chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: three weeks later in the hospital with pneumonia; three weeks later was in the hospital with flu; Initial information received on 16-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who, three weeks later was in the hospital with flu and pneumonia after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication 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 suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza immunisation).  On an unknown date the patient developed a serious event of getting the flu vaccine and three weeks later was in the hospital with flu and pneumonia (influenza, pneumonia) (3 weeks latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available.  Action taken: Not applicable for both the events.  Corrective treatment: Not reported for both the events.  Outcome: Unknown for both the events.  Seriousness criteria: Medically Significant for Pneumonia and Hospitalized for both the events.; Sender's Comments: Sanofi company comment dated 21-Dec-2022: This case involves an unknown age and unknown gender patient who, three weeks later was in the hospital with flu and pneumonia after receiving vaccine influenza vaccine. Additional information regarding condition at the time of vaccination, medical history, concomitant medication, would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Immune system disorder, Influenza, Pneumonia
Clinical narrative: pneumonia; glitch in immune system; have gotten the flu twice in 2022 in spite of flu shots both times; Initial information received on 17-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an adult and unknown gender patient who experienced pneumonia, have gotten the flu twice in 2022 in spite of flu shots both times and glitch in immune system while receiving vaccine Influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, expiry date, strength, form, route, site was unknown) for flu ('influenza Immunization).  Patient got pneumonia from the flu that was administered in April (unspecified year), so reportedly they don't work well for everyone (unknown latency) following the administration of Influenza vaccine. This event was assessed as medically significant. It was reported that the patient had gotten the flu twice in 2022 (influenza) (unknown latency) in spite of flu shots both times, but the patient has a glitch in my immune system (Immune system disorder; unknown latency).   No lab data reported.  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 the events.; Sender's Comments: Sanofi Company Comment dated 22-Dec-2022: This case involves an adult and unknown gender patient who experienced pneumonia while receiving vaccine Influenza vaccine. Additional information regarding condition at the time of vaccination, medical history, concomitant medication, would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB diluent being administered to a patient with no reported adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp(healthcare professional).  This case involves Adult and unknown gender patient to whom expired Haemophilus type B (HIB) vaccine [ACT-HIB] administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Dec-2022, the patient received a dose of suspect Haemophilus type B (HIB) vaccine(with unknown formulation, frequency, strength,  route and at administration site) for immunization.  On 13-Dec-2022 the patient received an expired Haemophilus type B (HIB) vaccine with no reported adverse event (expired product administered)(latency: same day) following the administration of Haemophilus type B (HIB) 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Pentacel  has been out of range and the max temperature reached was 10.1C with no reported adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a patient of an unknown age and gender and reporter reported Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] has been out of range and the max temperature reached was 10.1c 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 an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection has been out of range since 09-Nov-2022 and the max temperature reached was 10.1c with no reported adverse event (product storage error) (latency: unknown) (With an unknown strength, administration site, route, dose, lot number and expiry date) for immunization.  It was reported Caller reporting a temperature excursion at their facility. The caller advised there was an issue with their data logger and it did not flag them that the temperature in the refrigerator was to warm. The caller requested stability data. Extended stability does not cover the excursion. The caller reported there has been a patient to receive the vaccine post excursion.  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: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: the diluent of of ACTHIB vaccine was expired and was administered to patient, with no reproted adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves the diluent of of HIB (PRP/T) VACCINE [ACT-HIB] vaccine was expired and was administered to 15 months old female patient, 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 pneumococcal vaccine conj 7v (crm197) (prevnar) for prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (dtap) for prophylactic vaccination.  On an unknown date, the patient received a 0.5ml dose of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection; strength: standard) (lot: UJ604AAA; expiry date; 29-Oct-2022, 13-Mar-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On an unknown date the diluent of of acthib vaccine was expired and was administered to patient, with no reported adverse event (expired product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2022SA511721:01408917
