chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Followup received wherein the patient age group and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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)) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Dose was reported as Additional Booster. No concomitant medications was reported. No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live non-significant follow up appended
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sick; Initial information received on 27-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who received INFLUENZA VACCINE and still got sick.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE for Immunisation.  On an unknown date, the patient received a Unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, Expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the even.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and gender patient who got the flu after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient got the flu (influenza) (latency: unknown) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  The outcome was Unknown.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac arrest, Resuscitation
Clinical narrative: Pt presented to the ED CPR in progress after apparent cardiac arrest at home.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Antibody test, COVID-19, COVID-19 immunisation, Renal transplant, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; HAD A KIDNEY TRANSPLANT; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) and concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient received non-company suspect vaccine included: elasomeran (Spikevax vaccine) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2).  On an unspecified date, the patient had a kidney transplant (dose number in series 2) and got tested for antibodies, which showed that the patient had not developed any antibodies, which was associated with suspected immunological vaccine failure (dose number in series 1). After one week, the patient became infected with COVID-19 (suspected covid-19 infection) (dose number in series 2). The reporter stated "I got JJ my first shot then the moderna got tested for antibodies because I have had a kidney transplant found out I didn't developed any antibodies. One week later I got covid-19. Lucky it was a mild case so I was ok ". The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the had a kidney transplant, suspected covid-19 infection, suspected immunological vaccine failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000264911.; Sender's Comments: V0-20221259453- Had a Kidney transplant-Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221259453-Suspected Immunological vaccination failure. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received- narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (an adult in her 40's received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28DEC2022).    The age of patient was reported as 40's.  Concomitant medications were not reported.  The patient had 2 primary doses more than 2 months ago and received a booster dose from a vial with NDC 80777-0275-05 instead of a Bivalent booster on 28-Dec-2022.  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: slight fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and FATIGUE (tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 014M21A and 003B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever) and FATIGUE (tired). At the time of the report, PYREXIA (slight fever) had resolved and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: After each shot patient had slight fever for a couple of hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment drug was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Contact was sick during this study; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Contact was sick during this study) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine.    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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Contact was sick during this study). At the time of the report, ILLNESS (Contact was sick during this study) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patients received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) 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 UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant medication was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received. Narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna COVID-19 Vaccine, Bivalent. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up information received: Added age group and updated narrative.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) 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 UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received age group, narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) 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 UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received age group, narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up document received includes no new information was added.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up appended where narrative updated
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) 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 UNDERDOSE (Vaccine underdose).    Concomitant medication was not provided. 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein Age group added and I narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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)) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent. It was unknown if patient received any other vaccines 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still got the flu; Initial information received on 27-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who reported still got the flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for flu (influenza).  On an unknown date, the patient reported still got the flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the strain of flu it didn't cover. Got Hospitalized; Initial information received on 28-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 got the strain of flu it (vaccine) didn't cover and got hospitalized after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (administration site, form, strength, frequency, route, expiry date, lot number not reported) for prophylactic vaccination.  On an unknown date the patient got the strain of flu it didn't cover. got hospitalized (influenza) (latency: unknown) after the administration of Influenza vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.  Seriousness criteria: event caused hospitalization for the Influenza; Sender's Comments: Sanofi Company Comment dated 30-Dec-2022: This case involves an unknown age and unknown gender patient who got the strain of flu it (vaccine) didn't cover and got hospitalized after receiving Influenza vaccine. The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, previous vaccination history, role of medical history, concomitants,  hospitalization details, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: i have the flu; sick; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu and sick after 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 dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date: unknown) not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious i have the flu (influenza) and sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster, Injection site pain
Clinical narrative: shingles; had a sore injection site; getting shingles is awful and mine could have been much worse; Initial information received on 29-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with shingles and had a sore injection site after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious shingles (herpes zoster), a sore injection site (vaccination site pain), getting shingles is awful and mine could have been much worse (condition aggravated) (unknown latency) following the administration of influenza vaccine.   It is unknown if there were lab data/results available  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event shingles and was Recovered / Resolved on an unknown date for the event had a sore injection site.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Every time I get the flu shot I get sick; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-helath care professional.  This case involves a patient of unknown demographics who every time get the flu shot, get sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for Flu(influenza). Information regarding batch number details has been requested.  On an unknown date the patient reported that every time i get the flu shot i get sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Every time I get the flu shot I get sick).  Outcome: Unknown
Age: 2.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 2.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 2.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 2.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Additional Details: Currently unsure on how many days symptoms will last due to having discovered error on day of reporting the event. Symptoms may last longer than the 1 day reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine involved in a temperature excrusion was administered; no additional adverse event; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006595, expiration date: 10-OCT-2024, administered as prophylaxis (strength, and route of administration were not provided) (Product storage error).  The vaccine was administered at a temperature of 57.49 Fahrenheit degrees for 1 hour and 45 minutes. No previous temperature excursions or additional adverse events were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 15 month old patient who was vaccinated on 30-NOV-2022 with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Amnesia, Extra dose administered, Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: This was followed by a dose of GARDASIL 9 on 10/12/2022; Therefore this AE is being filed as a full AE out of the possibility the patient has memory loss issues.; a dose of a 4 valent HPV vaccine in March 2016, followed by a dose of GARDASIL 9 in June of 2016.; the patient received a dose of an unspecified HPV vaccine in 2013 (at 20 years old), then a dose of a 4 valent HPV vaccine in March 2016, followed by a dose of GARDASIL 9 in June of 2016. This was followed by a dose of GARDASIL 9 on 10/12/2022; a dose of a 4 valent HPV vaccine in March 2016; an unspecified HPV vaccine in 2013; This spontaneous report has been received from an other health professional and refers a 20-year-old female patient. The information regarding the patient's concurrent conditions, concomitant therapies details and medical history was not provided.  On an unspecified date in 2013, the patient received a dose of an unspecified HPV vaccine (manufacturer unknown) (dose, strength, route of administration, anatomical location, lot# and expiration date were not reported) (Product origin unknown). On an unspecified date in March 2016, the patient received a dose of an unspecified 4-valent HPV vaccine (manufacturer unknown) (dose, strength, route of administration, anatomical location, lot# and expiration date were not reported) (Inappropriate schedule of product administration, Product origin unknown). On an unspecified date in June 2016, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location, lot# and expiration date were not reported) (Interchange of vaccine products). On 12-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location, lot# and expiration date were not reported) (extra dose administered). All vaccines were administered for prophylaxis.  The caller mentioned that something might not be right with the patient because she did not even remember receiving the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on 12-OCT-2022 (amnesia). The outcome of amnesia was not reported.  The causal relationship between amnesia and any of the suspect vaccines was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additonal AE's; A nurse reported that an expired dose of VAQTA pediatric vaccine was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 28-DEC-2022, the patient was vaccinated with expired dose of pediatric hepatitis a vaccine, inactivated (VAQTA) 25U intramuscular injection, lot #U031911 has been verified to be valid, expiration date was reported as 11-NOV-2022 for prevention of hepatitis A infection (dose, anatomical location, and route of administration were not provided) (expired product administered).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP states that ROTATEQ vaccine, that underwent a supported temperature excursion, was administered to a patient on Dec 27, 2022.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 27-DEC-2022, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # W010331, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 01-NOV-2023) (dose, anatomical location and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion (temperature: 8.9C, during 1 hour 49 minutes and 0 seconds) (Product storage error). The vaccine did not suffer previous temperature excursions.  No additional adverse events were reported.