chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Woke up with a temperature of 99.5; Has a little soreness where the injection was; Feels a little rundown; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Woke up with a temperature of 99.5), VACCINATION SITE PAIN (Has a little soreness where the injection was) and FATIGUE (Feels a little rundown) 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 24-Aug-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 August 2021, the patient experienced VACCINATION SITE PAIN (Has a little soreness where the injection was) and FATIGUE (Feels a little rundown). On 24-Aug-2021, the patient experienced PYREXIA (Woke up with a temperature of 99.5). At the time of the report, PYREXIA (Woke up with a temperature of 99.5), VACCINATION SITE PAIN (Has a little soreness where the injection was) and FATIGUE (Feels a little rundown) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) woke up with a temperature of 99.5.         No concomitant medications were reported. No treatment medications were reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Facial discomfort, Headache, Hypoaesthesia, Paraesthesia, Tinnitus
Clinical narrative: Tinnitus; Parestesia rt side; Facial pressure rt side; Facial Numbness rt side; headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), PARAESTHESIA (Parestesia rt side), FACIAL DISCOMFORT (Facial pressure rt side), HYPOAESTHESIA (Facial Numbness rt side) and HEADACHE (headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2020 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2020 at 3:00 AM, 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 TINNITUS (Tinnitus), PARAESTHESIA (Parestesia rt side), FACIAL DISCOMFORT (Facial pressure rt side), HYPOAESTHESIA (Facial Numbness rt side) and HEADACHE (headache). The patient was treated with PREDNISONE for Adverse event, at a dose of 40 mg and ACETAZOLAMIDE (DIAMOX [ACETAZOLAMIDE]) ongoing since an unknown date for Tinnitus, at a dose of 500 mg. At the time of the report, TINNITUS (Tinnitus) was resolving and PARAESTHESIA (Parestesia rt side), FACIAL DISCOMFORT (Facial pressure rt side), HYPOAESTHESIA (Facial Numbness rt side) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) Normal - MRIs (w/ & w/o contrast). On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter. In order of onset (time of symptom): Tinnitus rt side (7plus mo, continuing), Headaches (3 mo), facial pressure rt side (3 mo), facial numbness rt side (1 week), Parestesia rt side (1 mo).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-SEP-2021: Contains Significant information - Updated Patient demographics, Lab data, Treatment medications and  new events added.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: contracted Covid; first vaccine in January and did not get 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 COVID-19 and PRODUCT DOSE OMISSION ISSUE of first vaccine in January and did not get 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.    In January 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 COVID-19 and PRODUCT DOSE OMISSION ISSUE first vaccine in January and did not get second dose. At the time of the report, COVID-19 outcome was unknown and PRODUCT DOSE OMISSION ISSUE of first vaccine in January and did not get second dose had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter. No treatment medication provided by the reporter.   Reporter did not allow further contact
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Swelling face
Clinical narrative: face swelled up three times since the first dose; he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swelled up three times since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021). On 26-Aug-2021, the patient experienced SWELLING FACE (face swelled up three times since the first dose). On 06-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021) had resolved. At the time of the report, SWELLING FACE (face swelled up three times since the first dose) outcome was unknown.      No Concomitant drugs were reported.  No Treatment information  were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-220883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Reporter contact information upated
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Product dose omission issue, Vertigo
Clinical narrative: If he could get the second shot; Vertigo; Fatigue; Increase in severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FATIGUE (Fatigue), HEADACHE (Increase in severe headaches) and PRODUCT DOSE OMISSION ISSUE (If he could get the second shot) 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 Traumatic brain injury in December 2020. Concomitant products included NAPROXEN SODIUM (ALEVE) and PARACETAMOL (TYLENOL) for Headache.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VERTIGO (Vertigo), FATIGUE (Fatigue) and HEADACHE (Increase in severe headaches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (If he could get the second shot). At the time of the report, VERTIGO (Vertigo) and FATIGUE (Fatigue) outcome was unknown and HEADACHE (Increase in severe headaches) and PRODUCT DOSE OMISSION ISSUE (If he could get the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired dose at 17 hours and 10 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired dose at 17 hours and 10 minutes) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired dose at 17 hours and 10 minutes). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired dose at 17 hours and 10 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by reporter. No treatment medication were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing) 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 VACCINATION COMPLICATION (Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction/Patient has been 4-5 months without working because of the symptoms she has been experiencing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter. No treatment medication provided by the reporter. Patient was performing a test with her neurologist that if that came positive it wouldn't had a cure.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Vaccination site warmth
Clinical narrative: Warm injection site; Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025PZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Hives and Speech disorder (he cannot read the handwriting of the lot #s of his wife or his vaccine card very well but will try his best.).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area). At the time of the report, VACCINATION SITE WARMTH (Warm injection site) and ARTHROPOD BITE (Insect bite is breakout is on right arm, hip by belt buckle, on foot and ankle that are raised area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use reported as none Treatment information was provided as none.   This case was linked to MOD-2021-062491 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: His arm was sore for two days but now it is getting worse like the muscle is very sore; His arm was sore for two days but now it is getting worse like the muscle is very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (His arm was sore for two days but now it is getting worse like the muscle is very sore) and MYALGIA (His arm was sore for two days but now it is getting worse like the muscle is very sore) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (His arm was sore for two days but now it is getting worse like the muscle is very sore) and MYALGIA (His arm was sore for two days but now it is getting worse like the muscle is very sore). At the time of the report, VACCINATION SITE PAIN (His arm was sore for two days but now it is getting worse like the muscle is very sore) and MYALGIA (His arm was sore for two days but now it is getting worse like the muscle is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reports that after  first dose his arm was sore for two days but it got worse as the muscle was very sore.  No concomitant products were reported. No treatment information was reported by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Product dose omission issue, Vaccination complication
Clinical narrative: She did get a little nauseated; she had a reaction; She tried to receive the second dose today, but the pharmacy turned her away; A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she had a reaction), NAUSEA (She did get a little nauseated), LYMPHADENOPATHY (A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks) and PRODUCT DOSE OMISSION ISSUE (She tried to receive the second dose today, but the pharmacy turned her away) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced LYMPHADENOPATHY (A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks). On 27-Aug-2021, the patient experienced VACCINATION COMPLICATION (she had a reaction) and PRODUCT DOSE OMISSION ISSUE (She tried to receive the second dose today, but the pharmacy turned her away). On an unknown date, the patient experienced NAUSEA (She did get a little nauseated). In February 2021, LYMPHADENOPATHY (A week after the first dose, swollen lymph node under my armpit/lymph node stayed about 3 weeks) had resolved. On 27-Aug-2021, PRODUCT DOSE OMISSION ISSUE (She tried to receive the second dose today, but the pharmacy turned her away) had resolved. At the time of the report, VACCINATION COMPLICATION (she had a reaction) and NAUSEA (She did get a little nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Off label use, Pruritus, Vaccination complication
Clinical narrative: pharmacist at a Medical Center that she utilizes refused to give her another Moderna; shingles; itching from the shingles; bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), PRURITUS (itching from the shingles), VACCINATION COMPLICATION (bad reaction) and OFF LABEL USE (pharmacist at a Medical Center that she utilizes refused to give her another Moderna) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol and Chickenpox (in childhood). Previously administered products included for an unreported indication: SHINGRIX in 2017. Concurrent medical conditions included Leukaemia in 1990 and Blood pressure high. Concomitant products included ACYCLOVIR [ACICLOVIR] for Shingles, ACETYLSALICYLIC ACID (ASPIRINE) and RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced HERPES ZOSTER (shingles), PRURITUS (itching from the shingles) and VACCINATION COMPLICATION (bad reaction). On an unknown date, the patient experienced OFF LABEL USE (pharmacist at a Medical Center that she utilizes refused to give her another Moderna). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 1 dosage form. In March 2021, HERPES ZOSTER (shingles) had resolved. At the time of the report, PRURITUS (itching from the shingles) had not resolved, VACCINATION COMPLICATION (bad reaction) outcome was unknown and OFF LABEL USE (pharmacist at a Medical Center that she utilizes refused to give her another Moderna) 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.   Hematologist believed that the medication Jakafi made her prone to developing shingles, and not the Moderna vaccine. Patient received the J&J (Jansen) vaccination on 03 Mar 2021, intramuscular injection into the right arm., She stated  that took unknown blood pressure medications and unknown cholesterol medication daily.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion, Oropharyngeal discomfort, Product dose omission issue
Clinical narrative: Throat issues; I am having congestion and allergies after receiving the vaccine.; I am having congestion and allergies after receiving the vaccine; Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Throat issues), NASAL CONGESTION (I am having congestion and allergies after receiving the vaccine.), HYPERSENSITIVITY (I am having congestion and allergies after receiving the vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (history of allergies for too many things including medals and antibiotics.), Allergic reaction to antibiotics and Allergy (Medals).    On 29-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 OROPHARYNGEAL DISCOMFORT (Throat issues), NASAL CONGESTION (I am having congestion and allergies after receiving the vaccine.), HYPERSENSITIVITY (I am having congestion and allergies after receiving the vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.). At the time of the report, OROPHARYNGEAL DISCOMFORT (Throat issues) and NASAL CONGESTION (I am having congestion and allergies after receiving the vaccine.) had not resolved, HYPERSENSITIVITY (I am having congestion and allergies after receiving the vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient does not plan on getting the second dose of the Moderna COVID-19 vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient reported adverse event kyriad ever since he received the maternal COVID-19 vaccine   The patient have allergies too many things including medals and antibiotics. Throat issues previously treated with steroids.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Received 3rd dose yesterday morning and have most of reported side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Received 3rd dose yesterday morning and have most of reported side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Received 3rd dose yesterday morning and have most of reported side effects). At the time of the report, VACCINATION COMPLICATION (Received 3rd dose yesterday morning and have most of reported side effects) outcome was unknown.            No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: second dose received 24 days after first dose/second dose on 27Aug21 and first dose on 03Aug21; Hot to the  touch at injection site; Feels hard as a rock; pain in the injection site on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the  touch at injection site), VACCINATION SITE INDURATION (Feels hard as a rock), VACCINATION SITE PAIN (pain in the injection site on left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received 24 days after first dose/second dose on 27Aug21 and first dose on 03Aug21) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004f21a) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, MAGNESIUM, ZINC, LOSARTAN, OMEPRAZOLE, SIMVASTATIN and LEVOTHYROXINE for an unknown indication.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the  touch at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received 24 days after first dose/second dose on 27Aug21 and first dose on 03Aug21). 27-Aug-2021, the patient experienced VACCINATION SITE INDURATION (Feels hard as a rock) and VACCINATION SITE PAIN (pain in the injection site on left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to the  touch at injection site), VACCINATION SITE INDURATION (Feels hard as a rock) and VACCINATION SITE PAIN (pain in the injection site on left arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose received 24 days after first dose/second dose on 27Aug21 and first dose on 03Aug21) had resolved.            Patient also took calcium v12 as concomitant medications and only put a hot compress in their  arm to treat those events.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Follow up received contains Added new event. On 02-Sep-2021: Follow up received contains no new information
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose from a vial with more than 12 hours of punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial with more than 12 hours of punctured) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) 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 EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial with more than 12 hours of punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial with more than 12 hours of punctured) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a dose of Moderna vaccine from a vial that had been punctured the previous day; 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 (Administered a dose of Moderna vaccine from a vial that had been punctured the previous day) 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 EXPIRED PRODUCT ADMINISTERED (Administered a dose of Moderna vaccine from a vial that had been punctured the previous day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of Moderna vaccine from a vial that had been punctured the previous day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  The reporter was an immunization coordinator at the facility.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Two months since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Two months since 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 01-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 PRODUCT DOSE OMISSION ISSUE (Two months since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Two months since first dose) had resolved.            The concomitant medications were not reported. The treatment information was not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Sweating; Pain at the injection site left arm; Mild fever; Tiredness; I have a severe throbbing headache that has lasted for 10 days,; I received my booster dose on 20AUG2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever), FATIGUE (Tiredness) and HEADACHE (I have a severe throbbing headache that has lasted for 10 days,) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever), FATIGUE (Tiredness) and HEADACHE (I have a severe throbbing headache that has lasted for 10 days,). 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster dose on 20AUG2021). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster dose on 20AUG2021) had resolved. On 30-Aug-2021, HEADACHE (I have a severe throbbing headache that has lasted for 10 days,) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.   This case was linked to MOD-2021-302375, MOD-2021-028030.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sweating; Pain at the injection site left arm; Mild fever; Tiredness; I have a severe throbbing headache that has lasted for 10 days,; I received my booster dose on 20AUG2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever), FATIGUE (Tiredness) and HEADACHE (I have a severe throbbing headache that has lasted for 10 days,) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 048A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever), FATIGUE (Tiredness) and HEADACHE (I have a severe throbbing headache that has lasted for 10 days,). 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster dose on 20AUG2021). On 20-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my booster dose on 20AUG2021) had resolved. On 30-Aug-2021, HEADACHE (I have a severe throbbing headache that has lasted for 10 days,) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Pain at the injection site left arm), PYREXIA (Mild fever) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.   This case was linked to MOD-2021-302375, MOD-2021-028030.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concurrent medical conditions included Immunocompromised. Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.    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 (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was using a biological medication at the time when she was getting the third dose of vaccination. Treatment information was not provided.   This case was linked to MOD-2021-303370, MOD-2021-301320 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: very bad headache; stomach bothered them/ached everywhere; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach bothered them/ached everywhere) and HEADACHE (very bad headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A10A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included FISH OIL, ACETYLSALICYLIC ACID and LISINOPRIL for an unknown indication.   On 16-Mar-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. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach bothered them/ached everywhere). On 16-Mar-2021 at 5:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Mar-2021, ABDOMINAL PAIN UPPER (stomach bothered them/ached everywhere) and HEADACHE (very bad headache) had resolved.            The patient's concomitant medications included vitamins.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received 1mL dose instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 milliliter. On 01-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL). At the time of the report, ACCIDENTAL OVERDOSE (Patient received 1mL dose instead of 0.5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Nurse manager states we had an issue during our administration this morning. Three employees received a double dose of the Moderna vaccine. They received 1 whole mL instead of 0.5mL. Caller states we reached out to the them and only able to get a hold of one of them. Still trying to contact the other two.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose given to a 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to a 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027AZI A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose given to a 15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information was provided. No concomitant medication information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Off label use
Clinical narrative: Exhausting 24 hours; Off label use; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Exhausting 24 hours) and OFF LABEL USE (Off label use) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history information was provided.  Concomitant products included GABAPENTIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced FATIGUE (Exhausting 24 hours) and OFF LABEL USE (Off label use). On 31-Aug-2021, OFF LABEL USE (Off label use) had resolved. On 01-Sep-2021, FATIGUE (Exhausting 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications also include steroids injections in the knee due to plane crash injuries in 2016.  No treatment medications were provided.   This case was linked to MOD-2021-312037 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received contains additional, patient demographics was added, event fatigue was added, event outcome and updated narrative accordingly.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine may have been administered after expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine may have been administered after expiration date) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine may have been administered after expiration date). On 19-Feb-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine may have been administered after expiration date) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose; pain in my left foot, pain in fingers; Sore throat every morning; Fatigue; Both knees ache really bad; Aching, soreness in right foot; Sore arm of injection; extreme fatigue; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (extreme fatigue) and MYALGIA (Myalgia) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee injury (Patient injured her right knee 15 years ago.). Concurrent medical conditions included Food allergy.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021 at 7:00 AM, the patient experienced FATIGUE (extreme fatigue) and MYALGIA (Myalgia). On an unknown date, the patient experienced PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (Fatigue), ARTHRALGIA (Both knees ache really bad), MYALGIA (Aching, soreness in right foot) and VACCINATION SITE PAIN (Sore arm of injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (Fatigue), ARTHRALGIA (Both knees ache really bad), MYALGIA (Aching, soreness in right foot) and VACCINATION SITE PAIN (Sore arm of injection) outcome was unknown and FATIGUE (extreme fatigue) and MYALGIA (Myalgia) had not resolved.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-304918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up document received on 09-Sep-2021, events and facility information were reported - significant
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose; pain in my left foot, pain in fingers; Sore throat every morning; Fatigue; Both knees ache really bad; Aching, soreness in right foot; Sore arm of injection; extreme fatigue; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (extreme fatigue) and MYALGIA (Myalgia) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee injury (Patient injured her right knee 15 years ago.). Concurrent medical conditions included Food allergy.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021 at 7:00 AM, the patient experienced FATIGUE (extreme fatigue) and MYALGIA (Myalgia). On an unknown date, the patient experienced PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (Fatigue), ARTHRALGIA (Both knees ache really bad), MYALGIA (Aching, soreness in right foot) and VACCINATION SITE PAIN (Sore arm of injection). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, PAIN (Achiness all over her body / More pain allover her body with the 2nd dose compared to the 1st dose), PAIN IN EXTREMITY (pain in my left foot, pain in fingers), OROPHARYNGEAL PAIN (Sore throat every morning), FATIGUE (Fatigue), ARTHRALGIA (Both knees ache really bad), MYALGIA (Aching, soreness in right foot) and VACCINATION SITE PAIN (Sore arm of injection) outcome was unknown and FATIGUE (extreme fatigue) and MYALGIA (Myalgia) had not resolved.            No relevant concomitant medications were reported.   This case was linked to MOD-2021-304918 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up document received on 09-Sep-2021, events and facility information were reported - significant
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Tongue blistering
Clinical narrative: feel better but now have blisters on my tongue.; received the vaccine on Saturday afternoon, had severe headaches and 101 fever; Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE BLISTERING (feel better but now have blisters on my tongue.), HEADACHE (received the vaccine on Saturday afternoon, had severe headaches and 101 fever) and PYREXIA (Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.) 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 TONGUE BLISTERING (feel better but now have blisters on my tongue.), HEADACHE (received the vaccine on Saturday afternoon, had severe headaches and 101 fever) and PYREXIA (Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.). At the time of the report, TONGUE BLISTERING (feel better but now have blisters on my tongue.) outcome was unknown and HEADACHE (received the vaccine on Saturday afternoon, had severe headaches and 101 fever) and PYREXIA (Received the vaccine on Saturday afternoon, had severe headaches and 101 fever.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported.  The treatment history was not provided.