chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Blood pressure increased, COVID-19, Chills, Cough
Clinical narrative: trouble talking; reaction to the fluzone high dose quadrivalent vaccine; started getting cold; shivering; shaking and trembling; was jerking; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who was administered influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent] and experienced reaction to the fluzone high dose quadrivalent vaccine.  The patient's past medical history included Vaccination adverse reaction (Immunisation reaction), Feverish (Pyrexia), COVID-19, Cough, Fatigue and brain fog (Depressed level of consciousness). At the time of the event, the patient had ongoing Anxiety. The patient's past medical treatment included MUCINEX and the patient's past vaccination(s) included COVID-19 Vaccine. The patient's past family history was not provided.  Concomitant medications included clonazepam (klonopin) for Anxiety.  On 04-Oct-2022, the patient received 0.7 ml dose once of suspect influenza quadrival a-b high dose hv vaccine (strength; lot number; expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 04-Oct-2022 the patient experienced reaction to the fluzone high dose quadrivalent vaccine (immunisation reaction), started getting cold (feeling cold), shivering (chills), shaking and trembling (tremor), was jerking (dyskinesia) and (speech disorder) (latency: same day) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported that the patient states that she was not having any itching or rash, any trouble breathing or swallowing, but her pharmacy stated that she should go to the ER.   Relevant laboratory test results included: Blood pressure measurement - On 04-Oct-2022: 175/115 UNK [blood pressure was 175/115 which is high for her] then 140/90 UNK [She states that the tremors stopped approximately 15 minutes later and her blood pressure was down to 140/90]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Depressed level of consciousness, Dyskinesia, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: trouble talking; reaction to the fluzone high dose quadrivalent vaccine; started getting cold; shivering; shaking and trembling; was jerking; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who was administered influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent] and experienced reaction to the fluzone high dose quadrivalent vaccine.  The patient's past medical history included Vaccination adverse reaction (Immunisation reaction), Feverish (Pyrexia), COVID-19, Cough, Fatigue and brain fog (Depressed level of consciousness). At the time of the event, the patient had ongoing Anxiety. The patient's past medical treatment included MUCINEX and the patient's past vaccination(s) included COVID-19 Vaccine. The patient's past family history was not provided.  Concomitant medications included clonazepam (klonopin) for Anxiety.  On 04-Oct-2022, the patient received 0.7 ml dose once of suspect influenza quadrival a-b high dose hv vaccine (strength; lot number; expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 04-Oct-2022 the patient experienced reaction to the fluzone high dose quadrivalent vaccine (immunisation reaction), started getting cold (feeling cold), shivering (chills), shaking and trembling (tremor), was jerking (dyskinesia) and (speech disorder) (latency: same day) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported that the patient states that she was not having any itching or rash, any trouble breathing or swallowing, but her pharmacy stated that she should go to the ER.   Relevant laboratory test results included: Blood pressure measurement - On 04-Oct-2022: 175/115 UNK [blood pressure was 175/115 which is high for her] then 140/90 UNK [She states that the tremors stopped approximately 15 minutes later and her blood pressure was down to 140/90]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Speech disorder, Tremor
Clinical narrative: trouble talking; reaction to the fluzone high dose quadrivalent vaccine; started getting cold; shivering; shaking and trembling; was jerking; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who was administered influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent] and experienced reaction to the fluzone high dose quadrivalent vaccine.  The patient's past medical history included Vaccination adverse reaction (Immunisation reaction), Feverish (Pyrexia), COVID-19, Cough, Fatigue and brain fog (Depressed level of consciousness). At the time of the event, the patient had ongoing Anxiety. The patient's past medical treatment included MUCINEX and the patient's past vaccination(s) included COVID-19 Vaccine. The patient's past family history was not provided.  Concomitant medications included clonazepam (klonopin) for Anxiety.  On 04-Oct-2022, the patient received 0.7 ml dose once of suspect influenza quadrival a-b high dose hv vaccine (strength; lot number; expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 04-Oct-2022 the patient experienced reaction to the fluzone high dose quadrivalent vaccine (immunisation reaction), started getting cold (feeling cold), shivering (chills), shaking and trembling (tremor), was jerking (dyskinesia) and (speech disorder) (latency: same day) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported that the patient states that she was not having any itching or rash, any trouble breathing or swallowing, but her pharmacy stated that she should go to the ER.   Relevant laboratory test results included: Blood pressure measurement - On 04-Oct-2022: 175/115 UNK [blood pressure was 175/115 which is high for her] then 140/90 UNK [She states that the tremors stopped approximately 15 minutes later and her blood pressure was down to 140/90]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patients taking fluzone high-dose quadrivalent under age 65 years old with no reported adverse event; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old male patient and reporter reported that patients taking Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] under age 65 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received a total dose of suspect Influenza quadrival A-B high dose HV vaccine 0.7 ml (with unknown strength, from, batch number, expiration date) via intramuscular route in Left Deltoid for immunization under age 65 years old with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Information on the batch number was requested.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (patients taking fluzone high-dose quadrivalent under age 65 years old with no reported adverse event).  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: 0.33
