chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:49 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.  Vaccine expiration date was 24 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received and it contains no significant information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021 at 3:39 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.  Vaccine expiration date was 24 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up document received included  ID confirmed and document contains Non-significant information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: swollen lymph nodes on the same side on the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on the same side on the injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on the same side on the injection). In March 2021, VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes on the same side on the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that the day after the first dose they got swollen lymph nodes on the same side on the injection, and they considerate the nodes in the neck an immune reaction and not an adverse event that lasted for 10 days.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-417787 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Night blindness, Visual impairment
Clinical narrative: her eyesight diminished; it was hard to see at night; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (her eyesight diminished) and NIGHT BLINDNESS (it was hard to see at night) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-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. On an unknown date, the patient experienced VISUAL IMPAIRMENT (her eyesight diminished) and NIGHT BLINDNESS (it was hard to see at night). At the time of the report, VISUAL IMPAIRMENT (her eyesight diminished) had not resolved and NIGHT BLINDNESS (it was hard to see at night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient did not took any medications to alleviate the symptoms.   This case was linked to MOD-2021-417686, MOD-2021-417772 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 16-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose)). On 16-Dec-2021, ACCIDENTAL UNDERDOSE (booster dose of Moderna Covid-19 vaccine (0.25ml) to a patient who was supposed to be given the 3rd dose (full dose)) had 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. No treatment was reported by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Patient had completed primary Pfizer vaccination series) on 03-Jun-2021 and Pfizer vaccine (Patient had completed primary Pfizer vaccination series) on 20-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series). On 16-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received Moderna Booster dose less than 6 months after 2 dose of Pfizer primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP mentioned that a patient received Moderna Booster dose within less than 6 months after completing Pfizer primary series. No concomitant and treatment information were reported by the reporter
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Fatigue, Pain in extremity, Pruritus, Rash
Clinical narrative: I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.; I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.; I was tired, more than usual; I had a  sore arm; A spot on my right shoulder was itching. It looked like dry skin.; A spot on my right shoulder was itching. It looked like dry skin.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.), RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013A21A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.) and FATIGUE (I was tired, more than usual). On 13-Dec-2021, the patient experienced RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.), RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.), RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and FATIGUE (I was tired, more than usual) outcome was unknown.            No concomitant medication was reported
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.; I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.; I was tired, more than usual; I had a  sore arm; A spot on my right shoulder was itching. It looked like dry skin.; A spot on my right shoulder was itching. It looked like dry skin.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.), RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013A21A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.) and FATIGUE (I was tired, more than usual). On 13-Dec-2021, the patient experienced RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I had a  sore arm), PRURITUS (A spot on my right shoulder was itching. It looked like dry skin.), DRY SKIN (A spot on my right shoulder was itching. It looked like dry skin.), RASH ERYTHEMATOUS (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.), RASH (I got a red patch on my right shoulder, near my neck. It's not quite as big as my hand. It's not really itching.) and FATIGUE (I was tired, more than usual) outcome was unknown.            No concomitant medication was reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Visual impairment
Clinical narrative: her eyesight got even worse; she felt like very dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (her eyesight got even worse) and DIZZINESS (she felt like very dizzy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 013M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-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. On 03-Nov-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 VISUAL IMPAIRMENT (her eyesight got even worse) and DIZZINESS (she felt like very dizzy). At the time of the report, VISUAL IMPAIRMENT (her eyesight got even worse) and DIZZINESS (she felt like very dizzy) 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 drug details were reported. Patient was in contact with an ophthalmologists.   This case was linked to MOD-2021-417751 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: persons vaccinated with Moderna vaccine that was opened beyond 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (persons vaccinated with Moderna vaccine that was opened beyond 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (persons vaccinated with Moderna vaccine that was opened beyond 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (persons vaccinated with Moderna vaccine that was opened beyond 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength) 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 UNDERDOSE (Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength). At the time of the report, UNDERDOSE (Moderna booster shot It was only 25% of the first two vaccines. I read it should have been 50% strength) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had receive Moderna vaccines then the Moderna booster shot and it was only 25 percent of the first two vaccines and the patient read it should have been 50 percent strength.   No concomitant and treatment information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site swelling
Clinical narrative: Itchy rash; Huge swelling around the shot; This spontaneous case was reported by a health care professional and describes the occurrence of RASH PRURITIC (Itchy rash) and VACCINATION SITE SWELLING (Huge swelling around the shot) 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 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced RASH PRURITIC (Itchy rash) and VACCINATION SITE SWELLING (Huge swelling around the shot). At the time of the report, RASH PRURITIC (Itchy rash) and VACCINATION SITE SWELLING (Huge swelling around the shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  No treatment medication was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that vaccines had remained in freezer at -24 degrees F up until the day of use ,then added each vial to refrigerator as needed. The temp of the refrigerator was kept at 4 degrees C.  Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  concomitant medication was provided.  No treatment medication was provided.  The vaccines had remained in freezer at -24 degrees F up until the day of the vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  The vaccines had remained in the freezer at -24 degrees F,  up until the day of the vaccine clinic, then each vial  was added to refrigerator as needed. The temp of the refrigerator was 4 degrees C.  No Treatment information was reported.   This case was linked to MOD-2021-412773 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Out of time range given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Out of time range given to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Out of time range given to patient). At the time of the report, PRODUCT ADMINISTRATION ERROR (Out of time range given to patient) had resolved.        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.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Patient felt depression for the last 3 days; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Patient felt depression for the last 3 days) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced DEPRESSION (Patient felt depression for the last 3 days). At the time of the report, DEPRESSION (Patient felt depression for the last 3 days) outcome was unknown.            The last 3 days (Thursday, Friday , and Saturday) the patient felt depression.  Concomitant products were not provided. Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I got  a trouble after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (I got  a trouble after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I got  a trouble after vaccination). At the time of the report, VACCINATION COMPLICATION (I got  a trouble after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Steroids between doses for their knee problems.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Steroids between doses for their knee problems.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 ARTHRALGIA (Steroids between doses for their knee problems.). The patient was treated with METHYLPREDNISOLONE (oral) for Knee pain, at an unspecified dose and frequency and CORTISONE for Knee pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Steroids between doses for their knee problems.) outcome was unknown.            Patient reported that after getting the 1st dose of the vaccine consumer was taking oral methyl prednisone and  is concerned she might not be protected from initial vaccination series because she was prescribed cortisone shots and oral steroids between her 2 dosing series.  No concomitant drugs were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-412773 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (a patient received the booster dose of the Moderna COVID-19 vaccine 3 hours after the 12 hour post-puncture expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The vaccine was administered at night. The patient was not experiencing symptoms after receiving the expired dose. The reporter mentioned that, the patient received the dose in the recommend way, but 3 hours after it expired. Date the vial was initially stored in the refrigerator: Probable within 5 days (as per the reporter); Date(s) and time(S) vial was first punctured: 16-Dec-2021 07.35 am, the syringe was at RT, not in the refrigerator, 3 hour after the 12-hour expiration. The vaccine did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 15 hours.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine used) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047C21A) for COVID-19  immunization. No medical history reported. On Dec 2, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 2, 2021, patient administered expired product (expired vaccine used). On Dec 2, 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vaccine remained in the freezer at -24 degrees F up until the day of the administration.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days between primary series; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between primary series) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between primary series). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between primary series) had resolved.            Date of birth of the patient reported was unspecified date.  No concomitant medications were reported.  No treatment medications were reported   This case was linked to MOD-2021-417297, MOD-2021-417942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received contains no new information.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Mild body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mild body ache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 030M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-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 (Mild body ache). At the time of the report, PAIN (Mild body ache) outcome was unknown.            Patient date of birth was reported as 21-Feb-2021  Treatment medication was not provided.  Concomitant medication was not provided.   This case was linked to MOD-2021-417941, MOD-2021-417297 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received and it contains no new information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Was given a full dose 0.5mL instead of 0.25mL as a booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Was given a full dose 0.5mL instead of 0.25mL as a booster) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 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 17-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Was given a full dose 0.5mL instead of 0.25mL as a booster). On 17-Dec-2021, ACCIDENTAL OVERDOSE (Was given a full dose 0.5mL instead of 0.25mL as a booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: she has excruciating body pain, in her all body since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she has excruciating body pain, in her all body since yesterday) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced PAIN (she has excruciating body pain, in her all body since yesterday). At the time of the report, PAIN (she has excruciating body pain, in her all body since yesterday) outcome was unknown.            Other medications were not provided. Treatment information was not provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Illness, Ocular discomfort, Somnolence
Clinical narrative: Felt "sickly"; slept all the time; eye issues; coughing; experienced fatigue, tired for about 3 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt "sickly"), SOMNOLENCE (slept all the time), OCULAR DISCOMFORT (eye issues), COUGH (coughing) and FATIGUE (experienced fatigue, tired for about 3 days) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrophy pancreas, Diarrhea, Constipation, Memory loss, Squamous cell carcinoma of scalp (recurring squamous cell cancer in his scalp, Chemo), COPD, Lung disorder NOS, Pollen allergy, Heart disorder, Blood pressure high and Narcolepsy. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for BPH, IMIQUIMOD for Chemotherapy NOS, DONEPEZIL HYDROCHLORIDE (ARICEPT) for Memory loss, PANCREATIN (CREON) for Pancreatic enzymes and Atrophy pancreas, OXYCODONE, CEFALEXIN (KEFLEX [CEFALEXIN]) and MUPIROCIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-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 ILLNESS (Felt "sickly"), SOMNOLENCE (slept all the time), OCULAR DISCOMFORT (eye issues), COUGH (coughing) and FATIGUE (experienced fatigue, tired for about 3 days). At the time of the report, ILLNESS (Felt "sickly"), SOMNOLENCE (slept all the time), OCULAR DISCOMFORT (eye issues), COUGH (coughing) and FATIGUE (experienced fatigue, tired for about 3 days) outcome was unknown.            Concomitant medication included heart medication, high blood pressure medication, narcolepsy medication, medication for Bowels used for diarrhea and constipation, sleep aid.  No treatment medication was provided.  Patient had eye issues and coughing which  reporter relates to pollen.   This case was linked to MOD-2021-416993 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was administered a  dose for their second dose of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient was administered a 50mcg dose for their second dose of the primary series) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B and 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (Patient was administered a 50mcg dose for their second dose of the primary series). On 16-Dec-2021, UNDERDOSE (Patient was administered a 50mcg dose for their second dose of the primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Interval between first and second doses was more than 35 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between first and second doses was more than 35 days) 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 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between first and second doses was more than 35 days). On 09-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between first and second doses was more than 35 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-418074 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination complication, Vaccination site swelling
Clinical narrative: she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.; swelling at the site of injection (Left Arm); nausea; fatigue that lasted for 4-weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.), VACCINATION SITE SWELLING (swelling at the site of injection (Left Arm)), NAUSEA (nausea) and FATIGUE (fatigue that lasted for 4-weeks) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-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. On an unknown date, the patient experienced VACCINATION COMPLICATION (she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.), VACCINATION SITE SWELLING (swelling at the site of injection (Left Arm)), NAUSEA (nausea) and FATIGUE (fatigue that lasted for 4-weeks). At the time of the report, VACCINATION COMPLICATION (she had a lot of side effects that lasted a long time after the 1st two Moderna vaccines.) and FATIGUE (fatigue that lasted for 4-weeks) had resolved and VACCINATION SITE SWELLING (swelling at the site of injection (Left Arm)) and NAUSEA (nausea) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-417541 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Booster dose was given in less than 6 months after second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was given in less than 6 months after second dose) 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 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was given in less than 6 months after second dose). On 15-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose was given in less than 6 months after second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was  not reported.    This case was linked to MOD-2021-418062 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Have muscle pain throughout his body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Have muscle pain throughout his body) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes, Stroke, Neuropathic pain and Heart disorder (Heart situation). Concomitant products included NORTRIPTYLINE and PREGABALIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Have muscle pain throughout his body). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in March 2021 for Muscle pain, at an unspecified dose and frequency. In March 2021, MYALGIA (Have muscle pain throughout his body) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient experienced muscle pain throughout his body for four to five days.   This case was linked to MOD-2021-418135 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Rash
Clinical narrative: It was an immune response; Rashes all over body but more specifically on hands and feet; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (It was an immune response) and RASH (Rashes all over body but more specifically on hands and feet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced IMMUNISATION REACTION (It was an immune response) and RASH (Rashes all over body but more specifically on hands and feet). At the time of the report, IMMUNISATION REACTION (It was an immune response) and RASH (Rashes all over body but more specifically on hands and feet) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Patient had emergency room visit and spoken to allergist. Allergist stated it was immune repose to something.   This case was linked to MOD-2021-417001 (Patient Link).