chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Had my flu shot but still got the flu; Initial information received on 09-Nov-2022 regarding an unsolicited valid social-media non-serious case received from a consumer.  This case involves an patient with unknown age gender who experienced had my flu shot but still got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose, route, administration site and lot number not reported) for Flu.  On an unknown date the patient had developed a non-serious event had my flu shot but still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: physicians ordered fluzone high dose QIV for both patients and the nurse accidentally pulled and administered vaxelis with no reported adverse event; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 76 years old male patient who was reported with physicians ordered influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] for both patients and the nurse accidentally pulled and administered vaxelis with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Nov-2022, the patient received suspect influenza quadrival a-b high dose hv vaccine lot number not reported via unknown route in unknown administration site (strength, form, dosage, frequency, expiry date: unknown) for Immunization.  On 07-Nov-2022 the patient reported a non-serious event of physicians ordered influenza quadrival a-b high dose hv vaccine for both patients and the nurse accidentally pulled and administered vaxelis with no reported adverse event (wrong product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 62.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient who is 62 years old and was given fluzone high dose quadrivalent with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 62 years old male patient who was given Influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2022, the patient who was 62 received 0.5 ml dose (once) of suspect Influenza quadrival A-B high dose hv vaccine (lot UJ937AB, exp date: 30-Jun-2023) via intramuscular route in the right deltoid for immunistion with no reported adverse event (product administered to patient of inappropriate age) (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 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: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient was administered expired quadracel around a month after expiration date with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reportedlly patient was administered expired quadracel around a month after expiration date with no reported adverse event. (DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV) (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5763AA  and expiry date: 26-Aug-2022) (form, strength, dose, frequency: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient was administered expired quadracel around a month after expiration date with no reported adverse event(expired product administered) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: The patient had prostate cancer and wanted to know how long he should wait before going back to his oncologist to receive chemotherapy after being given the Yellow Fever vaccine with no reported adverse event; Initial information received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had prostate cancer and wanted to know how long he should wait before going back to his oncologist to receive chemotherapy after being given the Yellow fever vaccine - [YF-Vax] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Prostate cancer.  On an unknown date patient in the past received YF-Vax (dose, strength, formulation, strength, route, site and batch lot details: unknown) for Immunization. However, the nurse discovered later on that the patient had not been honest about his health history. The patient had prostate cancer and wanted to know how long he should wait before going back to his oncologist to receive chemotherapy after being given the Yellow Fever vaccine with no reported adverse events (contraindicated product administered) (unknown latency).  The patient and his wife were going on a cruise and came to their clinic to receive the vaccine. The caller thinks that the doctors refused to administer it to him. The patient came up, got the vaccine, and then went right back for the cruise. The caller was not positive as to whether this patient was still receiving cancer treatment at the time the vaccine was given, or if the patient had treatment in the past. This is situation is reported as a medication error due to the administration of YF Vax to a patient that it may have been contraindicated to administer.   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: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: vaccine was administered subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case from other health professional.  This case involves a 13 years old male patient to whom INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] was administered subcutaneously instead of intramuscularly with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), HPV VACCINE, HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) and MENINGOCOCCAL VACCINE for Immunisation.  On 24-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE at a dose of 0.5 ml once (lot UT7695LA, expiry date: 30-Jun-2023) via subcutaneous route in the left arm for prophylactic vaccination.  On 24-Oct-2022 the patient developed a non-serious vaccine was administered subcutaneously instead of intramuscularly with no reported adverse event (incorrect route of product administration, latency: same day).  It was reported that a patient was administered the vaccine with a 5/8 inch needle instead of the recommended needle and the vaccine was administered subcutaneously instead of intramuscularly. Wanting to know if the dose needs to be repeated.  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: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: has administered adacel to a patient that leaked out and spilled on the patient's arm, with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 35 years old female patient who Was administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] that leaked out and spilled on the patient's arm, 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 influenza vaccine RHA 3V (BACULOVIRUS) (Flublok) for Prophylactic vaccination.  On 07-Nov-2022, the patient received dose 5 of suspect standard diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at a dosage of 0.5 ml once (lot U7624AA, Expiry date - 06-Dec-2024) via intramuscular route in the left deltoid for Immunization.  On 07-Nov-2022 the patient developed a non-serious event of Was administered diphtheria-2/tetanus/5 ac pertussis vaccine that leaked out and spilled on the patient's arm, with no reported adverse event (accidental exposure to product) (latency: same day) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: was accidentally given Fluzone High Dose Quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine, with no reported adverse event; an 8 year old patient was accidentally given Fluzone High Dose Quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine with no reported averse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 8 years old male patient who was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine, with no reported adverse event and an 8 year old patient was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine with no reported averse event after receiving influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Nov-2022, the patient received a dose of 0.7 ml suspect influenza quadrival a-b high dose hv vaccine (formulation, strength, expiry date, lot number not reported) via unknown route in the left deltoid for immunization.  On 06-Nov-2022 the patient developed a non-serious events of was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine, with no reported adverse event (wrong product administered) and an 8 year old patient was accidentally given fluzone high dose quadrivalent in the left deltoid instead of an age-appropriate influenza vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 45.0
Sex: M
Vaccine: FLUC3
Symptoms: COVID-19, Hypersensitivity, Malaise, SARS-CoV-2 test positive
Clinical narrative: Symptomatic for COVID/Tested positive for COVID; Allergy; This spontaneous case was received on 26-Oct-2022 from Pfizer Inc. with additional information received on the same date (being process together) via Communications and concerned a 46-years-old, male patient.  The patient's concurrent condition included unspecified allergy. The patient's concomitant medications included: rosuvastatin, Fibercon (polycarbophil calcium) and escitalopram. The patient historical vaccines included three dosages of Moderna COVID-19 vaccine (elasomeran), received on 13-Jan-2021 (batch number: 012L20A), 11-Feb-2021 (batch number: 030620A) and 02-Nov-2021 (batch number: 032F21A), for unreported indication and with no adverse events reported.  On 22-Sep-2022, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml; anatomical location: right arm, route of administration: not reported) for prevention of influenza disease. The batch number was not reported.  On the same date, the patient was vaccinated with non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine, Bivalent (tozinameran, riltozinameran; dose: reported as 'four', anatomical location: left arm, route of administration and indication: not reported). The batch number reported was 6H9694.  On unspecified date in 2022, an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent, the patient experienced allergy.  On 01-Oct-2022, nine days after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent, the patient started to be symptomatic for COVID.   On 03-Oct-2022, the Nasal Swab (Binax) COVID-19 test was positive.  On 05-Oct-2022, the patient was tested for COVID-19, however, results were not provided.  At the time of initial reporting on 26-Oct-2022, the patient was recovering from the event COVID-19.  The outcome of the event allergy was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 46-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. Nine days later, the patient started to be symptomatic for COVID. An unknown amount of time after vaccination, the patient experienced allergy. Considering unclear chronology, causality is unassessable for the event of allergy. Based on biological implausibility, COVID-19 is assessed as not related to the suspect vaccine.; Sender's Comments: A 46-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. Nine days later, the patient started to be symptomatic for COVID. An unknown amount of time after vaccination, the patient experienced allergy. Considering unclear chronology, causality is unassessable for the event of allergy. Based on biological implausibility, COVID-19 is assessed as not related to the suspect vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered after a temperature excursion to one patient; This spontaneous report was received from licensed practical nurse and refers to a patient of unknown age and gender.  Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided..  On 14-OCT-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, once, lot #W012165, expiration date: 12-APR-2024, administered for prophylaxis (strength, and route of administration were not provided).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 48 degree fahrenheit for 23 hours and 45 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the vaccine and got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: This case was reported by a patient's son/daughter via interactive digital media. The patient received a dose of Shingles vaccine and got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: almost didn't hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer case US2022AMR164334).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR164334   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: : This case was reported by a patient via interactive digital media. The patient just got the second dose of Shingles vaccine and experienced pain. The patient also stated that it almost didn't hurt, it went very bad with the first one, but he/she was fine at the time of reporting.  The patient's doctor told him/her that he/she could get a shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR164334:same reporter and patient
