chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) 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, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  Clinical course: Enjoy your billions while patient had a well documented stroke from the second shot. Disgraceful.  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: Incorrect dose administered, No adverse event, Underdose
Clinical narrative: Vaccine dripped out of the syringe and the patient didn't receive the full dose, with no adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age/gender patient to whom while administering INFLUENZA VACCINE dripped out of the syringe and the patient didn't receive the full dose, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, while administering INFLUENZA VACCINE (lot/expiry; unknown) dripped out of the syringe and the patient didn't receive the full dose, with no adverse event (incorrect dose administered) (dose, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  At time of reporting, the outcome was Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Illness, Malaise, Secretion discharge
Clinical narrative: really sick all week; cough for the last 3 days; mucus on his throat; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 63 years old male patient who was really sick all week, cough for the last 3 days and mucus on his throat while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On 17-Oct-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  In Oct-2022 the patient was really sick all week (illness) had cough for the last 3 days (cough) mucus on his throat (secretion discharge) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.   Action taken was not applicable.  The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE (DELSYM) for Cough.  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
Age: 8.0
Sex: M
Vaccine: FLUR3
Symptoms: Expired product administered, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUBLOK to a pediatric patient with no reported adverse event; Expired vaccine administered with no reported adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 8 years old male patient who experienced administration of flublok to a pediatric patient with no reported adverse event and expired vaccine administered with no reported adverse event 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 22-Oct-2022, the patient received 0.5 mL total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation, strength not reported; lot QFAA238 and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On 22-Oct-2022, (latency: same day) there was administration of flublok to a pediatric patient with no reported adverse event (product administered to patient of inappropriate age) and expired vaccine administered with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  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.; Sender's Comments:  01335662:
Age: 0.33
Sex: M
Vaccine: DTAPIPV, UNK
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient received an incorrect vaccine which was QUADRACEL instead of Pentacel with no adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient received an incorrect vaccine which was DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 20-Oct-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml (lot U7526AA, expiry date: 07-Sep-2024) via intramuscular route in the left thigh for immunization.  On 20-Oct-2022 the patient developed a non-serious patient received an incorrect vaccine which was QUADRACEL instead of Pentacel with no adverse event (wrong product administered). Caller reported the patient had not received any previous vaccinations. The patient came in to start his vaccinations, and one of the providers wrote orders for him to receive pentacel among other vaccinations to start the catch-up process. Another provider wrote orders for a different patient to receive quadracel, the orders were inadvertently mixed up and this patient received quadracel in 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 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: 12.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 12-year-old patients that received the FLUZONE High-Dose Quadrivalent accidentlywith no reported AE; 12-year-old patients that received the FLUZONE High-Dose Quadrivalent that is for 65 plus age group with no reported AE; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2022SA443948(CLUSTER).  This case involves a 12 years old and unknown gender patient who received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] accidently that was for 65 plus age group with no reported adverse event (AE).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.7 ml once (lot number, expiry date: not reported) via intramuscular route in unknown administration site for immunisation.  On an unknown date 12-year-old patients received the fluzone high-dose quadrivalent accidently with no reported ae that is for 65 plus age group (accidental exposure to product, product administered to patient of inappropriate age) (same day latency).  Action taken: Not applicable.  Outcome: 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.
