chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fall, Investigation, Loss of consciousness
Clinical narrative: blacked out; nauseated; dizzy; cold sweat; fell to the floor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: pistachio nuts" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Past drug history included: Isoniazide, reaction(s): "Known allergies: isoniazide". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "blacked out"; NAUSEA (non-serious), outcome "unknown", described as "nauseated"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; COLD SWEAT (non-serious), outcome "unknown"; FALL (non-serious), outcome "unknown", described as "fell to the floor". The patient underwent the following laboratory tests and procedures: tests: Unknown results.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195599 Same patient, same events, different dose;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: blacked out; nauseated; dizzy; cold sweat; fell to the floor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2022 at 13:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: pistachio nuts" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Past drug history included: Isoniazide, reaction(s): "Known allergies: isoniazide". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "blacked out"; NAUSEA (non-serious), outcome "unknown", described as "nauseated"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; COLD SWEAT (non-serious), outcome "unknown"; FALL (non-serious), outcome "unknown", described as "fell to the floor". The patient underwent the following laboratory tests and procedures: tests: Unknown results.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195599 Same patient, same events, different dose;
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: burning chest; no appetite; fatigue; Generally feels miserable; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 52 years 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: FEELING ABNORMAL (non-serious) with onset 26Sep2022, outcome "unknown", described as "Generally feels miserable"; CHEST PAIN (non-serious) with onset 26Sep2022, outcome "unknown", described as "burning chest"; FATIGUE (non-serious) with onset 26Sep2022, outcome "unknown"; DECREASED APPETITE (non-serious) with onset 26Sep2022, outcome "unknown", described as "no appetite".  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: U
Vaccine: COVID19-2
Symptoms: Vision blurred
Clinical narrative: blurred vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, 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. Vaccination history included: Covid-19 vaccine (Primary immunization series, unknown manufacturer), for Covid-19 immunization. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision".  Additional information: Reprter asked was blurred vision a side effect of the new Covid vaccine and stated patient received Pfizer Bival Covid (12Y+) VACC MDV yesterday and today they had blurry vision. They appreciate response.   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: F
Vaccine: MENB
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: body aches; headaches; had a fever of 102 degrees; This is a spontaneous report received from contactable reporter (Other HCP) from a sales representative.  A female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "had a fever of 102 degrees"; PAIN (non-serious), outcome "unknown", described as "body aches"; HEADACHE (non-serious), outcome "unknown", described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Off label use, Product use issue, Pyrexia, Vaccination site pain
Clinical narrative: low grade fever; Pain at injection site; Flu vaccine received at same time in opposing arm Comirnaty Bivalent formulation received.; Flu vaccine received at same time in opposing arm Comirnaty Bivalent formulation received.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown), in arm. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 , MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 3, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at injection site"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Flu vaccine received at same time in opposing arm Comirnaty Bivalent formulation received.". Therapeutic measures were taken as a result of pyrexia.  Additional information: Flu vaccine received at same time in opposing arm Bivalent formulation received. It was the 4th dose, approximately 1 year after the 3rd dose. Fever managed by Tylenol. Event took place after use of product.  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: Malaise
Clinical narrative: The patient has not felt well since he had the 3rd mRNA booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "The patient has not felt well since he had the 3rd mRNA booster".  Additional information: It was reported that a patient started treatment on an unspecified date, over a year ago, with Pfizer BioNTech COVID-19 vaccine (Tozinameran) as a third dose (booster). It was reported the patient has not felt well since he had the third mRNA booster, and he won't get another mRNA vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: It was reported that after the 1st dose his arm hurt and he was tired.; It was reported that after the 1st dose his arm hurt and he was tired.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 38-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "heart disease" (unspecified if ongoing), notes: history of heart disease in his family. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "It was reported that after the 1st dose his arm hurt and he was tired.".  Additional information: On 16Sep2022, it was reported that a patient started treatment on Feb2021 with Pfizer-BioNTech COVID-19 Vaccine of two doses for unspecified indication. It was reported that after the 1st dose his arm hurt and he was tired. He had a history of heart disease in his family.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to the COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction to the COVID-19 Vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: All 4 doses were administered to both of them, and got covid after that; All 4 doses were administered to both of them, and got covid after that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "All 4 doses were administered to both of them, and got covid after that". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: All 4 doses were administered to both of them, and got covid after that. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: He was not able to swallow the pill as it is too big, he did not chew it, his wife was taking the medication (PAXLOVID), she did not experienced any symptoms. All 4 doses were administered to both of them, and got covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198093 same reporter/drug/event, different patient;
