chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: past away a few hours after getting the Moderna booster; This spontaneous case was reported by a physician and describes the occurrence of DEATH (past away a few hours after getting the Moderna booster) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Patient had hypertension, gout and atrial fib for 6 years), Gout (Patient had hypertension, gout and atrial fib for 6 years), Atrial fibrillation (Patient had hypertension, gout and atrial fib for 6 years) and Catheterization arterial (Patient had a catherization of an artery 6 years ago). Concomitant products included DIGOXIN for Atrial fibrillation, PROBENECID for Gout, POTASSIUM, VERAPAMIL, COLCHICINE and ALLOPURINOL (ALOPURINOL) for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 25-Oct-2021 The patient died on 25-Oct-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that patient did not had covid-19.  Patient was very active, biked 12miles a day and roller skated 3-4 hours a day, 3 days a week, with no cardiac symptoms. Patient was not overweight. Patient passed away at 6pm.  Treatment information was not provided.  Company Comment: This case concerns a 75-year-old, male patient, with medical history hypertension, atrial fibrillation and arterial catheterization, who experienced the serious, unexpected event of death. The patient passed away on the floor of his house on the same day after the third dose of mRNA 1273 vaccine. It is unknown if an autopsy was done. The patient history of hypertension, atrial fibrillation and arterial catheterization remains as confounder to event death. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up information included no new information.; Sender's Comments: This case concerns a 75-year-old, male patient, with medical history hypertension, atrial fibrillation and arterial catheterization, who experienced the serious, unexpected event of death. The patient passed away on the floor of his house on the same day after the third dose of mRNA 1273 vaccine. It is unknown if an autopsy was done. The patient history of hypertension, atrial fibrillation and arterial catheterization remains as confounder to event death. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Benadryl), Drug allergy (Requip), Drug allergy (Statins), Supraventricular tachycardia, CVA and Chronic kidney disease. Concomitant products included AMLODIPINE, WARFARIN, METOPROLOL and GABAPENTIN for an unknown indication.    On 18-Nov-2021 at 10:47 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a booster dose of .25mL outside of the 12 hour range of vial being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment information were provided.  The via was first punctured on 17-NOV-2021 at 9 am. No temperature excursions were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received includes updated reporter address, patient demographics (Height, weight, race, ethnicity), allergies, medical history, concomitant medications, time and site of vaccine administration.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Presyncope, Thyroid disorder, Thyroid function test
Clinical narrative: fell like head has fast pulse; Funny sensation; felt like was going to pass out like something was happening to her; After [getting the booster] my thyroid seems to be giving me some difficulty/ took thyroid test and come out a little high; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (fell like head has fast pulse), FEELING ABNORMAL (Funny sensation), PRESYNCOPE (felt like was going to pass out like something was happening to her) and THYROID DISORDER (After [getting the booster] my thyroid seems to be giving me some difficulty/ took thyroid test and come out a little high) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016m20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Dysfunction thyroid.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced HEAD DISCOMFORT (fell like head has fast pulse), FEELING ABNORMAL (Funny sensation), PRESYNCOPE (felt like was going to pass out like something was happening to her) and THYROID DISORDER (After [getting the booster] my thyroid seems to be giving me some difficulty/ took thyroid test and come out a little high). At the time of the report, HEAD DISCOMFORT (fell like head has fast pulse) and FEELING ABNORMAL (Funny sensation) had not resolved, PRESYNCOPE (felt like was going to pass out like something was happening to her) outcome was unknown and THYROID DISORDER (After [getting the booster] my thyroid seems to be giving me some difficulty/ took thyroid test and come out a little high) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2021, Thyroid function test: high (High) High.         No Medical History information was reported.  It was reported that patient had to lower the doses of Tyrod, and didn't change Thyroid levels and had to stop taking Centroid.  Patient had not been able to take Tyrod in several weeks, and had to wait to take it back and rebuild and thinks she feels better and improved.   This case was linked to MOD-2021-398519, MOD-2021-398901 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Follow-up received contains Reporter's details, Patient demographics, first and second dose information and additional events added.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Malaise, Pruritus, Rash, Vaccination complication
