chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Feeling abnormal, Off label use
Clinical narrative: Does not feel really good [Feeling bad]; Prescribed, 18 breaths, inhaled, four times daily (QID) [Off label dosing]; Initial information was received on 15-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.This is a Courtesy case received from Therapeutics.  This case involves 79 years old male patient (73.5 kg) who experienced does not feel really good [feeling bad] and prescribed, 18 breaths, inhaled, four times daily (qid) [off label dosing] after receiving vaccine Influenza vaccine, COVID-19 Vaccine and Treprostinil sodium.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included Amlodipine for Product used for unknown indication.  On an unknown date, the patient received a  dose of suspect Influenza vaccine (produced by unknown manufacturer) (formulation, strength, dosage, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On 15-Dec-2020, the patient started taking Treprostinil Sodium formulation at a dose of 108 ug QID via inhalational route (lot - 2102219, Expiry date: 30-Nov-2023) for Pulmonary arterial hypertension.  On 11-Aug-2022, the patient started taking Covid-19 Vaccination (with an unknown formulation, strength, route, dosage, batch number, expired date) for COVID-19 immunization.  On 08-NOV-2022 the patient developed non-serious does not feel really good [feeling bad] (feeling abnormal) and prescribed, 18 breaths, inhaled, four times daily (qid) [off label dosing] (off label use) 2 months 28 days following the first dose intake of Covid-19 vaccine and 1 year 10 months 24 days following the first dose intake of Treprostinil Sodium and (unknown latency) following the administration of  Influenza vaccine.  On 08-NOV-2022 the patient does not feel really good [feeling bad] (feeling abnormal)prescribed, 18 breaths, inhaled, four times daily (qid) [off label dosing] (off label use) (unknown latency) following the administration of Influenza Vaccine,2 months 28 days following the first dose intake of Covid-19 vaccine and 1 year 10 months 24 days following the first dose intake of Treprostinil Sodium.  Action taken : Not applicable for Covid-19 vaccine and Influenza vaccine for both events and unknown for Treprostinil sodium for feeling bad and not applicable for off label use.  It was not reported if the patient received a corrective treatment for the event (Does not feel really good [Feeling bad].  At time of reporting, the outcome was Unknown for both  the events.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got so sick a couple days later; Initial information received on 14-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got so sick a couple days later after receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation, route,lot number not reported) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event got so sick a couple days later (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (illness).  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got so sick afterwards; Initial information received on 15-Nov-2022 regarding an unsolicited valid Social -Media non-serious case from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got so sick afterwards after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine once (dose, lot number, expiry date, route, administration site, manufacturer: not reported) for Prophylactic vaccination.  On an unknown date the patient developed a non-serious got so sick afterwards (illness) (unknown latency) following the administration of influenza vaccine. The patient never had been so sick. Patient rarely got sick.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got so sick afterwards.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: been in the hospital with the flu; Initial information received from on 17-Nov-2022 regarding an unsolicited valid  serious case received from a patient.  This case involves a patient of unknown age and gender who had been in the hospital with the flu after receiving Influenza Vaccine .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, route, formulation, administration site, lot number and expiry date unknown) for Influenza immunization.  The patient reported that he had been in the hospital with the flu since Tuesday 3:00am (influenza) (latency: 1 month) following the administration of Influenza Vaccine.   Action taken: not applicable.  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.  Seriousness Criteria : Hospitalization for the event; Sender's Comments: Sanofi company comment dated 08-Nov-2022:  This case involves a patient of unknown age and gender who had been in the hospital with the flu after receiving vaccine Influenza Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick; Initial information was received on 17-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who got sick while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for influenza Immunization.  On an unknown date the patient had a non-serious event of sick (illness) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: got the shot and then got sick; Initial information received on 17-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who got the shot and then got sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient developed a non-serious event got the shot and then got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: Not applicable.  Corrective treatment: Not reported.  At time of reporting, the outcome was Unknown for the event got the shot and then got sick.
