chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ischemic stroke shortly after taking your mRNA jab; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (ischemic stroke shortly after taking your mRNA jab) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ISCHAEMIC STROKE (ischemic stroke shortly after taking your mRNA jab) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (ischemic stroke shortly after taking your mRNA jab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications was provided by the reporter.  Company comment.  This spontaneous case concerns a patient (unknown age and gender), with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI ischaemic stroke. The event occurred after an unknown time of interval from receiving a dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. it is unknown previous vaccination schedule. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (unknown age and gender), with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI ischaemic stroke. The event occurred after an unknown time of interval from receiving a dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. it is unknown previous vaccination schedule. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Cerebrovascular accident, Computerised tomogram, Confusional state
Clinical narrative: memory; Mental confusion; each time stroke- like problems; covid-19; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (each time stroke- like problems) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (each time stroke- like problems) (seriousness criterion medically significant), COVID-19 (covid-19), MEMORY IMPAIRMENT (memory) and CONFUSIONAL STATE (Mental confusion). At the time of the report, CEREBROVASCULAR ACCIDENT (each time stroke- like problems), COVID-19 (covid-19), MEMORY IMPAIRMENT (memory) and CONFUSIONAL STATE (Mental confusion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood test: result not reported result not reported. On an unknown date, Computerised tomogram: normal (normal) clear and normal. On an unknown date, Lumbar puncture: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced cognitive problems (Anaphase, Brian Fog, and memory etc. and other health related issues as well) associated with Moderna Vaccinations and after having covid and after booster shot.  On unknown date in Jan 2022 recovered booster. same problems. The patient still had deficits from the 2nd vaccine shot and after covid and booster the patient got worse each time.  No concomitant medication was provided. No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious event of Cerebrovascular accident and the unexpected, non-serious, AESI event of COVID-19. The events occurred an unknown duration after the third dose of mRNA-1273 vaccine. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-470555 (Patient Link).; 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, serious event of Cerebrovascular accident and the unexpected, non-serious, AESI event of COVID-19. The events occurred an unknown duration after the third dose of mRNA-1273 vaccine. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Lumbar puncture, Memory impairment, SARS-CoV-2 test
Clinical narrative: memory; Mental confusion; each time stroke- like problems; covid-19; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (each time stroke- like problems) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (each time stroke- like problems) (seriousness criterion medically significant), COVID-19 (covid-19), MEMORY IMPAIRMENT (memory) and CONFUSIONAL STATE (Mental confusion). At the time of the report, CEREBROVASCULAR ACCIDENT (each time stroke- like problems), COVID-19 (covid-19), MEMORY IMPAIRMENT (memory) and CONFUSIONAL STATE (Mental confusion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood test: result not reported result not reported. On an unknown date, Computerised tomogram: normal (normal) clear and normal. On an unknown date, Lumbar puncture: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced cognitive problems (Anaphase, Brian Fog, and memory etc. and other health related issues as well) associated with Moderna Vaccinations and after having covid and after booster shot.  On unknown date in Jan 2022 recovered booster. same problems. The patient still had deficits from the 2nd vaccine shot and after covid and booster the patient got worse each time.  No concomitant medication was provided. No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious event of Cerebrovascular accident and the unexpected, non-serious, AESI event of COVID-19. The events occurred an unknown duration after the third dose of mRNA-1273 vaccine. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-470555 (Patient Link).; 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, serious event of Cerebrovascular accident and the unexpected, non-serious, AESI event of COVID-19. The events occurred an unknown duration after the third dose of mRNA-1273 vaccine. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heavy menstrual bleeding, Pregnancy test, Thrombosis, Vaginal haemorrhage
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2022 and was forwarded to Moderna on 03-Feb-2022. WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN. The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of THROMBOSIS (Clotting). The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jan-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (Started bleeding/bleeding started 2.5 weeks before my actual period date/all the blood that was coming out/how heavy her period was) and VAGINAL HAEMORRHAGE (Vaginal bleeding). On 02-Feb-2022, the patient experienced THROMBOSIS (Clotting) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Worried). At the time of the report, THROMBOSIS (Clotting), HEAVY MENSTRUAL BLEEDING (Started bleeding/bleeding started 2.5 weeks before my actual period date/all the blood that was coming out/how heavy her period was), VAGINAL HAEMORRHAGE (Vaginal bleeding) and ANXIETY (Worried) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, Pregnancy test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient had to go to the doctor because of how heavy her period was. Her appointment is later today 03-Feb-2022. Her last cycle was 18-Jan-2022 to 21-Jan-2022. Patient thought she had a miscarriage because of all the blood that was coming out. Patient wants to know if normal and how long it lasts. The patient confirmed that it was vaginal bleeding. Treatment medication was not provided by the reporter. Company comment: This regulatory authority case concerns a 25-year-old female patient with no reported relevant medical history, who experienced the serious unexpected event of thrombosis approximately 6 days after the last dose of mRNA-1273 (Spikevax). The patient experienced the possible manifestations of heavy menstrual bleeding, vaginal haemorrhage and anxiety. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Sender's Comments: This regulatory authority case concerns a 25-year-old female patient with no reported relevant medical history, who experienced the serious unexpected event of thrombosis approximately 6 days after the last dose of mRNA-1273 (Spikevax). The patient experienced the possible manifestations of heavy menstrual bleeding, vaginal haemorrhage and anxiety. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy injection site; Swelling on the injection site like the size of a softball; itchy injection site and painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swelling on the injection site like the size of a softball) and VACCINATION SITE PAIN (itchy injection site and painful) 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 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swelling on the injection site like the size of a softball) and VACCINATION SITE PAIN (itchy injection site and painful). On 28-Jan-2022, VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swelling on the injection site like the size of a softball) and VACCINATION SITE PAIN (itchy injection site and painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Patient was not willing to provide any other information and mentioned that patient would contact her HCP.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Peripheral coldness
Clinical narrative: having trouble breathing; When gave first vaccine in right arm, the opposite arm (left) was completely numb; When gave first vaccine in right arm, the opposite arm (left) was ice cold; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (having trouble breathing) in a 42-year-old female patient 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 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, the patient experienced DYSPNOEA (having trouble breathing) (seriousness criterion medically significant), HYPOAESTHESIA (When gave first vaccine in right arm, the opposite arm (left) was completely numb) and PERIPHERAL COLDNESS (When gave first vaccine in right arm, the opposite arm (left) was ice cold). On 05-Jan-2022, DYSPNOEA (having trouble breathing), HYPOAESTHESIA (When gave first vaccine in right arm, the opposite arm (left) was completely numb) and PERIPHERAL COLDNESS (When gave first vaccine in right arm, the opposite arm (left) was ice cold) had resolved.        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.   Reporter reported that patient came to get the second dose of the Moderna COVID-19 vaccine. Post first dose patient developed numbness, coldness on the left arm and breathing difficulty .The event started within couple of minutes and got recovered within couple of hours. . First dose lot number and expiration date not available. No concomitant medications were reported. The patient refused the treatment.  Company comment: This Spontaneous case concerns a 42-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (medically significant) event of Dyspnoea. The event occurred immediately after receiving the first dose of mRNA-1273 vaccine. The event required emergency medical assistance, however the patient declined treatment. The patient recovered within a couple hours. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 42-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (medically significant) event of Dyspnoea. The event occurred immediately after receiving the first dose of mRNA-1273 vaccine. The event required emergency medical assistance, however the patient declined treatment. The patient recovered within a couple hours. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; Lack of Efficacy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2022 and was forwarded to Moderna on 03-Feb-2022.    This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of Efficacy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Dec-2021, the patient experienced COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of Efficacy). At the time of the report, COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of Efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-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 medications reported by reporter No treatment medications provided by the reporter.  This is a spontaneous case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19 and drug ineffective. The event occurred approximately 8 months and 20 days after the second dose of the mRNA  1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2022-464885 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19 and drug ineffective. The event occurred approximately 8 months and 20 days after the second dose of the mRNA  1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Post menopausal bleeding) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Post menopausal bleeding) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Post menopausal bleeding) outcome was unknown.            The concomitant medication was not reported. The treatment medication was not reported. The reporter stated she knew about 3 other women who had post menopausal bleeding after Covid-19 booster doses from unknown manufacturers.  