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: administered the liquid portion of the PENTACEL to a patient and reconstitute the Hib portion with sterile water and administer to a patient as well with no reported adverse event; administered the liquid portion of the PENTACEL to a patient and reconstitute the Hib portion with sterile water and administer to a patient as well with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 4-month-old male patient to whom administered the liquid portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] to a patient and reconstitute the hib portion with sterile water and administer to a patient as well and administered the liquid portion of the pentacel to a patient and reconstitute the hib portion with sterile water and administer to a patient as well 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 PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 07-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (strength: standard) (lot number: UJ598AAA expiry date: 05-Dec-2022) via intramuscular route in the left thigh (leg) for Immunization and on the same day, administered the liquid portion of the pentacel to a patient and reconstitute the hib portion with sterile water and administer to a patient as well with no reported adverse event (product preparation error) (single component of a two-component product administered).  Reportedly, Pharmacy director wants to know if the doses are valid. This is reported as potential AE because of use against local labelling.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for both 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: 0.5
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient received IPOL from a punctured vial after it was exposed to a temperature excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 07-Oct-2022. Agency number: 01312677.  This case involves a 6-month-old female patient received IPV (VERO) [IPOL] from a punctured vial after it was exposed to a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA416564, 2022SA416822, 2022SA418179, 2022SA419029 and 2022SA417858.   The temperature excursion situation occurred due to fridge malfunction Max/Low Temperature reached 16.6C, 8.9C, +9.6C, +8.6C, +12.8C for 1st excursion 6 HOURS and 17 MINUTES 2nd excursion 23 MINUTES 3rd excursion 15 MINUTES 4th excursion 8 MINUTES 5th excursion 6HOURS and 16 MINUTES. Human error was not involved.  On 12-Sep-2022, the patient received punctured vial suspect IPOL suspension for injection from a at dose 0.5 ml (lot V1B901M; Expiration Date :22-Jun-2024) via unknown route in unknown administration site for immunization post temperature excursion with no reported adverse event (poor quality product administered) (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.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally received two doses of IPOL with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 5-year-old male patient who accidentally received two doses of IPV (VERO) [IPOL] 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On 07-Oct-2022, the patient received 1ml total dose of suspect IPV (VERO) injection (strength: standard) (lot number: V1A121M and expiry date: 15-Feb-2024), in the upper arm laterality for Immunization and on the same day patient accidentally received two doses of ipol with no reported adverse event (extra dose administered).  It was reported, Physician requesting any available information regarding guidance or safety related concerns. This situation is reported as a medication error due to accidental administration of 2 IPOL doses to the patient on the same day. The initial administration on 07OCT2022 was the 4th dose in the series. No concerns or symptoms noted prior to the patient leaving the clinic.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) 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: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired menactra to a patient with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 17 years old male patient who was administered an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 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 was administered expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at dose of 0.5mL, once (lot number not reported) with no reported adverse event (expired product administered) (unknown latency) via unknown route in unknown administration site for immunization.  First time product used : No Still using product : No  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired menactra to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Incorrect product formulation administered, No adverse event, Product storage error
