chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Influenza like illness, Interchange of vaccine products, Pain
Clinical narrative: Had Johnson n Johnson Covid vaccine/Moderna shot made me sick /Pfizer shot did the same thing; Sick; Terrible aches/Pains; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, (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: Johnson n johnson (Dose number unknown), for COVID-19 immunization, reaction(s): "No adverse event"; Moderna (Dose number unknown), for COVID-19 immunization, reaction(s): "Sick", "Flu like symptoms", "Pains", "Terrible aches"; Flu vaccine (Dose number unknown, manufacture unknown), for immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Had Johnson n Johnson Covid vaccine/Moderna shot made me sick /Pfizer shot did the same thing"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; PAIN (non-serious), outcome "unknown", described as "Terrible aches/Pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Patient had Johnson n Johnson COVID vaccine at beginning of pandemic. No negative effects at all. Moderna shot made me sick with terrible aches n pains n flu like symptoms for 24 hours. Pfizer shot did the same thing. Patient was asking as will there be a future vaccine that doesn't give u these horrible side effects. No other vaccines such as flu has ever made me sick. Patient was 68 in good medical shape.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Illness, Influenza like illness, Pain
Clinical narrative: Had Johnson n Johnson Covid vaccine/Moderna shot made me sick /Pfizer shot did the same thing; Sick; Terrible aches/Pains; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, (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: Johnson n johnson (Dose number unknown), for COVID-19 immunization, reaction(s): "No adverse event"; Moderna (Dose number unknown), for COVID-19 immunization, reaction(s): "Sick", "Flu like symptoms", "Pains", "Terrible aches"; Flu vaccine (Dose number unknown, manufacture unknown), for immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Had Johnson n Johnson Covid vaccine/Moderna shot made me sick /Pfizer shot did the same thing"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; PAIN (non-serious), outcome "unknown", described as "Terrible aches/Pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Patient had Johnson n Johnson COVID vaccine at beginning of pandemic. No negative effects at all. Moderna shot made me sick with terrible aches n pains n flu like symptoms for 24 hours. Pfizer shot did the same thing. Patient was asking as will there be a future vaccine that doesn't give u these horrible side effects. No other vaccines such as flu has ever made me sick. Patient was 68 in good medical shape.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: I know someone who received one and can no longer walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I know someone who received one and can no longer walk".  Additional information: I would never consider a COVID vaccine. I know someone who received one and can no longer walk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got the shot and still got COVID; I got the shot and still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got the shot and still got COVID".  Clinical course: It was reported that, the patient lost interest because she was tired of companies and the government telling her to get boosters. She got the shot and still got COVID. Also now they were hearing about so many bad side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Bronchitis, Haemoptysis, Illness, Influenza like illness
Clinical narrative: TB; severe bronchitis; coughing up blood; severe asthma; flu-like symptoms; made me so sick/ ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history included: "mitral valve prolapse" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: I have a pre-cancer diagnosis; "second hand smoke" (unspecified if ongoing), notes: second hand smoke by illegal aiens after a brief hotel state; "severe asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for asthma, immunisation. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: TUBERCULOSIS (medically significant), outcome "unknown", described as "TB"; BRONCHITIS (non-serious), outcome "unknown", described as "severe bronchitis"; HAEMOPTYSIS (non-serious), outcome "unknown", described as "coughing up blood"; ASTHMA (non-serious), outcome "unknown", described as "severe asthma"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; ILLNESS (non-serious), outcome "unknown", described as "made me so sick/ ill". The patient underwent the following laboratory tests and procedures: diagnosed with severe bronchitis: severe bronchitis, notes: diagnosed with severe bronchitis; variable, notes: Test results variable.  Clinical course: The patient had a pre-cancer diagnosis, mitral valve prolapse, recent TB exposure due to the County malfeasance - second hand smoke by illegal aiens after a brief hotel state, which a county nurse later reached out to guests to advise of TB exposure - and severe asthma  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Tuberculosis
Clinical narrative: TB; severe bronchitis; coughing up blood; severe asthma; flu-like symptoms; made me so sick/ ill; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history included: "mitral valve prolapse" (unspecified if ongoing); "cancer" (unspecified if ongoing), notes: I have a pre-cancer diagnosis; "second hand smoke" (unspecified if ongoing), notes: second hand smoke by illegal aiens after a brief hotel state; "severe asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for asthma, immunisation. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: TUBERCULOSIS (medically significant), outcome "unknown", described as "TB"; BRONCHITIS (non-serious), outcome "unknown", described as "severe bronchitis"; HAEMOPTYSIS (non-serious), outcome "unknown", described as "coughing up blood"; ASTHMA (non-serious), outcome "unknown", described as "severe asthma"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; ILLNESS (non-serious), outcome "unknown", described as "made me so sick/ ill". The patient underwent the following laboratory tests and procedures: diagnosed with severe bronchitis: severe bronchitis, notes: diagnosed with severe bronchitis; variable, notes: Test results variable.  Clinical course: The patient had a pre-cancer diagnosis, mitral valve prolapse, recent TB exposure due to the County malfeasance - second hand smoke by illegal aiens after a brief hotel state, which a county nurse later reached out to guests to advise of TB exposure - and severe asthma  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got the vaccine and still ended up getting COVID; I got the vaccine and still ended up getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got the vaccine and still ended up getting COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Pyrexia
