chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: has had numbness in her arm and now does not have any feeling down her entire left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001228 (Novavax).  A female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "has had numbness in her arm and now does not have any feeling down her entire left arm". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "has had numbness in her arm and now does not have any feeling down her entire left arm".  Additional information: It was reported that a white patient started treatment on unreported date with Pfizer BioNTech COVID-19 vaccine primary series and booster for COVID-19 immunisation. It was reported that since her injections, the patient has had numbness in her arm and now does not have any feeling down her entire left arm. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300168693 Same patient/event, different dose;US-PFIZER INC-PV202300168695 Same patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: has had numbness in her arm and now does not have any feeling down her entire left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001228 (Novavax).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "has had numbness in her arm and now does not have any feeling down her entire left arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "has had numbness in her arm and now does not have any feeling down her entire left arm". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "has had numbness in her arm and now does not have any feeling down her entire left arm". Additional information:On 26Sep2023, it was reported that a patient (Age: 65, units not specified) started treatment on unreported date with Pfizer BioNTech COVID-19 vaccine primary series and booster for COVID-19 immunisation. It was reported that since her injections, the patient has had numbness in her arm and now does not have any feeling down her entire left arm. No further follow-up is anticipated  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300168693 Same patient/event, different dose;US-PFIZER INC-PV202300168694 Same patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Influenza like illness, Pain, Pyrexia
Clinical narrative: ill; feeling "shot down"; high fever; body aches; flu-like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001216.  A 57-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling "shot down""; PYREXIA (non-serious), outcome "unknown", described as "high fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms".  Additional information: It was reported that a patient started treatment on an unreported date with an unreported number of doses (reported as "vaccine series") of Pfizer BioNTech COVID-19 vaccine for COVID-19 vaccination. It was reported the patient became ill after the shots. The patient was feeling "shot down" for 2 days and experienced high fever, body aches, and flu-like symptoms. No further follow-up is anticipated.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001221 (Novavax).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems". The event "heart problems" required physician office visit.  Additional information: Patient age reported as 63 (no units). On 26Sep2023, it was reported that a patient started treatment on unreported dates with 3 doses of Pfizer BioNTech COVID-19 vaccine, primary series and booster, for COVID-19 immunization. It was reported the patient started having heart problems and did not have these problems before taking the vaccine. He started to see doctors.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: He struggled with COVID-19 for weeks; He struggled with COVID-19 for weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001223.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He struggled with COVID-19 for weeks".  Additional information: it was reported that the patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine for the primary series and "at least 1 Pfizer booster" for COVID-19 immunisation. It was reported the patient had COVID-19 once, and then COVID-19 again. She struggled with COVID-19 for weeks.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: She struggled with COVID-19 for weeks; She struggled with COVID-19 for weeks; then COVID-19 again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001224 (Novavax).  A 60 (unit of measure not reported) female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She struggled with COVID-19 for weeks"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "then COVID-19 again". On 26Sep2023, it was reported that a patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine for the primary series and "at least 1 Pfizer booster" for COVID-19 immunisation. It was reported the patient had COVID-19 once, and then COVID-19 again. She struggled with COVID-19 for weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Endocrine ophthalmopathy
Clinical narrative: thyroid eye disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): FMC-CASE-005494, FMC-EVENT-001359.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "thyroid eye disease". Consumer experienced thyroid eye disease from an unspecified COVID-19 vaccination on an unspecified date  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: however her wife got Covid; however her wife got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "however her wife got Covid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: they got COVID, and then they were killed; they got COVID, and then they were killed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP)  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "they got COVID, and then they were killed". Caller's Concern: A caller said that she heard our commercials on the radio all the time, and she wants us to know that she wouldn't buy our product if it was the last thing if it would save her life because she doesn't trust our company. She said that's how much she has hated the COVID vaccine that we forced on them, and we didn't give them all the negative inner reactions to it. She said she wouldn't buy anything from Pfizer. She and her husband didn't take anything from Pfizer because a friend of theirs rushed to the hospital or the doctor's office to get the shot, and then they got COVID, and then they were killed, and the doctor is asking them why they shouldn't take it. She said they didn't take it because it doesn't work and she is not a stupid person. She mentioned that Pfizer are all crooks, thieves, and murderers. Inform the caller that I have documented this and make sure it goes to the appropriate department. I needed to end the call because the caller didn't stop talking bad things about Pfizer. The patient date of death was unknown. Reported cause of death: "got COVID, and then they were killed". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: got COVID, and then they were killed; got COVID, and then they were killed
Age: 91.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Fatigue, Gout, Hypokinesia, Illness
Clinical narrative: i also got gout; i had terrible fatigue; nausea; was sick for 6 days to the point where i could not get out of bed; was sick for 6 days to the point where i could not get out of bed; i ached all over; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 91 years old female patient (63.5 kg) who experienced terrible fatigue, nausea, sick for 6 days to the point where she could not get out of bed, ached all over and got gout after receiving Influenza Vaccine.  The patient's past medical history included Gout with i also got gout on the sixth day, and that lasted 3 days. 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 Atrial fibrillation, Blood pressure high and Drug allergy with Allergies: Lamisil, Oxycodone, Tetracycline.  Concomitant medications included Lasix, Levothyroxine Sodium; Apixaban (Eliquis); Prednisone And Ascorbic Acid, Copper Gluconate, Fish Oil, Tocopherol, Xantofyl, Zeaxanthin, Zinc Oxide (Ocuvite Adult 50+ [Ascorbic Acid; Copper Gluconate; Fish Oil; Tocopherol ; Xantofyl; Zeaxanthin; Zinc Oxide]).  On 12-Sep-2023, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On 12-Sep-2023 the patient developed aterrible fatigue (fatigue), nausea, sick for 6 days to the point where i could not get out of bed (illness) (hypokinesia), ached all over (pain) (latency: same day).  On 18-Sep-2023 the patient developed gout (latency: 6 days)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment or the events.  At time of reporting, the outcome was Recovered / Resolved on 19-Sep-2023 for the event (fatigue), nausea, (illness) (hypokinesia), (pain) (duration: 7 days) and was Recovered / Resolved on 21-Sep-2023 for the event gout (duration: 3 days).
Age: 91.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Mobility decreased, Nausea, Pain
Clinical narrative: i also got gout; i had terrible fatigue; nausea; was sick for 6 days to the point where i could not get out of bed; was sick for 6 days to the point where i could not get out of bed; i ached all over; Initial information received on 03-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 91 years old female patient (63.5 kg) who experienced terrible fatigue, nausea, sick for 6 days to the point where she could not get out of bed, ached all over and got gout after receiving Influenza Vaccine.  The patient's past medical history included Gout with i also got gout on the sixth day, and that lasted 3 days. 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 Atrial fibrillation, Blood pressure high and Drug allergy with Allergies: Lamisil, Oxycodone, Tetracycline.  Concomitant medications included Lasix, Levothyroxine Sodium; Apixaban (Eliquis); Prednisone And Ascorbic Acid, Copper Gluconate, Fish Oil, Tocopherol, Xantofyl, Zeaxanthin, Zinc Oxide (Ocuvite Adult 50+ [Ascorbic Acid; Copper Gluconate; Fish Oil; Tocopherol ; Xantofyl; Zeaxanthin; Zinc Oxide]).  On 12-Sep-2023, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On 12-Sep-2023 the patient developed aterrible fatigue (fatigue), nausea, sick for 6 days to the point where i could not get out of bed (illness) (hypokinesia), ached all over (pain) (latency: same day).  On 18-Sep-2023 the patient developed gout (latency: 6 days)  Action taken: not applicable.  It was not reported if the patient received a corrective treatment or the events.  At time of reporting, the outcome was Recovered / Resolved on 19-Sep-2023 for the event (fatigue), nausea, (illness) (hypokinesia), (pain) (duration: 7 days) and was Recovered / Resolved on 21-Sep-2023 for the event gout (duration: 3 days).
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got horribly sick; Initial information received on 08-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves an unknown age and unknown gender patient who got horribly sick 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 in 1976, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, strength, expiry date and lot number) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date, the patient got horribly sick (illness) (unknown latency).  It was reported, got flu shot in 1976, got horribly sick and never had shot again.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event ( got horribly sick).  At time of reporting, the outcome was Unknown for the event  got horribly sick.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 40 year-old man received FLUZONE HIGH-DOSE QUADRIVALENT rather than the indicated FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 40-year-old man received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] rather than the indicated fluzone quadrivalent 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 hepatitis B vaccine for Prophylactic vaccination.  On 02-Oct-2023, the patient received a 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form: unknown) (lot: U8135CA, expiry date: 30-Jun-2024) via intramuscular route in unknown administration site for Immunization and a 40 year-old man received fluzone high-dose quadrivalent rather than the indicated fluzone quadrivalent with no reported adverse event (product administered to patient of inappropriate age) (latency: same day)  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was 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: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion for fluzone QIV at a high temperature of 72.7F out of range for 7 weeks with no reported adverse event; Fluzone QIV administered post temperature excursion with no reported adverse event; Initial information received on 03-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 46 years old male patient and reporter reported temperature excursion for influenza quadrival A-B vaccine [Fluzone QIV] at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event and fluzone QIV administered post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Caller reported that influenza quadrival A-B vaccine Suspension for injection at a dose of 0.5 ml total (lot UT8055JA, expiry date- 30-JUN-2024) via intramuscular route in unknown administration site for Immunization was exposed to temperature excursion being left out at room temperature at a high temperature of 72.7f out of range for 7 weeks with no reported adverse event (product storage error) (unknown latency) and On 03-OCT-2023, fluzone qiv administered post temperature excursion with no reported adverse event (poor quality product administered) (latency- same day).    Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA305541:01790050 US-SA-2023SA304864:01789997
Age: 1.83
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: she was supposed to take Infanrix but instead gave ADACEL with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 22 months old female patient who was supposed to take infanrix but instead gave diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] 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 hepatitis A vaccine for Prophylactic vaccination.  On 03-Oct-2023, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot- U7624AA and expiration date- 06-Dec-2024) via intramuscular route in the left thigh (strength: not provided) for Immunisation (wrong product administered) (latency- same day).  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.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event; Initial information was received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who reported that influenza quadrival a-b multidose vaccine preserved fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrival a-b multidose vaccine preserved (lot U890BA, Expiry date : 30-Jun-2024, strength was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of fluzone qiv t that causes a lot of bubbles when it was inverted to draw out doses, 6 vials have been given to patients with no reported adverse event (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b multidose vaccine preserved.  Reportedly "HCP called to report 50 vials of FLUZONE QIV T that appeared to be bubbly or soapy when it was inverted to draw a dose. Caller mentioned that the syringe was hard to push and that 6 vials have been used. Patient information was not obtained during the call. Caller wanted to know if it was still good to use. Caller mentioned that 6 vials have been given to patients. Patient information was not obtained during the call. Call got disconnected."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event "poor quality product administered".  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: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally gave FLUBLOK to a patient under 16 (minor) with no reported adverse event; Initial information was received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old and unknown gender patient who was received accidentally influenza quadrivalent recombinant vaccine [Flublok QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect influenza quadrivalent recombinant vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for Immunization. The information on batch number was requested.  On an unknown date the patient was accidentally gave flublok to a patient under 16 (minor) with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly "Reporter wasn't able to obtain consent for the office to be contacted. Sales rep was informed that the office may call us to provide additional information. Sales rep has very limited information to provide as the event was just randomly mentioned. No further information provided by the reporter."  Action taken with QUADRIVALENT RECOMBINANT influenza vaccine (Flublok QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (accidentally gave Flublok to a patient under 16 (minor) with no reported adverse event).  At time of reporting, the outcome was Unknown for the event accidentally gave flublok to a patient under 16 (minor) with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered tenivac that has expired on 24Sep2023 to a patient with no reported adverse event; Initial information was received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] that has expired on 24sep2023 to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Sep-2023, the patient received a unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (Suspension for injection) (lot U7183AA, strength, expiry date unknown) via unknown route in unknown administration site for Immunization.  On 28-Sep-2023 the patient was administered tenivac that has expired on 24sep2023 to a patient with no reported adverse event (expired product administered) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered tenivac that has expired on 24sep2023 to a patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: patient pulled away and the full dose was not given. when the patient pulled away, the vaccine leaked out of the syringe and was not administered with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of an unknown age and gender and reporter reported that the patient pulled away and the full dose was not given. when the patient pulled away, the Influenza Quadrival A-B Vaccine [Fluzone Qiv] leaked out of the syringe and was not administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (strength: unknown, expiry date: Jun-2024 and lot UT8038MA) via unknown route in unknown administration site as Influenza and patient pulled away and the full dose was not given. when the patient pulled away, the vaccine leaked out of the syringe and was not administered with no reported adverse event (incorrect dose administered) (same day latency).  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: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: sibling patient who received FLUZONE QUADRIVALENT twice with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA312142(CLUSTER).  This case involves a 6 years old male patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] twice with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Sep-2023, the patient received Dose 1 of suspect Influenza quadrival a-b vaccine Suspension for injection (lot number: UT8144LA) (Expiry date: 30-Jun-2024) via unknown route in unknown administration site for immunisation. On 07-Oct-2023 he also received Dose 2 of the same vaccine via unknown route in unknown administration site.  On 07-Oct-2023, the patient received Influenza Quadrival A-B Vaccine twice with no reported adverse event (extra dose administered) (latency: same day).  It was reported, called stating that they have sibling patient who received FLUZONE QUADRIVALENT twice and would like to know what to do moving forward and what to look for. Nurse stated that siblings came Saturday, 07Oct2023 and was given FLUZONE QUADRIVALENT The 8-month old patient was has her first flu shot 16Sept2023 and second 07Oct2023 which is just 3 weeks apart The 6-year-old patient had his first injection 08Sep2023 and the second 07Oct2023. Nurse would like to know what to look for and whether they need to revaccinate the patients.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: there was a device malfunction and the patient only received half the dose with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient, there was a device malfunction and the patient only received half the dose with no reported adverse event with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection via unknown route in unknown administration site for influenza (strength, formulation, batch number and expiry date: unknown), there was a device malfunction and the patient only received half the dose with no reported adverse event (incorrect dose administered) (latency same day). Information on the batch number was requested  Reportedly, The information provided was that there was a device malfunction and the patient only received half the dose.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event incorrect dose administered   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: 58.0
Sex: F
Vaccine: FLUR4, FLUX
Symptoms: No adverse event, Viral titre, Wrong product administered
Clinical narrative: two years ago she was at the doctor's office to receive a dose of flublok, but was administered a different influenza vaccine instead with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case is linked to case 2023SA311693(CLUSTER).  This case involves a 58 years old female patient where reporter reported two years ago she was at the doctor's office to receive a dose of influenza quadrivalent recombinant vaccine [Flublok QIV], but was administered a different Influenza vaccine instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine and influenza vaccine lot number not reported via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for Immunisation (wrong product administered). Information on the batch number was requested.  Patient states that two years ago she was at the doctor's office to receive a dose of Flublok, but was administered a different influenza vaccine instead. She states after running some titers her doctor did administer a dose of the Flublok about two months afterwards  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: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under the left arm; Initial information received on 09-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 55 years old female patient who experienced swollen lymph nodes under the left arm after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2023, the patient received 0.5 ml of suspect Influenza Quadrivalent Recombinant Vaccine (Frequency: once, Strength: Standard) (lot number: U8058BA) (with an unknown expiry date) via intramuscular route in the left deltoid for immunization.  On an unknown date, the patient developed swollen lymph nodes under the left arm (lymphadenopathy) (unknown latency).  It was reported, Call received from pharmacist reporting a patient who received a dose of FLUBLOK QIV, on Friday, 06OCT2023, called to report she is experiencing swollen lymph nodes under the left arm. Patient called pharmacy today, 09OCT2023, stating that she noticed the swollen lymph nodes after she exercised, denies any other symptoms.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (swollen lymph nodes under the left arm).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event swollen lymph nodes under the left arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: child had the first dose today at 4 years old with no reported adverse event; expiration date on the box of pentacel is Oct 1, 2023 with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who was received first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event and expiration date on the box of pentacel was oct 1, 2023 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 VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination (Immunization).  On 10-Oct-2023, the 4 years old male patient received 0.5 mL dose 1 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE with no reported adverse event (inappropriate schedule of product administration) and expiration date on the box was oct 1, 2023 with no reported adverse event (expired product administered) (latency: same day)(Suspension for injection) (Frequency = once) (Strength = standard) (lot UJ807AA) via intramuscular route in the left deltoid for Immunization.  Action taken: not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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: 80.0
Sex: F
Vaccine: FLUA4
Symptoms: Eye contusion
Clinical narrative: Patient woke up two black eyes going from corner of her eye to her temple; This spontaneous case was received on 03-Oct-2023 from other healthcare professional via Company (reference number SEQW23-02899) with additional document received on the same date from Company (reference number: SEQW23-02899) (being processed together) and concerned an 80-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included Zetia (ezetimibe), losartan, alprazolam, hydrochlorothiazide (reported as hydroclorothyosine), rosuvastatin and warfarin, all used for unreported indication.  On 02-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration and anatomical location: not reported) as influenza immunization. The batch number reported was 370679 and expiration date 10-May-2024.  On 03-Oct-2023, one day after receiving Fluad Quadrivalent, the patient experienced two black eyes going from corner of her eye to her temple.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 80-year-old female patient experienced eye contusion on both eyes one day after being vaccinated with Fluad Quadrivalent. Causality is confounded by therapy with concomitant medication warfarin. Patient's medical history and relevant diagnostic findings were not provided. Due to temporal plausibility, causal role of the suspect vaccine is assessed as possibly related for the reported event.; Sender's Comments: A 80-year-old female patient experienced eye contusion on both eyes one day after being vaccinated with Fluad Quadrivalent. Causality is confounded by therapy with concomitant medication warfarin. Patient's medical history and relevant diagnostic findings were not provided. Due to temporal plausibility, causal role of the suspect vaccine is assessed as possibly related for the reported event.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect dose administered, Injection site pain, Vaccination site pain
Clinical narrative: It couldn't be fully administered because they said it hurt; Patient was given a dose and it couldn't be full administered; This spontaneous case was received on 09-Oct-2023 from a pharmacist (reference number: SEQW23-03138) and concerned a 57-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included unspecified cholesterol medication.  On 06-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine innact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: arm,) as a every year shot. As reported, the patient was given a dose and it couldn't be fully administrated because it hurt (explicitly coded 'Incomplete dose administered'). The batch number reported was 944465 and the expiry date was 22-Jun-2024.  The outcome of event of 'vaccination site pain' was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: Due to plausible temporal relationship and location of an event, causal role of Flucelvax Quadrivalent is assessed as possibly related for vaccination site pain, while incomplete dose administrated is assessed as not related per company's conventions.; Sender's Comments: Due to plausible temporal relationship and location of an event, causal role of Flucelvax Quadrivalent is assessed as possibly related for vaccination site pain, while incomplete dose administrated is assessed as not related per company's conventions.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lip pain, Oral herpes, Therapeutic product ineffective
Clinical narrative: Very large, painful cold sores on lip.  Used Abreva.  Did not help.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac function test, Cardiac monitoring, Dyspnoea, Echocardiogram, Myocarditis
Clinical narrative: Myocarditis. Shortness of breath, palpitations. Wore a heart sensor for 2 weeks until symptoms started to subside (took 3 months).
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Palpitations
Clinical narrative: Myocarditis. Shortness of breath, palpitations. Wore a heart sensor for 2 weeks until symptoms started to subside (took 3 months).
Age: 35.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Bone pain, Chest pain, Pain, Pain of skin
Clinical narrative: Some moderate to extreme left chest pain, collar bone pain. Skin around the heart aggressively hurts, with sharp shooting pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Extrasystoles, Fatigue, Headache
Clinical narrative: 10/13/23 Friday, Approx 7:00 pm, about 5 hours after Moderna COVID19 vaccine injection: shaking chills, headache, fatigue, which continued all night and through Saturday, 10/14/23. On 10/14/23, I had bad diarrhea 3x, splitting headache, nausea, shaking chills, body aches, left arm soreness, I also had some weird heartbeats similar to fast heartbeats and skipped heartbeats.