chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Doses three months apart; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Doses three months apart) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Doses three months apart). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Doses three months apart) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Patient traveled out of the country and missed 2nd dose, almost 3 months apart. Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Sinusitis, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), ASTHENIA (a little weakness) and VACCINATION SITE PAIN (Sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The patient's past medical history included Sinus infection in April 2021. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection), ASTHENIA (a little weakness) and VACCINATION SITE PAIN (Sore arm). At the time of the report, SINUSITIS (Sinus infection), ASTHENIA (a little weakness) and VACCINATION SITE PAIN (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that she started taking antibiotic since 7-8 days as she has a sinus infection. The antibiotic didn't help so she visited ENT twice. Patient has a lot of allergies. The current sinus infection started about 2 weeks ago. No concomitant medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest discomfort, Fatigue
Clinical narrative: temperature of 102°F ,then following 2 days they have temperature of 100°F; really fatigued,They are still really fatigued; felt like something was sitting on their chest; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature of 102°F ,then following 2 days they have temperature of 100°F), FATIGUE (really fatigued,They are still really fatigued) and CHEST DISCOMFORT (felt like something was sitting on their chest) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature of 102°F ,then following 2 days they have temperature of 100°F), FATIGUE (really fatigued,They are still really fatigued) and CHEST DISCOMFORT (felt like something was sitting on their chest). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 01-Jul-2021, BODY TEMPERATURE INCREASED (temperature of 102°F ,then following 2 days they have temperature of 100°F) had resolved. At the time of the report, FATIGUE (really fatigued,They are still really fatigued) and CHEST DISCOMFORT (felt like something was sitting on their chest) had not 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.
Sex: F
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: shoulder injury because of an improper administration of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury because of an improper administration of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. RA6059) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury because of an improper administration of the vaccine). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury because of an improper administration of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: Racing heart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Racing heart) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Racing heart). At the time of the report, PALPITATIONS (Racing heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Increased heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Can I get the second dose after 4 month; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can I get the second dose after 4 month) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Can I get the second dose after 4 month). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can I get the second dose after 4 month) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was reported.   Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of severe depression (he felt he had no control over) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced severe depression (he felt he had no control over). At the time of the report, severe depression (he felt he had no control over) outcome: unknown.  No concomitant medication or treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) After the second dose, tested positive for Covid..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Product dose omission issue
Clinical narrative: Hearing problem; 1st vaccine in March, wanted to find out if can get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Hearing problem) and PRODUCT DOSE OMISSION ISSUE (1st vaccine in March, wanted to find out if can get the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (Hearing problem) and PRODUCT DOSE OMISSION ISSUE (1st vaccine in March, wanted to find out if can get the 2nd dose). At the time of the report, HYPOACUSIS (Hearing problem) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (1st vaccine in March, wanted to find out if can get the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Vaccination site pain
Clinical narrative: sore throat/had soup and "felt like her throat was on fire"; trouble with voice; experiencing congestion; blowing nose; soreness at left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat/had soup and "felt like her throat was on fire"), DYSPHONIA (trouble with voice), NASAL CONGESTION (experiencing congestion), NASAL DISCOMFORT (blowing nose) and VACCINATION SITE PAIN (soreness at left arm injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and LISINOPRIL for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat/had soup and "felt like her throat was on fire"), DYSPHONIA (trouble with voice), NASAL CONGESTION (experiencing congestion), NASAL DISCOMFORT (blowing nose) and VACCINATION SITE PAIN (soreness at left arm injection site). At the time of the report, OROPHARYNGEAL PAIN (sore throat/had soup and "felt like her throat was on fire"), DYSPHONIA (trouble with voice), NASAL CONGESTION (experiencing congestion), NASAL DISCOMFORT (blowing nose) and VACCINATION SITE PAIN (soreness at left arm injection site) 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.   Treatment medications included allergy pills.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Outcome updated to recovered.
