chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Death after Moderna mRNA vaccines; This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Death after Moderna mRNA vaccines) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       Concurrent medical conditions included Lung disease and Rheumatoid arthritis. Concomitant products included LEFLUNOMIDE for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (Death after Moderna mRNA vaccines) (seriousness criteria death and hospitalization). The reported cause of death was SARS-CoV-2 infection. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Death after Moderna mRNA vaccines) to be related.    Concomitant therapy also included B cell depleting therapy. Treatment medications were not reported. The patient was on invasive ventilation.  Company Comment: This literature non-study case concerns a 66-year-old, female patient with pre-existing lung disease, rhematoid arthrits and with concomitant treatment of B cell depletion therapy and Leflunomide, who experienced the unexpected, fatal AESI of COVID-19. The event occurred after receiving mRNA-1273 as second dose of COVID-19 vaccine. The patient was hospitalized due to the event and required invasive mechanical ventilation. She subsequently died on an unknown date. Clinical course leading demise were not reported in the case. It is unknown if autopsy was performed. The patient's pre-existing conditions and concomitant medications remain as confounders for contracting the COVID-19 and for the fatal outcome. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-496508, MOD-2022-496509, MOD-2022-496510 (Patient Link).; Sender's Comments: This literature non-study case concerns a 66-year-old, female patient with pre-existing lung disease, rhematoid arthrits and with concomitant treatment of B cell depletion therapy and Leflunomide, who experienced the unexpected, fatal AESI of COVID-19. The event occurred after receiving mRNA-1273 as second dose of COVID-19 vaccine. The patient was hospitalized due to the event and required invasive mechanical ventilation. She subsequently died on an unknown date. Clinical course leading demise were not reported in the case. It is unknown if autopsy was performed. The patient's pre-existing conditions and concomitant medications remain as confounders for contracting the COVID-19 and for the fatal outcome. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: SARS-CoV-2 infection
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Fatigue, Urticaria
Clinical narrative: Was given zantac for his stomach; Little hivey (second episode); Getting hives (first episode); Since getting moderna covid-19 vaccine patient experienced an increase in fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Was given zantac for his stomach), URTICARIA (Little hivey (second episode)), URTICARIA (Getting hives (first episode)) and FATIGUE (Since getting moderna covid-19 vaccine patient experienced an increase in fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) for aHUS.    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 and RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Was given zantac for his stomach), URTICARIA (Little hivey (second episode)), URTICARIA (Getting hives (first episode)) and FATIGUE (Since getting moderna covid-19 vaccine patient experienced an increase in fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE for Abdominal discomfort, at an unspecified dose and frequency; CORTISONE for Abdominal discomfort, at an unspecified dose and frequency and RANITIDINE HYDROCHLORIDE for Abdominal discomfort, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Was given zantac for his stomach), URTICARIA (Little hivey (second episode)) and FATIGUE (Since getting moderna covid-19 vaccine patient experienced an increase in fatigue) outcome was unknown and URTICARIA (Getting hives (first episode)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For the co-suspect Ultomiris(ravulizumab), the concentration was 250cc bolus of fluid. No concomitant medications was provided. On an unspecified date, the patient experienced an increase in fatigue (FATIGUE) since getting Moderna COVID vaccine. The patient had also noticed increase fatigue since starting ravulizumab. The patient reported getting hives (URTICARIA) (first episode) with his first dose but received medications (unspecified) and had not had reaction since then. The patient reported getting a little hivey (URTICARIA) (second episode) after his second ravulizumab dose to back of arms and around his face. Corrective treatment included unspecified medications for the event of urticaria and not reported for fatigue.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Sore arm; Redness around the injection area; A little bit of swelling on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia (Start Date 15 years ago, no changes), Blood pressure high (Start Date 20 years ago, no changes) and Kidney stones (improvement or worsening is unknown). Concomitant products included LEVOTHYROXINE, AMLODIPINE, SIMVASTATIN, TAMSULOSIN and ALPRAZOLAM for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at an unspecified dose and frequency. On 31-Mar-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's height reported as 6'.  Patient had no allergy.  Patient experienced same symptoms after every vaccine for around 7 to 9 days.   This case was linked to MOD-2022-496528, MOD-2022-496529 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Sore arm; Redness around the injection area; A little bit of swelling on his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones. Concurrent medical conditions included Chronic lymphocytic leukemia and Blood pressure high. Concomitant products included LEVOTHYROXINE, AMLODIPINE, SIMVASTATIN, TAMSULOSIN and ALPRAZOLAM for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at an unspecified dose and frequency. On 29-Apr-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the injection area) and VACCINATION SITE SWELLING (A little bit of swelling on his left arm) had resolved.            Patient had no allergies.  Reportedly, Patient visited a dermatologist and an allergist and doctors prescribed a medication (patient do not remember name), but stopped treatment about a week ago, because he felt like his skin was burning and his hands were peeling. Patient Stated that his life style remained the same, so the only different thing was the vaccine.  After getting the vaccine, patient experienced same symptoms after every vaccine for around 7 to 9 days.   This case was linked to MOD-2022-496478, MOD-2022-496529 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hallucination, auditory, Nightmare, Pain in extremity
Clinical narrative: hearing little voices every once in a while only in the mornings; arm hurt, both of his arms hurt; bad dreams/dreamy thing; getting tired; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION, AUDITORY (hearing little voices every once in a while only in the mornings) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024 and 007) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 HALLUCINATION, AUDITORY (hearing little voices every once in a while only in the mornings) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm hurt, both of his arms hurt), NIGHTMARE (bad dreams/dreamy thing) and FATIGUE (getting tired). At the time of the report, HALLUCINATION, AUDITORY (hearing little voices every once in a while only in the mornings), NIGHTMARE (bad dreams/dreamy thing) and FATIGUE (getting tired) was resolving and PAIN IN EXTREMITY (arm hurt, both of his arms hurt) had resolved.            The patient had concomitant medication of thyroid medication and high blood pressure medication.  Arm hurt which took a long time to go away and 3 weeks ago patient started to experience hearing little voices. Occasionally he did get tired but never experienced this before. Health care professional advised him to see a doctor as he was not able to take a booster dose. His symptoms went away a little bit and he had never had a dreamy thing before.  No treatment information was provided.  Company Comment: This is a Spontaneous case concerning a 73-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Hallucination auditory. The event occurred on a date after the second dose of mRNA-1273 vaccine. Patient reports that he started hearing little voices every once in a while only in the mornings. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case concerning a 73-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Hallucination auditory. The event occurred on a date after the second dose of mRNA-1273 vaccine. Patient reports that he started hearing little voices every once in a while only in the mornings. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received booster dose instead of full dose for 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster dose instead of full dose for 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster dose instead of full dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Received booster dose instead of full dose for 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  Patient is immunocompromised and accidentally received half of the full dose. However, he was supposed to receive the 3rd full dose as part of the primary dose and then get a booster as per the current information from CDC
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Swelling and pain went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (Joint pain in the past) and Joint swelling (Joint swelling in the past). Concurrent medical conditions included Osteoarthritis, Psoriatic arthritis and Alopecia. Concomitant products included METHOTREXATE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away) outcome was unknown.            After 2 days receiving the vaccine The swelling and pain went away. No treatment information details were reported.   This case was linked to MOD-2021-079053, MOD-2022-496958, MOD-2022-496962 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Swelling and pain went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 010A21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (Joint pain in the past) and Joint swelling (Joint swelling in the past). Concurrent medical conditions included Osteoarthritis, Psoriatic arthritis and Alopecia. Concomitant products included METHOTREXATE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, 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 THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information details were reported.   This case was linked to MOD-2022-496953, MOD-2021-079053, MOD-2022-496962 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Therapeutic response unexpected
Clinical narrative: Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose; 31AUG2021 3 rd dose and 20-feb-22 booster dose; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose) and EXTRA DOSE ADMINISTERED (31AUG2021 3 rd dose and 20-feb-22 booster dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A, 020F21A, 018B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (Joint pain in the past) and Joint swelling (Joint swelling in the past). Concurrent medical conditions included Osteoarthritis, Psoriatic arthritis and Alopecia (Patient has not had any changes to her alopecia.). Concomitant products included METHOTREXATE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (31AUG2021 3 rd dose and 20-feb-22 booster dose). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away / Her arthritis symptoms also improved after the 3rd dose and booster dose) and EXTRA DOSE ADMINISTERED (31AUG2021 3 rd dose and 20-feb-22 booster dose) outcome was unknown.            Patient received fourth Moderna COVID-19 vaccine (Booster dose). Prior to receiving all of these doses she stopped taking her methotrexate. Her arthritis symptoms also improved after the 4th dose which was a booster. She continues to have no pain today and has not restarted her methotrexate since receiving the 4th dose. No treatment information details were reported.   This case was linked to MOD-2022-496953, MOD-2022-496958, MOD-2021-079053 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: she had severe tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (she had severe tinnitus) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 007J212A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2022, the patient experienced TINNITUS (she had severe tinnitus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, TINNITUS (she had severe tinnitus) was resolving.            No concomitant medications were reported.  It was reported that patient had severe tinnitus after twenty eight hours on 27-Feb-2022. She states that she has tinnitus generally, but it's mild. She took Benadryl to sleep and she was feeling better on 28-Feb-2022.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Maternal exposure during pregnancy
Clinical narrative: 0.5 mL booster instead of 0.25 mL; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (0.5 mL booster instead of 0.25 mL) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 047B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Jul-2022. On 28-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (0.5 mL booster instead of 0.25 mL) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 28-Feb-2022, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (0.5 mL booster instead of 0.25 mL) outcome was unknown.            No treatment information provided No concomitant medication information provided
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: recently diagnosed  with an "immunocompromised situation; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (recently diagnosed  with an "immunocompromised situation) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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 IMMUNODEFICIENCY (recently diagnosed  with an "immunocompromised situation). At the time of the report, IMMUNODEFICIENCY (recently diagnosed  with an "immunocompromised situation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow-up received contain non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Gave immunocompromised patient a half dose (booster dose); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave immunocompromised patient a half dose (booster dose)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Gave immunocompromised patient a half dose (booster dose)). At the time of the report, ACCIDENTAL UNDERDOSE (Gave immunocompromised patient a half dose (booster dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The patient had no allergies and had never been tested positive for COVID disease.  The pharmacist reported that they did not know about the patient's immunocompromise situation at the time of vaccination and gave the patient a half booster dose, and wanted to know whether the patient could be given a fourth vaccine shot and at what dosages should they give the patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 2nd dose administered after 30-day Use By Date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered after 30-day Use By Date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A and 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported  The vial was initially stored in the refrigerator on 27JAN2022 and first removed from the Freezer on 27JAN2022. The 30 day use by date expiration was reached on 27FEB2022. No Treatment medication reported
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNODEFICIENCY (after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced IMMUNODEFICIENCY (after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (after booster dose-A few months later, the patient was diagnosed with an immunocompromising condition) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A healthy patient received the 1st and 2nd dose of Moderna vaccine at 0.5 mL volume . After which, she received the 0.25 mL recommended booster dose . A few months later, the patient was diagnosed with an immunocompromising condition Reporter stated that will the patient get the 0.25 mL dose as the booster dose? What happen to the 0.25mL 3rd dose the patient received? Will it provide the patient sufficient protection. Concomitant product use was not provided by reporter. Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected event of immunodeficiency. On unknown dates, the patient received 3 doses (2 doses of 0.5 ml and 3rd dose of 0.25 ml) of mRNA 1273 COVID-19 vaccine. A few months after the third dose of mRNA 1273 vaccine, patient was diagnosed with an immunocompromising condition. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected event of immunodeficiency. On unknown dates, the patient received 3 doses (2 doses of 0.5 ml and 3rd dose of 0.25 ml) of mRNA 1273 COVID-19 vaccine. A few months after the third dose of mRNA 1273 vaccine, patient was diagnosed with an immunocompromising condition. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Feeling hot, Pain in extremity
Clinical narrative: Arm is warm; Arm is painful to the touch; Had a blister on arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm is warm), PAIN IN EXTREMITY (Arm is painful to the touch) and BLISTER (Had a blister on arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Arm is warm), PAIN IN EXTREMITY (Arm is painful to the touch) and BLISTER (Had a blister on arm). At the time of the report, FEELING HOT (Arm is warm) and PAIN IN EXTREMITY (Arm is painful to the touch) had not resolved and BLISTER (Had a blister on arm) was resolving.            No concomitant medication was reported by the reporter.  Patient received the booster dose on Saturday and by Sunday patient had bister on arm.  No treatment medication was reported by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: HCP is not sure patients have been administered from expired vaccines/ only few patients were involved/6 patients received expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is not sure patients have been administered from expired vaccines/ only few patients were invnolved/6 patients received expired doses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP is not sure patients have been administered from expired vaccines/ only few patients were invnolved/6 patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is not sure patients have been administered from expired vaccines/ only few patients were invnolved/6 patients received expired doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, other vaccine history was unknown.  No concomitant medications were reported.  On 04-Nov-2021 and 01-Dec-2021, the vial as initially stored in the refrigerator. The vial had not undergone any temperature excursions. The vial thawed on the same day of administration of vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-497407, MOD-2022-497396 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow-up information contains individual Patient demographics and suspect vaccine dosage details(Significant box not checked as regulatory clock is getting updated as per FRD)
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site discomfort, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Upper arm is sore), VACCINATION SITE PAIN (Pain reached the point is now painful) and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0BF21A, 039K20A and 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Upper arm is sore), VACCINATION SITE PAIN (Pain reached the point is now painful) and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort). At the time of the report, PAIN IN EXTREMITY (Upper arm is sore) and VACCINATION SITE PAIN (Pain reached the point is now painful) had not resolved and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient experienced no other symptoms, no bleeding scab or swelling. It was reported that the patient felt as if something was going on. Upper arm was sore. On a scale of 1 to 10 the patient reported that the level of pain was 3. Patient stated that it has not let up it has moved from a 2 to 4. No treatment medications were reported. This case was linked to MOD-2022-497428 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Upper arm is sore), VACCINATION SITE PAIN (Pain reached the point is now painful) and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0BF21A, 039K20A and 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Upper arm is sore), VACCINATION SITE PAIN (Pain reached the point is now painful) and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort). At the time of the report, PAIN IN EXTREMITY (Upper arm is sore) and VACCINATION SITE PAIN (Pain reached the point is now painful) had not resolved and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient experienced no other symptoms, no bleeding scab or swelling. It was reported that the patient felt as if something was going on. Upper arm was sore. On a scale of 1 to 10 the patient reported that the level of pain was 3. Patient stated that it has not let up it has moved from a 2 to 4. No treatment medications were reported. This case was linked to MOD-2022-497428 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Initial pain after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Initial pain after dose 1) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Initial pain after dose 1). At the time of the report, PAIN (Initial pain after dose 1) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-497342.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Initial pain after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Initial pain after dose 1) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Initial pain after dose 1). At the time of the report, PAIN (Initial pain after dose 1) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-497342.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Booster; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Booster) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.- On 04-Nov-2021, the vial as initially stored in the refrigerator. The vial had not undergone any temperature excursions.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), URTICARIA (Welts in her armpit) and RASH (Rash on face) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products MIRABEGRON (MYRBETRIQ) tablet for Hypertonic bladder and LINACLOTIDE (LINZESS) tablet for an unknown indication. The patient's past medical history included Constipation. Previously administered products included for Bladder disorder: Trospium. Past adverse reactions to the above products included Constipation with Trospium. Concurrent medical conditions included Drug allergy (Sulfa allergy, cannot take bactrim) and Hypertonic bladder. Concomitant products included CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (CALADRYL [CALAMINE; DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 10-Jan-2022, the patient started MIRABEGRON (MYRBETRIQ) (unknown route) 50 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and LINACLOTIDE (LINZESS) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CONSTIPATION (Constipation), URTICARIA (Welts in her armpit) and RASH (Rash on face). At the time of the report, CONSTIPATION (Constipation) and RASH (Rash on face) outcome was unknown and URTICARIA (Welts in her armpit) was resolving. No lab test information was provided. It was reported that, the patient took Trospium before mirabegron for her bladder problem, but the patient had constipation after taking this, so her doctor changed it to mirabegron. The patient stated that, she pees 800 miles per hour unless she took medicine for overactive bladder. The patient also reported that, after taking mirabegron for 2.5 to 3 weeks, she had welts in her armpits, six in one and three in another armpit. The welts looked like a spider bite. The patient stopped taking both mirabegron and linaclotide on 29 Jan 2022 and started taking Caladryl and so far this helped with the welts. The patient had no angioedema or symptoms of angioedema. The patient was trying to decide whether she should re challenge or took either mirabegron or Linzess first to see which one caused the problem of the welts in her armpit. Action taken with mirabegron treatment with response to events was discontinued on 29 Jan 2022. Action taken with linaclotide treatment was withdrawn. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Products were reported. No Treatment information was reported. Date vial moved from freezer to refrigerator- 24-JAN-2022.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. On 04-Nov-2021 and 01-Dec-2021, the vial as initially stored in the refrigerator. The vial had not undergone any temperature excursions. This case was linked to MOD-2022-497308 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patients received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported. The vial did not undergone any temperature excursions. The vial thawed on the same day of administration of vaccine.   This case was linked to MOD-2022-497308 (Patient Link).