Clinical narrative: adverse reaction to your booster shot; she just didn't feel good; Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks; It is still very red; Rash on her neck, chest, & scattered on her back; Her left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction to your booster shot), MALAISE (she just didn't feel good), PRURITUS (Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks), ERYTHEMA (It is still very red) and RASH (Rash on her neck, chest, & scattered on her back) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (adverse reaction to your booster shot), MALAISE (she just didn't feel good), PRURITUS (Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks), ERYTHEMA (It is still very red), RASH (Rash on her neck, chest, & scattered on her back) and VACCINATION SITE PAIN (Her left arm hurt). At the time of the report, VACCINATION COMPLICATION (adverse reaction to your booster shot) and VACCINATION SITE PAIN (Her left arm hurt) outcome was unknown, MALAISE (she just didn't feel good), PRURITUS (Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks) and RASH (Rash on her neck, chest, & scattered on her back) was resolving and ERYTHEMA (It is still very red) had not resolved.            Patient had no problems after receiving 1st and 2nd dose.  No concomitant medications were reported.  Treatment including use of cream prescribed by the physician was reported.     Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Include all the 3 vaccination dose details, events updated, treatment medication added in iNarrative.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: adverse reaction to your booster shot; she just didn't feel good; Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks; It is still very red; Rash on her neck, chest, & scattered on her back; Her left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction to your booster shot), MALAISE (she just didn't feel good), PRURITUS (Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks), ERYTHEMA (It is still very red) and RASH (Rash on her neck, chest, & scattered on her back) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 031L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (adverse reaction to your booster shot), MALAISE (she just didn't feel good), PRURITUS (Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks), ERYTHEMA (It is still very red), RASH (Rash on her neck, chest, & scattered on her back) and VACCINATION SITE PAIN (Her left arm hurt). At the time of the report, VACCINATION COMPLICATION (adverse reaction to your booster shot) and VACCINATION SITE PAIN (Her left arm hurt) outcome was unknown, MALAISE (she just didn't feel good), PRURITUS (Rash was raised initially, very itchy, very irritable/It is improving/had it for 6 weeks) and RASH (Rash on her neck, chest, & scattered on her back) was resolving and ERYTHEMA (It is still very red) had not resolved.            Patient had no problems after receiving 1st and 2nd dose.  No concomitant medications were reported.  Treatment including use of cream prescribed by the physician was reported.     Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Include all the 3 vaccination dose details, events updated, treatment medication added in iNarrative.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever for 4 days) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Fever for 4 days). On 14-Apr-2021, PYREXIA (Fever for 4 days) had resolved.            The patient was taking Menacycline as concomitant medications.  No treatment medications were reported by the reporter.  The patient had not taking any medication at the time of vaccination and had not experienced any side effects after receiving 1st dose of Moderna COVID 19 vaccine.   This case was linked to MOD-2021-400090 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental impairment
Clinical narrative: ever since he got the second vaccine (is been to unintelligible); This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) (seriousness criterion medically significant). At the time of the report, MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported. Patient reported that ever since he got the second vaccine (is been to unintelligible), and after the booster dose, was worst, having to take naps during the day, had never been like this before.  Company comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Mental Impairment. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-399720 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Mental Impairment. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: ever since he got the second vaccine (is been to unintelligible); This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) (seriousness criterion medically significant). At the time of the report, MENTAL IMPAIRMENT (ever since he got the second vaccine (is been to unintelligible)) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported. Patient reported that ever since he got the second vaccine (is been to unintelligible), and after the booster dose, was worst, having to take naps during the day, had never been like this before.  Company comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Mental Impairment. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-399720 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Mental Impairment. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental impairment
Clinical narrative: after the booster dose, is worst, having to take naps during the day/has never been like this before; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (after the booster dose, is worst, having to take naps during the day/has never been like this before) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 SOMNOLENCE (after the booster dose, is worst, having to take naps during the day/has never been like this before). At the time of the report, SOMNOLENCE (after the booster dose, is worst, having to take naps during the day/has never been like this before) outcome was unknown.            Patient reported that ever since he got the second vaccine, he felt like unintelligible, and after the booster  dose, he  had to take naps during the day. It was never happen before. Concomitant product use was not provided by reporter. Treatment information was not provided.  Company comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Somnolence. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since event only happened on the third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-398620 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Somnolence. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since event only happened on the third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: after the booster dose, is worst, having to take naps during the day/has never been like this before; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (after the booster dose, is worst, having to take naps during the day/has never been like this before) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 SOMNOLENCE (after the booster dose, is worst, having to take naps during the day/has never been like this before). At the time of the report, SOMNOLENCE (after the booster dose, is worst, having to take naps during the day/has never been like this before) outcome was unknown.            Patient reported that ever since he got the second vaccine, he felt like unintelligible, and after the booster  dose, he  had to take naps during the day. It was never happen before. Concomitant product use was not provided by reporter. Treatment information was not provided.  Company comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Somnolence. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since event only happened on the third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-398620 (Patient Link).; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Somnolence. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since event only happened on the third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Hyperhidrosis, Inappropriate schedule of product administration, Influenza like illness, Lymphadenopathy
Clinical narrative: I had a reaction; Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed; Fever; Inappropraite schedule of vaccine; Sweats; The whole nine yards and felt like he had the flu; Cough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a reaction), HYPERHIDROSIS (Sweats), COUGH (Cough), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu) and LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: pfizer (The first dose was given ,into his left arm (he thinks) . The lot number was ER3729) on 12-Apr-2021, pfizer (The second dose was given  and Also into his left arm (he thinks) Lot number EV0175.Each of these doses were given) on 03-May-2021. Past adverse reactions to the above products included No adverse event with pfizer and pfizer.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced COUGH (Cough). On 23-Nov-2021, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropraite schedule of vaccine). On 26-Nov-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed). On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a reaction). In November 2021, COUGH (Cough) and LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed) had resolved. On 23-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropraite schedule of vaccine) had resolved. On 24-Nov-2021, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION COMPLICATION (I had a reaction) outcome was unknown.            Patient received the Moderna booster shot on 23NOV2021 into the muscle of his right, upper arm at the,Lot number was difficult to discern, but thinks it was 06721A. No expiration date was provided. Patient received the Pfizer vaccines as the primary series.Also into his left arm (Patient  thinks).  No concomitant medication  were reported. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Significant Follow-up appended-Includes event updates, historical vaccine updates.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: I had a reaction; Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed; Fever; Inappropraite schedule of vaccine; Sweats; The whole nine yards and felt like he had the flu; Cough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a reaction), HYPERHIDROSIS (Sweats), COUGH (Cough), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu) and LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: pfizer (The first dose was given ,into his left arm (he thinks) . The lot number was ER3729) on 12-Apr-2021, pfizer (The second dose was given  and Also into his left arm (he thinks) Lot number EV0175.Each of these doses were given) on 03-May-2021. Past adverse reactions to the above products included No adverse event with pfizer and pfizer.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced COUGH (Cough). On 23-Nov-2021, the patient experienced HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropraite schedule of vaccine). On 26-Nov-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed). On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a reaction). In November 2021, COUGH (Cough) and LYMPHADENOPATHY (Lymph nodes underneath my arm began to swell/Underneath my arm it's like a water bed) had resolved. On 23-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropraite schedule of vaccine) had resolved. On 24-Nov-2021, HYPERHIDROSIS (Sweats), INFLUENZA LIKE ILLNESS (The whole nine yards and felt like he had the flu) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION COMPLICATION (I had a reaction) outcome was unknown.            Patient received the Moderna booster shot on 23NOV2021 into the muscle of his right, upper arm at the,Lot number was difficult to discern, but thinks it was 06721A. No expiration date was provided. Patient received the Pfizer vaccines as the primary series.Also into his left arm (Patient  thinks).  No concomitant medication  were reported. No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Significant Follow-up appended-Includes event updates, historical vaccine updates.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Pain, Vaccination complication
