chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021). On 11-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Updated additional contact information.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 with no associated AEs. However, for the event Inappropriate schedule of product administration of mRNA-1273, causality is not applicable.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, HIV antibody
Clinical narrative: tired and exhausted for three days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired and exhausted for three days) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011J20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Imodium (He didn't take any Imodium after vaccination). Concurrent medical conditions included HIV disease (He might have had HIV back in 70s), BPH, High cholesterol and Dementia. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and OXYBUTYNIN for Benign prostatic hyperplasia, PARACETAMOL (TYLENOL) and IBUPROFEN for Pain.   On 12-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. In February 2021, the patient experienced FATIGUE (tired and exhausted for three days). In February 2021, FATIGUE (tired and exhausted for three days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: negative (Negative) no HIV in his blood. On an unknown date, HIV antibody: positive (Positive) his second test showed HIV antibodies.         Patient's current medications include high cholesterol medications and 11 to 12 other medications. No treatment details were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Patient went to his neurologist and ran a battery of tests such as a heart scan and thorough blood tests to check for things like Lyme disease and HIV. Patient stated that he does not have a fax machine to return the PDF document sent to him and he can't sent it through email.   This case was linked to MOD-2021-262569 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Followup Document has No New Information (NNI)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Decreased appetite
Clinical narrative: Hair is falling off; After the first dose for one day it's appetite wasn't real good; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair is falling off) and DECREASED APPETITE (After the first dose for one day it's appetite wasn't real good) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Schizophrenia and Depression. Concomitant products included TRAZODONE for Depression and Sleep difficult, OLANZAPINE (ZYPREXA) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair is falling off) and DECREASED APPETITE (After the first dose for one day it's appetite wasn't real good). At the time of the report, ALOPECIA (Hair is falling off) and DECREASED APPETITE (After the first dose for one day it's appetite wasn't real good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter said the patient had a lack of oxygen at birth and developed a mild case of schizophrenia. Other concomitant medications included crocrial (needs to have the blood drawn once a month to receive it)takes small doses and schizophrenia medication. No treatment information was provided by reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Delayed reaction at injection site; Arm Pain / the arm is painful; Itchy Arm; Moderate swelling; Red Arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Delayed reaction at injection site), PAIN IN EXTREMITY (Arm Pain / the arm is painful), VACCINATION SITE PRURITUS (Itchy Arm), VACCINATION SITE SWELLING (Moderate swelling) and VACCINATION SITE ERYTHEMA (Red Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Delayed reaction at injection site), PAIN IN EXTREMITY (Arm Pain / the arm is painful), VACCINATION SITE PRURITUS (Itchy Arm), VACCINATION SITE SWELLING (Moderate swelling) and VACCINATION SITE ERYTHEMA (Red Arm). At the time of the report, VACCINATION SITE REACTION (Delayed reaction at injection site), PAIN IN EXTREMITY (Arm Pain / the arm is painful), VACCINATION SITE PRURITUS (Itchy Arm), VACCINATION SITE SWELLING (Moderate swelling) and VACCINATION SITE ERYTHEMA (Red Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin discolouration
Clinical narrative: Multiple red spots on his legs; Colors have faded and turned brown; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Multiple red spots on his legs) and SKIN DISCOLOURATION (Colors have faded and turned brown) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-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 ERYTHEMA (Multiple red spots on his legs) and SKIN DISCOLOURATION (Colors have faded and turned brown). At the time of the report, ERYTHEMA (Multiple red spots on his legs) and SKIN DISCOLOURATION (Colors have faded and turned brown) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided. No concomitant was provided. Patient took second dose and didn't remember the exact date of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received first dose of the Moderna vaccine in mid May and wants to get the second dose today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose of the Moderna vaccine in mid May and wants to get the second dose today) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose of the Moderna vaccine in mid May and wants to get the second dose today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose of the Moderna vaccine in mid May and wants to get the second dose today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: My son took the first dose of Moderna in April.  He was out of the country for 2 months and is just now getting his second dose.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My son took the first dose of Moderna in April.  He was out of the country for 2 months and is just now getting his second 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 15-Jul-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My son took the first dose of Moderna in April.  He was out of the country for 2 months and is just now getting his second dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My son took the first dose of Moderna in April.  He was out of the country for 2 months and is just now getting his second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 1 dose of the Moderna COVID-19 vaccine 24 hours after it was punctured) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis noninfective
Clinical narrative: I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS NONINFECTIVE (I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048AZ1A and 0006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Pepcid), Drug allergy (Sulfa), Drug allergy (Minocycline), Drug allergy (Foxin), Drug allergy (Amatiza), Drug allergy (Macrobid) and Latex allergy. Concomitant products included DENOSUMAB (PROLIA) for Bone density abnormal, MULTIVITAMIN [VITAMINS NOS], BIOTIN, VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 15-Mar-2021, the patient experienced CYSTITIS NONINFECTIVE (I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month). On 17-Apr-2021, CYSTITIS NONINFECTIVE (I had a infalmmation of bladder wall/bladder pressur existed approximately 1 month) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.   This case was linked to MOD-2021-028461 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Ultrasound scan
Clinical narrative: Pain in her leg and worried it could have been a blood clot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her leg and worried it could have been a blood clot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her leg and worried it could have been a blood clot). At the time of the report, PAIN IN EXTREMITY (Pain in her leg and worried it could have been a blood clot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Blood test: normal (normal) normal. On 09-Feb-2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue, Product dose omission issue
Clinical narrative: its been 2 months since my first dose; the county I live in doesn't have any second doses; the county I live in doesn't have any second doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (its been 2 months since my first dose), PRODUCT AVAILABILITY ISSUE (the county I live in doesn't have any second doses) and PRODUCT ADMINISTRATION INTERRUPTED (the county I live in doesn't have any second doses) 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 PRODUCT DOSE OMISSION ISSUE (its been 2 months since my first dose), PRODUCT AVAILABILITY ISSUE (the county I live in doesn't have any second doses) and PRODUCT ADMINISTRATION INTERRUPTED (the county I live in doesn't have any second doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (its been 2 months since my first dose), PRODUCT AVAILABILITY ISSUE (the county I live in doesn't have any second doses) and PRODUCT ADMINISTRATION INTERRUPTED (the county I live in doesn't have any second doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Arm tingling; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Arm tingling) and MYALGIA (Arm soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Arm tingling) and MYALGIA (Arm soreness). At the time of the report, PARAESTHESIA (Arm tingling) and MYALGIA (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not  provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore Arm after shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm after shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 MYALGIA (Sore Arm after shot). At the time of the report, MYALGIA (Sore Arm after shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Moderna Vaccine that is beyond recommended 12 hour period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Vaccine that is beyond recommended 12 hour period) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in thumb since 28-Apr-2021.    On 21-Jul-2021 at 4:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Vaccine that is beyond recommended 12 hour period). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Vaccine that is beyond recommended 12 hour period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Patient was administered with a vial which was opened on 20-JUL-2021 10:46AM. He was realized that he was given expired vaccine after discharged from the clinic. During follow up he was contacted multiple times but no response, messages left on patients voicemail to contact clinic.  No Concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received contains Patient demographic details, Medical History and Vaccine information. On 26-Jul-2021: Follow up received has other patient information linked to this case.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) 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 VACCINATION SITE REACTION (covid arm). At the time of the report, VACCINATION SITE REACTION (covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant products information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products
Clinical narrative: Patient got a covid-19 after first dose of the Pfizer vaccine; Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021) and COVID-19 (Patient got a covid-19 after first dose of the Pfizer vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021). On an unknown date, the patient experienced COVID-19 (Patient got a covid-19 after first dose of the Pfizer vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient got a Pfizer vaccine on April 2021 and a Moderna vaccine on June 2021) had resolved and COVID-19 (Patient got a covid-19 after first dose of the Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient  No Treatment was received by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients  received doses 1 week after expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients  received doses 1 week after expiration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 (Patients  received doses 1 week after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients  received doses 1 week after expiration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experience a lot of something (unknown); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experience a lot of something (unknown)) 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 13-Jul-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 VACCINATION COMPLICATION (experience a lot of something (unknown)). At the time of the report, VACCINATION COMPLICATION (experience a lot of something (unknown)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Serious adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Serious adverse event) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2020, the patient experienced ADVERSE EVENT (Serious adverse event). At the time of the report, ADVERSE EVENT (Serious adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Antibody test, Antinuclear antibody, Tinnitus
Clinical narrative: Ringing in left ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in left ear) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 015A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (ANA abnormal no reason found) since 30-Sep-2019 and Acid reflux (oesophageal) since 2020. Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), ALPHA LIPOIC ACID, VITAMIN B COMPLEX, MAGNESIUM and L-ASCORBIC ACID for an unknown indication.    On 26-Feb-2021 at 12:40 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced TINNITUS (Ringing in left ear). The patient was treated with CURCUMIN for Tinnitus, at a dose of 750 mg; ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, PECTIN, RUTOSIDE (SOLARAY SUPA BIO C) for Tinnitus, at a dose of 250 mg; LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) for Tinnitus, at an unspecified dose and frequency; FLUTICASONE for Tinnitus, at an unspecified dose and frequency and AZELASTINE for Tinnitus, at an unspecified dose and frequency. At the time of the report, TINNITUS (Ringing in left ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Acoustic stimulation tests: abnormal (abnormal) lost hearing (mainly high pitched tones). On 25-Jun-2021, Antibody test: 2.7 (Low) 2.7. On an unknown date, Antinuclear antibody: positive (Positive) Positive.     The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: been 3 months since I had the first dose.  Can I still get the second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (been 3 months since I had the first dose.  Can I still get the second dose?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (been 3 months since I had the first dose.  Can I still get the second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (been 3 months since I had the first dose.  Can I still get the second dose?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment information's was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: non-significant follow-up. no new information provided.; Reporter's Comments: Med Info Agent:  AE submitted with chatbot.  It's been 3 months since I had the first dose.  Can I still get the second dose? Consent for follow up accepted.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 10 weeks since I had the first dose, longer than 28 days since I had my first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (10 weeks since I had the first dose, longer than 28 days since I had my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT DOSE OMISSION ISSUE (10 weeks since I had the first dose, longer than 28 days since I had my first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (10 weeks since I had the first dose, longer than 28 days since I had my first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: caller's daughter received the 1st dose and forgot to schedule the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (caller's daughter received the 1st dose and forgot to schedule the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included ADHD since an unknown date.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller's daughter received the 1st dose and forgot to schedule the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (caller's daughter received the 1st dose and forgot to schedule the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed ringing in theirs ears after the first Moderna shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of TINNITUS (Developed ringing in theirs ears after the first Moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Developed ringing in theirs ears after the first Moderna shot). At the time of the report, TINNITUS (Developed ringing in theirs ears after the first Moderna shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs were not reported concomitant drugs were not reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: stiff arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff arm) and MYALGIA (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol allergy, Caffeine, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Macular degeneration. Concomitant products included VITAMIN B NOS, VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D3), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and SIMVASTATIN (AVASTINEE) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff arm) and MYALGIA (sore arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff arm) and MYALGIA (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not reported.   This case was linked to MOD-2021-262826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Medical history updated. On 22-Jul-2021: Concomitant medication Avastin added.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 1st dose on: 03May2021 and 2nd dose on: 14Jun2021; Patient received Moderna Covid-19 vaccine at age 16; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on: 03May2021 and 2nd dose on: 14Jun2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on: 03May2021 and 2nd dose on: 14Jun2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16). On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on: 03May2021 and 2nd dose on: 14Jun2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at age 16) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.   This case was linked to MOD-2021-101703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site hot/warm; Swollen in a big knot larger than an egg; Swollen in a big knot larger than an egg; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site hot/warm), VACCINATION SITE MASS (Swollen in a big knot larger than an egg) and VACCINATION SITE SWELLING (Swollen in a big knot larger than an egg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site hot/warm), VACCINATION SITE MASS (Swollen in a big knot larger than an egg) and VACCINATION SITE SWELLING (Swollen in a big knot larger than an egg). At the time of the report, VACCINATION SITE WARMTH (Injection site hot/warm), VACCINATION SITE MASS (Swollen in a big knot larger than an egg) and VACCINATION SITE SWELLING (Swollen in a big knot larger than an egg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided. .
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication
Clinical narrative: had a really adverse reaction to my Moderna shot,the blouse and the bra and a white necklace (that was wearing) was so black; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a really adverse reaction to my Moderna shot,the blouse and the bra and a white necklace (that was wearing) was so black) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's disease (Sister disease to lupus) and Kidney failure. Concomitant products included METOPROLOL SUCCINATE (TOPROL XL) for Blood pressure, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Depression, RANITIDINE HYDROCHLORIDE (ZANTAC) for GERD, BISOPROLOL FUMARATE (CONCOR) for High cholesterol, CEFIXIME (FLEXERIL [CEFIXIME]) for Muscle spasms, ROPINIROLE HYDROCHLORIDE (REQUIP) for Restless leg syndrome, ATORVASTATIN CALCIUM (RESTEROL) for Sleep loss, CLARITHROMYCIN (CLAVIX [CLARITHROMYCIN]) for Stroke, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had a really adverse reaction to my Moderna shot,the blouse and the bra and a white necklace (that was wearing) was so black). At the time of the report, VACCINATION COMPLICATION (had a really adverse reaction to my Moderna shot,the blouse and the bra and a white necklace (that was wearing) was so black) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Got COVID 3 days after first dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug details was provided.   This case was linked to MOD-2021-262769 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: She could not get the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She could not get the second dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Amlodipine 10mg, CELECOXIB (CELEXA [CELECOXIB]) and LEVONORGESTREL (MIRENA L) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She could not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She could not get the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: severe Allergic to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (severe Allergic to vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa drug) and Disability.    On 12-Feb-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (severe Allergic to vaccine). At the time of the report, ALLERGY TO VACCINE (severe Allergic to vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information were not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Vaccination site pain
Clinical narrative: Dead arm; Pain at the injection site; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (A little tired) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included OMEPRAZOLE, VITAMIN B12 NOS, VITAMIN D3, PLECANATIDE (TRULANCE), AMLODIPINE and LIDOCAINE for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (A little tired). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jul-2021 at a dose of 500 mg. At the time of the report, HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (A little tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Sea Moss used for unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow- up document received on 27-JUL-2021 Event outcome was updated from unknown to recovered/resolved.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: No energy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jul-2021 and was forwarded to Moderna on 21-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (No energy). At the time of the report, ASTHENIA (No energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab data was not provided. Patient had suffered from temperature for week due to  first dose of COVID-19 vaccine.   This case was linked to MOD-2021-262837 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: foot pain which he described as it feels like he is standing on small pebbles or ball Barings; suffered joint pain in every joint in his body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (foot pain which he described as it feels like he is standing on small pebbles or ball Barings) and ARTHRALGIA (suffered joint pain in every joint in his body) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083B21a and 007B21a) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-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 PAIN IN EXTREMITY (foot pain which he described as it feels like he is standing on small pebbles or ball Barings) and ARTHRALGIA (suffered joint pain in every joint in his body). At the time of the report, PAIN IN EXTREMITY (foot pain which he described as it feels like he is standing on small pebbles or ball Barings) outcome was unknown and ARTHRALGIA (suffered joint pain in every joint in his body) had resolved.            No concomitant medications were reported.  No Treatment medications were reported   This case was linked to MOD-2021-262831 (Patient Link).