bladder retention, and constipation that lasted 11 days. The paralysis in legs turned into weakness that would get worse the more I attempted to walk. When I stood up, I experienced my heart rate going up to 180 bpm and blood pressure would go up to around 150/100. I developed numbness frequently in my left foot and toes. My left lower back hurts and knee hurts while I walk. I developed left foot drop. When I rest completely in bed, my legs get less weak. Once, I try to walk a bit, my legs decline in strength. I?m currently in the hospital and have been here for 2 1/2 weeks since the day I got the shots. I have had a ton of imaging and labs done. Currently my legs are declining again. When I try to walk with the walker, I can?t make steps, my feet drag, and I shake a lot. It did get better once I was in bed rest for 2 days. Currently awaiting an acute rehab bed for physical therapy. We have not tried any treatments.
Age: 20.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Dyskinesia, Dyspnoea, Gait disturbance, Heart rate increased, Hemiparesis
Clinical narrative: symptoms: left arm numbness and left sided neck numbness at first. Led to left side body numbness and weakness. I had tachycardia and trouble breathing. My left hand was stuck in a clenched fist position. About 17 hours after shots, I developed a low grade fever and chills. My heart rate rapidly increased to 180 bpm, my whole body developed paralysis, I had double vision, and my lips went numb so I couldn?t open my mouth and couldn?t breathe. This developed into waist down paralysis, bladder retention, and constipation that lasted 11 days. The paralysis in legs turned into weakness that would get worse the more I attempted to walk. When I stood up, I experienced my heart rate going up to 180 bpm and blood pressure would go up to around 150/100. I developed numbness frequently in my left foot and toes. My left lower back hurts and knee hurts while I walk. I developed left foot drop. When I rest completely in bed, my legs get less weak. Once, I try to walk a bit, my legs decline in strength. I?m currently in the hospital and have been here for 2 1/2 weeks since the day I got the shots. I have had a ton of imaging and labs done. Currently my legs are declining again. When I try to walk with the walker, I can?t make steps, my feet drag, and I shake a lot. It did get better once I was in bed rest for 2 days. Currently awaiting an acute rehab bed for physical therapy. We have not tried any treatments.
Age: 20.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Imaging procedure, Magnetic resonance imaging normal, Microcephaly
Clinical narrative: symptoms: left arm numbness and left sided neck numbness at first. Led to left side body numbness and weakness. I had tachycardia and trouble breathing. My left hand was stuck in a clenched fist position. About 17 hours after shots, I developed a low grade fever and chills. My heart rate rapidly increased to 180 bpm, my whole body developed paralysis, I had double vision, and my lips went numb so I couldn?t open my mouth and couldn?t breathe. This developed into waist down paralysis, bladder retention, and constipation that lasted 11 days. The paralysis in legs turned into weakness that would get worse the more I attempted to walk. When I stood up, I experienced my heart rate going up to 180 bpm and blood pressure would go up to around 150/100. I developed numbness frequently in my left foot and toes. My left lower back hurts and knee hurts while I walk. I developed left foot drop. When I rest completely in bed, my legs get less weak. Once, I try to walk a bit, my legs decline in strength. I?m currently in the hospital and have been here for 2 1/2 weeks since the day I got the shots. I have had a ton of imaging and labs done. Currently my legs are declining again. When I try to walk with the walker, I can?t make steps, my feet drag, and I shake a lot. It did get better once I was in bed rest for 2 days. Currently awaiting an acute rehab bed for physical therapy. We have not tried any treatments.