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Headache, Off label use, Product use issue
Clinical narrative: headaches; he also received the flu vaccine at the same appointment; he also received the flu vaccine at the same appointment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12-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: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3 (1st booster)), for Covid-19 Immunization; Bnt162b2 (Dose: 2), for Covid-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Oct2022, outcome "unknown" and all described as "he also received the flu vaccine at the same appointment"; HEADACHE (non-serious), outcome "unknown", described as "headaches". Therapeutic measures were taken as a result of headache.  Additional information: 12-year old boy who received the Bivalent Pfizer booster vaccine on 01Oct2022 and reported headaches over the next 24 hours and had to take Tylenol for it. Of note, he also received the flu vaccine at the same appointment.  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: U
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days; I was so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. 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 3 (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: Bnt162b2 (DOSE 1, SINGLE; LOT NUMBER: UNKNOWN), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; LOT NUMBER: UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "In your shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days"; ILLNESS (non-serious), outcome "unknown", described as "I was so sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that patient had trouble with the 3 shots. Was there eggs, milk products and aluminum die. Patient had shot. 1. 100 temp 2. 101 temp 3. 102 temp for 4 days and stated that so sick that I a, scared to get a booster shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: flublok being administered to pediatric patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER), 2022SA402514(CLUSTER) and 2022SA402505(CLUSTER).  This case involves a 16-year-old female patient to whom Influenza Quadrivalent Recombinant Vaccine [Flublok] being administered to pediatric patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Sep-2022, the patient received 0.5ml total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE strength: standard (formulation: unknown); Duration of Drug Administration 1 day, (lot number: UJ887AA and expiry date: 09-Jun-2023) via intramuscular route in Left Deltoid for Immunization and it was being administered to pediatric patient with no reported adverse event (product use issue) (latency: unknown).  It was reported, this situation is reported as a medication error.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Regulatory Authority. 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: patient was pregnant with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves Adult female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV] in context of patient was pregnant with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. Event occurred at unknown gestation period<<the gestation period at onset and gestation period at exposure data needs to be populated, if available>>  The date of last menstrual period was reported as 22-Apr-2022. The estimated due date is 23-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies.   On an unknown date, the patient received 1 dosage form (DF); dose number: 1 of suspect Influenza Quadrival A-B Vaccine Suspension for injection (strength, route, frequency: unknown) (lot number: UT7682KA and expiry date: unknown) via unknown route in the left deltoid for Prophylactic vaccination (Immunisation). Date of last injection was 22-Sep-2022.  On an unknown date, the patient developed a non-serious event of, patient was pregnant with no reported adverse event (maternal exposure during pregnancy) (unknown latency).  It is unknown if there were lab data/results available.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: wrong dilutant was used to reconstitute ActHib with no reported adverse event; Initial information received on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (healthcare professional)  This case involves an unknown age and unknown gender patient who used wrong dilutant to reconstitute vaccine HIB (PRP/T) VACCINE [ACT-HIB] 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 used wrong dilutant to reconstitute ACT-HIB with no reported adverse event (product preparation error) (unknown latency). The dilutant used was 0.7 mL of sterile water.   No lab data was provided.  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: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient had already received a dose at age 11 and again vaccinated with no adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 13 years old male patient who experienced patient had already received a dose at age 11 and again vaccinated with no adverse event while receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and influenza vaccine INACT SPLIT 3V (Fluzone High Dose) both for Immunisation.  On an unknown date at age of 11 years was administered meningococcal A-C-Y-W135 (T CONJ) vaccine at an unknown dose (lot details and expiry date: not reported) via unknown route in unknown administration site for immunisation.  On 22-Sep-2022, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine at a dose of 0.5 ml once (lot U7373AA, expiry date: 06-Aug-2024) via intramuscular route in the right arm for immunisation.  On 22-Sep-2022 the patient had already received a dose at age 11 and again vaccinated with no adverse event (inappropriate schedule of product administration) (latency: same 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 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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB that was administered, with no reported adverse event; Initial information was received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case a patient with unknown demographics who administered expired dose of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2022, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (with unknown with unknown strength, dose, route, batch number, expiration date and administration site) for Immunization. Information on the batch number was requested.  