Company comment: This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected event of postmenopausal hemorrhage. The event occurred on an unknown date after the third (booster) dose of mRNA-1273. No further information was provided regarding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected event of postmenopausal hemorrhage. The event occurred on an unknown date after the third (booster) dose of mRNA-1273. No further information was provided regarding the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Patient felt very bad; Patient felt very achy; Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Patient felt very bad), MYALGIA (Patient felt very achy) and PYREXIA (Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights) in an 80-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 vaccine (Patient stated got 2 first shots of Pfizer vaccine (did not remember dates of vaccination).) in 2021 and Pfizer vaccine (Patient stated got 2 first shots of Pfizer vaccine (did not remember dates of vaccination).) in 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced FEELING ABNORMAL (Patient felt very bad), MYALGIA (Patient felt very achy) and PYREXIA (Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights). The patient was treated with SECUKINUMAB (COSENTYX) ongoing since an unknown date for Arthritis, at an unspecified dose and frequency; IRBESARTAN ongoing since an unknown date for Blood pressure, at an unspecified dose and frequency; ROSUVASTATIN ongoing since an unknown date for Blood cholesterol abnormal, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 28-Jan-2022, FEELING ABNORMAL (Patient felt very bad), MYALGIA (Patient felt very achy) and PYREXIA (Patient experienced fever of 101°F/Patient experienced fever of up to 105°F during the nights) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 105°f (High) Fever.         On 27-Jan-2022 patient felt very bad, very achy, and experienced fever of 101°F. For almost one week caller felt fine throughout the day, but experienced fever of up to 105°F during the nights. Patient took Tylenol and symptoms finally gone away. Patient was under treatment with Cosentyx injections for arthritis, Irbesartan for blood pressure, and Rosuvastatin for cholesterol. No concomitant medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: I also had a steroid shot in my hip 2 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (I also had a steroid shot in my hip 2 weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (hospitalized with pneumonia in past.). Concurrent medical conditions included Brain cancer metastatic, Autoimmune disorder NOS and Asthma.   In September 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (I also had a steroid shot in my hip 2 weeks ago). At the time of the report, MUSCULOSKELETAL DISCOMFORT (I also had a steroid shot in my hip 2 weeks ago) outcome was unknown. Not Provided          No concomitant medications was reported. Patient received unspecified steroid as treatment medication. It was reported that, The patient did not feel protected and had hospitalized with pneumonia in the past and patient don't want to repeat visit with COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had the omcron covid two weeks ago; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had the omcron covid two weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (had the omcron covid two weeks ago). At the time of the report, COVID-19 (had the omcron covid two weeks ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The patient had the omcron COVID two weeks ago and now symptom free. No treatment information was provided.  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 Jan 2022 while the received dose of the mRNA  1273 vaccine occurred on an unknown date. At the time of report Covid-19 had resolved. The reporter did not provide any causality assessments. 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 Jan 2022 while the received dose of the mRNA  1273 vaccine occurred on an unknown date. At the time of report Covid-19 had resolved. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Headache, Hypertension
Clinical narrative: Diplopia in one eye/ double vision in one eye.; High blood pressure; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Diplopia in one eye/ double vision in one eye.), HYPERTENSION (High blood pressure) and HEADACHE (Headache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLOPIA (Diplopia in one eye/ double vision in one eye.), HYPERTENSION (High blood pressure) and HEADACHE (Headache). At the time of the report, DIPLOPIA (Diplopia in one eye/ double vision in one eye.) and HEADACHE (Headache) had not resolved and HYPERTENSION (High blood pressure) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash from the booster/received all three shots now I started to brake out in a bad rash/This rash I'm getting 6 weeks after the booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash from the booster/received all three shots now I started to brake out in a bad rash/This rash I'm getting 6 weeks after the booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced RASH (Rash from the booster/received all three shots now I started to brake out in a bad rash/This rash I'm getting 6 weeks after the booster shot). At the time of the report, RASH (Rash from the booster/received all three shots now I started to brake out in a bad rash/This rash I'm getting 6 weeks after the booster shot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient had a rash with booster. The patient started to break out in a bad rash and had happen three times in a week. The patient got rash 6 weeks after the booster shot.  No treatment information was provided.   This case was linked to MOD-2022-471976 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2022: Added administration date of booster dose and Event verbatim was updated. On 04-Feb-2022: Updated the event verbatim and added the event onset date.
Sex: U
Vaccine: COVID19
Symptoms: Hand dermatitis, Skin haemorrhage
Clinical narrative: Bleeding from the hands; exzema fully on both hands; This spontaneous case was reported by a consumer and describes the occurrence of HAND DERMATITIS (exzema fully on both hands) and SKIN HAEMORRHAGE (Bleeding from the hands) 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 July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced HAND DERMATITIS (exzema fully on both hands). On an unknown date, the patient experienced SKIN HAEMORRHAGE (Bleeding from the hands). At the time of the report, HAND DERMATITIS (exzema fully on both hands) had not resolved and SKIN HAEMORRHAGE (Bleeding from the hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 031L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy, Fruit allergy (Banana), Scleroderma on 15-Jan-2004, Palpitations on 15-Jan-2004 and Intermediate coronary syndrome (Intermed coronary syndrome) on 15-Jan-2004.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) PCR.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter   This case was linked to MOD-2022-472140, MOD-2022-460301 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested Positive for Covid-19; Lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested Positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Allergic to Banana), Dust allergy, Scleroderma since 15-Jan-2004, Palpitations since 15-Jan-2004 and Intermediate coronary syndrome (Intermed coronary syndrome) since 15-Jan-2004.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milligram. On 06-Jan-2022, the patient experienced COVID-19 (Patient tested Positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Patient tested Positive for Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.  Company Comment: This is a Spontaneous case concerning a 54-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was reported. The event occurred approximately 1 year, 1 month and 4 days after the administration of a dose of the mRNA-1273 vaccine of a proper schedule of vaccination, the patient has received 2 doses of mRNA-1273 vaccine (with an interval of 28 days between two doses). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.   This case was linked to MOD-2022-472088, MOD-2022-460301 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 54-year-old female patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. Also, the special situation of Drug ineffective was reported. The event occurred approximately 1 year, 1 month and 4 days after the administration of a dose of the mRNA-1273 vaccine of a proper schedule of vaccination, the patient has received 2 doses of mRNA-1273 vaccine (with an interval of 28 days between two doses). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment was provided to the patient.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  The Pharmacist reported administration of an expired  Moderna vaccine to patients of around 490 to 500 people on the date last 20 Oct 2021 to 29 Nov 2021.  Reporter has provided lot Number of vaccine as follows, 006C21A (10-10-2021), 026B21A (09-17-2021), and 031B21A (9-22-2021).  Reporter stated that vaccines were stored in freezer and used one to two vials which were placed in fridge each day as needed.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 040B21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Senile nuclear sclerosis. Concurrent medical conditions included Hypothyroidism since 08-Oct-2016, Hypertension since 05-Nov-2017, Hearing loss bilateral since 08-Oct-2016 and Diabetes mellitus since 08-Oct-2018. Concomitant products included GLIMEPIRIDE, INSULIN GLARGINE and METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]) for Diabetes, LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Hypertension, LEVOTHYROXINE for Hypothyroidism.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Jan-2022 at 9:24 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    No treatment information provided by the reporter.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administration/ Received Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration/ Received Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Phenytoin), Tuberous sclerosis, Seizure and Lung nodule (Multiple).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 11:09 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 11:09 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration/ Received Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.). On 24-Jan-2022 at 11:09 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration/ Received Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Patient received their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date. Patient did not experience adverse event.  No treatment medications were provided.   This case was linked to MOD-2022-472490 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dyspnoea, Pyrexia, Syncope
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Experiencing passing out or almost passing out whenever I stand up) 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 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Experiencing passing out or almost passing out whenever I stand up) (seriousness criterion medically significant), DIZZINESS (Severe with dizziness), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 100.6). At the time of the report, SYNCOPE (Experiencing passing out or almost passing out whenever I stand up), DIZZINESS (Severe with dizziness), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 100.6) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) Fever of 100.6. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Syncope. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The patient experienced passing out or almost passing out whenever she/he stands up. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Syncope. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The patient experienced passing out or almost passing out whenever she/he stands up. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) and DRUG INEFFECTIVE (tested positive for COVID-19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Oral contraceptive. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (NORGESTIMATE & ETHINYL ESTRADIOL) for Oral contraceptive.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) and DRUG INEFFECTIVE (tested positive for COVID-19). On 01-Dec-2021, DRUG INEFFECTIVE (tested positive for COVID-19) had resolved. 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 01-Dec-2021, Polymerase chain reaction: positive (Positive) Tested positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was reported.  Company comment: This is a spontaneous case concerning a 25-year-old female patient with no medical history reported, who experienced the unexpected events of SARS-CoV-2 test positive and drug ineffective. The events occurred approximately 9 months and 4 days after the second dose of the mRNA-1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2022-472265 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 25-year-old female patient with no medical history reported, who experienced the unexpected events of SARS-CoV-2 test positive and drug ineffective. The events occurred approximately 9 months and 4 days after the second dose of the mRNA-1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.