chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since the first shot was given; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot was given) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (patient  take medication for high blood pressure).    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot was given). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot was given) 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 treatment  was provided. Concomitant Medication provided was Medication for high blood pressure      Nurse Practitioner called to ask if a dose could be given to a patient after 53 days from the first dose.    More than 35 days since the first shot was given   Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: lost his sense of taste; lost his sense of smell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost his sense of taste) and ANOSMIA (lost his sense of smell) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost his sense of taste) and ANOSMIA (lost his sense of smell). At the time of the report, AGEUSIA (lost his sense of taste) and ANOSMIA (lost his sense of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         No concomitant medication were reported. No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lip disorder
Clinical narrative: She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there; She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21); This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental cleaning ((unable to recall more precise date)) in 2021. Previously administered products included for an unreported indication: FLU in 2020. Concurrent medical conditions included Hashimoto's disease, Penicillin allergy and Allergy to animals. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and SPIRONOLACTONE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-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 LIP DISORDER (She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21)). At the time of the report, LIP DISORDER (She had hard lumps to both lips/ tiny bit of lumps to the top and bottom were still there) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She had the Moderna COVID-19 vaccine (1st dose: 4/21/21 and 2nd dose: 4/30/21)) had resolved.            Treatment information was not provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain in extremity, Paraesthesia
Clinical narrative: arm was sore; left hand (region of pinky and ring finger) has a tingling and numb sensation; left hand (region of pinky and ring finger) has a tingling and numb sensation; lymph nodes swell up and were very large; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PARAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation), HYPOAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) and LYMPHADENOPATHY (lymph nodes swell up and were very large) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm was sore), PARAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation), HYPOAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) and LYMPHADENOPATHY (lymph nodes swell up and were very large). In 2021, PAIN IN EXTREMITY (arm was sore) and LYMPHADENOPATHY (lymph nodes swell up and were very large) had resolved. At the time of the report, PARAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) and HYPOAESTHESIA (left hand (region of pinky and ring finger) has a tingling and numb sensation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was concerned about it and asked if it was Guillen Barre's syndrome. Patient also has concerns about getting second dose. Patient did not take medication to treat symptoms. Patient does not take any concomitant medication.  No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: follow up received on 08-Nov-2021 contain no new information On 08-Nov-2021: follow up received on 08-Nov-2021 contain no new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025A21A) for COVID-19 vaccination. No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.  Concomitant drug information was not reported. Treatment medications were not reported.   This case was linked to MOD-2021-281226 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: chills when had the vaccination/chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills when had the vaccination/chills), PYREXIA (fever) and HEADACHE (headache) 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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, 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 CHILLS (chills when had the vaccination/chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (chills when had the vaccination/chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested for COVID twice during that period and was negative on the blood work..         No concomitant medication were  provided. No treatment medication were  provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Product dose omission issue, Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and the patient has not received the second dose), HYPERSENSITIVITY (allergic reaction), URTICARIA (hives), PRURITUS (itching really bad) and RASH (rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), URTICARIA (hives), PRURITUS (itching really bad) and RASH (rash). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and the patient has not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been more than 36 days since the first dose and the patient has not received the second dose) had resolved and HYPERSENSITIVITY (allergic reaction), URTICARIA (hives), PRURITUS (itching really bad) and RASH (rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information was provided. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: live follow up: missed dose event added.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: feel Sleepy; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feel Sleepy) and HEADACHE (headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 SOMNOLENCE (feel Sleepy) and HEADACHE (headache). At the time of the report, SOMNOLENCE (feel Sleepy) and HEADACHE (headache) had resolved.            No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-280620 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received contained no new information.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: I am feeling very anxious/I have anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (I am feeling very anxious/I have anxiety) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 ANXIETY (I am feeling very anxious/I have anxiety). At the time of the report, ANXIETY (I am feeling very anxious/I have anxiety) 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.  Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose on 24th may 2021, till now have not yet taken 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose on 24th may 2021, till now have not yet taken 2nd 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 24-May-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 (1st dose on 24th may 2021, till now have not yet taken 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose on 24th may 2021, till now have not yet taken 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: trying to get second dose of moderna COVID-19 vaccine/received the first dose on 04Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (trying to get second dose of moderna COVID-19 vaccine/received the first dose on 04Jul2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002539) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 (trying to get second dose of moderna COVID-19 vaccine/received the first dose on 04Jul2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (trying to get second dose of moderna COVID-19 vaccine/received the first dose on 04Jul2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is trying to get second dose of moderna COVID-19 vaccine, but they received the first dose in another country and wants to know if it is okay to give it. since the Lot number 3002539 (expiration date 24Oct2021)  came back as invalid on the Lot look up. Wants to know if the dose is the same in another country  No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Micturition urgency, Urine abnormality
