chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, Urticaria
Clinical narrative: Looked like blisters; Hives; Severe itching arms, torso, back of legs; He had a very bad rash all over his body, on arms, torso, and back of legs; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Looked like blisters), URTICARIA (Hives), PRURITUS (Severe itching arms, torso, back of legs) and RASH (He had a very bad rash all over his body, on arms, torso, and back of legs) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, the patient experienced BLISTER (Looked like blisters), URTICARIA (Hives), PRURITUS (Severe itching arms, torso, back of legs) and RASH (He had a very bad rash all over his body, on arms, torso, and back of legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and CAMPHOR, MENTHOL, PHENOL (SARNA [CAMPHOR;MENTHOL;PHENOL]) at an unspecified dose and frequency. At the time of the report, BLISTER (Looked like blisters), URTICARIA (Hives), PRURITUS (Severe itching arms, torso, back of legs) and RASH (He had a very bad rash all over his body, on arms, torso, and back of legs) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. He used Benadryl on his own which did not help. He has to take more than therapeutic amount of Zyrtec, for the itching to improve. He is still taking the antihistamine and using the Sarna lotion. Wife does not remember if her husband had a rash after the second vaccine.   This case was linked to MOD-2022-487118 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm injection site was sore) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm injection site was sore). At the time of the report, VACCINATION SITE PAIN (Left arm injection site was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-487475, MOD-2022-487476 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm injection site was sore) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm injection site was sore). At the time of the report, VACCINATION SITE PAIN (Left arm injection site was sore) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-487384, MOD-2022-487476 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Breath odour, Chest X-ray, Hypertension
Clinical narrative: she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's; Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.; blood pressure runs up; This spontaneous case was reported by a consumer and describes the occurrence of BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (prior to receiving the vaccine).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up). At the time of the report, BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: high (High) blood pressure runs up. In February 2022, Blood test: results not provided Results not provided. In February 2022, Chest X-ray: returned negative (Negative) returned negative.         No history of Myocarditis/pericarditis. No concomitant medications were reported.  The caller's wife received her booster dose about two months ago. Smell was particularly bad on 16-Feb-2022. The caller's wife went to the hospital about one week ago. The hospital discharged her after doing blood work and chest x-rays. The patient was discharged from the emergency room. Patient developed a smell of chemicals when she breaths out through her nose. The caller's wife also developed higher blood pressure than her normal baseline blood pressure. Cause was not determined. Chest x-rays taken at the hospital returned negative.  No Treatment was given.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's; Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.; blood pressure runs up; This spontaneous case was reported by a consumer and describes the occurrence of BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (prior to receiving the vaccine).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up). At the time of the report, BREATH ODOUR (she gets a chemical breath/Smell was particularly bad/Smell from her breath comes and go's), VACCINATION COMPLICATION (Doctor said that the caller's wife may be having a reaction to the Moderna Covid-19 vaccine.) and HYPERTENSION (blood pressure runs up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: high (High) blood pressure runs up. In February 2022, Blood test: results not provided Results not provided. In February 2022, Chest X-ray: returned negative (Negative) returned negative.         No history of Myocarditis/pericarditis. No concomitant medications were reported.  The caller's wife received her booster dose about two months ago. Smell was particularly bad on 16-Feb-2022. The caller's wife went to the hospital about one week ago. The hospital discharged her after doing blood work and chest x-rays. The patient was discharged from the emergency room. Patient developed a smell of chemicals when she breaths out through her nose. The caller's wife also developed higher blood pressure than her normal baseline blood pressure. Cause was not determined. Chest x-rays taken at the hospital returned negative.  No Treatment was given.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Sore arm; Immunocompromised patient receive 2 booster doses.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and EXTRA DOSE ADMINISTERED (Immunocompromised patient receive 2 booster doses.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart transplant (Heart transplant was before the administration of the Moderna COVID-19 vaccines.). Concurrent medical conditions included Immunocompromised and Immunosuppression. Concomitant products included TACROLIMUS and MYCOPHENOLIC ACID for Immunosuppressant drug therapy.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and EXTRA DOSE ADMINISTERED (Immunocompromised patient receive 2 booster doses.). At the time of the report, PAIN IN EXTREMITY (Sore arm) and EXTRA DOSE ADMINISTERED (Immunocompromised patient receive 2 booster doses.) outcome was unknown.            It was reported that patient received 2 booster doses because he was a heart transplant patient, and his Doctor advised him to do it.  