chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: She got all the Pfizer COVID-19 vaccine but the concern she had a problem with her thyroid hormone level but now it's normal; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: A female 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: THYROID DISORDER (non-serious), outcome "recovered" (2022), described as "She got all the Pfizer COVID-19 vaccine but the concern she had a problem with her thyroid hormone level but now it's normal".  Additional information: she was concerned because she had read that there had been some people who have developed problems with thyroid as a result of having the studies hypothesizes conclude that from getting the Pfizer vaccine. and he asked any advice or information about it.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: had a heart attack after first dose of COVID 19 vaccine and was treated at hospital; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: had COVID really bad 4 months earlier and then got the vaccine four months. The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, life-threatening)), outcome "unknown", described as "had a heart attack after first dose of COVID 19 vaccine and was treated at hospital".  Additional Information: Age was reported as "just below 40".  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 cannot be excluded and are Related to the suspected drug.  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, UNK
Symptoms: Blood pressure abnormal, Blood pressure measurement
Clinical narrative: blood pressure 110/74; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2022-121579 .  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since Jul2022 (ongoing) (Lot number: 2612335) at 10 mg daily (10 mg, daily (started second week of July)), oral for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure 110/74". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was dosage not changed. Additional information: The patient had 3 missed doses (dates unknown) due to hospitalization (for 3 days - dates unknown) for unspecified reaction due to covid vaccine (query sent). Unknown if side effects or adverse reactions due to missed doses. Blood pressure at the time of the report was 110/74. MD was aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID on 12Dec2022.; tested positive for COVID on 12Dec2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Dec2022, outcome "unknown" and all described as "tested positive for COVID on 12Dec2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Dec2022) Positive. Course of events: A Pfizer employee in good health (no underlying health concerns or chronic conditions) received the Pfizer/BioNTech Bivalent booster vaccine on 14Oct2022 and tested positive for COVID on 12Dec2022. Her symptoms started with a headache and dry cough and progressed to stuffy nose, sinus drainage, productive cough. Experiencing some GI issues of diarrhea and certain foods not tasting right.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200145615 same reporter/patient/product, different dose.;
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pulmonary congestion, Respiratory tract congestion, Vaccination failure
Clinical narrative: Flu shot was useless; Lungs and head full of congestion; flu; Lungs and head full of congestion; Initial information received on 11-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown age and gender who reported that flu shot was useless and had lungs and head full of congestion and flu after receiving vaccine influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (dose, strength, formulation, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that flu shot was useless (vaccination failure), had lungs and head full of congestion (pulmonary congestion) (head discomfort) and flu (influenza) (unknown latency) following the administration of influenza vaccine.   Reportedly, Got the flu shot, got the flu 6 weeks later. Didn't help in the least. Lungs and head full of congestion. Flu shot was useless. I have taken it for years, but this one was worthless.   It is unknown if the patient experienced any additional symptoms/events.  It is 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 events.  At time of reporting, the outcome was Unknown for the events.  Seriousness criteria: Medically significant for the event flu shot was useless and pulmonary congestion.; Sender's Comments: Sanofi company comment dated 15-Dec-2022:  This case involves a patient of unknown age and gender who reported that flu shot was useless and had lungs and head full of congestion and flu after receiving vaccine influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: very sick; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender patient who experienced very sick , after receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient developed a non-serious very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (very sick).  At time of reporting, the outcome was Unknown for the event very sick.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: cold; Initial information received on 11-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced cold after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine (manufacturer, dose, lot number, expiry date, route, administration site: not reported) for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious cold (nasopharyngitis) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Chest discomfort, Illness, Paranasal sinus hypersecretion, SARS-CoV-2 test, Speech disorder
Clinical narrative: I got So sick; to get this mucus off my chest could not talk; Initial information received on 09-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/Non-Health Care professional   This case involves Adult and unknown gender patient who experienced i got so sick and to get this mucus off my chest could not talk after receiving vaccine Influenza vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient experienced any additional symptoms/events It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a suspect Influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Flu   On an unknown date the patient developed a non-serious events  i got so sick (illness), to get this mucus off my chest could not talk (chest discomfort) (unknown latency) following the administration of Influenza vaccine.  It was reported last tuesday I got So sick went to pharmacy To get somihing to get this mucus off my chest could not talk Phars told me see my But my spointment wasent untile febuary 16 but i got onthat phone right away glaid idid nois was leakin got antibiotics bitter tasting but its workin Ididt no what was happing couldt get my booster shot untile next week you go dock.breath test good covid test good.Yea I had All 4 boosters.flu shot to.cought fluid in system made noise leak my sines actv act up seneseing N leakingl anti b. Are. Working i fell It.  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 (I got So sick).  At time of reporting, the outcome was Unknown for the event i got so sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  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 influenza vaccine produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site (strength, expiry date: unknown) for flu.  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was 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.
