chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Took a at home Covid test that came back positive.; Took a at home Covid test that came back positive.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "adhd" (unspecified if ongoing); "was in close contact with son that tested positive Saturday for Covid" (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 "Took a at home Covid test that came back positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: She was in close contact with son that tested positive Saturday for Covid. Sunday evening she felt exhausted. Monday morning she woke up extremely exhausted, body aches, chills, cough, severe headache, severe sinus pressure. Took a at home Covid test that came back positive.Symptoms started 1.5 days after son started showing symptoms  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug Ineffective and COVID-19  and the suspect drug BNT162b2.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: I've had facial droop on the corner of the right side of my mouth/I'm still dealing with nerve damage in my face. And It's gotten worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 33-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "unknown", described as "I've had facial droop on the corner of the right side of my mouth/I'm still dealing with nerve damage in my face. And It's gotten worse".  Clinical course: Reporter stated, I have had facial droop on the corner of the right side of my mouth since I was vaccinated with your first dose. I got vaccinated to work and educate myself in this city, and 9 months later I'm still dealing with nerve damage in my face. And It's gotten worse. I'm seeing a neurologist today, who I will try to get to file a report stating this is a side effect from pfizer's covid vaccine. I seek reparations for my lost quality of life.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Cardiac flutter, Full blood count, Lipase, Metabolic function test
Clinical narrative: heart flutter; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 at 08:11 as dose 1, single (Lot number: FK9894) at the age of 67 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "GERD", start date: 17Mar2019 (ongoing); "Hypercholesterolemia", start date: 19Mar2011 (ongoing); "Hypertension", start date: 17Sep2019 (ongoing); "Prediabetes", start date: 16Nov2016 (ongoing). The patient's family history included: "Diabetes" (unspecified if ongoing), notes: Father- Diabetes, stroke, heart failure; "stroke" (unspecified if ongoing), notes: Father- Diabetes, stroke, heart failure; "heart failure" (unspecified if ongoing), notes: Father- Diabetes, stroke, heart failure. Concomitant medication(s) included: METFORMIN oral taken for glucose tolerance impaired, start date: 16Nov2016 (ongoing); LOSARTAN oral taken for hypertension, start date: 17Sep2019 (ongoing); ATORVASTATIN oral taken for hypercholesterolaemia, start date: 19Mar2011 (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease, start date: 07Jan2015 (ongoing). The following information was reported: CARDIAC FLUTTER (medically significant) with onset 12Apr2022, outcome "recovered" (May2022), described as "heart flutter". The patient underwent the following laboratory tests and procedures: Blood glucose: (06Apr2022) mildly elevated; Full blood count: (06Apr2022) normal; Lipase: (06Apr2022) 51 uL; (09Apr2022) 57 uL; Metabolic function test: (06Apr2022) Normal. Therapeutic measures were not taken as a result of cardiac flutter.  Patient Reported to the office on 27May2022 that she had been having intermittent heart fluttering since COVID vaccine on 11Apr2022 but that it had already resolved after a few weeks. She received on 27May2022 her 2nd COVID Vaccine reports immediately having a "medicinal" taste in her mouth that went away after <1 minute. No treatments were needed or provided for either of these.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of CARDIAC FLUTTER. 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: PNC20
Symptoms: Erythema, Pyrexia, Vaccination site swelling
Clinical narrative: redness; small amount of swelling at the injection site; fever; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "recovered", described as "redness"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "small amount of swelling at the injection site"; PYREXIA (non-serious), outcome "recovered", described as "fever". Additional information: Patient called clinic after receiving Prevnar 20 experiencing redness, small amount of swelling at the injection site and fever. Symptoms resolved within 48 hours. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Caller said that she had the symptoms and got covid; Caller said that she had the symptoms and got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis B" (unspecified if ongoing), notes: if the product will affect her liver as she had hepatitis B when she was 19 years old. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Caller said that she had the symptoms and got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Clinical course: Caller, 67 years of age wanted to know before starting to take her Paxlovid pills if the product will affect her liver as she had hepatitis B when she was 19 years old. Caller was fully vaccinated with the two shots and one booster of Pfizer. Resolution: Caller said that they had power outage right now and she was calling from her mobile phone. Caller said that will contact again and caller hung up. Medical inquiry was not forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: developed alopecia after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "developed alopecia after receiving the vaccine". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the parent.  A 10-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: URTICARIA (non-serious), outcome "unknown".  Additional information:  Dr. s daughter developed urticaria after receiving the vaccine. This adverse event was reported within the 24 hour time frame. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: hearing problems; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: HYPOACUSIS (non-serious) with onset Mar2022, outcome "unknown", described as "hearing problems".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.92
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: had given an 11 month old the 11 year old vaccines-adacel and menactra no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from health professional via sale representative.   This case involves a 11-month-old and unknown gender patient to whom vaccines Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] and Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] for the 11-year-old were given no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported from hospital staff that 11-month-old patient was administered vaccines-Adacel and Menactra (all dosing details unknown) meant for the 11-year-old with no reported adverse event (product administered to patient of inappropriate age) same day latency.  Action taken: Not applicable for both suspects.  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.
