chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Infected with COVID and experiencing symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Infected with COVID and experiencing symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Infected with COVID and experiencing symptoms). At the time of the report, COVID-19 (Infected with COVID and experiencing symptoms) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter. COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old  patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning an unknown-year-old  patient with no clinical history who experienced the unexpected event of COVID-19 (AESI) The event occurred unknown days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: I am currently experiencing Covid-19 or Omicron symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I am currently experiencing Covid-19 or Omicron symptoms.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced SUSPECTED COVID-19 (I am currently experiencing Covid-19 or Omicron symptoms.). At the time of the report, SUSPECTED COVID-19 (I am currently experiencing Covid-19 or Omicron symptoms.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.  Paitent reported their scheduled planning about Moderna booster on Jan 3rd. but  currently experiencing Covid-19 or Omicron symptoms. Also  a rapid test scheduled for Friday, Dec 31st.  Paitent stated about Query that If the test positive should  go ahead with the booster on Monday, January 3rd? If no, how long should need wait before getting booster? as well as If the test negative should  go ahead with the booster on Monday?.   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up received contain non-significant information contact info updated.; Sender's Comments: This case concerns a patient of an unknown age and gender with no reported medical history, who experienced the non-serious, unexpected AESI of Suspected COVID-19. The event of occurred after an unknown dose sequence of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive after two doses of Moderna Vaccine/tested positive for COVID; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive after two doses of Moderna Vaccine/tested positive for COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (Tested positive after two doses of Moderna Vaccine/tested positive for COVID). At the time of the report, COVID-19 (Tested positive after two doses of Moderna Vaccine/tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medications reported by reporter No treatment medications provided by the reporter. COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old male patient with no clinical history who experienced the unexpected events of COVID-19  The events occurred unknown days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority    Reporter did not allow further contact; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old male patient with no clinical history who experienced the unexpected events of COVID-19  The events occurred unknown days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat; Cold; He was exposed to covid; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Cold), COVID-19 (He was exposed to covid) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Cold), COVID-19 (He was exposed to covid) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASOPHARYNGITIS (Cold), COVID-19 (He was exposed to covid) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.  Patient was exposed to COVID that past weekend, he was exposed over Friday, Saturday and Sunday. Patient was not sure, he thought it might be just a cold.  Company comment:This is a spontaneous case concerning a  65-year-old male patient with no medical history reported, who experienced the non serious unexpected events of Oropharyngeal pain, Nasopharyngitis, and expected event of Headache. These events occurred on an unspecified date in December 2021. In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).The rechallenge was unknown since there's only information about first dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  65-year-old male patient with no medical history reported, who experienced the non serious unexpected events of Oropharyngeal pain, Nasopharyngitis, and expected event of Headache. These events occurred on an unspecified date in December 2021. In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine).The rechallenge was unknown since there's only information about first dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: Tested covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested covid positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested covid positive). At the time of the report, COVID-19 (Tested covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient was part of Moderna clinical study for the booster dose. No concomitant medication reported. No treatment medication details reported. Company comment: This is a spontaneous case concerning a unknown age, female patient with no medical history reported, who experienced the non- serious unexpected, according RA, AESI of COVID-19. The event occurred after the unknown dose of mRNA-1273 vaccine. The rechallenge was not applicable.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a unknown age, female patient with no medical history reported, who experienced the non- serious unexpected, according RA, AESI of COVID-19. The event occurred after the unknown dose of mRNA-1273 vaccine. The rechallenge was not applicable.