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Has not received 2nd dose, 68 days since first dose 7May2021; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Has not received 2nd dose, 68 days since first dose 7May2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Has not received 2nd dose, 68 days since first dose 7May2021). On 07-May-2021, INTENTIONAL PRODUCT USE ISSUE (Has not received 2nd dose, 68 days since first dose 7May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated not receiving the second dose due to personal reasons as he had to fly out of the country for 3 months.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 5 other patients who experienced tinnitus after receiving a Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (5 other patients who experienced tinnitus after receiving a Covid-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (5 other patients who experienced tinnitus after receiving a Covid-19 vaccine). At the time of the report, TINNITUS (5 other patients who experienced tinnitus after receiving a Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Glycosylated haemoglobin
Clinical narrative: Yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast infection) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011021A and 027D21A) for COVID-19 vaccination.     The patient's past medical history included Asthma, Seizures, Anxiety, Arthritis and Bacterial vaginosis. Previously administered products included for Product used for unknown indication: Flu shot. Concurrent medical conditions included Diabetes. Concomitant products included PROCATEROL HYDROCHLORIDE (PRO-AIR), SITAGLIPTIN PHOSPHATE (JANUVIA), GLUCOSE and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2021, the patient experienced FUNGAL INFECTION (Yeast infection). The patient was treated with METRONIDAZOLE ongoing since an unknown date at an unspecified dose and frequency and ZINC OXIDE (DESITIN [ZINC OXIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FUNGAL INFECTION (Yeast infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: a1c was at 9 (abnormal) A1C was at 9 for at least three months to date.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-253057 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna; doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) and POOR QUALITY PRODUCT ADMINISTERED (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) and POOR QUALITY PRODUCT ADMINISTERED (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna). At the time of the report, PRODUCT STORAGE ERROR (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) and POOR QUALITY PRODUCT ADMINISTERED (doses determined to be invalid due to improper storage, knowsomeone who had same situation happen with Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Arm progressively sore; Pains in the right arm/Pains in the right leg; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm progressively sore) and PAIN IN EXTREMITY (Pains in the right arm/Pains in the right leg) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M29A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Arm progressively sore) and PAIN IN EXTREMITY (Pains in the right arm/Pains in the right leg). At the time of the report, MYALGIA (Arm progressively sore) and PAIN IN EXTREMITY (Pains in the right arm/Pains in the right leg) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient got Pfizer vaccine 28 days ago and Moderna today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient got Pfizer vaccine 28 days ago and Moderna today) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient got Pfizer vaccine 28 days ago and Moderna today). On 14-Jul-2021, PRODUCT ADMINISTRATION ERROR (Patient got Pfizer vaccine 28 days ago and Moderna today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus, Sjogren's syndrome, Myopathy (small cell fiber myopathy) and Myalgia (fiber myalgia).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-020819, MOD-2021-020819 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: rash on day 3 following both shots; 2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on day 3 following both shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Allergic to sulfa drugs) and Allergy to antibiotic (Cipro allergy).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021). On an unknown date, the patient experienced RASH (rash on day 3 following both shots). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash all over, at an unspecified dose and frequency. On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021) had resolved. At the time of the report, RASH (rash on day 3 following both shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient consulted with her doctor prior to getting the second dose of the Moderna COVID-19 vaccine via a Teledoc appt. Her doctor thought that the rash may had been an allergic reaction to the first dose. No concomitant medication information were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-015969 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: she felt tingling in her facial area; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (she felt tingling in her facial area) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PARAESTHESIA (she felt tingling in her facial area).        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.