Age: 20.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Muscular weakness, Musculoskeletal disorder, Orthostatic hypertension, Pain, Paralysis
Clinical narrative: symptoms: left arm numbness and left sided neck numbness at first. Led to left side body numbness and weakness. I had tachycardia and trouble breathing. My left hand was stuck in a clenched fist position. About 17 hours after shots, I developed a low grade fever and chills. My heart rate rapidly increased to 180 bpm, my whole body developed paralysis, I had double vision, and my lips went numb so I couldn?t open my mouth and couldn?t breathe. This developed into waist down paralysis, bladder retention, and constipation that lasted 11 days. The paralysis in legs turned into weakness that would get worse the more I attempted to walk. When I stood up, I experienced my heart rate going up to 180 bpm and blood pressure would go up to around 150/100. I developed numbness frequently in my left foot and toes. My left lower back hurts and knee hurts while I walk. I developed left foot drop. When I rest completely in bed, my legs get less weak. Once, I try to walk a bit, my legs decline in strength. I?m currently in the hospital and have been here for 2 1/2 weeks since the day I got the shots. I have had a ton of imaging and labs done. Currently my legs are declining again. When I try to walk with the walker, I can?t make steps, my feet drag, and I shake a lot. It did get better once I was in bed rest for 2 days. Currently awaiting an acute rehab bed for physical therapy. We have not tried any treatments.
Age: 20.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Peroneal nerve palsy, Pyrexia, Tachycardia, Tremor, Urinary retention
Clinical narrative: symptoms: left arm numbness and left sided neck numbness at first. Led to left side body numbness and weakness. I had tachycardia and trouble breathing. My left hand was stuck in a clenched fist position. About 17 hours after shots, I developed a low grade fever and chills. My heart rate rapidly increased to 180 bpm, my whole body developed paralysis, I had double vision, and my lips went numb so I couldn?t open my mouth and couldn?t breathe. This developed into waist down paralysis, bladder retention, and constipation that lasted 11 days. The paralysis in legs turned into weakness that would get worse the more I attempted to walk. When I stood up, I experienced my heart rate going up to 180 bpm and blood pressure would go up to around 150/100. I developed numbness frequently in my left foot and toes. My left lower back hurts and knee hurts while I walk. I developed left foot drop. When I rest completely in bed, my legs get less weak. Once, I try to walk a bit, my legs decline in strength. I?m currently in the hospital and have been here for 2 1/2 weeks since the day I got the shots. I have had a ton of imaging and labs done. Currently my legs are declining again. When I try to walk with the walker, I can?t make steps, my feet drag, and I shake a lot. It did get better once I was in bed rest for 2 days. Currently awaiting an acute rehab bed for physical therapy. We have not tried any treatments.
Age: 20.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Walking aid user
Clinical narrative: symptoms: left arm numbness and left sided neck numbness at first. Led to left side body numbness and weakness. I had tachycardia and trouble breathing. My left hand was stuck in a clenched fist position. About 17 hours after shots, I developed a low grade fever and chills. My heart rate rapidly increased to 180 bpm, my whole body developed paralysis, I had double vision, and my lips went numb so I couldn?t open my mouth and couldn?t breathe. This developed into waist down paralysis, bladder retention, and constipation that lasted 11 days. The paralysis in legs turned into weakness that would get worse the more I attempted to walk. When I stood up, I experienced my heart rate going up to 180 bpm and blood pressure would go up to around 150/100. I developed numbness frequently in my left foot and toes. My left lower back hurts and knee hurts while I walk. I developed left foot drop. When I rest completely in bed, my legs get less weak. Once, I try to walk a bit, my legs decline in strength. I?m currently in the hospital and have been here for 2 1/2 weeks since the day I got the shots. I have had a ton of imaging and labs done. Currently my legs are declining again. When I try to walk with the walker, I can?t make steps, my feet drag, and I shake a lot. It did get better once I was in bed rest for 2 days. Currently awaiting an acute rehab bed for physical therapy. We have not tried any treatments.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Brain fog, Fall, Fatigue, Insomnia, Movement disorder
