chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: heat travel up to my neck and my ears and around my face; left side of my tongue, cheek, lips, throat, all are numb; pins and needle feeling; My tongue and cheek are sick; the lower left side of my face was numb; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (heat travel up to my neck and my ears and around my face), HYPOAESTHESIA ORAL (left side of my tongue, cheek, lips, throat, all are numb), PARAESTHESIA (pins and needle feeling), FACIAL DISCOMFORT (My tongue and cheek are sick) and HYPOAESTHESIA (the lower left side of my face was numb) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 032M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Novocaine shot. Past adverse reactions to the above products included Pins and needles with Novocaine shot.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FEELING HOT (heat travel up to my neck and my ears and around my face), HYPOAESTHESIA ORAL (left side of my tongue, cheek, lips, throat, all are numb), PARAESTHESIA (pins and needle feeling) and HYPOAESTHESIA (the lower left side of my face was numb). 03-Apr-2021, the patient experienced FACIAL DISCOMFORT (My tongue and cheek are sick). At the time of the report, FEELING HOT (heat travel up to my neck and my ears and around my face), HYPOAESTHESIA ORAL (left side of my tongue, cheek, lips, throat, all are numb), PARAESTHESIA (pins and needle feeling), FACIAL DISCOMFORT (My tongue and cheek are sick) and HYPOAESTHESIA (the lower left side of my face was numb) was resolving.            No concomitant medications were reported. No treatment medications were reported. It was reported that no symptoms after first dose. It's really not awful Patient was afraid to get a booster, afraid to have this happened again and be really numb forever. Patient had  stroke assessment and there was no stroke. The doctor did not give her any treatment Patient experienced symptoms on her left side.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: And I had a terrible time with both the other doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (And I had a terrible time with both the other doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (And I had a terrible time with both the other doses). At the time of the report, VACCINATION COMPLICATION (And I had a terrible time with both the other doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-437608, MOD-2022-437619 (Patient Link).   Reporter did not allow further contact
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 10 doses of Moderna as a booster and later realized the vial was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 10 doses of Moderna as a booster and later realized the vial was expired) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 10 doses of Moderna as a booster and later realized the vial was expired). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered 10 doses of Moderna as a booster and later realized the vial was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-438657, MOD-2022-438669, MOD-2022-438670, MOD-2022-438671, MOD-2022-438673, MOD-2022-438674, MOD-2022-438675, MOD-2022-438676, MOD-2022-438677 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain in extremity, Vaccination site pain
Clinical narrative: Last week she started having a sore arm on the arm where they gave the injection (left); a slight headache; 1st dose 30Jul2021 / 2nd dose 10Sep2021; pain on her arm and everything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her arm and everything), VACCINATION SITE PAIN (Last week she started having a sore arm on the arm where they gave the injection (left)), HEADACHE (a slight headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 30Jul2021 / 2nd dose 10Sep2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain on her arm and everything) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 30Jul2021 / 2nd dose 10Sep2021). In December 2021, the patient experienced VACCINATION SITE PAIN (Last week she started having a sore arm on the arm where they gave the injection (left)) and HEADACHE (a slight headache). On 10-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 30Jul2021 / 2nd dose 10Sep2021) had resolved. At the time of the report, PAIN IN EXTREMITY (pain on her arm and everything) had resolved and VACCINATION SITE PAIN (Last week she started having a sore arm on the arm where they gave the injection (left)) and HEADACHE (a slight headache) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: she has swollen lymph nodes under her right arm; patients right arm is sore; patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (she has swollen lymph nodes under her right arm), VACCINATION SITE PAIN (patients right arm is sore) and HEADACHE (patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (she has swollen lymph nodes under her right arm), VACCINATION SITE PAIN (patients right arm is sore) and HEADACHE (patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (she has swollen lymph nodes under her right arm) and VACCINATION SITE PAIN (patients right arm is sore) outcome was unknown and HEADACHE (patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose) was resolving.            No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up received and contains no new information.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Tendon pain, Vaccination complication
Clinical narrative: Reactions for this one seem to be very light; There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.; There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions for this one seem to be very light), TENDON PAIN (There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.) and ARTHRALGIA (There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 040B21A and 044A21A) for an unknown indication.     Previously administered products included for Product used for unknown indication: SHINGRIX (shingles shot in right arm.) in 2021 and FLU (flu shot in left arm.) in 2021. Past adverse reactions to the above products included No adverse effect with FLU and SHINGRIX. Concomitant products included COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (COQ-10), MAGNESIUM and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-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 VACCINATION COMPLICATION (Reactions for this one seem to be very light), TENDON PAIN (There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.) and ARTHRALGIA (There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Reactions for this one seem to be very light), TENDON PAIN (There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.) and ARTHRALGIA (There been anything reported about shoulder pain a month after the shot as maybe an adverse reaction to maybe a tendon or pain.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-396066 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jan-2022: The recent Follow up contains significant information due to medical history, additional events, treatment medication, secondary reporter updated. On 03-Jan-2022: Non Significant Follow Up appended