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: it went very bad with the 1st; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR164330   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received 1st dose of Shingles vaccine and it went very bad with the first one, but he/she was fine at the time of reporting.  The patient's doctor told him/her that he/she could get a shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available. Note: In narrative it was mentioned as after 2nd dose it almost didn't hurt but it was not clear whether patient hurt after 1st dose also, hence only feeling bad event was captured in the case.; Sender's Comments:  US-GSK-US2022AMR164330:same reporter and patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient was already vaccinated, although it hurts, but it was better to be safe than sorry. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medication was reported.     27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 4th of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml. No treatment information was provided by the reporter.  This case contains information for the 17 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medication was reported.     27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was reported.  This case contains information for the 21 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported. 27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5ml.                                 No treatment information was provided by the reporter. This case contains information for the 20 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant product use was not provided by the reporter.  27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.  Treatment information was not provided.  This case contains information for the 6th of 27 adult patients described by the reporter.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID approximately 7 months after second shot.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID approximately 8 months after last vaccine
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID on 12/31/2021.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Patient was administered expired PNEUMOVAX 23 via PNEUMOVAX 23 Prefilled Syringe on 11/07/2022; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 07-NOV-2022, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U010534, expiration date: 31-OCT-2022, administered for prophylaxis (strength, dosing schedule, and route of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received doses after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and NO ADVERSE EVENT (No adverse event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030g22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses after its beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 (received doses after its beyond use date).    No concomitant medication information was provided.  It was reported that Individual vials or unbroken cartons was in the box, Vial size was 2.5ml Date the vial was initially stored in the refrigerator was 03-Oct-2022. Vial did not undergo any temperature excursions. No treatment medications were provided.     Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2022: Live follow up received included patient information.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Migraine, Nervous system disorder, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: parasethsia, migraine-Severe, Systemic: Headache-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cold sweat, Dizziness, Flushing, Hyperhidrosis, Tachycardia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient felt they were going to pass out. assisted to floor. called 911. vitals good. slight tachycardia. clammy skin resolved quickly. patient commented they thought their blood sugar was low. administered glucose tablet. patient went to emergency room as precaution- was being discharged when follow up call was made- event approx 12:05pm. discharge approx 2:30pm
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient felt they were going to pass out. assisted to floor. called 911. vitals good. slight tachycardia. clammy skin resolved quickly. patient commented they thought their blood sugar was low. administered glucose tablet. patient went to emergency room as precaution- was being discharged when follow up call was made- event approx 12:05pm. discharge approx 2:30pm
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Feeling hot, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was exhibiting symptoms of syncope: sweatiness, hot, dizziness, and also vomited. BP was 111/62 HR 65. We have her water and monitored for an additional 10 minutes. She felt better after throwing up and drinking water. She also received her flu vaccine that day.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was exhibiting symptoms of syncope: sweatiness, hot, dizziness, and also vomited. BP was 111/62 HR 65. We have her water and monitored for an additional 10 minutes. She felt better after throwing up and drinking water. She also received her flu vaccine that day.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash went from just above the injection site down to the elbow and was hot to the touch. A goose egg also developed at the bend of the elbow. Benadryl helped to resolve symptoms
