chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave patient expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received included no new information. On 08-Aug-2021: Follow up information received contains significant information. Ethnicity and Race information of the patient added. Vaccination facility type updated.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting COVID After the Vaccine) 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 18-Feb-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. In 2021, the patient experienced COVID-19 (Getting COVID After the Vaccine). At the time of the report, COVID-19 (Getting COVID After the Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test (positive-negative): positive (Positive) Positive.         No relevant concomitant medications were reported.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pustular
Clinical narrative: Rash that went up a few spots on left arm; On the right arm rash looked like spider bites. They started as pustules and then opened (became weeping sores); Left ring finger rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rash that went up a few spots on left arm), RASH PUSTULAR (On the right arm rash looked like spider bites. They started as pustules and then opened (became weeping sores)) and RASH (Left ring finger rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced RASH MACULAR (Rash that went up a few spots on left arm), RASH PUSTULAR (On the right arm rash looked like spider bites. They started as pustules and then opened (became weeping sores)) and RASH (Left ring finger rash). At the time of the report, RASH MACULAR (Rash that went up a few spots on left arm), RASH PUSTULAR (On the right arm rash looked like spider bites. They started as pustules and then opened (became weeping sores)) and RASH (Left ring finger rash) 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 medication was reported.   This case was linked to MOD-2021-264351 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vaccination site movement impairment
Clinical narrative: Pain in my fingers is normal, especially the pinky; my armpit is swollen; Its difficult to move my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my fingers is normal, especially the pinky), SWELLING (my armpit is swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Its difficult to move my 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 21-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 PAIN IN EXTREMITY (Pain in my fingers is normal, especially the pinky), SWELLING (my armpit is swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Its difficult to move my arm). At the time of the report, PAIN IN EXTREMITY (Pain in my fingers is normal, especially the pinky), SWELLING (my armpit is swollen) and VACCINATION SITE MOVEMENT IMPAIRMENT (Its difficult to move my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Menstruation irregular, Uterine leiomyoma
Clinical narrative: Early Menses; Fibroids that were protruding from her uterus; feeling tired.; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (Early Menses), UTERINE LEIOMYOMA (Fibroids that were protruding from her uterus) and FATIGUE (feeling tired.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 MENSTRUATION IRREGULAR (Early Menses), UTERINE LEIOMYOMA (Fibroids that were protruding from her uterus) and FATIGUE (feeling tired.). At the time of the report, MENSTRUATION IRREGULAR (Early Menses), UTERINE LEIOMYOMA (Fibroids that were protruding from her uterus) and FATIGUE (feeling tired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient will now require surgery.  No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine) 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 COVID-19 (Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine). At the time of the report, COVID-19 (Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Patient tested positive for COVID19.     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.   No concomitant medication were reported. No treatment medication was reported.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: sick; 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 COMPLICATION (sick) 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 COMPLICATION (sick). At the time of the report, VACCINATION COMPLICATION (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Hot flush
Clinical narrative: felt hot chills; dizziness; hard time exhaling; tired; 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 HOT FLUSH (felt hot chills), DIZZINESS (dizziness), DYSPNOEA (hard time exhaling) and FATIGUE (tired) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (felt hot chills), DIZZINESS (dizziness), DYSPNOEA (hard time exhaling) and FATIGUE (tired). At the time of the report, HOT FLUSH (felt hot chills), DIZZINESS (dizziness), DYSPNOEA (hard time exhaling) and FATIGUE (tired) outcome was unknown.            No concomitants were provided by reporter. No treatment details were provided.   This case was linked to MOD-2021-264195 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: Lymph nodes were swollen in left armpit; The lymph nodes are still slight sore and hurting; Had difficulty lifting left arm; Arm was swollen near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Had difficulty lifting left arm), VACCINATION SITE SWELLING (Arm was swollen near the injection site), LYMPHADENOPATHY (Lymph nodes were swollen in left armpit) and LYMPH NODE PAIN (The lymph nodes are still slight sore and hurting) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011P21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Had difficulty lifting left arm) and VACCINATION SITE SWELLING (Arm was swollen near the injection site). On 18-Jul-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes were swollen in left armpit) and LYMPH NODE PAIN (The lymph nodes are still slight sore and hurting). On 18-Jul-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (Had difficulty lifting left arm) and VACCINATION SITE SWELLING (Arm was swollen near the injection site) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph nodes were swollen in left armpit) and LYMPH NODE PAIN (The lymph nodes are still slight sore and hurting) 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.   The patient stated that she had colonoscopy two weeks prior receiving the vaccine and have taken medications prior or after colonoscopy (information not provided).  No concomitant medications were reported.  No treatment medications provided.   This case was linked to MOD-2021-264301 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle discomfort, Muscle fatigue
Clinical narrative: she wakes up with her back muscles exhausted; Her muscles continue to be bad; she wakes up with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MUSCLE DISCOMFORT (Her muscles continue to be bad) and FATIGUE (she wakes up with fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-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 MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MUSCLE DISCOMFORT (Her muscles continue to be bad) and FATIGUE (she wakes up with fatigue). The patient was treated with IBUPROFEN for Adverse reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MUSCLE DISCOMFORT (Her muscles continue to be bad) and FATIGUE (she wakes up with fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications was not provided.   This case was linked to MOD-2021-214683 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I have your vaccine but still caught Covid while wearing a mask, feeling great though; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I have your vaccine but still caught Covid while wearing a mask, feeling great though) 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 COVID-19 (I have your vaccine but still caught Covid while wearing a mask, feeling great though). At the time of the report, COVID-19 (I have your vaccine but still caught Covid while wearing a mask, feeling great though) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was provided. No treatment was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Urticaria
Clinical narrative: She had a bad feeling in receiving the second shot adn so, did not take it; hives all over the body, , waist, shoulders, thighs, feet, check, face; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She had a bad feeling in receiving the second shot adn so, did not take it) and URTICARIA (hives all over the body, , waist, shoulders, thighs, feet, check, face) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Hives. Concomitant products included TRAMADOL for Stenosis, FENOFIBRATE, RIVAROXABAN (XARELTO), LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MAGNESIUM and VITAMIN B COMPLEX for an unknown indication.    On 25-Feb-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 PRODUCT DOSE OMISSION ISSUE (She had a bad feeling in receiving the second shot adn so, did not take it) and URTICARIA (hives all over the body, , waist, shoulders, thighs, feet, check, face). The patient was treated with PREDNISONE for Allergy, at an unspecified dose and frequency; FAMOTIDINE at a dose of 20 milligram; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 10 milligram and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She had a bad feeling in receiving the second shot adn so, did not take it) had resolved and URTICARIA (hives all over the body, waist, shoulders, thighs, feet, check, face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient  used bone joint supplement for arthritis as concomitant medication Treatment medications includes Antihistamines. Patient reported 1st shot Expired date not written on vaccination card.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Dry throat
Clinical narrative: lightheadedness / dizziness; dry mouth; dry throat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness / dizziness), DRY MOUTH (dry mouth) and DRY THROAT (dry throat) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheadedness / dizziness), DRY MOUTH (dry mouth) and DRY THROAT (dry throat). The patient was treated with EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. At the time of the report, DIZZINESS (lightheadedness / dizziness), DRY MOUTH (dry mouth) and DRY THROAT (dry throat) outcome was unknown. Not Provided      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.   No concomitant product information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second dose.; 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 PRODUCT DOSE OMISSION ISSUE (Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second 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 04-Jun-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 (Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received first dose of the Moderna COVID-19 vaccine on 04JUN2021 and by 22JUL2021 had still not received the second dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up was received on 10-AUG-2021 and contain no new information. The outcome was corrected to recovered , causality for (Privacy) and action taken were corrected from the initial version
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Received multiple doses of vaccine; The patient recieved multiple vaccinations with different companies; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Received multiple doses of vaccine) and INTERCHANGE OF VACCINE PRODUCTS (The patient recieved multiple vaccinations with different companies) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and Janssen COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   On 29-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 19-Apr-2021, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to at an unspecified dose. On 28-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient started Janssen COVID-19 VACCINE (unknown route) at an unspecified dose. On 21-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, Janssen COVID-19 VACCINE (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received multiple doses of vaccine) and INTERCHANGE OF VACCINE PRODUCTS (The patient recieved multiple vaccinations with different companies). At the time of the report, EXTRA DOSE ADMINISTERED (Received multiple doses of vaccine) and INTERCHANGE OF VACCINE PRODUCTS (The patient recieved multiple vaccinations with different companies) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient received multiple Moderna, Pfizer, and Janssen Covid-19 vaccines.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Vaccination complication
Clinical narrative: A bad reaction that lasted for about a week; bed ridden; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (A bad reaction that lasted for about a week) and BEDRIDDEN (bed ridden) 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 VACCINATION COMPLICATION (A bad reaction that lasted for about a week) and BEDRIDDEN (bed ridden). At the time of the report, VACCINATION COMPLICATION (A bad reaction that lasted for about a week) and BEDRIDDEN (bed ridden) 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.   No relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Dry throat
Clinical narrative: lightheadedness / dizziness; dry mouth; dry throat; 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 DIZZINESS (lightheadedness / dizziness), DRY MOUTH (dry mouth) and DRY THROAT (dry throat) in an elderly patient of an unknown 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 DIZZINESS (lightheadedness / dizziness), DRY MOUTH (dry mouth) and DRY THROAT (dry throat). The patient was treated with EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. At the time of the report, DIZZINESS (lightheadedness / dizziness), DRY MOUTH (dry mouth) and DRY THROAT (dry throat) outcome was unknown. Not Provided      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.   No concomitant product information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair falling out; 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 ALOPECIA (hair falling out) 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 ALOPECIA (hair falling out). At the time of the report, ALOPECIA (hair falling out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site swelling
Clinical narrative: Swollen arm near injection site; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm near injection site) and MYALGIA (Arm was sore) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm near injection site) and MYALGIA (Arm was sore). On 16-Jul-2021, VACCINATION SITE SWELLING (Swollen arm near injection site) and MYALGIA (Arm was sore) 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 reported by the reporter. No treatment medications were reported by the reporter.   This case was linked to MOD-2021-264236 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: My second Moderna vaccine in May; Minor body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My second Moderna vaccine in May), MYALGIA (Minor body aches) and HEADACHE (headache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My second Moderna vaccine in May), MYALGIA (Minor body aches) and HEADACHE (headache). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My second Moderna vaccine in May) had resolved and MYALGIA (Minor body aches) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-092400 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Gave patient expired dose of vaccine; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) and PRODUCT STORAGE ERROR (Product storage error). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        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.   No concomitant medications were provided. Treatment medications were unknown.  The pharmacist stated that the patient did not express experiencing any side effects.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up was received on 04-aug-2021 and contains significant information. Added patient demographics, updated action taken and event outcome.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: just a little warm face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (just a little warm face) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (just a little warm face). At the time of the report, FEELING HOT (just a little warm face) 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.   This case was linked to MOD-2021-264348 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Revaccinated next day; gave patient expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave patient expired dose of vaccine) and EXTRA DOSE ADMINISTERED (Revaccinated next day) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021 at 4:08 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021 at 3:31 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient expired dose of vaccine). On 23-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (Revaccinated next day). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (gave patient expired dose of vaccine) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Revaccinated next day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information  was not provided by the reporter. Treatment information  was not provided. Patient was revaccinated on 23 Jul 2021   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received contains patient race, ethnicity and patient was revaccinated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave patient expired dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included BUDESONIDE, LISINOPRIL and OMEPRAZOLE for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Gave patient expired dose of vaccine) 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.   Treatment details were not provided.   This case was linked to MOD-2021-276704 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Patient's demographic details and Patient route of administration was added.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Joint injury, Rotator cuff syndrome
Clinical narrative: fell like a ton of bricks; felt off balance; damaged rotary cuff in the right shoulder; damaged AC joint in the right shoulder; This spontaneous case was reported by a nurse and describes the occurrence of FALL (fell like a ton of bricks), BALANCE DISORDER (felt off balance), ROTATOR CUFF SYNDROME (damaged rotary cuff in the right shoulder) and JOINT INJURY (damaged AC joint in the right shoulder) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced FALL (fell like a ton of bricks), BALANCE DISORDER (felt off balance), ROTATOR CUFF SYNDROME (damaged rotary cuff in the right shoulder) and JOINT INJURY (damaged AC joint in the right shoulder). The patient was treated with CORTISONE at an unspecified dose and frequency; GABAPENTIN (NEURONTIN) at an unspecified dose and frequency and TRAMADOL HYDROCHLORIDE (TRAMACET [TRAMADOL HYDROCHLORIDE]) for Discomfort, at an unspecified dose and frequency. At the time of the report, FALL (fell like a ton of bricks), BALANCE DISORDER (felt off balance), ROTATOR CUFF SYNDROME (damaged rotary cuff in the right shoulder) and JOINT INJURY (damaged AC joint in the right shoulder) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.   This case was linked to MOD-2021-033543 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: Mildly numb at sight of injection, feel numb; it was sore; "It's a sharp stinging pain at injection site, stinging in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Mildly numb at sight of injection, feel numb), VACCINATION SITE PAIN (it was sore) and VACCINATION SITE PAIN ("It's a sharp stinging pain at injection site, stinging in arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030B21A) for COVID-19 vaccination.     No Relevant Medical History was provided.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-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 HYPOAESTHESIA (Mildly numb at sight of injection, feel numb), VACCINATION SITE PAIN (it was sore) and VACCINATION SITE PAIN ("It's a sharp stinging pain at injection site, stinging in arm). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Mildly numb at sight of injection, feel numb), VACCINATION SITE PAIN (it was sore) and VACCINATION SITE PAIN ("It's a sharp stinging pain at injection site, stinging in arm) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.   This case was linked to MOD-2021-264317 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (slight body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 1, 2021, patient received the 1st  dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 30, 2021, patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 30, 2021, patient experienced myalgia (slight body aches). At the time of the report, myalgia (slight body aches): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-222958 (patient link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash up right arm and a little on the left arm, jaw line and cheek; was; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash up right arm and a little on the left arm, jaw line and cheek; was) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 031B21A) for COVID-19 vaccination.     No Medical history were provided.  Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash up right arm and a little on the left arm, jaw line and cheek; was). The patient was treated with PREDNISONE for Rash, at a dose of 1 dosage form. At the time of the report, RASH (Rash up right arm and a little on the left arm, jaw line and cheek; was) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-264211 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information received and contains No new information
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received their first dose 4 months ago and have yet to receive their second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received their first dose 4 months ago and have yet to receive their second 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 (Received their first dose 4 months ago and have yet to receive their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received their first dose 4 months ago and have yet to receive their second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site pain
Clinical narrative: arm pain; injection site pain which was worse than the 1st vaccine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (injection site pain which was worse than the 1st vaccine) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (injection site pain which was worse than the 1st vaccine) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (injection site pain which was worse than the 1st vaccine) and HEADACHE (Headache) had resolved.            Concomitant medications was not provided Treatment medications was not provided   This case was linked to MOD-2021-021347 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Muscle spasms, Myalgia, Pain
Clinical narrative: Muscle spasms / back spasm; discomfort; pain has significantly increased; muscle ache; joint pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 23-Dec-2020 to 22-Jan-2021 and Chickenpox. Concurrent medical conditions included Diabetes, Blood pressure high, Obesity, Arthritis and Vitamin D deficiency.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain). The patient was treated with ACETAMINOPHEN for Pain, at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.         The concomitant medication was not reported.   This case was linked to MOD-2021-264514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: follow up received on 23-07-21 with Non-significant information.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Muscle spasms / back spasm; discomfort; pain has significantly increased; muscle ache; joint pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from 23-Dec-2020 to 22-Jan-2021 and Chickenpox. Concurrent medical conditions included Diabetes, Blood pressure high, Obesity, Arthritis and Vitamin D deficiency.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain). The patient was treated with ACETAMINOPHEN for Pain, at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (Muscle spasms / back spasm), DISCOMFORT (discomfort), PAIN (pain has significantly increased), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.         The concomitant medication was not reported.   This case was linked to MOD-2021-264514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: follow up received on 23-07-21 with Non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Somnolence
Clinical narrative: very sleepy; I did had very uncomfortable flu symptoms; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (very sleepy) and INFLUENZA LIKE ILLNESS (I did had very uncomfortable flue symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy) and INFLUENZA LIKE ILLNESS (I did had very uncomfortable flu symptoms). At the time of the report, SOMNOLENCE (very sleepy) and INFLUENZA LIKE ILLNESS (I did had very uncomfortable flue symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient states that she had very uncomfortable flue symptoms that lasted for more than a month and I was very sleepy also. Concomitant product use was unknown by the reporter. Treatment information was not provided.