Clinical narrative: They bit me up a little bit; Achy all over; Felt like a good flu; Tired; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (They bit me up a little bit), PAIN (Achy all over), INFLUENZA (Felt like a good flu) and FATIGUE (Tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma (The patient was a cancer survivor (late stage lymphoma), 24 year remission. ) in 1997. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (They bit me up a little bit), PAIN (Achy all over), INFLUENZA (Felt like a good flu) and FATIGUE (Tired). At the time of the report, VACCINATION COMPLICATION (They bit me up a little bit), PAIN (Achy all over), INFLUENZA (Felt like a good flu) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was nit reported.   This case was linked to MOD-2021-400091 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation
Clinical narrative: Mixed 1st and 2nd dose from different manufacturers; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (Mixed 1st and 2nd dose from different manufacturers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Astra-Zeneca COVID19 Vaccine (First dose). Past adverse reactions to the above products included No adverse event with Astra-Zeneca COVID19 Vaccine.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced COVID-19 IMMUNISATION (Mixed 1st and 2nd dose from different manufacturers). On 17-Jun-2021, COVID-19 IMMUNISATION (Mixed 1st and 2nd dose from different manufacturers) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist states that a female patient received a dose of Astra-Zeneca COVID19 Vaccine f, then a dose of Moderna COVID19 Vaccine.  No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received contains patient details, additional reporter and narrative supplement updated.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021 at 8:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered a booster dose of the Moderna Covid-19 vaccine from a vial which was first punctured on 24Nov2021) 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Non-Significant follow up appended
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs; Received 3rd dose of vaccine too early; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No concurrent condition, medical history, or concomitant therapy was reported.    On 03-AUG-2021, and 16-SEP-2021, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis.  On 26-OCT-2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 (unit was not provided), lot # T039466 with expiration date 20-MAY-2023) intramuscularly for prophylaxis (inappropriate schedule of vaccine administered). No additional adverse event was reported.
Age: 1.83
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional adverse event / no reaction noted; GARADSIL 9 versus a flu vaccine; This spontaneous report was received from a pharmacist and assistant director and refers to a 22-month-old female patient. The patient had no known allergies (NKA), none illnes at the time of vaccination, none concomitant medications and concurrent conditions.  On 04-NOV-2021, the patient was inadvertently vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1659422, expiration date 04-SEP-2021, intramuscularly (dose and anatomical location were not reported) for prophylaxis versus a flu vaccine (wrong product administered). The patient was in flu clinic to receive flu vaccine and her sibling to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (also reported by assistant director as HPV 9). Siblings were both in the room and the health professional inadvertently gave hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to the patient thinking it was flu. No patient's reaction was noted (no adverse event). No prescription drug treatment was required.  It was reported by the assistant director that new processes in place were implemented to minimize/eliminate error, for example separate baskets for each patient or one patient per room when possible. Provider, poison control, pharmacy and manufacturer were notified. Internal reporting was completed as well as a new process.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; vaccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant referring to a male patient of unknown age. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not provided      On 25-OCT-2021 (also reported as 1 month after excursion and after the short date), the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, and anatomical location were not reported; lot number T032321, had been verified to be a valid number; expiration date 22-SEP-2022). The  temperature  excursion was at 55.9 degrees Farhrenheit on 15-SEP-2021 for a time frame of 30 minutes. No additional adverse event reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA002247: US-009507513-2111USA002253:
Age: 20.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 20-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions or concomitant therapies provided. On 05-NOV-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) single dose, lot # S032352, expiration date reported as 14-NOV-2021 but upon internal validation established as 14-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No temperature excursion nor adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 42-year-old male patient. No information regarding the patient's concurrent condition, medical history or concomitant medications was provided. On an unknown date in June 2020, the patient was administered the first dose (initial dose) and on an unknown date in July 2020, the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date in October 2021, the patient was vaccinated with the third and final dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml (route of administration, lot# and expiration date were not reported) for prophylaxis, outside of the recommended interval. The reporter stated that no additional adverse event (AE) was reported by patient.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE reported; patient might have received a dose of VARlVAX administered intramuscularly; This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 18-NOV-2021 the patient might have been vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) intramuscularly, 0.5 milliliter, lot # U019904, expiration date 24-JUN-2023, for prophylaxis (formulation, concentration, dose number, frequency, were not reported). The patient was very lean and the angle used to administer varicella virus vaccine live (oka/merck)(VARIVAX) might have reached the patients muscle. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HPV9
Symptoms: Syringe issue
Clinical narrative: This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-NOV-2021, while administering vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1780867, expiration date 08-AUG-2023 for prophylaxis (exact dose, anatomical location and route of administration were not reported), the finger flange broke (Syringe broken) and cut the health care professional (HCP) (Laceration of finger). The patient receiving the vaccine had no injury and received all of the vaccine. The office manager reported that they still have the defective product and no damage had been noted to the cartoon or that specific syringe before use. There was no difficulty trying to attach the syringe needle to the syringe and the syringe broke during use into 2 or more pieces. The syringe tip cap was attached properly prior to use and the syringe tray was intact and undamaged on receipt. The outcome of the event was unknown. The reporter considered the event of laceration of finger to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). This is one of two reports received from the same reporter. Sender's Comments:  US-009507513-2111USA009249:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Poor quality device used, Syringe issue
Clinical narrative: This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1780867, expiration date 08-AUG-2023 for prophylaxis (exact dose, anatomical location and route of administration were not reported). While administering the vaccine, the finger flange broke (Syringe broken, poor quality device used) and cut the health care professional (HCP). The patient had no injury and received all of the vaccine (no adverse event). The office manager reported that they still have the defective product and no damage had been noted to the cartoon or that specific syringe before use. There was no difficulty trying to attach the syringe needle to the syringe and the syringe broke during use into 2 or more pieces. The syringe tip cap was attached properly prior to use and the syringe tray was intact and undamaged on receipt. This is a non-valid case due to lack of patient's identifier. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-2111USA008646.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose of M-M-R II was administered to the patient; Information has been received from registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On 29-NOV-2021 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S037500, expiration date: 20-NOV-2021, 0.5 milliliter (route of administration and anatomical location were not reported) (expired product administered) for prophylaxis. The dose did not experience any known temperature excursions. No additional adverse event was reported (no adverse event).
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a consumer referring to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies was provided. On 29-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # T035411 has been verified to be a valid lot number, expiration date was reported and established as 14-APR-2022; dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported) as prophylaxis to a 17-year-old patient (product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On 30-NOV-2021, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (vaccine scheme, route of administration and anatomical location were not reported; lot number T035409 has been verified to be a valid number, expiration date reported and established as 14-APR-2022), as prophylaxis after the vaccine had undergone a temperature excursion (product storage error). The vaccine was stored for the time frame of 1 hours 16 minutes in the temperature of 8.6 Fahrenheit (F). There was no previous temperature excursion. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: No Adverse event; Administration of an expired dose of M-M-R II vaccine; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. Patient's medical history, historical drug, concomitant therapies were not provided.  On 30-N0V-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status of rha (recombinant human albumin) (M-M-R II) (lot # S037499, Expiration date; 20-NOV-2021) (dose, route and site of administration not reported) and expired product administered and diluted in a sterile diluent (MERCK STERILE DILUENT) (lot # T032311, Expiration date; 05-MAY-2023) for prophylaxis.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other details provided or known at this time.; fourth dose of GARDASIL 9 was inadvertently administered to a 17 year old patient; This spontaneous report was received from a physician internist and refers to a 17-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 29-NOV-2021, the patient was inadvertently vaccinated with a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, administered intramuscularly, lot # T027789, expiration date 27-FEB-2023 (anatomical location was not provided) for prophylaxis (extra dose administered). No additional adverse event was reported.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 18-OCT-2013 and 19-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.       On an unknown date the patient experienced sore arm. The outcome of the event was unknown. The causality assessment was related.  The case was split from a legal case referring the same patient.; Sender's Comments:  US-009507513-2107USA008917: US-009507513-2111USA009925:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she asked did the 2nd dose cause shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.