chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Gait disturbance, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient developed a breakthrough infection of COVID-19 after being vaccinated with the Moderna COVID-19 vaccine.), FEELING ABNORMAL (Patient felt under the weather after second dose of the Moderna COVID-19 vaccine.), GAIT DISTURBANCE (had trouble walking) and PYREXIA (patient developed a fever) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COVID-19 (Patient developed a breakthrough infection of COVID-19 after being vaccinated with the Moderna COVID-19 vaccine.), FEELING ABNORMAL (Patient felt under the weather after second dose of the Moderna COVID-19 vaccine.), GAIT DISTURBANCE (had trouble walking) and PYREXIA (patient developed a fever). At the time of the report, COVID-19 (Patient developed a breakthrough infection of COVID-19 after being vaccinated with the Moderna COVID-19 vaccine.), FEELING ABNORMAL (Patient felt under the weather after second dose of the Moderna COVID-19 vaccine.), GAIT DISTURBANCE (had trouble walking) and PYREXIA (patient developed a fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had trouble walking and was taken to emergency room and was discharged with antibiotics (unspecified antibiotics). Concomitant product use was not provided.  The nurse reported that it was never actually confirmed that the patient had contracted COVID-19 through a test or lab result.   This case was linked to MOD-2021-344054 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a 86-year-old, male patient with no listed medical history, who experienced the unexpected events of COVID-19, Feeling abnormal, Gait disturbance and listed event Pyrexia. The events  occurred approximately 3 months after the second dose of Covid19 Moderna. This is a case of lack of effect assuming the patient had 2 doses of Moderna vaccine in the correct interval. The rechallenge was unknown since no event after the first dose was disclosed. The benefit-risk relationship of Covid19 Moderna is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Accidentally injected her with the Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Accidentally injected her with the Pfizer vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Accidentally injected her with the Pfizer vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Accidentally injected her with the Pfizer vaccine) had resolved. Not Provided          No concomitant medication details was provided.  Patient reported that their niece was vaccinated a little over a month ago for first vaccine and later went for her second vaccine.  No treatment medication details was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity
Clinical narrative: Felt a little flu-ey; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt a little flu-ey) and PAIN IN EXTREMITY (arm was a little sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient put off having the vaccination because they felt they had antibodies.) in January 2021 and Hip surgery (Bad back.). Concomitant products included PARACETAMOL (TYLENOL), GABAPENTIN, TRAMADOL, IRON, OLMESARTAN, ATORVASTATIN, LORATADINE and MONTELUKAST for an unknown indication.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Felt a little flu-ey) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, INFLUENZA (Felt a little flu-ey) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was unknown.   This case was linked to MOD-2021-344232 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, Rhinitis allergic, Suspected COVID-19
Clinical narrative: Cold; Fever; Thinks had a breakthrough infection; Allergic rhinitis; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (Thinks had a breakthrough infection), RHINITIS ALLERGIC (Allergic rhinitis), NASOPHARYNGITIS (Cold) and PYREXIA (Fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced SUSPECTED COVID-19 (Thinks had a breakthrough infection) and RHINITIS ALLERGIC (Allergic rhinitis). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and PYREXIA (Fever). At the time of the report, SUSPECTED COVID-19 (Thinks had a breakthrough infection) and RHINITIS ALLERGIC (Allergic rhinitis) had resolved and NASOPHARYNGITIS (Cold) and PYREXIA (Fever) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-344005.; Sender's Comments: This case concerns a 86-year-old female patient with no previous relevant medical history, who experienced the non serious event of Suspected COVID-19 without laboratory confirmation and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 3 months after the second dose of Spikevax. Patient had nasopharyngitis and pyrexia, and the reporter suspected COVID-19 but the patient was not tested. The rechallenge is not applicable, since the schedule of vaccination has been completed and a further dose is not expected. The benefit-risk relationship of Spikevax vaccine is not affected by this report
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Hunger, Hyperhidrosis
Clinical narrative: Dizzy; Can hardly do anything; Sweat; Very hot; Really sleep; Hungry; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot) and SOMNOLENCE (Really sleep) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot), SOMNOLENCE (Really sleep), HUNGER (Hungry), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot), SOMNOLENCE (Really sleep), HUNGER (Hungry), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 20 minutes after the vaccination patient stated experiencing fever, dizzy, sweat, very hot, really sleepy, hungry, fatigue, and she can hardly do anything. She took Tylenol extra strength . She had COVID-19 in JULY 2020 and she has had more symptoms with the vaccine than when she had COVID-19. No concomitant medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pyrexia, Somnolence
Clinical narrative: Dizzy; Can hardly do anything; Sweat; Very hot; Really sleep; Hungry; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot) and SOMNOLENCE (Really sleep) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, the patient experienced DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot), SOMNOLENCE (Really sleep), HUNGER (Hungry), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), IMPAIRED WORK ABILITY (Can hardly do anything), HYPERHIDROSIS (Sweat), FEELING HOT (Very hot), SOMNOLENCE (Really sleep), HUNGER (Hungry), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       About 20 minutes after the vaccination patient stated experiencing fever, dizzy, sweat, very hot, really sleepy, hungry, fatigue, and she can hardly do anything. She took Tylenol extra strength . She had COVID-19 in JULY 2020 and she has had more symptoms with the vaccine than when she had COVID-19. No concomitant medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Muscle spasms, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inflammation (inflammation in legs), muscle spasms (cramping in shins), myalgia (achy muscles/muscle pain) and arthralgia (joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included blood pressure and stroke issues. On Mar 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inflammation (inflammation in legs), muscle spasms (cramping in shins), myalgia (achy muscles/muscle pain) and arthralgia (joint pain). At the time of the report, inflammation (inflammation in legs), muscle spasms (cramping in shins), myalgia (achy muscles/muscle pain) and arthralgia (joint pain): not resolved. Concomitant medications included unspecified blood pressure and stroke medication. Patient's symptoms started 5-6 months after the second shot. Patient went to the neurologist who did an MRI of his back. Neurologist recommended the patient to go to the rheumatology and have a biopsy of his leg muscle. Patient received unspecified cream for treatment.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 infection) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) 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.   Physician reported that a patient had first dose of Moderna COVID-19 vaccine. Developed COVID-19 infection on 13-Sep-2021 and received monoclonal antibodies.  No concomitant medications were reported.; Sender's Comments: This case concerns a 21-year-old, male patient, with no disclosed medical history, who experienced the non-serious, unexpected, event of Covid-19. Time interval between first dose of Moderna vaccine and event is unknown. The rechallenge is not applicable as patient only received first dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Syncope
Clinical narrative: Fainted; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 67-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.     Concurrent medical conditions included Heart disorder and Blood pressure high.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and HYPOTENSION (Low blood pressure). In February 2021, SYNCOPE (Fainted) and HYPOTENSION (Low blood pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking some unspecified medications. No treatment reported.  The patient fainted after the second vaccine dose due to a low blood pressure. His blood pressure was low for two days after the second vaccine.  Company comment: This case concerns a  67-year-old, female patient with history of heart condition and hypertension, who experienced the unexpected events of Syncope and Hypotension. The patient fainted after the second dose and experience hypotension for 2 days. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. The medical history of heart condition remains a confounder.; Sender's Comments: This case concerns a  67-year-old, female patient with history of heart condition and hypertension, who experienced the unexpected events of Syncope and Hypotension. The patient fainted after the second dose and experience hypotension for 2 days. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. The medical history of heart condition remains a confounder.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: My arm was sore for several days /  I had body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My arm was sore for several days / I had body aches) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (My arm was sore for several days / I had body aches) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (My arm was sore for several days / I had body aches) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter   This case was linked to MOD-2021-344168 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-344139.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter. It was reported that,  the vial did not undergo any temperature excursions.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder
Clinical narrative: Could not eat anything for 5 days she could only drink liquids; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Could not eat anything for 5 days she could only drink liquids) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 49E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced FEEDING DISORDER (Could not eat anything for 5 days she could only drink liquids). At the time of the report, FEEDING DISORDER (Could not eat anything for 5 days she could only drink liquids) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received contains non significant information
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-344114 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Gastrooesophageal reflux disease, Pain, Pyrexia
Clinical narrative: Pain; Reflux/gargling acids moving inside my body.; Intestinal hyperactivity; Weakness; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux/gargling acids moving inside my body.), ABDOMINAL DISCOMFORT (Intestinal hyperactivity), ASTHENIA (Weakness) and PYREXIA (Feverish) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux/gargling acids moving inside my body.), ABDOMINAL DISCOMFORT (Intestinal hyperactivity), ASTHENIA (Weakness) and PYREXIA (Feverish). The patient was treated with ESOMEPRAZOLE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux/gargling acids moving inside my body.), ABDOMINAL DISCOMFORT (Intestinal hyperactivity), ASTHENIA (Weakness) and PYREXIA (Feverish) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Patient consume only natural sugars (found in fruits etc) and I am on a low sodium diet. Concomitant medication was not provided.   This case was linked to MOD-2021-344284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow-up received on 11-OCT-2021 contains no new information.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LABETALOL for Blood pressure high.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced MYALGIA (body aches) and HEADACHE (headache). On 04-Sep-2021, MYALGIA (body aches) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-344340 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant Follow up received on 08-OCT-2021- ADR form received, batch number updated
Age: 58.0
Sex: M
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 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 28-Sep-2021, 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 medications were provided  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-337484 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant Follow up -ADR form received, Medical history provided, Gender added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-337484:MOD21-148785
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Dizziness, Hyperhidrosis
Clinical narrative: severe cramps; broke out into a sweat; very dizzy / she had never been so dizzy in her life; her eyes wouldn't focus; diarrhea; was so weak; passed out twice; seizure; fever/temperature up to a 100; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out twice) and SEIZURE (seizure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 0D8ZZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Aug-2021, the patient experienced PYREXIA (fever/temperature up to a 100). On 01-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out twice) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea) and ASTHENIA (was so weak). At the time of the report, LOSS OF CONSCIOUSNESS (passed out twice), SEIZURE (seizure), PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea), ASTHENIA (was so weak) and PYREXIA (fever/temperature up to a 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 100 degree (High) up to 100 degrees.         No concomitant medications were reported No treatment medications were reported.  Company Comment: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle spasms, Pain in extremity, Pyrexia, Seizure
Clinical narrative: severe cramps; broke out into a sweat; very dizzy / she had never been so dizzy in her life; her eyes wouldn't focus; diarrhea; was so weak; passed out twice; seizure; fever/temperature up to a 100; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out twice) and SEIZURE (seizure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 0D8ZZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Aug-2021, the patient experienced PYREXIA (fever/temperature up to a 100). On 01-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out twice) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea) and ASTHENIA (was so weak). At the time of the report, LOSS OF CONSCIOUSNESS (passed out twice), SEIZURE (seizure), PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea), ASTHENIA (was so weak) and PYREXIA (fever/temperature up to a 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 100 degree (High) up to 100 degrees.         No concomitant medications were reported No treatment medications were reported.  Company Comment: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: severe cramps; broke out into a sweat; very dizzy / she had never been so dizzy in her life; her eyes wouldn't focus; diarrhea; was so weak; passed out twice; seizure; fever/temperature up to a 100; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out twice) and SEIZURE (seizure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 0D8ZZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Aug-2021, the patient experienced PYREXIA (fever/temperature up to a 100). On 01-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out twice) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea) and ASTHENIA (was so weak). At the time of the report, LOSS OF CONSCIOUSNESS (passed out twice), SEIZURE (seizure), PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea), ASTHENIA (was so weak) and PYREXIA (fever/temperature up to a 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 100 degree (High) up to 100 degrees.         No concomitant medications were reported No treatment medications were reported.  Company Comment: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose on 5-Oct-2021 from vial that was beyond 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose on 5-Oct-2021 from vial that was beyond 30 day use by date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered dose on 5-Oct-2021 from vial that was beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The vial was initially stored in the refrigerator on 30-Aug-2021 at 8:45 pm and had 30 day use by date expiration of 29-Sep-2021.  The vial was punctured on 05-Oct-2021 at approximately around 9:55am.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: Loss of muscle in the arm where she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE ATROPHY (Loss of muscle in the arm where she got the injection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced MUSCLE ATROPHY (Loss of muscle in the arm where she got the injection). At the time of the report, MUSCLE ATROPHY (Loss of muscle in the arm where she got the injection) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Pruritus, Rash
Clinical narrative: Burning sensation on the heels of feet; itching; blisters on different parts of body/blisters are still popping out here & there; rash & blisters on different parts of body; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation on the heels of feet), PRURITUS (itching), BLISTER (blisters on different parts of body/blisters are still popping out here & there) and RASH (rash & blisters on different parts of body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F20A, 022M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on the heels of feet), PRURITUS (itching), BLISTER (blisters on different parts of body/blisters are still popping out here & there) and RASH (rash & blisters on different parts of body). The patient was treated with BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPRIONATE) for Adverse event, at a dose of 0.05 percent; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Adverse event, at a dose of 1 dosage form; GABAPENTIN for Adverse event, at a dose of 600 mg and CANNABIDIOL for Adverse event, at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (Burning sensation on the heels of feet) and PRURITUS (itching) was resolving, BLISTER (blisters on different parts of body/blisters are still popping out here & there) had not resolved and RASH (rash & blisters on different parts of body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient's burning and itching was very intense and hence patient soaked feet in ice water. On 05-Oct-2021 after using CBD cream, patient slept four hours for the first time since 22-Sep-2021 as the cream worked well for her. Patient had no reaction to the first and second dose.  No concomitant medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: veins satrted feeling different(veins satrted pulsating in arm); This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISORDER (veins satrted feeling different(veins satrted pulsating in arm)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis (No recent change in status of chronic condition) since 2010 and Drug allergy. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CROMOGLICATE SODIUM (NASALCROM) for Allergy NOS, CARMELLOSE SODIUM, GLYCEROL (REFRESH OPTIVE) for Dry eyes.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VEIN DISORDER (veins satrted feeling different(veins satrted pulsating in arm)). At the time of the report, VEIN DISORDER (veins satrted feeling different(veins satrted pulsating in arm)) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Multi Vitamin for energy. On 30-Aug-2021, patient got a steroid shot and on 01-Sep-2021, patient got B12 shot.   This case was linked to MOD-2021-301573 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: He started noticing the improvement more after his 2nd dose and at the end August 2021; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (He started noticing the improvement more after his 2nd dose and at the end August 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breathing difficult.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (He started noticing the improvement more after his 2nd dose and at the end August 2021). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (He started noticing the improvement more after his 2nd dose and at the end August 2021) outcome was unknown.            Patient stated that prior to receiving his Moderna vaccine he always had problems with his lungs and breathing. During activity he couldn't run without breathing problems.  Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeding disorder, Frustration tolerance decreased, Head discomfort
Clinical narrative: Felt tingling in arms; Pain from middle of back, up to neck; Felt like head was being squeezed, I never had a headache like that in my life.; having trouble eating; Patient expressed frustration; Fatigue; The patient did not receive their second dose; Headache worsened by second day, I couldn't lay my head down/Pounding Headache/wrapped around head; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Felt tingling in arms), BACK PAIN (Pain from middle of back, up to neck), HEAD DISCOMFORT (Felt like head was being squeezed, I never had a headache like that in my life.), FEEDING DISORDER (having trouble eating) and FRUSTRATION TOLERANCE DECREASED (Patient expressed frustration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient medical history was not provided.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Felt tingling in arms), BACK PAIN (Pain from middle of back, up to neck), HEAD DISCOMFORT (Felt like head was being squeezed, I never had a headache like that in my life.), FEEDING DISORDER (having trouble eating), FRUSTRATION TOLERANCE DECREASED (Patient expressed frustration), FATIGUE (Fatigue), HEADACHE (Headache worsened by second day, I couldn't lay my head down/Pounding Headache/wrapped around head) and PRODUCT DOSE OMISSION ISSUE (The patient did not receive their second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Felt tingling in arms), BACK PAIN (Pain from middle of back, up to neck), HEAD DISCOMFORT (Felt like head was being squeezed, I never had a headache like that in my life.), FEEDING DISORDER (having trouble eating), FRUSTRATION TOLERANCE DECREASED (Patient expressed frustration) and FATIGUE (Fatigue) outcome was unknown and HEADACHE (Headache worsened by second day, I couldn't lay my head down/Pounding Headache/wrapped around head) and PRODUCT DOSE OMISSION ISSUE (The patient did not receive their second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.