Clinical narrative: accidentally received last year's expired dose of fluzone high dose with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA417918(Cluster) and 2022SA420369(Cluster).  This case involves an unknown age female patient who accidentally received last year's expired dose of fluzone high dose with no reported adverse event. (Influenza quadrival A-B high dose HV vaccine) [Fluzone high-dose quadrivalent.  The patient's past medical history, medical treatment(s) and family history were not provided.   On 06-Oct-2022, the patient accidentally received last year's expired dose of influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (0.7 ml 1X)(lot number: UJ748AA; expiry date : 30-Jun-2022: strength, formulation unknown) via unknown route in left deltoid for immunization, with no reported adverse event (expired product administered)(latency : same day).  It was reported Pharmacist reporting that 3 patients accidentally received last year's expired dose of FLUZONE HIGH DOSE and requesting revaccination recommendations regarding dosing and timing of administration. A nurse practitioner (same as prescriber) accidentally administered 3 expired FLUZONE HIGH DOSE vaccines from the previous year on 06OCT2022. The pharmacist identified the administration of expired products today, 10OCT2022, stating that she did not know "why last year's formulation was in the fridge." Pharmacist inquired what the recommendations are for the timing and need for revaccination with current FLUZONE HIGH DOSE QIV. SRDs emailed to requestor. Pharmacist denied any untoward effects from the administration of the expired vaccines at this time and advised that the patients would be revaccinated with current FLUZONE HIGH DOSE QIV    Action taken with 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 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: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: inadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who was inadvertently given expired product with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a  dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength: unknown) lot UT7378MA, expiration date: 30-Jun-2022 via intramuscular route in the thigh nos (not other wise specified) (vastus lateralis) as Immunization  On 07-OCT-2022 the patient was inadvertently given expired product with no reported adverse event (expired product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently given expired product 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: 12.0
Sex: M
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK Quad was accidentally given to 2 patients under the age of 18 with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2022SA419831(CLUSTER).  This case involves a 12 years old male patient to whom influenza quadrivalent recombinant vaccine [flublok] was accidentally given under the age of 18 with no reported adverse event.   On 10-Oct-2022, the patient under the age of 18 received a 0.5 ml (once) dose of suspect influenza quadrivalent recombinant vaccine with no reported adverse event (product administered to patient of inappropriate age) (lot UJ 887AA) via intramuscular route in the left deltoid for immunization. (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.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: FLUZONE PFS, that were expired was administered to 19 patients; Initial information was received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case US-SA-2022SA417187(CLUSTER).  This case involves a 3 years old male patient and reporter reported Influenza quadrival A-B vaccine [Fluzone QIV] that were expired was administered to 19 patients.  No other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 07-Oct-2022, the patient received a total dose of suspect Influenza quadrival A-B vaccine suspension for injection 0.5 ml (lot UT7378MA, expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for immunization which was expired (expired product administered) (latency: same day).  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: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: inadvertently given expired product with no adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious received from a other health professional.  This case involves a 2 years old male patient who was given an expired influenza quadrival a-b vaccine [fluzone qiv] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, (latency: same day) the patient inadvertently received a 0.5 ml (once) dose of expired influenza quadrival a-b vaccine with no adverse event (expired product administered) (lot UT7378MA, expiry date: 30-Jun-2022) via intramuscular route in the left vastus lateralis for immunization.  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: 0.58
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC
Symptoms: Expired product administered
Clinical narrative: fluzone pfs, that were expired was administered,with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case is linked to cases 2022SA417187(CLUSTER) and 2022SA418817(CLUSTER).  This case involves a 7 months old male patient who whom expired Influenza Quadrival  A-B Vaccine [Fluzone QIV] was administered 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 Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar); Hepatitis A Vaccine (Hepatitis A) and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Immunisation.  On 07-Oct-2022, the patient received 0.5 ml of expired Influenza Quadrival  A-B Vaccine with no reported adverse event (expired product administered) (lot UT7378MA and expiry date- 30-Jun-2022) via intramuscular route in unknown administration site for immunization or TB test.  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: 9.0
Sex: M
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok being administered to pediatric patients with no reported adverse event; Initial information received  on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health care professional.  This case is linked to cases 2022SA420021, 2022SA419213, 2022SA418226, 2022SA419186 and 2022SA420094.  This case involves a 9 years old male patient and health professional reported flublok being administered to pediatric patients with no reported adverse event. (Influenza quadrivalent recombinant vaccine) [Flublok]   The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 10-Oct-2022, the pediatric patient received a 0.5 ml dose of suspect Influenza quadrivalent recombinant vaccine (with unknown strength and formulation) (lot: QFAA223, expiration date: 30-Jun-2023) via intramuscular route in the left deltoid for Influenza Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  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: 5.0
