chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Tinnitus
Clinical narrative: Tinnitus, like ringing in ear; dizziness really very bad; sense of like off balance; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus, like ringing in ear"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness really very bad"; BALANCE DISORDER (non-serious), outcome "unknown", described as "sense of like off balance".  Additional Information: The patient got something very similar to many diseases which were tinnitus, dizziness, and all of that the patient had it for approximately 9 months. The tinnitus, dizziness like many other diseases could be ENT kind of problem. The patient had Tinnitus like ringing in ear, dizziness really very bad and sense of like off balance. The side effects were terrible and horrendous. The patient was in back control, but it was terrible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (including Paxlovid from 03May2023 to 08May2023).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), in Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Flares have worsened since Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): NUS2023US094002 (RA).  A 60-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Flares have worsened since Covid-19 Vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: TTOX
Symptoms: Injection site pain
Clinical narrative: it hurt like heck; Initial information received on 11-May-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient where patient had tetanus toxoid vaccine and it hurt like heck.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a Booster dose of suspect tetanus toxoid produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, frequency, formulation, strength and expiration date: not provided) for prophylactic vaccination, Information on the batch number was requested and it hurt like hell (injection site pain) (unknown latency) following the administration of tetanus toxoid.  It was unknown if there were lab data/results available.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event (it hurt like heck).  At time of reporting, the outcome was Unknown for the event it hurt like heck.
Sex: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Allergies; Initial information received on 11-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a female patient of an unknown age who experienced allergies after receiving vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received suspect TETANUS TOXOID produced by unknown manufacturer (dosage, strength, formulation, expiry date, lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed allergies (hypersensitivity) (unknown latency).  It was unknown if there were lab data/results available.  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: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: patient received adacel after it experienced a temperature excursion, with no reported adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who received vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] after it experienced a temperature excursion, 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 Meningococcal Vaccine A/C/Y/W CONJ (Crm197) (Menveo) and Tozinameran (Pfizer Biontech Covid-19 Vaccine) for Immunisation.  On an unknown date temperature excursion happened, on 05-May-2023, the patient received ADACEL was after temperature excursion that was not supported at a dose 0.5 ml (1x) total of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection (lot: U76658A, Expiry date:  04-Mar-2025) via unknown route in unknown administration site for Immunisation (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Vaccine administration error/Expired vaccine given with no reported adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient where diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (Vero)] vaccine administration error/expired vaccine given with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 01-Feb-2023, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (expiration date- 28-Jan-2023) (dose, frequency, strength: not provided) for immunization, Information on the batch number was requested.  On 02-Feb-2023 the vaccine administration error/expired vaccine given with no reported adverse event (expired product administered) (latency- 1 day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/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 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error
Clinical narrative: expired menactra administered to a patient with no reported adverse event; Initial information received on 12-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics and is reported expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 0.5 ml of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection strength, lot number not reported expiry date: feb-2023 via unknown route in unknown administration site for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed a non-serious expired menactra administered to a patient with no reported adverse event (expired product administered) on the same day following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event expired menactra administered to a patient 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: ACTHIB was administered to 6 patients and the diluent supplied was expired with no reported adverse event; Initial information received on 12-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 patients who were administered HIB (PRP/T) VACCINE [ACT-HIB] and the diluent supplied was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of 0.5 ml once of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (LYOPHILIZED POWDER LOT: UJ674AB, EXP: 04-Jun-2023; DILUENT LOT # U7261AA, EXP: 07-Apr-2023; strength: standard) via unknown route in unknown administration site for immunization.  On an unknown date 6 patients were administered HIB (PRP/T) VACCINE [ACT-HIB] and the diluent supplied was expired with no reported adverse event (expired product administered) (latency: same day).  It was reported, "They are declining to provided any patient information citing possible HEPA violations. Caller is upset stating that Sanofi supplied these vaccines but the expiration dates are different. Caller is asking if the vaccines can be replaced. Caller is questioning the use of alternative diluents with the product and ask is this a contamination issue with the expired diluent. Caller is requesting a case summary to be emailed. Caller was attempting to justify the use of the diluent and states, "it is bad on you all" for supplying the product with different expiration dates on the diluent. Caller asks, "Am I going to get in trouble?"  Action taken was 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: 0.42