Sex: U
Vaccine: FLUX
Symptoms: Fatigue, Influenza
Clinical narrative: tired of getting the flu; tired of getting the flu; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case from a consumer/non-healthcare professional.  This case involves an unknown age/gender patient who experienced tired of getting the flu after being vaccinated with INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, route, formulation, lot number, expiry date, administration site: for prophylactic vaccination (Immunisation).  On an unknown date the patient developed non-serious events tired of getting the flu (fatigue) (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.  Outcome: Unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Felt aches for a day; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who reported that felt aches for a day after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Covid-19 Vaccine.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, dosage, expiry date, lot number not reported) via unknown route in unknown administration site in prophylactic vaccination(Immunization).  On an unknown date the patient developed non-serious event of felt aches for a day (pain) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (Felt aches for a day).  At time of reporting, the outcome was Unknown for the event felt aches for a day.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: was sick for weeks; Initial information received  on 17-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was sick for weeks after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was sick for weeks (illness) after receiving an unknown dose of suspect Influenza vaccine produced by unknown manufacturer, lot number not reported in unknown administration site for immunization with unknown form, strength, frequency, route, expiry date.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (was sick for weeks).  Outcome: Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: get sick around; Initial information was received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non healthcare professional.  This case involves a patient with unknown demographics who get sick around after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for Flu vaccination.  On an unknown date the patient get sick around (illness) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Sex: U
Vaccine: FLU3, MNQ, TDAP
Symptoms: Product dose omission issue
Clinical narrative: Pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from the patient's parent.  This case involves child of unknown gender patient whose parent reported that pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event, after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], meningococcal vaccine A/C/Y/W conj (Tet Tox) [Menquadfi], influenza quadrival A-B multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection (strength, dose, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for immunisation.  On an unknown date, the patient received a dose of suspect, meningococcal vaccine A/C/Y/W conj (Tet Tox) (strength, formulation, dose, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect influenza quadrival A-B multidose vaccine preserved suspension for injection (strength, dose, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient's parent reported non-serious event of, pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event (product dose omission issue) (latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine, meningococcal vaccine A/C/Y/W conj (Tet Tox), influenza quadrival A-B multidose vaccine preserved.  It was reported that, "Pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused. She asked how long these vaccines will be good for. Vaccines involved are; Menquadfi, Adacel and Fluzone QUADRIVELENT. MIS discussed and emailed stability SRD".  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: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Medication error, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: developed a fever of 103.9° FAHRENHEIT; weakness; FLUZONE HIGH-DOSE QUADRIVALENT was inadvertently given to a patient who was under the age of 65; Initial information was received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 54 years old female patient who developed fever of 103.9° fahrenheit, weakness and Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] was inadvertently given to a patient who was under the age of 65.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included: Bivalent COVID booster for Immunization.  On 09-Nov-2022, the suspect Influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UJ926AC, expiration date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization was inadvertently given to a patient who was under the age of 65 (product administered to patient of inappropriate age) (latency: same day).  On 09-Nov-2022 the patient developed fever of 103.9° fahrenheit (pyrexia) and weakness (asthenia) on the same day following the administration of Influenza quadrival A-B high dose HV vaccine.  Relevant laboratory test results included: Pyrexia - On 09-Nov-2022: 109 ° Fahrenheit.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for all the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Injection site pain, Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: a sore arm at injection site; FLUZONE HIGH DOSE QIV was inadvertently administered to a 14-year-old patient; FLUZONE HIGH DOSE QIV was inadvertently administered to a 14-year-old patient; Initial information was received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 14 years old female patient who experienced a sore arm at injection site and fluzone high dose qiv was inadvertently administered to a 14-year-old patient after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for Immunisation.  On 13-Nov-2022, the patient received 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation, strength)  (expiry date: 30-Jun-2023  frequency: once) (lot:UJ933AC) via intramuscular route in the right arm for Immunization.  On 13-Nov-2022 the patient had a non-serious event a sore arm at injection site (vaccination site pain), fluzone high dose qiv was inadvertently administered to a 14-year-old patient (accidental exposure to product) and (Product administered to patient of inappropriate age) (Latency: same day) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event a sore arm at injection site, was Unknown for the events fluzone high dose qiv was inadvertently administered to a 14-year-old patient.  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: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired TENIVAC today, with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 76 years old female patient who experienced patient received an expired tenivac today, with no reported adverse event after receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 14-Nov-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection dose 0.5 ml, lot U6852AA expiry date: 07-Oct-2022 via intramuscular route in unknown administration site for immunization (strength unknown).  On 14-Nov-2022 the patient received an expired tenivac today, with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event   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 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: 1.25