Clinical narrative: High fever; confused state; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient in his 70's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (hospitalization), outcome "unknown", described as "High fever"; CONFUSIONAL STATE (hospitalization), outcome "unknown", described as "confused state". The patient underwent the following laboratory tests and procedures: Body temperature: High fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: Dizziness
Clinical narrative: lightheaded/Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization; Bnt162b2 (Dose: 3 (Booster)), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "lightheaded/Dizziness".  Additional information: Patient received 4th COVID vaccine (all were Pfizer) and 10 days out, experiencing a great deal of lightheaded/ dizziness, that feel was related to the last vaccine. It started 3 or 4 days after the last jab. Patient was researching it online and saw was not alone here. Patient did not experience this symptom with the first 3 vaccines. It was not pleasant.  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: FLU4
Symptoms: SARS-CoV-2 test negative, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case is linked to case 2022SA431439(CLUSTER).  This case involves a 76 years old female patient who developed an area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep, after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history included prior to the vaccination she had got over the virus which was not Covid and that virus caused her not have a voice (Aphonia) (viral infection) in 2022 . She was 3 days post feeling better from the virus when she got the flu vaccine. It was also reported that always reported being tender at the injection site with getting her vaccinations such as flu vaccine in the past and also received Fluzone high dose Quadrivalent and had tenderness to the arm, the reaction was noted next night after the injection and the reaction had down. The patient's past medical treatment(s) and family history were not provided.    On 12-Oct-2022, the patient received a  dose of 0.7 ml once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , injection, with an unknown strength , (lot number and expiry date:  not reported) via intramuscular route in the left arm for immunization. Information regarding batch number has been requested  On the same day,  the patient developed a non-serious events of area of redness, swelling, warm to touch , and tenderness located further down the left arm on the bicep (vaccination site erythema), (vaccination site swelling), (vaccination site pain), (vaccination site warmth), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.. The patient wanted to know  if it was a common side effect for the soreness to travel along the arm like that  since she received the shot in her upper arm , around the shoulder. The patient never had this reaction other than tenderness to the arm . These events lasted for 2 days.    Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Negative  Action taken : not applicable for all the events.  Corrective treatment: not reported for all the events  Outcome:  Recovered / Resolved on 14-Oct-2022 for all the events
Age: 6.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Medication error, Product administered to patient of inappropriate age, Somnolence
Clinical narrative: groggy night of vaccine; 6 yr old received Flublok which is licensed for 18 yrs and older; very tired; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 years old female patient who was very tired, had groggy night of vaccine and received flublok which is licensed for 18 yrs and older while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient had no medical history, concomitant disease or risk factor.    On 21-Sep-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine lot UJ887AA (with an unknown dosage, strength, formulation, expiry date) via intramuscular route in unknown administration site for Flu.  On 21-Sep-2022, the patient had developed a non-serious events groggy night of vaccine (somnolence), very tired (fatigue) and received flublok which is licensed for 18 yrs and older (product administered to patient of inappropriate age) latency same day following the administration of influenza quadrivalent recombinant vaccine. Patient reported that Back to baseline by following morning.  There were no lab data/results available.  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 Recovered / Resolved in September 2022 for the event groggy night of vaccine and for the event very tired, was Unknown for the event 6 yr old received flublok which is licensed for 18 yrs and older .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: reported that a 4-month old consumer was prescribed DTap, but was given both a DTap and PENTACEL at the same visit with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 months old female patient who was prescribed dtap, but was given both a vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 14-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left thigh for prophylactic vaccination. On 14-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation was unknown, lot UJ674AA and expiry date: 04-Jun-2023)  via intramuscular route in the left thigh for Immunization.  On 14-OCT-2022 the patient developed a non-serious event of reported that a 4-month old consumer was prescribed dtap, but was given both a dtap and pentacel at the same visit (extra dose administered) (Latency: same day)  Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered the HIGH DOSE to patients under 65 with no adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age/gender patient who experienced administered the high dose to patients under 65 with no 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.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ904AD; expiry date: 30-Jun-2023) in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event administered the high dose to patients under 65 with no adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  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: 14.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Off label use
Clinical narrative: patient was given flublok to14 years old with no reported adverse event; Initial information was received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 14 years old female patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK] was given with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ893AA expiry-09-Jun-23) (dose, formulation and strength: unknown) intramuscular route in the left arm for immunization.  On 15-OCT-2022, patient was given flublok to14 years old with no reported adverse event (off label use) (latency same day).    Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was given flublok to14 years old with no reported adverse event.
