chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: knocked out for 3 to 4 days after 2nd dose; headache; being very tired 2nd dose; left arm hurt after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (knocked out for 3 to 4 days after 2nd dose), HEADACHE (headache), FATIGUE (being very tired 2nd dose) and VACCINATION SITE PAIN (left arm hurt after 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Mar-2021, the patient experienced HEADACHE (headache), FATIGUE (being very tired 2nd dose) and VACCINATION SITE PAIN (left arm hurt after 2nd dose). On an unknown date, the patient experienced FATIGUE (knocked out for 3 to 4 days after 2nd dose). At the time of the report, FATIGUE (knocked out for 3 to 4 days after 2nd dose) had resolved and HEADACHE (headache), FATIGUE (being very tired 2nd dose) and VACCINATION SITE PAIN (left arm hurt after 2nd dose) outcome was unknown.            No concomitant medication information was provided.  It was reported that in the immunization card and other documents from Pharmacy shows that 1ml of Moderna Covid-19 Vaccine for each of primary doses and for booster dose received on 28-Mar-2022 was 0.5ml. Patient said that inappropriate doses of primary and booster doses were given for primary series of the Moderna Covid-19 vaccine. The patient also reported that the records now showed as 0.5ml for primary series and received 0.25ml for booster dose. Patient was not sure which dose she received for her primary series.  No treatment medication information was given.   This case was linked to MOD-2022-526395, MOD-2022-526424 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Mar-2022: Follow up received contains no new information
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tenderness at the injection site for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site for 2 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site for 2 days). In January 2021, VACCINATION SITE PAIN (tenderness at the injection site for 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-526482, MOD-2022-526483, MOD-2022-527361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2022: No newinformation received, MI SD attached.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to toxic agent, Fatigue, Rash, Vaccination site pain
Clinical narrative: exposed to Poison Ivy 5 days after her Moderna Covid-19 booster dose; developed a skin rash; tired; right arm injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO TOXIC AGENT (exposed to Poison Ivy 5 days after her Moderna Covid-19 booster dose), VACCINATION SITE PAIN (right arm injection site soreness), FATIGUE (tired) and RASH (developed a skin rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 025120-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (right arm injection site soreness). On 26-Oct-2021, the patient experienced FATIGUE (tired). On 30-Oct-2021, the patient experienced EXPOSURE TO TOXIC AGENT (exposed to Poison Ivy 5 days after her Moderna Covid-19 booster dose) and RASH (developed a skin rash). At the time of the report, EXPOSURE TO TOXIC AGENT (exposed to Poison Ivy 5 days after her Moderna Covid-19 booster dose), VACCINATION SITE PAIN (right arm injection site soreness) and FATIGUE (tired) outcome was unknown and RASH (developed a skin rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  Patient took injectable steroid and was placed on a steroid dose pack.   This case was linked to MOD-2022-526482, MOD-2022-526433 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2022: Follow up received contain non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel well after the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well after the first dose of the Moderna Covid 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Did not feel well after the first dose of the Moderna Covid 19 vaccine). At the time of the report, MALAISE (Did not feel well after the first dose of the Moderna Covid 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Drug details were reported.  Patient received the booster dose of the Moderna Covid 19 vaccine on January 2022 or beginning of February 2022.  No Treatment information was provided.   This case was linked to MOD-2022-526723 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS got worst after 2nd shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MULTIPLE SCLEROSIS (MS got worst after 2nd shot) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (MS got worst after 2nd shot) outcome was unknown. No concomitant medications was reported. No treatment was reported. Company Comment. This spontaneous case concerns a 63 year old female, with relevant medical history of multiple sclerosis, who experienced the unexpected, serious (medically significant) AESI Multiple Sclerosis on the same day as vaccination with a second dose of mRNA-1273. She reports that her multiple sclerosis got worse after the vaccine.  Concomitant medications, labs and treatment details were not reported. The outcome of the event is unknown. The medical history of multiple sclerosis remains a strong confounder. The benefit risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 63 year old female, with relevant medical history of multiple sclerosis, who experienced the unexpected, serious (medically significant) AESI Multiple Sclerosis on the same day as vaccination with a second dose of mRNA-1273.  She reports that her multiple sclerosis got worse after the vaccine. Concomitant medications, labs and treatment details were not reported. The outcome of the event is unknown. The medical history of multiple sclerosis remains a strong confounder. The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-526778, MOD-2022-526820, MOD-2022-526823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2022: Non-significant follow up appended. No new information was added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Heart rate increased, Malaise, Pain in extremity
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (she started having cardiac issues (a rapid heart beat)), MALAISE (not felling well for 24 hours), FATIGUE (tiredness) and ACCIDENTAL OVERDOSE (Full 3rd dose without being immunocompromised) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 026L20A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy, Allergic reaction to bee sting and Osteopenia. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia. On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Full 3rd dose without being immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (she started having cardiac issues (a rapid heart beat)), MALAISE (not felling well for 24 hours) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and METOPROLOL SUCCINATE (TOPROL) for Cardiac disorder, at a dose of 12.5 milligram once a day. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEART RATE INCREASED (she started having cardiac issues (a rapid heart beat)) and FATIGUE (tiredness) had not resolved, MALAISE (not felling well for 24 hours) had resolved and ACCIDENTAL OVERDOSE (Full 3rd dose without being immunocompromised) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had allergy to scalps. The patient was not tested or diagnosed with COVID. The patient had no acute and chronic illnesses at the time of vaccination. The patient had no history of cardiac issues and the events were ongoing at the time of report. This case was linked to MOD-2022-527368 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-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 OVERDOSE (got full 3rd dose and not immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (barely sore arm) and FATIGUE (little tiredness/barely tired). At the time of the report, PAIN IN EXTREMITY (barely sore arm), FATIGUE (little tiredness/barely tired) and ACCIDENTAL OVERDOSE (got full 3rd dose and not immunocompromised) outcome was unknown. The reporter informed that patient was over 70 years and not immunocompromised. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. This case was linked to MOD-2022-527276 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30-day Use By Date or after manufacturer date of expiry) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 022c21A and 014c21a) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 28-Dec-2021. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was initially stored in the refrigerator was on 9 March 2022 and the date of administration of vaccine was on 24 march 2022. The vial did not undergo any temperature excursion. It was reported that patient had no allergies (medications, food and other products). It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Adverse event did not caused patient to seek medical care. The patient had not experienced any similar event in the past. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: chills after third full Moderna dose; body aches after third full Moderna dose; fatigue after third full Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills after third full Moderna dose), MYALGIA (body aches after third full Moderna dose) and FATIGUE (fatigue after third full Moderna dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 07-Jan-2021, the patient 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 received third 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 CHILLS (chills after third full Moderna dose), MYALGIA (body aches after third full Moderna dose) and FATIGUE (fatigue after third full Moderna dose). At the time of the report, CHILLS (chills after third full Moderna dose), MYALGIA (body aches after third full Moderna dose) and FATIGUE (fatigue after third full Moderna dose) outcome was unknown.            The reporter was reporting for her friend. No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-526433 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: not felling well for 24 hours; Sore arm; tiredness; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (not felling well for 24 hours), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Patient is allergic to Z-Pak), Allergy to arthropod sting (Patient is allergic to Bee stings), Allergic reaction (Patient is allergic to Scalps) and Osteopenia. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteopenia.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (not felling well for 24 hours), PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (not felling well for 24 hours) had resolved and PAIN IN EXTREMITY (Sore arm) and FATIGUE (tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported Symptoms were not worsened they are same and patient did not experience any similar events in the past.   This case was linked to MOD-2022-527083, MOD-2022-527368 (Patient Link).
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was vaccinated with a booster dose (0.25mL) of Moderna Covid-19 vaccine from a vial that had been out in room temperature beyond 12 hrs.) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 25-Mar-22 and administered on 29-Mar-22 from a vial that had been out in room temperature beyond 12 hours) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2022 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was vaccinated with a booster dose (0.25mL) of Moderna Covid-19 vaccine from a vial that had been out in room temperature beyond 12 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 25-Mar-22 and administered on 29-Mar-22 from a vial that had been out in room temperature beyond 12 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was vaccinated with a booster dose (0.25mL) of Moderna Covid-19 vaccine from a vial that had been out in room temperature beyond 12 hrs.) and PRODUCT STORAGE ERROR (Vials were initially stored in the refrigerator on 25-Mar-22 and administered on 29-Mar-22 from a vial that had been out in room temperature beyond 12 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was unknown whether patient had experienced a similar event in the past, any allergies (medications, food and other products), had ever COVID positive test or diagnosis. No concomitant medications were reported. It was unknown if the Adverse event caused patient to seek medical care (office visit, Urgent care, ER) and if other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The vial was initially stored in the refrigerator was on 25 March 2022, date on which vial was first punctured was 28 March 2022 at 10:30 am the date of administration of vaccine was on 29 march 2022 at 3:30 pm. The vail was stored at room temperature post puncture. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius equals to 46 degree Celsius to 77 degree farad) was 30.5 hrs. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient was administered with vaccine that has been stored in the refrigerator for 31 days; patient was administered with vaccine that has been stored in the refrigerator for 31 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (patient was administered with vaccine that has been stored in the refrigerator for 31 days) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered with vaccine that has been stored in the refrigerator for 31 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient was administered with vaccine that has been stored in the refrigerator for 31 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (patient was administered with vaccine that has been stored in the refrigerator for 31 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Days after vaccine 30 days use by expiry -1. The vaccine was stored in refrigerator on 15-Feb-2022. The patient didn't experience any adverse event so far. No treatment medications was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 3 patients were administered with vaccine that has been stored in the refrigerator for 31 days; 3 patients were administered with vaccine that has been stored in the refrigerator for 31 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) and PRODUCT STORAGE ERROR (3 patients were administered with vaccine that has been stored in the refrigerator for 31 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient does not reported any adverse events so far.  The vaccine had been stored in the refrigerator on 15-FEB-2022.  No treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER (Diagnosed with prostate cancer) in a 79-year-old male patient 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. In October 2021, the patient experienced PROSTATE CANCER (Diagnosed with prostate cancer) (seriousness criterion medically significant). The patient was treated with ABIRATERONE ACETATE (ZYTIGA) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PROSTATE CANCER (Diagnosed with prostate cancer) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient weight was 190. No concomitant medication information was provided. Patient states he was diagnosed with prostate cancer after receiving the vaccine on Oct2021. He does not have his dosage dates or lot numbers to provide for safety. He states he is on Zytiga and wants to know if there are any drug interactions? He is also on Prednisone. He does not have any past medical history. Company comment: This spontaneous case concerns an elderly 79-year-old male patient with no medical history, who experienced the serious (medically significant) unexpected event of Prostate cancer, unknown days after receiving an unspecified dose of mRNA-1273. Patient´s advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: Company comment: This spontaneous case concerns an elderly 79-year-old male patient with no medical history, who experienced the serious (medically significant) unexpected event of Prostate cancer, unknown days after receiving an unspecified dose of mRNA-1273. Patient´s advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site swelling
Clinical narrative: swelling on the injection site on the left side; 4th shot on 28Mar2022; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site on the left side) and EXTRA DOSE ADMINISTERED (4th shot on 28Mar2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (started 20 years ago, Patient had it entire life, still the same).   On 28-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient experienced EXTRA DOSE ADMINISTERED (4th shot on 28Mar2022). On 30-Mar-2022, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site on the left side). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site on the left side) and EXTRA DOSE ADMINISTERED (4th shot on 28Mar2022) outcome was unknown.            No concomitant medication was reported.  Patient had never been diagnosed with or tested positive for COVID-19. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Patient stated they have received 3 shots of Moderna COVID-19 vaccine and had no problems with it.  Treatment medication was not provided by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of COVID-19 (Covid-19 infection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Clinical effectiveness of additional primary SARS-CoV-2 vaccine doses for solid organ transplant recipients. Clinical Transplant. 2022;36(3): e14601. 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19 infection) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Covid-19 infection) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Covid-19 infection) to be related. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This is a literature non-study case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected serious adverse event of special interest COVID-19, which led to hospitalization, 2 days after receiving the third dose of mRNA-1273 vaccine (no information disclosed on previous doses of COVID-19 vaccine). Date of vaccination and onset of event were not specified. No details about the clinical course, diagnostic procedures and treatment were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-528036, MOD-2022-528035 (Patient Link). Sender's Comments: This is a literature non-study case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected serious adverse event of special interest COVID-19, which led to hospitalization, 2 days after receiving the third dose of mRNA-1273 vaccine (no information disclosed on previous doses of COVID-19 vaccine). Date of vaccination and onset of event were not specified. No details about the clinical course, diagnostic procedures and treatment were provided. Outcome of the events were unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in his left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in his left injection site arm.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE PAIN (soreness in his left injection site arm.). At the time of the report, VACCINATION SITE PAIN (soreness in his left injection site arm.) outcome was unknown.            No concomitant medication information was reported.  No treatment information were reported. It was reported that patient had received the vaccine on his left shoulder deltoid muscle. Patient does not recall any other adverse reactions or side effects.   This case was linked to MOD-2022-527836 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Numbness on his left shoulder, abdomen, left thigh and left leg; Soreness in his injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on his left shoulder, abdomen, left thigh and left leg) and VACCINATION SITE PAIN (Soreness in his injection site arm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 014C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness in his injection site arm). On 27-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness on his left shoulder, abdomen, left thigh and left leg). At the time of the report, HYPOAESTHESIA (Numbness on his left shoulder, abdomen, left thigh and left leg) and VACCINATION SITE PAIN (Soreness in his injection site arm) outcome was unknown.            No information on concomitant medication was reported.  Three to four days after the booster dose the patient started to feel numbness on his left shoulder and in his abdomen. The patient says that this area of numbness is about the size of the palm of his hand. For a few days after the booster dose the patient experienced numbness in his left thigh. However, this numbness in his left leg has subsided. The patient says that he has had this abdominal numbness since 27-Dec-2021.  No information on treatment medications was reported.   This case was linked to MOD-2022-528199, MOD-2022-527836 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients), PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered after 25-35 days interval) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033H21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered after 25-35 days interval). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients), PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered after 25-35 days interval) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Vial was initially stored in refrigerator on 26 Mar 2022. Vial did not undergone any temperature excursions. No treatment information was reported. This case was linked to MOD-2022-528520 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Investigation
Clinical narrative: After my booster dose, it started gradually, but my hair started to fall out, and is still doing so.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (After my booster dose, it started gradually, but my hair started to fall out, and is still doing so.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Naproxen).    On 28-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ALOPECIA (After my booster dose, it started gradually, but my hair started to fall out, and is still doing so.). At the time of the report, ALOPECIA (After my booster dose, it started gradually, but my hair started to fall out, and is still doing so.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: discovered that her hormone levels were low Discovered that her hormone levels were low.         Patient did not had positive COVID test or diagnosis..  Patient had screenings for menopause. It was discovered that her hormone levels were low, but not enough to require any treatment. No concomitant medications were reported. It was reported that the symptoms were worsened. On 17 Jan 2022, patient saw her dermatologist. No treatment medication was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Immunisation reaction
Clinical narrative: some reactions; a little tired; received a third full Moderna dose, instead of a booster half dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some reactions), FATIGUE (a little tired) and ACCIDENTAL OVERDOSE (received a third full Moderna dose, instead of a booster half dose) in a 79-year-old female patient 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) (Intramuscular) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION COMPLICATION (some reactions), FATIGUE (a little tired) and ACCIDENTAL OVERDOSE (received a third full Moderna dose, instead of a booster half dose). At the time of the report, VACCINATION COMPLICATION (some reactions), FATIGUE (a little tired) and ACCIDENTAL OVERDOSE (received a third full Moderna dose, instead of a booster half dose) outcome was unknown.            No concomitant medications were reported.   It was reported that the patient was not considered immunocompromised.  No treatment details were reported.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Impaired quality of life, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (early stage) and Mastectomy (which was cured now) in 2021. Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (Batch Number JANSEN: 1805022) on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life). On 23-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Tinnitus, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm) was resolving and TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life) had not resolved. The patient had no known allergies. The patient never tested positive for COVID-19. The patient side effects from which she was struggling. 12 hours after the booster dose the patient got the usual effects like being tired, achy and had a sore arm. She went to sleep and rested then felt better the next day. Within the week after receiving the vaccine she developed tinnitus and which was nonstop since. She read tinnitus could be something linked to a COVID-19 vaccine. She noticed tinnitus when it was quiet. Tinnitus interferes with her relaxation and sleep. Tinnitus became constant and was still ongoing. The patient had not gone to see a doctor but as an appointment coming up. The feeling was unexplainable for the patient, and it was further mentioned that if she would know about those side effects, she would never take COVID-19 Vaccination. Other treatment included unspecified anti-inflammatories, acupuncture, and ear massages but nothing worked for her.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (early stage) and Mastectomy (which was cured now) in 2021. Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (Batch Number JANSEN: 1805022) on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concomitant products included LEVOTHYROXINE and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life). On 23-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Tinnitus, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), FATIGUE (Tired) and PAIN IN EXTREMITY (Sore arm) was resolving and TINNITUS (Tinnitus), SLEEP DISORDER (Interferes with my relaxation and sleep), FEELING ABNORMAL (Feeling was unexplainable/ it was annoying) and IMPAIRED QUALITY OF LIFE (Affecting my quality of life) had not resolved. The patient had no known allergies. The patient never tested positive for COVID-19. The patient side effects from which she was struggling. 12 hours after the booster dose the patient got the usual effects like being tired, achy and had a sore arm. She went to sleep and rested then felt better the next day. Within the week after receiving the vaccine she developed tinnitus and which was nonstop since. She read tinnitus could be something linked to a COVID-19 vaccine. She noticed tinnitus when it was quiet. Tinnitus interferes with her relaxation and sleep. Tinnitus became constant and was still ongoing. The patient had not gone to see a doctor but as an appointment coming up. The feeling was unexplainable for the patient, and it was further mentioned that if she would know about those side effects, she would never take COVID-19 Vaccination. Other treatment included unspecified anti-inflammatories, acupuncture, and ear massages but nothing worked for her.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Inflammation
Clinical narrative: acute inflammatory process; difficult walking; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (acute inflammatory process) and GAIT DISTURBANCE (difficult walking) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2021.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (acute inflammatory process) and GAIT DISTURBANCE (difficult walking). At the time of the report, INFLAMMATION (acute inflammatory process) and GAIT DISTURBANCE (difficult walking) outcome was unknown.            No concomitant medications were reported.  It was reported that patient cannot have booster from Moderna.  No treatment medications were provided.