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: infant received their second Flu vaccine yesterday and administration was 25 days after their first Flu vaccine no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15 months old male patient who received their second influenza quadrival A-B vaccine [Fluzone QIV] yesterday and administration was 25 days after their first flu vaccine 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); and HIB vaccine (Haemophilus influenzae TYPE B).  On 14-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine once  with standard strength (form, lot number, expiry date: unknown)  via intramuscular route in the right deltoid for Immunization.  On 14-NOV-2022 the patient who received their second flu vaccine yesterday and administration was 25 days after their first flu vaccine no reported adverse event (inappropriate schedule of product administration) (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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: highest temperature it reached was 11.5C for a total duration out of range 1 hour and 15 minutes with no reported adverse event; open IPOL has been administered post excursion with no reported adverse event; Initial information received on 15-Nov-2022 regarding an unsolicited valid case received from a other health professional.  This case involves an unknown age and gender patient who was  administered IPOL vaccine whose highest temperature reached to 11.5 Celsius for a total duration out of 1 hour and 15 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of poliomyelitis vaccine (inactivated)IPV (VERO)( lot  no.-V1B891M )(Expiry date-01Jun-2024) (with unknown formulation, strength, dose, route and administration site)for immunization.  On an unknown date, highest temperature it reached was 11.5c for a total duration out of range 1 hour and 15 minutes with no reported adverse event (product storage error) and  open ipol has been administered post excursion (poor quality product administered) (unknown latency)  1 day following the administration of IPV (VERO).  It was also reported that The products unopened were: Adacel, Menquadfi, IPOL (open and closed). . Caller asking for stability information. Extended stability data covers unopened products with the exception of the open IPOL. Caller reporting a temperature excursion due to putting away a shipment received and the refrigerator door was open  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for all  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: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: have administered menquadfi to a patient 6 months earlier with no reported adverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who have been administered to meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] 6 months earlier with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and HPV vaccine, both for prophylactic vaccination.  On 15-Nov-2022, the patient was administered with dose 2 of meningococcal A-C-Y-W135 (T CONJ) vaccine of dose 0.5 milliliter (ml) with (lot: U7576AB & expiry date: 28-Feb-2025), 6 months earlier with no reported adverse event (inappropriate schedule of product administration) via intramuscular route in the right deltoid, (formulation, strength: unknown) for immunization.  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.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: that a nurse administered FLUZONE HIGH DOSE to a patient intravenously, with no reported adverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age and unknown gender who was administered influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] intravenously, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, formulation, batch number and expiry date: unknown) via intravenous route in unknown administration site for immunization (incorrect route of product administration) (latency: same day).   Lab tests were not reported.   Action taken: Not applicable.  At time of reporting, the outcome was unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Illness, Malaise, Muscular weakness, Tremor
Clinical narrative: sick; muscle weakness; tremors; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 71 years old male patient who had  muscle weakness, tremors and sick while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for Immunization.  On an unknown date the patient had  muscle weakness (muscular weakness), sick (illness) and tremors (tremor) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE..  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for the events; Sender's Comments:  US-SA-2022SA478968:
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site swelling
Clinical narrative: patient use to take FLUZONE HD QIV every year but her arm would swell up each time; Initial information received  on 18-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to case 2022SA477113(CLUSTER).  This case involves Adult female patient who used to take influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] every year but her arm would swell up each time.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Egg allergy.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine (with an unknown dose, strength, route) (lot number and expiry date: not reported) in unknown administration site for immunization, every year but her arm would swell up each time (vaccination site swelling) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: the person who took out the vaccine accidentally took out the FLUZONE HIGH DOSE QIV instead of the regular FLUZONE QIV with no adverse event; Initial information was received on 18-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 64 years old female patient who took out the vaccine accidentally took out the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] instead of the regular fluzone qiv with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE).  On 19-Oct-2022, the patient received 0.7 ml once dose of suspect influenza quadrival A-B high dose HV vaccine (lot number: UJ924AB, expiration date, formulation: unknown) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) instead of the regular fluzone qiv with no adverse event (wrong product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event the person who took out the vaccine accidentally took out the fluzone high dose qiv instead of the regular fluzone qiv with no 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.
