chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive 7 months after vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive 7 months after vaccination) 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 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced COVID-19 (Tested positive 7 months after vaccination). On 15-Dec-2021, COVID-19 (Tested positive 7 months after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, SARS-CoV-2 test: positive (Positive) tested positive. On 15-Dec-2021, SARS-CoV-2 test: negative (Negative) tested negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Company comment: This is a  spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The events occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a  spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The events occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Intervertebral disc injury
Clinical narrative: inflammation in his joint; torn disc from basketball; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (inflammation in his joint) and INTERVERTEBRAL DISC INJURY (torn disc from basketball) 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 first 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. On an unknown date, the patient experienced ARTHRITIS (inflammation in his joint) and INTERVERTEBRAL DISC INJURY (torn disc from basketball). The patient was treated with MELOXICAM for Joint inflammation, at a dose of 1 UNK. At the time of the report, ARTHRITIS (inflammation in his joint) and INTERVERTEBRAL DISC INJURY (torn disc from basketball) outcome was unknown.            No concomitant medication reported.  This case concerns a male patient of an unknown age with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis, and other non-serious events. The event of occurred on an unknown interval after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was given. It was reported that the outcome of the events was unknown. Patient was treated with Meloxicam for joint inflammation, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis, and other non-serious events. The event of occurred on an unknown interval after receiving an unspecified and undated dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was given. It was reported that the outcome of the events was unknown. Patient was treated with Meloxicam for joint inflammation, no other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: tiredness; Headache; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), HEADACHE (Headache) and MYALGIA (Muscle Pain) 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 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), HEADACHE (Headache) and MYALGIA (Muscle Pain). At the time of the report, FATIGUE (tiredness), HEADACHE (Headache) and MYALGIA (Muscle Pain) outcome was unknown.            Concomitant medications were not reported.   The patient received his second dose of the Moderna vaccine yesterday, on 26-Feb-2021. He was scheduled for a deep tissue laser procedure and wanted to know whether it may affect the efficacy of the vaccine as he fears it may cause more side effects.   Treatment information was not reported.  He also wanted to know whether it was safe to take Advil or Tylenol and how long it takes for the vaccine to provide protection after the second dose. On 31-Dec-2021,MOD-2021-427838 became invalid as it was confirmed that the patient did not experience any adverse event following vaccine administration. Therefore, this case will be logically deleted from the safety database.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains no newinformation On 09-Jan-2022: Follow up received: In initial version missing valid criteria (adverse event) hence initially case was invalid but in FU version adverse event was reported which made the case valid. Added newevents
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Came down with a breakthrough COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Came down with a breakthrough COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 2021, the patient experienced COVID-19 (Came down with a breakthrough COVID). At the time of the report, COVID-19 (Came down with a breakthrough COVID) outcome was unknown. Not Provided          Concomitant products were not provided. Treatment medication were not reported.  No medical history was provided by the reporter.  Patient had a two-shot Moderna series (no booster) and recently came down with a breakthrough COVID case.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced non serious,  unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced non serious,  unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19/breakthrough infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19/breakthrough infection) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 044A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for COVID-19/breakthrough infection). At the time of the report, COVID-19 (Positive for COVID-19/breakthrough infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19 in the morning.         No concomitant medication was reported. The treatment information was not reported.  Company comment: This is a spontaneous case concerning a 62-year-old male  patient with no medical history reported, who experienced non serious, unexpected events of COVID-19 (AESI). The event occurred 1 month 24 days after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 62-year-old male  patient with no medical history reported, who experienced non serious, unexpected events of COVID-19 (AESI). The event occurred 1 month 24 days after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Reactions causing arthritis flairs, less to the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRITIS (Reactions causing arthritis flairs, less to 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 ARTHRITIS (Reactions causing arthritis flairs, less to the booster). At the time of the report, ARTHRITIS (Reactions causing arthritis flairs, less to the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines was reported.  No treatment medicines was reported.  This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis. The event of occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the second dose was given. It was reported that the outcome of the events was unknown. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-428053 (Patient Link). Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis. The event of occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the second dose was given. It was reported that the outcome of the events was unknown. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Eye colour change, SARS-CoV-2 test
Clinical narrative: inner corner of the eye is black and blue; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EYE COLOUR CHANGE (inner corner of the eye is black and blue) and COVID-19 (COVID-19) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A and 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced COVID-19 (COVID-19). On 27-Dec-2021, the patient experienced EYE COLOUR CHANGE (inner corner of the eye is black and blue). At the time of the report, EYE COLOUR CHANGE (inner corner of the eye is black and blue) had not resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication provided. Patient states no medical conditions or medications. Patient does not have a health insurance or PCP. Company comment: This spontaneous case concerns a 34-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event AESI of COVID-19. The event COVID-19 occurred five days after the second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 test: positive was performed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old female patient, with no medical history reported, who experienced the non-serious unexpected event AESI of COVID-19. The event COVID-19 occurred five days after the second dose of mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. A SARS-CoV-2 test: positive was performed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost my taste; lost my smell; This spontaneous case was reported by an other health care professional and describes the occurrence of AGEUSIA (lost my taste) and ANOSMIA (lost my smell) 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.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost my taste) and ANOSMIA (lost my smell). At the time of the report, AGEUSIA (lost my taste) and ANOSMIA (lost my smell) 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.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: This spontaneous case concerns a patient with no relevant medical history who experienced non-serious unexpected AESI of ageusia and anosmia, that occurred after the dose of the mRNA-1273.  The exact time to onset and dose number were not provided. The rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient with no relevant medical history who experienced non-serious unexpected AESI of ageusia and anosmia, that occurred after the dose of the mRNA-1273.  The exact time to onset and dose number were not provided. The rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Insomnia, Nausea
Clinical narrative: 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 HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired) and FEELING ABNORMAL (Feeling heavy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B212A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired), FEELING ABNORMAL (Feeling heavy), INSOMNIA (Insomnia/she will wake up at 3-4 am and won't be able to go back to sleep) and PETECHIAE (Petechiae on her abdominal/Petechiae on her chest). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired), FEELING ABNORMAL (Feeling heavy), INSOMNIA (Insomnia/she will wake up at 3-4 am and won't be able to go back to sleep) and PETECHIAE (Petechiae on her abdominal/Petechiae on her chest) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.  Company Comment: This case concerns a 58-year-old female, with no relevant reported medical history in this case, who experienced the non-serious unexpected AESI event of Petechiae. The event occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine. At the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-433967, MOD-2021-433568 (Patient Link).; Sender's Comments: This case concerns a 58-year-old female, with no relevant reported medical history in this case, who experienced the non-serious unexpected AESI event of Petechiae. The event occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine. At the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Pyrexia
Clinical narrative: 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 HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired) and FEELING ABNORMAL (Feeling heavy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B212A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired), FEELING ABNORMAL (Feeling heavy), INSOMNIA (Insomnia/she will wake up at 3-4 am and won't be able to go back to sleep) and PETECHIAE (Petechiae on her abdominal/Petechiae on her chest). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Feeling tired), FEELING ABNORMAL (Feeling heavy), INSOMNIA (Insomnia/she will wake up at 3-4 am and won't be able to go back to sleep) and PETECHIAE (Petechiae on her abdominal/Petechiae on her chest) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.  Company Comment: This case concerns a 58-year-old female, with no relevant reported medical history in this case, who experienced the non-serious unexpected AESI event of Petechiae. The event occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine. At the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-433967, MOD-2021-433568 (Patient Link).; Sender's Comments: This case concerns a 58-year-old female, with no relevant reported medical history in this case, who experienced the non-serious unexpected AESI event of Petechiae. The event occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine. At the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Infection
Clinical narrative: has an infection; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (has an infection) and COVID-19 (COVID-19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025J20A and 032L20A) for COVID-19 vaccination.     Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), LOSARTAN and AMLODIPINE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (has an infection) and COVID-19 (COVID-19). At the time of the report, INFECTION (has an infection) and COVID-19 (COVID-19) outcome was unknown.            No treatment medication provided.  Company comment:This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history provided, who experienced the non serious unexpected events of Covid-19 and Infection. The event of Covid-19 occurred approximatively  6 months after the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine).The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history provided, who experienced the non serious unexpected events of Covid-19 and Infection. The event of Covid-19 occurred approximatively  6 months after the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine).The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: pain in the back of her legs; pain in her left arm; body aches; COVID-19; 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 30-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the back of her legs), VACCINATION SITE PAIN (pain in her left arm), MYALGIA (body aches) and COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (The patient received the Pfizer vaccine for her primary series of the vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. In December 2021, the patient experienced COVID-19 (COVID-19). On 28-Dec-2021, the patient experienced PAIN IN EXTREMITY (pain in the back of her legs), VACCINATION SITE PAIN (pain in her left arm) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (pain in the back of her legs), VACCINATION SITE PAIN (pain in her left arm), MYALGIA (body aches) and COVID-19 (COVID-19) outcome was unknown.            No concomitant medication and treatment information was reported.  Company Comment: This case concerns a female patient of unknown age with a history of tozinameran COVID-19 vaccine who experienced the unexpected adverse event of special interest of COVID-19 which occurred on an unknown date relative to vaccination with mRNA-1273 administered as a booster third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This case concerns a female patient of unknown age with a history of tozinameran COVID-19 vaccine who experienced the unexpected adverse event of special interest of COVID-19 which occurred on an unknown date relative to vaccination with mRNA-1273 administered as a booster third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: later diagnosed as being immunocompromised sometime; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (later diagnosed as being immunocompromised sometime) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. 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 2021, the patient experienced IMMUNODEFICIENCY (later diagnosed as being immunocompromised sometime) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (later diagnosed as being immunocompromised sometime) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment drug details was reported.  The pharmacist stated the patient was later diagnosed as being immunocompromised sometime after 29 Oct 2021.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history in this case, who experienced the serious unexpected event of Immunodeficiency. The event occurred in an unknown date after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history in this case, who experienced the serious unexpected event of Immunodeficiency. The event occurred in an unknown date after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: breakthrough infection; This spontaneous case was reported by a physician and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (breakthrough infection) 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 VACCINE BREAKTHROUGH INFECTION (breakthrough infection). At the time of the report, VACCINE BREAKTHROUGH INFECTION (breakthrough infection) 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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Patient received a breakthrough covid-19 infection after receiving the Moderna covid-19 vaccine primary series. Unknown dates of vaccination, unknown lot numbers, unknown patient information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, SARS-CoV-2 test, Sinusitis
Clinical narrative: Coughing; Lack of drug effect; COVID-19; Sinusitis; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinusitis), COUGH (Coughing), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced SINUSITIS (Sinusitis), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (Coughing). The patient was treated with AMOXICILLIN for Sinusitis, at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinusitis), COUGH (Coughing), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported by the reporter. Patient had coughing before the booster dose but this was due to sinusitis. Patient has received Amoxicillin for his sinusitis which coincides with the diagnosis of COVID-19.  Company comment This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history reported, who experienced the non-serious unexpected, AESI event of COVID-19 and other non-serious events. Drug ineffective was considered an additional event. The events occurred on an unknown date, approximately 5 months after the second dose of mRNA-1273. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-435715 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with no relevant medical history reported, who experienced the non-serious unexpected, AESI event of COVID-19 and other non-serious events. Drug ineffective was considered an additional event. The events occurred on an unknown date, approximately 5 months after the second dose of mRNA-1273. The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Muscle spasms, Pyrexia
Clinical narrative: muscle cramps; chills; I now have a headache; fever 100.4; This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE SPASMS (muscle cramps), CHILLS (chills), HEADACHE (I now have a headache) and PYREXIA (fever 100.4) 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 MUSCLE SPASMS (muscle cramps), CHILLS (chills), HEADACHE (I now have a headache) and PYREXIA (fever 100.4). At the time of the report, MUSCLE SPASMS (muscle cramps), CHILLS (chills), HEADACHE (I now have a headache) and PYREXIA (fever 100.4) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 100.4 (High) fever 100.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I'mstarting to have some chest pain.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (I'mstarting to have some chest pain.). At the time of the report, CHEST PAIN (I'mstarting to have some chest pain.) outcome was unknown.            No Concomitant product use was reported.  The patient had COVID shot from Moderna back on 26-Apr-2021 and had not been able to get in to get the booster shot. The patient was starting to have some chest pain and was asking were there any alternative that could do because there was no of that shot. The patient was quite concerned. The patient wanted to get the booster shot, and apparently the patient had difficulty finding a place to get that, and the only time the patient could get that was early in the morning. The patient had to stand in the line, so missed out two times. The patient further stated that they needed to get that shot because patient's neighbor just came down with COVID and was in the hospital. The patient just wanted to find out if they still had some protection.  The patient had COVID shot from Moderna back on 26-Apr-2021 and had not been able to get in to get the booster shot. The patient was starting to have some chest pain and was asking were there any alternative that could do because there was no of that shot. The patient was quite concerned.  The patient wanted to get the booster shot, and apparently the patient had difficulty finding a place to get that, and the only time the patient could get that was early in the morning. The patient had to stand in the line, so missed out two times. The patient further stated that they needed to get that shot because patient's neighbor just came down with COVID and was in the hospital. The patient just wanted to find out if they still had some protection.  Reportedly, the patient was going to be 81 years old.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Localised infection
Clinical narrative: arm became an infection; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (arm became an infection) 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 LOCALISED INFECTION (arm became an infection). At the time of the report, LOCALISED INFECTION (arm became an infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details included antibiotics for the infected arm.   This case was linked to MOD-2022-445073 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022; A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) and PRODUCT STORAGE ERROR (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) 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 (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) and PRODUCT STORAGE ERROR (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) and PRODUCT STORAGE ERROR (A Moderna Covid-19 Vaccine vial that hit 30 days of refrigerated storage on 3Jan2022, and 2 doses were given from that vial on 6Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  Date the vial was first stored in the refrigerator on 04 Dec 2021. Vaccine vial hit 30 days of refrigerated storage on 03 Jan 2022.  Nurse reported that two patients received expired vaccine for their booster shots, past 30 days use by date.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jan-2022: Significant Follow up received. Patient information ( Initials, Gender, Date of birth) was updated. Suspect product dose number was added. Batch/lot number was added.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (The patient had Pfizer series dose before getting Moderna COVID-19 booster dose.). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine.    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 EXPIRED PRODUCT ADMINISTERED (They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (They provided 6 patients with Moderna vaccines from a vial that they realized expired two days prior) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no adverse reactions post expired vaccine administration.  No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot; site is sore; swollen a little; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (site is sore) and VACCINATION SITE SWELLING (swollen a little) 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 an unknown date, the patient experienced VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (site is sore) and VACCINATION SITE SWELLING (swollen a little). At the time of the report, VACCINATION SITE WARMTH (hot), VACCINATION SITE PAIN (site is sore) and VACCINATION SITE SWELLING (swollen a little) 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Got Moderna booster 3 months after Pfizer booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Got Moderna booster 3 months after Pfizer booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (First dose) on 08-Mar-2021, pfizer (2nd shot) on 29-Mar-2021 and pfizer (Booster) on 21-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, pfizer and pfizer. Concurrent medical conditions included Diabetes.    On 05-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Jan-2022, the patient experienced EXTRA DOSE ADMINISTERED (Got Moderna booster 3 months after Pfizer booster). On 05-Jan-2022, EXTRA DOSE ADMINISTERED (Got Moderna booster 3 months after Pfizer booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided.   Patient was not immunocompromised
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body pain) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (Body pain) and PYREXIA (Fever). At the time of the report, MYALGIA (Body pain) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2022-441951, MOD-2022-441961 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Had a Fever 101F daily around 1PM for 3- 4 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a Fever 101F daily around 1PM for 3- 4 weeks) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 011J20A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Had a Fever 101F daily around 1PM for 3- 4 weeks). On 02-Mar-2021, PYREXIA (Had a Fever 101F daily around 1PM for 3- 4 weeks) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 101 (High) 101F daily around 1PM for 3- 4 weeks. In May 2021, SARS-CoV-2 antibody test: 0.04 (Negative) 0.04. On an unknown date, SARS-CoV-2 antibody test: 26.75 The booster shoot up his antibody levels sky high to 26.75.         No Concomitant product use was reported.  The reporter was calling on behalf of their husband who was the patient. The patient had 3 doses of Moderna COVID-19 vaccine and after the 2nd shot, had a Fever of 101F daily around 1PM for 3- 4 weeks. The patient did not take medicine for it. The reporter stated tat the patient with Leukemia tested negative for vaccine produced antibody on May-2021 and the antibody results were 0.04 but the booster shoot up their antibody levels sky high to 26.75.  No treatment information was provided.   This case was linked to MOD-2022-441925 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Covid arm) 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 VACCINATION COMPLICATION (Covid arm). At the time of the report, VACCINATION COMPLICATION (Covid arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.