chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: GOT SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Respiratory tract congestion
Clinical narrative: CHEST CONGESTION; SORE THROAT; BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced chest congestion, sore throat, body aches, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest congestion, sore throat, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: BROKE OUT IN HIVES; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced broke out in hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out in hives was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Haemoptysis, Headache, Laboratory test
Clinical narrative: COUGHING UP BLOOD; DOWN FOR WEEKS; TERRIBLE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the patient experienced coughing up blood, down for weeks, and terrible headache. Laboratory data included: Laboratory test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coughing up blood, terrible headache and down for weeks was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heart rate
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of AMENORRHOEA (Since the 1st dose my period is missing) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. On 02-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (Since the 1st dose my period is missing). At the time of the report, AMENORRHOEA (Since the 1st dose my period is missing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, Heart rate: 95 (Inconclusive) Heart rate is 95bpm. Country of patient/reporter was Unknown and so, it was put as UNKNOWN. Source document states hyperthyroidism /hypothyroidism both (under medical history), so, it was unclear what thyroid disorder patient has. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD-2021-246768 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Non-Significant Follow-up appended.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity, Rash, Swelling face
Clinical narrative: Facial swelling; Facial rash; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling), RASH (Facial rash) and HYPERSENSITIVITY (Allergic reaction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NALTREXONE (VIVITROL) for Alcoholism.    Concurrent medical conditions included Alcoholism.   In April 2021, the patient received dose of NALTREXONE (VIVITROL) (Intramuscular) 380 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SWELLING FACE (Facial swelling), RASH (Facial rash) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, SWELLING FACE (Facial swelling), RASH (Facial rash) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.            Patient was still taking vivitrol 380 mg intramuscularly in gluteal region every four weeks.  Concomitant drugs were not reported. Treatment details were not given.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 13-Oct-2021 and placed in refrigerator on 29-Oct-2021 (expired vaccine placed in refrigerator); Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was expired on 13-Oct-2021 and placed in refrigerator on 29-Oct-2021 (expired vaccine placed in refrigerator)) and EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 13-Oct-2021 and placed in refrigerator on 29-Oct-2021 (expired vaccine placed in refrigerator)). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was expired on 13-Oct-2021 and placed in refrigerator on 29-Oct-2021 (expired vaccine placed in refrigerator)) and EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test
Clinical narrative: Dose was administered two days after their expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered two days after their expiration date) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2022. Concurrent medical conditions included Allergy to antibiotic (Levaquin allergy).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered two days after their expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered two days after their expiration date) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter had been informed that the patient received Moderna vaccine dose several days after their expiration date. The booster Moderna dose was administered 2 days after expiration date.  The Expiration date was 22-Sep-2021 and the booster dose was administered on 24-Sep-2021.  The vaccine arrived on 30-Aug-2021 and was placed in refrigerator and the doses were administered on day 25 after receipt and refrigeration.  No other events were reported by the patient.  No treatment information was provided.   This case was linked to MOD-2022-508128 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Significant follow-up was received: Updated the reporter details and added patient details. Added allergic condition and historical conditions in the patient's medical history and lab test was added. Dose 1 and dose 2 details of the suspect drug was also added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Moderna Vaccine received after patient received a different COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine received after patient received a different COVID-19 vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: AstraZeneca on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with AstraZeneca.   On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine received after patient received a different COVID-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Vaccine received after patient received a different COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient had no adverse reactions to the vaccine. The Moderna Covid-19 vaccines were administered greater than 35 days apart.  Treatment information was not provided.   This case was linked to MOD-2022-507075 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Insomnia, Irritability, Tinnitus
Clinical narrative: Tinnitus/Caller describes this side effect as grasshopper sound, its likes hearing bugs at night / that they experience tinnitus mostly at night./She says sometimes it is low and sometimes higher; It has interrupted the normal sleeping cycle; Says it's very annoying; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus/Caller describes this side effect as grasshopper sound, its likes hearing bugs at night / that they experience tinnitus mostly at night./She says sometimes it is low and sometimes higher), INSOMNIA (It has interrupted the normal sleeping cycle) and IRRITABILITY (Says it's very annoying) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (heart problems).    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus/Caller describes this side effect as grasshopper sound, its likes hearing bugs at night / that they experience tinnitus mostly at night./She says sometimes it is low and sometimes higher), INSOMNIA (It has interrupted the normal sleeping cycle) and IRRITABILITY (Says it's very annoying). At the time of the report, TINNITUS (Tinnitus/Caller describes this side effect as grasshopper sound, its likes hearing bugs at night / that they experience tinnitus mostly at night./She says sometimes it is low and sometimes higher), INSOMNIA (It has interrupted the normal sleeping cycle) and IRRITABILITY (Says it's very annoying) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: tinnitus tinnitus.         No concomitant medications was provided. No allergy was reported. No prior covid-19 diagnosis. The patient had side effect as grasshopper sound, its likes hearing bugs at night. The caller states that they experience tinnitus mostly at night. It has interrupted the normal sleeping cycle. She says it's very annoying. She says sometimes it was low and sometimes higher. It's usually ok during the day. No treatment medications was provided.   This case was linked to MOD-2022-507293, MOD-2022-507713, MOD-2022-507717 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 026A21A and 041J21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder (heart problems).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. It was reported that patient did not had any allergies or prior COVID-19 diagnosis.   This case was linked to MOD-2022-507166, MOD-2022-507717, MOD-2022-507713, MOD-2022-507719 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose) 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.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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 .25 milliliter. On 28-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocomprised patient received 0.25mL as 3rd dose instead of a 0.5mL full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: side effect as grasshopper sound, it's likes hearing bugs at night; interrupted the normal sleeping cycle; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 026A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory disorder (have upper respiratory illness in the past).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle). At the time of the report, TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle) outcome was unknown.      Concomitant drugs were not reported.  It was reported that, following the booster shot first husband and later herself developed tinnitus. Caller described this side effect as grasshopper sound, it was likes hearing bugs at night. The caller stated that they experience tinnitus mostly at night. It had interrupted the normal sleeping cycle. She said it was very annoying. She said sometimes it was low and sometimes higher. It was usually ok during the day. Caller was yet to visit primary care doctor.   It was reported that patient did not have any allergies or prior COVID-19 diagnosis  Treatment medications were not provided.   This case was linked to MOD-2022-507719, MOD-2022-507166, MOD-2022-507293, MOD-2022-507717, MOD-2022-507720 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: side effect as grasshopper sound, it's likes hearing bugs at night; interrupted the normal sleeping cycle; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 026A21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory disorder (have upper respiratory illness in the past).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle). At the time of the report, TINNITUS (side effect as grasshopper sound, it's likes hearing bugs at night) and SLEEP DISORDER (interrupted the normal sleeping cycle) outcome was unknown.      Concomitant drugs were not reported.  It was reported that, following the booster shot first husband and later herself developed tinnitus. Caller described this side effect as grasshopper sound, it was likes hearing bugs at night. The caller stated that they experience tinnitus mostly at night. It had interrupted the normal sleeping cycle. She said it was very annoying. She said sometimes it was low and sometimes higher. It was usually ok during the day. Caller was yet to visit primary care doctor.   It was reported that patient did not have any allergies or prior COVID-19 diagnosis  Treatment medications were not provided.   This case was linked to MOD-2022-507719, MOD-2022-507166, MOD-2022-507293, MOD-2022-507717, MOD-2022-507720 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory disorder (Patient had upper respiratory illness in the past).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) outcome was unknown.            No concomitant medications were reported. Patient stated that she had no pre-existing conditions, no allergy and no prior COVID-19 diagnosis. No treatment medications were reported.   This case was linked to MOD-2022-507713, MOD-2022-507720, MOD-2022-507717, MOD-2022-507293, MOD-2022-507166 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Upper respiratory disorder (Patient had upper respiratory illness in the past).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) outcome was unknown.            No concomitant medications were reported. Patient stated that she had no pre-existing conditions, no allergy and no prior COVID-19 diagnosis. No treatment medications were reported.   This case was linked to MOD-2022-507713, MOD-2022-507720, MOD-2022-507717, MOD-2022-507293, MOD-2022-507166 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified (Heart problems).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2022-507293, MOD-2022-507166, MOD-2022-507720, MOD-2022-507719, MOD-2022-507713 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster Moderna dose administered two days after expiration date.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster Moderna dose administered two days after expiration date.) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A092621) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021 at 4:59 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021 at 4:59 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster Moderna dose administered two days after expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster Moderna dose administered two days after expiration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested positive for COVID-19. No concomitant medications were reported.  Treatment information was not provided. The vaccine was placed in the refrigerator on 30-Aug-2021. No known adverse effects were reported.  The dose of the booster dose was reported as 0.5.   This case was linked to MOD-2022-508128 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Flu vaccination: Flu Shot on 01-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu Shot. Concurrent medical conditions included Hay fever and Allergic asthma.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced SWELLING (The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning). At the time of the report, SWELLING (The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning) had not resolved.            No concomitant medications were reported.  Patient reported that she saw her doctor and they felt she was just having a reaction after the booster, however, she conveyed that she didn't tell doctor it's been 3 1/2 months. Date administered was reported as 02-Dec-2021. AE outcome was reported as the swelling got a little bigger. It was reported that symptoms worsened.  No treatment medications were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given a dose from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given a dose from an expired vial) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 12:04 PM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given a dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given a dose from an expired vial) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: it had only been 21 days and not 28 days since the first dose, Patient ended up receiving the second dose on 26Feb2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it had only been 21 days and not 28 days since the first dose, Patient ended up receiving the second dose on 26Feb2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it had only been 21 days and not 28 days since the first dose, Patient ended up receiving the second dose on 26Feb2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it had only been 21 days and not 28 days since the first dose, Patient ended up receiving the second dose on 26Feb2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient has received first dose on 05Feb2022 and was due 28 days later on 05Mar2022 but the patient confused the time frame for 21 days after and not 28 days. Patient ended up receiving the second dose on 26Feb2022. No concomitant medication were provided No treatment details were provided   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: No new information received
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant when received 1st shot; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when received 1st shot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when received 1st shot). Rreported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. In 2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when received 1st shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. It was reported that a healthy baby was delivered after first shot.   This case was linked to MOD-2022-508349, MOD-2022-508339 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: he also received a full dose as a Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (he also received a full dose as a 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 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 ACCIDENTAL OVERDOSE (he also received a full dose as a Booster dose). At the time of the report, ACCIDENTAL OVERDOSE (he also received a full dose as a Booster dose) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea after booster; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea after booster) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 18-Apr-2021.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced NAUSEA (Nausea after booster). At the time of the report, NAUSEA (Nausea after booster) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2022-508309, MOD-2022-508339 (Patient Link).   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A female patient was administered an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A female patient was administered an expired vaccine.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A female patient was administered an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A female patient was administered an expired vaccine.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient ever had tested COVID positive or diagnosis.   No concomitant medications were reported.  No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022; 7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator January 26 2022 and administered  March 3 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 26 January 2022  the vial was initially stored in the refrigerator. Reported was unaware if vial undergo any temperature excursions. The dosage was reported in the verbatim as Booter .25  No treatment medication information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022; Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster dose ,found out that they were possibly expired due to past the thirty days) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was on 26 Jan 2022 and administered on 03 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was reported that the patient received dose as 0.25. The vial was initially stored in the refrigerator was on 26 Jan 2022 and the reporter was unaware if  the vial undergo any temperature excursions. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator was on 26-Jan-2022. It was reported that patient received Moderna booster dose .25 No Concomitant information was reported. No Treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients received a Moderna vaccine past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients received a Moderna vaccine past the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On January 26 2022 vial was initially stored in the refrigerator No concomitant medication information provided. No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: My left armpits is inching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (My left armpits is inching) 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 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (My left armpits is inching). At the time of the report, PRURITUS (My left armpits is inching) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Follow up contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered the Moderna vaccine about 36 hours after the use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine about 36 hours after the use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine about 36 hours after the use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine about 36 hours after the use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   The reporter was a pharmacist.  Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was on 25-Jan-2022 and the vial did not undergo any temperature excursions. The reporter did not have more information about the patient.  No treatment information was provided by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, SARS-CoV-2 test
Clinical narrative: immunocompromised patient received booster dose instead of third dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of third dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (before second dose. She may had it later on, but not positive. Not sure of exact date.) in May 2021. Concurrent medical conditions included Immunocompromised, Reaction to preservatives (food preservative) and Seasonal allergy (regular seasonal allergies). Concomitant products included DICLOFENAC for Antiinflammatory therapy.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of third dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she may have had COVID19+ later on, but not positive. Not sure of exact date.No treatment information was reported.   This case was linked to MOD-2022-508410 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Emotional disorder, Hypertension, SARS-CoV-2 test
Clinical narrative: After receiving the first dose, I had severe emotional reactions that hadn't occurred before; very high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: EMOTIONAL DISORDER (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "After receiving the first dose, I had severe emotional reactions that hadn't occurred before"; HYPERTENSION (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "very high blood pressure". The events "after receiving the first dose, i had severe emotional reactions that hadn't occurred before" and "very high blood pressure" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of emotional disorder, hypertension.  Additional information: No other vaccine in four weeks and two weeks. No COVID prior vaccination. The patient also had very high blood pressure which was not the case prior to the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.