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Product storage error
Clinical narrative: diluent that came with it was frozen with no adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 24 years old male patient who experienced diluent that came with it was frozen with no adverse event 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 14-Dec-2022, the patient received a 1 dose of suspect rabies (hdc) vaccine Powder and solvent for suspension for injection (unknown strength, dose and expiration date) lot V1B591M via intramuscular route in the left deltoid for immunization.  On an unknown date the patient developed diluent that came with it was frozen with no adverse event (product storage error) (unknown latency).  Lab data was not reported.  Action taken: not applicable.  Outcome: Unknown for the event diluent that came with it was frozen 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: 2 doses of FLUZONE HIGH DOSE QUADRIVALENT to a patient 20 minutes apart with no reported adverse event; Initial information received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 71 years old female patient who took 2 doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] 20 minutes apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Dec-2022, the patient received 1st 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ932AD) via intramuscular route in the left deltoid and received 2nd 0.7 ml dose of the same vaccine via intramuscular route in the right deltoid for Immunization.  On an unknown date the patient administered 2 doses of fluzone high dose quadrivalent to a patient 20 minutes apart with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 15 month-old girl received her ACTHIB vaccine, but it was later noted that the diluent of that box of ACTHIB vaccines was expired with no adverse event; Initial information received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received her ACTHIB vaccine, but it was later noted that the diluent of that box of ACTHIB vaccines was expired with no adverse event, while receiving HIB (PRP/T) Vaccine [ACT-HIB].  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 a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, dose and expiry date: unknown).  On an unknown date, 15 month-old girl received her ACTHIB vaccine, but it was later noted that the diluent of that box of ACTHIB vaccines was expired with no adverse event with no adverse event (expired product administered) (unknown latency).  Child also received Prevnar and DTaP (manufacturer not provided) during that visit.   Action taken: not applicable  Outcome was Unknown for the event acthib vaccines was expired 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2022SA511887:01408917
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: DAPTACEL was  used post excursion with no reported adverse event; exposed to highest temperature of 25.26 degrees C for 3 hours due to unknown reason with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA513749.  This case involves a 6 years old male patient and it was reported Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason and product was  used post excursion 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 Polio Vaccine Inact 3v (Vero) (Ipol [Polio Vaccine Inact 3v (Vero)]); Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) ; Varicella Zoster Vaccine (Varicella Vaccine) For Prophylactic Vaccination; And Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine]) For Prophylactic Vaccination.  On 29-Nov-2022, Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine exposed to highest temperature of 25.26 degrees c for 3 hours due to unknown reason with no reported AE (product storage error).  On 08-Dec-2022, the patient received  dose 4  once Strength: Standard of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine post excursion with no reported ae (poor quality product administered) Suspension for injection (lot number: C5816AA) (Expiry date: Unknown) via intramuscular route in the left deltoid for prophylactic vaccination.  Action taken: not applicable.  Outcome: Unknown for all the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: Patient was given DAPTACEL at 3 years and 11 months instead of at 4 years-old, with no reported adverse event); Initial information received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old male who was given diphtheria -15/tetanus/5 AC pertussis vaccine [Daptacel] at 3 years and 11 months instead of at 4 years-old, with no reported adverse event.  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 an unknown (dose 4) of suspect diphtheria -15/tetanus/5 AC pertussis vaccine, Suspension for injection (strength, lot number and expiry date - not reported) at 3 years and 11 months instead of at 4 years-old, with no reported adverse event) (inappropriate schedule of product administration) (unknown latency) via unknown route in unknown administration site for prophylactic vaccination.  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: Hives all over the body
