chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: FLUZONE QUADRIVALENT was given to 2 months old patient/ no adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from other healthcare professional and non-healthcare professional via Media information (under the reference 00859792).  This case involves a 2 months old male patient (date of birth: 15-SEP-2021) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 15-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (total, solution for injection in pre-filled syringe, lot number: UJ775AA and expiry date: 30-JUN-2022) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration (same day).  It was reported "The Fluzone Quadrivalent was given to the wrong patient, it was supposed to be given to his sibling."   At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported 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: 14.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: The patient received partial dose of vaccine with no adverse event; some if not all of the vaccine came out of the side of the syringe with no adverse event; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from other health professional, consumer/ non health care professional and physician (under reference 00860005).  This case involves a 14 years old male patient who received partial dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (underdose), due to the needle was not tightly secured to the prefilled syringe and when they went to administer the vaccine, some if not all of the vaccine came out of the side of the syringe (syringe issue).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.   On 13-Nov-2021, the patient received a partial dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Total, lot UJ775AA and expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose and syringe leak (same day latency).  It was reported "Caller stated that they believe the needle was not tightly secured to the prefilled syringe and when they went to administer the vaccine, some if not all of the vaccine came out of the side of the syringe. Caller asking if patient should receive another dose and if so, what time frame would they need to give dose in. A clinic reporting a medication error for FLUZONE QUADRIVALENT 0.5 mL prefilled syringe described as the vaccine squirting out the side between the needle attachment and the syringe tipe. The caller reported that it was hard to tell if the consumer received any of the dose and that the needle attached was a 25G X 1 inch needle."  The clear location of the leakage was under the Luer-Lok adaptor, out of the vial stopper puncture mark.   There were no signs of damage or tampering with the vial, stopper, flip seal and carton.  At time of reporting, no adverse event reported.
Age: 32.0
Sex: M
Vaccine: TD, TDAP
Symptoms: Wrong product administered
Clinical narrative: received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines with no reported adverse event; received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines with no reported adverse event; Initial information was received on 16-Nov-2021 regarding an unsolicited valid  non-serious case from a other health professional via Agency (under reference:00860371).  This case involves a 32-year-old male patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and not the prescribed DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] due to the staff member getting confused on the labeling between the two vaccines (product label confusion, wrong product administered)  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 15-Nov-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (0.5mL, lot U6603AA, expiry date: 05-Mar-2022) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered).   It was an actual case of medication error due to product label confusion and wrong vaccine administered (same day latency)  It was reported "A clinic reporting a medication error described as a 32-year-old male received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines. The caller did not report a defect with the products but that the clinic was confused and chose the wrong product."  At time of reporting, no adverse event was reported.  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.  There will be no information available on the lot number for ADACEL  this case.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction; hives throughout his face, trunk, legs, and top of feet; Erythema throughout his face, trunk, legs, and top of feet; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Global Medical Information (Reference number- 00862288) and transmitted to Sanofi on 17-Nov-2021.  This case involves a 32 year old male patient who had allergic reaction (hypersensitivity) with associated symptoms hives throughout his face, trunk, legs, and top of feet (urticaria) and erythema throughout his face, trunk, legs, and top of feet (erythema) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no concomitant vaccination.   On 02-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7006NA and expiry: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 02-Oct-2020 the patient developed a non-serious allergic reaction (hypersensitivity) with associated symptoms hives throughout his face, trunk, legs, and top of feet (urticaria) and erythema throughout his face, trunk, legs, and top of feet (erythema) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Caller states that he had an allergic reaction to the FLUZONE QIV vaccine when he received it on 02-Oct-2020. The symptoms included hives and erythema throughout his face, trunk, legs, and top of feet. The symptoms persisted for 1 week. Caller wanted to know if there was any information available regarding changes made to the FLUZONE QIV vaccine from the 2020 season to the 2021 season so that he could possibly identify what he was allergic to. Caller asked for information on the product composition of FLUZONE QIV from 2019. Caller states that he does not have egg or protein allergies and asked what additional information was available regarding FLUZONE QIV and other types of allergies."  No laboratory data was reported.  The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Hypersensitivity.  On an unknown date, the patient had recovered from the event.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation error, Product preparation issue
Clinical narrative: received only the HIB powder portion of PENTACEL with no reported adverse event; PENTACEL that was diluted with normal saline with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00862445).  This case is linked to case 2021SA388591(CLUSTER).  This case involves a 4 months old male patient (date of birth: 9-JUL-2021) who received only the haemophilus influenzae type b (HIB) powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue) and that was diluted with normal saline (product preparation error).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 16-Nov-2021, the patient received a (second, 0.7 ml) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once, lot number: UJ580AAA and expiry date: 10-SEP-2022) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique and wrong solution used in drug reconstitution (same day).  It was reported "Caller asked if this would count as a valid ACTHIB dose for these patients or if they required re-vaccination with PENTACEL. Caller asked if the Safety department would attempt to contact the patients prior to the doctors in the practice having the opportunity to address the situation with the patients' families. Caller asked for information regarding the HIB portion of PENTACEL not counting as a valid dose if administered with any diluent other than 0.4% NaCl saline solution. Caller states that the diluent used on the two patients were from vials containing 0.7 ml normal saline."  Caller states that after checking the refrigerator to see how many doses of the DTAP-IPV liquid portion of PENTACEL and HIB powder portion of PENTACEL were remaining, it was determined that two patients on 16NOV2021 received only the HIB powder portion of PENTACEL that was diluted with normal saline by a nurse in the facility.   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 by the regulatory authorities. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: received only the HIB powder portion of PENTACEL, with no reported adverse event; PENTACEL that was diluted with normal saline, with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via Global Medical Information (GMI) (Reference number- 00862514).  This case is linked to case 2021SA388584 (CLUSTER).  This case involves a 1 years old male patient (date of birth: 15-AUG-2020) who received only the haemophilus influenzae type b (HIB) powder portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product preparation issue) and that was diluted with normal saline (product preparation error).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  On 16-Nov-2021, the patient received a (fourth, 0.7 ml) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once, total, lot number: UJ580AAA and expiry date: 10-SEP-2022) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique and wrong solution used in drug reconstitution (same day).  It was reported "Caller states that after checking the refrigerator to see how many doses of the DTAP-IPV liquid portion of PENTACEL and HIB powder portion of PENTACEL were remaining, it was determined that two patients on 16NOV2021 received only the HIB powder portion of PENTACEL that was diluted with normal saline by a nurse in the facility. Caller asked if this would count as a valid ACTHIB dose for these patients or if they required re-vaccination with PENTACEL. Caller asked if the Safety department would attempt to contact the patients prior to the doctors in the practice having the opportunity to address the situation with the patients' families. Caller asked for information regarding the HIB portion of PENTACEL not counting as a valid dose if administered with any diluent other than 0.4 percent NaCl saline solution."  At the time of reporting, no adverse event reported.   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 by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: reconstituted ACTHIB with sterile water and administered to a patient with no reported adverse event; Initial information received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone via the Agency (Reference number- 00862748).  This case involves a patient of (unknown demographics) who received reconstituted HIB (PRP/T) VACCINE [ACT-HIB] with sterile water and administered to a patient (product preparation error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (once, total, lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution (same day).  It was reported "Caller states that someone in the office reconstituted ACTHIB with sterile water and administered to a patient. Caller is not in the office currently and does not have any event, patient, or product information."  At the time of reporting, no adverse event reported.  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.  There will be no information on batch number for this case.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient recieved vaccine  FLUZONE QUADRIVALENT but she already received the "flu mist with no adverse event; Initial information was received on 17-Nov-2021 regarding an unsolicited valid non-serious case received from a other health professional and non-healthcare professional via Medical information (MI) under reference number - 00862943).  This case involves a 2-year-old female patient who received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] but she already received dose of flu mist (extra dose administered).  The patient's past medical treatments, concomitant medication and family history were not provided.  Concomitant medications included INFLUENZA VACCINE LIVE REASSORT 3V (FLUMIST) for prophylactic vaccination.  On 17-Nov-2021, the patient received a 0.5ml {total} dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UJ776AA and expiry date 30-Jun-2022 was reported) via intramuscular route at an unknown administration site for prophylactic vaccination (it was also reported as left leg).   It was case of actual medication error due to extra dose administered (latency was on same day).   At the time of report, no adverse event was reported.  There were no laboratory data/results available.  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: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccine was exposed to 31 degrees Fahrenheit for a couple of days/ no AE; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Global Media Information (under reference- 00864089) and transmitted to Sanofi on 18-Nov-2021.  This case is linked to cases 2021SA389706, 2021SA392839 and 2021SA392842(CLUSTER).  This case involves a 67-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 12-Nov-2021, the patient received 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ764AC and expiry date 30-Jun-2022] via intramuscular route in left arm for prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event was reported.  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: Medication error, No adverse event, Product storage error
Clinical narrative: vacccine exposed to temperatures 31 degrees Fahrenheit for a couple of days with no A/E; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (under reference- 00864179) and transmitted to Sanofi on 18-Nov-2021.  This case is linked to cases 2021SA389706, 2021SA392836 and 2021SA392842 (CLUSTER).  This case involves a 65 year old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.  On 13-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ764AC and expiry date: 30-Jun-2022) (frequency : once) via intramuscular route in the left arm in prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event was reported.   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: 76.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was exposed to 31 degrees Fahrenheit for a couple of days/ no AE; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist (under reference- 00864195) and transmitted to Sanofi on 18-Nov-2021.  This case is linked to cases 2021SA389706, 2021SA392839 and 2021SA392836 (CLUSTER).  This case involves a 76-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 12-Nov-2021, the patient received 0.7 mL (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ764AC and expiry date 30-Jun-2022] via intramuscular route in left arm for prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Medication error, Wrong product administered
Clinical narrative: A patient received PENTACEL instead of QUADRACEL no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00864409) and transmitted to Sanofi on 18-Nov-2021  This case involves a 4 year old patient (unknown gender) who was received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  It was a case of an actual medication error due to Wrong vaccine administered (latency same day).  It was reported "An medical assistant (MA) inadvertently gave a PENTACEL instead of a QUADRACEL to a 4 year old patient. What should they do? She requests that the information be e-mailed to her since she will be out for the rest of the week."  No other adverse event was reported.    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 by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: MNQ
Symptoms: Headache, Hypotension, Nausea, Tachycardia, Tremor
Clinical narrative: headache 10/10; Initial information received on 19-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via the Agency (under the reference 00865885).  This case was linked to case 2021SA392402(CLUSTER).  This case involves a 16-year-old female patient who experienced headache 10/10 (headache) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation.  On 18-Nov-2021, the patient received a 0.5 mL total dose of suspect MENACTRA (0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test-0.5 mL, frequency: once, lot U7208AA and expiration date: 10-FEB-2023) via intramuscular route in the left deltoid for prophylactic vaccination.   On 18-Nov-2021, the patient developed a non-serious headache 10/10 (headache) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported "A nurse is calling to report adverse reactions with two patients after they received the MENACTRA vaccine. Caller is wanting to know if the vaccine is safe to continue to use. Both patients were seen in the emergency room. The status of the first patient has only been reported so far from the emergency room. The first patient had a headache 10/10, body shakes, nausea and vomiting and tachycardia as well as hypotension. Patient was given IV fluids and released. The second patient report a headache 10/10 and no other information as been reported other than the patient went to the emergency room."  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event headache.
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: headache 10/10; Initial information received on 19-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via the Agency (under the reference 00865885).  This case was linked to case 2021SA392402(CLUSTER).  This case involves a 16-year-old female patient who experienced headache 10/10 (headache) after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation.  On 18-Nov-2021, the patient received a 0.5 mL total dose of suspect MENACTRA (0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test-0.5 mL, frequency: once, lot U7208AA and expiration date: 10-FEB-2023) via intramuscular route in the left deltoid for prophylactic vaccination.   On 18-Nov-2021, the patient developed a non-serious headache 10/10 (headache) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported "A nurse is calling to report adverse reactions with two patients after they received the MENACTRA vaccine. Caller is wanting to know if the vaccine is safe to continue to use. Both patients were seen in the emergency room. The status of the first patient has only been reported so far from the emergency room. The first patient had a headache 10/10, body shakes, nausea and vomiting and tachycardia as well as hypotension. Patient was given IV fluids and released. The second patient report a headache 10/10 and no other information as been reported other than the patient went to the emergency room."  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event headache.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired MENACTRA was administered to a patient with no AE; Initial information was received on 19-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via Global Medical Information (GMI) (under reference: 00866702).  This case involves a 13-year-old female patient who was administered expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 16-Nov-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (0.5mL, lot U6586BA, expiry date Apr-2021) via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency: same day).  It was reported "An expired MENACTRA was administered to a patient. Pharmacist wants to know what to do?"  At time of reporting, no adverse event was reported.  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 by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Body temperature, Decreased appetite, Extra dose administered, Fatigue, Pyrexia
Clinical narrative: The patient was vaccinated with FLUZONE HIGH DOSE QUADRIVALENT instead of COVID-19 VACCINE; The patient was vaccinated with FLUZONE HIGH DOSE QUADRIVALENT twice instead of COVID-19 VACCINE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Regulatory Authority (RA) (Reference number- 00868442) and transmitted on 22-Nov-2021. This case involves a 66-year-old female patient who had no appetite (decreased appetite), fever of 100.3 (pyrexia) and fatigue after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of Coronavirus disease (COVID-19) VACCINE (wrong product administered and extra dose administered) The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On 18-Nov-2021, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ7760C, expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination instead of booster dose of COVID-19 VACCINE. It was a case of an actual medication error due to extra dose administered and Wrong vaccine administered (latency same day) On 19-Nov-2021 the patient developed a non-serious no appetite (decreased appetite), fever of 100.3 (pyrexia) and fatigue 1 month 12 days following first dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and 1 day following last dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "The caller stated that a patient came into the office to receive a COVID Booster vaccine on 18 NOV 2021, however the patient was given the FLUZONE HIGH DOSE QUADRIVALENT injection in error. The caller stated that the patient has now received 2 doses of the flu shot, as she received a prior flu shot on 07 OCT 2021. The patient reported fatigue, fever of 100.3 and no appetite on 19 NOV 2021. The caller wants to know how to care for the patient. consumer who received two Fluzone HD. She asks for appropriate follow-up" No other relevant test was provided. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of clinical events 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. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: The patient was vaccinated with FLUZONE HIGH DOSE QUADRIVALENT instead of COVID-19 VACCINE; The patient was vaccinated with FLUZONE HIGH DOSE QUADRIVALENT twice instead of COVID-19 VACCINE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Regulatory Authority (RA) (Reference number- 00868442) and transmitted on 22-Nov-2021. This case involves a 66-year-old female patient who had no appetite (decreased appetite), fever of 100.3 (pyrexia) and fatigue after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of Coronavirus disease (COVID-19) VACCINE (wrong product administered and extra dose administered) The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On 18-Nov-2021, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ7760C, expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination instead of booster dose of COVID-19 VACCINE. It was a case of an actual medication error due to extra dose administered and Wrong vaccine administered (latency same day) On 19-Nov-2021 the patient developed a non-serious no appetite (decreased appetite), fever of 100.3 (pyrexia) and fatigue 1 month 12 days following first dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and 1 day following last dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "The caller stated that a patient came into the office to receive a COVID Booster vaccine on 18 NOV 2021, however the patient was given the FLUZONE HIGH DOSE QUADRIVALENT injection in error. The caller stated that the patient has now received 2 doses of the flu shot, as she received a prior flu shot on 07 OCT 2021. The patient reported fatigue, fever of 100.3 and no appetite on 19 NOV 2021. The caller wants to know how to care for the patient. consumer who received two Fluzone HD. She asks for appropriate follow-up" No other relevant test was provided. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of clinical events 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. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Palpitations, Rhinorrhoea, Tinnitus
Clinical narrative: Shortness of breath; Really bad runny nose; Cough; It was like a drum on back of ear drum; Racing in chest; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), RHINORRHOEA (Really bad runny nose), COUGH (Cough), TINNITUS (It was like a drum on back of ear drum) and PALPITATIONS (Racing in chest) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A, 003A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DYSPNOEA (Shortness of breath), RHINORRHOEA (Really bad runny nose), COUGH (Cough), TINNITUS (It was like a drum on back of ear drum) and PALPITATIONS (Racing in chest). On 21-Nov-2021, DYSPNOEA (Shortness of breath), RHINORRHOEA (Really bad runny nose), COUGH (Cough), TINNITUS (It was like a drum on back of ear drum) and PALPITATIONS (Racing in chest) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he had a bunch of concomitant medications which were not provided. Treatment information was not provided.  Patient stated that there was no cardiac history or diagnosis of Myocarditis/ Pericarditis until the day of report. And stated that the heartbeat slowed as of 21-Nov-2021 morning.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (I know other people who fainted after 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (I know other people who fainted after 2nd dose) (seriousness criterion medically significant). At the time of the report, SYNCOPE (I know other people who fainted after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment information was not provided by reporter. Company Comment : This spontaneous  case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of syncope. The event occurred  approximately 20 hours after the second dose of the Moderna COVID-19 vaccine. No further details regarding clinical course were provided. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant follow up received includes updated contact information and correspondence contact ticked for SO follow up.; Sender's Comments: This spontaneous  case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of syncope. The event occurred  approximately 20 hours after the second dose of the Moderna COVID-19 vaccine. No further details regarding clinical course were provided. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm [after first two doses]; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm [after first two doses]) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm [after first two doses]). At the time of the report, PAIN IN EXTREMITY (sore arm [after first two doses]) outcome was unknown.            No treatment medication was reported. No concomitant medication was reported.   This case was linked to MOD-2021-375273, MOD-2021-395806 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (same flu like symptoms but was not intense as after the 1st dose.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported.On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (same flu like symptoms but was not intense as after the 1st dose.). At the time of the report, INFLUENZA LIKE ILLNESS (same flu like symptoms but was not intense as after the 1st dose.) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medication was reported. The treatment information was unknown.This case was linked to MOD-2021-395698,  MOD-2021-395584 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Limb discomfort, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: she was so sick; like an airplane had crashed on me/The second one was really bad; could not take my pajamas off and could not take a shower; so sick I could not raise my arm; high fever at night; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (she was so sick), FEELING ABNORMAL (like an airplane had crashed on me/The second one was really bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take my pajamas off and could not take a shower), LIMB DISCOMFORT (so sick I could not raise my arm) and PYREXIA (high fever at night) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ILLNESS (she was so sick), FEELING ABNORMAL (like an airplane had crashed on me/The second one was really bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take my pajamas off and could not take a shower), LIMB DISCOMFORT (so sick I could not raise my arm) and PYREXIA (high fever at night). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. On 21-Feb-2021, ILLNESS (she was so sick), FEELING ABNORMAL (like an airplane had crashed on me/The second one was really bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take my pajamas off and could not take a shower) and LIMB DISCOMFORT (so sick I could not raise my arm) had resolved. At the time of the report, PYREXIA (high fever at night) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2021-395697, MOD-2021-395733 (Patient Link).