Age: 29.0
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Patient was administered IPOL 0.1 ML intradermally instead of the ordered PPD test with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 29 years old female patient who was administered IPV (VERO) [IPOL] 0.1 ml intradermally instead of the ordered ppd test with no reported adverse event.  The patient's past medical history, medical treatment(s),  vaccination(s) and family history were not provided. Patient had no other concomitant medication.  On 25-Oct-2022, the patient received 0.1 ml, 1 X(once) dose of suspect IPV (VERO) (strength, formulation was unknown, lot V1B901M and expiry date: 02-Jun-2024) via intradermal route in the right forearm for Immunization.  On 25-Oct-2022 the patient developed a non-serious event of  was administered ipol 0.1 ml intradermally instead of the ordered ppd test (strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination) with no reported adverse event (wrong product administered) (Latency: same day)following the administration of IPV (VERO).  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: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: opened IPOL had been administered since the excursion with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom opened IPV (VERO) [IPOL] had been administered since the 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 temperature excursion occurs for unopened ACTHIB, MENACTRA, DAPTACEL, ADACEL and opened IPOL due to power outage and refrigerator issue (Human Error: no) with reported Temperature 48.9°F for 153 hours, 12 minutes. All products deemed unsuitable for use. None of the products were used to administer a dose except for the opened IPOL. 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. Reporter noted that the opened IPOL had been administered since the excursion with no reported adverse event (poor quality product administered) (dose, strength, formulation: unknown) (lot number:V1A021M, exp date: 17-Feb-2022) via unknown route in unknown administration site for Immunization.  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: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event, Off label use
Clinical narrative: off-label use as per local labelling due to ADACEL administration as part of a primary series with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 13 years old and unknown gender patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and it was reported as off-label use as per local labelling due to adacel administration as part of a primary series with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Feb-2022, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization.  On 22-FEB-2022 there was off-label use as per local labelling due to adacel administration as part of a primary series with no reported adverse event (inappropriate schedule of product administration) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported that a 13 year old patient who received a dose of ADACEL on 22FEB2022 to have 3 more doses of the DAPTACEL for complete immunization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (off--label use as per local labelling due to ADACEL administration as part of a primary series with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: sweats; chills; vomiting; diarrhea for almost 2 days; Initial information received on 27-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 65-year-old female patient who experienced sweats, chills, vomiting and diarrhea for almost 2 days while receiving vaccine influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Allergy to chemicals (allergy to propolis and benzochromium chloride).  Concomitant medications included pneumococcal vaccine for prophylactic vaccination (Immunisation).  On 24-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.7 ml total (lot number and expiry date: not reported) via intramuscular route in the left deltoid for Influenza.  On 25-Oct-2022 the patient developed a non-serious chill, vomiting, diarrhea for almost 2 days (diarrhoea), sweats (hyperhidrosis), 1 day following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: Not applicable.  The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Chills, Vomiting, sweats and Diarrhoea.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in Oct-2022 for the event chills, vomiting, sweats and was Not Recovered / Not Resolved for the event diarrhea for almost 2 days.
Age: 75.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 75-year-old male patient received the FLUZONE QIV instead of the FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; 75-year-old male patient received the FLUZONE QIV instead of the FLUZONE HIGH DOSE QUADRIVALENT with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 75-year-old male patient who received the influenza quadrival A-B vaccine [Fluzone Quadrivalent] instead of the fluzone high dose quadrivalent 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 an unknown date, the patient received suspect influenza quadrival A-B vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the 75-year-old male patient received the fluzone qiv instead of the fluzone high dose quadrivalent with no reported adverse event (wrong product administered, product administered to patient of inappropriate age) (same day latency).  Action taken: Not applicable.  Outcome: 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: U
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: receive Fluzone High Dose in error with no reported  adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 3 adult patients of an unknown age (under age of 65)  who received fluzone high dose in error with no reported  adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 3 patients received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , (lot: UT7729BA ; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the 3 residents under the age of 65 received fluzone high dose in error with no reported  adverse event (wrong product administered) (latency: unknown).  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: 22.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of TENIVAC was given to a patient with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 years old male patient and an expired dose of tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) was given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications: None   On 19-Oct-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022 via intramuscular route in the right arm as Immunization.  On 19-OCT-2022 an expired dose of tenivac was given to a patient with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event ( an expired dose of TENIVAC was given to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: Chest pain, Electrocardiogram ST segment depression