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Fibromyalgia, Headache, Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; FIBRO FLARE; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number series 1). The patient was previously received with covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis. Patient didn't flare for the second injection (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-DEC-2022 for covid-19 prophylaxis which was off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On DEC-2022, the patient was sick with chills, headache, fatigue and fibro flare (Dose number in series 3). It was reported as "Johnson and Johnson I had the last booster on Thursday. I'm sick with headache and chills, fatigue. I'm fibro flaring brought on by booster. I didn't flare for the second injection." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fibro flare, and the outcome of headache, chills, fatigue and off label dosing frequency was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    Concomitant medications were not reported.  They reported their beyond use date was on 12Dec2022 but they discovered it on 17Dec2022. This case contains information for the patient 3 out of 10 adult patients. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    Concomitant medications were not reported.  They reported their beyond use date was on 12Dec2022 but they discovered it on 17Dec2022. This case contains information for the patient 7 out of 10 adult patients. Treatment medications were not reported.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DAPTACEL being administered to a patient over 7 years old instead of ADACEL. with no reported adverse event; DAPTACEL being administered to a patient over 7 years old instead of ADACEL. with no reported adverse event; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 47 years old female patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] being administered instead of Adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 16-Dec-2022, the patient administered with a Booster dose 1 at dosage 0.5mL of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, (lot number: C5828AA and Expiry date: 30-Mar-2023) (strength, frequency: not reported) via intramuscular route in the right deltoid for immunization over 7 years old instead of Adacel with no reported adverse event (product administered to patient of inappropriate age), (wrong product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for 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: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Tinnitus, has increased after each vaccination (original and boosters), occured within a day of shot. Has worsened after getting covid
Age: 0.75
Sex: F
Vaccine: DTPPVHBHPB, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Double dose of HIB was given on 12/19/22 due to using Vaxelis Combo vaccine as well as ActHIB vaccine
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: localized redness, swelling, and warmth just below injection site. sore, but no real pain nor itching. advised to monitor and to contact dr if it gets worse or does not improve.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Mild
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: Flushing, Hyperhidrosis, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site swelling, Lymph node pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: painful for 2-3 days and lymph nodes were swollen hard had to go for scans-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: pt only told me yesterday of this reaction in february 2022 she said she still has swollen lymph nodes
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: painful for 2-3 days and lymph nodes were swollen hard had to go for scans-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: pt only told me yesterday of this reaction in february 2022 she said she still has swollen lymph nodes
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Headache, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Headache-Mild, Additional Details: eyes swollen. headache. took benadryl and advil.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Electrocardiogram, Endocarditis, Magnetic resonance imaging, Mitral valve incompetence
Clinical narrative: Inflamation around my heart, had to take medication. Diagnosed with a heart murmer, mitral and tricuspid regurgitation.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence
Clinical narrative: Inflamation around my heart, had to take medication. Diagnosed with a heart murmer, mitral and tricuspid regurgitation.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case   All Pfizer dose 1 1/14/21  EL3249 dose 2 2/4/21  EM9810 dose 3 10/14/21  FH8020 dose 4 5/23/22  FM7553
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received 0.2 mL of undiluted vaccine (Pfizer-BioNTech Covid-19 Vaccine, FT9142, 1/2022).  Received 6 mcg instead of 3 mcg.  Family informed after vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: CHILLS, SWEATY
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Injection site warmth, Rash
Clinical narrative: Received flu shot on Tuesday (12/13/2022). Tuesday patient states that she had a large reddened area at the injection site in the shape of an eye. It was warm to touch and had a knot under it. On Thursday on (12/15/2022) began to break out in a rash under bilateral arms, bilateral thighs, and behind bilateral knees. Patient states that they did itch but she takes allergy medication and patient states that she typically has a reaction to immunizations when given.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient presented for routine visit with provider, provider noted the patient received a monkey pox vaccine #1 in August but it was not marked at administered . provider also noticed when viewing the chart that the patient had several bicillin and cefriaxone medication administration that were given but not marked as done so no documentation was noted.