Clinical narrative: brain fog: fatigue; sleep disruption; Autoimmune, Autonomic, and Neurological Injuries; Autoimmune, Autonomic, and Neurological Injuries; Autoimmune, Autonomic, and Neurological Injuries; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; had very little sleep; fallen twice; movement disorder: tremors and twitching; Information has been received from a lawyer regarding a case in litigation and referred to an adult female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. Pt was vaccinated with the first and second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection for preventing cancer on 06-NOV-2017 and 21-MAY-2018, respectively (strength, dose, route, lot#, and expiration date were not reported). Pt began experiencing tremors occurring mostly at night. On the morning of 01-SEP-2018, pt's mother took her to the emergency room. She had fallen twice, had very little sleep, and was twitching. Over time, her movement disorder became increasingly worse, and she experienced various other symptoms such as fatigue, brain fog, and sleep disruption. Pt had serious and debilitating injuries, including but not limited to autonomic, autoimmune, neurological injuries/dysfunctions as well as a constellation of adverse symptoms, complications, other adverse events, and resulting sequalae. Pt began to suspect that the vaccine/vaccine-induced autoimmune disorder was the cause of her symptoms and injuries. As a direct and proximate result of her vaccine-induced injuries, she had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur these losses and expenses in the future. She had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her injuries. The outcome of events was not resolved.    All the events were considered to be disabling by the lawyer. Upon on internal review, autoimmune disorder was considered to be medically significant.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching, Sleep disorder, Tremor
Clinical narrative: brain fog: fatigue; sleep disruption; Autoimmune, Autonomic, and Neurological Injuries; Autoimmune, Autonomic, and Neurological Injuries; Autoimmune, Autonomic, and Neurological Injuries; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; had very little sleep; fallen twice; movement disorder: tremors and twitching; Information has been received from a lawyer regarding a case in litigation and referred to an adult female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. Pt was vaccinated with the first and second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection for preventing cancer on 06-NOV-2017 and 21-MAY-2018, respectively (strength, dose, route, lot#, and expiration date were not reported). Pt began experiencing tremors occurring mostly at night. On the morning of 01-SEP-2018, pt's mother took her to the emergency room. She had fallen twice, had very little sleep, and was twitching. Over time, her movement disorder became increasingly worse, and she experienced various other symptoms such as fatigue, brain fog, and sleep disruption. Pt had serious and debilitating injuries, including but not limited to autonomic, autoimmune, neurological injuries/dysfunctions as well as a constellation of adverse symptoms, complications, other adverse events, and resulting sequalae. Pt began to suspect that the vaccine/vaccine-induced autoimmune disorder was the cause of her symptoms and injuries. As a direct and proximate result of her vaccine-induced injuries, she had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she would continue to incur these losses and expenses in the future. She had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her injuries. The outcome of events was not resolved.    All the events were considered to be disabling by the lawyer. Upon on internal review, autoimmune disorder was considered to be medically significant.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: st dose of Menveo on 01Mar2023 and an early 2nd dose on 07Dec2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3553D, expiry date 28-FEB-2025) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 01-MAR-2023).   On 07-DEC-2023, the patient received the 2nd dose of Menveo. On 07-DEC-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: st dose of Menveo on 01Mar2023 and an early 2nd dose on 07Dec2023). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 29-JAN-2024 A patient received 1st dose of Menveo and received an early 2nd dose, which led to extra dose administered. The reporter consented to follow-up via email.
