chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (consumer also mentioned patient's daughter just tested positive for COVID-19) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 7, 2022, patient experienced COVID-19 (consumer also mentioned patient's daughter just tested positive for COVID-19). At the time of the report, COVID-19 (consumer also mentioned patient's daughter just tested positive for COVID-19) outcome: unknown. Diagnostic results: On Jan 7, 2022, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2022-444983 (patient link). Sender's comments: This case concerns a female patient (with no reported medical history), who experienced unexpected SARS-CoV-2 test positive that occurred after the dose of the mRNA-1273. The re-challenge not applicable due to unspecified number of doses administered and nature of the event. The benefit-risk relationship of mRNA-1273 not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Contracted covid last week; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (Contracted covid last week) 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, 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 SUSPECTED COVID-19 (Contracted covid last week). At the time of the report, SUSPECTED COVID-19 (Contracted covid last week) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.  It was reported that the patent contracted COVID-19 last week, felt fine now and was still quarantined. The patient also reported that none of the people that was in contact with the patient had symptoms and tested negative.Lack of efficacy, Covid after 2 shots and the booster was reported.  Company Comment: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious AESI event of Suspected COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that the patient contracted COVID-19 last week, felt fine now and was still quarantined. The patient also reported that none of the people that was in contact with the patient had symptoms and tested negative. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected non-serious AESI event of Suspected COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that the patient contracted COVID-19 last week, felt fine now and was still quarantined. The patient also reported that none of the people that was in contact with the patient had symptoms and tested negative. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 046A21A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.   On 16-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021 at 12:04 AM, 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 AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter. Company comment: This is a spontaneous case concerning a 64-year-old, female patient with no relevant medical history reported, who experienced the non-serious unexpected, according CCDS, AESI of Ageusia. The event occurred after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable. At the time of the report the event outcome was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This is a spontaneous case concerning a 64-year-old, female patient with no relevant medical history reported, who experienced the non-serious unexpected, according CCDS, AESI of Ageusia. The event occurred after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable. At the time of the report the event outcome was recovered/resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: recently recovering from COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (recently recovering from COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (recently recovering from COVID-19). At the time of the report, COVID-19 (recently recovering from COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 in an unknown timeframe after the second dose of mRNA-1273 vaccine. The exact details regarding the first and the second dose were not provided, therefore lack of efficacy cannot be determined. 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 non-serious AESI of COVID-19 in an unknown timeframe after the second dose of mRNA-1273 vaccine. The exact details regarding the first and the second dose were not provided, therefore lack of efficacy cannot be determined. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: exposed to COVID-19; positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to COVID-19) and SARS-COV-2 TEST POSITIVE (positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to COVID-19) and SARS-COV-2 TEST POSITIVE (positive for COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to COVID-19) and SARS-COV-2 TEST POSITIVE (positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported  Company Comment: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI event of SARS-CoV-2 test positive. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a male patient of unknown age, with no medical history reported, who experienced the unexpected, non serious, and AESI event of SARS-CoV-2 test positive. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: getting COVID.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (getting COVID.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 COVID-19 (getting COVID.). At the time of the report, COVID-19 (getting COVID.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) positive.     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 & Treatment drug reported.  The patient wanted to check for how long should he/she should wait to get the booster, after getting COVID.     Company comment: This case concerns a patient of an unknown age and gender with no medical history provided, who developed non serious unexpected event of special interest - COVID-19 after vaccination with the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined since no dates were provided. There were no reported signs or symptoms of COVID-19 infection and no information regarding the clinical course of the event was disclosed. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided, who developed non serious unexpected event of special interest - COVID-19 after vaccination with the mRNA-1273 vaccine. The temporal relationship between the event occurrence and vaccination cannot be determined since no dates were provided. There were no reported signs or symptoms of COVID-19 infection and no information regarding the clinical course of the event was disclosed. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: severe hives/flare-up hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (severe hives/flare-up hives) in a 30-year-old male patient 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 March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (severe hives/flare-up hives) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at a dose of UNK, prn; HYDROXYZINE for Hives, at a dose of UNK, prn and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (severe hives/flare-up hives) had not resolved.            No relevant concomitant medications were reported.  Patient reported that 10 days after getting the booster dose, he broke out into severe hives, initially he thought it might be food allergy and to went urgent care and was prescribed with medicines for 6 days. Patient went to an allergist on 1-Jan-2022, as the hives got flared up.  Company Comment: This is a spontaneous case concerning a 30-year-old, male patient with no medical history reported, who experienced the unexpected serious event of urticaria. The event occurred approximately 10 days after the booster dose of mRNA-1273 vaccine. The patient received treatment with methylprednisolone and antihistaminic drugs. Additionally, inappropriate schedule was noted for the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition.   This case was linked to MOD-2022-449257 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 30-year-old, male patient with no medical history reported, who experienced the unexpected serious event of urticaria. The event occurred approximately 10 days after the booster dose of mRNA-1273 vaccine. The patient received treatment with methylprednisolone and antihistaminic drugs. Additionally, inappropriate schedule was noted for the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical condition.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced COVID-19 (COVID symptoms). At the time of the report, COVID-19 (COVID symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 47-year-old male  patient with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred 29 days after the first dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 47-year-old male patient with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred 29 days after the first dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     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.  It was reported that the patient have booster scheduled for 14 Jan 2022.  Company comment: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred  on 03-Jan-2022, after the administration of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  patient of an unknown age and gender with no medical history reported, who experienced non serious, unexpected event of COVID-19 (AESI). The event occurred  on 03-Jan-2022, after the administration of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Headache, Malaise, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of malaise (felt unwell on a daily basis), feeling abnormal (little overwhelmed), bone pain (pain in bone), headache and nausea in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 4, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In January 2022, patient experienced malaise (felt unwell on a daily basis), feeling abnormal (little overwhelmed), bone pain (pain in bone), headache and nausea. In January 2022, bone pain (pain in bone) resolved. At the time of the report, malaise (felt unwell on a daily basis), headache and nausea: not resolved and feeling abnormal (little overwhelmed) outcome: unknown. No concomitant medication reported. The treatment information unknown. Most recent follow-up information incorporated: On Jan 12, 2022: Significant information: event added and dose number added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Immunodeficiency
Clinical narrative: Immune system is compromised; Had a stroke after both doses of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Immune system is compromised) and CEREBROVASCULAR ACCIDENT (Had a stroke after both doses of moderna vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke after both doses of moderna vaccine) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced IMMUNODEFICIENCY (Immune system is compromised) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in December 2021 to sometime in December 2021 due to CEREBROVASCULAR ACCIDENT and IMMUNODEFICIENCY. The patient was treated with Physical therapy for Cerebrovascular accident. At the time of the report, IMMUNODEFICIENCY (Immune system is compromised) had not resolved and CEREBROVASCULAR ACCIDENT (Had a stroke after both doses of moderna vaccine) outcome was unknown.            Concomitant medications were not provided by the reporter. Patient stated that she was ok and did not had any deficit. Company Comment: This is a spontaneous case concerning a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI Cerebrovascular accident and the unexpected serious event of Immunodeficiency. The event Cerebrovascular accident occurred approximately 8 months 19 days after the second dose of mRNA-1273 vaccine. The patient required hospitalization for 3 days. She was treated with physical therapy and stated that she did not have any deficit. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization and important medical event.; Sender's Comments: This is a spontaneous case concerning a 59-year-old, female patient with no medical history reported, who experienced the unexpected serious AESI Cerebrovascular accident and the unexpected serious event of Immunodeficiency. The event Cerebrovascular accident occurred approximately 8 months 19 days after the second dose of mRNA-1273 vaccine. The patient required hospitalization for 3 days. She was treated with physical therapy and stated that she did not have any deficit. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to hospitalization and important medical event.
Sex: U
Vaccine: COVID19
Symptoms: Appendicectomy
Clinical narrative: Appendectomy; This spontaneous case was reported by an other health care professional and describes the occurrence of APPENDICECTOMY (Appendectomy) 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 March 2021, the patient experienced APPENDICECTOMY (Appendectomy) (seriousness criterion hospitalization). In March 2021, APPENDICECTOMY (Appendectomy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient took first 2 doses back in Jan/Feb and ended up with an appendectomy a month later.  Treatment information was not provided.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender  with no medical history reported, who experienced serious, unexpected event of appendicectomy. The event occurred approximately 1 month after the administration of second dose of mRNA-1273 vaccine. Clinical course was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-450490 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender  with no medical history reported, who experienced serious, unexpected event of appendicectomy. The event occurred approximately 1 month after the administration of second dose of mRNA-1273 vaccine. Clinical course was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Diagnosed with Blood clots in my left leg; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Diagnosed with Blood clots in my left leg) 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 November 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 THROMBOSIS (Diagnosed with Blood clots in my left leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with Blood clots in my left leg) outcome was unknown.        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.  Patient had the booster dose in November and was recently diagnosed with Blood clots in the left leg. Company Comment: This is a spontaneous case concerning patient ok unknown age and gender with no medical history reported, who experienced the unexpected serious AESI Thrombosis (reported as Blood clots in my left leg). The event occurred at an unknown day after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.    Treatment information was not provided.   This case was linked to MOD-2022-450463 (Patient Link). Sender's Comments: This is a spontaneous case concerning patient ok unknown age and gender with no medical history reported, who experienced the unexpected serious AESI Thrombosis (reported as Blood clots in my left leg). The event occurred at an unknown day after the booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to important medical event and medical judgement.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Very adnormal and not right; could not stand or dress myself.; Dizziness; Hypersensitivity reaction; body aches; headache; nausea; Chills; 103 degree fever; Fatigue; Severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain), FEELING ABNORMAL (Very adnormal and not right), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to nuts (Reactions - Itchiness, Throat tightening/constricting, esophagus pain, stomach pain, vomiting), Fish allergy (Reactions - Hives, itchiness, throat constriction, stomach pain, vomiting) since March 2015, Drug allergy (Reaction - Severe hives), Anaphylaxis and Hypersensitivity.   On 11-Feb-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 4:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Very adnormal and not right). In March 2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.), DIZZINESS (Dizziness), HYPERSENSITIVITY (Hypersensitivity reaction), MYALGIA (body aches), HEADACHE (headache), NAUSEA (nausea), CHILLS (Chills), PYREXIA (103 degree fever) and FATIGUE (Fatigue). On 11-Mar-2021, FEELING ABNORMAL (Very adnormal and not right) had resolved. In March 2021, DIZZINESS (Dizziness), HYPERSENSITIVITY (Hypersensitivity reaction), MYALGIA (body aches), HEADACHE (headache), NAUSEA (nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (Severe arm pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.) and PYREXIA (103 degree fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 103 degree 103 degree fever.         Symptoms of Hypersensitivity reaction include Itching/pruritus (The Skin on my throat started to get very itchy), Swelling of upper airway (lips, tongue, throat, uvula, or larynx), Stridor, Unusual taste(very strong metallic taste in mouth)  Event description includes tongue and mouth felt very strange and abnormal, about twelve hours later (around 7:30 am), side effects hit like flipping on a light switch.  It was reported that By 5 pm, the symptoms of patient began to resolve followed by severe fatigue for a day and half.  No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-420991 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Very adnormal and not right; could not stand or dress myself.; Dizziness; Hypersensitivity reaction; body aches; headache; nausea; Chills; 103 degree fever; Fatigue; Severe arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain), FEELING ABNORMAL (Very adnormal and not right), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to nuts (Reactions - Itchiness, Throat tightening/constricting, esophagus pain, stomach pain, vomiting), Fish allergy (Reactions - Hives, itchiness, throat constriction, stomach pain, vomiting) since March 2015, Drug allergy (Reaction - Severe hives), Anaphylaxis and Hypersensitivity.   On 11-Feb-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 4:45 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Very adnormal and not right). In March 2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.), DIZZINESS (Dizziness), HYPERSENSITIVITY (Hypersensitivity reaction), MYALGIA (body aches), HEADACHE (headache), NAUSEA (nausea), CHILLS (Chills), PYREXIA (103 degree fever) and FATIGUE (Fatigue). On 11-Mar-2021, FEELING ABNORMAL (Very adnormal and not right) had resolved. In March 2021, DIZZINESS (Dizziness), HYPERSENSITIVITY (Hypersensitivity reaction), MYALGIA (body aches), HEADACHE (headache), NAUSEA (nausea), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (Severe arm pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not stand or dress myself.) and PYREXIA (103 degree fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 103 degree 103 degree fever.         Symptoms of Hypersensitivity reaction include Itching/pruritus (The Skin on my throat started to get very itchy), Swelling of upper airway (lips, tongue, throat, uvula, or larynx), Stridor, Unusual taste(very strong metallic taste in mouth)  Event description includes tongue and mouth felt very strange and abnormal, about twelve hours later (around 7:30 am), side effects hit like flipping on a light switch.  It was reported that By 5 pm, the symptoms of patient began to resolve followed by severe fatigue for a day and half.  No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-420991 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: old vial that was stored at room temp was used for an injection; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (old vial that was stored at room temp was used for an injection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (old vial that was stored at room temp was used for an injection). At the time of the report, EXPIRED PRODUCT ADMINISTERED (old vial that was stored at room temp was used for an injection) 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.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered more than 12 to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12(US) to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s)). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 to patient(s)/Another pharmacist left out the vial past 12 hour mark yesterday and today Intern gave it to a patient(s)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Another pharmacist left out the vial past 12 hour marked on 14-Jan-2022 and on 15-Jan-2022 an Intern gave it to a patient.  The reporter wanted to know if patient would need to be re-dosed or not.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Chronic headache; Fatigue; fever; Body aches; Chills; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Chronic headache), FATIGUE (Fatigue), PYREXIA (fever), MYALGIA (Body aches) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced HEADACHE (Chronic headache), FATIGUE (Fatigue), PYREXIA (fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, HEADACHE (Chronic headache) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (fever), MYALGIA (Body aches) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported by the reporter. It was reported that the patient have had chronic headache and fatigue since receiving the booster shot and for first 3 days had mild fever and body aches and chills.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dysstasia, Fatigue, Muscular weakness
Clinical narrative: Other pains going on; Slept more than 8 hours; Muscle weakness; Unable to stand for long periods of time; Runny nose; Feeling weak; Cough; Tired/muscles are tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time) and RHINORRHOEA (Runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2022, the patient experienced PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time), RHINORRHOEA (Runny nose), ASTHENIA (Feeling weak), COUGH (Cough) and FATIGUE (Tired/muscles are tired/fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time), RHINORRHOEA (Runny nose), ASTHENIA (Feeling weak), COUGH (Cough) and FATIGUE (Tired/muscles are tired/fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was reported by the reporter.  It was reported that, the patient had symptoms listed under Covid-19.  Treatment included dirking liquids (orange and apple juice).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test, Somnolence
Clinical narrative: Other pains going on; Slept more than 8 hours; Muscle weakness; Unable to stand for long periods of time; Runny nose; Feeling weak; Cough; Tired/muscles are tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time) and RHINORRHOEA (Runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2022, the patient experienced PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time), RHINORRHOEA (Runny nose), ASTHENIA (Feeling weak), COUGH (Cough) and FATIGUE (Tired/muscles are tired/fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Other pains going on), SOMNOLENCE (Slept more than 8 hours), MUSCULAR WEAKNESS (Muscle weakness), DYSSTASIA (Unable to stand for long periods of time), RHINORRHOEA (Runny nose), ASTHENIA (Feeling weak), COUGH (Cough) and FATIGUE (Tired/muscles are tired/fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication was reported by the reporter.  It was reported that, the patient had symptoms listed under Covid-19.  Treatment included dirking liquids (orange and apple juice).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Very severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very severe reaction) 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 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION COMPLICATION (Very severe reaction). At the time of the report, VACCINATION COMPLICATION (Very severe reaction) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 23 weeks pregnant and got vaccinated; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and got vaccinated) 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 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 16-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and got vaccinated). On 16-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and got vaccinated) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product given by reporter. No treatment product given by reporter. The health care worker wrote same lot number of Moderna vaccine in my vaccination passport. The patient was worried that they did not administer the correct vaccine. This incident gives so much worry to the patient.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Nausea
Clinical narrative: Cannot sleep on left shoulder; constant left shoulder pain / cannot sleep on left shoulder; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cannot sleep on left shoulder), ARTHRALGIA (constant left shoulder pain / cannot sleep on left shoulder) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Cannot sleep on left shoulder), ARTHRALGIA (constant left shoulder pain / cannot sleep on left shoulder) and NAUSEA (Nausea). At the time of the report, INSOMNIA (Cannot sleep on left shoulder) and ARTHRALGIA (constant left shoulder pain / cannot sleep on left shoulder) had not resolved and NAUSEA (Nausea) had resolved.            Patient stated within two months of second dose patient experienced constant pain. Patient stated that he cannot sleep on left shoulder till the time of report.  No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died from the your vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died from the your vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 14-Jan-2022 The patient died on 14-Jan-2022. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown time after a dose of mRNA-1273 vaccine. Cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to death and important medical event.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown time after a dose of mRNA-1273 vaccine. Cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Case was assessed as serious due to death and important medical event.; Reported Cause(s) of Death: Death NOS