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: One week before getting the second Moderna shot husband got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (One week before getting the second Moderna shot husband got covid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (One week before getting the second Moderna shot husband got covid). At the time of the report, COVID-19 (One week before getting the second Moderna shot husband got covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was provided. It was reported that patient  waited to get  second shot in December since he had COVID-19 one week before the second shot. Company comment: This is a spontaneous case concerning a 65-year-old, male patient with no  medical history reported, who experienced the non- serious unexpected, according CCDS, AESI of COVID-19. The event occurred after the first dose of mRNA-1273 vaccine. The rechallenge is unknown, as the outcome of the event after the first dose has not been reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     This case was linked to MOD-2021-435269 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65-year-old, male patient with no  medical history reported, who experienced the non- serious unexpected, according to tj, AESI of COVID-19. The event occurred after the first dose of mRNA-1273 vaccine. The rechallenge is unknown, as the outcome of the event after the first dose has not been reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had a maderna booster and in that same day found out I had COVID; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Dec-2021 and was forwarded to Moderna on 31-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Had a maderna booster and in that same day found out I had COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had a maderna booster and in that same day found out I had COVID). At the time of the report, COVID-19 (Had a maderna booster and in that same day found out I had COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Found COVID-19..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID infection (omicron) after the booster; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID infection (omicron) after the booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID infection (omicron) after the booster). At the time of the report, COVID-19 (COVID infection (omicron) after the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter Company comment: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the non- serious unexpected, according, AESI of COVID-19. The event occurred after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning unknown age and gender patient with no medical history reported, who experienced the non- serious unexpected, according, AESI of COVID-19. The event occurred after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site). At the time of the report, VACCINATION SITE HAEMORRHAGE (While getting my Moderna booster, the technician jabbed the needle very hard into my arm. There was blood at the injection site. Is this OK Should it bleed at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.  Patient reported that while getting the Moderna booster, the technician jabbed the needle very hard into the arm and there was blood at the injection site.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling ill; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (feeling ill) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced MALAISE (feeling ill). At the time of the report, MALAISE (feeling ill) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Anxiety, Illness, Nucleic acid test
Clinical narrative: I was feeling ill that evening; I was feeling ill that evening, and am worried; Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was feeling ill that evening), ANXIETY (I was feeling ill that evening, and am worried) and ACCIDENTAL OVERDOSE (Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 038C21A and 026C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 11-Nov-2020. Concurrent medical conditions included Grass allergy.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021 at 10:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced ILLNESS (I was feeling ill that evening), ANXIETY (I was feeling ill that evening, and am worried) and ACCIDENTAL OVERDOSE (Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.). On 28-Dec-2021, ACCIDENTAL OVERDOSE (Was injected with an immunocompromised dosage of the Moderna shot instead of my intended regular booster.) had resolved. At the time of the report, ILLNESS (I was feeling ill that evening) and ANXIETY (I was feeling ill that evening, and am worried) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2020, Nucleic acid test: positive (Positive) tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.  Patient  have had COVID and received 2 full doses of the Moderna vaccine, and now have received the incorrect vaccine. The patient height was 180 cm.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered 1st dose of the moderna vaccine to a 11-year-old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of the moderna vaccine to a 11-year-old patient) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of the moderna vaccine to a 11-year-old patient). On 09-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of the moderna vaccine to a 11-year-old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The HCP stated that the patient did not have any adverse reactions.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (low grade fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered with exp date 24 Oct 21; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered with exp date 24 Oct 21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered with exp date 24 Oct 21). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Vaccine administered with exp date 24 Oct 21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter No treatment information provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: booster have to same portion as Moderna 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (booster have to same portion as Moderna 2nd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE in April 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced OFF LABEL USE (booster have to same portion as Moderna 2nd shot). At the time of the report, OFF LABEL USE (booster have to same portion as Moderna 2nd shot) had resolved.            No concomitant medication were reported   No treatment information was reported
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pruritus, Skin discomfort, Urticaria
