chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Partial seizures
Clinical narrative: Patient having a focal seizure, like they were out of it a week after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PARTIAL SEIZURES (Patient having a focal seizure, like they were out of it a week after the first dose) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARTIAL SEIZURES (Patient having a focal seizure, like they were out of it a week after the first dose) (seriousness criterion medically significant). At the time of the report, PARTIAL SEIZURES (Patient having a focal seizure, like they were out of it a week after the first dose) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient having a focal seizure, like they were out of it a week after the first dose. No treatment information was reported.  Company Comment:  This is a spontaneous case concerning an elderly patient of an unknown gender with no medical history reported, who experienced the unexpected serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on an unknown date after receiving the first dose of mRNA-1273 vaccine and was resolved after a week. No further details about the clinical course, diagnostic procedures and treatments were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-542528, MOD-2022-542594 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an elderly patient of an unknown gender with no medical history reported, who experienced the unexpected serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on an unknown date after receiving the first dose of mRNA-1273 vaccine and was resolved after a week. No further details about the clinical course, diagnostic procedures and treatments were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Itchy rash; bumpy rash; Red rash This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), RASH PAPULAR (bumpy rash) and RASH ERYTHEMATOUS (Red rash) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine (Patient receives the flu vaccine regularly). Past adverse reactions to the above products included No adverse event with flu vaccine.    On 08-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 09-Apr-2022, the patient experienced RASH PRURITIC (Itchy rash), RASH PAPULAR (bumpy rash) and RASH ERYTHEMATOUS (Red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency and CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash), RASH PAPULAR (bumpy rash) and RASH ERYTHEMATOUS (Red rash) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Acquired immunodeficiency syndrome
Clinical narrative: have aids now because of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACQUIRED IMMUNODEFICIENCY SYNDROME (have aids now because of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACQUIRED IMMUNODEFICIENCY SYNDROME (have aids now because of the vaccine) (seriousness criterion medically significant). At the time of the report, ACQUIRED IMMUNODEFICIENCY SYNDROME (have aids now because of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported  Company Comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who reported the unexpected serious (medically significant) event of Acquired immunodeficiency syndrome that occurred on an unknown date after receiving the dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not reported. At the time of reporting, the outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2022: QE number-017247 received; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who reported the unexpected serious (medically significant) event of Acquired immunodeficiency syndrome that occurred on an unknown date after receiving the dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not reported. At the time of reporting, the outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Patient has arthritis; This spontaneous case was reported by a physician and describes the occurrence of ARTHRITIS (Patient has arthritis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Patient has arthritis). At the time of the report, ARTHRITIS (Patient has arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A patient who was scheduled to get the second booster, received from another doctor an Intramuscular  injection of prednisone and would like to know if that can affect the immune response or if there are any studies about how much the immune response decrease when a shot of prednisone is given to a patient. Reporter mentioned that the patient has arthritis, agent was not able to clarify if the patient was diagnosed before or after receiving the Moderna vaccines. Treatment information was not provided.  Company comment:  This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious, AESI of Arthritis, unspecified days after receiving a dose of mRNA-1273 vaccine.  Date of vaccination was unknown. Clinical course and treatment details are not available in this report. Reporter mentioned that the patient has arthritis, but it could not be clarified, if the patient was diagnosed with Arthritis, before or after receiving the Moderna vaccines. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious, AESI of Arthritis, unspecified days after receiving a dose of mRNA-1273 vaccine.  Date of vaccination was unknown. Clinical course and treatment details are not available in this report. Reporter mentioned that the patient has arthritis, but it could not be clarified, if the patient was diagnosed with Arthritis, before or after receiving the Moderna vaccines. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had sore right arm injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had sore right arm injection site arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Breast cancer (The patient first had breast cancer 10 years ago). Concomitant products included EXEMESTANE for Breast cancer. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Had sore right arm injection site arm). In 2021, VACCINATION SITE PAIN (Had sore right arm injection site arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient received her first Moderna COVID-19 vaccine in January or February 2021. The sore arm lasted for a week. No treatment medication was provided. This case was linked to MOD-2022-542707 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal pruritus, Paraesthesia
