chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Took an antibody test and was negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Took an antibody test and was negative) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 SARS-COV-2 ANTIBODY TEST NEGATIVE (Took an antibody test and was negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Took an antibody test and was negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.  No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Updated the report type from Invalid case to Spontaneous. Added lab data, reporter and patient details. The country of incidence, reporter and event country was updated from unknown to United States. Suspect product coding, event coding and narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vomiting
Clinical narrative: Vomiting; Uncontrollable Shivering; Terrible Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Uncontrollable Shivering) and MYALGIA (Terrible Myalgia) 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 September 2021, the patient experienced VOMITING (Vomiting), CHILLS (Uncontrollable Shivering) and MYALGIA (Terrible Myalgia). At the time of the report, VOMITING (Vomiting), CHILLS (Uncontrollable Shivering) and MYALGIA (Terrible Myalgia) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  The patient was going on day 2 of incapacitating illness (vomiting, uncontrollable shivering, terrible myalgia) from Moderna shot.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Updated the report type from Invalid case to Spontaneous. Added reporter and patient details. The country of incidence, reporter and event country was updated from unknown to (country name). Suspect product coding and narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Worst flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Worst flu 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Worst flu symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Worst flu symptoms) had resolved.            Concomitant medication and treatment drugs were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Report type updated as Spontaneous. Outcome of event updated. Suspect coding and dose details updated. narrative regenerated.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: bad side effects from the second Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (bad side effects from the second Moderna shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (bad side effects from the second Moderna shot). At the time of the report, IMMUNISATION REACTION (bad side effects from the second Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Report type updated as Spontaneous. Reporter details added. Country of incidence, Reporter country, Obtain and Drug authorization country updated.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain) 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 PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Added reporter details and updated the report type from Invalid case to Spontaneous. The suspect product coding, event coding and narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymphedema; This spontaneous case was reported by a patient and describes the occurrence of LYMPHOEDEMA (Lymphedema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mastectomy.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced LYMPHOEDEMA (Lymphedema). At the time of the report, LYMPHOEDEMA (Lymphedema) had not resolved.            Concomitant medication was not reported.  Patient got lymphedema in the opposite arm (mastectomy side) immediately after the 2nd shot in May. Patient had no history of lymphedema. Felt the effect happening while waiting the 15 min afterwards. It was not temporary, patient still had it. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Upon internal review on 26-May-2022, significant correction was performed. Report type updated as Spontaneous. Reporter details added. Country of incidence, Reporter country, patient details updated, Obtain and Drug authorization country updated. Suspect coding, dose details and event outcome updated. Narrative regenerated.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: similar reaction to the flu vaccine/Suspected vaccination failure; similar reaction to the flu vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was received from patient's daughter-in-law via interactive digital media. The reporter stated that the patient had a similar reaction (got flu after vaccinated for them) to the flu vaccine, so they did not get that either nor did they ever get the flu. The reporter suggested that at least find out if you or a family member had ever had a vaccine reaction before risking it. So great you're questioning it versus just jumping on the bandwagon. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR084028, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084028:Same reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Developed Covid symptoms after Moderna Dose 3; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed Covid symptoms after Moderna Dose 3) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.   On 18-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021 at 12:00 PM, 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 COVID-19 (Developed Covid symptoms after Moderna Dose 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 14-May-2022 for COVID-19 prophylaxis, at a dose of 1 dosage form. At the time of the report, COVID-19 (Developed Covid symptoms after Moderna Dose 3) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date was reported as 19May2022.  Company Comment: This spontaneous case concerns a 74-year-old, female patient with past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious of COVID-19. The event occurred approximately 5 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19 symptoms (unspecified). She took and completed a 6-day course of Paxlovid (nirmatrelvir, ritonavir) from 09May2022 to 14May2022. It was reported that the patient again developed COVID-19 symptoms (unspecified) 5 days after treatment with Paxlovid. No additional details were provided at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old, female patient with past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious of COVID-19. The event occurred approximately 5 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19 symptoms (unspecified). She took and completed a 6-day course of Paxlovid (nirmatrelvir, ritonavir) from 09May2022 to 14May2022. It was reported that the patient again developed COVID-19 symptoms (unspecified) 5 days after treatment with Paxlovid. No additional details were provided at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthritis, Crohn's disease, Feeling abnormal
