chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: Administered expired dose of vaccine to patient/ Vaccine administered after 30 minute of thawing at room temperature; Sore arm for about a day; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose of vaccine to patient/ Vaccine administered after 30 minute of thawing at room temperature) and VACCINATION SITE PAIN (Sore arm for about a day) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID] and CANNABIDIOL (CBD OIL) for an unknown indication.    On 27-Aug-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose of vaccine to patient/ Vaccine administered after 30 minute of thawing at room temperature) and VACCINATION SITE PAIN (Sore arm for about a day). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired dose of vaccine to patient/ Vaccine administered after 30 minute of thawing at room temperature) had resolved. On 29-Aug-2021, VACCINATION SITE PAIN (Sore arm for about a day) 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 considered VACCINATION SITE PAIN (Sore arm for about a day) to be possibly related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired dose of vaccine to patient/ Vaccine administered after 30 minute of thawing at room temperature).    Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up was received on 1-SEP-2021 and has no new information On 02-Sep-2021: Follow-up was received on 2-SEP-2021 and contains reporter details, patient details (race and ethnic information), concomitant medications, updated anatomical location of the suspect drug administered and new adverse event was updated to the case - SORE ARM
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Soreness / Pain in my arm; Light headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness / Pain in my arm) and HEADACHE (Light headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included RISPERIDONE (RISPERDAL), BENZATROPINE and PROPRANOLOL for an unknown indication.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN IN EXTREMITY (Soreness / Pain in my arm) and HEADACHE (Light headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness / Pain in my arm) and HEADACHE (Light headache) had not resolved.            Patient reported that she experienced symptoms on the next day morning after the vaccination and is currently ongoing.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: general fever after the first dose; little headache after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (general fever after the first dose) and HEADACHE (little headache after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PYREXIA (general fever after the first dose) and HEADACHE (little headache after the first dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (general fever after the first dose) and HEADACHE (little headache after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient was drinking water for fever.   This case was linked to MOD-2021-300062 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Fatigue; Fever; Muscle aches on & off; Swollen gland in the throat; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), MYALGIA (Muscle aches on & off) and LYMPHADENOPATHY (Swollen gland in the throat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic fatigue syndrome (She used to have Chronic Fatigue Syndrome 10 years ago and did not have it prior to vaccination.). Concurrent medical conditions included Blood pressure (Taking medicine for High blood pressure).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever), MYALGIA (Muscle aches on & off) and LYMPHADENOPATHY (Swollen gland in the throat). At the time of the report, FATIGUE (Fatigue), PYREXIA (Fever) and MYALGIA (Muscle aches on & off) had not resolved and LYMPHADENOPATHY (Swollen gland in the throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeding disorder, Feeling abnormal, Hyperphagia, Pruritus
Clinical narrative: It makes her feel like she has no cravings for food; She can't eat any food; It makes her sick of her stomach, like if she wants to throw up; It felt itchy; She felt stoned, like you want to eat unstopped; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (It makes her feel like she has no cravings for food), FEEDING DISORDER (She can't eat any food), FEELING ABNORMAL (It makes her sick of her stomach, like if she wants to throw up), PRURITUS (It felt itchy) and HYPERPHAGIA (She felt stoned, like you want to eat unstopped) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRURITUS (It felt itchy) and HYPERPHAGIA (She felt stoned, like you want to eat unstopped). On 21-Aug-2021, the patient experienced DECREASED APPETITE (It makes her feel like she has no cravings for food), FEEDING DISORDER (She can't eat any food) and FEELING ABNORMAL (It makes her sick of her stomach, like if she wants to throw up). On 20-Aug-2021, PRURITUS (It felt itchy) and HYPERPHAGIA (She felt stoned, like you want to eat unstopped) had resolved. At the time of the report, DECREASED APPETITE (It makes her feel like she has no cravings for food), FEEDING DISORDER (She can't eat any food) and FEELING ABNORMAL (It makes her sick of her stomach, like if she wants to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included depression meds (until a day before she received the vaccine)  Treatment information included Stomach meds, Sprite, Water.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered to patient after improper storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anaemia, Penicillin allergy and Allergy to antibiotic (Amoxicillin). Concomitant products included FERROUS SULPHATE [FERROUS SULFATE] from 18-Aug-2021 to an unknown date for Anaemia.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  It was reported that patient was given vaccine that was thawed, frozen and thawed.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional information included patient details, medical history, concomitant and event.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to patient after improper storage and handling; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy since 11-Apr-2019. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE) from 28-May-2021 to an unknown date for Epilepsy, OLANZAPINE (ZYPREXA) from 09-Aug-2021 to an unknown date, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 10-Aug-2021 to an unknown date and MIRTAZAPINE from 23-Aug-2021 to an unknown date for Mental state abnormal.   On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient race information was given as black  It was reported that patient was given vaccine that was thawed, frozen and thawed.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional information received and contains new information. Reporter details, Patient details , vaccine details, Concomitant medications were updated.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (general fever after the second dose) and headache (little headache after the second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jul 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 18, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (general fever after the second dose) and headache (little headache after the second dose). Patient treated with Tylenol (paracetamol) for fever, at an unspecified dose and frequency. At the time of the report, pyrexia (general fever after the second dose) and headache (little headache after the second dose) resolved. No concomitant medication  reported. Treatment information included drinking water for fever. Action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. This case linked to MOD-2021-299977 (patient link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered to patient after improper storage and handling/Patient was given vaccine that had been thawed, re-frozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling/Patient was given vaccine that had been thawed, re-frozen and thawed again) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain. Concomitant products included PARACETAMOL (TYLENOL) from 15-Aug-2021 to an unknown date for Pain.    On 26-Aug-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling/Patient was given vaccine that had been thawed, re-frozen and thawed again). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling/Patient was given vaccine that had been thawed, re-frozen and thawed again) 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 medication was provided.  It was reported that no adverse event occurred.  The patient race was Black.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received: patient details, concomitant medication, time and route of administration for first dose of vaccine was updated.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14-year-old received the Moderna vaccine; 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old received the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14-year-old received the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As per source document a 14-year-old who was supposed to received a Pfizer vaccine, but instead received Moderna. They wanted to know if they can receive the 2nd dose of another vaccine. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having constant headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (having constant headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032b21a and 026a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (having constant headache). At the time of the report, HEADACHE (having constant headache) had not resolved.            No Concomitant medications were reported  Patient had several studies done to them with nothing found to be wrong with them. They got CT scan and MRI done. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No second dose since 6Apr2021; 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 PRODUCT DOSE OMISSION ISSUE (No second dose since 6Apr2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose since 6Apr2021). In 2021, PRODUCT DOSE OMISSION ISSUE (No second dose since 6Apr2021) had resolved.            Concomitant medication were not reported. Treatment medication were not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash
Clinical narrative: denied her second dose (has not received it); rash the next day; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash the next day) and PRODUCT DOSE OMISSION ISSUE (denied her second dose (has not received it)) in a 40-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 the reporter.  .  Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT) and ESTRADIOL (ESTROGEL) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH (rash the next day). On 28-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (denied her second dose (has not received it)). On 28-Aug-2021, PRODUCT DOSE OMISSION ISSUE (denied her second dose (has not received it)) had resolved. At the time of the report, RASH (rash the next day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided by the reporter. She was denied her second dose (has not received it). She went to go get her second dose today but the vaccination provider told her she needed to speak with her doctor.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: husband has a very sore arm; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (husband has a very sore arm) and PERIPHERAL SWELLING (arm was swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (husband has a very sore arm) and PERIPHERAL SWELLING (arm was swollen). At the time of the report, PAIN IN EXTREMITY (husband has a very sore arm) and PERIPHERAL SWELLING (arm was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Myocardial infarction (MI) on 16-Dec-2016, Fusion lumbar spine (L5S1OR) in 1985 and Fusion lumbar spine (L4-S1 fusion twice) in 1999. Concurrent medical conditions included Allergy to antibiotic (Allergic to bactrim), Drug allergy (Allergic to toradol), Chronic back pain since 1972, Nerve pain (post fusion), BPH and Clot blood (CV anti clot). Concomitant products included ALFUZOSIN from April 2010 to an unknown date for BPH, ASPIRIN [ACETYLSALICYLIC ACID] from 2010 to an unknown date for Clot blood, LAMOTRIGINE from 2001 to an unknown date for Nerve pain, TIZANIDINE from 2001 to an unknown date, AMITRIPTYLINE from 2001 to an unknown date, RANOLAZINE (RANEXA), ROSUVASTATIN, CARVEDILOL and LOSARTAN POTASSIUM for an unknown indication.    On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 antibody test: 2070 (Positive) SARS-CoV-2 semi-quant total Ab was reported as 2070 U/mL.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.  Patient did not notice any ill effects from or attributable to her medications.   This case was linked to MOD-2021-300198 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Live followup document contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Barely feel 2 of my fingers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Barely feel 2 of my fingers) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Barely feel 2 of my fingers). At the time of the report, HYPOAESTHESIA (Barely feel 2 of my fingers) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication listed.   No treatment information provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 36 days after the first dose without receiving the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days after the first dose without receiving the second dose.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis (Infusion for Ulcerative Colitis).    In 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 (more than 36 days after the first dose without receiving the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days after the first dose without receiving the second dose.) had resolved.            No treatment medication were provided by the reporter. patient is taking  Infusion for ulcerative colitis as concomitant medication. No lab data provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: mild side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild side effects) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Scleroderma and Heart disorder.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (mild side effects). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (mild side effects) outcome was unknown.            No relevant concomitant medications were reported  Patient was taking heart, blood pressure medications and statin as concomitant medication.  Patient was on prescription creams for schleroderma  The patient received a 3rd dose on 25Aug2021 on her left arm (lot#01TR17, no expiration date provided) and the same day she had pain on her left arm. On Thursday 26Aug2021 morning she was very sick with chills, fever, a bad headache, she was sick all day, and today 27Aug2021 she feels a little better, she still has a very swollen area on her arm but not as tender, and also today the headache is not as bad.   This case was linked to MOD-2021-300131 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Pyrexia, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash on the injection site; Bump on the injection site; Fever; Had no energy immediately after the vaccine; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Had no energy immediately after the vaccine), COUGH (Coughing), VACCINATION SITE RASH (Rash on the injection site), VACCINATION SITE SWELLING (Bump on the injection site) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced ASTHENIA (Had no energy immediately after the vaccine), COUGH (Coughing) and PYREXIA (Fever). On 28-Aug-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE SWELLING (Bump on the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Had no energy immediately after the vaccine), COUGH (Coughing) and PYREXIA (Fever) outcome was unknown and VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE SWELLING (Bump on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Eye disorder, Influenza like illness
Clinical narrative: eye surgery; Flu like symptoms  6 days after their first dose; Notice that they lost, and have thinner hair after getting their Moderna Covid19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms  6 days after their first dose), ALOPECIA (Notice that they lost, and have thinner hair after getting their Moderna Covid19 vaccine) and EYE DISORDER (eye surgery) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013a21a and 028a21a) for COVID-19 vaccination.     Concomitant products included PROBIOTICS NOS, LEVOTHYROXINE SODIUM (SYNTHROID), LEVOTHYROXINE, NABUMETONE and FUROSEMIDE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms  6 days after their first dose). In 2021, the patient experienced ALOPECIA (Notice that they lost, and have thinner hair after getting their Moderna Covid19 vaccine). On an unknown date, the patient experienced EYE DISORDER (eye surgery). The patient was treated with Surgery for Eye disorder. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms  6 days after their first dose), ALOPECIA (Notice that they lost, and have thinner hair after getting their Moderna Covid19 vaccine) and EYE DISORDER (eye surgery) outcome was unknown.            The consumer stated that they felt flu like symptoms  6 days after their first dose of Moderna vaccine. The consumer also stated that they noticed hair loss and have thinner hair after getting the Moderna COVID-19 vaccine.  The consumer stated that they received a treatment of steroid shot for their back and underwent eye surgery.  The consumer stated that  they always have adverse reaction to medications.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough
Clinical narrative: Had a fairly mild breakthrough case of COVID; Loss of smell; Loss of taste; runny nose; Nasal congestion; Diarrhea; Cough; Vomiting; Chills; Muscle ache; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion) and DIARRHOEA (Diarrhea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2016. Concurrent medical conditions included Cardiovascular disease, unspecified (stent implaced).    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea). On 22-Jul-2021, the patient experienced COVID-19 (Had a fairly mild breakthrough case of COVID). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency and ASCORBIC ACID (VITAMIN C ASC ACID) for Adverse event, at an unspecified dose and frequency. On 26-Jul-2021, COVID-19 (Had a fairly mild breakthrough case of COVID) had resolved. At the time of the report, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 13-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided.   Treatment information was not  provided.  Patient is being told  to get a booster right now and not wait the eight months by everyone.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received: Added Patient details, treatment medications, current condition, lab data, events and narrative was updated accordingly.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Myalgia, Nasal congestion, Nausea
Clinical narrative: Had a fairly mild breakthrough case of COVID; Loss of smell; Loss of taste; runny nose; Nasal congestion; Diarrhea; Cough; Vomiting; Chills; Muscle ache; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion) and DIARRHOEA (Diarrhea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2016. Concurrent medical conditions included Cardiovascular disease, unspecified (stent implaced).    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea). On 22-Jul-2021, the patient experienced COVID-19 (Had a fairly mild breakthrough case of COVID). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency and ASCORBIC ACID (VITAMIN C ASC ACID) for Adverse event, at an unspecified dose and frequency. On 26-Jul-2021, COVID-19 (Had a fairly mild breakthrough case of COVID) had resolved. At the time of the report, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 13-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided.   Treatment information was not  provided.  Patient is being told  to get a booster right now and not wait the eight months by everyone.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received: Added Patient details, treatment medications, current condition, lab data, events and narrative was updated accordingly.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vomiting
Clinical narrative: Had a fairly mild breakthrough case of COVID; Loss of smell; Loss of taste; runny nose; Nasal congestion; Diarrhea; Cough; Vomiting; Chills; Muscle ache; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion) and DIARRHOEA (Diarrhea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2016. Concurrent medical conditions included Cardiovascular disease, unspecified (stent implaced).    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea). On 22-Jul-2021, the patient experienced COVID-19 (Had a fairly mild breakthrough case of COVID). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Adverse event, at an unspecified dose and frequency and ASCORBIC ACID (VITAMIN C ASC ACID) for Adverse event, at an unspecified dose and frequency. On 26-Jul-2021, COVID-19 (Had a fairly mild breakthrough case of COVID) had resolved. At the time of the report, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), RHINORRHOEA (runny nose), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Diarrhea), COUGH (Cough), VOMITING (Vomiting), CHILLS (Chills), MYALGIA (Muscle ache), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 13-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 22-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided.   Treatment information was not  provided.  Patient is being told  to get a booster right now and not wait the eight months by everyone.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received: Added Patient details, treatment medications, current condition, lab data, events and narrative was updated accordingly.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Lymphadenopathy, Muscle fatigue, Nasopharyngitis
Clinical narrative: Third dose caused chills; third dose fever; third dose aching to the bone; third dose muscle fatigue; third dose kidneys hurt; first dose lymph node swelling in arm; bad cold; second dose fever; second dose aches; second dose chills to the bones; First dose lymph node swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (First dose lymph node swelling in arm), CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ) and MUSCLE FATIGUE (third dose muscle fatigue) in a 45-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.     Concurrent medical conditions included Cold since 16-Jul-2021 and Allergy (They are really bad). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy and Cold.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced LYMPHADENOPATHY (First dose lymph node swelling in arm). On 20-Jan-2021, the patient experienced PYREXIA (second dose fever), PAIN IN EXTREMITY (second dose aches) and CHILLS (second dose chills to the bones). On 16-Jul-2021, the patient experienced NASOPHARYNGITIS (bad cold). On 27-Aug-2021, the patient experienced CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ), MUSCLE FATIGUE (third dose muscle fatigue), RENAL PAIN (third dose kidneys hurt ) and PERIPHERAL SWELLING (first dose lymph node swelling in arm). At the time of the report, LYMPHADENOPATHY (First dose lymph node swelling in arm), CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ), MUSCLE FATIGUE (third dose muscle fatigue), RENAL PAIN (third dose kidneys hurt ), PERIPHERAL SWELLING (first dose lymph node swelling in arm), PYREXIA (second dose fever), PAIN IN EXTREMITY (second dose aches), CHILLS (second dose chills to the bones) and NASOPHARYNGITIS (bad cold) outcome was unknown.            This case was linked to MOD-2021-300195, MOD-2021-300196 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Renal pain
Clinical narrative: Third dose caused chills; third dose fever; third dose aching to the bone; third dose muscle fatigue; third dose kidneys hurt; first dose lymph node swelling in arm; bad cold; second dose fever; second dose aches; second dose chills to the bones; First dose lymph node swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (First dose lymph node swelling in arm), CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ) and MUSCLE FATIGUE (third dose muscle fatigue) in a 45-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.     Concurrent medical conditions included Cold since 16-Jul-2021 and Allergy (They are really bad). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy and Cold.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced LYMPHADENOPATHY (First dose lymph node swelling in arm). On 20-Jan-2021, the patient experienced PYREXIA (second dose fever), PAIN IN EXTREMITY (second dose aches) and CHILLS (second dose chills to the bones). On 16-Jul-2021, the patient experienced NASOPHARYNGITIS (bad cold). On 27-Aug-2021, the patient experienced CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ), MUSCLE FATIGUE (third dose muscle fatigue), RENAL PAIN (third dose kidneys hurt ) and PERIPHERAL SWELLING (first dose lymph node swelling in arm). At the time of the report, LYMPHADENOPATHY (First dose lymph node swelling in arm), CHILLS (Third dose caused chills), PYREXIA (third dose fever), ARTHRALGIA (third dose aching to the bone   ), MUSCLE FATIGUE (third dose muscle fatigue), RENAL PAIN (third dose kidneys hurt ), PERIPHERAL SWELLING (first dose lymph node swelling in arm), PYREXIA (second dose fever), PAIN IN EXTREMITY (second dose aches), CHILLS (second dose chills to the bones) and NASOPHARYNGITIS (bad cold) outcome was unknown.            This case was linked to MOD-2021-300195, MOD-2021-300196 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Hordeolum, Lymphadenopathy, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching) and PAIN OF SKIN (felt like she was stung by a wasp) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Allergy to penicillin) and Allergy to insect sting. Concomitant products included ALPRAZOLAM (XANAX) and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for an unknown indication. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced VOMITING (she woke up and started to throw up/threw up clear film). On 23-Aug-2021, the patient experienced HORDEOLUM (Stye) and EYE SWELLING (eye was swelling). On 24-Aug-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen). On 25-Aug-2021, the patient experienced URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), PAIN (still sore to the touch) and DYSPNOEA (short or breath as she is talking). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Swelling, at an unspecified dose and frequency and NONOXINOL, SODIUM LAURYL SULFATE (POISON IVY [NONOXINOL;SODIUM LAURYL SULFATE]) for Itching and Swelling, at an unspecified dose and frequency. At the time of the report, HORDEOLUM (Stye), EYE SWELLING (eye was swelling), URTICARIA (big welt,), PRURITUS (itching), PAIN OF SKIN (felt like she was stung by a wasp), VACCINATION SITE MASS (big nodule on the left injection site), DYSPNOEA (short or breath as she is talking) and VOMITING (she woke up and started to throw up/threw up clear film) outcome was unknown and PAIN (still sore to the touch), VACCINATION SITE LYMPHADENOPATHY (they're huge lymph nodes under the left injection site) and LYMPHADENOPATHY (the lymph nodes under her arm were swollen/lymph nodes on her neck that are large/glands are still swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.