Clinical narrative: felt sick; itchy nose; ping sensation in legs; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), NASAL PRURITUS (itchy nose) and PARAESTHESIA (ping sensation in legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Singulair on 30-Sep-2021 and Zyrtec on 30-Sep-2021. Past adverse reactions to the above products included No adverse event with Singulair and Zyrtec. Concurrent medical conditions included Allergic to cats, Allergic to dogs and Seasonal allergy.    On 02-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced MALAISE (felt sick), NASAL PRURITUS (itchy nose) and PARAESTHESIA (ping sensation in legs). At the time of the report, MALAISE (felt sick), NASAL PRURITUS (itchy nose) and PARAESTHESIA (ping sensation in legs) was resolving.            Concomitant medications was not provided by the reporter. Patient experienced her side effects was still ongoing but its not major happening every 2 weeks. Patient visited her primary care doctor to get consultation for booster shot. Reporter initially said that felt fine, however next day felt sick, The patient felt ok so didn't take medications anymore.   This case was linked to MOD-2021-046577 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Patient is still feeling chills periodically 4 weeks after 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Patient is still feeling chills periodically 4 weeks after 2nd booster dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Patient is still feeling chills periodically 4 weeks after 2nd booster dose). At the time of the report, CHILLS (Patient is still feeling chills periodically 4 weeks after 2nd booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient stated he received 2nd booster shot of Moderna COVID-19 Vaccine, and after 4 weeks and he was still feeling chills periodically. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received an expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received the Moderna Covid 19 vaccine from a vial that had already expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that had already expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms
Clinical narrative: up and down all night long; legs are cramping so bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (up and down all night long) and MUSCLE SPASMS (legs are cramping so bad) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced FEELING ABNORMAL (up and down all night long) and MUSCLE SPASMS (legs are cramping so bad). At the time of the report, FEELING ABNORMAL (up and down all night long) and MUSCLE SPASMS (legs are cramping so bad) outcome was unknown.            Concomitant medication included blood pressure medication. Treatment medications were not provided.  It was reported that patient had received second booster dose.  It was reported that patient had no side effects with other doses.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided.  The vaccine was expired on 30-Dec-2021.  No treatment drug information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Myalgia, Pain
Clinical narrative: achy type; off for a day or two; felt miserable for a day or two; headache; muscle aches, body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy type), MALAISE (off for a day or two), FEELING ABNORMAL (felt miserable for a day or two), HEADACHE (headache) and MYALGIA (muscle aches, body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient stated he has a lot of medical issues.    On 02-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy type), MALAISE (off for a day or two), FEELING ABNORMAL (felt miserable for a day or two), HEADACHE (headache) and MYALGIA (muscle aches, body aches). At the time of the report, PAIN (achy type), HEADACHE (headache) and MYALGIA (muscle aches, body aches) outcome was unknown and MALAISE (off for a day or two) and FEELING ABNORMAL (felt miserable for a day or two) had resolved.            No concomitant medications were reported.  After the first booster taken on 02Nov2021, he stated he was off for a day or two. He felt miserable for a day or two. He was fine the third day. He talked to his physician and they were scheduling him to get his second booster dose next week.  No treatment information was provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose); This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027K20A and 025L20A) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19. The patient did not take any other vaccine within 1 month prior to Moderna COVID-19 vaccination. The patient did not have a medical history of high blood pressure.  Concurrent medical conditions included Immunocompromised, Diabetic (The diabetic condition goes up an down, 8.3 in the last one, and last year she did not have any 8.3) since 2002, Drug allergy (Allergy to Epinephrine) and Thyroid disorder (patient takes thyroid medication). Concomitant products included INSULIN, METFORMIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), LEVOTHYROXINE, INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), ZOLPIDEM and ALPRAZOLAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 HYPERTENSION (Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose)). At the time of the report, HYPERTENSION (Raising blood pressure after getting every shot of the Moderna COVID-19 vaccine (second dose)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) Raising blood pressure after getting every shot of Moderna vaccine.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication also included unspecified thyroid medication.  The patient was suggested by the physician to take a tranquilizer, a beta blocker, Atenolol at a dose of 25 mg and call, whenever the blood pressure rises.   This case was linked to MOD-2022-543448, MOD-2021-021010 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose) 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.   Concomitant medications details were not reported by the reporter. It was reported that one dose expired of vaccine was administered by mistake. Treatment details was not reported by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Poor quality sleep
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. Patient had never tested positive for COVID-19 or diagnosed with COVID. Concurrent medical conditions included Penicillin allergy, Allergy to vaccine (Tetanus) and Blood pressure abnormal. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure management. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good). At the time of the report, VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient stated that she was ok with the first 2 doses of the Moderna COVID-19 vaccine and stated that she was under the weather and did not sleep good. No treatment was received. This case was linked to MOD-2022-543463, MOD-2022-543464, MOD-2022-543468 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor quality sleep
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. Patient had never tested positive for COVID-19 or diagnosed with COVID. Concurrent medical conditions included Penicillin allergy, Allergy to vaccine (Tetanus) and Blood pressure abnormal. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure management. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good). At the time of the report, VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient stated that she was ok with the first 2 doses of the Moderna COVID-19 vaccine and stated that she was under the weather and did not sleep good. No treatment was received. This case was linked to MOD-2022-543463, MOD-2022-543464, MOD-2022-543468 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling hot, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. Patient had never tested positive for COVID-19 or diagnosed with COVID. Concurrent medical conditions included Penicillin allergy, Allergy to vaccine (Tetanus) and Blood pressure abnormal. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure management. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good). At the time of the report, VACCINATION COMPLICATION (Under the weather) and POOR QUALITY SLEEP (Did not sleep good) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient stated that she was ok with the first 2 doses of the Moderna COVID-19 vaccine and stated that she was under the weather and did not sleep good. No treatment was received. This case was linked to MOD-2022-543463, MOD-2022-543464, MOD-2022-543468 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Poor quality sleep
Clinical narrative: She was under the weather and did not sleep good; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (She was under the weather and did not sleep good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination.     Patient never had a positive COVID-19 test or diagnosis.  The patient's past medical history included Tetanus. Concurrent medical conditions included Penicillin allergy. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure management.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (She was under the weather and did not sleep good). At the time of the report, POOR QUALITY SLEEP (She was under the weather and did not sleep good) outcome was unknown.            The patient stated that she was ok with the first 2 doses of the Moderna covid-19 vaccine and was reported that the patient was under the weather and did not sleep good. No treatment received.   This case was linked to MOD-2022-543447, MOD-2022-543464 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor quality sleep
Clinical narrative: She was under the weather and did not sleep good; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (She was under the weather and did not sleep good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination.     Patient never had a positive COVID-19 test or diagnosis.  The patient's past medical history included Tetanus. Concurrent medical conditions included Penicillin allergy. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure management.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (She was under the weather and did not sleep good). At the time of the report, POOR QUALITY SLEEP (She was under the weather and did not sleep good) outcome was unknown.            The patient stated that she was ok with the first 2 doses of the Moderna covid-19 vaccine and was reported that the patient was under the weather and did not sleep good. No treatment received.   This case was linked to MOD-2022-543447, MOD-2022-543464 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling hot, Tremor
Clinical narrative: She was under the weather and did not sleep good; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (She was under the weather and did not sleep good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination.     Patient never had a positive COVID-19 test or diagnosis.  The patient's past medical history included Tetanus. Concurrent medical conditions included Penicillin allergy. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure management.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POOR QUALITY SLEEP (She was under the weather and did not sleep good). At the time of the report, POOR QUALITY SLEEP (She was under the weather and did not sleep good) outcome was unknown.            The patient stated that she was ok with the first 2 doses of the Moderna covid-19 vaccine and was reported that the patient was under the weather and did not sleep good. No treatment received.   This case was linked to MOD-2022-543447, MOD-2022-543464 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Poor quality sleep
Clinical narrative: Got real warm after 1st booster dose; Shaking after 1st booster dose; Had chills after 1st booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 039B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Tetanus and Blood pressure. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021 at 9:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose). At the time of the report, FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had not had Covid test nor diagnosed to Covid.  No treatment medications was reported.   This case was linked to MOD-2022-543463, MOD-2022-543468 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Poor quality sleep
Clinical narrative: Got real warm after 1st booster dose; Shaking after 1st booster dose; Had chills after 1st booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 039B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Tetanus and Blood pressure. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021 at 9:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose). At the time of the report, FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had not had Covid test nor diagnosed to Covid.  No treatment medications was reported.   This case was linked to MOD-2022-543463, MOD-2022-543468 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling hot, Tremor
Clinical narrative: Got real warm after 1st booster dose; Shaking after 1st booster dose; Had chills after 1st booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 039B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Tetanus and Blood pressure. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021 at 9:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose). At the time of the report, FEELING HOT (Got real warm after 1st booster dose), TREMOR (Shaking after 1st booster dose) and CHILLS (Had chills after 1st booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had not had Covid test nor diagnosed to Covid.  No treatment medications was reported.   This case was linked to MOD-2022-543463, MOD-2022-543468 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: After third dose she also have a raise of her blood pressure/raising blood pressure after getting every shot of  the Moderna covid19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (After third dose she also have a raise of her blood pressure/raising blood pressure after getting every shot of  the Moderna covid19 vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 027K20A and 025L20A) for COVID-19 vaccination.     The patient was not tested positive or diagnosed for COVID-19.  Concurrent medical conditions included Drug allergy (Epinephrine allergy), Diabetes since 2002 and Immunocompromised. Concomitant products included INSULIN, METFORMIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), LEVOTHYROXINE, INSULIN DETEMIR (LEVEMIR), INSULIN ASPART (NOVOLOG), ZOLPIDEM and ALPRAZOLAM for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced HYPERTENSION (After third dose she also have a raise of her blood pressure/raising blood pressure after getting every shot of  the Moderna covid19 vaccine). At the time of the report, HYPERTENSION (After third dose she also have a raise of her blood pressure/raising blood pressure after getting every shot of  the Moderna covid19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: raised (High) Raise of her blood pressure.         Concomitant medications included unspecified thyroid medication. It was reported that patient had a recent change in diabetes, it goes up an down,8.3 was the last one, and last year she did not have any 8.3. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was reported that in her vaccination card it was marked as a booster and her symptoms improved. No treatment information was provided.   This case was linked to MOD-2022-543442, MOD-2021-021010 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired doses) 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.   No concomitant medications were reported.   It was reported that two providers reported to have administered expired doses by mistake. Vaccine was expired on 09-Nov-2021.  No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.   No Medical History information was reported.   On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided.  It was reported providers had administered expired doses by mistake. No treatment medication information was given.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 1st booster dose in aug2021 of 0.5 ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (1st booster dose in aug2021 of 0.5 ml) 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.   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In August 2021, the patient experienced ACCIDENTAL OVERDOSE (1st booster dose in aug2021 of 0.5 ml). At the time of the report, ACCIDENTAL OVERDOSE (1st booster dose in aug2021 of 0.5 ml) outcome was unknown.     No concomitant medication was provided. Patient stated that she was not immunocompromised. It was reported that patient had received her 1st booster dose 0.5 ml before as she states the 0.25 ml was recommended. She wanted to know if she had more protected because she got a higher booster dose and if the 2nd booster dose was ok for her to get now. Treatment medication was not provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temperature Excursion issue; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A, 036C21A, 036A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received their first primary series dose of the Moderna vaccine on 10-Feb-2021 and had no adverse Reactions to their first dose of the Moderna Covid-19 vaccine. The patient received the second primary series dose of the Moderna vaccine on 10-Mar-2021 and had no adverse Reactions to their second dose of the Moderna vaccine. It was reported that the Immunocompromised patient did not receive 3 full primary series doses. The patient received the first Booster Dose on 11-Nov-2021 and reported no other adverse events to their booster dose. The patient received expired Moderna Covid-19 vaccine as their Second Booster dose on 18-Apr-2022. Reportedly, the patient reported no other adverse reactions.  The dose was administered after 30-day Use by Date or after manufacturer date of expiry. The date the vial initially stored in the refrigerator was 21-Mar-2022 and it was also reported that the vial did undergo the temperature excursions.  The patient's weight was unknown.  No treatment information was provided.   This case was linked to MOD-2022-545321 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; Immunocompromised patient did not received 3 full primary series doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient did not received 3 full primary series doses) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Primary dose.). Past adverse reactions to the above products included No adverse reaction with Pfizer. Concurrent medical conditions included Immunocompromised.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient did not received 3 full primary series doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised patient did not received 3 full primary series doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient received their first dose of the Moderna vaccine on 30-Apr-2021 and received the Primary dose as a Pfizer vaccine. No other information was known about these doses or adverse reactions.  The patient received expired Moderna Covid-19 vaccine as their first booster dose on 18-Apr-2022. Reportedly, no other adverse reactions or side effects reported on 18-Apr-2022.  It was also reported that the Immunocompromised patient did not receive 3 full primary series doses.  The patient's weight was unknown.  No treatment information was provided.   This case was linked to MOD-2022-544265 (Patient Link).