chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Influenza like illness, Myalgia, Nausea
Clinical narrative: Feelings of weakness; Nausea; Chills; Sickness; Flu like symptoms; Black stool; Diarrhea/still had a little diarrhea; Unable to eat; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea) and FEEDING DISORDER (Unable to eat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034P21A, 044A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced HEADACHE (Headache). On 16-Nov-2021, the patient experienced ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea), FEEDING DISORDER (Unable to eat), MYALGIA (Body ache), NAUSEA (Nausea) and CHILLS (Chills). On 18-Nov-2021, the patient experienced ASTHENIA (Feelings of weakness). At the time of the report, ILLNESS (Sickness), INFLUENZA LIKE ILLNESS (Flu like symptoms), FAECES DISCOLOURED (Black stool), DIARRHOEA (Diarrhea/still had a little diarrhea), FEEDING DISORDER (Unable to eat), MYALGIA (Body ache), ASTHENIA (Feelings of weakness), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) had not resolved.            The patient experienced her intestinal did a number on her, and she still has a little diarrhea. No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose more than 35 days after the first; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first). On 15-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days after the first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Vaccine after the 12 hour post-puncture expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Vaccine after the 12 hour post-puncture expiration) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCORTISONE, SPIRONOLACTONE, THYROID (ARMOUR THYROID) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 15-Nov-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Vaccine after the 12 hour post-puncture expiration). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered Vaccine after the 12 hour post-puncture expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medications include Arthritis pain relief medications. No treatment medications were provided by the reporter.  Initially the vial was punctured on 10-NOV-2021 at 20.00 and stored in refrigerator on same day. Post puncture the vial stored in fridge. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow-up received reporter details, updated patient demographics, suspect product details, route of administration, expiration date and concomitant medications added
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headaches; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and MYALGIA (Body aches) 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 HEADACHE (Headaches) and MYALGIA (Body aches). At the time of the report, HEADACHE (Headaches) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were mentioned.  Patient experienced headaches, body aches for 48 hours.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up received on 18-Nov-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). In November 2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment medication were reported.  The pharmacist administered booster doses of the Moderna COVID-19 vaccine to patients  on 12 Nov 2021, 15 Nov 2021 and 16 Nov 2021. Date the vial was initially stored in the refrigerator was Unknown, Vial has not undergone any temperature excursion. No other further adverse events were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up received contains non-significant information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: Body aches; Slight fever/fever of 100 degrees Farenheight; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches), PYREXIA (Slight fever/fever of 100 degrees Farenheight) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Slight fever/fever of 100 degrees Farenheight) and HEADACHE (Headache). On 04-Feb-2021, MYALGIA (Body aches), PYREXIA (Slight fever/fever of 100 degrees Farenheight) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 100 (High) Fever reached 100 degrees Fahrenheit.     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 product use was reported. No treatment information was provided.   This case was linked to MOD-2021-390831 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently given expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (Allergic to Influenza vaccine).    On 10-Nov-2021 at 11:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  No adverse reaction was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received  a 3 weeks expired vaccine; 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  a 3 weeks expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received  a 3 weeks expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received  a 3 weeks expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the vial was initially stored in refrigerator on 20-Oct-2021 and the vial did not undergone any temperature excursions.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Mild symptoms I had with my second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms I had with my second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 COMPLICATION (Mild symptoms I had with my second shot). At the time of the report, VACCINATION COMPLICATION (Mild symptoms I had with my second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After taking the 1st dose, it helped with wheezing that he was experiencing; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After taking the 1st dose, it helped with wheezing that he was experiencing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient was sick for almost 8 months and was constantly on low dose Medrol pack + doxycycline.) in 2020 and Wheezing.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After taking the 1st dose, it helped with wheezing that he was experiencing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After taking the 1st dose, it helped with wheezing that he was experiencing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-390861, MOD-2021-390908 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Hyperhidrosis, Rash, Vaccination site rash
Clinical narrative: Rash on her chest; Rash on her chest & where she got the shot; Chills; Sweats; freezing and sweat it off; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (freezing and sweat it off), RASH (Rash on her chest), VACCINATION SITE RASH (Rash on her chest & where she got the shot) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (freezing and sweat it off) and CHILLS (Chills). On 18-Nov-2021, the patient experienced RASH (Rash on her chest) and VACCINATION SITE RASH (Rash on her chest & where she got the shot). At the time of the report, HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (freezing and sweat it off), RASH (Rash on her chest), VACCINATION SITE RASH (Rash on her chest & where she got the shot) and CHILLS (Chills) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient received their 2nd dose on 16-Nov-2021 and was fine that 1st day. On the next day, they had sweats and chills and would be freezing and sweat it off, freezing & sweat it off. On 18-Nov-2021, the patient noticed a rash on their chest & where they received the shot. The patient also had a history of Asthma.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: cold; slight cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and COUGH (slight cough) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 NASOPHARYNGITIS (cold) and COUGH (slight cough). The patient was treated with CEFDINIR for Cough and Cold, at a dose of 300 mg, for 8 days. At the time of the report, NASOPHARYNGITIS (cold) and COUGH (slight cough) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient is supposed to be getting the booster shot on Saturday 20-Nov-2021. The doctor has had him on antibiotics because he had a slight cough and cold. He has been taking cefdinir 300 mg for 8 days; he still has another 2 or 3 days.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, PHENYTOIN, QUETIAPINE and OXCARBAZEPINE for an unknown indication.  On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that they had just received the vaccine on 18-OCT-2021 and did not realize it expired 07-NOV-2021.The vial was initially stored in the refrigerator on 18-OCT-21 and vial didn't undergo any temperature excursions. When reporter was providing information, she realized one patient had not received a Moderna vaccine. So the total number reported was 47.  No concomitant medication details was provided. No treatment medication details was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a booster dose out of expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a booster dose out of expired vial) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a booster dose out of expired vial). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a booster dose out of expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that dose vial mentioned that the vial didn't undergo any temperature excursions.  No treatment details were reported.  This is a spontaneous case concerning a 40-year-old, female patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine (lot number 041C21A). The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 16 days past expiration date (Date of mRNA-1273 vaccine administration: 17 November 2021, expiration date of administered mRNA-1273 vaccine: 1 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 40-year-old, female patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine (lot number 041C21A). The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 16 days past expiration date (Date of mRNA-1273 vaccine administration: 17 November 2021, expiration date of administered mRNA-1273 vaccine: 1 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired date was 07-NOV-2021. Concomitant medications were not reported. Treatment information was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. Vaccine expiration date was mentioned as 07-NOV-2021
Age: 72.0
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 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.  This is a case of Expired Product Administered concerning a 66-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 66-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 70.0
Sex: U
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 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-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 reported.  Treatment information was not provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: get another booster shot by accident on 09Nov2021/received 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (get another booster shot by accident on 09Nov2021/received 2nd booster dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (get another booster shot by accident on 09Nov2021/received 2nd booster dose). On 09-Nov-2021, EXTRA DOSE ADMINISTERED (get another booster shot by accident on 09Nov2021/received 2nd booster dose) had resolved.            No treatment medications were reported by the reporter. No concomitant medication were reported by the reporter.   Patient was then taken to urgent care. Per staff patient did not had any reactions and the doctor said that if he was going to have a bad reaction, he would have had it immediately. Per caller, patient was fairly healthy, did not know the medical conditions in detail. No concomitant medication were given.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID-19 after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID-19 after the second dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced COVID-19 (got COVID-19 after the second dose). At the time of the report, COVID-19 (got COVID-19 after the second dose) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. This case concerns a 77-year-old female patient, with no medical history reported, who experienced non serious unexpected AESI of COVID-19 after second dose of mRNA-1273. The event occurred approximately 4 months after dose. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 77-year-old female patient, with no medical history reported, who experienced non serious unexpected AESI of COVID-19 after second dose of mRNA-1273. The event occurred approximately 4 months after dose. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: itching; slight little pain when the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and VACCINATION SITE PAIN (slight little pain when the needle went in) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE PAIN (slight little pain when the needle went in). On 05-Feb-2021, PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE PAIN (slight little pain when the needle went in) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-391910 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: felt tired; He had aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) and MYALGIA (He had aches) 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 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FATIGUE (felt tired) and MYALGIA (He had aches). At the time of the report, FATIGUE (felt tired) and MYALGIA (He had aches) outcome was unknown.            No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) 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. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). In November 2021, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: Could not move; Extreme nausea almost to the point of vomiting; Chills; Headache; Extreme fatigue/Fatigued/just tired/Tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not move), NAUSEA (Extreme nausea almost to the point of vomiting), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Extreme fatigue/Fatigued/just tired/Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 023C21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arm fracture (Broken arm). Concomitant products included MELOXICAM (MOBIC) for Arm fracture.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced MOBILITY DECREASED (Could not move), NAUSEA (Extreme nausea almost to the point of vomiting), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Extreme fatigue/Fatigued/just tired/Tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at a dose of UNK mg. At the time of the report, MOBILITY DECREASED (Could not move), NAUSEA (Extreme nausea almost to the point of vomiting), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Extreme fatigue/Fatigued/just tired/Tired) outcome was unknown.            Patient stated that after getting her shot (booster dose) yesterday, she woke up with extreme nausea almost to the point of vomiting, chills, headache, extreme fatigue, and chills. She was just immobile yesterday when it happened, just tired and fatigued, she could not move her due to headache just pounding. She took Extra Strength Tylenol 1000 mg; she could not take Ibuprofen because is taking Mobic 15 mg for broken arm.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Lymphadenopathy
Clinical narrative: tastes different; swelling of lymph nodes under arm/swelling of lymph nodes in neck; 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 AGEUSIA (tastes different) and LYMPHADENOPATHY (swelling of lymph nodes under arm/swelling of lymph nodes in neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21 and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced AGEUSIA (tastes different) and LYMPHADENOPATHY (swelling of lymph nodes under arm/swelling of lymph nodes in neck). At the time of the report, AGEUSIA (tastes different) and LYMPHADENOPATHY (swelling of lymph nodes under arm/swelling of lymph nodes in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information was reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tiredness; Shivering; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), CHILLS (Shivering) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), CHILLS (Shivering) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), CHILLS (Shivering) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: 3 friends got COVID-19 infection after completing the Moderna COVID-19 primary series because their immunity went down.; people who have gotten the Moderna COVID-19 vaccine earlier on in the; 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 COVID-19 (3 friends got COVID-19 infection after completing the Moderna COVID-19 primary series because their immunity went down.) and MALAISE (people who have gotten the Moderna COVID-19 vaccine earlier on in the) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (3 friends got COVID-19 infection after completing the Moderna COVID-19 primary series because their immunity went down.) and MALAISE (people who have gotten the Moderna COVID-19 vaccine earlier on in the). At the time of the report, COVID-19 (3 friends got COVID-19 infection after completing the Moderna COVID-19 primary series because their immunity went down.) and MALAISE (people who have gotten the Moderna COVID-19 vaccine earlier on in the) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   Caller reported three friends have come down with COVID-19 infection after completing the Moderna COVID-19 primary series because their immunity went down. She also reported the Moderna vaccine does not provide any long-term protection against COVID-19. The caller also stated that people who have gotten the Moderna COVID-19 vaccine earlier on in the year are now getting sick because their antibodies are dropping.  This is a spontaneous case concerning an unknown years old, unknown gender patient with unknown clinical history who experienced the unexpected events of COVID-19 (AESI) and MALAISE. The events occurred unknown days after the first dose of mRNA-1273 vaccine. The rechallenge is not applicable as the events occurred after the first dose and no more doses will be received by the patient.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an unknown years old, unknown gender patient with unknown clinical history who experienced the unexpected events of COVID-19 (AESI) and MALAISE The events occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge is not applicable as the events occurred after the first dose and no more doses will be received by the patient  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.