chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Computerised tomogram thorax, Endotracheal intubation, Hypercapnia, Lung assist device therapy
Clinical narrative: 7/17/2022 Admitted due to complete white out of left lung, elevated C-reactive protein, and low white blood cells with Acute Hypoxic respiratory Failure secondary to Parainfluenza infection opacification left lung, pneumonia mucus plugging with a total of fifty-one days admitted (51 days admitted)  7/21/2022 Bronchoscopy with intubation and removal mucous plug subsequently developed severe Acute Respiratory Distress Syndrome (ARDS) & persistent fevers requiring escalation of respiratory support to APRV and broad spectrum antimicrobial coverage  7/26/22 Patient became hypoxic requiring bagging mask ventilation. She became bradycardia soon after and found to be PEA requiring three rounds of CPR/epinephrine. After ROSC was obtained she was transitioned to HFOV for management of worsening oxygenation and hypercarbia  7/27/22 Oxygenation and hypercarbia worsened requiring VV ECMO and transferred to hospital unit of facility for management with a total of three weeks on VV ECMO. 09/06/22 Discharged home with prescription oxygen therapy, nebulizer, Albuterol solution prescription, and inhaler prescription which continues treatment and following with Pulmonology every six months presently (12/15/2024) at Facility outpatient care clinic attempting to get adequate Pulmonary Function Test completed last visit on 10/22/2024 to investigate restrictive airway disease and found the leading cause of this condition is the rare interstitial lung disease side effect from Coronavirus vaccine.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Lung opacity, Mechanical ventilation, Oxygen saturation decreased, Parainfluenzae virus infection, Pneumonia
Clinical narrative: 7/17/2022 Admitted due to complete white out of left lung, elevated C-reactive protein, and low white blood cells with Acute Hypoxic respiratory Failure secondary to Parainfluenza infection opacification left lung, pneumonia mucus plugging with a total of fifty-one days admitted (51 days admitted)  7/21/2022 Bronchoscopy with intubation and removal mucous plug subsequently developed severe Acute Respiratory Distress Syndrome (ARDS) & persistent fevers requiring escalation of respiratory support to APRV and broad spectrum antimicrobial coverage  7/26/22 Patient became hypoxic requiring bagging mask ventilation. She became bradycardia soon after and found to be PEA requiring three rounds of CPR/epinephrine. After ROSC was obtained she was transitioned to HFOV for management of worsening oxygenation and hypercarbia  7/27/22 Oxygenation and hypercarbia worsened requiring VV ECMO and transferred to hospital unit of facility for management with a total of three weeks on VV ECMO. 09/06/22 Discharged home with prescription oxygen therapy, nebulizer, Albuterol solution prescription, and inhaler prescription which continues treatment and following with Pulmonology every six months presently (12/15/2024) at Facility outpatient care clinic attempting to get adequate Pulmonary Function Test completed last visit on 10/22/2024 to investigate restrictive airway disease and found the leading cause of this condition is the rare interstitial lung disease side effect from Coronavirus vaccine.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, Pulseless electrical activity, Pyrexia, Resuscitation, White blood cell count decreased
Clinical narrative: 7/17/2022 Admitted due to complete white out of left lung, elevated C-reactive protein, and low white blood cells with Acute Hypoxic respiratory Failure secondary to Parainfluenza infection opacification left lung, pneumonia mucus plugging with a total of fifty-one days admitted (51 days admitted)  7/21/2022 Bronchoscopy with intubation and removal mucous plug subsequently developed severe Acute Respiratory Distress Syndrome (ARDS) & persistent fevers requiring escalation of respiratory support to APRV and broad spectrum antimicrobial coverage  7/26/22 Patient became hypoxic requiring bagging mask ventilation. She became bradycardia soon after and found to be PEA requiring three