The treatment information was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021; Patient received vaccine from vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J121A, 036B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022 at 10:48 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from vial punctured more than 12 hours ago/ received vaccine from vial with expiry date state as 29 APR 2021) and PRODUCT STORAGE ERROR (Patient received vaccine from vial punctured more than 12 hours ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.   Date the vial  initially stored in the refrigerator  was 07-Feb-2022, date and time the vial first punctured was16-Feb-2022 at 10 am. The vial did not undergo any temperature excursions. Post puncture the vial was stored at room temperature and quarantined. Total amount of time the vial was exposed to room temperature range was 27 hours. Reporter does not know whether patient experienced events after vaccination.  No treatment details were reported.   This case was linked to MOD-2022-487921, MOD-2022-487957 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Scab, Skin exfoliation, Vaccination site erythema, Vaccination site pain
Clinical narrative: Started like a big whelp, and the skin  come off; A scab nasty; Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off; Whole shoulder was red; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Started like a big whelp, and the skin  come off), SCAB (A scab nasty), VACCINATION SITE PAIN (Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off) and VACCINATION SITE ERYTHEMA (Whole shoulder was red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (Started like a big whelp, and the skin  come off), SCAB (A scab nasty), VACCINATION SITE PAIN (Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off) and VACCINATION SITE ERYTHEMA (Whole shoulder was red). At the time of the report, SKIN EXFOLIATION (Started like a big whelp, and the skin  come off), SCAB (A scab nasty), VACCINATION SITE PAIN (Two inch by two inch  were  originally burn the skin off/like a severe severe burn/major layers of his skins were burn off) and VACCINATION SITE ERYTHEMA (Whole shoulder was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient report a severe reaction with the Moderna  shot .The place where he got it (the vaccine) was shock.  No concomitant medication was reported. No treatment medication was reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to 2 patients after more than 30 days stored in the refrigerator; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Product storage error) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 2 patients after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Product storage error) outcome 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.   This case was linked to MOD-2022-489166 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Significant FU appended- dose 1 and dose 2 details and patient details were added
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: was down for a day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was down for a day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Fibromyalgia.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 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 MALAISE (was down for a day). At the time of the report, MALAISE (was down for a day) had resolved.            No concomitant medications were reported.  Treatment information was not provided.  It was reported that patient was slightly immunocompromised with fibromyalgia. Patient received a full dose of Moderna booster in September 2021 and patient was down for a day. Patient stated that the third shot was strong but the side effects did not last.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Follow up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: normal reactions but no out of ordinary reaction.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (normal reactions but no out of ordinary reaction.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (normal reactions but no out of ordinary reaction.). At the time of the report, VACCINATION COMPLICATION (normal reactions but no out of ordinary reaction.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medication was reported.   This case was linked to MOD-2022-488543 (Patient Link).   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: Received booster dose (0.25 ml) in error/since she was immunocompromised; Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster dose (0.25 ml) in error/since she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 045A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome (since from birth), Immunocompromised (since from birth) and Airway obstruction NOS (since from birth).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received booster dose (0.25 ml) in error/since she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.). At the time of the report, ACCIDENTAL UNDERDOSE (Received booster dose (0.25 ml) in error/since she was immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 3rd primary series dose (0.5 ml)/his daughter should have received a 3rd primary series dose (0.5 ml), and then the booster dose (0.25 ml) since she was immunocompromised.) outcome was unknown.      No concomitant medications were reported.  It was reported that no AE cause patient to seek medical care.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Contrast media allergy, Vaccination complication
Clinical narrative: Normal reactions but no out of ordinary reaction; Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Normal reactions but no out of ordinary reaction) and CONTRAST MEDIA ALLERGY (Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Normal reactions but no out of ordinary reaction) and CONTRAST MEDIA ALLERGY (Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component). At the time of the report, VACCINATION COMPLICATION (Normal reactions but no out of ordinary reaction) and CONTRAST MEDIA ALLERGY (Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: results not reported Results not reported.         No concomitant medications were reported.  It was reported that the patient was now worried if she should continue to get her booster shot if it had lipids.  No treatment medications were reported.   This case was linked to MOD-2022-488522 (Patient Link).   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Peripheral swelling
Clinical narrative: 1st dose: 12Mar2021, 2nd dose: 19Apr2021; Swollen arm ,  It has worsened , The swelling is spreading; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm ,  It has worsened , The swelling is spreading) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 12Mar2021, 2nd dose: 19Apr2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043821A and Q38A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm ,  It has worsened , The swelling is spreading). On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 12Mar2021, 2nd dose: 19Apr2021). The patient was treated with VITAMIN D NOS for Swollen arm, at an unspecified dose and frequency; CORTISONE for Swollen arm, at an unspecified dose and frequency and PREDNISONE for Swollen arm, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm ,  It has worsened , The swelling is spreading) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 12Mar2021, 2nd dose: 19Apr2021) outcome was unknown.     Concomitant medication included thyroid medication. It was reported that, swelling arm was Worsen.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (dose given after 30-BUD) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025L21B) for COVID-19 immunization. No medical history reported. On Feb 17, 2022, at 9:57 am, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2022, at 9:57 am, patient administered expired product (dose given after 30-BUD). At the time of the report, administered expired product (dose given after 30-BUD) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vial initially stored in refrigerator Jan 17, 2022, at 16:00 (first punctured on Feb 17, 2022, at 09:57), was stored at room temperature after puncture. That vial remained at room temperature 2 hours and 28 minutes prior to first puncture.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 084J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to 1 patient/ 1 moderna dose was administered to 1 patient passed the 30 days shelf life.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  Date the vial was initially stored in the refrigerator was 29-Dec-2021. Vial did not go under any temperature excursions.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Leukocytosis, White blood cell count
Clinical narrative: elevated white cell count of 11800, blood cell count of 15000, now down to 13000/ Moderna vaccine could cause Leukocytosis and a elevated unintelligible; This spontaneous case was reported by a physician and describes the occurrence of LEUKOCYTOSIS (elevated white cell count of 11800, blood cell count of 15000, now down to 13000/ Moderna vaccine could cause Leukocytosis and a elevated unintelligible) in an 80-year-old male patient 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) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LEUKOCYTOSIS (elevated white cell count of 11800, blood cell count of 15000, now down to 13000/ Moderna vaccine could cause Leukocytosis and a elevated unintelligible). At the time of the report, LEUKOCYTOSIS (elevated white cell count of 11800, blood cell count of 15000, now down to 13000/ Moderna vaccine could cause Leukocytosis and a elevated unintelligible) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, White blood cell count: 11800 (High) elevated white cell count of 11800. In January 2022, White blood cell count: 15000 (High) blood cell count of 15000. In February 2022, White blood cell count: 13000 (High) down to 13000.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details and treatment details were not reported by the reporter.   Reportedly, Patient had no allergies to medications, food and other products and there was no acute and Chronic illnesses at the time of vaccination.  Patient never experienced similar events in the past and have no symptoms that could have improved or worsened, neither seek any medical care (office visit, Urgent care, ER, hospitalized). Patient who was a physician asked that the Moderna vaccine could cause Leukocytosis or not and a elevated white blood cell count  was unintelligible, and very suspicious which can be vaccinated induce but he could not be absolute sure also patient did not have any other medications that could cause this event, therefore had an appointment with a Hematologist.  Patient height was reported as 7 Foot 1 Inch.   This case was linked to MOD-2022-488673 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2022: Follow-up document contains updated patient demographics and route of administration of suspect vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: After booster, Itching got worst; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (After booster, Itching got worst) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced PRURITUS (After booster, Itching got worst). The patient was treated with DOXYCYCLINE for Itching, at an unspecified dose and frequency and HYDROXYZINE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (After booster, Itching got worst) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient was not sure if itching was caused by the vaccine. Other Treatment medications include Antihistamines and an unknown injection. Patient's dermatologist prescribed several unknown creams as treatment. This case was linked to MOD-2022-488823 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Felt sick after first shot; Arm hurt  after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot). On 09-Feb-2021, MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2022-489191, MOD-2022-489192 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discolouration, Vaccination site induration, Vaccination site mass
Clinical narrative: Felt sick after first shot; Arm hurt  after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot). On 09-Feb-2021, MALAISE (Felt sick after first shot) and PAIN IN EXTREMITY (Arm hurt  after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2022-489191, MOD-2022-489192 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Hard deltoid muscle injection site after booster; Mass in the deltoid muscle (Nod) after booster; Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard deltoid muscle injection site after booster), VACCINATION SITE MASS (Mass in the deltoid muscle (Nod) after booster) and VACCINATION SITE DISCOLOURATION (Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced VACCINATION SITE INDURATION (Hard deltoid muscle injection site after booster), VACCINATION SITE MASS (Mass in the deltoid muscle (Nod) after booster) and VACCINATION SITE DISCOLOURATION (Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster). At the time of the report, VACCINATION SITE INDURATION (Hard deltoid muscle injection site after booster), VACCINATION SITE MASS (Mass in the deltoid muscle (Nod) after booster) and VACCINATION SITE DISCOLOURATION (Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster) had not resolved.            No concomitant medication were provided.  No treatment medication were provided.   This case was linked to MOD-2022-489037, MOD-2022-489191 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discolouration, Vaccination site induration, Vaccination site mass
Clinical narrative: Hard deltoid muscle injection site after booster; Mass in the deltoid muscle (Nod) after booster; Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard deltoid muscle injection site after booster), VACCINATION SITE MASS (Mass in the deltoid muscle (Nod) after booster) and VACCINATION SITE DISCOLOURATION (Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced VACCINATION SITE INDURATION (Hard deltoid muscle injection site after booster), VACCINATION SITE MASS (Mass in the deltoid muscle (Nod) after booster) and VACCINATION SITE DISCOLOURATION (Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster). At the time of the report, VACCINATION SITE INDURATION (Hard deltoid muscle injection site after booster), VACCINATION SITE MASS (Mass in the deltoid muscle (Nod) after booster) and VACCINATION SITE DISCOLOURATION (Discoloration from Deltoid towards Bicept (1.5 x 6 Inches) after booster) had not resolved.            No concomitant medication were provided.  No treatment medication were provided.   This case was linked to MOD-2022-489037, MOD-2022-489191 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received a 0.50 ml  BOOSTER dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received a 0.50 ml  BOOSTER dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2nd dose) and PFIZER BIONTECH COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (received a 0.50 ml  BOOSTER dose). At the time of the report, ACCIDENTAL OVERDOSE (received a 0.50 ml  BOOSTER dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.  It was reported that patient received a 0.50 ml BOOSTER dose instead of a 0.25ml booster dose because of a administration error.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to patient after more than 30 days stored in the refrigerator; Dose administered to patient after more than 30 days stored in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days stored in the refrigerator) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 088D21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Depression, High cholesterol and Dementia.   On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after more than 30 days stored in the refrigerator) and PRODUCT STORAGE ERROR (Dose administered to patient after more than 30 days stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Regular medications reported included unspecified medications for hypertension, depression, high cholesterol, dementia. Patient has no history of allergies.  Off-label shot reported was patient's booster shot. Vial used was initially stored in refrigerator on 11-Jan-2022.  No treatment medications were reported.   This case was linked to MOD-2022-488503 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: felt sick for 7 days; arm hurt for 7 days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick for 7 days) and PAIN IN EXTREMITY (arm hurt for 7 days) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    No Medical History information was reported.  On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (felt sick for 7 days) and PAIN IN EXTREMITY (arm hurt for 7 days). On 09-Mar-2021, MALAISE (felt sick for 7 days) and PAIN IN EXTREMITY (arm hurt for 7 days) had resolved.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-489037, MOD-2022-489192 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient; had an issue where the syringe failed; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient) and SYRINGE ISSUE (had an issue where the syringe failed) 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 INCORRECT DOSE ADMINISTERED (Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient) and SYRINGE ISSUE (had an issue where the syringe failed). At the time of the report, INCORRECT DOSE ADMINISTERED (Incomplete dose administered/25 percent of vaccine slipped out without being administered to the patient) and SYRINGE ISSUE (had an issue where the syringe failed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided. The administering facility had previously called and reported this dosing administration error.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".   Additional information:Lot unknown reason was reported as Not available/provided to reporter at the time of report completion  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: A lot of brain fog; Dizziness; Joint pain; Trouble sleeping; Confusion; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01, Age: 63 Years), when the patient was 63 years old, for Covid-19 immunization, reaction(s): "Joint pain", "Dizziness", "Brain fog", "Headache". The following information was reported: FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "unknown", described as "A lot of brain fog"; DIZZINESS (non-serious) with onset Feb2021, outcome "unknown", described as "Dizziness"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "unknown", described as "Joint pain"; INSOMNIA (non-serious) with onset Feb2021, outcome "unknown", described as "Trouble sleeping"; CONFUSIONAL STATE (non-serious) with onset Feb2021, outcome "unknown", described as "Confusion"; FATIGUE (non-serious) with onset Feb2021, outcome "unknown", described as "Fatigue".  Additional information: The patient received his 3rd (Booster) dose of Pfizer Coronavirus vaccines on 31Aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.