Sex: F
Vaccine: UNK
Symptoms: Incomplete course of vaccination
Clinical narrative: missed getting the 2nd dose on the seventh day with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves female patient of unknown age who missed getting the 2nd dose on the seventh day with no reported adverse event after receiving vaccine IPV (VERO) [IMOVAX].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination. Information regarding batch and expiry date was requested.  It was reported that patient went to local medical department to receive the first dose of the Imovax. When patient returned 7 days later she told they would not give the booster because the initial vaccine should not have been given and said it was a long story. Reportedly patient stated that disease control now recommends 2 doses instead of 3. Patient had non-serious event of obviously missed getting the 2nd dose on the seventh day (product dose omission issue) (latency: 7 day).   Action taken : not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Medication error, Product preparation error
Clinical narrative: Pentacel was administered to a patient without being mixed properly with no reported AE; Initial information received on 21-Jun-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 administered the vaccine without being mixed properly with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Jun-2022, the patient received a  dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine ( lot U6970BA and expiration date: 31-Jan-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On 17-Jun-2022 , it was reported that the Pentacel was administered to a patient without being mixed properly with no reported ae (product preparation error)(latency: same day). It was also reported that the patient was only administered the liquid component of Pentacel.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (Pentacel was administered to a patient without being mixed properly with no reported AE).  At time of reporting, the outcome was Unknown for the event pentacel was administered to a patient without being mixed properly with no reported ae.  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: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: pentacel was administered to a patient using only the dtap-ipv portion and not the hib component/ DTaP-IPV portion of PENTACEL being administered without the Hib component.with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 month few weeks old female patient who experienced pentacel was administered to a patient using only the dtap-ipv portion and not the hib component/ dtap-ipv portion of pentacel being administered without the hib component.with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) and rotavirus vaccine live reassort ORAL 5V (ROTATEQ) both for Immunisation.  On 21-Jun-2022, the patient received suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine at a dose of 0.5 ml total (lot UJ593AAA, expiry date, strength: not reported) via intramuscular route in the left thigh for immunisation.  On 21-Jun-2022, latency same day, pentacel was administered to a patient using only the dtap-ipv portion and not the hib component/ dtap-ipv portion of pentacel being administered without the hib component.with no reported adverse event (single component of a two-component product administered) following the administration of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.   Outcome Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received a dose of expired ACTHIB with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who received a dose of expired acthib with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for immunisation.  On 22-Jun-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml (lot UJ513AD, expiry date, form) via unknown route in the left thigh for immunisation.  On 22-Jun-2022 the patient developed a non-serious received a dose of expired acthib with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) vaccine.  Reporter wanted to know if the patient need to be revaccinated.  Action taken: not applicable.   Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ, PPV
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: Unknown amount of time with a minimum temperature of 24.9°F with no adverse event; vaccines were administered post-excursion with no adverse event; Initial information received on 27-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom vaccines was administered post-excursion with no adverse event and Pneumovax,  meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was kept at unknown amount of time with a minimum temperature of 24.9°f with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date it was reported that vaccines was kept at unknown amount of time with a minimum temperature of 24.9°f with no adverse event (product storage error).  On an unknown date, the patient received a  dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine, Solution for injection, (lot U7483AA, Expiry date; 20-Oct-2023) via unknown route in unknown administration site and patient received a  dose of suspect PNEUMOVAX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Prophylactic vaccination was administered post-excursion with no adverse event (poor quality product administered) (unknown latency)   Action taken : not applicable.  Outcome : Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01164014: 01164336:
Age: 1.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong patient received product, Wrong product administered
Clinical narrative: 12-month old patient was given Menactra, Adacel in error, pulled from inventory for administration to a different patient, and there was a mixu-up and they were given to the wrong patient, not due for DTaP with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old and unknown gender patient who was given menactra(DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE), adacel (MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE) in error, pulled from inventory for administration to a different patient, and there was a mix-up and they were given to the wrong patient, not due for dtap with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Jun-2022, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site as Prophylactic vaccination. The lot number was requested.  On 28-JUN-2022 the 12-month old patient was given menactra, adacel in error, pulled from inventory for administration to a different patient, and there was a mix-up and they were given to the wrong patient, not due for dtap with no reported adverse event (wrong patient received product) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable for both suspects.  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: 19.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Product use issue, Unintentional use for unapproved indication
Clinical narrative: gave IPOL 0.1 ml intradermally for TB skin test with no adverse events; gave IPOL 0.1 ml intradermally for TB skin test with no adverse events; gave IPOL 0.1 ml intradermally for TB skin test with no adverse events; Initial information was received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 19 years old female patient who experienced gave IPOL 0.1 ml intradermally for TB skin test with no adverse events while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 29-Jun-2022, the patient received 0.1 ml of suspect IPV (VERO) (lot V1A022M) (formulation, strength and expiry date: unknown) via intradermal route in unknown administration site for routine TB skin test (Tuberculin test).    On 29-JUN-2022 the patient developed a non-serious gave IPOL 0.1 ml intradermally for TB skin test with no adverse events (unapproved dose administered, inappropriate route of vaccination and unintentional use for unapproved indication) (latency same day) following the administration of IPV (VERO).  Action taken: not applicable.  Outcome-Unknown for all 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: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was inadvertently administered an expired dose of the Adacel single-dose vial with no adverse event; Initial information was received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who experienced patient was inadvertently administered an expired dose of the adacel single-dose vial with no adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 29-Jun-2022, the patient received 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6702AA, expiry-20-JUN-2022) (formulation, and strength: unknown) via intramuscular route in unknown administration site for Immunization.    On 29-JUN-2022 the patient developed a non-serious patient was inadvertently administered an expired dose of the adacel single-dose vial with no adverse event (expired product administered) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient was inadvertently administered an expired dose of the adacel single-dose vial with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired dose of the Adacel with no reported adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had inadvertently administered an expired dose of the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] 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 HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 27-Jun-2022, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6702AA and expiry date:  20-Jun-2022) via intramuscular in right deltoid for Immunization.  On 27-Jun-2022 the patient developed a non-serious inadvertently administered an expired dose of the adacel with no reported adverse event (expired product administered, Latency: same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired DT vaccine was administered with no reported adverse event; Initial information received on 30-Jun-2022 regarding an unsolicited valid non-serious case received from medical assistant. Number: 01170883  This case involves a 66-year-old female patient to whom expired (Diphtheria and Tetanus Toxoids) TENIVAC vaccine was administered with no reported adverse event.  The patient presented with a laceration on her right foot (Skin laceration). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 20-Jun-2022, the patient received a dose of suspect TENIVAC vaccine at dose of 0.5ml once with (lot: U6265A, expiry date: 19-Apr-2021) via intramuscular route in unknown administration site for Immunization (expired product administered, latency same day).  It was reported that "HCP reports about a patient of the practice presented with a laceration on her right foot. She was administered a DT vaccine which was later noted to have expired 4/19/2021. No adverse events have been reported."    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: M
