chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine to patients from a batch that was stored on April 13th and that should have been discarded on May 13th) 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 and treatment information not provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-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 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication were not reported. Treatment information were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Tired; Sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and MYALGIA (Sore) 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 FATIGUE (Tired) and MYALGIA (Sore). At the time of the report, FATIGUE (Tired) and MYALGIA (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Platelet count, Vaccination complication, White blood cell count
Clinical narrative: Developed side effects and symptoms after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Developed side effects and symptoms after second dose) 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 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION COMPLICATION (Developed side effects and symptoms after second dose). At the time of the report, VACCINATION COMPLICATION (Developed side effects and symptoms after second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: decreased (Low) Decreased. On an unknown date, Platelet count: decreased (Low) Off. On an unknown date, White blood cell count: decreased (Low) Decreased.         No concomitant medications were reported.   Treatment information was not provided. On 12 Apr 2021, the patient reported she  had developed side effects and symptoms and has been going to several doctors which have been unable to diagnose what is wrong. Patient reports her hemoglobin was low, platelets were off, low white blood cell count which  has to do with the blood.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Malaise, Vaccination complication
Clinical narrative: HAVING A REACTION TO COVID VACCINE; NOT FEELING WELL; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (NOT FEELING WELL) and VACCINATION COMPLICATION (HAVING A REACTION TO COVID VACCINE) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB for Crohn's disease.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (Intramuscular) at an unspecified dose. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (NOT FEELING WELL). On an unknown date, the patient experienced VACCINATION COMPLICATION (HAVING A REACTION TO COVID VACCINE). At the time of the report, MALAISE (NOT FEELING WELL) and VACCINATION COMPLICATION (HAVING A REACTION TO COVID VACCINE) had not 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 was provided by the reporter.  No treatment medications was provided by the reporter This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of MALAISE (NOT FEELING WELL) and VACCINATION COMPLICATION (HAVING A REACTION TO COVID VACCINE) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB for Crohn's disease.    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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (Intramuscular) at an unspecified dose. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (NOT FEELING WELL). On an unknown date, the patient experienced VACCINATION COMPLICATION (HAVING A REACTION TO COVID VACCINE). At the time of the report, MALAISE (NOT FEELING WELL) and VACCINATION COMPLICATION (HAVING A REACTION TO COVID VACCINE) had not 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 was provided by the reporter.  No treatment medications was provided by the reporter
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). 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, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported after 1st dose vaccination    This case was linked to MOD-2021-044883 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: This spontaneous case was reported by a consumer, describes the occurrence of dizziness (dizzy after second shot) and asthenia (can't do anything after second shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 10, 2021, patient experienced dizziness (dizzy after second shot) and asthenia (can't do anything after second shot). At the time of the report, dizziness (dizzy after second shot) and asthenia (can't do anything after second shot) outcome: unknown. No concomitant medication or treatment information provided.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: soreness on the vaccination site; first dose of the Moderna Covid-19 Vaccine administered to a 14 year old patient; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the vaccination site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of the Moderna Covid-19 Vaccine administered to a 14 year old patient) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness on the vaccination site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of the Moderna Covid-19 Vaccine administered to a 14 year old patient). At the time of the report, VACCINATION SITE PAIN (soreness on the vaccination site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose of the Moderna Covid-19 Vaccine administered to a 14 year old patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Musculoskeletal stiffness, Pain in extremity, X-ray
Clinical narrative: Pain in upper thighs; Groin Pain; One week later upper arms stiffness/ pain in the joints and upper arms; One week later upper arms stiffness/ pain in the joints and upper arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in upper thighs), GROIN PAIN (Groin Pain), MUSCULOSKELETAL STIFFNESS (One week later upper arms stiffness/ pain in the joints and upper arms) and ARTHRALGIA (One week later upper arms stiffness/ pain in the joints and upper arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 045B21A) for COVID-19 vaccination.     No medical history reported by the reporter.    On 31-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in upper thighs), GROIN PAIN (Groin Pain), MUSCULOSKELETAL STIFFNESS (One week later upper arms stiffness/ pain in the joints and upper arms) and ARTHRALGIA (One week later upper arms stiffness/ pain in the joints and upper arms). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in upper thighs), GROIN PAIN (Groin Pain), MUSCULOSKELETAL STIFFNESS (One week later upper arms stiffness/ pain in the joints and upper arms) and ARTHRALGIA (One week later upper arms stiffness/ pain in the joints and upper arms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       weight of the patient reported as 170 Concomitant medication was reported as pROTONICS at a dose of 25 milligram Patient reported that she work full time as an executive and do the treadmill 3to 5 times a week Patient reported that she did not have Arthritis   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received and contains significant information-Patient contact details and patient demographics details added. Concomitant medicine details provided. Treatment information added. New Events added- Groin pain, Mucoskeletal stiffness and Arthralgia. Event outcome updated for the event Pain in extremity from Unknown to Not Recovered/ Resolved. Dose 2  details added.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Hyperventilation
Clinical narrative: Had difficulties breathing; Hyperventilation; Dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had difficulties breathing), HYPERVENTILATION (Hyperventilation) and DRY MOUTH (Dry mouth) 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 DYSPNOEA (Had difficulties breathing), HYPERVENTILATION (Hyperventilation) and DRY MOUTH (Dry mouth). At the time of the report, DYSPNOEA (Had difficulties breathing), HYPERVENTILATION (Hyperventilation) and DRY MOUTH (Dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Herpes zoster, Muscle twitching, Ventricular extrasystoles
Clinical narrative: Developed shingles on the left side of body; Started having PVC's whenever lying down; Nerves on left side & upper left thigh kept twitching; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR EXTRASYSTOLES (Started having PVC's whenever lying down), MUSCLE TWITCHING (Nerves on left side & upper left thigh kept twitching) and HERPES ZOSTER (Developed shingles on the left side of body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Left) and Hysterectomy. Previously administered products included for Breast cancer: Tamoxifen. Past adverse reactions to the above products included Premature ventricular contractions with Tamoxifen. Family history included Autoimmune disorder (Family history.) since an unknown date.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VENTRICULAR EXTRASYSTOLES (Started having PVC's whenever lying down) and MUSCLE TWITCHING (Nerves on left side & upper left thigh kept twitching). On 09-Mar-2021, the patient experienced HERPES ZOSTER (Developed shingles on the left side of body). At the time of the report, VENTRICULAR EXTRASYSTOLES (Started having PVC's whenever lying down) and HERPES ZOSTER (Developed shingles on the left side of body) had resolved and MUSCLE TWITCHING (Nerves on left side & upper left thigh kept twitching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Electrocardiogram ambulatory: 1 pvc (Inconclusive) Experienced 1 PVC during the 24 hour period..         No concomitant medications were not reported. The treatment information was not provided.  Post vaccination on 18-MAR-2021 patient took an Echocardiogram at cardiologist's office. On 23-MAR-2021 cardiologists reported that the events were triggered from neurological factors. The events were recovered after two weeks.   The action taken with mRNA 1273 with the events was considered as not applicable.   This case was linked to MOD-2021-216609 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Asthma. Concomitant products included IRON for an unknown indication.    On 05-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 MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient identifiers obtained; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) in a 30-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 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 EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient identifiers obtained) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Description of Event or Problem: New crosslinked cases: MOD21-109324, MOD21-109532, MOD21-109542, MOD21-109544,MOD21-109546, MOD21-109548, MOD21-109552, MOD21-109553, MOD21-109567
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was sore; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) 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 VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE PAIN (Arm was sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects due to the Moderna injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects due to the Moderna injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects due to the Moderna injection). At the time of the report, VACCINATION COMPLICATION (Side effects due to the Moderna injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information about concomitant medication provided.  No treatment information provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, PROGESTERONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE (CLARITIN [LORATADINE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MAGNESIUM and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: supplied patient identifiers for the patient involved in the adverse event; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (supplied patient identifiers for the patient involved in the adverse event) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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, the patient experienced VACCINATION COMPLICATION (supplied patient identifiers for the patient involved in the adverse event). At the time of the report, VACCINATION COMPLICATION (supplied patient identifiers for the patient involved in the adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that the caller then supplied patient identifiers for the patient involved in the adverse event initially filed by the previous agent. No concomitant medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after allowed time after first vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) 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 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-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 EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after allowed time after first vial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Oropharyngeal pain
Clinical narrative: Sore throat; Flu like symptoms; Sleeping all day; Sweating; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Sleeping all day), HYPERHIDROSIS (Sweating) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy NOS. Concomitant products included IRON for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Sleeping all day), HYPERHIDROSIS (Sweating), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 05-Jun-2021, OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Sleeping all day), HYPERHIDROSIS (Sweating), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) had resolved.            Concurrent medications reported included asthma and allergy medications but stopped since the onset of events. The patient continued to take iron event after the onset of events. The patient experienced events 12 to 18 hours post second dose of vaccine administration and took treatment medications alternatively.   This case was linked to MOD-2021-216667 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Sore throat; Flu like symptoms; Sleeping all day; Sweating; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Sleeping all day), HYPERHIDROSIS (Sweating) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A-1 and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy NOS. Concomitant products included IRON for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Sleeping all day), HYPERHIDROSIS (Sweating), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 05-Jun-2021, OROPHARYNGEAL PAIN (Sore throat), INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Sleeping all day), HYPERHIDROSIS (Sweating), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) had resolved.            Concurrent medications reported included asthma and allergy medications but stopped since the onset of events. The patient continued to take iron event after the onset of events. The patient experienced events 12 to 18 hours post second dose of vaccine administration and took treatment medications alternatively.   This case was linked to MOD-2021-216667 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included multiple sclerosis (relapsing forms of multiple sclerosis). Concomitant products included ocrelizumab for an unknown indication. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had fatigue. At the time of the report, fatigue resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment information provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nasopharyngitis, Pain in extremity
Clinical narrative: Stomach upset; Felt Cold; Headache; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Stomach upset), NASOPHARYNGITIS (Felt Cold) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm hurt). On 14-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), NASOPHARYNGITIS (Felt Cold) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Stomach upset), NASOPHARYNGITIS (Felt Cold) and HEADACHE (Headache) had not resolved.            No concomitant medication reported. No treatment information reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Patient stated that on 14MAR2021 she woke up with stomach upset, head ache, and she felt cold. These symptoms were better on Monday 15MAR2021 however now they are back on 16MAR2021.   This case was linked to MOD-2021-046111, MOD-2021-046111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up information received on 15-JUN-2021 contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Illness, Myalgia, Vaccination complication
Clinical narrative: Have been sick since I got it; That shot came very close to killing me; pain in that lift arm; Still get really tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Have been sick since I got it), VACCINATION COMPLICATION (That shot came very close to killing me), MYALGIA (pain in that lift arm) and FATIGUE (Still get really tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Have been sick since I got it), VACCINATION COMPLICATION (That shot came very close to killing me), MYALGIA (pain in that lift arm) and FATIGUE (Still get really tired). At the time of the report, ILLNESS (Have been sick since I got it), VACCINATION COMPLICATION (That shot came very close to killing me), MYALGIA (pain in that lift arm) and FATIGUE (Still get really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were provided. No treatment details were provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 25-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 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No Treatment medication was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal), CLONAZEPAM (KLONOPIN) for Seizures, CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-217052 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up received on 21-JUN-2021. Consent for FU denied.
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema to flare up; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema to flare up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Eczema.    Concurrent medical conditions included Eczema.   In 2020, the patient started DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. 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 ECZEMA (Eczema to flare up). At the time of the report, ECZEMA (Eczema to flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that he just wanted to report what he thought was a reaction he had after receiving first dose of Covid-19 vaccine. It caused his eczema to flare up and even after administering dupilumab shot it seemed to not be effective at all. He had been taking dupilumab for a little under a year with great success up until he received chicken vaccine. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Product details and event information updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect after the 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect after the 1st vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect after the 1st vaccine). At the time of the report, VACCINATION COMPLICATION (Side effect after the 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction with the Moderna COVID-19 vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Reaction with the Moderna COVID-19 vaccine) 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) (Intramuscular) Unknown. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction with the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction with the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information not provided.  Treatment information not provided.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain very badly; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain very badly) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (pain very badly). At the time of the report, PAIN (pain very badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: extended vaccination schedule; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (extended vaccination schedule) 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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (extended vaccination schedule). At the time of the report, PRODUCT DOSE OMISSION ISSUE (extended vaccination schedule) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C2119) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus, Rash, Vaccination site erythema
Clinical narrative: Itching; Little rash(a few red spots); Pain in my arm; Light headaches; Redness at the injection site; Redness at the injection site the size of a baseball; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a  patient of an unknown age and gender 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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-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 PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Redness at the injection site the size of a baseball) and FATIGUE (Fatigue). At the time of the report, PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Redness at the injection site the size of a baseball) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Itching; Little rash(a few red spots); Pain in my arm; Light headaches; Redness at the injection site; Redness at the injection site the size of a baseball; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a  patient of an unknown age and gender 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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-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 PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Redness at the injection site the size of a baseball) and FATIGUE (Fatigue). At the time of the report, PRURITUS (Itching), RASH (Little rash(a few red spots)), VACCINATION SITE PAIN (Pain in my arm), HEADACHE (Light headaches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Redness at the injection site the size of a baseball) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.    Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm) and headache (light headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 0021C21A) for COVID-19 immunization. No medical history reported. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (sore arm) and headache (light headaches). At the time of the report, vaccination site pain (sore arm) and headache (light headaches) resolved. This case linked to MOD-2021-217218 (patient link). Most recent follow-up information incorporated: On Jun 29, 2021: Updated reporter information, added patient details, updated product information, dose-1 batch number and route of administration changed from unknown to intramuscular.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.