rounds of CPR/epinephrine. After ROSC was obtained she was transitioned to HFOV for management of worsening oxygenation and hypercarbia  7/27/22 Oxygenation and hypercarbia worsened requiring VV ECMO and transferred to hospital unit of facility for management with a total of three weeks on VV ECMO. 09/06/22 Discharged home with prescription oxygen therapy, nebulizer, Albuterol solution prescription, and inhaler prescription which continues treatment and following with Pulmonology every six months presently (12/15/2024) at Facility outpatient care clinic attempting to get adequate Pulmonary Function Test completed last visit on 10/22/2024 to investigate restrictive airway disease and found the leading cause of this condition is the rare interstitial lung disease side effect from Coronavirus vaccine.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received extra dose of flu vaccine on 12/10/2024 in error. First dose of season was received on 11/01/2024.  Attempted to reach out to patient several times to follow up but no response.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA ( shoulder bursitis)
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Abdominal pain, Blood thyroid stimulating hormone, Cough, Dyspnoea, Nausea
Clinical narrative: Nck pain approx 5 days post vaccination. Pain with swallowing. C/o malaise and body aches. Went to ED, Thyroid mass palpated. Ultrasound completed. Per ENT: Non-toxic multinodular goiter Potentially an inflammatory thyroid reaction to the recent flu vaccine. Sx resolved within a couple weeks. No changes in thyroid function. Repeat sono one year later noted no changes in nodules.   Symptoms: PAIN IN THROAT(R070), OTHER FATIGUE(R5383), PAIN IN UNSPECIFIED JOINT(M2550).
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Neck mass, Neck pain, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Nck pain approx 5 days post vaccination. Pain with swallowing. C/o malaise and body aches. Went to ED, Thyroid mass palpated. Ultrasound completed. Per ENT: Non-toxic multinodular goiter Potentially an inflammatory thyroid reaction to the recent flu vaccine. Sx resolved within a couple weeks. No changes in thyroid function. Repeat sono one year later noted no changes in nodules.   Symptoms: PAIN IN THROAT(R070), OTHER FATIGUE(R5383), PAIN IN UNSPECIFIED JOINT(M2550).
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Thyroid mass, Thyroxine free normal, Ultrasound thyroid abnormal, Vomiting
Clinical narrative: Nck pain approx 5 days post vaccination. Pain with swallowing. C/o malaise and body aches. Went to ED, Thyroid mass palpated. Ultrasound completed. Per ENT: Non-toxic multinodular goiter Potentially an inflammatory thyroid reaction to the recent flu vaccine. Sx resolved within a couple weeks. No changes in thyroid function. Repeat sono one year later noted no changes in nodules.   Symptoms: PAIN IN THROAT(R070), OTHER FATIGUE(R5383), PAIN IN UNSPECIFIED JOINT(M2550).
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Arthralgia, Blood thyroid stimulating hormone normal, Fatigue, Goitre, Malaise
Clinical narrative: Nck pain approx 5 days post vaccination. Pain with swallowing. C/o malaise and body aches. Went to ED, Thyroid mass palpated. Ultrasound completed. Per ENT: Non-toxic multinodular goiter Potentially an inflammatory thyroid reaction to the recent flu vaccine. Sx resolved within a couple weeks. No changes in thyroid function. Repeat sono one year later noted no changes in nodules.   Symptoms: PAIN IN THROAT(R070), OTHER FATIGUE(R5383), PAIN IN UNSPECIFIED JOINT(M2550).
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Neck pain, Odynophagia, Oropharyngeal pain, Pain, Thyroid mass
Clinical narrative: Nck pain approx 5 days post vaccination. Pain with swallowing. C/o malaise and body aches. Went to ED, Thyroid mass palpated. Ultrasound completed. Per ENT: Non-toxic multinodular goiter Potentially an inflammatory thyroid reaction to the recent flu vaccine. Sx resolved within a couple weeks. No changes in thyroid function. Repeat sono one year later noted no changes in nodules.   Symptoms: PAIN IN THROAT(R070), OTHER FATIGUE(R5383), PAIN IN UNSPECIFIED JOINT(M2550).
