chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Semen analysis, Semen liquefaction
Clinical narrative: change in my seminal fluid/seminal fluid has changed from normal (thick-white in appearance) to clear and watery; This spontaneous case was reported by a consumer and describes the occurrence of SEMEN LIQUEFACTION (change in my seminal fluid/seminal fluid has changed from normal (thick-white in appearance) to clear and watery) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 010MZ0A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-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 SEMEN LIQUEFACTION (change in my seminal fluid/seminal fluid has changed from normal (thick-white in appearance) to clear and watery). At the time of the report, SEMEN LIQUEFACTION (change in my seminal fluid/seminal fluid has changed from normal (thick-white in appearance) to clear and watery) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Semen analysis: abnormal (abnormal) from the first dose until current seminal fluid has changed from normal (thick-white in appearance) to clear and watery.         The patient had no underlying conditions, overall, very healthy, runner and athlete.  Concomitant medication of the patient was not reported.  A few weeks after the first dose, the patient started noticing the adverse event. As per the patient there had been no health-related changes or changes in sexual activity. The patient had researched that this could be a sudden sign of infertility, possibly autoimmune infertility.  No treatment information was provided by the reporter.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021 at 2:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (233 Patients given expired doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  8 vials removed from -20C freezer at 12:30pm, 3 Dec 2021,thawed for 30 min at room temp, drawn up and placed in fridge (3.8C) for duration of clinic, from 1pm-4pm on 3 Dec 2021.  No Treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ACCIDENTAL UNDERDOSE (An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ACCIDENTAL UNDERDOSE (An immunocompromised patient received booster dose of 0.25 mL instead of a 3rd full dose of 0.5 mL that is meant for immunocompromised patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling hot, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid19; Hotness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills). In May 2021, SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had no allergies and no medical history reported. The patient did not receive other vaccines within one month prior to Moderna. No concomitant medications were provided.No treatment medications were provided.  Company comment: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-475434, MOD-2022-475425 (Patient Link).; Sender's Comments: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Burning sensation, Chest discomfort, Feeling hot, Influenza like illness
Clinical narrative: Tested positive for covid19; Hotness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills). In May 2021, SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had no allergies and no medical history reported. The patient did not receive other vaccines within one month prior to Moderna. No concomitant medications were provided.No treatment medications were provided.  Company comment: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-475434, MOD-2022-475425 (Patient Link).; Sender's Comments: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Neck mass, Neck pain, Pain, Vaccination site pain
Clinical narrative: Tested positive for covid19; Hotness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills). In May 2021, SARS-COV-2 TEST POSITIVE (Tested positive for covid19), FEELING HOT (Hotness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had no allergies and no medical history reported. The patient did not receive other vaccines within one month prior to Moderna. No concomitant medications were provided.No treatment medications were provided.  Company comment: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-475434, MOD-2022-475425 (Patient Link).; Sender's Comments: This case concerns a 47-year-old female patient with no reported medical history, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive on the same day after receiving first dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain, SARS-CoV-2 test
Clinical narrative: Hotness; A lot of pain in the body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hotness) and PAIN (A lot of pain in the body) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced FEELING HOT (Hotness) and PAIN (A lot of pain in the body). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. In May 2021, FEELING HOT (Hotness) and PAIN (A lot of pain in the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient had no allergy.  Concomitant medication was not reported.  Patient was not given other vaccines prior to Moderna COVID-19.  It was reported events lasted for 2 nights.   This case was linked to MOD-2022-475434, MOD-2022-475393 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Inner ear disorder
Clinical narrative: Hearing loss; Inner ear problems, A lot of vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DEAFNESS (Hearing loss) (seriousness criterion medically significant) and INNER EAR DISORDER (Inner ear problems, A lot of vertigo). At the time of the report, DEAFNESS (Hearing loss) and INNER EAR DISORDER (Inner ear problems, A lot of vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  After the Moderna shots, patient had been having inner ear problems and a lot of vertigo and hearing loss.  No treatment information was provided.  Company comment : This spontaneous case concerns a patient of unknown age and gender with no medical history reported , who experienced the serious unexpected event of Deafness(serious criterion-Important medical event), unspecified days after the dose of mRNA-1273 Vaccine. The patient also reported to have inner ear problems and vertigo after the vaccination. No further information regarding clinical course of the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported , who experienced the serious unexpected event of Deafness(serious criterion-Important medical event), unspecified days after the dose of mRNA-1273 Vaccine. The patient also reported to have inner ear problems and vertigo after the vaccination. No further information regarding clinical course of the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Laboratory test