Clinical narrative: Hives; skin writing, where if you scratch your skin it resulted in hives; It was strong itching; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), SKIN DISCOMFORT (skin writing, where if you scratch your skin it resulted in hives), PRURITUS (It was strong itching), CHILLS (chills) and MYALGIA (body aches) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 048B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced CHILLS (chills) and MYALGIA (body aches). On 13-Dec-2021, the patient experienced URTICARIA (Hives), SKIN DISCOMFORT (skin writing, where if you scratch your skin it resulted in hives) and PRURITUS (It was strong itching). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives) was resolving and SKIN DISCOMFORT (skin writing, where if you scratch your skin it resulted in hives), PRURITUS (It was strong itching), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient sometimes  take treatment medications Zyretic and Benadryl at night, depending on whether the hives start back up that evening. No concomitant medications were reported.   This case was linked to MOD-2022-443685 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: booster shot office gave them .5 dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (booster shot office gave them .5 dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (booster shot office gave them .5 dose.). At the time of the report, ACCIDENTAL OVERDOSE (booster shot office gave them .5 dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported  Patient got his booster shot instead of getting .25 dose
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2022-445032, MOD-2022-445046 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: booster dose given to one patient where vial had been punctured for approximately 50hrs; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster dose given to one patient where vial had been punctured for approximately 50hrs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster dose given to one patient where vial had been punctured for approximately 50hrs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (booster dose given to one patient where vial had been punctured for approximately 50hrs) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue
Clinical narrative: she did not pay much attention; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (she did not pay much attention) and FATIGUE (Really tired) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002331) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (she did not pay much attention) and FATIGUE (Really tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, DISTURBANCE IN ATTENTION (she did not pay much attention) and FATIGUE (Really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2022-443324, MOD-2022-443290 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hot flush, Illness, Inappropriate schedule of product administration
Clinical narrative: flu like symptoms; achy; burst of hot flashes; The booster shots of the Moderna was given after two doses of the Pfizer; sick; worse headache; 102 fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy), HOT FLUSH (burst of hot flashes), ILLNESS (sick) and HEADACHE (worse headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccines (Both doses). Past adverse reactions to the above products included No adverse event with Pfizer vaccines.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The booster shots of the Moderna was given after two doses of the Pfizer). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy), HOT FLUSH (burst of hot flashes), ILLNESS (sick), HEADACHE (worse headache) and PYREXIA (102 fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 05-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The booster shots of the Moderna was given after two doses of the Pfizer) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy) and HOT FLUSH (burst of hot flashes) outcome was unknown and ILLNESS (sick), HEADACHE (worse headache) and PYREXIA (102 fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         No relevant concomitant medications were reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; achy; burst of hot flashes; The booster shots of the Moderna was given after two doses of the Pfizer; sick; worse headache; 102 fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy), HOT FLUSH (burst of hot flashes), ILLNESS (sick) and HEADACHE (worse headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer vaccines (Both doses). Past adverse reactions to the above products included No adverse event with Pfizer vaccines.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The booster shots of the Moderna was given after two doses of the Pfizer). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy), HOT FLUSH (burst of hot flashes), ILLNESS (sick), HEADACHE (worse headache) and PYREXIA (102 fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 05-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The booster shots of the Moderna was given after two doses of the Pfizer) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achy) and HOT FLUSH (burst of hot flashes) outcome was unknown and ILLNESS (sick), HEADACHE (worse headache) and PYREXIA (102 fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid vaccine negative response; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Covid vaccine negative response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Covid vaccine negative response). At the time of the report, VACCINATION COMPLICATION (Covid vaccine negative response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Product dose omission issue
Clinical narrative: Patient have not received the second dose yet; feeling bad all day, during one day; headache, during one day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad all day, during one day), HEADACHE (headache, during one day) and PRODUCT DOSE OMISSION ISSUE (Patient have not received the second dose yet) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure) and Anxiety.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad all day, during one day), HEADACHE (headache, during one day) and PRODUCT DOSE OMISSION ISSUE (Patient have not received the second dose yet). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (feeling bad all day, during one day), HEADACHE (headache, during one day) and PRODUCT DOSE OMISSION ISSUE (Patient have not received the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took a low dose of a medication for high blood pressure and antianxiety medicine. She did not remember the medications names.  The patient received the first dose at the end of March 2021. The patient received the vaccine in right arm (non-dominant).  The patient wanted to know the most time between the first shot and the second shot and she wanted to know if she can receive the second dose or go back and receive the first dose again.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin irritation, Urticaria