Age: 36.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Thyroxine normal, Ultrasound thyroid abnormal
Clinical narrative: Nck pain approx 5 days post vaccination. Pain with swallowing. C/o malaise and body aches. Went to ED, Thyroid mass palpated. Ultrasound completed. Per ENT: Non-toxic multinodular goiter Potentially an inflammatory thyroid reaction to the recent flu vaccine. Sx resolved within a couple weeks. No changes in thyroid function. Repeat sono one year later noted no changes in nodules.   Symptoms: PAIN IN THROAT(R070), OTHER FATIGUE(R5383), PAIN IN UNSPECIFIED JOINT(M2550).
Age: 30.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthenia, Gait disturbance, Laboratory test normal, Nausea, Vertigo
Clinical narrative: neurological symptoms; severe vertigo; nausea; can't focus; eyes were constantly beating; still can't focus and his eyes were constantly beating; unstable on feet; Initial information received on 09-Dec-2024 regarding an unsolicited valid non-serious case received (live follow up processed together on CSD: 09-Dec-2024) from Physician via Health Authorities.  This case involves a 30 years old male patient who still can't focus and his eyes were constantly beating, unstable on feet, neurological symptoms, severe vertigo, nausea, can't focus and eyes were constantly beating after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant: no other vaccines.  On 29-Nov-2024, the patient received (Standard) 1ml (1X- once) RABIES (HDC) VACCINE Powder and solvent for suspension for injection (lot X1C161M, expiry date: 31-Aug-2026) via intramuscular route in the left deltoid for prophylactic vaccination.  On 03-Dec-2024 the patient developed still can't focus and his eyes were constantly beating (visual impairment) and unstable on feet (dysstasia) , can't focus (vision blurred) and eyes were constantly beating (eye disorder) (latency-4 days) and on 05-Dec-2024 the patient developed severe vertigo (vertigo) (latency- 7 days), nausea and neurological symptoms (neurological symptom) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Reportedly, Physician stated her son (patient), who's a veterinary student, received the IMOVAX rabies vaccine on 29-Nov-2024 and he's had severe adverse reaction to it. The weekend went by and patient's symptoms only began on Tuesday. On 03-Dec-2024, patient woke up and he was unable to stand. He had severe vertigo and nausea. Six to seven days later, patient still can't focus and his eyes were constantly beating and he's unstable on his feet. Patient went to the emergency room on 05-Dec-2024. He was medication in the hospital. The ER physician and physical therapist evaluated him and physician (patient's mother) said the HCPs didn't agree with her that she wanted an infectious disease specialist and CAT scan for her son. Patient was sent home with Reglan. Physician and her husband, both being doctors, started the patient on Prednisone on 06-Dec-2024. Patient felt a little better but had a setback on the 8th and today, patient can't still do much. Patient's almost finished with veterinary school but he can't do anything right now.  Action taken  was not applicable.  The patient was treated with Prednisone on 06-Dec-2024 and Metoclopramide hydrochloride (Reglan) for Product used for unknown indication.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 30.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Balance disorder, Nausea, Neurological symptom, Vertigo, Vision blurred
Clinical narrative: neurological symptoms; severe vertigo; nausea; can't focus; eyes were constantly beating; still can't focus and his eyes were constantly beating; unstable on feet; Initial information received on 09-Dec-2024 regarding an unsolicited valid non-serious case received (live follow up processed together on CSD: 09-Dec-2024) from Physician via Health Authorities.  This case involves a 30 years old male patient who still can't focus and his eyes were constantly beating, unstable on feet, neurological symptoms, severe vertigo, nausea, can't focus and eyes were constantly beating after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  List concomitant: no other vaccines.  On 29-Nov-2024, the patient received (Standard) 1ml (1X- once) RABIES (HDC) VACCINE Powder and solvent for suspension for injection (lot X1C161M, expiry date: 31-Aug-2026) via intramuscular route in the left deltoid for prophylactic vaccination.  