Sex: M
Vaccine: DTAPHEPBIP, HPV4, MNQ, UNK
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: Administered PENTACEL instead of Menveo with no reported adverse event; Initial information received from on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Child male patient who was administered pentacel instead of menveo with no reported adverse event while receiving vaccines MENVEO and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination.  On 18-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation and strength not reported; lot UJ594ABA) via intramuscular route in the deltoid nos instead of MENVEO not produced by Sanofi Pasteur, for prophylactic vaccination.  On 18-Oct-2022, (latency: same day) the patient was administered pentacel instead of menveo with no reported adverse event (wrong product administered).  Action taken was not applicable with both the suspects.  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: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: FLUZONE HIGH DOSE QUADRIVALENT was administered post excursion with no adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from Nurse.  This case involves an unknown age and unknown gender patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at an unknown dose total (lot number, expiry date: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date, fluzone high dose quadrivalent was administered post excursion with no adverse event (poor quality product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: was given an expired FLUZONE HD QIV with no adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old male patient who experienced was given an expired fluzone hd qiv with no 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 COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 19-Oct-2022, the patient received a  0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ768AC; expiry date: 30-Jun-2022) via intramuscular route in the deltoid NOS for immunization.  On 19-OCT-2022 the patient developed a non-serious event was given an expired fluzone hd qiv with no adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  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: FLUR3
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: received flublok after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event; vaccine experienced a temperature excursion that was not covered by the extended stability data with no adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to case 2022SA435204(CLUSTER).  This case involves 2 patients of unknown age and unknown gender who received influenza quadrivalent recombinant vaccine [Flublok] after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patients received suspect influenza quadrivalent recombinant vaccine at an unknown dose (lot UJ893AA, expiry date: 09-Jun-2023) via unknown route in unknown administration site for immunisation.  On an unknown date vaccine experienced a temperature excursion that was not covered by the extended stability data with no adverse event (product storage error) (unknown latency) and patients received flublok after the vaccine experienced a temperature excursion that was not covered by the extended stability data with no reported adverse event (poor quality product administered) same day latency.  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Expired dose of pentacel was administered with no adverse event; Initial information was received on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient to whom expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered with no adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Oct-2022, the patient received expired dose (expiry date-11-Oct-22) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (expired product administered, latency same day) (dose, formulation, strength, and lot: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event  expired dose of pentacel was administered with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: was administered to a patient 7 days past the expiration date with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an unknown age and unknown gender patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] vaccine was administered to a patient 7 days past the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (strength, formulation, dose, route: unknown) (lot number: C5779AA and expiry date: 07-Oct-2022) in unknown administration site for Immunization, on the same day, the patient was administered 7 days past the expiration date with no reported adverse event (expired product administered).  It was reported, the reporter wanted to reach out and see if anyone could advise whether there is any wiggle room with the expiration date. If not, is there any recommendation on whether the patient be re-vaccinated immediately or wait a certain amount of time?". Healthcare professional reported expired Tenivac vaccine administered 1 week after it expired. No additional information reported.  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: HCP gave a patient TENIVAC on 19Oct2022 that expired on 08Oct2022 with no reported adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 42 years old female patient to whom healthcare professional (HCP) gave DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC on 19-Oct-2022 that expired on 08-Oct-2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Oct-2022, the patient received a expired second dose 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Strength: Standard (lot U6831AA, exp date:08-Oct-2022 ) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency: same day)  Action taken: not applicable.  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: 42.0
Sex: M
Vaccine: FLUC3
Symptoms: Body temperature increased, Condition aggravated, Cough, Headache, Pyrexia
