chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Arm is very red/Red circle of about 5 inches; Hot to the touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is very red/Red circle of about 5 inches), VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE PRURITUS (Itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced ERYTHEMA (Arm is very red/Red circle of about 5 inches), VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, ERYTHEMA (Arm is very red/Red circle of about 5 inches), VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Purple big dots/some of them are big and some are smaller/ I have spots on my arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Purple big dots/some of them are big and some are smaller/ I have spots on my arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B214 and 046AZ-A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Purple big dots/some of them are big and some are smaller/ I have spots on my arm). The patient was treated with PARAFFIN (PENATEN [PARAFFIN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Purple big dots/some of them are big and some are smaller/ I have spots on my arm) outcome was unknown.            No concomitant medications were reported.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort
Clinical narrative: October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037a21b and 001a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, PRAVASTATIN, LEVOTHYROXINE, MONTELUKAST, LOSARTAN, DILTIAZEM, ALBUTEROL [SALBUTAMOL] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NASAL DISCOMFORT (October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice). At the time of the report, NASAL DISCOMFORT (October or September their nasal passages were burning and went to the doctor that gave them antibiotics and these happened twice) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to the doctor that gave him antibiotic and also mention that he is going on a trip and that wanted to know if these is a normal side effect. Lastly he stated that he will be  going to go to the doctor   This case was linked to MOD-2021-368936 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: She experienced muscle aches; She was worn out, spent all day in bed/exhaustion and fatigue/tired; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (She experienced muscle aches) and FATIGUE (She was worn out, spent all day in bed/exhaustion and fatigue/tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (She experienced muscle aches) and FATIGUE (She was worn out, spent all day in bed/exhaustion and fatigue/tired). The patient was treated with PARACETAMOL (TYLENOL ACHES & STRAINS) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (She experienced muscle aches) and FATIGUE (She was worn out, spent all day in bed/exhaustion and fatigue/tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received the full dose instead of the half dose for the booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (received the full dose instead of the half dose for the booster dose) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (received the full dose instead of the half dose for the booster dose). On 28-Oct-2021, ACCIDENTAL OVERDOSE (received the full dose instead of the half dose for the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   No treatment medications were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 83-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: Flu Vaccine. Past adverse reactions to the above products included No adverse event with Flu Vaccine.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-369007, MOD-2021-369010 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: has a bump; redness all around like a bull's eye; pain in my arm/moderate pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (has a bump), VACCINATION SITE ERYTHEMA (redness all around like a bull's eye) and VACCINATION SITE PAIN (pain in my arm/moderate pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 031B21A. and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION SITE MASS (has a bump), VACCINATION SITE ERYTHEMA (redness all around like a bull's eye) and VACCINATION SITE PAIN (pain in my arm/moderate pain). At the time of the report, VACCINATION SITE MASS (has a bump), VACCINATION SITE ERYTHEMA (redness all around like a bull's eye) and VACCINATION SITE PAIN (pain in my arm/moderate pain) outcome was unknown.            no concomitant and treatment medications are provided by the reporter. Vaccination facility address for dose 1 and 2 is given as Airport, for 3rd dose is Pharmacy/Drug Store.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm a little bit sore) in an 84-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: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm a little bit sore). At the time of the report, PAIN IN EXTREMITY (Arm a little bit sore) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-368995, MOD-2021-369010 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 24M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) 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 drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Non Significant follow-up.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity, Pruritus
Clinical narrative: Arm is a little itchy; Arm was quite sore; Had no energy at all; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm is a little itchy), PAIN IN EXTREMITY (Arm was quite sore) and ASTHENIA (Had no energy at all) in an 84-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: Flu shot (Patient received the regular flu shot two weeks ago) in October 2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced PRURITUS (Arm is a little itchy) and PAIN IN EXTREMITY (Arm was quite sore). 24-Oct-2021, the patient experienced ASTHENIA (Had no energy at all). On 29-Oct-2021, ASTHENIA (Had no energy at all) had resolved. At the time of the report, PRURITUS (Arm is a little itchy) and PAIN IN EXTREMITY (Arm was quite sore) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-368995, MOD-2021-369007 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to the Moderna booster injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the Moderna booster injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the Moderna booster injection). At the time of the report, VACCINATION COMPLICATION (reaction to the Moderna booster injection) outcome was unknown.            No concomitant medication  were reported. No Treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccinated from expired vial (about 50 days refrigerated); received the vaccine from a vial that was refrigerated, that was about 20 days past the 30 day mark; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated from expired vial (about 50 days refrigerated)) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated from expired vial (about 50 days refrigerated)).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication was not reported. Treatment information was not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain; Arm Swelling; Armpit swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm Swelling) and LYMPHADENOPATHY (Armpit swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025O21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm Swelling) and LYMPHADENOPATHY (Armpit swelling). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (Arm Swelling) and LYMPHADENOPATHY (Armpit swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient stated that those symptoms are very painful. Symptoms are ongoing after a week.  No concomitant products were reported
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Throat edema; Arm soreness; Swelling in both hands and fingers; Aches; Fever; Fatigue; Right handed could not move; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, PERPHENAZINE, PRAVASTATIN, LOSARTAN, MELOXICAM, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), PREGABALIN and SULFASALAZINE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches), PYREXIA (Fever), FATIGUE (Fatigue) and MOBILITY DECREASED (Right handed could not move). The patient was treated with SULFASALAZINE at an unspecified dose and frequency. At the time of the report, PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches), PYREXIA (Fever), FATIGUE (Fatigue) and MOBILITY DECREASED (Right handed could not move) was resolving.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal oedema, Pyrexia
Clinical narrative: Throat edema; Arm soreness; Swelling in both hands and fingers; Aches; Fever; Fatigue; Right handed could not move; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, PERPHENAZINE, PRAVASTATIN, LOSARTAN, MELOXICAM, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA), PREGABALIN and SULFASALAZINE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches), PYREXIA (Fever), FATIGUE (Fatigue) and MOBILITY DECREASED (Right handed could not move). The patient was treated with SULFASALAZINE at an unspecified dose and frequency. At the time of the report, PHARYNGEAL OEDEMA (Throat edema), PAIN IN EXTREMITY (Arm soreness), PERIPHERAL SWELLING (Swelling in both hands and fingers), PAIN (Aches), PYREXIA (Fever), FATIGUE (Fatigue) and MOBILITY DECREASED (Right handed could not move) was resolving.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect dose administered, Product storage error
Clinical narrative: full dose instead of a half dose; Five doses of the Moderna Covid-19 Vaccine were given to patients after being in the refrigerator starting on 8Sep2021; Vaccine being in the refrigerator starting on 8Sep2021; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses of the Moderna Covid-19 Vaccine were given to patients after being in the refrigerator starting on 8Sep2021) and PRODUCT STORAGE ERROR (Vaccine being in the refrigerator starting on 8Sep2021) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 037K20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses of the Moderna Covid-19 Vaccine were given to patients after being in the refrigerator starting on 8Sep2021) and PRODUCT STORAGE ERROR (Vaccine being in the refrigerator starting on 8Sep2021). On 29-Oct-2021, INCORRECT DOSE ADMINISTERED (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses of the Moderna Covid-19 Vaccine were given to patients after being in the refrigerator starting on 8Sep2021) and PRODUCT STORAGE ERROR (Vaccine being in the refrigerator starting on 8Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow up received contains additional events and Contact information (Fax No.) was updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered the Moderna COVID 19 vaccine a day after the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna COVID 19 vaccine a day after the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna COVID 19 vaccine a day after the expiration date). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna COVID 19 vaccine a day after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter  No treatment medications provided by the reporter.   On 06 Oct 2021 , the vial was initially stored in the refrigerator . The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received states that the patient experienced no adverse events.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash pruritic
Clinical narrative: from neck to feet; it is still itching; Allergy/Hypersensitivity; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (from neck to feet), PRURITUS (it is still itching) and HYPERSENSITIVITY (Allergy/Hypersensitivity) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 002B21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included METFORMIN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL, SITAGLIPTIN PHOSPHATE (JANUVIA), EZETIMIBE (ZETIA), ARIPIPRAZOLE, NIFEDIPINE, ESCITALOPRAM, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), SALBUTAMOL SULFATE (ALBUTEROL SULFATE), TESTOSTERONE and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced RASH PRURITIC (from neck to feet), PRURITUS (it is still itching) and HYPERSENSITIVITY (Allergy/Hypersensitivity). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; AMMONIUM LACTATE at an unspecified dose and frequency and LEVOCETIRIZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (from neck to feet), PRURITUS (it is still itching) and HYPERSENSITIVITY (Allergy/Hypersensitivity) outcome was unknown.            The patient went to several doctors (primary, kidney doctor, dermatologist and allergist) and none could solve the problem. About 3 weeks ago, patient had a biopsy and it returned that he had allergies to a medication. Caregiver said that the only thing that changed was the vaccination.Kidney doctor said to stop almost all the regular medications  Other treatment included Eucerin
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided It was reported that more people got doses from vials with this lot number in another pharmacy of the same chain.   This case was linked to MOD-2021-369020 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination complication
Clinical narrative: AE with limited information; Sore arm; Felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (AE with limited information), PAIN IN EXTREMITY (sore arm) and FATIGUE (felt a little tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-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 VACCINATION COMPLICATION (AE with limited information), PAIN IN EXTREMITY (sore arm) and FATIGUE (felt a little tired). At the time of the report, VACCINATION COMPLICATION (AE with limited information), PAIN IN EXTREMITY (sore arm) and FATIGUE (felt a little tired) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received: Added patient demographics, doses information of suspect product and new events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy, Somnolence
Clinical narrative: I mean out in the bed, can't wake up; Lethargic; Took second one got sick again; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I mean out in the bed, can't wake up), LETHARGY (Lethargic) and ILLNESS (Took second one got sick again) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Was hospitalized for 21 days on ICU but not intubated.) in June 2020. Concurrent medical conditions included Asthma, Prediabetes, Obesity and Blood pressure high. Concomitant products included SERTRALINE for Anxiety, MONTELUKAST, METFORMIN, LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) from 2020 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Took second one got sick again). On an unknown date, the patient experienced SOMNOLENCE (I mean out in the bed, can't wake up) and LETHARGY (Lethargic). At the time of the report, SOMNOLENCE (I mean out in the bed, can't wake up), LETHARGY (Lethargic) and ILLNESS (Took second one got sick again) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-368965, MOD-2021-369059 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December, but it turned out it expired on 27Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2021-369020, MOD-2021-368822 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: has experiences a significant series of side effects after the Moderna booster, she is concern that they have linger for 6 days/ feels better but that it was a rough week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (has experiences a significant series of side effects after the Moderna booster, she is concern that they have linger for 6 days/ feels better but that it was a rough week) 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 25-Oct-2021 at 3:00 PM, the patient 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 received first 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 VACCINATION COMPLICATION (has experiences a significant series of side effects after the Moderna booster, she is concern that they have linger for 6 days/ feels better but that it was a rough week). At the time of the report, VACCINATION COMPLICATION (has experiences a significant series of side effects after the Moderna booster, she is concern that they have linger for 6 days/ feels better but that it was a rough week) was resolving.            No concomitant medications reported. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired booster dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-369020 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I just got sick with the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I just got sick with the first shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (hospitalized for 21days on ICU but not intubated.) in June 2020. Concurrent medical conditions included Asthma, Prediabetes, Obesity, Blood pressure high and Anxiety. Concomitant products included SERTRALINE for Anxiety, MONTELUKAST, METFORMIN, LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION COMPLICATION (I just got sick with the first shot). At the time of the report, VACCINATION COMPLICATION (I just got sick with the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-368965, MOD-2021-369052 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, ATORVASTATIN, METFORMIN, INSULIN GLARGINE (BASAGLAR), EZETIMIBE (ZETIA), TAMSULOSIN, PREGABALIN and PIOGLITAZONE for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-369137 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  It was reported that the vial was initially stored in refrigerator on 20-Apr-2021.The vial didn't undergone any temperature excursions.  HCP mentioned that there were 14 patients instead of 18 because of some duplicates.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Reporter's Details and Narrative were updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Red itchy patches slightly showing up wrist; Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.) and RASH PRURITIC (Red itchy patches slightly showing up wrist) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 003A21A and 030420A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULO-PAPULAR (Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.). On 29-Oct-2021, the patient experienced RASH PRURITIC (Red itchy patches slightly showing up wrist). At the time of the report, RASH MACULO-PAPULAR (Red itchy patches on her arm ,chest and back/The patches are slightly raised, some are the size of a dime, some are bigger, and some are smaller.) and RASH PRURITIC (Red itchy patches slightly showing up wrist) had not resolved.            No concomitant medication reported. No treatment information was provided It was reported that she had been using some cream she had from her dermatologist to stop the itching; it provided temporary relief, but they are starting to itch again. She had not reached to her doctor.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Sore injection site arm; Did not feel good for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm) in a 69-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 COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION COMPLICATION (Did not feel good for a day) had resolved and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-369096 (Patient Link).