On 03-Dec-2024 the patient developed still can't focus and his eyes were constantly beating (visual impairment) and unstable on feet (dysstasia) , can't focus (vision blurred) and eyes were constantly beating (eye disorder) (latency-4 days) and on 05-Dec-2024 the patient developed severe vertigo (vertigo) (latency- 7 days), nausea and neurological symptoms (neurological symptom) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Reportedly, Physician stated her son (patient), who's a veterinary student, received the IMOVAX rabies vaccine on 29-Nov-2024 and he's had severe adverse reaction to it. The weekend went by and patient's symptoms only began on Tuesday. On 03-Dec-2024, patient woke up and he was unable to stand. He had severe vertigo and nausea. Six to seven days later, patient still can't focus and his eyes were constantly beating and he's unstable on his feet. Patient went to the emergency room on 05-Dec-2024. He was medication in the hospital. The ER physician and physical therapist evaluated him and physician (patient's mother) said the HCPs didn't agree with her that she wanted an infectious disease specialist and CAT scan for her son. Patient was sent home with Reglan. Physician and her husband, both being doctors, started the patient on Prednisone on 06-Dec-2024. Patient felt a little better but had a setback on the 8th and today, patient can't still do much. Patient's almost finished with veterinary school but he can't do anything right now.  Action taken  was not applicable.  The patient was treated with Prednisone on 06-Dec-2024 and Metoclopramide hydrochloride (Reglan) for Product used for unknown indication.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Balance disorder, Dysphagia, Dysstasia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient developed weakness requiring hospitalization. Neurologist and subsequent lumbar puncture confirmed diagnosis of Guillain-Barre syndrome. Patient required ICU admission and intubation (current state). She has received a course of IVIG.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Intensive care, Limb discomfort, Muscular weakness, Pain
Clinical narrative: Patient developed weakness requiring hospitalization. Neurologist and subsequent lumbar puncture confirmed diagnosis of Guillain-Barre syndrome. Patient required ICU admission and intubation (current state). She has received a course of IVIG.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Paraesthesia, Productive cough, Respiratory failure, Walking aid user, Wheelchair user
Clinical narrative: Patient developed weakness requiring hospitalization. Neurologist and subsequent lumbar puncture confirmed diagnosis of Guillain-Barre syndrome. Patient required ICU admission and intubation (current state). She has received a course of IVIG.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, CSF protein increased, CSF white blood cell count negative, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Patient developed weakness requiring hospitalization. Neurologist and subsequent lumbar puncture confirmed diagnosis of Guillain-Barre syndrome. Patient required ICU admission and intubation (current state). She has received a course of IVIG.
Age: 77.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Intensive care
Clinical narrative: Patient developed weakness requiring hospitalization. Neurologist and subsequent lumbar puncture confirmed diagnosis of Guillain-Barre syndrome. Patient required ICU admission and intubation (current state). She has received a course of IVIG.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Rash in shot arm; warmth on arm; This non-serious case was reported by a other health professional via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-NOV-2024, the patient received the 2nd dose of Shingrix. On 16-NOV-2024, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash in shot arm) and skin warm (Verbatim: warmth on arm). The outcome of the rash and skin warm were unknown.   The reporter considered the rash and skin warm to be related to Shingrix.     The company considered the rash and skin warm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-NOV-2024 It was reported that patient had rash in shot arm with warmth on arm.