Clinical narrative: very bad hives/itchy welts on skin; red resin spot comes and gets irritated; itchy welts on skin; she scratches it, there is a red resin spot that comes and gets very irritated; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (very bad hives/itchy welts on skin), ERYTHEMA (red resin spot comes and gets irritated), PRURITUS (itchy welts on skin) and SKIN IRRITATION (she scratches it, there is a red resin spot that comes and gets very irritated) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, SPIRONOLACTONE for an unknown indication.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (very bad hives/itchy welts on skin), ERYTHEMA (red resin spot comes and gets irritated), PRURITUS (itchy welts on skin) and SKIN IRRITATION (she scratches it, there is a red resin spot that comes and gets very irritated). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, URTICARIA (very bad hives/itchy welts on skin), ERYTHEMA (red resin spot comes and gets irritated), PRURITUS (itchy welts on skin) and SKIN IRRITATION (she scratches it, there is a red resin spot that comes and gets very irritated) had not resolved.            It was reported that the treatment drug prednisone did not help much in resolving the adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: some side effects and they weren't significant; waited 5 moths to take the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some side effects and they weren't significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 5 moths to take the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (some side effects and they weren't significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 5 moths to take the second dose). At the time of the report, VACCINATION COMPLICATION (some side effects and they weren't significant) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 5 moths to take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant and treatment information were reported by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Palpitations
Clinical narrative: Experiences trouble breathing, and this happened for only an hour; Its been two times that they experiences  heart palpitations; Its been two times that they experiences chest pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Its been two times that they experiences  heart palpitations), CHEST PAIN (Its been two times that they experiences chest pain) and DYSPNOEA (Experiences trouble breathing, and this happened for only an hour) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PALPITATIONS (Its been two times that they experiences  heart palpitations) and CHEST PAIN (Its been two times that they experiences chest pain). On 07-Jan-2022 at 2:00 PM, the patient experienced DYSPNOEA (Experiences trouble breathing, and this happened for only an hour). On 07-Jan-2022 at 3:00 PM, DYSPNOEA (Experiences trouble breathing, and this happened for only an hour) had resolved. At the time of the report, PALPITATIONS (Its been two times that they experiences  heart palpitations) and CHEST PAIN (Its been two times that they experiences chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient experienced trouble breathing, which happened for only an hour and it happened between 2 to 3.  No concomitant medications were reported. No treatment information were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving dose from a vial that was left out open in room temperature for 24hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving dose from a vial that was left out open in room temperature for 24hours) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving dose from a vial that was left out open in room temperature for 24hours). On 07-Jan-2022 at 9:00 AM, EXPIRED PRODUCT ADMINISTERED (Receiving dose from a vial that was left out open in room temperature for 24hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported. Date the vial was initially stored in the refrigerator was on 05 Jan 2022 at 5 PM, first punctured on 06 Jan 2022 at  8 AM.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Myalgia, Rash
Clinical narrative: face getting red; little red rash on his face that started to grow; tiredness; sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (face getting red), RASH (little red rash on his face that started to grow), FATIGUE (tiredness) and MYALGIA (sore arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ERYTHEMA (face getting red), RASH (little red rash on his face that started to grow), FATIGUE (tiredness) and MYALGIA (sore arm). At the time of the report, ERYTHEMA (face getting red), RASH (little red rash on his face that started to grow), FATIGUE (tiredness) and MYALGIA (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medication was reported as none.  Treatment information  was reported as none.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Swelling
Clinical narrative: a little soreness on the arm; swelling in the armpit area; swelling of the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness on the arm), SWELLING (swelling in the armpit area) and LYMPHADENOPATHY (swelling of the lymph nodes) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), TRAZODONE and NORTRIPTYLINE for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little soreness on the arm), SWELLING (swelling in the armpit area) and LYMPHADENOPATHY (swelling of the lymph nodes). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Allergy NOS, at an unspecified dose and frequency; FAMOTIDINE at a dose of 21 milligram and PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little soreness on the arm), SWELLING (swelling in the armpit area) and LYMPHADENOPATHY (swelling of the lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include Birth control pill. No medical history was provided by the reporter.   This case was linked to MOD-2022-445637, MOD-2022-445638 (Patient Link).