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Mass, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash went from just above the injection site down to the elbow and was hot to the touch. A goose egg also developed at the bend of the elbow. Benadryl helped to resolve symptoms
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: Pt claims chills, weakness, headache, and difficulty walking since recieving vaccination. Has not had this issue with prior vaccines.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Lethargy, Pain, Pyrexia, Tremor
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: Pt claims chills, weakness, headache, and difficulty walking since recieving vaccination. Has not had this issue with prior vaccines.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deafness, Dizziness, Flushing, Hyperhidrosis, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: also stated "could not hear"
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Confusional state, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Medium
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: TINGLING SENSATION/ NUMBENESS-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: PT REPORTS SHE COULD NOT MAKE A FIST WITH HER LEFT ARM. TINGLING SENSATION/ NUMBNESS THIS STARTED 24 HOURS POST VACCINE AND LASTED FOR ABOUT 2-3 MINS
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Underdose
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: she heard a pop during injection-Mild, Additional Details: patient did not receive full dose of vaccine as she jumped out of chair during vaccination and needle came out of arm. she received only part of the dose and she said she heard a pop.  she immediatelyleft the pharmacy . pharmacist asked her to stay for 15minutes and patient refused.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 17.0
Sex: F
Vaccine: FLUC4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: known issue of fainting when pt experiences events involving needles. mother and pcp are both aware of recovery.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for a Pfizer Bivalent booster. Received a regular Pfizer in error.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was vaccinated with full dose of Moderna Bivalent vaccine by mistake. Patient was kept for 30 minutes of observation, but no adverse event was reported or noticed. We also reached out to the patient on 11/14/22 and family stated patient was doing well, with no adverse effects reported.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Flushing, Skin warm
Clinical narrative: flushing Narrative:  Pt received Pfizer COVID vaccine and reported feeling dizzy with red face and flushed. Pt was lightheaded and warm to the touch with redness in the face increasing over time. VS stable. Pt was sent to ER at 11:55am, stable and discharged to home at 1pm. Pt reported feeling well the next day and is scheduled for repeat dose on 01/31/2021.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Pericarditis, Ultrasound scan
Clinical narrative: PERICARDITIS
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: patient received a second flu shot this year
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Tired, muscle pain, headache, shivering, fever, stomach pain, kidney pain, nausea & diarrhea
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia, Renal pain
Clinical narrative: Tired, muscle pain, headache, shivering, fever, stomach pain, kidney pain, nausea & diarrhea
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Asthenia, Blood creatinine increased, Blood culture, Blood gases
Clinical narrative: Patient is a 70-year-old female with history of atrial fibrillation on Eliquis and Plavix, hypertension, hypothyroidism presenting to the emergency department via EMS from home for altered mental status and decreased oxygenation.  Patient has been feeling well for the past 3 days, she went to take a nap today and rolled out of bed, her sister who she lives with heard her and called 911.  Upon EMS arrival to patient's home, they found patient's oxygen to be in the low 80s, they placed her on a nonrebreather with an oxygen saturation in the 90s.  Patient denies any injury or pain from rolling out of bed.  She does states she has had a cough and fatigue over the past 3 days along with decreased appetite.  She denies nausea, vomiting, diarrhea or abdominal pain.  She does not normally wear oxygen at home.  She is somewhat a poor historian as she keeps falling asleep during my exam. Associated Symptoms: bruise easily, cough, fatigue, shortness of breath, weakness
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood lactic acid increased, Blood test abnormal, Brain natriuretic peptide increased, COVID-19
Clinical narrative: Patient is a 70-year-old female with history of atrial fibrillation on Eliquis and Plavix, hypertension, hypothyroidism presenting to the emergency department via EMS from home for altered mental status and decreased oxygenation.  Patient has been feeling well for the past 3 days, she went to take a nap today and rolled out of bed, her sister who she lives with heard her and called 911.  Upon EMS arrival to patient's home, they found patient's oxygen to be in the low 80s, they placed her on a nonrebreather with an oxygen saturation in the 90s.  Patient denies any injury or pain from rolling out of bed.  She does states she has had a cough and fatigue over the past 3 days along with decreased appetite.  She denies nausea, vomiting, diarrhea or abdominal pain.  She does not normally wear oxygen at home.  She is somewhat a poor historian as she keeps falling asleep during my exam. Associated Symptoms: bruise easily, cough, fatigue, shortness of breath, weakness