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: finger stick following administration of a flu shot to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of needle stick/puncture in a female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On 26-OCT-2024, the patient received FluLaval 2024-2025 season. On 26-OCT-2024, less than a day after receiving FluLaval 2024-2025 season, the patient experienced needle stick/puncture (Verbatim: finger stick following administration of a flu shot to a patient). The outcome of the needle stick/puncture was unknown.   It was unknown if the reporter considered the needle stick/puncture to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.     It was unknown if the company considered the needle stick/puncture to be related to FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 Pharmacist called stating she had a finger stick following administration of a flu shot to a patient. She thought it was FluLaval but could be Flucelvax. She was not certain. She stated when she pulled it out as she was going to shave it with activating the device to cover the needle she ended up sticking her finger. This went through her workman's comp and she got another Hepatitis B shot. This case is linked with US2024125581, same reporter.; Sender's Comments:  US-GSK-US2024125581:same reporter
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: temperature excursion; 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 a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   In SEP-2024, the patient received Bexsero, FluLaval 2024-2025 season, Havrix, Kinrix, Pediarix, Boostrix, Infanrix and Engerix B. On an unknown date, an unknown time after receiving Bexsero, FluLaval 2024-2025 season, Havrix, Kinrix, Pediarix, Boostrix, Infanrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: temperature excursion). 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: 18-NOV-2024 Healthcare professional requests stability data for Bexsero, Flulaval, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B stored at 10.1 Celsius by 9 hours. No prior excursion. Patient Involvement as excursions occurred in September 2024, unknown number of patients as they see 200 patients per day which led to incorrect storage of drug. Healthcare professional states that she thought that all of the vaccines that were part of the excursion were administered to patients already, no patient demographics available.
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (1st dose received on 16 November 2018).   On an unknown date, the patient did not receive the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 A pharmacist send a message via chat and she mentioned they had a patient that received the first dose in the series a couple years ago, were they required to start the series over or do they only need a booster dose. The HCP mentioned that she did not had the lot number or expiry date Also, she did not provide the info where the patient get the 1st dose. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination.
Age: 87.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Possible administration in an 87 asplenic patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 87-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concurrent medical conditions included asplenia.   On 18-NOV-2024, the patient received Menveo. On 18-NOV-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Possible administration in an 87 asplenic patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 18-NOV-2024 A healthcare professional contacted to request data on the administration of the one vial presentation of Menveo to an 87 year old asplenic patient, as the GlaxoSmithKline insert only mentioned it was approval until 55 years of age which led to inappropriate age at vaccine administration. This case is linked with US2020009793, same reporter.; Sender's Comments:  US-GSK-US2020009793:same reporter
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: needed another dose of DTap, but ended up receiving Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number D252F, expiry date 10-APR-2027) for prophylaxis.   On 13-NOV-2024, the patient received Pediarix. On 13-NOV-2024, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: needed another dose of DTap, but ended up receiving Pediarix). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 A nurse called to inform that a patient received a dose of Pediarix, the child just needed another dose of DTap, but ended up receiving Pediarix, which means that they received an additional dose of polio and Hepatitis B which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: itchy rash; rash then became more confluent; This non-serious case was reported by a physician via sales rep and described the occurrence of itchy rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash) and red rash (Verbatim: rash then became more confluent). The outcome of the itchy rash and red rash were unknown.   It was unknown if the reporter considered the itchy rash and red rash to be related to Shingrix.     It was unknown if the company considered the itchy rash and red rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-NOV-2024 Reporter was a GlaxoSmithKline representative who was reporting on behalf of an physician. The Healthcare professional had a patient who developed a rash a week after getting a dose of Shingrix (dose number unknown). The patient was between 55 and 60 years old and female. The rash looked like shingles, was not vasicular, and black instead of red. It was also itchy. The rash then became more confluent and red.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: Infanrix was administered instead of Tdap; Infanrix was administered instead of Tdap; Infanrix was administered instead of Tdap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 64-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 06-OCT-2024, the patient received Infanrix. On an unknown date, the patient received Tdap Vaccine. On 06-OCT-2024, an unknown time after receiving Infanrix and not applicable after receiving Tdap Vaccine, the patient experienced wrong vaccine administered (Verbatim: Infanrix was administered instead of Tdap), adult use of a child product (Verbatim: Infanrix was administered instead of Tdap) and underdose (Verbatim: Infanrix was administered instead of Tdap). (Dechallenge was negative). The outcome of the wrong vaccine administered, adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 A pharmacy director called to report the administration of Infanrix to a 64 year-old patient. Infanrix was administered instead of Tdap which led to wrong vaccine administered, adult use of a child product and underdose. The health care provider asked for recommendations on this situation. The reporter did not provide the lot number and expiration date of the Infanrix dose given to this patient.
