chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Headache, Malaise, Nausea, Pain
Clinical narrative: Nausea; Fever; Burning eyes; Body aches; Headache; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2 (COMIRNATY), as dose 4 (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 (DOSE: 3, First Booster, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 2, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE:1, Manufacturer unknown), for covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; EYE IRRITATION (non-serious), outcome "unknown", described as "Burning eyes"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; Fever; Burning eyes; Body aches; Headache; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2 (COMIRNATY), as dose 4 (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 (DOSE: 3, First Booster, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 2, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE:1, Manufacturer unknown), for covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; EYE IRRITATION (non-serious), outcome "unknown", described as "Burning eyes"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Behcet's syndrome, Ulcer
Clinical narrative: vasculopathy; she developed ulcerations; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prothrombin clotting disorder" (unspecified if ongoing), notes: a clotting disorder for decades; "She had 6 live births" (unspecified if ongoing), notes: She had 6 live births; "1 miscarriage in her life" (unspecified if ongoing), notes: 1 miscarriage in her life. The patient's concomitant medications were not reported. The following information was reported: BEHCET'S SYNDROME (medically significant), outcome "unknown", described as "vasculopathy"; ULCER (non-serious), outcome "unknown", described as "she developed ulcerations". Clinical course: Patient with prothrombin clotting disorder developed vasculopathy and ulcerations on her feet after receiving the Pfizer COVID 19 vaccine. The woman had a clotting disorder for decades, but without symptom manifestation. She had 6 live births, 1 miscarriage in her life. Her entire family developed COVID 19. So to protect herself she got the COVID 19 shot. After receiving the shot she developed ulcerations and vasculopathy that had been unmanageable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events 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 drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Breast disorder
Clinical narrative: Breast changes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Adverse reaction to Pfizer Vaccine first dose 05Apr2022), administration date: 05Apr2021, for Covid-19 immunization. The following information was reported: BREAST DISORDER (non-serious), outcome "unknown", described as "Breast changes". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Breast changes. Previously, in remission 22 years.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac stress test, Echocardiogram, Electrocardiogram ambulatory, Heart rate
Clinical narrative: atrial fibrillation; hyperthyroidism; This is a literature report.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown"; HYPERTHYROIDISM (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Cardiac stress test: Negative; Echocardiogram: showed an ejection fraction of 65% with borderline, notes: left ventricular hypertrophy and mild left atrial dilation; Electrocardiogram ambulatory: revealed paroxysmal atrial fibrillation; Heart rate: 160s to 170, notes: Units: beats/min  elevated; laboratory results: An autoimmune response was suspected against the, notes: thyroid gland, confirmed by laboratory results.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with 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.
Sex: M
Vaccine: COVID19
Symptoms: Hyperthyroidism, Laboratory test
Clinical narrative: atrial fibrillation; hyperthyroidism; This is a literature report.  A 44-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown"; HYPERTHYROIDISM (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Cardiac stress test: Negative; Echocardiogram: showed an ejection fraction of 65% with borderline, notes: left ventricular hypertrophy and mild left atrial dilation; Electrocardiogram ambulatory: revealed paroxysmal atrial fibrillation; Heart rate: 160s to 170, notes: Units: beats/min  elevated; laboratory results: An autoimmune response was suspected against the, notes: thyroid gland, confirmed by laboratory results.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with 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.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: non-stop throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, 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: VOMITING (non-serious) with onset Nov2021, outcome "not recovered", described as "non-stop throwing up". The event "non-stop throwing up" required physician office visit.  Additional information: Caller mentioned that she took her COVID-19 Vaccine shot last November and after getting vaccinated the caller stated that she had been non-stop throwing up and the doctor can't figure out what's wrong she is assuming that it came from the vaccine and she is having a side effect. As per caller she stated that she took her 1st dose 08Nov2021 and then the 2nd dose three weeks after. Suspected Pfizer Products:Product: Pfizer-Biontech COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Feeling abnormal
Clinical narrative: tightness in my chest; fatigue; brain fog; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2021 as dose 1, single (Lot number: EW0164) at the age of 21 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety", start date: 2017 (ongoing); "Depression", start date: 2017 (unspecified if ongoing); "ADHD", start date: 2017 (unspecified if ongoing); "Hives Edema", start date: Jul2021 (ongoing); "Angioedema", start date: Sep2021 (ongoing). Concomitant medication(s) included: ZYRTEC HIVES RELIEF oral taken for urticaria, start date: Jul2021 (ongoing); XOLAIR taken for angioedema, start date: Oct2021 (ongoing); SINGULAIR taken for urticaria, start date: Dec2021 (ongoing); ALLEGRA oral taken for urticaria, start date: Jul2021 (ongoing). The following information was reported: FEELING ABNORMAL (non-serious) with onset 23Apr2021, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 23Apr2021, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset 23Apr2021, outcome "recovered" (23Apr2021), described as "tightness in my chest".  Additional information: Did the patient provide information to you regarding the reported adverse event(s) With the use of the product: Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event: Yes. Are you willing to be contacted again by Pfizer on the reported adverse event(s): Yes. Vaccine Facility Type Hospital. Vaccine Administered at Military Facility: No. PRIOR VACCINATION (within 4 weeks): None.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: where she would receive the vaccine she would develop a swollen lymph node within two days after the vaccine which began on 23Apr2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4625954.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Swollen lymph node" (unspecified if ongoing); "Marijuana usage" (unspecified if ongoing); "Relapsing remitting multiple sclerosis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex ptsd" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing); "Disk degeneration" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN; CBD CANNABIDIOL HANFOEL EXTRAKT. Vaccination history included: BNT162b2, administration date: 21Apr2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered" (May2021), described as "where she would receive the vaccine she would develop a swollen lymph node within two days after the vaccine which began on 23Apr2021".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Burning sensation, Discomfort, Erythema, Eyelid rash, Facial pain
Clinical narrative: Face red; fever; Swelling of face; rash on Eyelid; Burning sensation in face; Urticaria localized; Pain in face; Discomfort; Rash trunk; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 44 years old female patient who experienced swelling of face, rash on eyelid, burning sensation in face, urticaria localized, pain in face, discomfort, rash trunk, face red and fever while receiving vaccine diphtheria, tetanus and acellular pertussis vaccine.  The patient's past medical history included Restless legs syndrome, Cystitis interstitial, Gastrooesophageal reflux disease, Rheumatoid arthritis, Epilepsy and Ankylosing spondylitis. The patient's past medical treatment included diltiazem, levofloxacin and furosemide. The patient's past vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity with levofloxacin allergy diltiazem allergy, zoster vaccine recombinant adjuvanted allergy, furosemide allergy.  Concomitant medications included adalimumab (humira) for ankylosing spondylitis and rheumatoid arthritis, tozinameran (pfizer biontech covid-19 vaccine), loratadine, pregabalin, estradiol, levetiracetam (keppra [levetiracetam]), hydroxychloroquine sulfate (plaquenil s), cetirizine hydrochloride (zyrtec allergy), cimetidine (tagamet [cimetidine]) and phenoxymethyl pencillin potassium.  On 29-Apr-2022, the patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (strength, dose, formulation, route, lot number: not reported) in unknown administration site for prophylactic vaccination.  On 05-MAY-2022 (latency: 7 days) the patient developed a non-serious events swelling of face (swelling face), rash on eyelid (eyelid rash), burning sensation in face (burning sensation), urticaria localized (urticaria), pain in face (facial pain), discomfort, rash trunk (rash) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  On an unknown date the patient developed a non-serious face red (erythema) and fever (pyrexia) (unknown latency) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (Swelling face, eyelid rash , Burning sensation in face, Urticaria, facial pain, Discomfort, Rash, erythema, fever).  At time of reporting, the outcome was Unknown for all the events.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Rash, Swelling face, Urticaria
Clinical narrative: Face red; fever; Swelling of face; rash on Eyelid; Burning sensation in face; Urticaria localized; Pain in face; Discomfort; Rash trunk; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 44 years old female patient who experienced swelling of face, rash on eyelid, burning sensation in face, urticaria localized, pain in face, discomfort, rash trunk, face red and fever while receiving vaccine diphtheria, tetanus and acellular pertussis vaccine.  The patient's past medical history included Restless legs syndrome, Cystitis interstitial, Gastrooesophageal reflux disease, Rheumatoid arthritis, Epilepsy and Ankylosing spondylitis. The patient's past medical treatment included diltiazem, levofloxacin and furosemide. The patient's past vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug hypersensitivity with levofloxacin allergy diltiazem allergy, zoster vaccine recombinant adjuvanted allergy, furosemide allergy.  Concomitant medications included adalimumab (humira) for ankylosing spondylitis and rheumatoid arthritis, tozinameran (pfizer biontech covid-19 vaccine), loratadine, pregabalin, estradiol, levetiracetam (keppra [levetiracetam]), hydroxychloroquine sulfate (plaquenil s), cetirizine hydrochloride (zyrtec allergy), cimetidine (tagamet [cimetidine]) and phenoxymethyl pencillin potassium.  On 29-Apr-2022, the patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (strength, dose, formulation, route, lot number: not reported) in unknown administration site for prophylactic vaccination.  On 05-MAY-2022 (latency: 7 days) the patient developed a non-serious events swelling of face (swelling face), rash on eyelid (eyelid rash), burning sensation in face (burning sensation), urticaria localized (urticaria), pain in face (facial pain), discomfort, rash trunk (rash) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  On an unknown date the patient developed a non-serious face red (erythema) and fever (pyrexia) (unknown latency) following the administration of diphtheria and tetanus and acellular pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (Swelling face, eyelid rash , Burning sensation in face, Urticaria, facial pain, Discomfort, Rash, erythema, fever).  At time of reporting, the outcome was Unknown for all the events.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: OPEN IPOL was exposed to 82.62 F for 15 minutes believes the door was left open with no reported adverse event; Open IPOL was administered to patient after excursion with no reported adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid non-serious case received from health professional. number: 01148676  This case involves a 5-year-old female patient to whom open IPV (VERO) [IPOL] was administered to patient after excursion with no reported adverse event and open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA234797, 2022SA235652, 2022SA235540 and 2022SA235642.  On an unknown date, It was reported that open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event (product storage error).  On 21-Feb-2022, the patient received suspect Ipol vaccine (lot T1871M, expiry date: 10-Oct-2022) at dose 0.5 ml via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 1.5
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: OPEN IPOL was exposed to 82.62 F for 15 minutes believes the door was left open with no reported adverse event; Open IPOL was administered to patient after excursion with no reported adverse event; Initial information received   on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA235228.  This case involves a 18 months old male patient open IPV (VERO) [IPOL] was administered to patient after excursion with no reported adverse event and open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, It was reported that open ipol was exposed to 82.62 f for 15 minutes believes the door was left open with no reported adverse event (product storage error).  On 23-Feb-2022, the patient received suspect Ipol vaccine (lot T1871M, expiry date: 10-Oct-2022) at dose 0.5 ml via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered, latency same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 54.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: received vaccine which  was product of temperature excursion with no reported adverse event; received vaccine which was product of temperature excursion with no reported adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 54 years old male patient (162 cm and 103.4 kg) who received vaccine which was product of temperature excursion with no reported adverse event and the  vaccine involved was DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was reported that the patient had received the  vaccine which was product of temperature excursion with no reported adverse event  (product temperature excursion issue)  (onset and latency: unknown)     On 16-Mar-2022, the patient received a 0.5 ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, once ( lot number and expiry date; not reported) via intramuscular route in the deltoid nos for prophylactic vaccination (poor quality product administered) (latency: same day)   Action taken : not applicable for both events.  Outcome: unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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:  SanofiPVPortal20220628000730: SanofiPVPortal20220628000755: 2022SA136253:
Sex: U
Vaccine: MNQ, TD
Symptoms: No adverse event, Product storage error
Clinical narrative: previous temperature excursion for GSK vaccines and that those products had been administered to patients since that excursion in November of 2021 with no adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves adult and unknown gender patient, with previous temperature excursion for gsk vaccines and that those products had been administered to patients since that excursion in november of 2021 with no adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (dose, strength, lot number and expiry date:  not reported) both Solution for injection via unknown route in unknown administration site as prophylactic vaccination.  There was previous temperature excursion for gsk vaccines and that those products had been administered to patients since that excursion in on an unknown date in Nov-2021,with no adverse event (product temperature excursion issue) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. It was reported that multiple patients had received multiple vaccines and that the vaccines had been evaluated by GSK and determined to be supported by GSKs stability data. The names of the vaccines involved were provided. Caller unable to provide additional details. After the call upon looking up each vaccine this writer noted that MENACTRA and TENIVAC  were company products.  Action taken : not applicable.  At time of reporting, the outcome was Unknown
