chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID.         Patient believed that on the 16th or 17th of November of 2021, the patient tested positive for COVID disease. No concomitant medications were given. No treatment information was provided.  Company Comment: This case concerns a 59 year-old male patient with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19, reported as a positive COVID-19 test, and the unexpected non-serious event of drug ineffective which occurred on unknown dates in November 2021 after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 59 year-old male patient with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19, reported as a positive COVID-19 test, and the unexpected non-serious event of drug ineffective which occurred on unknown dates in November 2021 after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Fear, Feeling abnormal, Illness
Clinical narrative: Appendicitis; Almost died; I'm now scared out of my mind; sick; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant), ILLNESS (sick), FEELING ABNORMAL (Almost died) and FEAR (I'm now scared out of my mind). At the time of the report, APPENDICITIS (Appendicitis), ILLNESS (sick), FEELING ABNORMAL (Almost died) and FEAR (I'm now scared out of my mind) outcome was unknown.            Concomitant medication were not reported Treatment medication were not reported The patient had sick for 5 days  Company Comment: This case concerns a female patient of an unknown age, with relevant medical history of COVID-19, who experienced the unexpected events of Appendicitis (AESI), Illness Feeling abnormal and Fear. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of COVID-19 remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received on 21-Dec-2021 as live follow up with medical history updated.; Sender's Comments: This case concerns a female patient of an unknown age, with relevant medical history of COVID-19, who experienced the unexpected events of Appendicitis (AESI), Illness Feeling abnormal and Fear. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of COVID-19 remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: whole body became itchy everywhere. Head, back, body and would come and go; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (whole body became itchy everywhere. Head, back, body and would come and go) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) 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) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced PRURITUS (whole body became itchy everywhere. Head, back, body and would come and go). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) on 12-Dec-2021 for Adverse event, at an unspecified dose and frequency and CETIRIZINE on 12-Dec-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (whole body became itchy everywhere. Head, back, body and would come and go) had not resolved.            No Concomitant medications were provided.  2 weeks after receiving the booster dose of the vaccine the whole body became itchy everywhere.  Patient continued to feel itching on the day of reporting. Patient had visited the doctor on 12 Dec 2021 and was prescribed with allergy medicines including Banophen and centrazine, but these medicines did not help.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: They were achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (They were achy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced PAIN (They were achy). At the time of the report, PAIN (They were achy) outcome was unknown.            No concomitant medication was provided.  No treatment medication was provided.  The patient was achy at the night after receiving the booster.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Little numb around the area; Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area) and HYPOAESTHESIA (Little numb around the area) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area). On an unknown date, the patient experienced HYPOAESTHESIA (Little numb around the area). At the time of the report, PAIN (Pain over her eyebrow/has the pain very frequently/at nighttime she rolls over other side/pain towards temporal area) and HYPOAESTHESIA (Little numb around the area) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not have concomitant medication.  No treatment was reported by the reporter.  Second dose was administered on 26 Mar 2021 with a batch number of 044A21A.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Lymphadenitis, Lymphadenopathy, Nervousness, Pain
Clinical narrative: Discomfort; Fever; she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast; she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.; Nervous; Experienced pain almost immediately; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), NERVOUSNESS (Nervous), PAIN (Experienced pain almost immediately), LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast) and LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 023C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced NERVOUSNESS (Nervous). 18-Dec-2021, the patient experienced PAIN (Experienced pain almost immediately). On 19-Dec-2021, the patient experienced LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast). 19-Dec-2021, the patient experienced LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.). On 19-Dec-2021 at 1:30 AM, the patient experienced DISCOMFORT (Discomfort) and PYREXIA (Fever). At the time of the report, DISCOMFORT (Discomfort), NERVOUSNESS (Nervous), PAIN (Experienced pain almost immediately), LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast), LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-421513 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Discomfort; Fever; she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast; she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.; Nervous; Experienced pain almost immediately; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), NERVOUSNESS (Nervous), PAIN (Experienced pain almost immediately), LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast) and LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 023C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced NERVOUSNESS (Nervous). 18-Dec-2021, the patient experienced PAIN (Experienced pain almost immediately). On 19-Dec-2021, the patient experienced LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast). 19-Dec-2021, the patient experienced LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.). On 19-Dec-2021 at 1:30 AM, the patient experienced DISCOMFORT (Discomfort) and PYREXIA (Fever). At the time of the report, DISCOMFORT (Discomfort), NERVOUSNESS (Nervous), PAIN (Experienced pain almost immediately), LYMPHADENITIS (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast), LYMPHADENOPATHY (she had inflammation in the armpit, and she thinks this is due to the lymph nodes between the armpit and the breast. It grew.) and PYREXIA (Fever) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-421513 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 16 year old was accidentally injected with Moderna's COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old was accidentally injected with Moderna's COVID-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old was accidentally injected with Moderna's COVID-19 vaccine). On 10-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old was accidentally injected with Moderna's COVID-19 vaccine) 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 reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication reported. No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19 and the unexpected non-serious event of drug ineffective which occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-422584 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow-up was received and included no significant information.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non-serious adverse event of special interest of COVID-19 and the unexpected non-serious event of drug ineffective which occurred 7 months 20 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (She felt sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M20A) for COVID-19 vaccination. The patient's past medical history included Sciatic hernia (Chronic sciatica with 3 bulging herniated disks on oxycontin), Heart attack, Alzheimer's disease and Schizophrenia. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), CLOPIDOGREL BISULFATE (PLAVIX), METOPROLOL, SIMVASTATIN, SERTRALINE HYDROCHLORIDE (ZOLOFT), DIAZEPAM and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (She felt sore). At the time of the report, PAIN (She felt sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that she had been previously put on a medication for schizophrenia, and had seen 12 psychiatrists at a nearby clinic. No history of bipolar disorder, or seizures.  No treatment medication was provided.   This case was linked to MOD-2021-421493, MOD-2021-421460 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The side effects were horrendous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The side effects were horrendous) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The side effects were horrendous). At the time of the report, VACCINATION COMPLICATION (The side effects were horrendous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Memory impairment, Speech disorder
Clinical narrative: HSV outbreak; hasn't been able to remember/issues remembering stuff; had problems with speech/Issues talking and stuff; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (hasn't been able to remember/issues remembering stuff), SPEECH DISORDER (had problems with speech/Issues talking and stuff) and HERPES SIMPLEX (HSV outbreak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included HSV infection (Patient has not had an outbreak in a really long time). Concurrent medical conditions included Memory impairment and Speech disorder.   On 16-Dec-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. In December 2021, the patient experienced MEMORY IMPAIRMENT (hasn't been able to remember/issues remembering stuff) and SPEECH DISORDER (had problems with speech/Issues talking and stuff). On 17-Dec-2021, the patient experienced HERPES SIMPLEX (HSV outbreak). At the time of the report, MEMORY IMPAIRMENT (hasn't been able to remember/issues remembering stuff) and SPEECH DISORDER (had problems with speech/Issues talking and stuff) had not resolved and HERPES SIMPLEX (HSV outbreak) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient got the shot on the 16 December 2021, she has not been able to remember and has had problems with speech. She has a HSV outbreak the day after. She has not had an outbreak in a really long time. Long term she has had issues with memory and talking. It was like a relapse.   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Lip erythema, Lip pruritus, Lip swelling
Clinical narrative: Swollen dry itchy lips; Swollen dry itchy lips; itchy lips; Redness around her lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen dry itchy lips), LIP DRY (Swollen dry itchy lips), LIP PRURITUS (itchy lips) and LIP ERYTHEMA (Redness around her lips) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-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 LIP SWELLING (Swollen dry itchy lips), LIP DRY (Swollen dry itchy lips), LIP PRURITUS (itchy lips) and LIP ERYTHEMA (Redness around her lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (Swollen dry itchy lips), LIP DRY (Swollen dry itchy lips), LIP PRURITUS (itchy lips) and LIP ERYTHEMA (Redness around her lips) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No any concomitant medications were reported. Patient took Oral steroid as treatment medication.   This case was linked to MOD-2021-421633 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured; A vial that was left outside of the fridge for more than 12 hours post punctured; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured) and PRODUCT STORAGE ERROR (A vial that was left outside of the fridge for more than 12 hours post punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured) and PRODUCT STORAGE ERROR (A vial that was left outside of the fridge for more than 12 hours post punctured). On 11-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured) and PRODUCT STORAGE ERROR (A vial that was left outside of the fridge for more than 12 hours post punctured) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial was initially stored in the refrigerator on 01-Dec-2021. The vial was first punctured 10-Dec-2021 at 1PM. Post puncture the vial was stored in the fridge. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: extreme chills booster dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (extreme chills booster dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (severe), Seizure and Heart murmur.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced CHILLS (extreme chills booster dose). On 19-Dec-2021, CHILLS (extreme chills booster dose) had resolved.            Patient had other medical problems. Patient had ten concomitant/regular medications which were not specified. Treatment information include Advil and Stayed in bed for unspecified dose.   This case was linked to MOD-2021-421798 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 3rd dose (full dose) of the Moderna Covid-19 vaccine because her job required her to to have person to person contact.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (3rd dose (full dose) of the Moderna Covid-19 vaccine because her job required her to to have person to person contact.) in a 71-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) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (3rd dose (full dose) of the Moderna Covid-19 vaccine because her job required her to to have person to person contact.). On 09-Sep-2021, ACCIDENTAL OVERDOSE (3rd dose (full dose) of the Moderna Covid-19 vaccine because her job required her to to have person to person contact.) had resolved.            Patient heard a doctor today that the booster dose has an effective rate of 83% for 2 months and wants to know for how long will this last. No treatment information was provided by the reporter. No Concomitant medicines were reported.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Accidental overdose, Chills, Illness, Vaccination site swelling
Clinical narrative: Felt really sick for day and half; Chills; Swelling at the sit of injection upto end of their biceps; received a 3rd dose which was full dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt really sick for day and half), CHILLS (Chills), VACCINATION SITE SWELLING (Swelling at the sit of injection upto end of their biceps) and ACCIDENTAL OVERDOSE (received a 3rd dose which was full dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (received a 3rd dose which was full dose). On an unknown date, the patient experienced ILLNESS (Felt really sick for day and half), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling at the sit of injection upto end of their biceps). On 10-Aug-2021, ACCIDENTAL OVERDOSE (received a 3rd dose which was full dose) had resolved. At the time of the report, ILLNESS (Felt really sick for day and half) and CHILLS (Chills) was resolving and VACCINATION SITE SWELLING (Swelling at the sit of injection upto end of their biceps) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Patient stated that they experienced chills, felt really sick for day and half, by Sunday afternoon they felt better.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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 medication was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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 drugs were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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 information was reported.   This case was linked to MOD-2021-418891 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after second dose). At the time of the report, VACCINATION COMPLICATION (Side effects after second dose) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The patient wanted to know what were the side effects of the second dose within an hour of receiving it .
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-421914 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-418891 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter. The patient had took booster dose.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported. No treatment drugs were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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 reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-418891 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) 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 information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-418891 (Patient Link).