chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hypersomnia, Migraine
Clinical narrative: migraine; got cold; muscles started jerking\kind of like a seizure jerk; sore arm for 3 days; slept the whole day; small headache; was so tired; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days) and HYPERSOMNIA (slept the whole day) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days), HYPERSOMNIA (slept the whole day), HEADACHE (small headache) and FATIGUE (was so tired). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days), HYPERSOMNIA (slept the whole day), HEADACHE (small headache) and FATIGUE (was so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This case concerns a  46-year-old, female patient with no relevant medical history, who experienced the unexpected events of Migraine, feeling cold, myoclonus, pain in extremity and hypersomnia, and listed events of headache and fatigue. The events occurred approximately 1 day after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed.  The benefit-risk relationship of Spikevax is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myoclonus, Pain in extremity
Clinical narrative: migraine; got cold; muscles started jerking\kind of like a seizure jerk; sore arm for 3 days; slept the whole day; small headache; was so tired; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days) and HYPERSOMNIA (slept the whole day) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days), HYPERSOMNIA (slept the whole day), HEADACHE (small headache) and FATIGUE (was so tired). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days), HYPERSOMNIA (slept the whole day), HEADACHE (small headache) and FATIGUE (was so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This case concerns a  46-year-old, female patient with no relevant medical history, who experienced the unexpected events of Migraine, feeling cold, myoclonus, pain in extremity and hypersomnia, and listed events of headache and fatigue. The events occurred approximately 1 day after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed.  The benefit-risk relationship of Spikevax is not affected by this report.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eating disorder, Myalgia, Nausea
Clinical narrative: he had difficulty eating much; tremendous amount of pain on his left side of his body; For a month after, he was extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 408D21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, IBUPROFEN (IBUPROFEN 2CARE4) and PARACETAMOL (TYLENOL) for Pain.    On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous). At the time of the report, EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous) outcome was unknown.            This case was linked to MOD-2021-342936 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: few of the tenants received the booster shot and have been throwing up / this patient stated that there were others; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others). At the time of the report, VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others) outcome was unknown. Not Provided          No concomitant treatment was provided. No treatment medication was provided. Reporter believes that the patients are immunocompromised since she knows Moderna has not approved a booster dose, but not sure patients are immunocompromised or not.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: sore left injection site arm; fever; fatigue; joint pain; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes). On 04-Sep-2021, PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included Birth Control. No treatment information provided.   This case was linked to MOD-2021-343341 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist stated that the patient claimed to be immuno-comprormised.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Lymphadenopathy
Clinical narrative: extreme vomiting; Fever of 99 to 101.1 degrees Farenheight; joint pain in both legs/joint pain in both knees; headache; chills; nausea; sore right injection site arm; swollen lymph node in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache) and CHILLS (chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm). At the time of the report, VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Body temperature: 99 to 101.1 (High) 99 to 101.1 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Birth control pills. Treatment medications were not reported.   This case was linked to MOD-2021-343259 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: extreme vomiting; Fever of 99 to 101.1 degrees Farenheight; joint pain in both legs/joint pain in both knees; headache; chills; nausea; sore right injection site arm; swollen lymph node in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache) and CHILLS (chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm). At the time of the report, VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Body temperature: 99 to 101.1 (High) 99 to 101.1 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Birth control pills. Treatment medications were not reported.   This case was linked to MOD-2021-343259 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Eye swelling, Lip swelling
Clinical narrative: Swollen lips; her eyelids and lips were swollen; allergic reaction to the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Swollen lips), EYE SWELLING (her eyelids and lips were swollen) and ALLERGY TO VACCINE (allergic reaction to the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Histamine intolerance, Multiple sclerosis and Immunocompromised.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swollen lips), EYE SWELLING (her eyelids and lips were swollen) and ALLERGY TO VACCINE (allergic reaction to the first dose). At the time of the report, LIP SWELLING (Swollen lips), EYE SWELLING (her eyelids and lips were swollen) and ALLERGY TO VACCINE (allergic reaction to the first dose) outcome was unknown. Not Provided      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.   Patient had anaphylactic reaction to tetanus toxoid and the shingles vaccine. The patient have pre serious allergic reactions so, to manage the allergic reaction she received five injections in a step wise manner three in one arm and two in another in 15-minute intervals. After the third injection, she did feelsome tingling in her arm, but it resolved on its own. No concomitants were reported. No treatment drugs were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy rash at the injection site; itchy rash at the injection site/itchy rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Immunoglobulins increased. Concurrent medical conditions included Bug bite (bug bite allergy).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site). In March 2021, VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications provided. No treatment medication was reported for the events happened for first dose.   This case was linked to MOD-2021-343352 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Non Significant Follow Up received contains picture.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Depression, Rash, Sensitive skin, Skin disorder
Clinical narrative: She has had outbreaks on her skin, then it appears on her back; It feels like a burning sensation It is spreading to part of her leg; it caused  her depression; Her leg is becoming sensitive; had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (She has had outbreaks on her skin, then it appears on her back), BURNING SENSATION (It feels like a burning sensation It is spreading to part of her leg), DEPRESSION (it caused  her depression), SENSITIVE SKIN (Her leg is becoming sensitive) and RASH (had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (She has had outbreaks on her skin, then it appears on her back), BURNING SENSATION (It feels like a burning sensation It is spreading to part of her leg), DEPRESSION (it caused  her depression), SENSITIVE SKIN (Her leg is becoming sensitive) and RASH (had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead). At the time of the report, SKIN DISORDER (She has had outbreaks on her skin, then it appears on her back), BURNING SENSATION (It feels like a burning sensation It is spreading to part of her leg), DEPRESSION (it caused  her depression), SENSITIVE SKIN (Her leg is becoming sensitive) and RASH (had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead) outcome was unknown.            Patient went to a dermatologist and she was given some medications.  No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-060501, MOD-2021-060501.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Thrombosis
Clinical narrative: she suffered a stroke; blood clots after the 2nd shot; she lost her speech for a while; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (she suffered a stroke) and THROMBOSIS (blood clots after the 2nd shot) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (she suffered a stroke) (seriousness criterion medically significant), THROMBOSIS (blood clots after the 2nd shot) (seriousness criterion medically significant) and APHASIA (she lost her speech for a while). At the time of the report, CEREBROVASCULAR ACCIDENT (she suffered a stroke), THROMBOSIS (blood clots after the 2nd shot) and APHASIA (she lost her speech for a while) outcome was unknown.            Concomitant medications was not provided by the reporter Treatment information was not provided  Company Comment : This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious events of stroke and blood clots. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Details are limited for the events and additional information is not expected.; Sender's Comments: This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious events of stroke and blood clots. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Details are limited for the events and additional information is not expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site pain
Clinical narrative: a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (a little soreness at the injection site). In August 2021, VACCINATION SITE PAIN (a little soreness at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 012 (abnormal) antibody reactive result of 012.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.   It was reported that the patient had just a little soreness at the injection site, started immediately and went away after a week.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction to Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction to Moderna vaccine) 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 VACCINATION COMPLICATION (Adverse reaction to Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Adverse reaction to Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains no new information. On 06-Oct-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: few people in my church started getting Covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (few people in my church started 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced COVID-19 (few people in my church started getting Covid). At the time of the report, COVID-19 (few people in my church started getting Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that even though vaccinated few people in his church got COVID-19 and none of them had to be in Hospital.  No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This spontaneous report concerns patients of unknown age and gender with no relevant medical history who experienced non-serious AESI event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The reporter stated that the patients were vaccinated, however still contracted COVID-19 infection. Re-challenge is unknown as there is no information on the vaccine doses. The benefit-risk relationship of mRNA-1273 is not affected by this report. Based on the available information, the case has been classified as invalid.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: rash/rash in stomach; rash in injected arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm). At the time of the report, RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Patient's symptoms subsided after a coupe of weeks.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Drug ineffective, Headache, Pyrexia
Clinical narrative: Chest discomfort; Pyrexia; Headache; Tested positive for COVID after vaccination; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after vaccination), DRUG INEFFECTIVE (Lack of efficacy), CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hepatitis C.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced COVID-19 (Tested positive for COVID after vaccination) and DRUG INEFFECTIVE (Lack of efficacy). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache). At the time of the report, COVID-19 (Tested positive for COVID after vaccination), DRUG INEFFECTIVE (Lack of efficacy), CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         No concomitant medication was reported by the reporter. No treatment was reported by the reporter.; Sender's Comments: This case concerns a 58-year-old male patient with medical history of Asthma and Hepatitis C, who experienced the unexpected events of SARS-CoV test positive and chest discomfort, and the expected events of pyrexia and headache. Latency 6 months and 8 days after the first dose of mRNA-1273. Drug ineffective was considered as an additional event. The rechallenge was not applicable, as no additional dosing will be given. The medical history of Asthma could be potentially confounder for the event of chest discomfort. The benefit-risk relationship of vaccine in not affected by this report. The case was assessed as non-serious based on reported seriousness and medical judgement.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Chest discomfort; Pyrexia; Headache; Tested positive for COVID after vaccination; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after vaccination), DRUG INEFFECTIVE (Lack of efficacy), CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hepatitis C.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced COVID-19 (Tested positive for COVID after vaccination) and DRUG INEFFECTIVE (Lack of efficacy). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache). At the time of the report, COVID-19 (Tested positive for COVID after vaccination), DRUG INEFFECTIVE (Lack of efficacy), CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         No concomitant medication was reported by the reporter. No treatment was reported by the reporter.; Sender's Comments: This case concerns a 58-year-old male patient with medical history of Asthma and Hepatitis C, who experienced the unexpected events of SARS-CoV test positive and chest discomfort, and the expected events of pyrexia and headache. Latency 6 months and 8 days after the first dose of mRNA-1273. Drug ineffective was considered as an additional event. The rechallenge was not applicable, as no additional dosing will be given. The medical history of Asthma could be potentially confounder for the event of chest discomfort. The benefit-risk relationship of vaccine in not affected by this report. The case was assessed as non-serious based on reported seriousness and medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The doses are greater than 42 days apart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The doses are greater than 42 days apart) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The doses are greater than 42 days apart). On 07-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The doses are greater than 42 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up document received contain no new information.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: has not administered the second dose/ to give the second dose but it is considered off-label; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label). At the time of the report, OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the Pharmacy staff did not notice the deviation until the patient came back to get her second dose on 03-OCT-2021. Pharmacist has not administered the second dose to the patient.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Lip swelling, Swelling face
Clinical narrative: his upper lip swollen, most of his whole upper lip and right side of his jaw; jaw are swollen, most of his whole upper lip and right side of his jaw.; He states he doesn't feel good; thinks it could be an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (his upper lip swollen, most of his whole upper lip and right side of his jaw), SWELLING FACE (jaw are swollen, most of his whole upper lip and right side of his jaw.), FEELING ABNORMAL (He states he doesn't feel good) and HYPERSENSITIVITY (thinks it could be an allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not provided by the reporter.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (his upper lip swollen, most of his whole upper lip and right side of his jaw), SWELLING FACE (jaw are swollen, most of his whole upper lip and right side of his jaw.), FEELING ABNORMAL (He states he doesn't feel good) and HYPERSENSITIVITY (thinks it could be an allergic reaction). At the time of the report, LIP SWELLING (his upper lip swollen, most of his whole upper lip and right side of his jaw), SWELLING FACE (jaw are swollen, most of his whole upper lip and right side of his jaw.), FEELING ABNORMAL (He states he doesn't feel good) and HYPERSENSITIVITY (thinks it could be an allergic reaction) had not resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant information was provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Improper steps prior to administration/vial was turned up and down a couple times; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times) 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. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times). At the time of the report, PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times) 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 medications were mentioned. No treatment details were reported. Caller reported that the patient stated, when the vaccine was brought out of the refrigerator, it was not left at room temperature for 15 minutes before it was administered. Also that she felt the bottle was still cold and frosty and that the vaccine provider did not gently swirl the bottle, but they turned the bottle up and down a couple times like they do for the Pfizer Covid-19 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness) 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. On an unknown date, the patient experienced PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness). At the time of the report, PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Now it is getting progressively worst.; her shoulder pops out of joint; If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all; complaints of muscle lock./can't lay on her left side at all.; It's hard for her to get her job done.; After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.), PAIN (Now it is getting progressively worst.), JOINT DISLOCATION (her shoulder pops out of joint), MOBILITY DECREASED (If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all) and MUSCLE SPASMS (complaints of muscle lock./can't lay on her left side at all.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E71A and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, PROGESTERONE and ESTRADIOL for an unknown indication.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.). On an unknown date, the patient experienced PAIN (Now it is getting progressively worst.), JOINT DISLOCATION (her shoulder pops out of joint), MOBILITY DECREASED (If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all), MUSCLE SPASMS (complaints of muscle lock./can't lay on her left side at all.) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It's hard for her to get her job done.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.), PAIN (Now it is getting progressively worst.), JOINT DISLOCATION (her shoulder pops out of joint), MOBILITY DECREASED (If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all), MUSCLE SPASMS (complaints of muscle lock./can't lay on her left side at all.) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It's hard for her to get her job done.) outcome was unknown.            This case was linked to MOD-2021-343734 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches) 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 MYALGIA (aches). At the time of the report, MYALGIA (aches) outcome was unknown.            No concomitant medication provided.  No treatment information given.  The reporter wants to know that whether patient can take Advil or not.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis. Concomitant products included PREDNISONE for Myasthenia gravis.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.   This case was linked to MOD-2021-339089 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 053E71A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, PROGESTERONE and ESTRADIOL for an unknown indication.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine) outcome was unknown.            This case was linked to MOD-2021-343679 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of memory impairment in a male 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 the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 6, 2021, patient experienced memory impairment. At the time of the report, memory impairment outcome: unknown.  No concomitant medications or treatment information reported.