Age: 14.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: max/low temperature reached: 9.3 C for 13 mins 10 C for 10 C with no reported adverse event; vaccine was administered to patient with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 14 years old female patient where reporter reported IPV (vero) [IPOL] max/low temperature reached: 9.3 c for 13 mins 10 c for 10 c with no reported adverse event and vaccine was administered to patient 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 influenza vaccine (flu vaccine vii), meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (tdap) and varicella zoster vaccine (varicella vaccine) for Prophylactic vaccination.  On 19-Dec-2023, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot W1C751M and expiration date- 18-Nov-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation (product storage error) and (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 and Regulatory Authority 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: 9.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL she 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; punctured IPOL she 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; Initial information received from Regulatory Authority on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 9 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 Hepatitis A Vaccine (Hepatitis A Vaccine) for Prophylactic vaccination.  On 22-Dec-2023, 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 22-Dec-2023, 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) (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: 10.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Punctured ipol exposed to 9.3 C for 13 mins with no reported adverse event; inappropriate use due to administration of punctured IPOL after excursion with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an 10 years old male patient who IPV (vero) [IPOL] temp. excursion due to unknown error, 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 influenza vaccine (influenza), hepatitis a vaccine, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (tdap) and varicella zoster vaccine (varicella vaccine) for Immunisation.  On 03-Jan-2024, the patient received 0.5 ml dose of suspect IPV (vero) Suspension for injection (lot W1C751M and expiration date- 18-Nov-2025) via intramuscular route in the left deltoid (strength: not provided) for Immunisation (product storage error) and (poor quality product administered)( same day latency).  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: 16.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: IPOL Max/low temperature reached: 9.3 C for 13 mins, with no reported adverse event; vaccine administered to patient with no reported adverse event; Initial information received on 29-Jan-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 16 years old female patient where reporter reported IPV (vero) [IPOL] max/low temperature reached: 9.3 c for 13 mins, with no reported adverse event and vaccine administered to patient 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 hepatitis b vaccine, hpv vaccine and meningococcal vaccine a/c/y/w conj (tet tox) (Menquadfi) for Prophylactic vaccination.  On 04-Jan-2024, the patient received 0.5 ml (TOTAL) dose of suspect IPV (vero) Suspension for injection (lot W1C751M and expiration date- 18-Nov-2025) via intramuscular route in unknown administration site (dose and strength: not provided) for Immunisation (product storage error) and (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: RSV
Symptoms: Arthralgia, Asthenia, Myalgia
Clinical narrative: Severe shoulders pain at the joints; astenia; myalgia; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in joint involving shoulder region 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 pain in joint involving shoulder region (Verbatim: Severe shoulders pain at the joints), asthenia (Verbatim: astenia) and myalgia (Verbatim: myalgia). The outcome of the pain in joint involving shoulder region, asthenia and myalgia were not reported.   It was unknown if the reporter considered the pain in joint involving shoulder region, asthenia and myalgia to be related to Arexvy.     It was unknown if the company considered the pain in joint involving shoulder region, asthenia and myalgia to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-JAN-2024 The case was received from the consumer via (Open field AE monitoring) interactive digital media. The patient received arexvy and had severe shoulders pain at the joints, asthenia and myalgia.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Reporter stated her husband received both Shingrix vaccines as mentioned and 14-JAN-2024 developed Shingles on his back that has not resolved.; Shingles on back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number 7tb74, expiry date 17-MAY-2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 4922J, expiry date 27-AUG-2022) for prophylaxis.   On 06-DEC-2020, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 19-JAN-2021, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 14-JAN-2024, 1134 days after receiving Shingrix and 1090 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Reporter stated her husband received both Shingrix vaccines as mentioned and 14-JAN-2024 developed Shingles on his back that has not resolved.) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on back). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2024 The reporter stated that the patient received 1st dose of Shingrix on 06th December 2020. Patient received 2nd dose on 19th January 2021. The patient experienced shingles on 14th January 2024 on his back. the reporter stated the shingles were better but not resolved. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter granted the permission for consent to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was inadvertently administered the Menveo liquid component only without the lyophilized powder component; patient was inadvertently administered the Menveo liquid component only without the lyophilized powder component; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA988A, expiry date 31-OCT-2025) for prophylaxis.   On 27-JAN-2024, the patient received Menveo (left deltoid). On 27-JAN-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient was inadvertently administered the Menveo liquid component only without the lyophilized powder component) and inappropriate dose of vaccine administered (Verbatim: patient was inadvertently administered the Menveo liquid component only without the lyophilized powder component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: RA Receipt Date: 29-JAN-2024 The registered nurse inquired, did the patient need to be revaccinated. The patient was inadvertently administered the Menveo liquid component only without the lyophilized powder component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 6.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: punctured IPOL she 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; punctured IPOL she 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; Initial information received on 29-Jan-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 6 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 influenza vaccine (influenza vaccine) for immunisation; hepatitis a vaccine (hepatitis a vaccine) for prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for Prophylactic vaccination.  On 08-Dec-2023, the patient received 0.5 ml total of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: W1B511M) (Expiry date: 08-Nov-2025) (Strength: standard) (Frequency: once) via intramuscular route in the right deltoid for immunization.  On 08-Dec-2023, 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) (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.