Sex: U
Vaccine: FLUX
Symptoms: Aphasia, Dysgeusia, Malaise, Productive cough, Rhinorrhoea
Clinical narrative: i got so sick wentto cvs to get something to get this mucus off my chest; could not talk; nois was leakin like hell; bitter tasting; Initial information received from on 09-Dec-2022 regarding an unsolicited valid non-serious social media case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who stated i got so sick went to pharmacy to get something to get this mucus off my chest, could not talk, nose was leaking like hell and bitter tasting after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (batch lot number, strength, form, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had non-serious events of i got so sick went to pharmacy to get something to get this mucus off my chest (productive cough), could not talk (aphasia), nose was leaking like hell (rhinorrhoea), bitter tasting (dysgeusia) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: IPOL vaccines that was 8 weeks expired had been accidentally administered to a child with no adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves Child and unknown gender patient and the reporter reported IPV (VERO) [IPOL] vaccines that was 8 weeks expired had been accidentally administered to a child with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (batch lot number, strength, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of ipol vaccines that was 8 weeks expired had been accidentally administered to a child with no adverse event (expired product administered) (unknown latency) following the administration of IPV (VERO).  Action taken with poliomyelitis vaccine (inactivated) (IPOL) was 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 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: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: maternal vaccine exposure with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 34 years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 AC pertussis vaccine [ADACEL] in context of maternal vaccine exposure with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported maternal vaccine exposure with no reported adverse event occurred at 17 weeks of pregnancy and the patient was exposed to Diphtheria-2/Tetanus/5 AC Pertussis vaccine at 17 weeks of pregnancy, during second pregnancy trimester for Diphtheria-2/tetanus/5 AC pertussis vaccine.  The date of last menstrual period was reported as 20-May-2022.  The estimated due date is 23-Feb-2023.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had unknown previous pregnancy/ies.   On 12-Sep-2022, the patient received a dose (dose number 1) of suspect Diphtheria-2/Tetanus/5 AC Pertussis vaccine Suspension for injection; lot U7549AA (strength, dose, frequency and expiry date: not reported) via intramuscular route in unknown administration site as prophylactic vaccination (Immunisation).  On 12-Sep-2022, the patient developed a non-serious event of maternal vaccine exposure with no reported adverse event (exposure during pregnancy) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (maternal vaccine exposure with no reported adverse event).  At time of reporting, the outcome was Unknown for the event maternal vaccine exposure with no reported adverse event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 12-Dec-2022 regarding an unsolicited valid serious case received via Social Media from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  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 influenza vaccine produced by unknown manufacturer(site, route, form, strength, lot number, expiry date: not reported) for prophylactic vaccination.  On an unknown date the patient developed a serious event of flu (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken with influenza vaccine was 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.  Seriousness criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 15-Dec-2022: This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: last week i got sick as a dog; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious Social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with last week i got sick as a dog after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious last week i got sick as a dog (illness) (unknown latency) following the administration of influenza vaccine.  It was reported "Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu about four days later and have had it for 3wks its been horrible; Initial information received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who stated got the flu about four days later and have had it for 3wks its been horrible after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (batch lot number, strength, form, expiry date: unknown) via unknown route in unknown administration site for Flu vaccine.  On an unknown date the patient had a non-serious event of got the flu about four days later and have had it for 3wks its been horrible (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Diarrhoea, Muscle tightness, Pyrexia
Clinical narrative: feels anxious; severe diarrhea; fever; tightness in his thighs and hip; Initial information received on 12-Dec-2022 regarding an unsolicited valid serious case from a pharmacist.  This case involves a 23 years old male patient who had severe diarrhea, fever, tightness in his thighs and hip and feels anxious after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 08-Dec-2022, the patient received a booster dose 1 at dosage 0.5 mL of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection Once (strength, lot number, expiry date: not reported) via intramuscular route in the left arm for immunisation.  On 10-Dec-2022 the patient had severe diarrhea (diarrhoea), fever (pyrexia), tightness in his thighs and hip (muscle tightness) (Latency: 2 days) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine. On 12-Dec-2022 the patient feels anxious (anxiety) (Latency: 4 days) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.   It was reported "as her son got the shot Thursday morning and starting on Saturday, he experienced severe diarrhea, fever, and tightness in his thighs and hip. She says that the tightness died down by a lot yesterday but patient feels anxious today".  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.   Seriousness criteria: Medically significant events severe diarrhea, fever,  feels anxious, and tightness in his thighs and hip.  The outcome was Recovering / Resolving for the event severe diarrhea,  fever,  feels anxious and Recovered / Resolved on an unknown date for the event tightness in his thighs and hip.; Sender's Comments: Sanofi company comment Follow up dated 14-Dec-2022:  This case involves a 23 years old male patient who experienced severe diarrhea, fever, feels anxious, and tightness in his thighs and hip after receiving diphtheria-2/tetanus/5 AC pertussis vaccine. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitant medications and vaccination history excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 47.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered 0.1ml of MENQUADFI, which is kept in the same storage container in the refrigerator as the TUBERSOL with no reported adverse event; When she prepared to administer, she removed product from refrigerator and administered with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 years old female patient who experienced administered 0.1ml of menquadfi, which is kept in the same storage container in the refrigerator as the tubersol with no reported adverse event and when she prepared to administer, she removed product from refrigerator and administered with no reported adverse event after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Dec-2022, the patient received a suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE(Dose-0.1mL)(Frequency-Total)( Strength = standard)(Formulation-Solution for injection) (Batch/lot number-U7294AA)(Expiry date-23-May-2024) via intradermal route in unknown administration site for Prophylactic vaccination   On 12-DEC-2022 the patient developed a non-serious events administered 0.1ml of menquadfi, which is kept in the same storage container in the refrigerator as the tubersol with no reported adverse event (wrong product administered), when she prepared to administer, she removed product from refrigerator and administered with no reported adverse event (product preparation error) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.(Latency-Same day)  It was reported Treatment- TUBERSOL will be repeated  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: 1.25
Sex: M
Vaccine: DTAP, DTAPIPVHIB, FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: diluent had expired with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was adminstered diluent had expired with no reported adverse event after receiving vaccines diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel], diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] and influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received  suspect influenza quadrival a-b vaccine, diphtheria-15/tetanus/5 ac pertussis vaccine, diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (dose, strength, frequency, formulation, route, batch number, expiry date, administration site: unknown) for prophylactic vaccination (immunization).  On 12-Sep-2022 the patient had a non-serious diluent had expired with no reported adverse event (expired product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine, (unknown latency) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine and (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  No lab data was reported.  Action taken was 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 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: 80.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: She has been giving it subcutaneously, however, today she gave it intramuscularly, wants to know if that was an approved administration route with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 80 years old female patient and pharmacist was giving it subcutaneously, however, today she gave it intramuscularly(vaccine yellow fever vaccine [YF-Vax]), wants to know if that was an approved administration route with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Dec-2022, the patient received a 0.5 ml dose of suspect yellow fever vaccine with standard strength (frequency: once)(lot UJ654AB and expiry date :10-Nov-2023) (form:unknown) via intramuscular route in the left deltoid for Immunization.  On an unknown date the patient developed a non-serious event of event she has been giving it subcutaneously, however, today she gave it intramuscularly, wants to know if that was an approved administration route with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of yellowfever vaccine.  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 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: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: MENQUADFI that were administered in August were administered in error again yesterday with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 13 years old male patient to whom menquadfi that were administered in august were administered in error again yesterday with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (hepatitis a vaccine) for prophylactic vaccination; hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; and varicella zoster vaccine (varicella zoster vaccine) for Prophylactic vaccination.  On 16-Aug-2022, the patient received suspect meningococcal a-c-y-w135 (t conj) vaccine at a dose of 0.5 ml (batch number: U7450AB) via intramuscular route in unknown administration site for Immunization 1 other doses were administered on unknown dates for suspect.  On 12-Dec-2022 the patient diagnosed with a non-serious event of menquadfi that were administered in august were administered in error again yesterday with no reported adverse event (inappropriate schedule of product administration) 3 months 27 days following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken was 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: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature reached 47.6F for a total excursion time of 55 minutes, with no reported adverse event; there was a patient to receive the vaccine post excursion, with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics and it was reported that the vaccine (IPV (VERO) [IPOL])  temperature reached 47.6f for a total excursion time of 55 minutes, with no reported adverse event and there was a patient to receive the vaccine post excursion, 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 of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date the temperature reached 47.6f for a total excursion time of 55 minutes, with no reported adverse event (product storage error).  On an unknown date there was a patient to receive the vaccine post excursion, with no reported adverse event (poor quality product administered) (same day latency) following the administration of IPV (VERO).   This temperature excursion was determined to be human error. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (temperature reached 47.6F for a total excursion time of 55 minutes, with no reported adverse event, there was a patient to receive the vaccine post excursion, with no reported adverse event).  At time of reporting, the outcome was Unknown for all.    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: 38.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Malaise
Clinical narrative: left deltoid pain. malaise.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder, Tinnitus
Clinical narrative: Ringing in my ears / central nervous system
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No Adverse event; HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster; Vaccine administered after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years - instead of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered after its beyond use date).    No concomitant medication was provided by the reporter.  It was reported that HCP administered 0.5ml doses of the Moderna COVID19 vaccine booster for children 6 years to 11 years instead of the bivalent booster to 2 adult patients, also after its beyond use date. The vial was initially thawed on 10-Oct-2022. HCP was unsure about how many doses the patient received in the past.  No treatment medication was provided by the reporter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site discharge, Underdose
Clinical narrative: Caller reports her 4 year old daughter stated part of the child's PROQUAD vaccine leaked out of the child's arm at time of vaccination.; PROQUAD vaccine leaked out of the child's arm at time of vaccination.; This spontaneous report was received from a consumer (patient's mother), referring to a 4-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On an unknown date in October 2022 (reported as "end of October 2022"), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection for prophylaxis (dose, strength, lot #, expiration date and route of administration were not provided), but part of the vaccine leaked out of the patient's arm at time of vaccination (injection site discharge; incorrect dose administered). The patient's mother was unable to provide site of administration as she was not at appointment but did report child had a band aid on her right arm. The patient's mother reported child's father was at visit where vaccine was administered and did not report leakage from site of vaccination. The patient's mother wished to confirm if her daughter received an adequate dose. She requested any information available about her child needing revaccination. At the time of reporting, the outcome of the event injection site discharge was unknown.   The causal relationship between injection site discharge and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE's.; Medical assistant calling to report that a patient received an expired dose of MMRII.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 17-NOV-2022, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T031436, expiration date: 15-SEP-2022 for prophylaxis (strength, dose, frequency, route of administration were not provided) (expired product administered). No other adverse event. No other issues or concerns noted. No temperature excursion.