Age: 5.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: dtap diven instead of Dtpa; dtap diven instead of Dtpa; dtap diven instead of Dtpa; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C7747, expiry date 20-JUN-2026) for prophylaxis.   Co-suspect products included DTPa (DTPa vaccine) for prophylaxis.   On 18-NOV-2024, the patient received the 1st dose of Boostrix. On an unknown date, the patient received DTPa vaccine. On 18-NOV-2024, an unknown time after receiving Boostrix and not applicable after receiving DTPa vaccine, the patient experienced adult use of a child product (Verbatim: dtap diven instead of Dtpa), wrong vaccine administered (Verbatim: dtap diven instead of Dtpa) and underdose (Verbatim: dtap diven instead of Dtpa). The outcome of the adult use of a child product, wrong vaccine administered and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 Licensed Practical Nurse called that one of nurses administered a Tdap Boostrix to a child who was 5 year and 11 months old, should have been the DTAP but she gave him the Tdap instead which led to adult use of a child product, wrong vaccine administered and underdose.
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Late 2nd dose; 3rd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 34-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in 2019).   On an unknown date, the patient did not receive the 3rd dose of Engerix B and the 2nd dose of Engerix B. On an unknown date, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose) and incomplete course of vaccination (Verbatim: 3rd dose not received yet). The outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 A pharmacist reported the following that had a patient that received the 1st dose (Engerix-B) back in 2019, the 2nd dose was given 7 months from the 1st dose and now in 2024, they wanted to know what we need to do. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination.
Age: 10.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient got administered Tdap, Menquadfi and HPV vaccines and by accident the patient got Bexsero. He was not supposed to received Bexsero along with the other vaccines.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included DTPa (Reduced antigen) (Tdap Vaccine), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) and HPV 16-18 (HPV vaccine).   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero and an unknown time after receiving Tdap Vaccine and HPV vaccine, the patient experienced wrong vaccine administered (Verbatim: Patient got administered Tdap, Menquadfi and HPV vaccines and by accident the patient got Bexsero. He was not supposed to received Bexsero along with the other vaccines.). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-NOV-2024 Clinic Manager called to report that a member of our staff accidentally gave Bexsero to a 10 year old patient which ed to wrong vaccine administered. Patient got administered Tdap, Menquadfi and HPV vaccines and by accident the patient got Bexsero. He was not supposed to received Bexsero along with the other vaccines.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: unsuitable product administered post-excursion with no reported adverse event; someone took something out of their fridge, causing the temperature excursion when the fridge was opened Max/low temperature reached: 8.05°C sept, oct: 9.7°C lasted less than half an hour with no reported AE; Initial information received on 10-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5-year-old male patient whom unsuitable IPV (VERO) [IPOL] administered post-excursion as someone took something out of their fridge, causing the temperature excursion when the fridge was opened max/low temperature reached: 8.05°c sept, oct: 9.7°c lasted less than half an hour 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 Immunisation.  On 17-Oct-2024, the patient received a 0.5 ml dose of suspect IPV (VERO) Suspension for injection of lot W1A191M and expiry date: 16-Dec-2025 frequency; once, strength; standard via subcutaneous route in the left arm for Immunization post-excursion as someone took something out of their fridge, causing the temperature excursion when the fridge was opened max/low temperature reached: 8.05°c sept, oct: 9.7°c lasted less than half an hour with no reported adverse event (poor quality product administered) (latency: on same day) (product storage error).  Reportedly, She stated that she believes someone took something out of their fridge, causing the temperature excursion when the fridge was opened. This prompted the data logger to alert them. However, this incident occurred last September and October, and she only noticed it today.Max/low temperature reached: 8.05°C sept, oct: 9.7°C She stated that on September the high temp was 8.05°C; and in October the highest temp was 9.76°C.Duration: She mentioned that she believes each incident in September and October lasted less than half an hour. However, because no one cleared the alerts from the data logger, it incorrectly recorded the temperature excursions as lasting 5 days in September and 3 days in October.Previous Excursion: None before September. Human error: Yes.  