chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: unapproved age/ 8-months-old patient was administered a dose of Kinrix; Kinrix was the patient's 3rd DTaP dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included DTaP vaccine (received 1st and 2nd dose on an unknown date).   On 23-APR-2024, the patient received Kinrix. On 23-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: unapproved age/ 8-months-old patient was administered a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was the patient's 3rd DTaP dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 25-APR-2024 The director of nursing reported that 8-months-old patient was administered a dose of Kinrix vaccine instead of separate DTaP and IPV vaccine, which led to an inappropriate age at vaccine administration. The Kinrix was the patient's 3rd DTaP dose, which led to an inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter. This case was linked with US2024053397 and US2024053395, reported by same reporter for different patients. The reporter consent to follow up.; Sender's Comments:  US-GSK-US2024053397:Same reporetr/Diffrent patient US-GSK-US2024053395:Same reporetr/Diffrent patient
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: unapproved age/ 3-year-old patient was administered a dose of Kinrix; Kinrix was the patient's 3rd DTaP dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included DTaP vaccine (received 1st and 2nd dose on an unknown date).   On 23-APR-2024, the patient received Kinrix. On 23-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: unapproved age/ 3-year-old patient was administered a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was the patient's 3rd DTaP dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 25-APR-2024 The director of nursing reported that 3-year-old patient was administered a dose of Kinrix vaccine instead of separate DTaP and IPV vaccine, which led to an inappropriate age at vaccine administration. The Kinrix was the patient's 3rd DTaP dose, which led to an inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter. This case was linked with US2024053392 and US2024053395, reported by same reporter for different patients. The reporter consent to follow up.; Sender's Comments:  US-GSK-US2024053392:Same reporetr/Diffrent patient US-GSK-US2024053395:Same reporetr/Diffrent patient
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue
Clinical narrative: Weakness; Fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced weakness (Verbatim: Weakness) and fatigue (Verbatim: Fatigue). The outcome of the weakness and fatigue were unknown.   It was unknown if the reporter considered the weakness and fatigue to be related to Shingrix.     It was unknown if the company considered the weakness and fatigue to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR057118   Additional Information: GSK Receipt Date: 25-APR-2024 The patient self reported this case. The patient states the he experienced fatigue and weakness. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024053398:same reporter/ Different patient US-GSK-US2024053399:Same reporter / different patient US-GSK-US2024AMR057118:Same patient / SECOND DOSE
Sex: F
Vaccine: MENB, MNQ
Symptoms: Intercepted product prescribing error
Clinical narrative: but for two of them (the Bexsero and Menveo) her age doesn't match what's on the box; This non-serious case was reported by a nurse via call center representative and described the occurrence of intercepted drug prescribing error in a elderly female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concurrent medical conditions included splenectomy.   On an unknown date, the patient did not receive Bexsero and Menveo. On an unknown date, an unknown time after receiving Bexsero and Menveo, the patient experienced intercepted drug prescribing error (Verbatim: but for two of them (the Bexsero and Menveo) her age doesn't match what's on the box). The outcome of the intercepted drug prescribing error 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: 26-APR-2024 The nurse at health department stated that, an elderly patient who was 87 or 88 had physician's orders for three vaccines to be given. One vaccine was fine, but for two of them (the Bexsero and Menveo) her age did not match what's on the box which led to intercepted drug prescribing error. Vaccines had not been given at time of call, but a prescription had been written by a physician. The nurse clarified the patient did not had a spleen.  Nurse already consulted with centers for disease control and prevention and was aware of centers for disease control and prevention guidelines.  Date of splenectomy was unknown to nurse.  No further details provided at time of call.  The reporter consented to follow up from safety by mail.
Sex: M
Vaccine: HEP, HEP
Symptoms: Extra dose administered
Clinical narrative: administered Engerix B 0.5ml to a young adult patient/15 minutes later she administered a 2nd 0.5 ml dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a adult male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 25-APR-2024, the patient received the 2nd dose of Engerix B (intramuscular) .5 ml and the 1st dose of Engerix B (intramuscular) .5 ml. On 25-APR-2024, an unknown time after receiving Engerix B and Engerix B, the patient experienced wrong technique in drug usage process (Verbatim: administered Engerix B 0.5ml to a young adult patient/15 minutes later she administered a 2nd 0.5 ml dose). The outcome of the wrong technique in drug usage process 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: 26-APR-2024 The clinic administered Engerix B 0.5 ml to a young adult patient instead of recommended 1ml dose and 15 minutes later she administered a second 0.5 ml dose, which led to wrong technique in drug usage process.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix Late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 4 years apart).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix Late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-APR-2024 The pharmacist Student reported that a patient received Shingrix first dose 4 years apart and never received second dose.  No details available for the patient. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received a 2nd dose of Arexvy inadvertently; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 85-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number H3L57, expiry date 08-OCT-2026) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 25-APR-2024, the patient received the 2nd dose of Arexvy. On 25-APR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received a 2nd dose of Arexvy inadvertently). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 26-APR-2024 The pharmacist reported that the patient received a 2nd dose of Arexvy inadvertently, which led to extra dose administered. The reporter consent to follow up via email.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Mobility decreased
Clinical narrative: chills; fever; headache; runny nose; nausea; Fatigued; sweating; in bed for 7 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of sweating in a 56-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included measles, mumps and chronic fatigue.   On 16-APR-2024, the patient received the 1st dose of Tdap Vaccine (left arm) and Shingrix (right arm). In APR-2024, 12 hrs after receiving Tdap Vaccine and Shingrix, the patient experienced sweating (Verbatim: sweating), bedridden (Verbatim: in bed for 7 days), chills (Verbatim: chills), fever (Verbatim: fever), headache (Verbatim: headache), runny nose (Verbatim: runny nose), nausea (Verbatim: nausea) and fatigue (Verbatim: Fatigued). The outcome of the sweating, chills, fever, headache, runny nose and nausea were not resolved and the outcome of the bedridden was resolved (duration 7 days) and the outcome of the fatigue was not reported.   It was unknown if the reporter considered the sweating, bedridden, chills, fever, headache, runny nose, nausea and fatigue to be related to Tdap Vaccine and Shingrix.     It was unknown if the company considered the sweating, bedridden, chills, fever, headache, runny nose, nausea and fatigue to be related to Tdap Vaccine and Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2024 and 29-APR-2024 The case was reported by patient itself. The patient reported that about 12 hours later she woke up in the middle of the night soaked in sweat.  The patient stated she had been in bed for 7 days, fatigued.  The patient had chills, fever, headache and nausea.  The patient had a twin and neither one of them had ever had the chicken pox but her parents did not remember for sure.  The patient was taking allergy meds not working for her constant runny nose.  The patient did not consented to follow up.
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: chills; fever; headache; runny nose; nausea; Fatigued; sweating; in bed for 7 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of sweating in a 56-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included measles, mumps and chronic fatigue.   On 16-APR-2024, the patient received the 1st dose of Tdap Vaccine (left arm) and Shingrix (right arm). In APR-2024, 12 hrs after receiving Tdap Vaccine and Shingrix, the patient experienced sweating (Verbatim: sweating), bedridden (Verbatim: in bed for 7 days), chills (Verbatim: chills), fever (Verbatim: fever), headache (Verbatim: headache), runny nose (Verbatim: runny nose), nausea (Verbatim: nausea) and fatigue (Verbatim: Fatigued). The outcome of the sweating, chills, fever, headache, runny nose and nausea were not resolved and the outcome of the bedridden was resolved (duration 7 days) and the outcome of the fatigue was not reported.   It was unknown if the reporter considered the sweating, bedridden, chills, fever, headache, runny nose, nausea and fatigue to be related to Tdap Vaccine and Shingrix.     It was unknown if the company considered the sweating, bedridden, chills, fever, headache, runny nose, nausea and fatigue to be related to Tdap Vaccine and Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2024 and 29-APR-2024 The case was reported by patient itself. The patient reported that about 12 hours later she woke up in the middle of the night soaked in sweat.  The patient stated she had been in bed for 7 days, fatigued.  The patient had chills, fever, headache and nausea.  