Clinical narrative: Severe urine issues; Severe urgency/Has to go  every couple hours; This spontaneous case was reported by a consumer and describes the occurrence of URINE ABNORMALITY (Severe urine issues) and MICTURITION URGENCY (Severe urgency/Has to go  every couple hours) 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 URINE ABNORMALITY (Severe urine issues) and MICTURITION URGENCY (Severe urgency/Has to go  every couple hours). At the time of the report, URINE ABNORMALITY (Severe urine issues) and MICTURITION URGENCY (Severe urgency/Has to go  every couple hours) outcome was unknown.    Concomitant and treatment medication was not provided.  Patient reported did not have this event with the first dose of vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078621A and 016C214) for COVID-19 vaccination.     No medical history reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain) had not resolved.            Concomitant medication reported as Balance of Nature Vitamins Fruits 3 pills daily & Vegetable tablet .   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up Received - Contain No New Information.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Neck pain
Clinical narrative: stiff neck; pain in neck area and base of the skull; Patient received the second dose more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in neck area and base of the skull) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (She takes Asthma inhalers, takes a tranquilizer very seldom) and GERD. Concomitant products included CLONAZEPAM (KLONOPIN), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), NECK PAIN (pain in neck area and base of the skull) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK, tid and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 16-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) and NECK PAIN (pain in neck area and base of the skull) had not resolved.            Upon internal review on 11-Nov-2021, Age units and date of birth removed   This case was linked to MOD-2021-281261, MOD-2021-281261 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: left arm pit really swollen; Really hurting bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm pit really swollen) and PAIN IN EXTREMITY (Really hurting bad) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PERIPHERAL SWELLING (left arm pit really swollen) and PAIN IN EXTREMITY (Really hurting bad). At the time of the report, PERIPHERAL SWELLING (left arm pit really swollen) and PAIN IN EXTREMITY (Really hurting bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Illness, Pyrexia
Clinical narrative: sick; sweats; Had a temperature; Chills; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ILLNESS (sick), HYPERHIDROSIS (sweats), PYREXIA (Had a temperature) and CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 11-Jan-2021 and the estimated date of delivery was date. On an unknown date, the patient experienced ILLNESS (sick), HYPERHIDROSIS (sweats), PYREXIA (Had a temperature) and CHILLS (Chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), HYPERHIDROSIS (sweats), PYREXIA (Had a temperature) and CHILLS (Chills) had resolved.            Concomitant medication included prenatal vitamin.   This case was linked to MOD-2021-281095 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: having tiny sore arm; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (having tiny sore arm) and FATIGUE (feeling tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZOA) for COVID-19 vaccination.     Concomitant products included L-THYROXINE [LEVOTHYROXINE], NALTREXONE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (having tiny sore arm) and FATIGUE (feeling tired). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (having tiny sore arm) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-281132 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: achy arm/hands began hurting; chills; was tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm/hands began hurting), CHILLS (chills) and FATIGUE (was tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     Concomitant products included TIZANIDINE for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (achy arm/hands began hurting), CHILLS (chills) and FATIGUE (was tired). At the time of the report, PAIN IN EXTREMITY (achy arm/hands began hurting), CHILLS (chills) and FATIGUE (was tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication: OTC allergy medications.  Treatment information was not provided.   This case was linked to MOD-2021-281085 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: has been sick since- waiting on a test result; This case was received via an unknown source (no reference has been entered for a health authority or  partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (has been sick since- waiting on a test result) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (has been sick since- waiting on a test result). At the time of the report, ILLNESS (has been sick since- waiting on a test result) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling tired) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Feeling tired). At the time of the report, FATIGUE (Feeling tired) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-060265 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed second dose schedule; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose schedule) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose schedule). On 25-Apr-2021, PRODUCT DOSE OMISSION ISSUE (missed second dose schedule) 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 are provided by reporter.  It was reported that patient missed his second scheduled dose on 25-Apr-2021 (reason not specified).   Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; being tired; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) and FATIGUE (being tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (being tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and FATIGUE (being tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.   This case was linked to MOD-2021-281445 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Really bad tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Really bad tachycardia) 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 TACHYCARDIA (Really bad tachycardia). At the time of the report, TACHYCARDIA (Really bad tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the nurse practitioner is a female around aged 30-40years  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Followup received contained No New Information (NNI)
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Fatigue, Heart rate
Clinical narrative: No appetitie; Feeling very tired; Fever at 102; Muscle ache; Nnausea; Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetitie), DIARRHOEA (Diarrhea), FATIGUE (Feeling very tired), NAUSEA (Nnausea) and VOMITING (Vomiting) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nnausea) and VOMITING (Vomiting). On 08-Aug-2021, the patient experienced DECREASED APPETITE (No appetitie), FATIGUE (Feeling very tired), PYREXIA (Fever at 102) and MYALGIA (Muscle ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetitie), DIARRHOEA (Diarrhea), NAUSEA (Nnausea), VOMITING (Vomiting), PYREXIA (Fever at 102) and MYALGIA (Muscle ache) was resolving and FATIGUE (Feeling very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Body temperature: 102 (High) On the 2nd day, she had a fever at 102. On 08-Aug-2021, Heart rate: 130 (High) rapid heart rate at 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: No appetitie; Feeling very tired; Fever at 102; Muscle ache; Nnausea; Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetitie), DIARRHOEA (Diarrhea), FATIGUE (Feeling very tired), NAUSEA (Nnausea) and VOMITING (Vomiting) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nnausea) and VOMITING (Vomiting). On 08-Aug-2021, the patient experienced DECREASED APPETITE (No appetitie), FATIGUE (Feeling very tired), PYREXIA (Fever at 102) and MYALGIA (Muscle ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (No appetitie), DIARRHOEA (Diarrhea), NAUSEA (Nnausea), VOMITING (Vomiting), PYREXIA (Fever at 102) and MYALGIA (Muscle ache) was resolving and FATIGUE (Feeling very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Body temperature: 102 (High) On the 2nd day, she had a fever at 102. On 08-Aug-2021, Heart rate: 130 (High) rapid heart rate at 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid on 8/5/21; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid on 8/5/21) 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 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced COVID-19 (tested positive for covid on 8/5/21). At the time of the report, COVID-19 (tested positive for covid on 8/5/21) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: Uncomfortable palpitations; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Uncomfortable palpitations) and DIZZINESS (Lightheadedness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Uncomfortable palpitations) and DIZZINESS (Lightheadedness). At the time of the report, PALPITATIONS (Uncomfortable palpitations) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given one week from the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given one week from the 1st dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 31-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given one week from the 1st dose). On 31-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given one week from the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm is really sore from the shot / It's just sore from where they put the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm is really sore from the shot / It's just sore from where they put the shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (My arm is really sore from the shot / It's just sore from where they put the shot). At the time of the report, VACCINATION SITE PAIN (My arm is really sore from the shot / It's just sore from where they put the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: At the site of injection, there is a rash 4 to 5 days later/noticed a rash yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (At the site of injection, there is a rash 4 to 5 days later/noticed a rash yesterday) 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 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE RASH (At the site of injection, there is a rash 4 to 5 days later/noticed a rash yesterday). At the time of the report, VACCINATION SITE RASH (At the site of injection, there is a rash 4 to 5 days later/noticed a rash yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Vaccination site reaction
Clinical narrative: Different and lesser side effects after second dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Different and lesser side effects after second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 REACTION (Different and lesser side effects after second dose). At the time of the report, VACCINATION SITE REACTION (Different and lesser side effects after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Antibody test: 35 (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-281076 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to the patient 48 hours after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient 48 hours after the vial was punctured) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient 48 hours after the vial was punctured). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient 48 hours after the vial was punctured) 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 medication information was reported.   No treatment medications were provided.   One vial was affected. The vial did not under go any temperature excursions. As the practice at the pharmacy is to remove a dose from the refrigerator to administer the Moderna COVID-19 vaccine the vial never reached room temperature.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up information received  contains no new significant information.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tonsillar hypertrophy
Clinical narrative: Swollen tonsils; Clogged ears (both left and right); This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (Swollen tonsils) and EAR DISCOMFORT (Clogged ears (both left and right)) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa containing drugs), Allergic to cats, Pollen allergy and Allergic to dogs.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced TONSILLAR HYPERTROPHY (Swollen tonsils) and EAR DISCOMFORT (Clogged ears (both left and right)). At the time of the report, TONSILLAR HYPERTROPHY (Swollen tonsils) and EAR DISCOMFORT (Clogged ears (both left and right)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Outcome of the events updated from unknown to not recovered.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: leaked and only a partial dose was given; backsplash or leakage of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (leaked and only a partial dose was given) and DEVICE CONNECTION ISSUE (backsplash or leakage of the vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced UNDERDOSE (leaked and only a partial dose was given) and DEVICE CONNECTION ISSUE (backsplash or leakage of the vaccine). On 06-Aug-2021, UNDERDOSE (leaked and only a partial dose was given) and DEVICE CONNECTION ISSUE (backsplash or leakage of the 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.   Concomitant product information was not reported. Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Impaired work ability, Memory impairment, Myalgia
Clinical narrative: can't focus; can't remember things; can't work; not had a menstrual cycle in two weeks which they say is not normal; feels like crap; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal) and MYALGIA (feels like crap) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal), MYALGIA (feels like crap) and FATIGUE (extremely fatigued). At the time of the report, DISTURBANCE IN ATTENTION (can't focus), MEMORY IMPAIRMENT (can't remember things), IMPAIRED WORK ABILITY (can't work), POLYMENORRHOEA (not had a menstrual cycle in two weeks which they say is not normal), MYALGIA (feels like crap) and FATIGUE (extremely fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.  No treatment medication were provided by the reporter.