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: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Patient experienced general rash; This spontaneous case, initially received on 03-Dec-2024, was reported by a non health professional and concerns a female patient.  Administration of company suspect drug: On an unknown date in 2024, the patient received Flucelvax (TIV) for Influenza disease, Dose regimen: 0.5 ml, route of administration: Not reported, Anatomical Location: Not reported. Lot number: Not reported and would be requested upon follow up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date in 2024, the patient experienced general rash (outcome: Not recovered / Not resolved). Patient took a flu shot a few weeks ago and had a reaction, she normally do not have any allergies. The patient never had a reaction to flu vaccine. Patient was going to consult with allergist.   Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality assessment was not reported.; Reporter's Comments: The event is related to Flucelvax TIV
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness from upper arm to elbow; Arm pain; Arm swollen; This spontaneous case, initially received on 02-Dec-2024, was reported by a non health professional and concerns an female patient.  Administration of company suspect drug: On 02-Dec-2024, the patient received Fluad (TIV) for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, Dose regimen: 0.5 ml, Route of Administration: Not Reported, Anatomical location: Not reported, Lot number: No batch number available and would be requested upon follow-up.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 02-Dec-2024, the patient experienced Redness from upper arm to elbow (outcome: Not recovered / Not resolved), Arm pain (outcome: Not recovered / Not resolved), Arm swollen (outcome: Not recovered / Not resolved). Patient experience few adverse events after taking flaud such as arm pain, arm swollen and redness.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter consider events as non-serious and causality assessment was not provided.; Reporter's Comments: casulaity was assessed related for all events
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Headache, Malaise, Mental status changes
Clinical narrative: Within a couple of minutes after I received the vaccination, I could feel something was different in my mental state. I got a little nauseated and confused. I walked out to my car and waited for 5 minutes or so before I drove home. I stayed on residential street in case my reaction got stronger. Once I got home, I looked on CDC's website to see what side effects were as I had all of them. I had a headache, muscle aches, fatigue, nausea, fever, etc.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngeal swab, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Within a couple of minutes after I received the vaccination, I could feel something was different in my mental state. I got a little nauseated and confused. I walked out to my car and waited for 5 minutes or so before I drove home. I stayed on residential street in case my reaction got stronger. Once I got home, I looked on CDC's website to see what side effects were as I had all of them. I had a headache, muscle aches, fatigue, nausea, fever, etc.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Within a couple of minutes after I received the vaccination, I could feel something was different in my mental state. I got a little nauseated and confused. I walked out to my car and waited for 5 minutes or so before I drove home. I stayed on residential street in case my reaction got stronger. Once I got home, I looked on CDC's website to see what side effects were as I had all of them. I had a headache, muscle aches, fatigue, nausea, fever, etc.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; inadvertently administering an expired dose of VAQTA to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-NOV-2024, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #X010373 has been verified to be a valid lot number,  expiration date 13-NOV-2024) for prophylaxis (strength, and route of administration were not provided) (expired product administered). Product did not undergo any temperature excursion and was supported per Post-Expiry Memo. No additional adverse event (no adverse event) was reported.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Vaccine was administered in my left arm just below the Acromion Process and not directly into the center of the deltoid muscle. Was advised by a NP to take OTC pain medication until it gets better. The reaction was normal and just needed a little time to get better. Reported the incident of the continuing pain in my left arm to the Clinic Manager and was advised to wait for a call from the person in charge of complaints and to date of this re port have never received a call. Arm is still painful when rotator cuff is activated.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Blood bicarbonate decreased, Blood creatine phosphokinase increased, Blood creatinine increased