Vaccine: RAB, RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Rather than rabies immune globulin being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event; Initial information received on 01-Jul-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age male patient in whom rather than rabies immune globulin being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event while receiving vaccines rabies vaccine and rabies (HDC) vaccine [Imovax rabies].  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 rabies (HDC) vaccine Injection (strength, dose, lot number and expiry date not reported) via intramuscular route in deltoid muscle and a dose of suspect rabies vaccine produced by unknown manufacturer (formulation, strength, dose, lot number and expiry date not reported) via intramuscular route in deltoid muscle, both for Post exposure immunization.  On an unknown date, the patient was rather than rabies immune globulin being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event (product administered at inappropriate site) following the administration of rabies (HDC) vaccine rabies vaccine.  Action taken 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01172953:
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: they inadvertently gave expired MENACTRA to a patient, with no reported adverse event; Initial information received on 01-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and it was reported that they inadvertently gave expired menactra 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 01-Jul-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6951AA, expiration date: 06-Jun-2022, (strength: unknown) with Intramuscular route in the left deltoid as Immunisation.  On 01-JUL-2022, they inadvertently gave expired menactra to a patient, with no reported adverse event (expired product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Still using product : No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (they inadvertently gave expired MENACTRA to a patient, with no reported adverse event).  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: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: rabies immune globulin (RIG) being administered at a different location than the IMOVAX RABIES injection, they were administered at the same location (deltoid muscle) with no reported adverse event; Initial information received on 01-Jul-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient to whom rabies immune globulin (RIG) being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event while receiving vaccines rabies immuneglobulin and rabies (HDC) vaccine [Imovax Rabies].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect RABIES (HDC) VACCINE  injection and RABIES IMMUNEGLOBULIN not produced by Sanofi Pasteur  injection both at an unknown dose (lot number, expiry date, form: not reported) via intramuscular route in the deltoid nos for post-exposure prophylaxis(immunisation).  On an unknown date it was reported rabies immune globulin (rig) being administered at a different location than the imovax rabies injection, they were administered at the same location (deltoid muscle) with no reported adverse event (product administered at inappropriate site) (unknown latency) following the administration of rabies (HDC) vaccine and (unknown latency) following the administration of rabies immuneglobulin. The physician's parents were both exposed to a bat, and it is unknown if they were bitten and there was no obvious wound, but of course they still went to receive post-exposure prophylaxis. Pharmacist wanted to confirm if patients should receive an extra dose of the IMOVAX RABIES vaccine, because the RIG might have inactivated the vaccine dose if administered at the same site? And if so, when should the extra dose be given. Pharmacist stated that she believed this occurred approximately 2 weeks ago, since the physician mentioned that his parents were due for the 14-day dose of the Imovax Rabies.  Action taken: not applicable.   Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  SAD20220701002228: 01172861:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: heart rate jumped to 100 bmp and remained throughout night while resting. Sleep was nearly impossible.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain
Clinical narrative: She developed  pain, diarrhea, chills, and temperature of 100.4
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Additional Details: patient requested call 911, 911 came , check blood presuure , they said everything is fine and advised the patient to follow up with the provider
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: Patients daughter called to state that after her Mom was given the second vaccine booster, there was a bruise that formed and lasted for up to 2 weeks. no other side affect or issue thereafter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
Clinical narrative: Daily fever (100-101) and chills since receiving vaccine.  Persistent moderate cervical lymphadenopathy
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Started hearing loud humming/tinny sound in my head (not really in my ears). Would intensify in the morning and late afternoon. It is a persistent high pitched noise.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray normal, Cough, Fatigue, Malaise
Clinical narrative: Had URI SX of congestion coughing slight fever at beginning of cruise May 27-June 3,2022. Tested neg for Covid on May 26, 22. Ran out of cough syrup on June 2, 22 and was very sick especially fatigued by then. Called ship infirmary who sent personnel with meds and Covid kit to stateroom. Tested positive. Moved to isolation on ship and for 5 days later at relatives home. Flew home June 7,22 and still tested positive June 8,22. Called PCP Dr. who prescribed Paxlovid which I took for 5 days. Tested neg for Covid June 9,22. Was fatigued but without URI symptoms for 10 more days. It was a lousy honeymoon.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory symptom, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Had URI SX of congestion coughing slight fever at beginning of cruise May 27-June 3,2022. Tested neg for Covid on May 26, 22. Ran out of cough syrup on June 2, 22 and was very sick especially fatigued by then. Called ship infirmary who sent personnel with meds and Covid kit to stateroom. Tested positive. Moved to isolation on ship and for 5 days later at relatives home. Flew home June 7,22 and still tested positive June 8,22. Called PCP Dr. who prescribed Paxlovid which I took for 5 days. Tested neg for Covid June 9,22. Was fatigued but without URI symptoms for 10 more days. It was a lousy honeymoon.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The patient is 11 years old and recieve the COVID19 Pfizer vaccine for ages 12 years old >  No adverse event was observed during observation after vaccination and no adverse reaction was reported when followed up with patient and caregiver.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pyrexia, Respiratory tract congestion
Clinical narrative: Covid 19 infection.  fever, cough, congestion, fatigue. Started June 19th 2022.  Fatigue persisted though July 6th.  Paxlovid was taken for 5 days beginning June 21st.  Otherwise, symptomatic treatment with Naproxen and tylenol.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid 19 infection.  fever, cough, congestion, fatigue. Started June 19th 2022.  Fatigue persisted though July 6th.  Paxlovid was taken for 5 days beginning June 21st.  Otherwise, symptomatic treatment with Naproxen and tylenol.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No known adverse s/sx.  Pt reported and  presented covid  vaccine cards at office visit indicating  she had  not received second booster so booster was administered. After visit pt called and reported she had already had second booster in April.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Erythema multiforme
Clinical narrative: erythema multiforme  rash
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Fall, Unresponsive to stimuli, Vomiting
Clinical narrative: Was notified by the assisted living home he was living in on 7/7/2022 that patient was found unresponsive that morning and rushed to the emergency department. Administrator states that after pt vaccine tuesday that the patient began throwing up on the next day Wednesday. During the vomit process patient had fallen going to the trash can. He states pt denied injury at this time. Pt was currently taking blood thinners during this time. He states that family refused emergency services after this fall. The next morning on 07/07/2022 staff went into his room and found him unresponsive. Administrator states the pt would not respond to sternal rub and ems was called at this time. No further information of patient status at this time.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Head discomfort, Nasopharyngitis, Tinnitus
Clinical narrative: Rapid onset hearing loss - left ear about May 19, 2022. Had a cold & suddenly got severe ringing in left ear & feeling of head under water. Had travelled by plane previously. Thought ringing in ear & loss of hearing would clear up, but 6 weeks later had hearing  test & left ear has had sudden large dip in hearing which seems permanent.  MRI scheduled. Doctor suspects Autoimmune Hearing Loss.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Extra dose administered, Fatigue, Headache, Injection site pain
Clinical narrative: 11 hours following vaccine woke with slight throat constriction, plugged ears, and extra mucus/mild respiratory distress. This is commonly my first sign that anaphylaxis May develop. Took 1 reditab Claritin, which sometimes helps. Symptoms continued and took 3ml Benedryl which is my second step for calming rxn - this worked. My history is that anaphylaxis rxns can increase overtime with more exposure. This same progression happened with Botox & 4th rxn was much stronger and have not had since.  Today symptoms are similar to previous post-vaccine symptoms: headache, fatigue, injection site soreness, achy, and unsure if fever & chills will develop later today (they did for last two Covid vaccines)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory distress, Secretion discharge, Sleep disorder, Throat tightness
Clinical narrative: 11 hours following vaccine woke with slight throat constriction, plugged ears, and extra mucus/mild respiratory distress. This is commonly my first sign that anaphylaxis May develop. Took 1 reditab Claritin, which sometimes helps. Symptoms continued and took 3ml Benedryl which is my second step for calming rxn - this worked. My history is that anaphylaxis rxns can increase overtime with more exposure. This same progression happened with Botox & 4th rxn was much stronger and have not had since.  Today symptoms are similar to previous post-vaccine symptoms: headache, fatigue, injection site soreness, achy, and unsure if fever & chills will develop later today (they did for last two Covid vaccines)