Clinical narrative: Crohns disease return; Arthritis; Both COVID-19 vaccination made his body felt weird; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohns disease return), ARTHRITIS (Arthritis) and FEELING ABNORMAL (Both COVID-19 vaccination made his body felt weird) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease return), ARTHRITIS (Arthritis) and FEELING ABNORMAL (Both COVID-19 vaccination made his body felt weird). At the time of the report, CROHN'S DISEASE (Crohns disease return) outcome was unknown, ARTHRITIS (Arthritis) was resolving and FEELING ABNORMAL (Both COVID-19 vaccination made his body felt weird) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  Company comment: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Arthritis which occurred at an unspecified date after receiving a dose of mRNA1273 as first dose of COVID -19 vaccine. Crohn's disease (described as Crohn's disease return) was also reported as an additional event in this case and may be in relation with Arthritis. Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of Arthritis which occurred at an unspecified date after receiving a dose of mRNA1273 as first dose of COVID -19 vaccine. Crohn's disease (described as Crohn's disease return) was also reported as an additional event in this case and may be in relation with Arthritis. Further details on the clinical course, diagnostic test and treatment regimen were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost sense of smell and taste after the first Moderna Covid-19 vaccine.; lost sense of smell and taste after the first Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost sense of smell and taste after the first Moderna Covid-19 vaccine.) and AGEUSIA (lost sense of smell and taste after the first Moderna Covid-19 vaccine.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 ANOSMIA (lost sense of smell and taste after the first Moderna Covid-19 vaccine.) and AGEUSIA (lost sense of smell and taste after the first Moderna Covid-19 vaccine.). At the time of the report, ANOSMIA (lost sense of smell and taste after the first Moderna Covid-19 vaccine.) and AGEUSIA (lost sense of smell and taste after the first Moderna Covid-19 vaccine.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Company comment This is  a spontaneous case reported by a consumer, concerning a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected, non serious of Anosmia and Ageusia, unknown days after receiving the 1 dose of mRNA 1273 vaccine in the COVID 19 vaccination series.  No information was provided on other symptoms, comorbidities, clinical course, labs, diagnostic investigations and treatment. The events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness assessed as per Regulatory Authority's report. Sender's Comments: This is  a spontaneous case reported by a consumer, concerning a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected, non serious of Anosmia and Ageusia, unknown days after receiving the 1 dose of mRNA 1273 vaccine in the COVID 19 vaccination series.  No information was provided on other symptoms, comorbidities, clinical course, labs, diagnostic investigations and treatment. The events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness assessed as per Regulatory Authority's report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Reoccurrence of Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Reoccurrence of Covid) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteopetrosis and Allergy (Allergy to unspecified drug).    On 21-Apr-2022 at 2:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022 at 6:00 AM, the patient experienced COVID-19 (Reoccurrence of Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (Reoccurrence of Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient not had any other medications/products within 2 weeks of starting COVID-19 treatment. Device date was reported as 20-May-2022 Treatment received reported as no.  Company Comment: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine and 7 days after the treatment with non-company product Nirmatrelvir, Ritonavir (Paxlovid). As reported, there was COVID recurrence after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine and 7 days after the treatment with non-company product Nirmatrelvir, Ritonavir (Paxlovid). As reported, there was COVID recurrence after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: Got Covid 19 after receiving the Moderna Covid 19 vaccine; She got Covid19 and was not able to receive the vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got Covid 19 after receiving the Moderna Covid 19 vaccine) and INCOMPLETE COURSE OF VACCINATION (She got Covid19 and was not able to receive the vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041JC1A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Chocolate).    On 07-Dec-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 (Got Covid 19 after receiving the Moderna Covid 19 vaccine) and INCOMPLETE COURSE OF VACCINATION (She got Covid19 and was not able to receive the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Got Covid 19 after receiving the Moderna Covid 19 vaccine) and INCOMPLETE COURSE OF VACCINATION (She got Covid19 and was not able to receive the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take any concomitant medication  Company comment-This spontaneous case concerns a female patient aged 53 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after first dose of mRNA-1273 vaccine. Additionally Incomplete course of vaccination was noted. She had covid before receiving the second dose of vaccine and missed the second dose. She was treated with Tylenol and Aspirin. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient aged 53 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after first dose of mRNA-1273 vaccine. Additionally Incomplete course of vaccination was noted. She had covid before receiving the second dose of vaccine and missed the second dose. She was treated with Tylenol and Aspirin. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.) in a 47-year-old female patient 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 14-May-2022, the patient experienced COVID-19 (Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 18-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported It was reported that patient had been vaccinated and boosted with Moderna Covid-19 Vaccine. Patient tested positive last Saturday on 14-May-2022. As of 20-May-2022 patient was on 3rd day of the Paxlovid. Unable to clarify what patient tested positive for as call disconnected before inbound transfer complete. Product complaint report was on Moderna Covid-19 Vaccine, not Paxlovid. No treatment drugs were reported  Company comment: This spontaneous case concerns a 47-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of booster dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19. Details about medical history, concomitant medications, other investigations, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2022: Follow-up received included product quality complaint number updated.