Age: 63.0
Sex: F
Vaccine: PNC15
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was administered an expired dose of VAXNEUVANCE; This spontaneous report was received from a nurse via Pfizer referring to a 63 years old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 17-NOV-2022, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #U029559 (also reported as package batch #), expiration date: 16-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided; fill batch 0001335181 had an assigned expiry of 21-NOV-2023, inconsistent information) (expired product administered). No additional adverse event (AE) was reported (no adverse event).
Age: 6.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Healthcare business professional states that a 6-year-old male was administered GARDASIL 9 today, 11/18/2022.; This spontaneous report has been received received from a Healthcare business professional and refers to a 6-year-old male patient.  Information regarding the patient's medical history, concurrent conditions, concomitant therapies, and past drug allergies or drug reactions were not provided.  On 18-NOV-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe injection, at a dose of 0.5 millimeters (ml) administered for prophylaxis (lot #1775808 confirmed to be valid, expiration date reported and stablished as 20-AUG-2023; strength, and route of administration were not provided) (product administered to patient of inappropriate age ). No additional adverse event (AE) was reported.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE reported; administered PROQUAD concomitantly with VARIVAX; This spontaneous report was received from an medical assistant and referring to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 28-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) subcutaneous injection, lot #W012739, expiration date: 16-OCT-2023, concomitantly with  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U002399, expiration date: 22-JAN-2023, administered for prophylaxis (both strength, dose and route of administration were not provided) (overdose). No additional adverse event (AE) reported (no adverse event).
Sex: F
Vaccine: PPV
Symptoms: Autism spectrum disorder, Condition aggravated, Post-acute COVID-19 syndrome, Vaccination failure
Clinical narrative: impaired responses to the pneumococcal vaccine (PPV23); This literature marketed report has been received from the authors in a published literature article, entitled as stated below and referred to a female male patient who initially presented in the author's clinic at 13 years of age secondary to recurrent infections. She was diagnosed with autism spectrum disorders (ASD) at 36 months of age due to a notable delay in development, followed by an onset of seizures at 40 months of age: her seizures were initially manifested as partial complex seizures, but became secondarily generalized. Her seizures were refractory to many anti-epileptic drugs (AEDs). She responded favorably to a modified Atkin's diet and became seizure-free between 6 and 11 years of age. However, clusters of clinical seizures recurred after starting puberty. A high dose of valproate (375 mg at breakfast, 1125 mg at lunch, and 2250 mg at night) was prescribed by her neurologist at the time of initial presentation. She then started to suffer from recurrent respiratory infection around 12 years of age. Since valproate induced hypogammaglobulinemia had been reported, she was worked up for secondary immunodeficiency caused by AEDs.   On an unspecified date, the patient treated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, strength, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the initial workup revealed impaired responses to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). Supplemental subcutaneous immunoglobulin (SQ Ig) controlled her recurrent respiratory infections and decreased seizure frequency. The outcome of vaccination failure was not reported. The causality between the vaccination failure and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was assessed as related.  A copy of the published article is attached as further documentation of the patient's experience.  Literature Report
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored vaccine involved in a temperature excursion was administered to a patient; no additional ae reported; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On an unknown date, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), intramuscular injection, dose frequency: 1, lot #W006595, expiration date: 10-OCT-2024, (strength, exact dose, dose#, route and site of vaccination were not provided) for prophylaxis. The suspect vaccine underwent a temperature excursion of 57.49 Fahrenheit (F) degrees for 1 hour and 45 minutes. Previous temperature excursion was reported as not applicable. No additional adverse event (AE) was reported (no adverse event).