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired PENTACEL was inadvertently administered with no reported AE; Initial information received on 15-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient to whom diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] was inadvertently administered 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 (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination.  On 15-May-2023, the patient received a expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ668AAA, expiry date: 13-MAY-2023 with unknown strength) via intramuscular route in the right thigh for immunization with no reported adverse event (expired product administered) (Latency: same day).  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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Allergy test, Anaemia, Arthralgia, Autonomic nervous system imbalance
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood test, Bowel movement irregularity, Capsule endoscopy, Cardiac monitoring
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Computerised tomogram, Dizziness, Echocardiogram, Endoscopy upper gastrointestinal tract
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Food intolerance, Gastrointestinal pain, Hypersensitivity, Hypoaesthesia
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mast cell activation syndrome, Mobility decreased, Myalgia, Pathology test, Postural orthostatic tachycardia syndrome
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitivity to weather change, Sensory processing sensitivity, Sleep disorder, Stress, Syncope
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Temperature intolerance, Tilt table test, Tremor, Visual impairment
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Severe, chronic GI pain, intolerance of most foods, change in bowel movements, chronic fatigue, chronic joint pain, muscular pain, tachycardia, blood pressure fluctuations, syncope, unintended weight loss, dysmotility, anemia, POTS, MCAS, Dysautonomia, hypersensitivity to: (environment, sensory stimuli, weather, temperature, stress), shaking hands, numbness of extremities, severely impacted mobility, dizziness, vision problems, sleep disturbances
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist reported that an adult might have received PROQUAD.; No additional adverse events; This spontaneous report was received from a pharmacist concerning an adult patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient might had been vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at injection site, Approximately softball size; swelling at injection site, Approximately softball size; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-MAR-2023, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site, Approximately softball size) and injection site swelling (Verbatim: swelling at injection site, Approximately softball size). The outcome of the injection site erythema and injection site swelling were resolved (duration 2 days).   The reporter considered the injection site erythema and injection site swelling to be possibly related to Shingrix.     The company considered the injection site erythema and injection site swelling to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient was 52-53 years old. Duration of adverse event was approximately 2 days.  Reporter believed that adverse events were related to immunization with Shingrix.  The reporter did not consent to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: dose of expired Kinrix was administered to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 08-MAY-2023, the patient received Kinrix. On 08-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: dose of expired Kinrix was administered to the patient). 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: 10-MAY-2023 The reporter was a Medical Assistant. The reporter consented to contact. An expired Kinrix was administered to the patient, which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Non-approved diluent Menveo/normal saline was used to reconstitute Menveo and it was administered to a patient; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number VA9024A) for prophylaxis.   On 08-MAY-2023, the patient received Menveo. On 08-MAY-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Non-approved diluent Menveo/normal saline was used to reconstitute Menveo and it was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 The reporter called to report normal saline was used to reconstitute Menveo and it was administered to a patient, which lead to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter.  No expiration date was reported. The reporter consented to follow up via email.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose of Kinrix a few weeks before their fourth birthday; This was patient's 3rd dose of IPV and DTaP.; 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 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 05-APR-2023, the patient received Kinrix. On 05-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix a few weeks before their fourth birthday) and inappropriate schedule of vaccine administered (Verbatim: This was patient's 3rd dose of IPV and DTaP.). 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: 11-MAY-2023 Medical assistant stated that a patient received a dose of Kinrix a few weeks before their fourth birthday. This was patient's 3rd dose of IPV and DTaP. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received Kinrix dose as 3rd IPV and 3rd DTap before 4th birthday, which lead to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Exposure during pregnancy, Oestrogen receptor assay, Pregnancy test positive, Sexually transmitted disease test
Clinical narrative: pregnancy test was done and it was positive, with no reported AE; Initial information was received on 15-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old female pregnant patient who was exposed to vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] in context of pregnancy test was done and it was positive, with no reported ae. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known occurred at unknown gestation period, the gestation period at onset and gestation period at exposure data needs to be populated, if available.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy/ies Unknown.  Concomitant medications included influenza vaccine (fluzone) for Prophylactic vaccination (Immunisation); and meningococcal vaccine b for Prophylactic vaccination (Immunisation).  On 19-Dec-2022, the patient received a  dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection at dose of 0.5 ml total once (1X) (lot number: U745OAA, expiration date: 10-Oct-2024, dose, strength, route: Unknown) in the right deltoid for Immunization (immunization).  On an unknown date the patient developed a non-serious event of pregnancy test was done and it was positive, with no reported ae (maternal exposure timing unspecified) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  Relevant laboratory test results included: Oestrogen receptor assay - On an unknown date:  [does not have the results] Pregnancy test - On an unknown date: Negative; on an unknown date: Positive  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event pregnancy test was done and it was positive, with no reported ae. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  Varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023) (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, this valid case was split from original case 2303USA002114. This spontaneous report was regarding a 4-year-old female patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 09-JAN-2023, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023) underwent temperature excursion for 30 minutes from 22:30 to 23:30. The digital data logger was involved in recording excursion details. On 10-JAN-2023, the patient was vaccinated with the improperly stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) (lot number W019628, expiration date 19-DEC-2023, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837:MSD US-009507513-2304USA007931:
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 10-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hypersensitivity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Allergic reaction; Shingles like lesions; Red rash, head to ankles all over her body; white blisters; painful rash; itchiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAR-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic reaction), vesicular rash (Verbatim: Shingles like lesions), red rash (Verbatim: Red rash, head to ankles all over her body), blister (Verbatim: white blisters), painful rash (Verbatim: painful rash) and itchy rash (Verbatim: itchiness). The outcome of the allergic reaction and vesicular rash were not reported and the outcome of the red rash, blister, painful rash and itchy rash were unknown.   It was unknown if the reporter considered the allergic reaction, vesicular rash, red rash, blister, painful rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the allergic reaction, vesicular rash, red rash, blister, painful rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The case was self reported by the patient. The patient received second dose at the doctor's office and reported it was a shingles like lesions. The patient experienced red rash from head to ankles all over her body and had white blisters and it was painful rash and extremely itchy. The patient reported that she had to go several times to the urgent care. The patient reported that she eventually visited a dermatologist and stated it was an allergic reaction to the preservatives in the vaccine. The reporter stated that healthcare professional ruled out shingles. The reporter reported that not all information was available. Lot and expiry date were unknown. The patient was informed that there were no preservatives in Shingrix. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Allergic reaction; Shingles like lesions; Red rash, head to ankles all over her body; white blisters; painful rash; itchiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAR-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic reaction), vesicular rash (Verbatim: Shingles like lesions), red rash (Verbatim: Red rash, head to ankles all over her body), blister (Verbatim: white blisters), painful rash (Verbatim: painful rash) and itchy rash (Verbatim: itchiness). The outcome of the allergic reaction and vesicular rash were not reported and the outcome of the red rash, blister, painful rash and itchy rash were unknown.   It was unknown if the reporter considered the allergic reaction, vesicular rash, red rash, blister, painful rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the allergic reaction, vesicular rash, red rash, blister, painful rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The case was self reported by the patient. The patient received second dose at the doctor's office and reported it was a shingles like lesions. The patient experienced red rash from head to ankles all over her body and had white blisters and it was painful rash and extremely itchy. The patient reported that she had to go several times to the urgent care. The patient reported that she eventually visited a dermatologist and stated it was an allergic reaction to the preservatives in the vaccine. The reporter stated that healthcare professional ruled out shingles. The reporter reported that not all information was available. Lot and expiry date were unknown. The patient was informed that there were no preservatives in Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Adult patient was supposed to get the 2nd dose of Engerix-B, but was accidentally administered a pediatric dose.; Accidentally administered a pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 11-MAY-2023, the patient received the 2nd dose of Engerix B pediatric. On 11-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Adult patient was supposed to get the 2nd dose of Engerix-B, but was accidentally administered a pediatric dose.) and accidental underdose (Verbatim: Accidentally administered a pediatric dose). The outcome of the adult use of a child product and accidental underdose were unknown.   Additional Information: GSK Receipt Date: 11-MAY-2023 An adult patient was supposed to get the dose of Engerix-B, but was accidentally administered a pediatric dose of such vaccine. The Vaccine Administration Facility is the same as primary reporter. The reporter consented to follow up. The adult patient accidentally received 2nd dose of Engerix-B pediatric, which led to adult use of a child product and accidental underdose.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arm amputation, Cerebrovascular accident
Clinical narrative: strokes; has an amputated arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (strokes) and ARM AMPUTATION (has an amputated arm) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant) and ARM AMPUTATION (has an amputated arm) (seriousness criterion disability). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes) and ARM AMPUTATION (has an amputated arm) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.  Company comment.  This spontaneous case concerns a 56  year  old male patient, with no medical history reported, who received a dose with mRNA  1273.222 (Original/Omicron BA.4/5) and experienced the unexpected, serious (medically significant) AESI Cerebrovascular accident, and the unexpected disabling event of arm amputation. Latency cannot be properly assessed since exact onset dates and vaccination date were not provided. The report stated that the patient "has been taking the Moderna vaccine. He has had a couple of strokes and he has an amputated arm". No further clinical details were provided for medical reviewing. Patient´s vaccination schedule was not disclosed. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid, Dyspnoea, Gait disturbance, Tryptase
Clinical narrative: Could not walk after each one of the doses of the vaccine; Wakes up without breath; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk after each one of the doses of the vaccine) and DYSPNOEA (Wakes up without breath) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Lyme disease.    In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Could not walk after each one of the doses of the vaccine) (seriousness criteria hospitalization, disability, medically significant and life threatening) and DYSPNOEA (Wakes up without breath) (seriousness criteria hospitalization, disability, medically significant and life threatening). At the time of the report, GAIT DISTURBANCE (Could not walk after each one of the doses of the vaccine) had not resolved and DYSPNOEA (Wakes up without breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood lactic acid: Abnormal. His acid lactic levels were through the roof. On an unknown date, Tryptase: His tryptase was extremely high in these episodes.         No relevant concomitant medications were reported. No treatment medication reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 30-year-old male patient, with relevant medical history of Lyme disease, who experienced the unexpected and serious (due to hospitalization, disability, life-threatening and medically significant) events of Dyspnoea and Gait disturbance, which occurred on an unknown date related to mRNA-1273 vaccine, administered as third dose within COVID-19 vaccination schedule. Blood lactic acid and tryptase had high values. No information disclosed about treatments received. At the time of the report, Gait disturbance had not resolved and Dyspnoea outcome was unknown. Underlying Lyme disease could be a confounding factor for Gait disturbance. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 92.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Dyspnoea, Erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 27 yo female arrived for vaccination appt for gardasil 9 ( dose 3) . Dose administered Im in left arm. Immediate redness to arms and face noted. Patient observed for allergic reaction potential. patient stated she felt dizzy but was ok. Administering pharmacist gave patient a grape dum dum lollipop. Patient felt said she felt dizzy but ok. Patient nodded and shook. EMS calledand said she couldnt breathe. patient given epi 1 dose. put on floor and as patient reovered given 5ml of diphen 12.5
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Flushing, Hyperhidrosis, Injection site erythema, Mouth swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 27 yo female arrived for vaccination appt for gardasil 9 ( dose 3) . Dose administered Im in left arm. Immediate redness to arms and face noted. Patient observed for allergic reaction potential. patient stated she felt dizzy but was ok. Administering pharmacist gave patient a grape dum dum lollipop. Patient felt said she felt dizzy but ok. Patient nodded and shook. EMS calledand said she couldnt breathe. patient given epi 1 dose. put on floor and as patient reovered given 5ml of diphen 12.5