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient received two COVID-19 vaccinations and then contracted COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient received two COVID-19 vaccinations and then contracted COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced COVID-19 (Patient received two COVID-19 vaccinations and then contracted COVID-19). At the time of the report, COVID-19 (Patient received two COVID-19 vaccinations and then contracted COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment details were reported.  Pharmacist could not confirm if the patient received the Moderna vaccine or Pfizer's vaccine.  Company comment: This case concerns a female patient of an unknown age with no reported medical history who experienced non-serious unexpected event of special interest COVID-19. The event occurred unspecified period of time following the second dose of mRNA-1273. However, it should be noted that no details regarding vaccination were provided. Furthermore, the Reporter could not confirm whether the patient received the Company product or Pfizer's vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no reported medical history who experienced non-serious unexpected event of special interest COVID-19. The event occurred unspecified period of time following the second dose of mRNA-1273. However, it should be noted that no details regarding vaccination were provided. Furthermore, the Reporter could not confirm whether the patient received the Company product or Pfizer's vaccine. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (A little flare up of arthritis) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) for COVID-19 vaccination. The patient's past medical history included Autoimmune arthritis (Autoimmune disease Arthritis) and Flare up of arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRITIS (A little flare up of arthritis). The patient was treated with CERTOLIZUMAB PEGOL (CIMZIA) for Arthritis, at an unspecified dose and frequency and ETANERCEPT (ENBREL) in July 2021 for Adverse event, at an unspecified dose and frequency. In May 2021, ARTHRITIS (A little flare up of arthritis) had resolved. The patient stated that she has not felt arthritis pain this bad (compared to after vaccination). Company Comment: This case concerns a 56-year-old female patient with relevant medical history of Autoimmune arthritis and Flare up of arthritis (before first dose of mRNA-1273), who experienced the unexpected non-serious adverse event of special interest, Arthritis (A little flare up of arthritis). The event occurred the same day after receiving the second dose of mRNA-1273 Vaccine. The patient was treated with CERTOLIZUMAB PEGOL (CIMZIA) and then with ETANERCEPT (ENBREL). It is reported that the event had resolved 1 month and 12 days after the event. Rechallenge is not applicable since the patient had a flare up before the first dose and it is not reported when it had resolved. The medical history of Autoimmune arthritis and Flare up of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD-2021-407194, MOD-2021-407413 (Patient Link).; Sender's Comments: This case concerns a 56-year-old female patient with relevant medical history of Autoimmune arthritis and Flare up of arthritis (before first dose of mRNA-1273), who experienced the unexpected non-serious adverse event of special interest, Arthritis (A little flare up of arthritis). The event occurred the same day after receiving the second dose of mRNA-1273 Vaccine. The patient was treated with CERTOLIZUMAB PEGOL (CIMZIA) and then with ETANERCEPT (ENBREL). It is reported that the event had resolved 1 month and 12 days after the event. Rechallenge is not applicable since the patient had a flare up before the first dose and it is not reported when it had resolved. The medical history of Autoimmune arthritis and Flare up of arthritis remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 039K20A and 034F21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LIOTHYRONINE, LEVOTHYROXINE, AMLODIPINE and LOSARTAN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not provided by the reporter.  Company Comment: This spontaneous case concerns a 71-year-old, female patient with relevant medical history of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 4 days after administration of the first dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event was unknown at the time of the report. The medical history of Hypertension, which is a known risk factor for COVID-19, as well as the patient's age remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-409286, MOD-2021-409287, MOD-2021-409283 (Patient Link).; Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with relevant medical history of Hypertension, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 4 days after administration of the first dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event was unknown at the time of the report. The medical history of Hypertension, which is a known risk factor for COVID-19, as well as the patient's age remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: 2nd dose not yet received; got covid at the time of the 2nd dose, 3 weeks after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid at the time of the 2nd dose, 3 weeks after the 1st dose) and PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced COVID-19 (got covid at the time of the 2nd dose, 3 weeks after the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received). At the time of the report, COVID-19 (got covid at the time of the 2nd dose, 3 weeks after the 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that he got Covid at the time of the 2nd dose, 3 weeks after the 1st dose and stated that he needs to get 2nd dose for his employment.