Clinical narrative: Rhabdomyolysis resulting in acute kidney injury requiring hemodialysis. CK elevated at 9089.  Hyperkalemia, Acute respiratory failure with hypoxia
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood magnesium increased, Blood potassium increased, Haemodialysis, Hyperkalaemia, Hypoxia
Clinical narrative: Rhabdomyolysis resulting in acute kidney injury requiring hemodialysis. CK elevated at 9089.  Hyperkalemia, Acute respiratory failure with hypoxia
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: Rhabdomyolysis resulting in acute kidney injury requiring hemodialysis. CK elevated at 9089.  Hyperkalemia, Acute respiratory failure with hypoxia
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: 5 min after giving patient PPD tubersol placement and fluzone influenza vaccine patient fainted and became unresponsive for 10 seconds. She came to and laid down for 10 min and was given water to slowly drink. She recovered fully and left the clinic. She stated feeling safe to leave the clinic.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: very painful and she could not use her arm for a week., Other Vaccines:  VaccineTypeBrand: PREVNAR 20; Manufacturer: PFIZER; LotNumber: LG5575; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy, Somnolence
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Additional Details: PATIENT SAYS THE DAY AFTER HER LAST SHINGLES VACCINE ADMINISTERED AT PHARMACY, SHE COULD NOT STAY AWAKE THE NEXT DAY. SHE WAS DRIVING AND FELL ASLEEP AT EACH RED LIGHT. SHE NEVER RECEIVED MEDICALL ATTENTION OR TOOK ANY MEDICATION. SHE SLEPT FOR RELEIF AND FELT BETTER THE FOLLOWING DAY.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Malaise
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Additional Details: PATIENT REPORTS THAT SHE FELT SICK AFTER COVID VACCINE. SHE EXPEREINCED HEADACHED AND TIREDNESS
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Vomiting-Mild, Additional Details: images taken by patient show that injection may have been too low., Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: pfizer; LotNumber: lj5281; Route: intramuscular; BodySite: right arm; Dose: 1; VaxDate: 12/03/2024
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Vomiting-Mild, Additional Details: images taken by patient show that injection may have been too low., Other Vaccines:  VaccineTypeBrand: prevnar 20; Manufacturer: pfizer; LotNumber: lj5281; Route: intramuscular; BodySite: right arm; Dose: 1; VaxDate: 12/03/2024
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: arm pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: pt states pain radiating down vaccinated arm toward wrist
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Head injury, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted and hit his head after receiving vaccine
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Confusional state, Dizziness, Flushing
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Shakiness-Medium, Additional Details: After reviewing the vaccine screening and consent form, I discussed with the patient the risks associated with the vaccine and her prior history of having chest pain after recieving the moderna vaccine. Patient has had histroy of myocardial infarcation x2 over the last 5 years. Patient discussed with cardiologist regarding recieving another dose of the Pfizer COVID vaccine. The Cardiologist recommended vaccination and I recommended patient wait 30 minutes after vaccine for safety purposes.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension, Tremor
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypertension-Severe, Systemic: Shakiness-Medium, Additional Details: After reviewing the vaccine screening and consent form, I discussed with the patient the risks associated with the vaccine and her prior history of having chest pain after recieving the moderna vaccine. Patient has had histroy of myocardial infarcation x2 over the last 5 years. Patient discussed with cardiologist regarding recieving another dose of the Pfizer COVID vaccine. The Cardiologist recommended vaccination and I recommended patient wait 30 minutes after vaccine for safety purposes.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Fever-Medium, Other Vaccines:  VaccineTypeBrand: fluzone; Manufacturer: sanofi; LotNumber: u8518ca; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: prevnar; Manufacturer: wyeth/pfizer; LotNumber: lg7759; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN