chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Heparin, reaction(s): "Known allergies: Heparin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Rebound. Covid came back one week after I'd tested negative; (2023) Negative, notes: Rebound. Covid came back one week after I'd tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose number unknown, single (Lot number: GJ5342) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Apr2022 as dose number unknown, single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Barrett's esophagus" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. It was unknown if the patient has medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given PAXLOVID from 15Sep2023 to 19Sep2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), 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) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 06Sep2023 to 10Sep2023 as treatment.  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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ3275), in right arm and on 28Apr2023 at 11:00 as dose 6 (booster), single (Lot number: GJ3270) at the age of 73 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 21Dec2020 at 17:00 as dose 1, single (Lot number: EJ1685), in left arm, on 11Jan2021 at 16:00 as dose 2, single (Lot number: EL3302), in left arm, on 01Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 20Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FP3175), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Afib S/P Successful Ablation", start date: 20Jan2015 (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Midazolam, reaction(s): "drug allergy"; Valproic acid, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive; (Sep2023) Negative; (19Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient took Paxlovid from 12Sep2023.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 administration.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment was Paxlovid from 05Sep2023 to 10Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Mild muscle aches roughly 18 hours after injection followed by a medium pressure headache.; Mild muscle aches roughly 18 hours after injection followed by a medium pressure headache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2023 at 12:45 as dose 4 (booster), single (Lot number: HF9275) at the age of 38 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), HEADACHE (non-serious) all with onset 19Sep2023 at 06:30, outcome "recovered" and all described as "Mild muscle aches roughly 18 hours after injection followed by a medium pressure headache.". Therapeutic measures were not taken as a result of myalgia, headache.
Sex: M
Vaccine: RSV
Symptoms: Injury, Post-acute COVID-19 syndrome, Pyrexia
Clinical narrative: My temperature was 104.1; injured; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A male patient received pf-06928316 (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "severe COVID", start date: 2020 (unspecified if ongoing); "on a ventilator" (unspecified if ongoing); "heart stopped" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (medically significant), outcome "unknown", described as "My temperature was 104.1"; INJURY (non-serious), outcome "not recovered", described as "injured". Clinical course: Back in 2020 the patient got hit with severe COVID. He was actually on a ventilator, his heart stopped three times, His temperature was 104.1 and he was a covid long haul. Even though he was still injured on duty.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: voice issues; This is a spontaneous report received from a contactable pharmacist. A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as booster dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: DYSPHONIA (non-serious) with onset 2022, outcome "not recovered", described as "voice issues".  Additional information: Patient received a booster of the covid 19 vaccine and experienced adverse events, he did not describe them, only to share that he had voice issues that still remain.   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.
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: I am unable to work.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 15May2021 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: IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "I am unable to work.". Additional information: the patient after received vaccine, was unable to work.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: maternal vaccine exposure with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 32 year old female patient patient who was at 31 weeks of pregnancy and was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] during third pregnancy trimester.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 07-Feb-2023. The estimated due date is 14-Nov-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 13-Sep-2023, the pregnant patient received a dose 1 with unknown dose of suspect Influenza Quadrival A-B Vaccine (expiry date, strength and lot number not reported) via intramuscular route in unknown administration site as prophylactic vaccination (maternal exposure during pregnancy) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: got the shot and then developed got gbs; paralyzed; Initial information received on 13-Sep-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got the shot and then developed got gbs and paralyzed 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 suspect influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient had got the shot and then developed got gbs (guillain-barre syndrome) and paralyzed (paralysis)(unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (guillain-barre syndrome and paralysis).  At time of reporting, the outcome was Unknown for the event guillain-barre syndrome and paralysis  Seriousness criteria: Medically significant for guillain-barre syndrome and paralysis; Sender's Comments: Sanofi Company Comment dated 19-Sep-2023: This case involves an unknown age and unknown gender patient who got the shot and then developed got gbs and paralyzed after receiving influenza vaccine. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: became very I'll from getting one years ago...this one would probably have killed her; Initial information received on 14-Sep-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who became very i'll from getting one years ago...this one would probably have killed her after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient became very i'll from getting one years ago...this one would probably have killed her (illness) (unknown latency) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  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 illness.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Maternal exposure during pregnancy
Clinical narrative: maternal vaccine exposure with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30 years old female patient who was at 17 weeks of pregnancy and was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] during second pregnancy trimester.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was reported as 13-May-2023. The estimated due date is 17-Feb-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies.   On 13-Sep-2023, the pregnant patient received with unknown dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection (expiry date, strength and lot number not reported) via intramuscular route in unknown administration site as prophylactic vaccination (maternal exposure during pregnancy) (latency: same day). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: fluzone quadrivalent given during pregnancy with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 38 years old female patient who was exposed to vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent] in context of fluzone quadrivalent given during pregnancy with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported fluzone quadrivalent given during pregnancy with no reported adverse event occurred at 19 weeks of pregnancy.  The date of last menstrual period was reported as 14-May-2023.  The estimated due date is 17-Feb-2024.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Sep-2023, the patient received a DOSE 1 dose of suspect Influenza Quadrival A-B Vaccine Suspension for injection dose, strength, expiry date, lot number not reported via intramuscular route in unknown administration site for prophylactic vaccination (immunization).  On 14-SEP-2023 fluzone quadrivalent given during pregnancy with no reported adverse event (exposure during pregnancy) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone quadrivalent given during pregnancy with no reported adverse event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information was received on 16-Sep-2023 regarding an unsolicited valid Legal case non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender of patient who experienced allergic reaction after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect influenza vaccine (produced by unknown manufacturer) (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). There will be no information available on batch number for this case.  On an unknown date the patient developed allergic reaction (hypersensitivity) (unknown latency) following the administration of influenza vaccine.  Reportedly "I can't take the fly shot. Every time I had one I had an allergic reaction to it so I quit taking them in 1996 .Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. "  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  No corrective treatment was received for the event (allergic reaction).  At time of reporting, the outcome was Unknown for the event allergic reaction.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Malaise
Clinical narrative: sick; had the flu a couple of times since then; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from a Patient.  This case involves Adult and unknown gender patient who was sick and had the flu a couple of times since then after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(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 lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunization. Information on the batch number was requested.  On an unknown date the patient was sick (illness) and had the flu a couple of times since then (influenza) (unknown latency) following the administration of influenza vaccine.  Made me really sick. I've had the flu a couple of times since then. Vitamins are the key for me. Echinacea is great.  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 Unknown for both the events.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: mistakenly gave (2) injections with no reported adverse event; Initial information received on 06-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 69-year-old female patient who mistakenly taken (2) injections with no reported adverse event while receiving vaccine Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and SHINGLES VACCINE for Prophylactic vaccination.   On 06-Sep-2023, the patient received a dose and strength of 0.7 ml (Frequency = once) suspect Influenza Quadrival A-B High Dose HV vaccine injection (lot: UT8079AA, Expiry date: 30-Jun-2024) via intramuscular route in the left deltoid for Immunization and patient had mistakenly (2) injections with no reported adverse event (extra dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Additional information was received on 06-Sep-2023 from a physician. Concomitant medication (SHINGRIX) added, CO updated, however no significant information received, text amended accordingly.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: left on the cooler after shipment for 3 days with no reported adverse event; patient was administered with FLUZONE HD with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves patients of unknown demographics who were administered with influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] after left on the cooler after shipment for 3 days 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 patients received a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength: not reported lot UT8104AA expiry date: 30-Jun-2024 via unknown route in unknown administration site for immunization and left on the cooler after shipment for 3 days with no reported adverse event (product storage error).  On an unknown date patients were administered with fluzone hd with no reported adverse event (poor quality product administered) on the same day following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event left on the cooler after shipment for 3 days with no reported adverse event and was Unknown for the event patient were administered with fluzone hd 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: IPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Highest/lowest temperature reached: 8.5°C, Duration of excursion: 6 minutes with no reported adverse event; products been administered post excursion with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of unknown demographics who was administered IPV (VERO) [IPOL] post excursion and highest/lowest temperature reached: 8.5°c, duration of excursion: 6 minutes 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 0.5 ml of suspect IPV (VERO) Suspension for injection strength: not reported lot V1B901M expiry date: 02-jun-2024 via unknown route in unknown administration site for immunization and highest/lowest temperature reached: 8.5°c, duration of excursion: 6 minutes with no reported adverse event (product storage error).  On an unknown date product been administered post excursion with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event highest/lowest temperature reached: 8.5°c, duration of excursion: 6 minutes with no reported adverse event and was Unknown for the event products been administered post excursion 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: RAB
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: diagnosed with covid via PCR testing; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who experienced diagnosed with COVID via PCR testing after receiving vaccine Rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received a dose of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection with unknown strength, dose, batch number & expiry date via unknown route in unknown administration site for pre-exposure immunization (Immunisation).  Information on batch number was requested.  On 13-Sep-2023, the patient diagnosed with COVID via PCR testing (covid-19) (latency: 2 days).  Relevant laboratory test results included: Polymerase chain reaction - On an unknown date: [covid]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was Unknown.
Sex: F
Vaccine: RAB
Symptoms: COVID-19
Clinical narrative: diagnosed with Covid a few days after her first dose of IMOVAX; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age female patient who diagnosed with covid a few days after her first dose of imovax after receiving vaccine rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2023, the patient received a dose 1 dose of suspect Rabies (HDC) Vaccine Powder and solvent for suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization).Information on the batch number was requested.  On 13-SEP-2023 the patient diagnosed with covid a few days after her first dose of imovax (covid-19) 2 days following the administration of Rabies (HDC) Vaccine.  Reportedly, The Vet Techs are required to get pre-exposure rabies prophylaxis. A vet tech student was diagnosed with Covid a few days after her first dose of IMOVAX. HCP is asking if the tech can still receive her day 7 dose on schedule.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event diagnosed with Covid a few days after her first dose of IMOVAX.  At time of reporting, the outcome was Unknown for the event diagnosed with covid a few days after her first dose of imovax.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product storage error
Clinical narrative: administering FLUBLOK QIV post excursion of 30.4F with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 60-years-old male patient who was administered influenza quadrivalent recombinant vaccine [Flublok QIV] post excursion of 30.4 f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2023, the patient received 0.5 mL dose of suspect influenza quadrivalent recombinant vaccine (formulation unknown) (Strength: Standard; Frequency: Once) (batch number: U8058BA; expiry date: 31-May-2024) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization, post excursion of 30.4f with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   No additional information at the time of call, caller declined follow-up.  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-2023SA284378:
Age: 68.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: FLUBLOK QIV was administered to patient post excursion with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old female patient to whom administered the Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv] after post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Sep-2023, the patient received a dose of 0.5 ml of suspect Influenza Quadrivalent Recombinant Vaccine after excursion(strength: standard, frequency: once, expiry date: 31-May-2025 and lot U8058BA) via intramuscular route in the deltoid nos as immunization (poor quality 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.; Sender's Comments:  US-SA-2023SA284375:
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C with no reported adverse event; the same vaccine had been administered to 2 patients with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-months-old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] post the excursion that lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 c 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, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (vero), tetanus vaccine toxoid (Pediarix); and pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 30-Aug-2023, suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ834AA; expiry date: 23-Feb-2024), was packed in the refrigerator with ice packs, however the ice packs were placed right beside the thermometer, so the reading went below zero, although none of the vaccines were actually frozen. The excursion lasted for 19 hrs and the thermometer showed the lowest cold reading as negative 2.2 C with no reported adverse event (product storage error) (unknown latency).   On 06-Sep-2023, the patient received 0.5 mL dose of same suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ834AA; expiry date: 23-Feb-2024) via intramuscular route in the thigh NOS (not otherwise specify) for immunization post temperature excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: 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.
Age: 20.0
Sex: F
Vaccine: MEN, MMR
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: medical assistant inadvertently administered a dose of menquadfi, when they were supposed to receive the mmr vaccine with no reported adverse event; Initial information received on 15-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 20-years-old female patient who was inadvertently administered with a dose of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi], when they were supposed to receive the measles vaccine, mumps vaccine, rubella vaccine [MMR] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Sep-2023, the patient inadvertently received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, Solution for injection (frequency: once) (batch number: U78278AA; expiry date: 30-Sep-2025) via unknown route in unknown administration site when they were supposed to receive the measles vaccine, mumps vaccine, rubella vaccine vaccine (formulation batch number and expiry unknown) for immunization with no reported adverse event (wrong product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT WAS GIVEN FLUZONE HD ON HIS VISIT ON 09/21/2023. LATER IT WAS REVEALED FROM HIS ELECTRONIC FILE THAT HE ALREADY RECEIVED FLUZONE HD ON PREVIOUS VISIT ON 09/06/23. PATIENT WAS CONTACTED SUCCESSFULLY ON 09/21/23 MORNING. PATIENT HAS REPORTED NO ADVERSE REACTION DUE TO SECOND FLUZONE HD DOSE HE RECEIVED. HIS PRIMARY CARE PHYSICIAN WAS INFORMED.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reported adverse events.  Patient had already received a bivalent COVID19 booster on 9/16/2022 and had no indication to receive another one.  The pharmacy notified patient's primary care physician.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: RN gave flu vaccine in error instead of the HPV vaccine to patient during appointment. Patient had already received flu shot for this season 2 days prior to this incident.  No immediate adverse reactions or side effects noted, but patient encouraged to monitor for expected side effects (flu like symptoms) post flu vaccine. Patient acknowledged understanding and was agreeable to also receiving the HPV #1 vaccine.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bacteraemia, COVID-19, Endocarditis, Gait disturbance, Muscular weakness
Clinical narrative: INPATIENT PHYSICAL THERAPY DAILY NOTE ==============================================================    ASSESSMENT: 67 year old male with COVID admitted for bacteremia, UTI and endocarditis. Patient was discharged from hospital on 9/5/23. He has thoracic vertebral fracture and has a TLSO for comfort when out of bed.  Patient requiring moderate assistance for bed mobility and was able to stand and take several steps using assistive device. Patient is limited by weakness in bilateral lower extremities, and decreased functional activity tolerance. He is below baseline and will benefit from additional therapy during hospital stay and daily therapy once discharged.  Request for OT evaluation. DISCHARGE RECOMMENDATIONS: Daily Physical Therapy   CAREGIVER TRAINING REQUIRED?: No, so long as patient   pt in house bed
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: INPATIENT PHYSICAL THERAPY DAILY NOTE ==============================================================    ASSESSMENT: 67 year old male with COVID admitted for bacteremia, UTI and endocarditis. Patient was discharged from hospital on 9/5/23. He has thoracic vertebral fracture and has a TLSO for comfort when out of bed.  Patient requiring moderate assistance for bed mobility and was able to stand and take several steps using assistive device. Patient is limited by weakness in bilateral lower extremities, and decreased functional activity tolerance. He is below baseline and will benefit from additional therapy during hospital stay and daily therapy once discharged.  Request for OT evaluation. DISCHARGE RECOMMENDATIONS: Daily Physical Therapy   CAREGIVER TRAINING REQUIRED?: No, so long as patient   pt in house bed
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt states arm was sore and swelling after the vaccine. Patient said it have been three weeks and she is having a hard time with mobility / range in motion.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: Pt states arm was sore and swelling after the vaccine. Patient said it have been three weeks and she is having a hard time with mobility / range in motion.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue
Clinical narrative: SUMMARY OF PATIENT PROGRESS:   STATUS: Progressing as expected towards goals - continuing present plan   Primary Problem: COVID    Key findings related to primary problem: Patient A&O x 4. Tele and vital signs monitored. No signs of respiratory distress noted. Patient denied any pain. Ambulation in room done with moderate fatigue. Patient up to chair. Patient tolerating diet. Patient encouraged to shift weight frequently to maintain skin integrity.    Other key findings: none at this time.          Note Details  Author  (R.N.) File Time 9/11/2023  2:47 PM Author Type REGISTERED NURSE Status Signed Last Editor  (R.N.) Specialty GENERAL, OTHER Hospital Acct #  Admit Date 9/8/2023  ED to Hosp-Admission (Discharged) on 9/8/2023  ED to Hosp-Admission (Discharged) on 9/8/2023   Detailed Report  Note shared with patient Care Timeline  09/09   Transferred to ICU 1210   Admitted from ED (Observation) 1210 09/10   Transferred out of ICU 1800 09/11   Discharged 2005
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Panic attacks that started several days after administration. Required prescription medication to manage panic symptoms (Citalopram).
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient called the pharmacy stating she had hives on her stomach and buttocks and redness and itching on her face.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Caller reported that patient received 1st dose one year ago, 2nd dose 7 months ago, and has not yet received 3rd dose of GARDASIL 9 due to rescheduling vaccination. 'AE; No adverse event; This spontaneous report as received from a Registered nurse refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  In September 2022, reported as one year ago, patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in March 2023 (conflicting information reported as 7 months ago), dose 0.5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported) for prophylaxis.  It was reported that the patient had not yet received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Inappropriate schedule of product administration) due to due to rescheduling vaccination. No symptoms reported.
Age: 58.0
Sex: U
Vaccine: HEPA
Symptoms: Hepatitis C, Incorrect dose administered
Clinical narrative: HCP called to report that on July 3rd 2023, a 58-year-old patient was administered a dose of 0.5mls of VAQTA Lot:X004813 Exp: 7/28/2024. Patient is currently undergoing treatment for HEP. C. Patient began treatment for Hep. C recently and this was af; Patient is currently undergoing treatment for HEP. C. Patient began treatment for Hep. C and this was after the dose of pediatric VAQTA 0.5ml was given; This spontaneous report has been received from a medical assistant, regarding a 58-years-old patient of unknow gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 03-JUL-2023, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, at a pediatric dose of 0.5 milliliters intramuscularly as prophylaxis (lot number: X004813, which was determined to be valid as syringe formulation, with an expiration date on 28-JUL-2024) (strength and anatomical location of administration were not reported) (Incorrect dose administered).  It was stated that on an unspecified date on 2023 (reported as currently), the patient started treatment for Hepatitis C. No additional information has reported. The outcome of hepatitis C was not provided.   The causal relationship between Hepatitis C and Hepatitis A Vaccine, Inactivated (VAQTA) was not reported.  Upon internal review, the event Hepatitis C was determined to be medically significant.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine stored in unapproved storage unit.
Age: 14.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 YEAR OLD PATIENT GIVE FLUBLOK INADVERTENTLY
Age: 37.0
Sex: M
Vaccine: RAB, TYP
Symptoms: Extra dose administered, Injection site reaction, Wrong product administered
Clinical narrative: Patient was scheduled for Rabies vaccine (RABAVERT) but was given Typhim instead. Patient already had Typhim on 9/12/23 and was given a second dose today 9/21/23 instead of the Rabies vaccine.  Reached out to patient 6 hours later and patient only has injection site reactions.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Tdap was ordered but Td was administered.