On 27-Sep-2022 the patient administered expired dose of acthib with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: highest temperature of IPOL reached 53.6 F and the total excursion lasted 3 hours and 40 minutes and was administered post excursion with no reported adverse event; highest temperature of IPOL reached 53.6 F and the total excursion lasted 3 hours and 40 minutes and was administered post excursion with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA401711 (cluster).  This case involves a 4 years old male patient who was administered IPV (vero) [ipol] post excursion which was exposed to highest temperature 53.6 F and the total excursion lasted 3 hours and 40 minutes 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap); measles vaccine, mumps vaccine, rubella vaccine (MMR); varicella zoster vaccine (varicella vaccine); and influenza vaccine (influenza) for prophylactic vaccination (Immunisation).  On 26-Sep-2022, the patient received a 0.5 ml dose once of suspect IPV (Vero) (Suspension for injection) (lot: V1A121M; expiry date: 15-Feb-2024; strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation) after Ipol was exposed to highest temperature 53.6 F and the total excursion lasted 3 hours and 40 minutes with no reported adverse event (product storage error) (poor quality product administered) (latency: same day).   It was unknown if there were lab data/results available.  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: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: yesterday patient was gave a flu vaccine that was last years with no reported adverse event; Initial information  was received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a female patient with unknown age who was gave Influenza Quadrival A-B Vaccine [Fluzone QIV] yesterday that was last years with no reported adverse event.  The patient received no other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 26-Sep-2022, the patient received a dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection 0.5 ml via intramuscular route in the left deltoid (lot: UJ694AB, expiration date: 30-Jun-2022) for Immunization.  On 26-Sep-2022 the patient was gave a flu vaccine that was last years with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered FLUZONE HD to a 44 yr old female with no adverse event; Initial information received on 28-Sep-2022 regarding an unsolicited valid non-serious case via pharmacist.  This case involves a 44 years old female patient who was administered influenza quadrival A-B HIGH dose HV vaccine [fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Sep-2022, the patient received suspect influenza quadrival A-B HIGH dose HV vaccine at an unknown dose (lot UT7718BA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunisation.  On 27-SEP-2022 influenza quadrival A-B HIGH dose HV vaccine was administered to a 44 year old female with no adverse event (product administered to patient of inappropriate age, latency: same day). They stated the patient had been contacted and they feel fine. They would like to know if there were any recommendations on what to do in this scenario.  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.
Age: 4.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUBLOK to a pediatric patient due to allergy to egg (anaphylaxis),with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case via pharmacist.  This case involves a 4 years old male patient who had administration of influenza quadrivalent recombinant vaccine [Flublok] to a pediatric patient due to allergy to egg (anaphylaxis), with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 28-Sep-2022, the patient received suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 ml total (lot UJ891AA, expiry date: 14-Jun-2023) via intramuscular route in left deltoid for immunisation.  On 28-Sep-2022 there was administration of flublok to a pediatric patient due to allergy to egg (anaphylaxis), with no reported adverse event (product administered to patient of inappropriate age, latency: same 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 Directive 2001/83/EC and Module VI of the Regulatory Authority. 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: F
Vaccine: UNK
Symptoms: Wrong technique in product usage process
Clinical narrative: only the liquid portion of PENTACEL was administered to a patient and the Acthib portion (lyophilized) was not reconstituted or used with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who was administered only the liquid portion of pentacel and the acthib portion (lyophilized) was not reconstituted or used 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.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), both for Prophylactic vaccination.  On 27-Sep-2022, the patient received 0.5 mL dose of dose 4 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot U7256AB and expiry: 13-May-2023) via intramuscular route in vastus lateralis for prophylactic vaccination.  On 27-Sep-2022, (latency: same day) only the liquid portion of pentacel was administered to a patient and the acthib portion (lyophilized) was not reconstituted or used with no reported adverse event (single component of a two-component product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion for products including opened IPOL with no adverse event; administering a vaccine to a patient after excursion with no reported adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case via other health professional.  This case is linked to case 2021SA154177.  This case involves a 14 years old male patient who was administered a vaccine IPV (VERO) [IPOL] after excursion with no reported adverse event and temperature excursion for products including opened ipol with no 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) both for Immunisation.  On 22-Sep-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot T1E872M, expiry date: 10-Oct-2022) via subcutaneous route in the left arm for immunisation.  On 22-Sep-2022 the patient was administered vaccine after excursion with no reported adverse event (poor quality product administered) same day latency. On an unknown date there was temperature excursion for products including opened ipol with no adverse event (product storage error).  