Clinical narrative: ST Depression; chest pain; Initial information received on 28-Oct-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves an unknown age female patient who was diagnosed with ST depression and chest pain after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Oct-2022,on Wednesday, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site for Influenza.  On 26-Oct-2022,on Wednesday, the patient had ST depression (electrocardiogram ST segment depression) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On 26-Oct-2022,on Wednesday, the patient had chest pain same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included: Electrocardiogram - On 26-Oct-2022:  [ST segment depression]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (ST Depression, chest pain).  At time of reporting, the outcome was Unknown for all.; Sender's Comments: Sanofi company comment dated on 03-Nov-2022:This case involves an unknown age female patient who was diagnosed with ST depression and chest pain after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Furthermore information regarding medical history, past medical treatment, vaccinations and condition at the time of vaccination excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: TENIVAC administered after the expiration date with no reported adverse event; Initial information received  on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 36 years old male patient and it was reported that tenivac (DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT) administered after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2022, the patient received a  dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot U6831AA, expiration date: 08-Oct-2022 via intramuscular route in the right deltoid as Immunization.  On 28-OCT-2022 the tenivac administered after the expiration date with no reported adverse event (expired product administered) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Action taken was not applicable.  Treatment: none.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: gave a dose of acthib on 10/28 that expired on 10/26, with no reported adverse event; Initial information received  on 28-Oct-2022 regarding an unsolicited valid  non-serious case from other health professional.  This case involves an unknown age female patient who was given a dose of HIB (PRP/T) VACCINE [ACT-HIB] on 10/28 that expired on 10/26, 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-Oct-2022, the patient received suspect HIB (PRP/T) VACCINE at an unknown dose (lot number not reported, expiry date: 26-Oct-2022) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On 28-Oct-2022 the patient was given a dose of acthib on 10/28 that expired on 10/26, with no reported adverse event (expired product administered, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 59.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect route of product administration, Injection site erythema, Local reaction
Clinical narrative: A small localized reaction (small than a dollar bill) with a redness around the injection site; A small localized reaction (small than a dollar bill) with a redness around the injection site; The vaccine was not administered via IM; This spontaneous case was received on 17-Oct-2022 from other healthcare professional (nurse) via agency (reference number: SEQW22-04563) and concerned a 59-year-old, female patient.  The patient's concurrent conditions included blood pressure and cholesterol. The patient's concomitant medications included unspecified blood pressure and cholesterol pills.  On 10-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza prophylaxis. As reported, the nurse reported that she clearly saw that the vaccine was not administered intramuscularly (IM) (explicitly coded as 'Inappropriate route of vaccination') for influenza prophylaxis. The batch number was not reported.  On the same day, after receiving the Flucelvax Quadrivalent, the patient experienced a small, localized reaction (small than a dollar bill) with a redness around the injection site.  On 14-Oct-2022, the patient recovered from the events of 'local reaction' and 'vaccination site erythema'.   The reporter did not provide a causality assessment.     The case was assessed as non-serious.  Company comment: A 59-year-old female patient was vaccinated with Flucelvax Quadrivalent. The vaccine was not administered intramuscularly (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed local reaction and vaccination site erythema. Inappropriate route of vaccination is assessed as not related per company's conventions. Causality for other events is assessed as possibly related due to biological and chronological plausibility.; Sender's Comments: A 59-year-old female patient was vaccinated with Flucelvax Quadrivalent. The vaccine was not administered intramuscularly (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed local reaction and vaccination site erythema. Inappropriate route of vaccination is assessed as not related per company's conventions. Causality for other events is assessed as possibly related due to biological and chronological plausibility.
Age: 12.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site bruising, Injection site haemorrhage, Nausea, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Vaccine drew blood and patient vomited in bathroomo shortly after seeing the blood
Age: 12.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site bruising, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Vaccine drew blood and patient vomited in bathroomo shortly after seeing the blood
Age: 12.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site bruising, Injection site haemorrhage, Nausea, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Vomiting-Mild
Age: 12.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site bruising, Vomiting
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Vomiting-Mild
Age: 0.58
Sex: M
Vaccine: DTAP, RV1
Symptoms: Crying, Pyrexia
Clinical narrative: 99-100 fever (12:30-3:00 AM) Inconsolable crying (12:30/1:23/3:00 AM)
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site bruising, Injection site pain, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling and numbness in arm started at night on 10/27/22
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haemorrhage, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: bleeding-Severe, Additional Details: patient bleed and was sqirting out of her arm for 1 second and was covered with cotton swab and resolved. patient waited in vaccine area for 15 min and felt well with no issues.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Ear pain, Eye swelling, Headache, Mouth swelling
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild, Systemic: Joint Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: PER THE PT HER FACE SWELL AND LIPS STILL NOT 100% RESOLVED ,BUT NO DIFFICULTY BREATHING , VERY BAD HEADACHE, SHOOTING SHARP PAIN IN THE EAR EVERY ONCE A WHILE, PER THE PT SHE IS ASTHMA MEDICATION FOR ALLERGIES SHE THIMK THIS LIMITED THE ADVERSE EFFECTS
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Swelling face, Swollen tongue, Tinnitus
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild, Systemic: Joint Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: PER THE PT HER FACE SWELL AND LIPS STILL NOT 100% RESOLVED ,BUT NO DIFFICULTY BREATHING , VERY BAD HEADACHE, SHOOTING SHARP PAIN IN THE EAR EVERY ONCE A WHILE, PER THE PT SHE IS ASTHMA MEDICATION FOR ALLERGIES SHE THIMK THIS LIMITED THE ADVERSE EFFECTS
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Fall, Joint injury, Syncope
Clinical narrative: Patient got up from the floor too fast watching mom get shot. Patient tolerated his shot well, walked six steps crumbled and hit his elbow when he fell, applied ice to his neck. Never past out, got weakened, has had no supper. Kept for 15 minutes, ate candy. BP 120/80 P84.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthritis infective, Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: The patient developed a joint infection in her elbow requiring a visit to the ER for antibiotics and a follow up with her primary provider.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: injection site is warm to touch and tender to touch.  advised pt to draw a surrounding line and monitor and take benadryl.  If not better see doctor
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: pt states 30 min after her vaccine her face and throat started to swell up and had difficulties breathing. she took 2 benadryl and 2 more 30 min later. she states she has never had a reaction to the flu vaccine in the past and within the hour she felt fine.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Mammogram, Menstrual disorder, Smear cervix
Clinical narrative: MAJOR changes on mental cycle, ongoing. Prior to Covid shot menstration was every 40-45 days, after Covid shot became every 20-30 days and unnaturally heavy. One year later, mental cycle comes every 3 weeks and still abnormally heavy!
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis, Mydriasis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: mydriasis for about 10 seconds-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: mydriasis for about 10 seconds-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Cough, Fatigue, Feeling cold, Headache
Clinical narrative: Began about 5 hrs after injection, tired, achy, chills in the middle of the night, feeling achy the next day for the whole day, symptoms of feeling Sick with dry cough (cold feeling in chest) which continued the rest of the week, as well as being tired, also head pain on left side of head that lasted the whole day upon waking and went away the following day.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Pain
Clinical narrative: Began about 5 hrs after injection, tired, achy, chills in the middle of the night, feeling achy the next day for the whole day, symptoms of feeling Sick with dry cough (cold feeling in chest) which continued the rest of the week, as well as being tired, also head pain on left side of head that lasted the whole day upon waking and went away the following day.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Additional Details: Patient walked into the pharmacy on 10/30 to ask if she had recieved a bad dose of the moderna bivalent shot. Patient showed the arm to the pharmacist and the arm injection site was black and blue very bruised. Patient reported getting 2 shots in same arm the FLUAD and Moderna Bivalent shot. Patient reported arm hurting 2 days later and then realizing that it was bruised. Counseled patient on treatment and recommened urgent care or ER visit if bruise persists. Immunizer: staff
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Rash, Rash pruritic, Sleep disorder
Clinical narrative: Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: pt reported severe itching rash that gets worse at night but goes away in am-Severe, Additional Details: pt said rash itching all over body in patches got worse about a week after shot. he felt due to covid shot. he took benadryl which helped sleep but very bad at night goes away in am and then returns especially when he exercises. i told him to contact md. itching feels like coming from inside not on skin tried hydrocortisone does not help told to reach out to md and we would report it
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Immunisation reaction, Raynaud's phenomenon
Clinical narrative: Started with COVID toe and moved into  Raynauds  syndrome
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Manager and I went together to look at our AVP stock as patient is uninsured.  I thought I grabbed the adult AVP one and didn't realize that we had pediatric ones.  Patient was given first dose of Hep A by me on 10/20/2022.  Patient was notified as well as the provider of this incident.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Flatulence, Hepatic cyst, Hepatic steatosis, Kidney fibrosis, Splenomegaly
Clinical narrative: Document Type: US Abdomen Complete Document Subject: US Abdomen Complete Performed By: MD on August 31, 2022 09:56 EDT Verified By: MD on August 31, 2022 10:16 EDT Encounter Info: Hospital, Outpatient, 08/31/22 - 08/31/22  * Final Report *  Reason For Exam screen for splenomegaly  Report EXAMINATION:  US Abdomen Complete  DATE:  08/31/2022 09:56  CLINICAL HISTORY: Abnormal labs.  COMPARISON: 8/25/2008 and 3/4/2008.  DISCUSSION: The pancreas is obscured by overlying bowel gas. The liver is heterogeneously hyperechoic suggesting diffuse fatty infiltration. Small hypoechoic structures in the left lobe appear to represent small cysts. There is focal sparing adjacent to the gallbladder fossa. The gallbladder has a normal appearance without evidence of intraluminal filling defect, wall thickening or pericholecystic fluid. The common bile duct is within normal limits at 0.2 cm diameter. The spleen is enlarged with a length of 16.3 cm. The right and left kidneys measure 12.5 and 10.5 cm in length, respectively. There is cortical scarring in the left kidney. The right kidney has a normal appearance. The abdominal aorta and inferior vena cava are obscured by overlying bowel gas.  IMPRESSION:  Nonvisualization of the pancreas, abdominal aorta and inferior vena cava due to overlying bowel gas.  Diffuse fatty infiltration of the liver. There are small cysts in the left hepatic lobe.  Mild splenomegaly.  Chronic cortical scarring of the left kidney.  Normal appearance of the gallbladder and common bile duct.  Electronically Signed by:  Dictated on: 8/31/2022 10:10 AM    Signature Line This examination and reported findings have been reviewed and confirmed by the undersigned.   Read By:  MD   I authorize my name to be Electronically affixed by using my unique signature access code.   Click VIEW IMAGE icon to Display Image This document has an image
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Document Type: US Abdomen Complete Document Subject: US Abdomen Complete Performed By: MD on August 31, 2022 09:56 EDT Verified By: MD on August 31, 2022 10:16 EDT Encounter Info: Hospital, Outpatient, 08/31/22 - 08/31/22  * Final Report *  Reason For Exam screen for splenomegaly  Report EXAMINATION:  US Abdomen Complete  DATE:  08/31/2022 09:56  CLINICAL HISTORY: Abnormal labs.  COMPARISON: 8/25/2008 and 3/4/2008.  DISCUSSION: The pancreas is obscured by overlying bowel gas. The liver is heterogeneously hyperechoic suggesting diffuse fatty infiltration. Small hypoechoic structures in the left lobe appear to represent small cysts. There is focal sparing adjacent to the gallbladder fossa. The gallbladder has a normal appearance without evidence of intraluminal filling defect, wall thickening or pericholecystic fluid. The common bile duct is within normal limits at 0.2 cm diameter. The spleen is enlarged with a length of 16.3 cm. The right and left kidneys measure 12.5 and 10.5 cm in length, respectively. There is cortical scarring in the left kidney. The right kidney has a normal appearance. The abdominal aorta and inferior vena cava are obscured by overlying bowel gas.  IMPRESSION:  Nonvisualization of the pancreas, abdominal aorta and inferior vena cava due to overlying bowel gas.  Diffuse fatty infiltration of the liver. There are small cysts in the left hepatic lobe.  Mild splenomegaly.  Chronic cortical scarring of the left kidney.  Normal appearance of the gallbladder and common bile duct.  Electronically Signed by:  Dictated on: 8/31/2022 10:10 AM    Signature Line This examination and reported findings have been reviewed and confirmed by the undersigned.   Read By:  MD   I authorize my name to be Electronically affixed by using my unique signature access code.   Click VIEW IMAGE icon to Display Image This document has an image
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave adult dose of Hep A instead of pediatric dose. No signs or symptoms at this time.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal disorder, Pain in extremity
Clinical narrative: 2 days after vaccine, right arm more sore than normal, progressively getting worse each day. Now has decreased ROM and increased pain. Basically unable to use right arm.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea
Clinical narrative: Hospitalization for shortness of breath from COVID-19 on dates 8/31/22- 9/6/22.  Treated with dexamethasone, baricitinib, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Eye pruritus, Nasal congestion, Pain
Clinical narrative: I did not have a reaction to the vaccine. I started having symptoms on 12/13/2021 of a runny nose with a cough. On 12/15/2021, I tested positive for COVID-19. I had terrible sinus pressure, stuffy nose, feeling achy all over and a fever. I tried various over the counter medications to help relieve my symptoms. I was sick for about two weeks. Prior to the vaccines and having COVID-19, I never had allergies. I noticed in January or February 2022, I started having random runny nose, sneezing and itchy eyes. On 06/06/2022 I started having symptoms again of a runny nose with a cough. I tested positive for COVID-19 on 06/07/2022. I went to see my doctor to confirm the diagnosis with a PCR test. I was not prescribed anything but advised to take over the counter medication.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I did not have a reaction to the vaccine. I started having symptoms on 12/13/2021 of a runny nose with a cough. On 12/15/2021, I tested positive for COVID-19. I had terrible sinus pressure, stuffy nose, feeling achy all over and a fever. I tried various over the counter medications to help relieve my symptoms. I was sick for about two weeks. Prior to the vaccines and having COVID-19, I never had allergies. I noticed in January or February 2022, I started having random runny nose, sneezing and itchy eyes. On 06/06/2022 I started having symptoms again of a runny nose with a cough. I tested positive for COVID-19 on 06/07/2022. I went to see my doctor to confirm the diagnosis with a PCR test. I was not prescribed anything but advised to take over the counter medication.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: 09/08/22 presents to ED for "altered mental status". PMHx of "paroxysmal A. fib, coronary artery disease, hypertension, hyperlipidemia, pulmonary hypertension"