Age: 93.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac arrest, Cardiac dysfunction, Cardiac pacemaker insertion, Endotracheal intubation, Implantable defibrillator insertion
Clinical narrative: sudden cardiac arrest, ems response, transported to hospital, intubation and restore heart function, four days in ccu, diagnosis myocarditis from the booster, left ventricle 35 percent function, pacemaker  and defibrillator installed, one week in hospital  discharged with medication and restrictions
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Intensive care, Myocarditis
Clinical narrative: sudden cardiac arrest, ems response, transported to hospital, intubation and restore heart function, four days in ccu, diagnosis myocarditis from the booster, left ventricle 35 percent function, pacemaker  and defibrillator installed, one week in hospital  discharged with medication and restrictions
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID breakthrough case
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm still painful with motion issues in shoulder down to elbow
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. Patient given Moderna Monovalet booster instead of Moderna bivalent booster. Patient notified.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gastric haemorrhage
Clinical narrative: Stomach bleeding
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lip swelling
Clinical narrative: Swollen lips
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. Patient given Moderna Monovalet booster instead of Moderna bivalent booster. Patient notified.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given the 2nd dose of Moderna 16 days early, Patient did not have any adverse reaction to the vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Oropharyngeal pain
Clinical narrative: I tested positive on November 29 I had fever, ache, cough, and sore throat. This lasted until December 1 and I lost my smell and taste for 11 days. I did take MOTRIN periodically for the fever. On December 9 I tested negative and was fully recovered.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: I tested positive on November 29 I had fever, ache, cough, and sore throat. This lasted until December 1 and I lost my smell and taste for 11 days. I did take MOTRIN periodically for the fever. On December 9 I tested negative and was fully recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. Patient given Moderna Monovalet booster instead of Moderna bivalent booster. Patient notified.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Echocardiogram, Heart rate increased, Hypertension
Clinical narrative: High Heart rate while resting (115bpm - 125bpm) in bed and high blood pressure (140/100). Never had these problems before, blood pressure has always been normal up till the second vaccination. To try to treat this condition I have lost weight per recommendation of my cardiologist as well as maintained a low sodium diet however the symptoms are still there. I have recently started taking a Beta blocker to maintain HR and BP as a band-aid fix to my issues.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound kidney
Clinical narrative: High Heart rate while resting (115bpm - 125bpm) in bed and high blood pressure (140/100). Never had these problems before, blood pressure has always been normal up till the second vaccination. To try to treat this condition I have lost weight per recommendation of my cardiologist as well as maintained a low sodium diet however the symptoms are still there. I have recently started taking a Beta blocker to maintain HR and BP as a band-aid fix to my issues.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine break though case
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Patient who is an adult was given 0.25mL of the Moderna Bivalent COVID booster vaccine, which is less than the authorized dose of 0.50mL. No adverse events were noted at the time of the administration.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. Patient given Moderna Monovalet booster instead of Moderna bivalent booster. Patient notified.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. Patient given Moderna Monovalet booster instead of Moderna bivalent booster. Patient notified.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anosmia, COVID-19, Chills, Ear pain, Exposure to SARS-CoV-2
Clinical narrative: I caught what I thought was  a cold and then began to feel not well. I had a low grade fever, chills, a very bad headache, my ears hurt as well. I had another family member test positive for COVID-19 after testing myself I tested positive for COVID-19 as well. This the second time I tested positive for COVID-19 and it is much worse this time with multiple symptoms.  Loss of smell or smell and taste disorder as well.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Influenza virus test negative, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I caught what I thought was  a cold and then began to feel not well. I had a low grade fever, chills, a very bad headache, my ears hurt as well. I had another family member test positive for COVID-19 after testing myself I tested positive for COVID-19 as well. This the second time I tested positive for COVID-19 and it is much worse this time with multiple symptoms.  Loss of smell or smell and taste disorder as well.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Taste disorder
Clinical narrative: I caught what I thought was  a cold and then began to feel not well. I had a low grade fever, chills, a very bad headache, my ears hurt as well. I had another family member test positive for COVID-19 after testing myself I tested positive for COVID-19 as well. This the second time I tested positive for COVID-19 and it is much worse this time with multiple symptoms.  Loss of smell or smell and taste disorder as well.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pfizer bivalent was given to 5yr old instead of dose 2 of the primary series. No adverse events. No further action indicated.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. Patient given Moderna Monovalet booster instead of Moderna bivalent booster. Patient notified.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: A 76-YEAR-OLD FEMALE PATIENT REFERS ITCHING IN THE PUNCTURE AREA, SYMPTOM THAT REFERS IMPROVEMENT WHEN REMOVING ADHESIVE BANDAGE.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 5/10/21, 6/7/21, 9/16/21. Positive on 12/21/22
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction. Patient given Moderna Monovalent booster instead of Moderna bivalent booster. Patient notified.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Biopsy muscle normal, Central nervous system lesion, Gait inability, Laboratory test
Clinical narrative: After both vaccines I got a fever, body aches, nausea, a sore arm, and swollen lymph nodes. In March, 1 month after my vaccine, I began having debilitating chronic pain in both legs. Primarily nerve pain. I went to the hospital for this numerous times and saw countless doctors, but no one was able to figure it out. I was given medications to try and help with these symptoms. A year and a few months after, I woke up one morning unable to walk and was hospitalized for 5 days. Lesions were found in my brain and spine and I was sent home with a walker. I completed PT for months twice a week and eventually stepped down to a cane and then nothing. I was diagnosed with MS in September of 2022.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lumbar puncture, Lymphadenopathy, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Multiple sclerosis
Clinical narrative: After both vaccines I got a fever, body aches, nausea, a sore arm, and swollen lymph nodes. In March, 1 month after my vaccine, I began having debilitating chronic pain in both legs. Primarily nerve pain. I went to the hospital for this numerous times and saw countless doctors, but no one was able to figure it out. I was given medications to try and help with these symptoms. A year and a few months after, I woke up one morning unable to walk and was hospitalized for 5 days. Lesions were found in my brain and spine and I was sent home with a walker. I completed PT for months twice a week and eventually stepped down to a cane and then nothing. I was diagnosed with MS in September of 2022.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neuralgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: After both vaccines I got a fever, body aches, nausea, a sore arm, and swollen lymph nodes. In March, 1 month after my vaccine, I began having debilitating chronic pain in both legs. Primarily nerve pain. I went to the hospital for this numerous times and saw countless doctors, but no one was able to figure it out. I was given medications to try and help with these symptoms. A year and a few months after, I woke up one morning unable to walk and was hospitalized for 5 days. Lesions were found in my brain and spine and I was sent home with a walker. I completed PT for months twice a week and eventually stepped down to a cane and then nothing. I was diagnosed with MS in September of 2022.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user
Clinical narrative: After both vaccines I got a fever, body aches, nausea, a sore arm, and swollen lymph nodes. In March, 1 month after my vaccine, I began having debilitating chronic pain in both legs. Primarily nerve pain. I went to the hospital for this numerous times and saw countless doctors, but no one was able to figure it out. I was given medications to try and help with these symptoms. A year and a few months after, I woke up one morning unable to walk and was hospitalized for 5 days. Lesions were found in my brain and spine and I was sent home with a walker. I completed PT for months twice a week and eventually stepped down to a cane and then nothing. I was diagnosed with MS in September of 2022.
Age: 17.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient is 17 years old and was administered an intradermal vaccine instead of recommended subcutaneous vaccine for people <18 years old
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient went in for First Monovalent Pfizer Vaccine. Pharmacy ensured that they were administering Monovalent First Dose, Pharmacist administering dose knowingly gave patient Bivalent Pfizer Booster instead on the Monovalent First Dose.   Patient did NOT have adverse reaction to Bivalent dose that was given.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Janssen 3/11/21, Moderna 11/1/21, 11/2/22, 7/22/22. Positive on 12/14/22
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Rash, Rash macular, Rash papular
Clinical narrative: Son had red splotchiness by the injection site on his arm, and  it was itchy so he scratched in the evening the day after the injection. He woke parents up after midnight that night complaining of hives which were all over his body, especially located around mid section of torso. Hives were raised and bubble like and extremely uncomfortable. No fever accompanied hives. Father took him to the ER where he received steroids. Hives disappeared over the following week but reappeared sporatically on and off for 2 weeks. He has an appointment for skin testing on January 25th, 2023.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular, Urticaria
Clinical narrative: Son had red splotchiness by the injection site on his arm, and  it was itchy so he scratched in the evening the day after the injection. He woke parents up after midnight that night complaining of hives which were all over his body, especially located around mid section of torso. Hives were raised and bubble like and extremely uncomfortable. No fever accompanied hives. Father took him to the ER where he received steroids. Hives disappeared over the following week but reappeared sporatically on and off for 2 weeks. He has an appointment for skin testing on January 25th, 2023.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Influenza virus test positive, Nasal congestion, SARS-CoV-2 test positive, Sinus headache
Clinical narrative: I was around my granddaughter, who had a sinus infection. I thought that was what I was getting as well. When I went to Urgent Care, they decided to do a Flu and Covid-19 test and it came back positive. I only had a bit of nasal congestion and a sinus headache. I was given Paxlovid. I guess it helped because my symptoms were gone within a day or two.