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: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: 4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; 4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; 4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received the ACTHIB component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] reconstituted with sterile water instead of the DTaP-IPV component with no adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 09-Sep-2022, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at dose of 0.5 ml once (lot UJ648AAA,exp date: 25-Feb-2023) via intramuscular route in the left thigh for Immunisation.  On 09-Sep-2022 the patient received the ACTHIB component of the PENTACEL vaccine reconstituted with sterile water instead of the DTaP-IPV with no reported adverse event(product preparation error) (single component of a two-component product administered).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: had bleeding pretty bad on the injection site; injection site bruising; pain on the injection site and tenderness; Initial information received on 30-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient who had bleeding pretty bad on the injection site, injection site bruising and pain on the injection site and tenderness while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Sep-2022, the patient received a  dose of 0.5 ml of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in the left arm as Immunization.Batch/lot number requested.The patient did not used the product for the first time.  On an unknown date in 2022, the patient had bleeding pretty bad on the injection site (injection site haemorrhage) injection site bruising and pain on the injection site and tenderness (injection site pain) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Patient called to inquire if she gets completed immunity or if the FLUBLOK administered to her was effective as she mentioned she did not get the expected effects of the vaccine when it was administered previously such as pain on the injection site and tenderness. Patient mentioned she thiought that the person who administered the vaccine does not know what she was doing as she had bleeding pretty bad on the injection site as well as bruising that was still present after 2 weeks of vaccine immunization which she did not have previously. Patient said that she was not even asked to stay after the vaccination and was asked to leave as soon as possible. Patient was concerned that she did not get the immunity she should get from the vaccine given. Patient also said that she thought that they need to change the needle to a pediatric needle as she was only 100 pounds.   Action taken was not applicable.  Corrective treatment for the events: None   At time of reporting, the outcome was unknown for all.
Age: 12.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: MENACTRA and MENQUADFI being administered within a week of each other on accident with no adverse event; Initial information received on 30-Sep-2022 regarding an unsolicited valid  non-serious case via other health professional.  This case involves a 12 years old female patient who had MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] being administered within a week of each other on accident with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 22-Sep-2022, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation. On 26-Sep-2022, the patient received, 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot U7447AC, expiry date: 20-Sep-2024) via intramuscular route in the right deltoid for immunisation.  On 26-Sep-2022, menactra and menquadfi were being administered within a week of each other on accident with no adverse event (extra dose administered) same day latency following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm began to hurt. That has happened with previous covid vaccines and pain went away in couple of days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (My arm began to hurt. that has happened with previous covid vaccines and pain went away in couple of days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K214 or A, 053E21A, 028L20A and 039K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol.   On 04-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021 at 4:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (My arm began to hurt. That has happened with previous covid vaccines and pain went away in couple of days). At the time of the report, VACCINATION SITE PAIN (My arm began to hurt. that has happened with previous covid vaccines and pain went away in couple of days) had resolved.            The anatomical Location was reported as Arm for all doses. No treatment medications were reported.   This case was linked to MOD-2022-649152 (Patient Link).
Age: 86.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure, Tremor
Clinical narrative: Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: PT REPORTED HAVING SEIZURES FROM HEAD TO TOE  UPON ARRIVING AT HOME AFTER RECEIVING FLUZONE HIGH DOSE VACCINE FROM PHARMACY AND PT HAD TO SEEK EMERGENCY CARE IN THE HOSPITAL
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Severe chills, fever, muscle aches, fatigue
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Injection site pain, Nausea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Additional Details: family told me something wrong. I checked up the patient was flustered with emotion. I just advise to give benadryl to calm the patient and rule off in case she wasn't able to breathe. Patient did what was described as a vasor motor response in which the patient was anxious of the shot. she did have a slight tear to which I did mention if it was painful  at all and was told no.  I also gave her water and monitored for another 5 minutes.  patient had no issue with 1st shot
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient descibes pain in shoulder after receiving flu shot. Patient states that the pain bothers him most at bedtime. The patient has taken tylenol for his pain but does not help much. Patient is able to move arm around.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, Eye swelling, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypersensitivity, Hypoaesthesia, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe