chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided No treatment information was reported Patient is not on any concomitant medication that the HCP is aware of. Patient had no known allergies. Patient was observed for 30 minutes after vaccination and was doing okay.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joints) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in joints). At the time of the report, ARTHRALGIA (Pain in joints) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  It was reported that patient thought it could be occurred due to work out.   This case was linked to MOD-2021-337202 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: back pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN LISPRO (HUMALOG) for an unknown indication, LEVOTHYROXINE.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment heating pad was taken.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site joint pain
Clinical narrative: sore left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (sore left shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE JOINT PAIN (sore left shoulder). At the time of the report, VACCINATION SITE JOINT PAIN (sore left shoulder) outcome was unknown.            No concomitant drugs are provided and treatment drugs are also not provided by the reporter.; Sender's Comments: This case concerns a 66-year-old male patient with current cancer, who experienced a non-serious unexpected event of vaccination site joint pain. The event occurred on the same day of the second dose of mRNA-1273. The rechallenge is not applicable as patient experienced AEs after second dose and no information about the first dose is available and no additional dosing will be given. The benefit-risk relationship of mRNA-1273, is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: unknown number of patients had been given doses of an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of an expired vaccine). In September 2021, EXPIRED PRODUCT ADMINISTERED (unknown number of patients had been given doses of 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.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up document received contain Email updated
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Moderna COVID-19 vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion). On 01-Sep-2021, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  It was reported that there was a temperature fluctuation that last for 15 hours (approximate 4:05pm through 6:50am the next morning). The lowest temperature was 32.7 with fluctuations until it was restored to 35 degrees and above at 6:50am).  It was also mentioned that when the vial was used, it was in a normal liquid state. The vial was moved from freezer to fridge on 31-Aug-2021 and was only in fridge for a day prior to administration. Because the vaccine did not get down to freezing, reporter did not send the excursion for evaluation.   Vaccine was administered intramuscularly in the upper deltoid and reporter was not sure which arm. It was stated that patients did not experience any adverse reactions following administration.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received and does not contain any new information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Throat irritation
Clinical narrative: Sinuses were running after 1st shot; Throat was burning after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Allergy (Another Doctor (ENT-2) did allergy test in MAY2021 and She has a history of allergies.).    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot). At the time of the report, SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SINUSITIS (Sinuses were running after 1st shot) and THROAT IRRITATION (Throat was burning after 1st shot) to be possibly related.    Concomitant medication was not provided.  The patient received the first dose of Moderna COVID-19 vaccine on 11Jul2021 (Lot# 048C21A & Exp. Date: unknown) in her right arm. Two weeks later, her sinuses were running and her throat was burning. She visited a doctor, but they did not do any COVID test.  Company Comment: This case concerns an 83-year-old, female patient with a medical history of Gastroesophageal reflux disease (GERD), who experienced the unexpected non-serious events of sinusitis and throat irritation. The events occurred 2 weeks after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was positive as the events recurred after admininstration of the second dose of the Moderna COVID-19 Vaccine. The medical history of GERD, which may cause throat irritation, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-335341 (Patient Link).; Sender's Comments: This case concerns an 83-year-old, female patient with a medical history of Gastroesophageal reflux disease (GERD), who experienced the unexpected non-serious events of sinusitis and throat irritation. The events occurred 2 weeks after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was positive as the events recurred after admininstration of the second dose of the Moderna COVID-19 Vaccine. The medical history of GERD, which may cause throat irritation, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema
Clinical narrative: Patch was the size of a softball; Red Patch on right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.   Concomitant products included ATORVASTATIN, LEVOTHYROXINE, CALCIUM, VITAMIN B12 [VITAMIN B12 NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm). At the time of the report, RASH (Patch was the size of a softball) and VACCINATION SITE ERYTHEMA (Red Patch on right injection site arm) outcome was unknown.      No treatment information was provided.  Patient had no adverse reactions after the first vaccination.; Sender's Comments: This case concerns a 71 years old female patient, with no reported relevant medical history, who experienced the non-serious unexpected event of Rash and the non-serious expected event of Vaccination site erythema. The events occurred the same day after the second dose of Spikevax. The rechallenge was not applicable for the events as no additional dosing will be given. Use of concomitant Atorvastatin remains a confouder to the event of Rash. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pain, Paraesthesia
Clinical narrative: progressively gotten worse; tingling in the same arm; throbbing, painful feeling, it's interrupted by pain, it's a dull pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the same arm), PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain) and CONDITION AGGRAVATED (progressively gotten worse) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV disease, ATORVASTATIN for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PARAESTHESIA (tingling in the same arm) and PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (progressively gotten worse). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in the same arm), PAIN (throbbing, painful feeling, it's interrupted by pain, it's a dull pain) and CONDITION AGGRAVATED (progressively gotten worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient said that pain had progressively gotten worse. The last week or two he could not find a comfortable position to sleep due to the pain he has been experiencing. His sleep has been getting interrupted by the pain. He says that he is normally a healthy person and he does not participate in any activities that would cause a throbbing pain like this.  He says that not having been able to sleep the last couple of weeks is most distressing. The patient was qualified to take third dose of Moderna vaccine. The patient could only point towards the Moderna vaccine for causing this.   This case was linked to MOD-2021-335659 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Diarrhoea, Dizziness, Headache
Clinical narrative: Diarrhea; Nauseas; fever over 100°F; Dizziness; No appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache) and PYREXIA (fever over 100°F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.    On 25-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced HEADACHE (Headache). On 26-Sep-2021, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and PYREXIA (fever over 100°F). On 27-Sep-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nauseas). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 27-Sep-2021, PYREXIA (fever over 100°F) had resolved. At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and HEADACHE (Headache) had not resolved and DIARRHOEA (Diarrhea) and NAUSEA (Nauseas) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Body temperature: 100 (High) 100 degree Fahrenheit..         This case was linked to MOD-2021-335510, MOD-2021-335520 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Diarrhea; Nauseas; fever over 100°F; Dizziness; No appetite; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache) and PYREXIA (fever over 100°F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.    On 25-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced HEADACHE (Headache). On 26-Sep-2021, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and PYREXIA (fever over 100°F). On 27-Sep-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nauseas). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 27-Sep-2021, PYREXIA (fever over 100°F) had resolved. At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (No appetite) and HEADACHE (Headache) had not resolved and DIARRHOEA (Diarrhea) and NAUSEA (Nauseas) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Body temperature: 100 (High) 100 degree Fahrenheit..         This case was linked to MOD-2021-335510, MOD-2021-335520 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Arm hurt; Couldn't lifted up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and LIMB DISCOMFORT (Couldn't lifted up) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 19-Jun-2021, SARS-CoV-2 test: negative (Negative) DDF SARS-COV-2 AB IgG was 8.52 reactive and under normal range it's an arrow going to -1.41 and under units index and sore dry blood spots.. On 09-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Reactive positive for Anti-SARS-COV-2 IgG antibodies. On 09-Sep-2021, SARS-CoV-2 test: DDF SARSCOV-2 AB IgG was 2.93 reactive and under normal range again it's an arrow going to -1.41 and under units it's index and sore dry blood spots..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.    This case was linked to MOD-2021-335697 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) had not resolved.            Treatment was not specified.   This case was linked to MOD-2021-335494, MOD-2021-335494 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose/Had vaccine that expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Emotional distress
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of emotional distress (started feeling an emotional choked-up feeling that lasted for an hour) and anxiety (she has very bad anxiety) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 039D21A and 93990Y) for COVID-19 immunization. No medical history reported. On Aug 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 28, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 28, 2021, patient experienced emotional distress (started feeling an emotional choked-up feeling that lasted for an hour). On an unknown date, patient experienced anxiety (she has very bad anxiety). At the time of the report,  emotional distress (started feeling an emotional choked-up feeling that lasted for an hour) and anxiety (she has very bad anxiety) outcome: unknown. Concomitant product use and treatment information not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach pain) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment using Pepto Bismuth was reported and it did nothing.  No concomitant medication were provided.; Sender's Comments: This case concerns a 34-year-old female patient with no medical history, who experienced the unexpected event of Abdominal pain upper. The event of Abdominal pain upper occurred on the same day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown. The information regarding the second dose was not provided.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 50.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19; accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Second dose) and Pfizer vaccine (First dose).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (vaccinated with a 2 dose series of Pfizer and reported he received an accidental 3rd dose of Moderna COVID-19) and EXTRA DOSE ADMINISTERED (accidental, inadvertent administration of a dose of Moderna COVID-19 vaccine) had resolved. Not Provided          Patient received an accidental third dose of Moderna COVID-19 vaccine when he was to receive Flu shot from his  pharmacy.he pharmacist realized the mistake aer administering the dose and proceeded to administer the Flu vaccine. No concomitant medications were reported. No treatment medications were mentioned.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain after the 2nd dose of the Moderna Covid Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain after the 2nd dose of the Moderna Covid Vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain after the 2nd dose of the Moderna Covid Vaccine). At the time of the report, CHEST PAIN (Chest pain after the 2nd dose of the Moderna Covid Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   This case was linked to (E2B Linked Report).; Sender's Comments: This case concerns a 46-year-old female, with no medical history, who experienced the unexpected event of Chest pain. The event of Chest pain occurred on an unknown day after receiving the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable. No more doses are expected for this patient. The benefit-risk relationship is not affected by this report. Case ID:AE-2021-14813
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 52-year-old male patient who received mRNA-1273 (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided No prior temperature excursions for the patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Nausea, Off label use
Clinical narrative: received a third dose although she was not immunocompromised; normal side effects; diarrhea; fatigued; nauseas; vomiting; fever; muscle ache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included LOSARTAN, Lexopril, bisoprolol/HCTZ and vitamin D.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever), MYALGIA (muscle ache), OFF LABEL USE (received a third dose although she was not immunocompromised) and VACCINATION COMPLICATION (normal side effects). At the time of the report, DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown, OFF LABEL USE (received a third dose although she was not immunocompromised) had resolved and VACCINATION COMPLICATION (normal side effects) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.   This case was linked to MOD-2021-335664, MOD-2021-335665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Significant follow up received at 1-OCT-2021 :Narrative concomitant medications, event updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: received a third dose although she was not immunocompromised; normal side effects; diarrhea; fatigued; nauseas; vomiting; fever; muscle ache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included LOSARTAN, Lexopril, bisoprolol/HCTZ and vitamin D.    On 22-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever), MYALGIA (muscle ache), OFF LABEL USE (received a third dose although she was not immunocompromised) and VACCINATION COMPLICATION (normal side effects). At the time of the report, DIARRHOEA (diarrhea), FATIGUE (fatigued), NAUSEA (nauseas), VOMITING (vomiting), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown, OFF LABEL USE (received a third dose although she was not immunocompromised) had resolved and VACCINATION COMPLICATION (normal side effects) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.   This case was linked to MOD-2021-335664, MOD-2021-335665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Significant follow up received at 1-OCT-2021 :Narrative concomitant medications, event updated.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Encephalitis, Meningitis
Clinical narrative: Encephalitis; Meningitis; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS (Encephalitis) and MENINGITIS (Meningitis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient received first dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant) and MENINGITIS (Meningitis) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (Encephalitis) and MENINGITIS (Meningitis) 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. Treatment information was not provided.   It was reported that consumer was to confused and could not answer more questions.  Company Comment : This case concerns a patient with gender and age unknown with no relevant history reported in this case, who experienced the serious unexpected events of Encephalitis and Meningitis. The events occurred on an unknow date, there is no information reported related the latency with the dose of the Moderna COVID-19 Vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. Concomitant medication reported as SHINGRIX (VARICELLA ZOSTER VACCINE RGE (CHO)) reminds as a confounder/co-suspects for the events. The events were considered related to the study drug as per the reporter's assessment with the presence of confounding mentioned factors. The benefit-risk relationship of drug x in not affected by this report.; Sender's Comments: This case concerns a patient with gender and age unknown with no relevant history reported in this case, who experienced the serious unexpected events of Encephalitis and Meningitis. The events occurred on an unknow date, there is no information reported related the latency with the dose of the Moderna COVID-19 Vaccine. The rechallenge is unknown for the events since no information about the dose sequence is provided. Concomitant medication reported as SHINGRIX (VARICELLA ZOSTER VACCINE RGE (CHO)) reminds as a confounder/co-suspects for the events. The events were considered related to the study drug as per the reporter's assessment with the presence of confounding mentioned factors. The benefit-risk relationship of drug x in not affected by this report.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Nausea, Trichoglossia
Clinical narrative: Black, hairy tongue; Nausea; Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), TRICHOGLOSSIA (Black, hairy tongue) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Stomach discomfort.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced AGEUSIA (Loss of taste). On an unknown date, the patient experienced TRICHOGLOSSIA (Black, hairy tongue) and NAUSEA (Nausea). On 28-Sep-2021, AGEUSIA (Loss of taste) had resolved. At the time of the report, TRICHOGLOSSIA (Black, hairy tongue) had resolved and NAUSEA (Nausea) had not resolved.      This case concerns a 86-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of ageusia and trichoglossia and expected non-serious event of nausea. The events occurred on the 5 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  No concomitant medications were reported.  Treatment medications included compounded mouth wash which cleared up the hairy tongue and nausea pills.; Sender's Comments: This case concerns a 86-year-old female patient with no relevant medical history, who experienced the unexpected non-serious events of ageusia and trichoglossia and expected non-serious event of nausea. The events occurred on the 5 months after receiving second dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the event Covid-19 occurred only after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Myalgia, SARS-CoV-2 test
Clinical narrative: body aches; chills; tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19), MYALGIA (body aches) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (tested positive for Covid-19). On 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (body aches) and CHILLS (chills). On 05-Feb-2021, MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, SARS-CoV-2 test: positive Positive.         No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-012786 (Patient Link).; Sender's Comments: This case concerns a 58-year-old male patient with no medical history, who experienced expected events of Myalgia, Chills and unexpected evet of COVID-19. The events of Myalgia and Chills occurred on the second day after receiving the second dose of mRNA-1273, Moderna COVID-19 Vaccine. The event of COVID-19 occurred on the second day after receiving the first dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge is Not applicable.  The benefit-risk relationship of  mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Product administered to patient of inappropriate age
Clinical narrative: Not receiving 2nd dose on time; 16 year old receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine) and INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time) had resolved.            No concomitant medication was provided. No treatment medication was provided.; Sender's Comments: This case concerns a 16 year old female patient with no relevant medical history reported, who experienced the non serious unexpected events of product administered to patient of inappropriate age and intentional dose omission. The event occurred on an unknown date after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown, since no information about second dose is provided and the event is resolved. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Fatigue, Head discomfort, Influenza
Clinical narrative: Felt like something in her chest like a bomb after getting 3rd dose; Had a cold; felt like a flu; she had sever reaction after receiving 3rd dose; Could lift her head up off the pillow this time; Patient is still experiencing little fatigue; little bit of a headache that is more toward sinus; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose), NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), SINUS HEADACHE (little bit of a headache that is more toward sinus) and VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Non-smoker and Vaccination adverse reaction. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced SINUS HEADACHE (little bit of a headache that is more toward sinus). On an unknown date, the patient experienced CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose), NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose), HEAD DISCOMFORT (Could lift her head up off the pillow this time) and FATIGUE (Patient is still experiencing little fatigue). The patient was treated with AZITHROMYCIN (Z-PAK) on 19-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Felt like something in her chest like a bomb after getting 3rd dose) and HEAD DISCOMFORT (Could lift her head up off the pillow this time) outcome was unknown and NASOPHARYNGITIS (Had a cold), INFLUENZA (felt like a flu), SINUS HEADACHE (little bit of a headache that is more toward sinus), VACCINATION COMPLICATION (she had sever reaction after receiving 3rd dose) and FATIGUE (Patient is still experiencing little fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative and. On 15-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: abnormal (abnormal) Had temperature.         Patient went on PCR COVID-19 test on 28-Sep-2021.   This case was linked to MOD-2021-334391, MOD-2021-335705 (Patient Link).