Age: 71.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: Rash; Red blotches near the spine on the lower back, leg and also on the left shoulder/ Red spots as being "more like a blotch the size of a dime''; They are "itchy" although she tries not to scratch them; This spontaneous case was received on 10-Nov-2022 from healthcare professional (consumer-former nurse) via Communications (reference number: SEQW22-05776) and concerned a 71-year-old, female patient.  The patient's concurrent conditions included type 2 diabetes, hypertension, and hypercholesterolemia. The patient's concomitant medications included Atacand (candesartan cilexetil), metformin, hctz and pravastatin, all used for unreported indication.  On 08-Nov-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) for the prevention of influenza disease. The batch number was not reported.  On 09-Nov-2022, one day after receiving Flucelvax Quadrivalent the patient developed a rash, red blotches near the spine on the lower back, leg and on the left shoulder. The patient described the red spots as being "more like a blotch the size of a dime'' adding that they are ''itchy'' although she tries not to scratch them. The patient did not take any medication because of the event at hand. The patient has been drinking a lot of water to mitigate the reaction and monitoring the blotches to make sure nothing is spreading.  At the time of initial reporting the patient had not recovered from the events. It was reported that the reaction has yet to stop.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The events of rash, red blotches, and itchy rash are assessed as possibly related to Flucelvax Quadrivalent due to temporal relationship.; Sender's Comments: The events of rash, red blotches, and itchy rash are assessed as possibly related to Flucelvax Quadrivalent due to temporal relationship.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B antibody abnormal, Off label use
Clinical narrative: Hepatitis B antibody titers were low; Off-label use (5 year old); On 19-OCT-2022, a spontaneous report was received from a consumer regarding a 5-year-old female who was potentially administered PREHEVBRIO (hepatitis B vaccine, recombinant; unknown manufacturer of hepatitis B vaccine administered and PREHEVBRIO cannot be excluded).  Medical history and concomitant products were not reported. On an unspecified date, the patient started hepatitis B vaccine series, potentially, of PREHEVBRIO (unknown manufacturer) at an unknown dose, route, and frequency for an unreported indication.   On an unspecified date, after completing the hepatitis B vaccine series, the patient experienced low hepatitis B antibody titers and was subsequently administered a hepatitis B vaccine booster (unknown manufacturer [PREHEVBRIO cannot be excluded] and dose; off-label use due to age). The reporter queried if the patient contracted hepatitis B because she was not immune (her antibodies were low) or was it because she was possibly sexually assaulted and contracted it (hepatitis B) from an infected person. Additionally, the reporter did not know what manufacturer of hepatitis B vaccine the patient received as her primary series nor her booster; and they read information on hepatitis B on the CDC (Center for Disease Control) website and found it's (PREHEVBRIO) contact number on a hepatitis B website. As of 19-OCT-2022, the event outcomes of low hepatitis B antibody titers and off-label use were unknown. No additional information was provided and the reporter declined follow-up.; Sender's Comments: Company comment: A 5-year-old female completed the hepatitis B vaccine series. She had low hepatitis B antibody titers and received a hepatitis B vaccine booster (manufacturers unknown for both). The child's mother queried if the patient contracted hepatitis B because her antibodies were low or a possible sexual assault by an infected person. The outcomes of low hepatitis B antibody titers and off-label use were unknown. Based on the information provided, a causal relationship cannot be determined. As per product labeling, the safety and effectiveness of PREHEVBRIO have not been established in individuals less than 18 years of age.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Accidental underdose
Clinical narrative: administering it to a patient, some of it came out and patient didn't get the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 997A5, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The registered pharmacist called and requested information regarding revaccination with Fluarix QIV.  When administered it to a patient, some of it came out and patient did not received the full dose The reporter consent to follow-up. Additional Supportive information: When the patient received Fluarix Quadrivalent some of it came out and patient did not receive the full dose, which led to accidental underdose.
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Received Boostrix instead of Flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The medical assistant reported that a colleague received a dose of Boostrix instead of an unamed flu vaccine, and wished to know how to proceed, initials, and gender were given for the patient, but specific age was withheld.  The vaccine administration facility was the same as primary reporter The reporter consent to follow-up. Additional Supportive information: The patient received Boostrix instead of an unamed flu vaccine, which led to wrong vaccine administered. This case has been linked to the cases US2022168201 US2022168197, reported by the same reporter.; Sender's Comments:  US-GSK-US2022168201:Same reporter US-GSK-US2022168197:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Unspecified AE after 2nd dose of primary series; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unspecified AE after 2nd dose of primary series) in a male 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 IMMUNISATION REACTION (Unspecified AE after 2nd dose of primary series). The patient was treated with PREDNISONE at an unspecified dose and frequency and APPLE CIDER VINEGAR [MALUS SPP. VINEGAR EXTRACT] at a dose of apple cider vinegar and water 50:50 3 times a day. At the time of the report, IMMUNISATION REACTION (Unspecified AE after 2nd dose of primary series) had resolved.            No concomitant medications were reported. after 2nd dose he experienced an AE unspecified that lasted 4 months and visited a dermatologist that treated the symptoms with Prednisone and also patient treated himself with apple cider vinegar and water 50:50 3 times a day.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient's wife called morning of 11/20 (2 days after he received vaccines) stating her husband felt very dizzy to the point of extreme nausea and constant vomiting.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: patient started experience a sore arm day after the injection. Says this has progressivly got worse each day and there is a nodule at the injection site. States that she is not able to use her arm for normal activity due to pain.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain, Neuralgia, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: pt came in to tell us about rx- 2nd vaccine-hit nerve jumped(admitted didn't tell vaccinator) 1 hr later throbbing in are "like a heart beat"  very painful took tramdol not help,took oxycodone 1:30am still painfull went to er - nothing could be done, advised him to see neurologist-  neurologist stated very vey rare -nothing can be done- give it time & aleve - is feeling better at the time he reported
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Intense body pain, all over body.-Severe
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness, Syncope, Tachycardia, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Medium, Additional Details: having a dessert and then passed out
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension
Clinical narrative: Systemic: Hypertension-Mild
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Injection site pain, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: fainted 30 seconds after recieving both flu and pfizer shots. was unresponsive for about 1 min.  was then nauseous and dizzy.  was seen by emt and declined to go to hospital.  left with a friend
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Blood culture, Full blood count, Influenza virus test, Metabolic function test, Respiratory syncytial virus test
Clinical narrative: Pateint received 6 vaccine shots yesterday per mother she is unsure which.  Vaccines in bilateral thighs
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: SARS-CoV-2 test, Unevaluable event
Clinical narrative: Pateint received 6 vaccine shots yesterday per mother she is unsure which.  Vaccines in bilateral thighs
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arrhythmia, Supraventricular tachycardia
Clinical narrative: Heart Arrhythmia diagnosed (SVT) post vaccine