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product storage error, Product use issue
Clinical narrative: the administration of a product that was no longer suitable for use post excursion, with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid  non-serious case received from  other health professional via call center.  This case involves an unknown age and unknown gender patient who experienced the administration of a product that was no longer suitable for use post excursion, with no reported adverse event while receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] and hib (prp/t) vaccine [act-hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and hib (prp/t) vaccine (unknown dosage, strength, formulation, batch lot number and expiry date for both vaccines) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of the administration of a product that was no longer suitable for use post excursion, with no reported adverse event (product storage error) (unknown latency)  following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and hib (prp/t) vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.   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: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: IPOL vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 09-May-2022, the patient received a 0.5ml  dose of suspect IPV (VERO) (batch lot U1C572M Expiry date :17-Jun-2023 )(unknown strength and formulation)via intramuscular route in right thigh for immunization.  On 09-May-2022 (latency :same day)the patient developed a non-serious event of  ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event (incorrect dose administered) following the administration of IPV (VERO).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.   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:  01148369:
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: IPOL vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 5 years old male patient who experienced ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event while receiving vaccine IPV (VERO) (IPOL).  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); and hepatitis a vaccine (Hepatitis A).  On 13-Jun-2022, the patient received a dose of suspect IPV (VERO) at a dose of 0.5 ml with lot U1C571M and expiry date: 17-Jun-2023 via intramuscular route in left deltoid for Immunization.  On 13-Jun-2022 (latency: same day) the patient developed a non-serious ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event (incorrect dose administered) following the administration of IPV (VERO).   Action taken: not applicable.  Outcome: Unknown    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 guidelines. 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: 1.83
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ADACEL was administered after exposed to 82.62 F for 15 minutes with no reported adverse event; ADACEL was administered after exposed to 82.62 F for 15 minutes with no reported adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old female patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was administered after exposed to 82.62 F for 15 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2021, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6964AA, Exp date: 19-FEB-2023) via unknown route in unknown administration site for prophylactic vaccination.  On 31-AUG-2021 the patient reported a non-serious event of ADACEL was administered after exposed to 82.62 F for 15 minutes with no reported adverse event (product storage error) (poor quality product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  IPOL was administered to 4 patients after excursion (Inquiry 01148676).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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:  01148676:
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received Adacel after a temperature excursion where the product was not suitable for use with no adverse event; temperature excursion where the product was not suitable for use with no adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 31 years old male patient who received diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] where the product was not suitable for use after a temperature excursion with no adverse event .  The patient's past vaccination(s) included diphtheria-2/tetanus/5 ac pertussis vaccine on 09-SEP-1997. The patient's past medical history, medical treatment(s) and family history were not provided.   On 15-Jun-2022, the patient received a 0.5 ml  dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine(batch lot U7453AA,Expiry date :29-Jun-2024)(unknown formulation and strength) via intramuscular route in the right deltoid for immunization.  On 15-Jun-2022 (latency :same day) the patient received adacel where the product was not suitable for use with no adverse event (poor quality product administered)  after a temperature excursion (product storage error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the events    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse gave an expired dose of menactra with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old male patient got expired dose of INGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Jun-2022, the patient received 0.5 ml total dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6920AA exp date: 15-Apr-2022 (formulation, strength: unknown) via intramuscular route in the right arm for Immunization.  On 16-JUN-2022 the patient developed a non-serious event "nurse gave an expired dose of menactra with no reported adverse event" (expired product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurse gave an expired dose of menactra with no reported adverse event.   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 guidelines. 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: 0.17
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a patient under 10 years of age was administered ADACEL instead of her first dose of PENTACEL (with no reported adverse event); Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 2 months old female patient who was under 10 years of age was administered adacel instead of her first dose of pentacel (with no reported adverse event) while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13); and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) both for Prophylactic vaccination.  On 24-May-2022, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine lot U7093AA, Expiry date: 18-Jun-2023, frequency: once, strength unknown via intramuscular route in the left thigh as immunization.  On 24-MAY-2022 the patient developed a non-serious event a patient under 10 years of age was administered adacel instead of her first dose of pentacel (with no reported adverse event) (wrong product administered) latency: same day following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (wrong product administered)  At time of reporting, the outcome was Unknown for the event a wrong product administered.     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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Exposed to 82.62 F for 15 minutes. Believes the door was left open. Vaccines were administered after the excursion with no adverse event was reported; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old female patient who experienced exposed to 82.62 f for 15 minutes. believes the door was left open. vaccines were administered after the excursion with no adverse event was reported while receiving vaccine IPV (VERO) (IPOL).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) at a dose of 0.5ml with lot T1871M and expiry date: 10-Oct-2022 via unknown route in unknown administration site for Immunization.  On 23-Feb-2022 the patient developed a non-serious exposed to 82.62 f for 15 minutes; believes the door was left open and vaccines were administered after the excursion with no adverse event was reported (product storage error) (unknown latency) following the administration of IPV (VERO).   Action taken: not applicable.  Outcome: Unknown   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 guidelines. 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:  01148666I: 01148676: 01150238: 01150239:
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: Injection site nodule, Product preparation issue, Vaccination site mass
Clinical narrative: patient was administered HIB portion with 0.4% saline solution instead of using the DTaP/IPV, which was not given; HIB portion was administered without the DTaP/IPV portion; She reports patient had a knot on leg at injection site; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old female patient who was administered hib portion with 0.4% saline solution instead of using the dtap/ipv, which was not given, hib portion was administered without the dtap/ipv portion and she reports patient had a knot on leg at injection site after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (UJ633AAB and expiry date 30-Jan-2023 )  via intramuscular route in the thigh nos for Immunization.  On an unknown date the reportedly patient was administered hib portion with 0.4% saline solution instead of using the dtap/ipv, which was not given (product preparation error) and  hib portion was administered without the dtap/ipv portion (incorrect dose administered) (unknown latency). On an unknown date the patient had a knot on leg at injection site (vaccination site mass) (unknown latency).  Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event. (She reports patient had a knot on leg at injection site).  At time of reporting, the outcome was Unknown for all the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired menactra with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 46 years old female patient who was administered expired menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jun-2022, the patient received a  0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine(unknown formulation, strength (batch lot number: U6952AB expiry date :09-Jun-2022) via unknown route in unknown administration site for immunization.  On 16-Jun-2022 (latency :same day)the patient developed a non-serious event of administered expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event .  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.