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company Comment: This is a spontaneous case of product dose omission issue for this 48-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 3 weeks after administration of the first dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event COVID-19 was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of product dose omission issue for this 48-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 3 weeks after administration of the first dose of the Moderna mRNA-1273 vaccine. No further details were provided. The outcome of the event COVID-19 was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.  Company Comment: This spontaneous case concerns a 72-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of the first dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19 on the same day after vaccination. No further details were provided. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive after administration of the first dose of the Moderna mRNA-1273 vaccine. The patient tested positive for COVID-19 on the same day after vaccination. No further details were provided. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19. At the time of the report, COVID-19 outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient had two initial shots of Moderna. Patient had COVID-19 before patient could get the booster. The COVID-19 was during Thanksgiving week and patient was out of the quarantine period. This spontaneous case concerns a patient, of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 2 doses of the Moderna COVID-19 vaccine and got COVID; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (2 doses of the Moderna COVID-19 vaccine and got COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (2 doses of the Moderna COVID-19 vaccine and got COVID). At the time of the report, COVID-19 (2 doses of the Moderna COVID-19 vaccine and got COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.   This case was linked to MOD-2021-414601 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the second dose of the Moderna mRNA-1273 vaccine on an unspecified date. The start date of the event was not provided. No further details were provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had the booster dose and then got COVID again; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Had the booster dose and then got COVID again) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had the booster dose and then got COVID again). At the time of the report, COVID-19 (Had the booster dose and then got COVID again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  No treatment medication details were reported.  Company comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported;  who experienced unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. The reporter of the case mentioned that he knows 1 person that got 2 doses of the Moderna COVID-19 vaccine and then got COVID. Then had the booster dose and then got COVID again. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2021-414521 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported;  who experienced unexpected event of COVID-19 (AESI). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. The reporter of the case mentioned that he knows 1 person that got 2 doses of the Moderna COVID-19 vaccine and then got COVID. Then had the booster dose and then got COVID again. 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: COVID-19, SARS-CoV-2 test
Clinical narrative: Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.) 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 March 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced COVID-19 (Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.). At the time of the report, COVID-19 (Fully vaccinated with Moderna in March of this year. On October 22nd tested positive.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.  Company comment: This spontaneous case concerns patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious (AESI) event of COVID-19 (AESI) after mRNA- 1273 vaccine. The event occurred approximately 6 months after the second dose of mRNA- 1273 vaccine. It was reported that the patient was fully vaccinated, but schedule of vaccination was not disclosed, thus vaccination failure is not assessable. Very limited information is available regarding clinical course and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns patient of unknown gender and age with no medical history reported, who experienced the unexpected non serious (AESI) event of COVID-19 (AESI) after mRNA- 1273 vaccine. The event occurred approximately 6 months after the second dose of mRNA- 1273 vaccine. It was reported that the patient was fully vaccinated, but schedule of vaccination was not disclosed, thus vaccination failure is not assessable. Very limited information is available regarding clinical course and treatment received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little achy), PAIN IN EXTREMITY (Had a sore arm) and ANOSMIA (Then he called me back & said he couldn't smell anymore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Couldn't smell anything).    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PAIN (A little achy), PAIN IN EXTREMITY (Had a sore arm) and ANOSMIA (Then he called me back & said he couldn't smell anymore). At the time of the report, PAIN (A little achy), PAIN IN EXTREMITY (Had a sore arm) and ANOSMIA (Then he called me back & said he couldn't smell anymore) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Company comment: This is a spontaneous case concerning a  male patient of an unknown age with medical history of COVID-19 and anosmia, who experienced non serious, unexpected event of anosmia. The event occurred the same date after the second dose of mRNA-1273 vaccine. No information about the first dose was disclosed. Treatment details were not provided. Medical history of the patient remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  male patient of an unknown age with medical history of COVID-19 and anosmia, who experienced non serious, unexpected event of anosmia. The event occurred the same date after the second dose of mRNA-1273 vaccine. No information about the first dose was disclosed. Treatment details were not provided. Medical history of the patient remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I just had covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I just had covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 COVID-19 (I just had covid). At the time of the report, COVID-19 (I just had covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on an unknown date, while the received second dose of mRNA  1273 vaccine was on April 2021. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on an unknown date, while the received second dose of mRNA  1273 vaccine was on April 2021. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Emphysema, SARS-CoV-2 test
Clinical narrative: Horrible breathing issues; Emphysema; Lack of drug effect; Tested positive/exacerbated by COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive/exacerbated by COVID), DYSPNOEA (Horrible breathing issues), EMPHYSEMA (Emphysema) and DRUG INEFFECTIVE (Lack of drug effect) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-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 02-Nov-2021, the patient experienced COVID-19 (Tested positive/exacerbated by COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced DYSPNOEA (Horrible breathing issues) and EMPHYSEMA (Emphysema). At the time of the report, COVID-19 (Tested positive/exacerbated by COVID), DYSPNOEA (Horrible breathing issues), EMPHYSEMA (Emphysema) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported.  Pulmonologist suggested that she get her booster shot. Patient wants to know if she can take the shot. Was there any harm in getting the booster after having COVID, and was there a time to wait before getting the booster.  Company Comment:  This is a spontaneous case of drug innefective,  concerning a 61-year-old, female patient with unknonw medical history, who experienced the unexpected non-serious, AESI event of COVID-19. At the momento of the report, the outcome is unknown. The event occurred 7 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow-up received:  follow-up-reporter, patient demographics, dose details, event has been added.; Sender's Comments: This is a spontaneous case of drug innefective,  concerning a 61-year-old, female patient with unknonw medical history, who experienced the unexpected non-serious, AESI event of COVID-19. At the momento of the report, the outcome is unknown. The event occurred 7 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: recently had COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (recently had COVID-19) 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. In 2021, the patient experienced COVID-19 (recently had COVID-19). At the time of the report, COVID-19 (recently had COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  The patient asked about how long do the patient have to wait to get the booster dose of the vaccine.  This is a regulatory case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on 2021 while the received second dose of mRNA  1273 vaccine occurred on an unknown date. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a regulatory case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on 2021 while the received second dose of mRNA  1273 vaccine occurred on an unknown date. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Exposure to SARS-CoV-2, Suspected COVID-19
Clinical narrative: Loss of smell; He can confirm he also had covid; Exposed to covid-19 lately and contracted it; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), SUSPECTED COVID-19 (He can confirm he also had covid) and EXPOSURE TO SARS-COV-2 (Exposed to covid-19 lately and contracted it) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B20A and 032M20A) for COVID-19 vaccination.     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 21-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 ANOSMIA (Loss of smell), SUSPECTED COVID-19 (He can confirm he also had covid) and EXPOSURE TO SARS-COV-2 (Exposed to covid-19 lately and contracted it). At the time of the report, ANOSMIA (Loss of smell), SUSPECTED COVID-19 (He can confirm he also had covid) and EXPOSURE TO SARS-COV-2 (Exposed to covid-19 lately and contracted it) outcome was unknown.            No concomitant medications were provided.  No treatment medications were taken by the patient.  The patient did not get tested for covid-19.  This is a spontaneous case concerning  a  50-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event of anosmia and Suspected COVID-19, Exposure to SARS-CoV-2 as an added event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2021-419369 (Patient Link).; Sender's Comments: This is a spontaneous case concerning  a  50-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event of anosmia and Suspected COVID-19, Exposure to SARS-CoV-2 as an added event. The events occurred approximately on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The events outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got COVID-19 after primary dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient got COVID-19 after primary dose) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 COVID-19 (Patient got COVID-19 after primary dose). At the time of the report, COVID-19 (Patient got COVID-19 after primary dose) 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 medication was reported.  This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on an unknown date while the second dose of mRNA  1273 vaccine was received on March 2021. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of Covid-19. The event occurred on an unknown date while the second dose of mRNA  1273 vaccine was received on March 2021. At the time of report outcome was still unknown. The rechallenge is not applicable since no information about the first dose was disclosed. The reporter's assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.