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient received first dose around 60 days ago and still had not gotten second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient received first dose around 60 days ago and still had not gotten second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received first dose around 60 days ago and still had not gotten second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received first dose around 60 days ago and still had not gotten second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. The treatment information was not provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: had his first Moderna vaccine on 9Apr21 in the left arm and never went back for second dose he will be getting it today 14Jul21; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (had his first Moderna vaccine on 9Apr21 in the left arm and never went back for second dose he will be getting it today 14Jul21) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (had his first Moderna vaccine on 9Apr21 in the left arm and never went back for second dose he will be getting it today 14Jul21). On 09-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (had his first Moderna vaccine on 9Apr21 in the left arm and never went back for second dose he will be getting it today 14Jul21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave a Moderna COVID vaccine that was at room temp for 6 hours and 20 minutes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a Moderna COVID vaccine that was at room temp for 6 hours and 20 minutes) 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 EXPIRED PRODUCT ADMINISTERED (Gave a Moderna COVID vaccine that was at room temp for 6 hours and 20 minutes). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna COVID vaccine that was at room temp for 6 hours and 20 minutes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Administered to 4 People; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to 4 People) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to 4 People). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to 4 People) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.  On 11-JUL-2021 around 10AM, one vial of vaccine was  first punctured. The vial was kept at room temperature for more than 24 hours.  On 12-JUL-2021, four doses were withdrawn out of the expired vial and administered to 4 people.  Treatment information, if any, was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching
Clinical narrative: She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg; She had all common symptoms like headache on same day 4 hours after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg) and HEADACHE (She had all common symptoms like headache on same day 4 hours after receiving 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced MUSCLE TWITCHING (She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg). 12-Jul-2021, the patient experienced HEADACHE (She had all common symptoms like headache on same day 4 hours after receiving 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 6 mg. At the time of the report, MUSCLE TWITCHING (She started with muscle twitching on her right leg on upper calf on same day of receiving vaccine/ then it moved to under the injection site of the left arm/ It is now in her left calf of her left leg) had not resolved and HEADACHE (She had all common symptoms like headache on same day 4 hours after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Muscle spasms, Myalgia
Clinical narrative: CRAMPS; DIZZINESS; EXHAUSTION; sore arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (CRAMPS), DIZZINESS (DIZZINESS), FATIGUE (EXHAUSTION) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (CRAMPS), DIZZINESS (DIZZINESS), FATIGUE (EXHAUSTION) and MYALGIA (sore arm). At the time of the report, MUSCLE SPASMS (CRAMPS), DIZZINESS (DIZZINESS), FATIGUE (EXHAUSTION) and MYALGIA (sore arm) outcome was unknown.        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.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-256663 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and contain non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Vaccination complication
Clinical narrative: side effects after receiving the Moderna covid-19 vaccine/"knocked her out."; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after receiving the Moderna covid-19 vaccine/"knocked her out.") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant (Patient had liver transplant last October.) in October 2020. Concurrent medical conditions included Diabetic.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after receiving the Moderna covid-19 vaccine/"knocked her out."). At the time of the report, VACCINATION COMPLICATION (side effects after receiving the Moderna covid-19 vaccine/"knocked her out.") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Low response.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Decreased appetite, Dizziness, Fatigue
Clinical narrative: cramps/off and on cramps in his hands and his feet; dizziness; doesn't feel right; stress; loss of appetite; feels like butterfly in his stomach/a tickling sensation in his stomach; blood pressure is a little higher than usual; exhaustion/Tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps/off and on cramps in his hands and his feet), DIZZINESS (dizziness), FEELING ABNORMAL (doesn't feel right), STRESS (stress) and DECREASED APPETITE (loss of appetite) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022d21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (cramps/off and on cramps in his hands and his feet), DIZZINESS (dizziness), FEELING ABNORMAL (doesn't feel right), STRESS (stress), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (feels like butterfly in his stomach/a tickling sensation in his stomach), BLOOD PRESSURE INCREASED (blood pressure is a little higher than usual), FATIGUE (exhaustion/Tired) and MYALGIA (sore arm). At the time of the report, MUSCLE SPASMS (cramps/off and on cramps in his hands and his feet), DIZZINESS (dizziness), FEELING ABNORMAL (doesn't feel right), STRESS (stress), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (feels like butterfly in his stomach/a tickling sensation in his stomach), BLOOD PRESSURE INCREASED (blood pressure is a little higher than usual), FATIGUE (exhaustion/Tired) and MYALGIA (sore arm) outcome was unknown.        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.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-256657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up - Event added
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle spasms, Myalgia, Stress
Clinical narrative: cramps/off and on cramps in his hands and his feet; dizziness; doesn't feel right; stress; loss of appetite; feels like butterfly in his stomach/a tickling sensation in his stomach; blood pressure is a little higher than usual; exhaustion/Tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps/off and on cramps in his hands and his feet), DIZZINESS (dizziness), FEELING ABNORMAL (doesn't feel right), STRESS (stress) and DECREASED APPETITE (loss of appetite) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022d21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (cramps/off and on cramps in his hands and his feet), DIZZINESS (dizziness), FEELING ABNORMAL (doesn't feel right), STRESS (stress), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (feels like butterfly in his stomach/a tickling sensation in his stomach), BLOOD PRESSURE INCREASED (blood pressure is a little higher than usual), FATIGUE (exhaustion/Tired) and MYALGIA (sore arm). At the time of the report, MUSCLE SPASMS (cramps/off and on cramps in his hands and his feet), DIZZINESS (dizziness), FEELING ABNORMAL (doesn't feel right), STRESS (stress), DECREASED APPETITE (loss of appetite), ABDOMINAL DISCOMFORT (feels like butterfly in his stomach/a tickling sensation in his stomach), BLOOD PRESSURE INCREASED (blood pressure is a little higher than usual), FATIGUE (exhaustion/Tired) and MYALGIA (sore arm) outcome was unknown.        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.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-256657 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up - Event added
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Premature ageing, Product dose omission issue
Clinical narrative: since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.; also experiencing hair loss.; scared to take the 2nd dose/ first dose on 17MAY2021.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PREMATURE AGEING (since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.), ALOPECIA (also experiencing hair loss.) and PRODUCT DOSE OMISSION ISSUE (scared to take the 2nd dose/ first dose on 17MAY2021.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RISPERIDONE for an unknown indication.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PREMATURE AGEING (since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.), ALOPECIA (also experiencing hair loss.) and PRODUCT DOSE OMISSION ISSUE (scared to take the 2nd dose/ first dose on 17MAY2021.). At the time of the report, PREMATURE AGEING (since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.), ALOPECIA (also experiencing hair loss.) and PRODUCT DOSE OMISSION ISSUE (scared to take the 2nd dose/ first dose on 17MAY2021.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs included
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA numbers went up; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA numbers went up) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA numbers went up). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA numbers went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Prostatic specific antigen: increased (High) increased.         No concomitant drug details were reported. No treatment details were reported. On follow-up Patient said he has a MRI for his prostate cancer coming up Friday (30Jul2021).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Suspected drug start dates has been updated.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Prefilled syringe from 16Jun2021 injected into another employee; Prefilled syringe from the same vial of the first dose used for second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Prefilled syringe from 16Jun2021 injected into another employee) and EXPIRED PRODUCT ADMINISTERED (Prefilled syringe from the same vial of the first dose used for second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Prefilled syringe from 16Jun2021 injected into another employee) and EXPIRED PRODUCT ADMINISTERED (Prefilled syringe from the same vial of the first dose used for second dose). On 14-Jul-2021, PRODUCT ADMINISTRATION ERROR (Prefilled syringe from 16Jun2021 injected into another employee) and EXPIRED PRODUCT ADMINISTERED (Prefilled syringe from the same vial of the first dose used for second 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.   This case was linked to MOD-2021-256700 (Parent-Child Link).   See case MOD-2021-256700 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-Significant Follow-up appended to AER
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Depression, Fatigue, Migraine
Clinical narrative: migraine headache; sleep apnea; incontinence in going to bathroom.; Depression; Runny nose; cough; She didn't get 2nd dose due to all these side effects; chills; fatigue; body aches; fever; muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) 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, LISINOPRIL and VITAMIN D2 for an unknown indication.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced MUSCLE SPASMS (muscle spasms), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever). On an unknown date, the patient experienced MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression), RHINORRHOEA (Runny nose), COUGH (cough) and PRODUCT DOSE OMISSION ISSUE (She didn't get 2nd dose due to all these side effects). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine headache), SLEEP APNOEA SYNDROME (sleep apnea), URINARY INCONTINENCE (incontinence in going to bathroom.), DEPRESSION (Depression), RHINORRHOEA (Runny nose), MUSCLE SPASMS (muscle spasms), COUGH (cough), CHILLS (chills), FATIGUE (fatigue), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She didn't get 2nd dose due to all these side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drugs included