Clinical narrative: Cough has intensified; Fever, I took it 4 times and got readings between 100.1 and 101.1; Slight headache; This spontaneous case was received on 08-Oct-2022 from other non-health professional (patient) (reference number: SEQW22-04224), with additional information received on 11-Oct-2022 2022 (reference number: SEQW22-04246) (being processed together) via agency, and concerned a 42-year-old male patient.  The patient's current conditions included mild discomfort/tickle in throat and cough. The patient's concomitant medications were not reported.  On 06-Oct-2022, the patient took a Covid test which was negative.   On 06-Oct-2022, at 9 am, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for seasonal prevention of influenza. The batch number reported was not reported.  On 08-Oct-2022, two days after receiving Flucelvax Quadrivalent,  the patient's cough had intensified and he experienced fever, with temperature between 100.1 and 101.1 (units not provided), and very slight headache. He had also did another Covid test that was still negative. The patient stated that he also noted these symptoms on the form at time of vaccination.  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 42-year-old patient experienced cough aggravated, pyrexia, and headache two days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: The patient stated that he also noted these symptoms on the form at time of vaccination.; Sender's Comments: A 42-year-old patient experienced cough aggravated, pyrexia, and headache two days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 42.0
Sex: M
Vaccine: FLUC3
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Cough has intensified; Fever, I took it 4 times and got readings between 100.1 and 101.1; Slight headache; This spontaneous case was received on 08-Oct-2022 from other non-health professional (patient) (reference number: SEQW22-04224), with additional information received on 11-Oct-2022 2022 (reference number: SEQW22-04246) (being processed together) via agency, and concerned a 42-year-old male patient.  The patient's current conditions included mild discomfort/tickle in throat and cough. The patient's concomitant medications were not reported.  On 06-Oct-2022, the patient took a Covid test which was negative.   On 06-Oct-2022, at 9 am, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for seasonal prevention of influenza. The batch number reported was not reported.  On 08-Oct-2022, two days after receiving Flucelvax Quadrivalent,  the patient's cough had intensified and he experienced fever, with temperature between 100.1 and 101.1 (units not provided), and very slight headache. He had also did another Covid test that was still negative. The patient stated that he also noted these symptoms on the form at time of vaccination.  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 42-year-old patient experienced cough aggravated, pyrexia, and headache two days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: The patient stated that he also noted these symptoms on the form at time of vaccination.; Sender's Comments: A 42-year-old patient experienced cough aggravated, pyrexia, and headache two days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Age: 21.0
Sex: F
Vaccine: FLUC3
Symptoms: Expired product administered, Fatigue, Pain in extremity
Clinical narrative: Arm was really hurting; Really tired; She received the vaccine and she saw that the vaccine was expired; This spontaneous case was received on 11-Oct-2022 from other non-healtcare professional (consumer) via Med Communications (reference number: SEQW22-04347) and concerned a 21-year-old, female patient.  The patient's concurrent condition included lupus. The patient  was not taking any concomitant medications.  On 10-Oct-2022, the patient was vaccinated with expired Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis (explicitly coded as 'Expired vaccine used'). The batch number was not reported.  On the same date, after receiving Flucelvax Quadrivalent, the patient started to be really tired and her arm was realy hurting. She took ibuprofen as a treatment measures.  The outcome of the events was not reported.  This case was assessed as non-serious.  Company comment: A 21-year-old, female patient was vaccinated with expired Flucelvax Quadrivalent. On the same date, after vaccination, the patient started to developed fatigue and pain in arm. Causality is assessed as possibly related for the events of fatigue and pain in arm. Expired product administered is assessed as unrelated per company's conventions.; Sender's Comments: A 21-year-old, female patient was vaccinated with expired Flucelvax Quadrivalent. On the same date, after vaccination, the patient started to developed fatigue and pain in arm. Causality is assessed as possibly related for the events of fatigue and pain in arm. Expired product administered is assessed as unrelated per company's conventions.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Myalgia, Paraesthesia
Clinical narrative: right shoulder pain; pins and needles sensation in her arm; muscle pain; stiffness in her shoulders; stiffness in her wrists and hips; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included scoliosis.   In September 2022, the patient received the 1st dose of Shingrix (intramuscular). In September 2022, 1 day after receiving Shingrix, the patient experienced muscle pain, stiffness shoulder and stiffness hip. On an unknown date, the patient experienced shoulder pain and pins and needles. On an unknown date, the outcome of the muscle pain, stiffness shoulder, stiffness hip and shoulder pain were not recovered/not resolved and the outcome of the pins and needles were recovered/resolved.   It was unknown if the reporter considered the muscle pain, stiffness shoulder, stiffness hip, shoulder pain and pins and needles to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's comment: The patient self-reported this case. The patient received her first Shingrix dose about one month ago into unknown arm and one day after she developed muscle pain and stiffness in her shoulders, wrists and hips (adverse events pain and stiffness was not recovered).  The patient mentioned she woke up one morning to right shoulder pain and pins and needles sensation in her right arm. The events pins and needles sensation was recovered.  The patient had not taken anything to treat the pain.  The patient had not yet seen her doctor. If the pain continued she planned to have a Lyme Disease test. The reporter had nothing else to report. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Overdose, Wrong product administered
Clinical narrative: received Pentacel and Infanrix; Pentacel and Infanrix, should have received Dtap and Prevnar; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL for prophylaxis.   On 14th October 2022, the patient received the 2nd dose of Infanrix, Infanrix Pre-Filled Syringe Device and PENTACEL. On 14th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's comment: Office Manager stated that a 4 month old received Pentacel and Infanrix (double dose of Dtap).  The patient should have received Dtap and Prevnar. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received Pentacel and Infanrix (double dose of Dtap) instead of Dtap and Prevnar, which led to overdose of Dtap component and wrong vaccine administered.