chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No symptoms or quality issues were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Patient initials and Event related information were updated. On 25-Nov-2021: Significant information received and updated dose number of the vaccine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Discomfort, Lymphadenopathy, Ultrasound scan
Clinical narrative: Had a lot of discomfort.; After the second shot, post 6 months later, the node became really hard like a large egg; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Had a lot of discomfort.) and LYMPHADENOPATHY (After the second shot, post 6 months later, the node became really hard like a large egg) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DISCOMFORT (Had a lot of discomfort.). 2021, the patient experienced LYMPHADENOPATHY (After the second shot, post 6 months later, the node became really hard like a large egg). The patient was treated with Surgery (Nodes surgically removed on 09-Nov-2021) for Lymphadenopathy. In 2021, DISCOMFORT (Had a lot of discomfort.) had resolved. On 09-Nov-2021, LYMPHADENOPATHY (After the second shot, post 6 months later, the node became really hard like a large egg) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Biopsy: abnormal (abnormal) node; results were benign. In September 2021, Ultrasound scan: abnormal (abnormal) node; results were benign.         No concomitant medications were reported  No treatment information was provided. It was looked like small eggs and there was 2 or 3 shrunken parts due to the biopsy. It was mobile and not attached to her body parts.   This case was linked to MOD-2021-395939 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: I am having a pounding and fluttering feeling in my heart.; I am having a pounding and fluttering feeling in my heart.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (I am having a pounding and fluttering feeling in my heart.) and PALPITATIONS (I am having a pounding and fluttering feeling in my heart.) 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 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (I am having a pounding and fluttering feeling in my heart.) and PALPITATIONS (I am having a pounding and fluttering feeling in my heart.). At the time of the report, CARDIAC FLUTTER (I am having a pounding and fluttering feeling in my heart.) and PALPITATIONS (I am having a pounding and fluttering feeling in my heart.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment This spontaneous case concerns a female patient with no reported relevant medical history, who experienced the unexpected non - serious events of palpitations and cardiac flutter (AESI event). The patient received a dose of mRNA-1273 on November 22, 2021. The date of onset of the events was not reported. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event cardiac flutter was automatically upgraded as a serious event as per IME list. However, as per medical judgment based on the information available, it is classified as Non-serious.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient with no reported relevant medical history, who experienced the unexpected non - serious events of palpitations and cardiac flutter (AESI event). The patient received a dose of mRNA-1273 on November 22, 2021. The date of onset of the events was not reported. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event cardiac flutter was automatically upgraded as a serious event as per IME list. However, as per medical judgment based on the information available, it is classified as Non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mental impairment, Pain in extremity, Peripheral swelling
Clinical narrative: having trouble thinking from migraine; sore arm; swollen up; lymph nodes swollen, but went down; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (having trouble thinking from migraine), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen up) and LYMPHADENOPATHY (lymph nodes swollen, but went down) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 24-Nov-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 MENTAL IMPAIRMENT (having trouble thinking from migraine), PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen up) and LYMPHADENOPATHY (lymph nodes swollen, but went down). At the time of the report, MENTAL IMPAIRMENT (having trouble thinking from migraine) outcome was unknown and PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen up) and LYMPHADENOPATHY (lymph nodes swollen, but went down) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported as migraine medication, it is also a blood thinner, and is a natural medication that also has magnesium for migraine. No treatment medications were reported.  Company comment - This case concerns a 78-year-old male patient with relevant medical history of Migraine, who experienced the non-serious unexpected events of Mental Impairment, Pain in Extremity, Peripheral Swelling, and Lymphadenopathy. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Migraine remains a confounder for the event Mental Impairment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 78-year-old male patient with relevant medical history of Migraine, who experienced the non-serious unexpected events of Mental Impairment, Pain in Extremity, Peripheral Swelling, and Lymphadenopathy. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of Migraine remains a confounder for the event Mental Impairment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: Today I felt dragging; running a fever of 100,tonight I have a temp on f 99; chills; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Today I felt dragging), PYREXIA (running a fever of 100,tonight I have a temp on f 99) and CHILLS (chills) 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 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PYREXIA (running a fever of 100,tonight I have a temp on f 99) and CHILLS (chills). On 26-Nov-2021, the patient experienced FEELING ABNORMAL (Today I felt dragging). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever and Chills, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Today I felt dragging) and CHILLS (chills) outcome was unknown and PYREXIA (running a fever of 100,tonight I have a temp on f 99) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Injection site swollen up, hard; Injection site swollen up, hard; Red area under the swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site swollen up, hard), VACCINATION SITE SWELLING (Injection site swollen up, hard) and VACCINATION SITE ERYTHEMA (Red area under the swelling) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, HYDROCHLOROTHIAZIDE for an unknown indication.   On 23-Nov-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, the patient experienced VACCINATION SITE INDURATION (Injection site swollen up, hard), VACCINATION SITE SWELLING (Injection site swollen up, hard) and VACCINATION SITE ERYTHEMA (Red area under the swelling). At the time of the report, VACCINATION SITE INDURATION (Injection site swollen up, hard), VACCINATION SITE SWELLING (Injection site swollen up, hard) and VACCINATION SITE ERYTHEMA (Red area under the swelling) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-398553 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival swelling, Oropharyngeal pain, Swelling face, Toothache
Clinical narrative: swelling of the right side of the face; sore throat; throbbing like tooth ache; gums have swelled up on the right side; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of the right side of the face), OROPHARYNGEAL PAIN (sore throat), TOOTHACHE (throbbing like tooth ache) and GINGIVAL SWELLING (gums have swelled up on the right side) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure abnormal.    On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced SWELLING FACE (swelling of the right side of the face), OROPHARYNGEAL PAIN (sore throat), TOOTHACHE (throbbing like tooth ache) and GINGIVAL SWELLING (gums have swelled up on the right side). At the time of the report, SWELLING FACE (swelling of the right side of the face), OROPHARYNGEAL PAIN (sore throat), TOOTHACHE (throbbing like tooth ache) and GINGIVAL SWELLING (gums have swelled up on the right side) outcome was unknown.  Concomitant medications included blood pressure medication and diabetes medication. The patient took Johnson and Johnson vaccine as primary series  Treatment details was not reported by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria
Clinical narrative: has not been urinating; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (has not been urinating) in an 87-year-old female 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 April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced DYSURIA (has not been urinating). At the time of the report, DYSURIA (has not been urinating) outcome was unknown.            No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.   This case was linked to MOD-2021-398856 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: They noticed the vaccine card states they received another Moderna vaccine dose. they wonder if this may be harmful for their health if they may have had a overdose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (They noticed the vaccine card states they received another Moderna vaccine dose. they wonder if this may be harmful for their health if they may have had a overdose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced OVERDOSE (They noticed the vaccine card states they received another Moderna vaccine dose. they wonder if this may be harmful for their health if they may have had a overdose). At the time of the report, OVERDOSE (They noticed the vaccine card states they received another Moderna vaccine dose. they wonder if this may be harmful for their health if they may have had a overdose) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/; The hives are also red and itchy; The hives are also red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/), PRURITUS (The hives are also red and itchy) and ERYTHEMA (The hives are also red and itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/) and PRURITUS (The hives are also red and itchy). On an unknown date, the patient experienced ERYTHEMA (The hives are also red and itchy). At the time of the report, URTICARIA (Patient started breaking out with terrible hives on her arms, feet, upper body and crotch/The hives move to different parts of her body/), PRURITUS (The hives are also red and itchy) and ERYTHEMA (The hives are also red and itchy) outcome was unknown.            No Concomitants and Treatment medication were reported
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headaches). At the time of the report, CHILLS (chills) and HEADACHE (headaches) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Light headedness (takes Bisoprolol Fumarate at least 3 years and get light headed all the time with it.), Anxiety (Patient have had it all her life) and Stress (Patient have had it all her life). Concomitant products included CLONAZEPAM for Anxiety and Stress, BISOPROLOL FUMARATE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). At the time of the report, PAIN IN EXTREMITY (My arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient have a Premature heartbeat.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-400034, MOD-2021-399963 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given moderna booster dose out of vial which was punctured 28 times; 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 EXPIRED PRODUCT ADMINISTERED (Patient was given moderna booster dose out of vial which was punctured 28 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given moderna booster dose out of vial which was punctured 28 times). On 20-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given moderna booster dose out of vial which was punctured 28 times) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Hardness in left injection site arm; Redness in left injection site arm; Sore left injection site arm; felt a general weakness.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt a general weakness.), VACCINATION SITE INDURATION (Hardness in left injection site arm), VACCINATION SITE ERYTHEMA (Redness in left injection site arm) and VACCINATION SITE PAIN (Sore left injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 832L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hereditary spastic paraplegia (Neurological disease. of hereditary spastic paraplegia) since 2020.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hardness in left injection site arm), VACCINATION SITE ERYTHEMA (Redness in left injection site arm) and VACCINATION SITE PAIN (Sore left injection site arm). In February 2021, the patient experienced ASTHENIA (felt a general weakness.). At the time of the report, ASTHENIA (felt a general weakness.) outcome was unknown and VACCINATION SITE INDURATION (Hardness in left injection site arm), VACCINATION SITE ERYTHEMA (Redness in left injection site arm) and VACCINATION SITE PAIN (Sore left injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient received their first Moderna Covid-19 vaccine and reported that they had a sore left injection site arm. hardness and redness in his left injection site arm. These lasted for several days. The patient also felt a general weakness. The patient also reported that they had a long standing case of Neurological Disease of Hereditary Spastic Paraplegia. The patient was diagnosed with this condition in 2020.   This case was linked to MOD-2021-400066 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Feeling abnormal
Clinical narrative: No appetite; Felt rotten; Got very warm; Very dizzy/ lightheaded; Very weak / still feel a little weak today; Feeling feverish (but never had a temperature); I was shaking to the point where I thought I was having a seizure; Horrible case of chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak / still feel a little weak today), TREMOR (I was shaking to the point where I thought I was having a seizure), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten) and FEELING HOT (Got very warm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 031L20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced TREMOR (I was shaking to the point where I thought I was having a seizure) and CHILLS (Horrible case of chills). On 24-Nov-2021, the patient experienced ASTHENIA (Very weak / still feel a little weak today), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten), FEELING HOT (Got very warm), DIZZINESS (Very dizzy/ lightheaded) and PYREXIA (Feeling feverish (but never had a temperature)). On 25-Nov-2021, DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten), FEELING HOT (Got very warm), DIZZINESS (Very dizzy/ lightheaded) and PYREXIA (Feeling feverish (but never had a temperature)) had resolved. At the time of the report, ASTHENIA (Very weak / still feel a little weak today) had not resolved and TREMOR (I was shaking to the point where I thought I was having a seizure) and CHILLS (Horrible case of chills) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that 24 hours later post getting the booster dose, on 23-Nov-2021, the patient had a horrible case of chills. The patient was shaking to the point where they thought they were having a seizure. On 24-Nov-2021-25-Nov-2021, the patient got very warm and was feeling feverish but never had a temperature, the patient was very weak, very dizzy, no appetite, lightheaded and felt rotten. Reportedly, the patient was still feeling a little weak on 29-Nov-2021, at the time of call but was glad that they got the vaccine.   This case was linked to MOD-2021-400085, MOD-2021-400094 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pyrexia, Tremor
Clinical narrative: No appetite; Felt rotten; Got very warm; Very dizzy/ lightheaded; Very weak / still feel a little weak today; Feeling feverish (but never had a temperature); I was shaking to the point where I thought I was having a seizure; Horrible case of chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak / still feel a little weak today), TREMOR (I was shaking to the point where I thought I was having a seizure), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten) and FEELING HOT (Got very warm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 031L20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced TREMOR (I was shaking to the point where I thought I was having a seizure) and CHILLS (Horrible case of chills). On 24-Nov-2021, the patient experienced ASTHENIA (Very weak / still feel a little weak today), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten), FEELING HOT (Got very warm), DIZZINESS (Very dizzy/ lightheaded) and PYREXIA (Feeling feverish (but never had a temperature)). On 25-Nov-2021, DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rotten), FEELING HOT (Got very warm), DIZZINESS (Very dizzy/ lightheaded) and PYREXIA (Feeling feverish (but never had a temperature)) had resolved. At the time of the report, ASTHENIA (Very weak / still feel a little weak today) had not resolved and TREMOR (I was shaking to the point where I thought I was having a seizure) and CHILLS (Horrible case of chills) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that 24 hours later post getting the booster dose, on 23-Nov-2021, the patient had a horrible case of chills. The patient was shaking to the point where they thought they were having a seizure. On 24-Nov-2021-25-Nov-2021, the patient got very warm and was feeling feverish but never had a temperature, the patient was very weak, very dizzy, no appetite, lightheaded and felt rotten. Reportedly, the patient was still feeling a little weak on 29-Nov-2021, at the time of call but was glad that they got the vaccine.   This case was linked to MOD-2021-400085, MOD-2021-400094 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Vaccination complication
Clinical narrative: they bit me up a little bit; achy all over; Felt like a good flu; tired; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (they bit me up a little bit), PAIN (achy all over), INFLUENZA LIKE ILLNESS (Felt like a good flu) and FATIGUE (tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Lymphoma (The patient was the cancer survivor and was on 24 th year of remission.) in 1997. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-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 VACCINATION COMPLICATION (they bit me up a little bit), PAIN (achy all over), INFLUENZA LIKE ILLNESS (Felt like a good flu) and FATIGUE (tired). At the time of the report, VACCINATION COMPLICATION (they bit me up a little bit), PAIN (achy all over), INFLUENZA LIKE ILLNESS (Felt like a good flu) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter. Reporter was a health care worker who had the first and second dose of Moderna. He was a cancer survivor (late stage lymphoma), diagnosed in 1997, 24th year remission. He participated in an study with (place name removed).   This case was linked to MOD-2021-400106 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Illness
Clinical narrative: Nausea; vomiting/cannot keep anything down; got sick; sleepy; headache; muscle pain; joint pain; chills; fever; fatigue/ tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), SOMNOLENCE (sleepy), NAUSEA (Nausea), VOMITING (vomiting/cannot keep anything down) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced SOMNOLENCE (sleepy), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue/ tired). On 17-Nov-2021, the patient experienced ILLNESS (got sick), NAUSEA (Nausea) and VOMITING (vomiting/cannot keep anything down). The patient was treated with SALINE [SODIUM CHLORIDE] on 20-Nov-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick) had not resolved and SOMNOLENCE (sleepy), NAUSEA (Nausea), VOMITING (vomiting/cannot keep anything down), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue/ tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient went to the emergency room on 20-Nov-2021 and there she received intravenous (IV) fluid, 3 bags of saline and unspecified anti emetic medication which helped her until the next day.   This case was linked to MOD-2021-401280, MOD-2021-401370 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Somnolence, Vomiting
Clinical narrative: Nausea; vomiting/cannot keep anything down; got sick; sleepy; headache; muscle pain; joint pain; chills; fever; fatigue/ tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick), SOMNOLENCE (sleepy), NAUSEA (Nausea), VOMITING (vomiting/cannot keep anything down) and HEADACHE (headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced SOMNOLENCE (sleepy), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue/ tired). On 17-Nov-2021, the patient experienced ILLNESS (got sick), NAUSEA (Nausea) and VOMITING (vomiting/cannot keep anything down). The patient was treated with SALINE [SODIUM CHLORIDE] on 20-Nov-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick) had not resolved and SOMNOLENCE (sleepy), NAUSEA (Nausea), VOMITING (vomiting/cannot keep anything down), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue/ tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient went to the emergency room on 20-Nov-2021 and there she received intravenous (IV) fluid, 3 bags of saline and unspecified anti emetic medication which helped her until the next day.   This case was linked to MOD-2021-401280, MOD-2021-401370 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Vomiting
Clinical narrative: sick/cant keep anything down; diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick/cant keep anything down), DIARRHOEA (diarrhea) and VOMITING (vomiting) 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 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ILLNESS (sick/cant keep anything down), DIARRHOEA (diarrhea) and VOMITING (vomiting). At the time of the report, ILLNESS (sick/cant keep anything down), DIARRHOEA (diarrhea) and VOMITING (vomiting) outcome was unknown.            No concomitant and treatment information were reported by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032821A and 006M20A) for COVID-19 immunisation.     No Medical history information was reported.  Concomitant products included PANTOPRAZOLE, TIMOLOL, GLYCERYL TRINITRATE (NITROSTAT), AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), IPRATROPIUM, CLOPIDOGREL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, DICLOFENAC, OXYCODONE, DIAZEPAM, GABAPENTIN, METAXALONE and METOPROLOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking Astelin nasal spray as concomitant medication.   This case was linked to MOD-2021-400060 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Muscle discomfort, Nausea, Pyrexia
Clinical narrative: On set almost exactly 12 hours later. Fever of 100.0 F, chills, nausea, general muscle discomfort, soreness at injection site.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Alcohol withdrawal syndrome, Angiogram normal, Anxiety, Atelectasis
Clinical narrative: Patient discharged after (2) inpatient admission. Patient is a 42-year-old female with past medical history of obesity and alcohol abuse and dependence who presented to the hospital with acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient was admitted to the hospital on high-flow nasal cannula.  Patient was able to be weaned to room air fairly quickly.  Patient was treated with IV steroids.  CT angiogram of the chest did not reveal any pulmonary embolism or significant respiratory disease.  I believe the patient had a large component of anxiety, as well as alcohol withdrawal.  Patient stated she drinks between 7-824 oz cans of beer every day and had stopped drinking the evening prior to admission.  Patient was treated with Librium to avoid alcohol withdrawal which she responded to well.  Patient was weaned to room air, she was not having any clinical signs of withdrawal. She was then considered stable for discharge home.  Patient will finish 10 day course of Decadron for her COVID pneumonia.  Patient will also be sent home on a Librium taper for a few days.  Patient was in agreement this plan.  Patient was counseled on cessation of alcohol use.  Patient will follow-up with PCP.  Patient discharged home in stable condition.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Computerised tomogram head normal, Condition aggravated, Dyspnoea exertional
Clinical narrative: Patient discharged after (2) inpatient admission. Patient is a 42-year-old female with past medical history of obesity and alcohol abuse and dependence who presented to the hospital with acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient was admitted to the hospital on high-flow nasal cannula.  Patient was able to be weaned to room air fairly quickly.  Patient was treated with IV steroids.  CT angiogram of the chest did not reveal any pulmonary embolism or significant respiratory disease.  I believe the patient had a large component of anxiety, as well as alcohol withdrawal.  Patient stated she drinks between 7-824 oz cans of beer every day and had stopped drinking the evening prior to admission.  Patient was treated with Librium to avoid alcohol withdrawal which she responded to well.  Patient was weaned to room air, she was not having any clinical signs of withdrawal. She was then considered stable for discharge home.  Patient will finish 10 day course of Decadron for her COVID pneumonia.  Patient will also be sent home on a Librium taper for a few days.  Patient was in agreement this plan.  Patient was counseled on cessation of alcohol use.  Patient will follow-up with PCP.  Patient discharged home in stable condition.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Echocardiogram normal, Ejection fraction, Fall, Head injury
Clinical narrative: Patient discharged after (2) inpatient admission. Patient is a 42-year-old female with past medical history of obesity and alcohol abuse and dependence who presented to the hospital with acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient was admitted to the hospital on high-flow nasal cannula.  Patient was able to be weaned to room air fairly quickly.  Patient was treated with IV steroids.  CT angiogram of the chest did not reveal any pulmonary embolism or significant respiratory disease.  I believe the patient had a large component of anxiety, as well as alcohol withdrawal.  Patient stated she drinks between 7-824 oz cans of beer every day and had stopped drinking the evening prior to admission.  Patient was treated with Librium to avoid alcohol withdrawal which she responded to well.  Patient was weaned to room air, she was not having any clinical signs of withdrawal. She was then considered stable for discharge home.  Patient will finish 10 day course of Decadron for her COVID pneumonia.  Patient will also be sent home on a Librium taper for a few days.  Patient was in agreement this plan.  Patient was counseled on cessation of alcohol use.  Patient will follow-up with PCP.  Patient discharged home in stable condition.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic cirrhosis, Myelopathy, SARS-CoV-2 test positive, Scan with contrast
Clinical narrative: Patient discharged after (2) inpatient admission. Patient is a 42-year-old female with past medical history of obesity and alcohol abuse and dependence who presented to the hospital with acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient was admitted to the hospital on high-flow nasal cannula.  Patient was able to be weaned to room air fairly quickly.  Patient was treated with IV steroids.  CT angiogram of the chest did not reveal any pulmonary embolism or significant respiratory disease.  I believe the patient had a large component of anxiety, as well as alcohol withdrawal.  Patient stated she drinks between 7-824 oz cans of beer every day and had stopped drinking the evening prior to admission.  Patient was treated with Librium to avoid alcohol withdrawal which she responded to well.  Patient was weaned to room air, she was not having any clinical signs of withdrawal. She was then considered stable for discharge home.  Patient will finish 10 day course of Decadron for her COVID pneumonia.  Patient will also be sent home on a Librium taper for a few days.  Patient was in agreement this plan.  Patient was counseled on cessation of alcohol use.  Patient will follow-up with PCP.  Patient discharged home in stable condition.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Decreased appetite, Full blood count, Malaise
Clinical narrative: sxs: weakness, malaise, anorexia time: 2 days tx:hydration, observational hospital admission
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Urine analysis
Clinical narrative: sxs: weakness, malaise, anorexia time: 2 days tx:hydration, observational hospital admission
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Vomiting
Clinical narrative: Client c/o not feeling well immediately after complaint, client vomited what appears to be a moderate amount of undigested food.  Medics alerted. Client examined by medics and released in care of her dad.  No acute distress.  Vital signs:  Oxygen sat 98-100% on room air, pulse 94, BP 102/56 and Resp. 22 and slightly labored.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever, chills, joint and body aches, severe headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: Two days after receiving my second dose of the Pfizer vaccine. I started spotting, my cycle came early. It gradually became heavier. A month later and I am still on my cycle. I have never had irregular periods.. After the first dose my cycle was significantly lighter lasting only 3 days.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Alanine aminotransferase normal, Anion gap normal, Aortic disorder
Clinical narrative: Patient currently inpatient at (5) days. Pt is a 77 y.o. male with past medical history significant for paroxysmal AFib on Coumadin, CVA, hypertension, type 2 diabetes who presents to the emergency department with generalized weakness and dyspnea on exertion.   Patient tested positive for COVID-19 on a home test yesterday.  He developed symptoms 2 days ago.  He is fully vaccinated with his last vaccine in February 2021 and has not received a booster.  Patient developed progressive generalized weakness, dyspnea on exertion, dry cough, wheezing, and malaise over the last 48 hours.  They called his PCP today who sent him into the emergency department.  He reports poor appetite.  No nausea, vomiting, diarrhea.  His wife is currently admitted.   In the emergency department patient was hypoxic and placed on 6 L nasal cannula.  Was weaned to 4 L. Chest x-ray shows COVID pneumonia.  He was given Decadron.   COVID-19 pneumonia Acute hypoxic respiratory failure Vaccinated, last vaccination February 2021 Positive home test 11/27, symptom onset 11/26 Chest x-ray shows COVID pneumonia Currently on 4 L nasal cannula Decadron PO Remdesivir IV Albuterol q6hr for wheezing mucinex BID Acapella, IS Prone as able Daily CBC, CMP, CRP, Ddimer   AKI on CKD stage 3 BUN 28, creatinine 1.48 with baseline creatinine 1.2 Hold ACE-I Normal saline 100 mL/hr for 1 L then Hep-Lock Trend BMP in a.m.   Recent left eye cataract surgery Left cataract surgery 1 and half weeks ago Family is unsure if he needs prednisolone and trimethoprim polymyxin B eyedrops still, will check bottles when they go home and call us with dosing instructions   Paroxysmal atrial fibrillation Continue atenolol On Coumadin with subtherapeutic INR 1.2 Pharmacy consult to manage Coumadin Daily INR Will place on Lovenox 40 mg subQ daily while INR is subtherapeutic for DVT prophylaxis   Generalized weakness PT/OT   History of CVA  Mild residual cognitive deficits Continue statin, Coumadin per above   Essential hypertension Hold ACE-inhibitor Continue amlodipine, atenolol   Diabetes mellitus type 2, insulin dependent Hold metformin, not on sliding scale insulin at home Decrease home Lantus from 60 units to 45 units and continue moderate dose sliding scale corrective   Mood disorder Paxil   Diet: General  VTE ppx: lovenox subQ daily while INR is subtherapeutic Code status:  Full code per patient and son at bedside.  Patient's sons share medical power of attorney for patient.   Disposition: admitted as inpatient for COVID pneumonia. Anticipated LOS > 2 midnights.