Clinical narrative: Fast heart rate 145 BPM after Eight hours of first shot; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate 145 BPM after Eight hours of first shot) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Fast heart rate 145 BPM after Eight hours of first shot). At the time of the report, HEART RATE INCREASED (Fast heart rate 145 BPM after Eight hours of first shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Heart rate: 145 (High) had a fast heart rate 145 BPM. On an unknown date, Laboratory test: normal (normal) All tests with cardiologist came back normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that patient had no medical history of heart conditions. No concomitant medications were reported.  She visited a cardiologist and wore heart monitor for a while. All tests with cardiologist came back normal. Also her diagnosis remained fast heart rate.  No treatment medications were reported.   This case was linked to MOD-2022-475635 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient got the first dose from an expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got the first dose from an expired vial) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got the first dose from an expired vial). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patient got the first dose from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: erythema multiforme reactions; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (erythema multiforme reactions) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)  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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA MULTIFORME (erythema multiforme reactions) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (erythema multiforme reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA MULTIFORME (erythema multiforme reactions) to be related.    Treatment and concomitant medications were not reported  Company Comment - This regulatory authority case concerns a 61 year old male patient with no relevant medical history, who experienced the serious unexpected events of erythema multiforme. The event occurred on an unknown date after a dose of mRNA-1273 vaccine, the outcome was unknown at the time of the report. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-475711 (Patient Link).; Sender's Comments: This regulatory authority case concerns a 61 year old male patient with no relevant medical history, who experienced the serious unexpected events of erythema multiforme. The event occurred on an unknown date after a dose of mRNA-1273 vaccine, the outcome was unknown at the time of the report. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: erythema multiforme reactions; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (erythema multiforme reactions) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA MULTIFORME (erythema multiforme reactions) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (erythema multiforme reactions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ERYTHEMA MULTIFORME (erythema multiforme reactions) to be related.    Treatment and concomitant medications were not reported  Company Comment - This regulatory authority case concerns a 53 year old female patient with no relevant medical history, who experienced the serious unexpected event of erythema multiforme. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-475693 (Patient Link).; Sender's Comments: This regulatory authority case concerns a 53 year old female patient with no relevant medical history, who experienced the serious unexpected event of erythema multiforme. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer-Biontech COVID-19 Vaccine (Dose 1 was administered in his Left arm) on 21-Mar-2021 and Pfizer-Biontech COVID-19 Vaccine (Dose 2 was administered in his Left arm) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer-Biontech COVID-19 Vaccine and Pfizer-Biontech COVID-19 Vaccine. Concurrent medical conditions included Ulcerative colitis since 1987, Allergy to antibiotic (experienced reaction with Amoxicillin.) and Allergy to antibiotic (and got sick with CIPRO). Concomitant products included MESALAMINE and MERCAPTOPURINE for an unknown indication.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021) had resolved.            Concomitant includes Curcumin with Bioterine 100mg one tablet per day  Treatment details were not given.   This case was linked to MOD-2022-476117 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Gastrointestinal haemorrhage
Clinical narrative: He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer-Biontech COVID-19 Vaccine (Dose 1 was administered in his Left arm) on 21-Mar-2021 and Pfizer-Biontech COVID-19 Vaccine (Dose 2 was administered in his Left arm) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer-Biontech COVID-19 Vaccine and Pfizer-Biontech COVID-19 Vaccine. Concurrent medical conditions included Ulcerative colitis since 1987, Allergy to antibiotic (experienced reaction with Amoxicillin.) and Allergy to antibiotic (and got sick with CIPRO). Concomitant products included MESALAMINE and MERCAPTOPURINE for an unknown indication.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 1st dose of Pfizer (March 21,2021),2nd dose of Pfizer (April 21,2021) and his 3rd dose a Moderna vaccine last August 2021) had resolved.            Concomitant includes Curcumin with Bioterine 100mg one tablet per day  Treatment details were not given.   This case was linked to MOD-2022-476117 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: headache; it makes me a little tired; dizziness; diarrhea; second dose greater than 36 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (it makes me a little tired), DIZZINESS (dizziness), DIARRHOEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip replacement. Concurrent medical conditions included Glaucoma (In the left eye), Blood pressure high and Drug allergy (codeine). Concomitant products included DORZOLAMIDE, LATANOPROST and LORATADINE for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose). On 28-Jan-2022, the patient experienced HEADACHE (headache), FATIGUE (it makes me a little tired), DIZZINESS (dizziness) and DIARRHOEA (diarrhea). At the time of the report, HEADACHE (headache) and DIZZINESS (dizziness) had not resolved and FATIGUE (it makes me a little tired), DIARRHOEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose) outcome was unknown.            Patient stated that the headache still comes and goes and still has a little dizziness.  The patient denied taking any medications for her symptoms.   This case was linked to MOD-2022-476120 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: headache; it makes me a little tired; dizziness; diarrhea; second dose greater than 36 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (it makes me a little tired), DIZZINESS (dizziness), DIARRHOEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip replacement. Concurrent medical conditions included Glaucoma (In the left eye), Blood pressure high and Drug allergy (codeine). Concomitant products included DORZOLAMIDE, LATANOPROST and LORATADINE for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose). On 28-Jan-2022, the patient experienced HEADACHE (headache), FATIGUE (it makes me a little tired), DIZZINESS (dizziness) and DIARRHOEA (diarrhea). At the time of the report, HEADACHE (headache) and DIZZINESS (dizziness) had not resolved and FATIGUE (it makes me a little tired), DIARRHOEA (diarrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose greater than 36 days from first dose) outcome was unknown.            Patient stated that the headache still comes and goes and still has a little dizziness.  The patient denied taking any medications for her symptoms.   This case was linked to MOD-2022-476120 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip prosthesis user (Artificial hip). Concurrent medical conditions included Drug allergy (Codeine), Glaucoma (Glaucoma in the left eye.) and Blood pressure high. Concomitant products included DORZOLAMIDE, LATANOPROST and LORATADINE for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use included blood pressure medication.  Patient stopped taking her blood pressure medication sometime in 2021 after the first dose because the blood pressure medications caused dizziness.  Patient denied taking any medications for her symptoms.   This case was linked to MOD-2022-475744 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hip prosthesis user (Artificial hip). Concurrent medical conditions included Drug allergy (Codeine), Glaucoma (Glaucoma in the left eye.) and Blood pressure high. Concomitant products included DORZOLAMIDE, LATANOPROST and LORATADINE for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use included blood pressure medication.  Patient stopped taking her blood pressure medication sometime in 2021 after the first dose because the blood pressure medications caused dizziness.  Patient denied taking any medications for her symptoms.   This case was linked to MOD-2022-475744 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: just got a new kidney; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (just got a new kidney) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In August 2021, the patient 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 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 RENAL DISORDER (just got a new kidney). The patient was treated with Surgery (Kidney transplant) for Renal disorder. At the time of the report, RENAL DISORDER (just got a new kidney) outcome was unknown.            The  concomitant medications on use were not provided.  Patient received first two doses and a booster dose in August. Patient was not sure that if they received full or half dose. The nurse told patient they have second Moderna booster doses available.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for over a week now, the side effects from it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for over a week now, the side effects from it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for over a week now, the side effects from it). At the time of the report, ILLNESS (Sick for over a week now, the side effects from it) had not resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Influenza, Malaise, Myalgia
Clinical narrative: Patient felt sick after she received her booster dose; Hurt all over; Felt like she had the flu; Every joint in her body hurt; Patient had a low grade temperature/patients temperature was 99 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine and Pfizer vaccine (The patient received her primary series of vaccination as a Pfizer vaccine and reported no adverse reactions.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine; and No adverse reaction with Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight). At the time of the report, MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 The patient had a low grade temperature. The patients temperature was 99 degrees Farenheight..         The patient received the booster dose in her left arm shoulder deltoid muscle. No concomitant medications were reported. There was no product complaint associated. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up includes no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient felt sick after she received her booster dose; Hurt all over; Felt like she had the flu; Every joint in her body hurt; Patient had a low grade temperature/patients temperature was 99 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine and Pfizer vaccine (The patient received her primary series of vaccination as a Pfizer vaccine and reported no adverse reactions.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine; and No adverse reaction with Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight). At the time of the report, MALAISE (Patient felt sick after she received her booster dose), MYALGIA (Hurt all over), INFLUENZA (Felt like she had the flu), ARTHRALGIA (Every joint in her body hurt) and PYREXIA (Patient had a low grade temperature/patients temperature was 99 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 The patient had a low grade temperature. The patients temperature was 99 degrees Farenheight..         The patient received the booster dose in her left arm shoulder deltoid muscle. No concomitant medications were reported. There was no product complaint associated. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up includes no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 08-Feb-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was removed from the freezer and placed in the refrigerator and given the 30 day expiration date of 02-Feb-2022. It was kept at the designated temperature in the refrigerator until it was administered on 08-Feb-2022. The lot number was reported as 065F21A with expiration date of 04-Feb-2022. It was reported symptoms were unknown at the time of reporting.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up received. Added patient demographics(initials, date of birth, age and gender) and first dose details.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: A patient received a dose from a vial that was transported outside of the recommended policy; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy). On 29-Jan-2022, PRODUCT STORAGE ERROR (A patient received a dose from a vial that was transported outside of the recommended policy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the patient received a dose from a vial that was transported outside of the recommended policy. The vial was removed from the cooler (unpunctured), placed in a glove with two ice cubes and transported for 15 minutes to a different location. Upon new site, vaccine was then punctured, and dose was administered.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up received contains no new information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: patient received wrong dose of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (patient received wrong dose of the Moderna COVID 19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) 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 ACCIDENTAL OVERDOSE (patient received wrong dose of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (patient received wrong dose of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The reporter reported that, five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine, Loratadine and Diphenhydramine allergy) and HIV infection. Concomitant products included AMLODIPINE BESILATE (NORVASC), COBICISTAT, DARUNAVIR ETHANOLATE, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (SYMTUZA), SERTRALINE HYDROCHLORIDE (ZOLOFT) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that the patient had a clinical history of HIV, and was under treatment for this illness.   No treatment drug details was reported.  Reporter stated that the vials had been moved to the fridge on 28-DEC-2021 and did not undergo temperature excursions..   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up received on 08-FEB-2022 contains significant information: Added patient demographics, patient medical history, suspect drug information, concomitant medications added.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient got only a half shot (0.25ML); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient got only a half shot (0.25ML)) 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. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In August 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient got only a half shot (0.25ML)). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient got only a half shot (0.25ML)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact