chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, single, lot number unknown), administration date: 06Jan2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162B2 (Dose 2, single, lot number unknown), administration date: 27Jan2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162B2 (Dose 3 (booster), single, LOT# FF2587), administration date: 05Oct2022, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown". The event "tinnitus" required physician office visit. Additional information: the reporter (patient, Registered Nurse) stated, "I guess I wanted to report to you something so, my husband and I both had four of the Pfizer COVID-19 Vaccination, Immunizations and I have been a very big vaccine protonate. I am registered nurse and I really believe in them and I have to tell you that in January my husband started complaining of Tinnitus and I ended up developing tinnitus. We both have, I mean we no way related it to the immunization at first. I mean the drug in our history we looked at what we are eating, no caffeine we did everything and that we are showing doctor and somebody when I was saying that we had tinnitus, they are like, your you got it from shot, I am like, no. Well, my gosh I did it and apparently there is small percentage of people that are reporting tinnitus which of course they can't say for sure they say maybe it just a correlation but there is nothing else that could happen and I want you all to know that you have got add up too in." The patient specified that dose 3 was administered on 05Oct2022 (the COVID 19 mRNA vaccine LOT# FF2587); dose 4 was administered in October like it was week later then that 2022 and that LOT# was GJ3277.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302191 Same reporter/patient/drug, different dose/AE.;US-PFIZER INC-202300302067 Same reporter/drug/AE, different patient.;
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, single, lot number unknown), administration date: 06Jan2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162B2 (Dose 2, single, lot number unknown), administration date: 27Jan2021, when the patient was 54-year-old, for Covid-19 Immunization; BNT162B2 (Dose 3 (booster), single, LOT# FF2587), administration date: 05Oct2022, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown". The event "tinnitus" required physician office visit. Additional information: the reporter (patient, Registered Nurse) stated, "I guess I wanted to report to you something so, my husband and I both had four of the Pfizer COVID-19 Vaccination, Immunizations and I have been a very big vaccine protonate. I am registered nurse and I really believe in them and I have to tell you that in January my husband started complaining of Tinnitus and I ended up developing tinnitus. We both have, I mean we no way related it to the immunization at first. I mean the drug in our history we looked at what we are eating, no caffeine we did everything and that we are showing doctor and somebody when I was saying that we had tinnitus, they are like, your you got it from shot, I am like, no. Well, my gosh I did it and apparently there is small percentage of people that are reporting tinnitus which of course they can't say for sure they say maybe it just a correlation but there is nothing else that could happen and I want you all to know that you have got add up too in." The patient specified that dose 3 was administered on 05Oct2022 (the COVID 19 mRNA vaccine LOT# FF2587); dose 4 was administered in October like it was week later then that 2022 and that LOT# was GJ3277.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300302191 Same reporter/patient/drug, different dose/AE.;US-PFIZER INC-202300302067 Same reporter/drug/AE, different patient.;
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Aug2023) negative; (29Aug2023) positive; (04Sep2023) negative.  Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 20Aug2023 to 24Aug2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19/ diagnosed with covid; Treatment of COVID-19/ diagnosed with covid; Moderna Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:15 as dose 4 (booster), single (Lot number: GJ5342) at the age of 46 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Feb2021 at 12:30 as dose 1, single (Lot number: EL13002), in left arm and on 23Feb2021 at 12:30 as dose 2, single (Lot number: EL9263), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Oct2021 at 12:15 as dose 3 (booster), single (Lot number: D24C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Oct2021 at 12:15, outcome "unknown", described as "Moderna Dose Number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Sep2023, outcome "unknown" and all described as "Treatment of COVID-19/ diagnosed with covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 02Sep2023 to 07Sep2023.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  An 85-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 28Apr2021 at 01:00 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CLL - Chronic Lymphocytic Leukemia" (unspecified if ongoing), notes: x 8 years. IVIG q 4 weeks.; "Known Allergies: Sulfa" (unspecified if ongoing); "Known allergies: Chocolate" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Known allergies: Meloxicam"; Lyrica, reaction(s): "Known allergies: Lyrica". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 31Aug2023 to 05Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Patient's relevant medical history of "CLL - Chronic Lymphocytic Leukemia may be a contributing factor. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300301862 same patient, different drug, different event;
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (batch/lot number: Gh9702) at the age of 39 years, in left arm for covid-19 immunization; covid-19 vaccine (COVID-19 VACCINE), 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC20
Symptoms: Product quality issue
Clinical narrative: Need to return an injection with a floater/ floater in the suspension/ Floater identified; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow up information on 11Sep2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FW6029, Expiration Date: Sep2023) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT DEPOSIT (non-serious), outcome "unknown", described as "Need to return an injection with a floater/ floater in the suspension/ Floater identified". Additional information: Vaccine was seen to have a floater in the suspension. Was not presented to a patient or given. The medication error occurred, when the product was prepared. The error was noticed and intercepted before the product was supplied to the patient.  The reporter considered "need to return an injection with a floater/ floater in the suspension/ floater identified" not related to pneumococcal 20-val conj vac (dipht crm197 protein). Causality for "need to return an injection with a floater/ floater in the suspension/ floater identified" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Very ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Very ill".  Additional information: When patient had Pfizer booster, she became very ill for 3 months; would not use Pfizer again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient has recurrent urticaria since getting the first 2 Covid vaccines; This is a spontaneous report received from contactable reporter (Other HCP). Other Case identifier: NUS2023US171505_NC (Novartis).  A 15-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization, reaction(s): "urticaria". The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "Patient has recurrent urticaria since getting the first 2 Covid vaccines".  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: Allergy to vaccine
Clinical narrative: She cannot take the vaccine herself due to an allergic reaction; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "She cannot take the vaccine herself due to an allergic reaction". Additional information: The patient wanted to know if the Pfizer COVID-19 vaccine EG.5 was available for her very disabled husband. The patient mentioned that she cannot take the vaccine herself due to an allergic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive covid; tested positive covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: she got tested positive for covid again after taking the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I currently have COVID and will be out of quarantine on 18Sep2023. How long do I wait until I can get my booster; I currently have COVID and will be out of quarantine on 18Sep2023. How long do I wait until I can get my booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "I currently have COVID and will be out of quarantine on 18Sep2023. How long do I wait until I can get my booster".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: clots/Clot blood; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: THROMBOSIS (medically significant), outcome "unknown", described as "clots/Clot blood". Clinical course: Patient/consumer details: Age: 50-99. The reporter considered event as caused by suspect product. The first Pfizer shots gave him clots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for a day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm for a day". Additional information: the patient had memories of all the Pfizer vaccines he got, had no side effects except a sore arm for a day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: He already had 5 doses of Pfizer COVID vaccines. He has Parkinsons; 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 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1, single), for COVID-19 immunisation; Pfizer covid vaccine (Dose 2, single), for COVID-19 immunisation; Pfizer covid vaccine (Dose 3, single), for COVID-19 immunisation; Pfizer covid vaccine (Dose 4, single), for COVID-19 immunisation. The following information was reported: PARKINSON'S DISEASE (medically significant), outcome "unknown", described as "He already had 5 doses of Pfizer COVID vaccines. He has Parkinsons".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease". Clinical details: the young lady stated that she received Pfizer vaccine and subsequently developed autoimmune disease.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: arm is sore; Initial information received on 13-Sep-2023 regarding an unsolicited valid social media non-serious case received from consumer/non-hcp.  This case involves Adult and unknown gender patient who had arm is sore after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included RSV vaccine for Immunisation.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, batch number, expiry date unknown) via unknown route in unknown administration site for Prophylactic Vaccination (immunization).  On an unknown date the patient had arm is sore (pain in extremity) (unknown latency) following the administration of influenza vaccine.  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 event (arm is sore).  At time of reporting, the outcome was Unknown for the event arm is sore.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired flu vaccine was given to patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who was given expired Influenza Quadrival A-B Vaccine [Fluzone quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),  concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received an expired dose of suspect Influenza Quadrival A-B Vaccine from 2022/2023 season (lot UT7759KA with unknown strength, dose and expiry date) via intramuscular route in unknown administration site as prophylactic vaccination with no reported adverse event (expired product administered) (latency: same day).  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: really sick; Initial information received on 13-Sep-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who was really sick after receiving influenza vaccine.  It is 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 suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, dose, formulation, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient was really sick (illness) (unknown latency).  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 event (illness).  At time of reporting, the outcome was Unknown for the event (illness).
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Rash macular, Urticaria
Clinical narrative: spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening; spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening; Initial information received on 08-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 7 months old male patient who had experienced spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Sep-2023, the patient received a dose 1 of suspect Influenza Quadrival A-B Vaccine at a dose of 0.5 ml  (Frequency: once, strength: standard and lot UT8076KA) (expiry date :unknown) via intramuscular route in the left thigh as Immunization.  On 06-Sep-2023 the patient developed spot behind his head then hives broke out on his legs and arms around 5 and 6 in the evening (rash macular) and (urticaria) (latency: same day).  Action taken: not applicable.  The patient was treated with Diphenhydramine Hydrochloride (Benadryl [Diphenhydramine Hydrochloride]) for Hives and rash macular.  At time of reporting, the outcome was Recovering / Resolving for the event (urticaria) and was Unknown for the event (rash macular).
Age: 1.5
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: administered pentacel, only the dtap/ipv component was given. caller with question on whether she could order the hib diluent in order to administer the hib portion of pentacel with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1-year-old female patient who administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], only the DTAP/IPV component was given 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 Influenza Vaccine for Prophylactic vaccination.  On 08-Sep-2023, the patient received a dose of 0.5 ml (frequency: once) suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength (lot: UJ877AA, Expiry date: 22-Mar-2024) via intramuscular route in the right thigh, only the DTAP/IPV component was given, the HIB diluent was not given and with question on whether she could order the HIB diluent in order to administer the HIB portion of Pentacel with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: patient is currently pregnant with no reported adverse event; patient received an expired FLUZONE QIV NP with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 20 years old female pregnant patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] where patient received an expired fluzone qiv np with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received an expired FLUZONE QIV NP with no reported adverse event occurred at 14 weeks of pregnancy during second pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 11-Jun-2023. The estimated due date is 17-Mar-2024.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 11-Sep-2023, the patient received 0.5 ml (TOTAL) dose 1 of suspect influenza quadrival a-b vaccine Suspension for injection (batch number- UT7680NA and expiration date- 30-Jun-2023) via unknown route in unknown administration site (strength: not provided) for Immunisation (expired product administered) (latency- same day).  On an unknown date the patient is currently pregnant with no reported adverse event (exposure during pregnancy) (unknown latency).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for both the events.  Additionally, at time of reporting, the pregnancy is still ongoing.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vial was exposed to 9-10 °C for 3 - 4 days with no reported adverse event; they did administer one vaccine to one person with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient with unknown demographics they did administer one vaccine to one person after influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] vial was exposed to 9-10 °c for 3 - 4 days 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 suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and vial was exposed to 9-10 °c for 3 - 4 days with no reported adverse event (product storage error).  On an unknown date they did administer one vaccine to one person with no reported adverse event (poor quality product administered) on the same day following the administration of Influenza Quadrival A-B Multidose Vaccine Preserved.  Reportedly, She states that they normally keep the Fluzone Quadrivalent MDV in the refrigerator but it "went bad" according to the temperature gauge and they did administer one vaccine to one person, and she would like to know what side effects the patient might experience. She states that the MDV vial was exposed to 9-10 °C for 3 - 4 days. It was not confirmed that it was an opened MDV. 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.  At time of reporting, the outcome was Unknown for the event vial was exposed to 9-10 °c for 3 - 4 days with no reported adverse event and was Unknown for the event they did administer one vaccine to one person with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: temp. excursion, Max/low temperature reached: Exposed to temperature of 11C with no reported adverse event; IPOL has been administered to a patient with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient where temp. excursion, max/low temperature reached: exposed to temperature of 11c with no reported adverse event and IPV (VERO) [IPOL] has been administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection (lot- W1A191M and expiration date- 16-Feb-2025) via unknown route in unknown administration site (dose, strength: not provided) for immunization (product storage error) and (poor quality product administered).  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: administrating the product after experienced a temperature excursion with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced administrating the product Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] after experienced a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.7 ml (frequency: once) suspect Influenza Quadrival A-B High Dose HV Vaccine lot UT8131DA, Expiry date: 30-Jun-2024) with unknown strength & formulation via intramuscular route in unknown administration site for Immunization after experienced a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) .  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion for Fluzone QIV NP that was left on the cooler after shipment for 3 days with no reported adverse event; Patient was vaccinated with Fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event); Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient and reporter reported temperature excursion for influenza quadrival A-B vaccine [Fluzone QIV] that was left on the cooler after shipment for 3 days with no reported adverse event and patient was vaccinated with fluzone QIV NP that was left on the cooler after shipment for 3 days (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 an unknown dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT8306MA, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization.  Caller reported temperature excursion for influenza quadrival A-B vaccine that was left on the cooler after shipment for 3 days with no reported adverse event (product storage error) (unknown latency) and patient was vaccinated with fluzone QIV NP that was left on the cooler after shipment for 3 days (with no reported adverse event) (poor quality product administered) (latency- same day).  Reportedly, Doctor calling from doctor's office wanted to know if the patient who was vaccinated FLUZONE QIV NP that were left on the cooler after shipment for 3 days should be revaccinated if the vaccines used were left inside the cooler with melted icepacks after shipment.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: RAB
Symptoms: No adverse event, Occupational exposure to product
Clinical narrative: preparing an IMOVAX RABIES vaccine and after mixing the vaccine and pulling it up the medicine came out the back of the syringe and went all over her and the counter with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional (Nurse).  This case involves an unknown age female patient (medical assistant) who was preparing Rabies (HDC) vaccine [Imovax Rabies] and after mixing the vaccine and pulling it up the medicine came out the back of the syringe and went all over her and the counter 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 (medical assistant) was preparing Rabies (HDC) Vaccine suspension for injection (lot: V1E122M, Expiry date:10-Apr-2024) and after mixing the vaccine and pulling it up the medicine came out the back of the syringe and went all over her and the counter with no reported adverse event (occupational exposure to product) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: Medical assistant called stating that diluent or liquid portion of PENTACEL is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient to whom administered the diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] and reporter stating that diluent or liquid portion of pentacel is missing so lyophilized portion was diluted with a normal saline diluent 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 unknown dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (strength: not reported, Expiry date: 09-Oct-2023, lot UJ790AA) via unknown route in unknown administration site as Immunization and medical assistant called stating that diluent or liquid portion of pentacel is missing so lyophilized portion was diluted with a normal saline diluent with no reported adverse event (product preparation error) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of pentacel was administered with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-month-old female patient for whom expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received an expired dose of 0.5 ml (frequency: once) suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) vaccine of standard strength Suspension for injection (lot: DTAP/IPV: U7311AA, HIB: UJ757AA, Expiry date: 09-Sep-2023) via intramuscular route in the right vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of acthib was inadvertently administered with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3-year-old male patient for whom expired dose of HIB (PRP/T) vaccine [ACT-HIB] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received an expired dose inadvertently at dose 0.5 ml dose 4 (frequency: once) of suspect HIB (PRP/T) vaccine of standard strength (lot UJ802AA, Expiry date: 14-Aug-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event  (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pt has had the Flu Shot in the past when pregnant with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [FLUZONE QIV] in the past when pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pt has had the Flu Shot in the past when pregnant with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had previous pregnancy/ies.   On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine suspension for injection (lot UT8069JA, expiry date: Jun-2024 with unknown strength and dose) via unknown route in unknown administration site as prophylactic vaccination in the past when pregnant with no reported adverse event (exposure during pregnancy) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.