The patient had a twin and neither one of them had ever had the chicken pox but her parents did not remember for sure.  The patient was taking allergy meds not working for her constant runny nose.  The patient did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; exhaustion; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-APR-2024, the patient received the 2nd dose of Shingrix. On 26-APR-2024, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: fever) and exhaustion (Verbatim: exhaustion). The outcome of the fever and exhaustion were unknown.   It was unknown if the reporter considered the fever and exhaustion to be related to Shingrix.     It was unknown if the company considered the fever and exhaustion to be related to Shingrix.   Additional Information: GSK receipt date: 26-APR-2024 This case was reported by patient itself. The patient reported that she received her 2nd dose of Shingrix vaccine and next day after vaccination she experienced with fever and extreme exhaustion. The patient reported that the lot and expiration date were unknown and she reported that the information of the site of the injection was not provided. The patient reported that no additional information was provided. The reporter did not consent to follow-up.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally administered 1 dose of Kinrix to a 2-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 23-JUN-2023, the patient received the 1st dose of Kinrix. On 23-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally administered 1 dose of Kinrix to a 2-year-old patient). The outcome of the inappropriate age at vaccine administration 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: 26-APR-2024 The medical assistant explained that they accidentally administered 1 dose of Kinrix to a 2-year-old patient, which led to an inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: They gave a 4 to 6 years old doses of Kinrix to a pair of twins 5 months old.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   On 29-APR-2024, the patient received Kinrix. On 29-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: They gave a 4 to 6 years old doses of Kinrix to a pair of twins 5 months old.). The outcome of the inappropriate age at vaccine administration 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 29 Apr 2024: The reporter gave a 4 to 6 years old doses of Kinrix to a pair of twins 5 months old patient which led to inappropriate age at vaccine administration. The reporter consent to follow up. This case has been linked with case US2024054892 reported by same reporter.; Sender's Comments:  US-GSK-US2024054892:Twin number 2
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HBV (Engerix B adult) (batch number 7B2YL, expiry date 25-FEB-2024) for prophylaxis.   On 29-APR-2024, the patient received Engerix B adult. On 29-APR-2024, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-APR-2024 The nurse reported that the patient received the Engerix B vaccine on 29 April 2024 which was expired on 25 February 2024 which led to expired vaccine used. The nurse was wondering if it had extended expiration date like Covid vaccine. The reporter consented to follow up.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; patient received his 2nd dose of PROQUAD on 4/16/2024 and then inadvertently received an additional dose of PROQUAD on 4/29/2024.; This spontaneous report was received from a Nurse and refers to a 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 16-APR-2024, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #X019557, expiration date: 19-JAN-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis. On 29-APR-2024, the patient was inadvertently vaccinated with an additional dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, 0.5 milliliter, lot #X019557, expiration date: 19-JAN-2025 (strength was not provided) administered subcutaneous for prophylaxis (Extra dose administered). Operator of device was reported as health professional. No other information provided. No additional adverse events (No adverse event) or product quality complaint reported.
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Myasthenia gravis; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 at 01:00 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 02:30 AM), administration date: 09Aug2023, for COVID-19 immunization. The following information was reported: MYASTHENIA GRAVIS (life threatening, medically significant), outcome "not recovered". The event "myasthenia gravis" required physician office visit. Therapeutic measures were taken as a result of myasthenia gravis with Mestonin.
Sex: M
Vaccine: RSV
Symptoms: COVID-19, Fatigue, Nasopharyngitis
Clinical narrative: he caught a cold which she also caught; covid 19; It's been cause long term fatigue and tiredness; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 80-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "It's been cause long term fatigue and tiredness"; COVID-19 (non-serious) with onset 2023, outcome "unknown", described as "covid 19"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "he caught a cold which she also caught". Therapeutic measures were taken as a result of nasopharyngitis. Additional information: The reporter's husband had two different shots (reported as "it is not the RSV") and then her husband caught a cold, was given antibiotics and could not get rid of it. The medication was Z-pack. The patient had RSV shot and he also had the covid 19 at the same time, fatigue and tiredness. It's been causing long term fatigue and tiredness from last year in 2023. The reported stated may be something in the chemical caused the events.  The information on the batch/lot number for [RSV VACCINE PROT.SUBUNIT PREF 2V] will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died in sleep; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 2024, outcome "fatal", described as "died in sleep". The patient date of death was 2024. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Additional information: The consumer stated that his wife died last week from fatal effects of Booster number three and died in her sleep.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: died in sleep
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Has pain at back of arm; Chest pain; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Has pain at back of arm"; CHEST PAIN (non-serious), outcome "unknown".  Additional information: Patient stated he has pain at back of arm where booster shot was given and also chest pain.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Colonoscopy, Electrocardiogram
Clinical narrative: Atrial fibrillation; This is a spontaneous report received from a nurse.  A 54-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 54 years, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Type II diabetes" (ongoing), notes: Managed with oral hypoglycemic; "Hyperlipidemia" (ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN oral taken for type 2 diabetes mellitus; ATORVASTATIN taken for hyperlipidaemia (ongoing); LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Oct2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: Colonoscopy: (Oct2022) Unknown results; Electrocardiogram: (Oct2022) Atrial fibrillation. Therapeutic measures were taken as a result of atrial fibrillation. There were no prior vaccinations (within 4 weeks). The patient got the Pfizer COVID-19 booster in 2022 (either on Apr2022 or May2022). The patient developed atrial fibrillation after COVID-19 vaccine. The patient was in pre-op, getting 10-minute EKG strip done before a colonoscopy (done in Oct2022). The patient was never symptomatic. Treatment or intervention for atrial fibrillation is as follows. First, a cardioversion that was synchronized, which was unsuccessful. Then referred to an electrophysiology doctor. The patient had 2 ablation surgeries for the atrial fibrillation. The first was Oct2022. The other was Feb2023. He was also placed on rivaroxaban (XARELTO), a blood thinner, which will probably be on rest of life. This was after the Pfizer COVID-19 booster vaccine, just seems coincidental that it was subsequent to receiving the Pfizer COVID-19 booster. It may not have been related. It is not conclusive, but it seemingly correlates.; Sender's Comments: As there is limited information in the case provided, the causal association between the event atrial fibrillation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Blindness unilateral, Glaucoma, Hallucination
Clinical narrative: each time I took that shot and came home, I had a psychedelic effect; blind in my right eye; glaucoma; Arthritis; This is a spontaneous report and received from Consumer or other non HCPs from medical information team, Program ID.  A 67-year-old patient received BNT162b2 (BNT162B2), on 13May2021 as dose 2, single (Lot number: EW0165) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FISH OIL; MAGNESIUM CHLORIDE. Vaccination history included: Bnt162b2 (The first was on 'Apr2021' (not clarified the date) and that LOT number is EW0169), administration date: Apr2021, for COVID-19 immunization, reaction(s): "Each time I took that shot and came home, I had a psychedelic effect"; Pneumococcal vaccine (manufacturer unknown), for immunisation. The following information was reported: HALLUCINATION (medically significant), outcome "unknown", described as "each time I took that shot and came home, I had a psychedelic effect"; BLINDNESS UNILATERAL (medically significant), outcome "unknown", described as "blind in my right eye"; GLAUCOMA (medically significant), outcome "unknown"; ARTHRITIS (non-serious), outcome "unknown".  Additional information: The patient experienced a psychodelic experience after taking the shots. She saw multiple flowers when she closed her eyes the day she had the shots. She was wondering if the shots caused this. She took four and the last one was on 27Aug2022 (date not clarified) and each time she took that shot and came home, she had a psychedelic effect. She closed her eyes and she will see flowers. It's colorful flowers. They just kept appearing. They would appear. Patient stated further, "Right, each time I took the shot. I took four. I completed, you know, the 'two' series and now I am blind in my right eye. I have asked around to see if anybody else. You just talk to people, when you ask people what kind of effect they had? I went to the doctor up because I wear glasses and I have been diagnosed with Arthritis. That's why I am calling you back to see if that (incomplete sentence) and I was diagnosed with glaucoma. I don't know if I should not have taken it because I had glaucoma. I just don't know. I am trying to find out from you because I don't want to lose my other eye. I didn't take it this year not this year last year, I haven't taken it since 2022. Like I said that was the effect that it had on me and then eventually I lost vision in my right eye, that's why I called." When asked if have any question regarding the vaccine, consumer stated, "That's what I am saying, the COVID-19 is when I took the vaccine that's when I had these problems with my eye. I would still have this psychedelic effect and then next thing I am blind in my right eye."