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of booster dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19. Details about medical history, concomitant medications, other investigations, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Relevant medical history and concurrent condition was reported as Heart.  Concurrent medical conditions included Allergy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            No concomitant medications were reported  No treatment medications were reported  Co-suspect was reported as COVID-19 Treatment with start date 6-MAY-2022 and stop date 10-MAY-2022. It was reported that the patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment It was reported that Started pills. Felt well after 2 days. Became ill again with same symptoms congestion, cough, fatigue, chills sweating to lesser intensity 5 days after stopping pills.  Device Date was reported as 20-May-2022  Company comment- This spontaneous case concerns a 67-year-old male patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. Patient was started on pills which made him feel better after 2 days. He then felt ill again with the same symptoms of congestion, cough, fatigue, chills and sweating 5 days after stopping the medication. Outcome of the event was resolved at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. Patient was started on pills which made him feel better after 2 days. He then felt ill again with the same symptoms of congestion, cough, fatigue, chills and sweating 5 days after stopping the medication. Outcome of the event was resolved at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: rebound COVID, horrific taste in mouth entire course of treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (rebound COVID, horrific taste in mouth entire course of treatment) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 003C21A and 031B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Depression and Allergy. Concomitant products included LAMOTRIGINE, SERTRALINE and TRAZODONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (rebound COVID, horrific taste in mouth entire course of treatment). At the time of the report, COVID-19 (rebound COVID, horrific taste in mouth entire course of treatment) had not resolved.            Company comment: This spontaneous case concerns a 55 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine in accordance with the recommended schedule, the last dose being given about 8 months prior to the third dose, with no reported adverse events. The patient reported rebound COVID-19, 3 days after cessation of treatment with Paxlovid for COVID-19. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-573531 (Patient Link).; Sender's Comments: This spontaneous case concerns a 55 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine in accordance with the recommended schedule, the last dose being given about 8 months prior to the third dose, with no reported adverse events. The patient reported rebound COVID-19, 3 days after cessation of treatment with Paxlovid for COVID-19. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Still testing positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Still testing positive for COVID) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssens (Dose Number: 1  Batch/Lot No: 202A21A) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Janssens. Concurrent medical conditions included Allergy, Asthma and Overweight. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022 at 12:30 PM, the patient experienced COVID-19 (Still testing positive for COVID). At the time of the report, COVID-19 (Still testing positive for COVID) had not resolved.            Patient started co-suspect pfizer on 12-May-2022 for indication treatment of COVID-19 and last administered date was 17-May-2022. Company comment: This spontaneous case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 200 days after administration of an unknown dose of mRNA-1273. Patient was administered with first dose of Janssen, no information regarding other doses. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 200 days after administration of an unknown dose of mRNA-1273. Patient was administered with first dose of Janssen, no information regarding other doses. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore Throat; Low Grade Fever after 1st booster; Fatigue after 1st booster; Swollen Gland; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (Low Grade Fever after 1st booster), FATIGUE (Fatigue after 1st booster) and LYMPHADENOPATHY (Swollen Gland ) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 024M20A, 026A21A and 049L21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Atrial fibrillation and Graves' disease. Concomitant products included METOPROLOL SUCCINATE, THIAMAZOLE (METHIMAZOLE) and FAMOTIDINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (Low Grade Fever after 1st booster), FATIGUE (Fatigue after 1st booster) and LYMPHADENOPATHY (Swollen Gland ). On 19-Nov-2021, OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (Low Grade Fever after 1st booster), FATIGUE (Fatigue after 1st booster) and LYMPHADENOPATHY (Swollen Gland ) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Body temperature: low (Low) Low grade fever.         Concomitant medication also included as supplements (unknown).  She stated that she received 4 doses of Moderna COVID-19 vaccine. She has a hard time reading the lot numbers. Patient reported that she took first booster dose on 18-Nov-2021 and reported that she had Low Grade Fever, Fatigue, Swollen gland, and  Sore Throat. On 19-NOV-2021 patient was back to baseline.  No treatment medication was reported by patient.   This case was linked to MOD-2022-573656, MOD-2022-573657, MOD-2022-573655 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection) in a 74-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: Sulfa (Sulfa). Past adverse reactions to the above products included Allergy with Sulfa. Concurrent medical conditions included Glaucoma and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT), DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT) and TRAVOPROST (TRAVATAN Z) for an unknown indication.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2022, the patient experienced COVID-19 (was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-May-2022 to 05-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Device Date was reported as 22-May-2022  Company Comment: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 7 months after receiving a dose of COVID-19 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days due to COVID-19 (unknown onset date of COVID-19). 3 days after the last dose of Nirmatrelvir/Ritonavir, COVID-19 recurred. The symptoms of cold and cough persisted for 3 weeks since the date of infection but the patient feels better. The benefit-risk relationship of mRNA-1273 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, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 7 months after receiving a dose of COVID-19 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days due to COVID-19 (unknown onset date of COVID-19). 3 days after the last dose of Nirmatrelvir/Ritonavir, COVID-19 recurred. The symptoms of cold and cough persisted for 3 weeks since the date of infection but the patient feels better. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Chronic diarrhea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (Chronic diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    In July 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 DIARRHOEA (Chronic diarrhea). At the time of the report, DIARRHOEA (Chronic diarrhea) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-573721 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: Patient didn't want to get out of the shower; Chills; Headache; Tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient didn't want to get out of the shower), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) in a 56-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 ((Before receiving the vaccines)) in August 2021 and COVID-19 ((Before receiving the vaccines)) in October 2021. Concurrent medical conditions included Iodine allergy and Contrast media allergy (X-ray dye allergy).  On 23-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-May-2022, the patient experienced FEELING ABNORMAL (Patient didn't want to get out of the shower), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, FEELING ABNORMAL (Patient didn't want to get out of the shower), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tired) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive(Before receiving the vaccines). In October 2021, SARS-CoV-2 test: positive (Positive) Positive(Before receiving the vaccines).  The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter.  Treatment for event included the patient took migraine pills and stated that he was feeling better at the time of report.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discomfort, Vaccination site pruritus
Clinical narrative: could feel the vaccination site on the left arm; Itching left arm vaccination site after first primary dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCOMFORT (could feel the vaccination site on the left arm) and VACCINATION SITE PRURITUS (Itching left arm vaccination site after first primary dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (could feel the vaccination site on the left arm) and VACCINATION SITE PRURITUS (Itching left arm vaccination site after first primary dose). At the time of the report, VACCINATION SITE DISCOMFORT (could feel the vaccination site on the left arm) and VACCINATION SITE PRURITUS (Itching left arm vaccination site after first primary dose) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.           Patient reported that the feeling goes away and comes back.   No treatment information was provided by the reporter.   This case was linked to MOD-2022-573734, MOD-2022-573732 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discomfort, Vaccination site pruritus
Clinical narrative: Itching right arm vaccination site after 2nd primary dose; Can feel the vaccination site on right arm after 2nd primary dose; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching right arm vaccination site after 2nd primary dose) and VACCINATION SITE DISCOMFORT (Can feel the vaccination site on right arm after 2nd primary dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching right arm vaccination site after 2nd primary dose) and VACCINATION SITE DISCOMFORT (Can feel the vaccination site on right arm after 2nd primary dose). At the time of the report, VACCINATION SITE PRURITUS (Itching right arm vaccination site after 2nd primary dose) and VACCINATION SITE DISCOMFORT (Can feel the vaccination site on right arm after 2nd primary dose) had not resolved.            At the time of vaccination the patient was aware that had shot there but no pain was reported.  Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-573734, MOD-2022-573727 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (extreme burning in chest cardio area), VACCINATION SITE MOVEMENT IMPAIRMENT (hands, elbows, fingers, shoulders locked after waking up) and VACCINATION SITE PAIN (deep burning pain in the site of injection (right arm)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21E and 022C21A) for COVID-19 vaccination. Concurrent medical conditions included Anxiety disorder (No recent change in status such as improvement or worsening) and Legal blindness, (No recent change in status such as improvement or worsening) since 2003. Concomitant products included MIRTAZAPINE, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (deep burning pain in the site of injection (right arm)). On 08-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (extreme burning in chest cardio area) and VACCINATION SITE MOVEMENT IMPAIRMENT (hands, elbows, fingers, shoulders locked after waking up). The patient was treated with DICLOFENAC for Burning sensation, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (extreme burning in chest cardio area) was resolving, VACCINATION SITE MOVEMENT IMPAIRMENT (hands, elbows, fingers, shoulders locked after waking up) had resolved and VACCINATION SITE PAIN (deep burning pain in the site of injection (right arm)) had not resolved. The patient had no allergies. He never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant product also included BENZODIAZEPINE for anxiety disorder. When patient tried to lift weight to do exercise, burning pain in injection site (right arm) was getting worse. Three days after the 1st dose, after waking up every day he felt that his hands, elbows, fingers, and shoulders were locked, this was happening for about 8 to 9 months. Patient treated his symptoms with Diclofenac, because it helped him with burning symptoms. The outcome of event extreme burning in chest cardio area was reported as residual effects, 95 percent better and the symptoms had been improved.