Sex: F
Vaccine: FLUR3
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok being administered to pediatric patients with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA418226(CLUSTER), 2022SA419186(CLUSTER), 2022SA420094(CLUSTER), 2022SA420021(CLUSTER) and 2022SA420025(CLUSTER).  This case involves a 5 years old female patient who was being administered influenza quadrivalent recombinant vaccine [flublok] to pediatric patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2022, the pediatric patient received a 0.5 ml (once) dose of suspect influenza quadrivalent recombinant vaccine (lot QFAA223, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for influenza with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flublok being administered to pediatric patients with no reported adverse event).  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: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: pharmacist gave an expired fluzone high dose quadrivalent on Saturday, with no reported adverse event; Initial information was received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 75 years old male patient who administered an expired Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] on saturday, with no reported adverse event.  No other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 08-Oct-2022, the patient received a dose of expired vaccine Influenza quadrival A-B high dose HV 0.7 ml (lot UJ7048A, expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (latency: same day).  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: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Abdominal pain upper, Chest discomfort, Dyspnoea, Feeding disorder
Clinical narrative: Patient described event as happening early in the morning with stomach cramps and chest tightness. Patient described he could not breath after walking a short distance. Patient described he stayed in bed most of the day until symptoms subsided but was not able to eat anything while resting due to stomach discomfort and general unwellness.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Malaise
Clinical narrative: Patient described event as happening early in the morning with stomach cramps and chest tightness. Patient described he could not breath after walking a short distance. Patient described he stayed in bed most of the day until symptoms subsided but was not able to eat anything while resting due to stomach discomfort and general unwellness.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given on 10/10/22 and the vaccine unknowingly expired on 9/30/22.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given on 10/10/22 and was unknowingly expired on 9/30/22
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given on 10/3/22 and unknowingly expired on 9/30/22.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills fever body aches
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Wrong product administered
Clinical narrative: Patient given vaccine dose that was expired on 9/30/22 and was incorrect vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Magnetic resonance imaging normal, Tinnitus
Clinical narrative: Tinnitus right ear. Whooshing sound
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Rapid onset ascending muscle weakness in legs, tingling, numbness presumed to be Guillain Barre by physician and neurologist
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Breath odour, Burning sensation
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cognitive disorder, Condition aggravated, Contusion, Cough
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Crohn's disease, Decreased appetite, Depression, Disorientation, Dizziness
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Dyspnoea, Ecchymosis, Fatigue, Feeling abnormal
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling cold, Gastrointestinal pain, General symptom, Haematuria, Headache
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Insomnia, Joint swelling, Malaise, Memory impairment
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Myalgia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parosmia, Peripheral swelling, Sleep apnoea syndrome, Taste disorder, Upper respiratory tract infection
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Visual impairment, Weight decreased
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Anxiety, Arthralgia, Breath odour
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Chills, Cognitive disorder, Contusion, Cough
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Dyspnoea exertional, Ecchymosis, Fatigue, Feeling abnormal
Clinical narrative: Ecchymosis/bruising Swelling and pain in left leg/ankle Cough Malaise Fatigue Chrones flare: GI/Head/Pain Shortness of breath can?t exert self physically  brain fog Headache Disorientation Dizziness/Vertigo brain fog/worsening memory loss of appetite  chills/cold all the time weight loss Kaleidoscope vision Ecchymosis Swollen left leg/ankle Achy/painful joints and muscles Depression/Anxiety Sleep apnea worsening Insomnia loss/change taste smell metallic taste and smell on breath Phantom smells- ammonia, gas, sweet smells Burning/tingling sensations Stronger headaches/migraines Hematuria Chrohns symptom flares Allergy symptoms uncontrolled/increased Upper respiratory infection Memory and cognitive issues Uncontrolled hypertension (with medication) Low and High peeks Neuropathy