Sex: U
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: kidneys suddenly and unexpectantly took a dive/ kidney disease; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL DISORDER (medically significant), outcome "not recovered", described as "kidneys suddenly and unexpectantly took a dive/ kidney disease". Clinical course: Patient now deal with kidney disease every day of life.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was given Adacel due to injury and the Adacel was found to have been stored at temperature of greater than 26 degree Celsius with no reported adverse event; adacel administered after excursion with no adverse event; Initial information received on 25-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 26 years old male patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (adacel) was administered after excursion and was given Adacel due to injury and the Adacel was found to have been stored at temperature of greater than 26 degree Celsius with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Apr-2024, the patient received 0.5 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection via intramuscular route in the right deltoid for immunization (strength, batch and expiry date- unknown) after excursion with no adverse event (poor quality product administered) (latency same day) and was given Adacel due to injury and the Adacel was found to have been stored at temperature of greater than 26 degree Celsius with no reported adverse event (product storage error) (unknown latency). Information on the batch number was requested.   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.; Sender's Comments:  US-SA-2024SA106031: US-SA-2024SA131163:
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: don't tolerate the regular QIV; Initial information received on 18-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 2 patients of unknown age and unknown gender who don't tolerate the regular influenza quadrival A-B vaccine [fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient(s) received a dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot number, strength, dose an expiry not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient(s) reported don't tolerate the regular influenza quadrival A-B vaccine (product intolerance) (unknown latency).  Reportedly, have patients that we give the FLUZONE regular QIV for those under 65 and the FLUZONE HD (High-dose) for those over 65 years of age. We have 2 patients that don't tolerate the regular QIV so we give them 1/2 a dose of the HD. We are thinking of changing our schedules to give everyone the "FLUBLOK that are under 65 and the FLUZONE QIV HD for those over 65."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Health Department did not realize that she was pregnant, so in addition to the TDaP vaccine, she also received IPOL, menquadfi and MenB vaccine with no reported adverse event; Initial information received on 25-Apr-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old female pregnant patient and it was reported that health department did not realize that she was pregnant, so in addition to the TDAP vaccine, she also received IPV (VERO) [IPOL], and MEN B vaccine with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  Gestation period was unknown. The date of last menstrual period was not reported. The estimated due date is 17-Jun-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  Concomitant medications included meningococcal vaccine B (MENB); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and meningococcal vaccine A/C/Y/W CONJ (TET TOX) (Menquadfi) all for Immunisation.  On 23-Apr-2024, the pregnant patient received a dose of 0.5 ml once of suspect IPV (VERO) (Suspension for injection) (lot: W1B511M; strength: standard; expiry date: unknown) via intramuscular route in unknown administration site and it was reported that health department did not realize that she was pregnant, so in addition to the tdap vaccine, she also received menquadfi, ipol, and menb vaccine with no reported adverse event (exposure during pregnancy) (latency: same day).  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 4.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of adacel instead of daptacel with no reported ae; Initial information received on 29-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient with administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (adacel) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (daptacel) with no reported ae (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); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); and POLIO VACCINE (POLIO) for Prophylactic vaccination.  On 29-Apr-2024, the patient received 0.5 ml of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection lot 2CA18C1 via intramuscular route in the right thigh for immunization (strength, expiry date- unknown) instead of daptacel with no reported ae (wrong 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 Module of the 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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of tenivac was administered with no reported adverse event; Initial information was received on 29-Apr-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2024, the patient received a 0.5 ml (once, total) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot: U7183AA, expiration date: 24-Sep-2023, strength: standard) via unknown route in unknown administration site for Immunisation and expired dose of tenivac was administered with no reported adverse event (expired product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: pentacel was administered in which only the dtap/ipv was administered, the hib portion was not administered with no reported adverse event; Initial information was received on 29-Apr-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 months old female patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] was administered in which only the dtap/ipv was administered, the hib portion was not administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included pneumonia.   On 29-Apr-2024, the patient received a 0.5 ml (dose 2, once) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ970AA, expiry date: 03-Nov-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and pentacel was administered in which only the dtap/ipv was administered, the hib portion was not administered with no reported adverse event (single component of a two-component product administered) (Latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administering expired PENTACEL (with no reported adverse event); Initial information received on 30-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old and unknown gender patient who was accidentally administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (pentacel) (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 PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On an unknown date, the patient received expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection lot UJ859AA, expiry- 02-APR-2024 via intramuscular route in the left thigh for immunization (strength, dose- unknown) (with no reported adverse event) (expired product administered) (latency same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of ActHib was administered to a patient with no reported adverse event; Initial information received on 30-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves patient unknown age and gender who was accidentally administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Apr-2024, the patient was accidentally administered an expired dose (unknown dose) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot number not reported: Expiration Date :25-Mar-2024) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: on same day). Information on the batch number was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion product administered with no reported adverse event; Initial information was received on 30-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom temperature excursion of HIB (PRP/T) vaccine [ACT-HIB] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Apr-2024, the patient received an unknown dose (total) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot number, expiry date, strength was unknown) via unknown route in unknown administration site for Immunization (poor quality product administered) (Latency: same day). The information on the batch number was requested.  This situation was not due to human error. Reason: Wire was not completely attached to the data logger  Max/Lowest Temp reached: 10.76F -13hrs 50minutes 10.69F - 8hrs 21 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.