chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Erythema multiforme, Glomerulonephritis, Nephrotic syndrome
Clinical narrative: Erythema multiforme; glomerulonephritis or kidney inflammation; nephrotic syndrome; 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 ERYTHEMA MULTIFORME (Erythema multiforme), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) and NEPHROTIC SYNDROME (nephrotic syndrome) 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 ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) (seriousness criterion medically significant) and NEPHROTIC SYNDROME (nephrotic syndrome) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) and NEPHROTIC SYNDROME (nephrotic syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided and no treatment information was provided.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Given vaccine after sitting out punctured for a day.; Given another dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) 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 reported.  It was reported that vaccine had been punctured on 10-May-2021 and left on the counter overnight before 3 doses were administered and the vaccine given to the patient was expired.  Reporter also stated that concerning dose of vaccine had not experienced any previous temperature excursions.  Patient did not experience any known symptoms on receiving 3 doses of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) 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.   Concomitant medications were not provided.  Treatment information was not reported.   This case was linked to MOD21-129698, MOD21-129760, MOD21-129760, MOD21-129763, MOD21-129764, MOD-2021-285598 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Intentional dose omission, Limb discomfort
Clinical narrative: she won't be getting the second dose of the vaccine; chills; headaches; side effects that she is not comfortable with; "Everything it's sticking to me and I don't like it at all"  to her arm and forehead.; she laid down on her phone and it got stuck to her arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all"  to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all"  to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine). At the time of the report, DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all"  to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: she won't be getting the second dose of the vaccine; chills; headaches; side effects that she is not comfortable with; "Everything it's sticking to me and I don't like it at all"  to her arm and forehead.; she laid down on her phone and it got stuck to her arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all"  to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all"  to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine). At the time of the report, DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all"  to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac flutter, Palpitations, Product dose omission issue
Clinical narrative: 5 months since first dose; Made my heart race and flutter for 3 weeks on and off; Made my heart race and flutter for 3 weeks on and off; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off) (seriousness criterion medically significant), PALPITATIONS (Made my heart race and flutter for 3 weeks on and off) and PRODUCT DOSE OMISSION ISSUE (5 months since first dose). At the time of the report, CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off), PALPITATIONS (Made my heart race and flutter for 3 weeks on and off) and PRODUCT DOSE OMISSION ISSUE (5 months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided. The patient did not get the second dose because of the adverse events.  Company Comment:  Very limited information regarding the events has been provided at this time insufficient for causality assessment.; Sender's Comments: Very limited information regarding the events has been provided at this time insufficient for causality assessment.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, Vaccination site pain
Clinical narrative: Rash; Painful arm and arm hurting a lot; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Mastectomy (In Right hand side) and Migraine. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine.    On 15-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 RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-285649 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Chest pain, Feeling abnormal, Headache
Clinical narrative: Did not want to receive the second dose; Horrible Headache; Hypokalemia; Chest Pain; Chest Pressure; Felt like I was hit by a train; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOKALAEMIA (Hypokalemia) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced HYPOKALAEMIA (Hypokalemia) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Pressure), FEELING ABNORMAL (Felt like I was hit by a train) and HEADACHE (Horrible Headache). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not want to receive the second dose). The patient was treated with POTASSIUM (intravenous) for Hypokalemia, at an unspecified dose and frequency. On 26-Dec-2020, FEELING ABNORMAL (Felt like I was hit by a train) had resolved. At the time of the report, HYPOKALAEMIA (Hypokalemia), CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Pressure) and HEADACHE (Horrible Headache) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not want to receive the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Blood pressure measurement: high (High) blood pressure was "through the roof.     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 by the reporter.  Additional treatment medications included intravenous fluids.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokalaemia, Intentional dose omission
Clinical narrative: Did not want to receive the second dose; Horrible Headache; Hypokalemia; Chest Pain; Chest Pressure; Felt like I was hit by a train; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOKALAEMIA (Hypokalemia) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced HYPOKALAEMIA (Hypokalemia) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Pressure), FEELING ABNORMAL (Felt like I was hit by a train) and HEADACHE (Horrible Headache). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not want to receive the second dose). The patient was treated with POTASSIUM (intravenous) for Hypokalemia, at an unspecified dose and frequency. On 26-Dec-2020, FEELING ABNORMAL (Felt like I was hit by a train) had resolved. At the time of the report, HYPOKALAEMIA (Hypokalemia), CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Pressure) and HEADACHE (Horrible Headache) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not want to receive the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Blood pressure measurement: high (High) blood pressure was "through the roof.     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 by the reporter.  Additional treatment medications included intravenous fluids.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Beyond 42 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 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 07-May-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 (Beyond 42 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness
Clinical narrative: Dizziness; Chest pains; 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 DIZZINESS (Dizziness) and CHEST PAIN (Chest pains) 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 DIZZINESS (Dizziness) and CHEST PAIN (Chest pains). At the time of the report, DIZZINESS (Dizziness) and CHEST PAIN (Chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications details were provided.  No Treatment Medications details were provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: rashes itch; rashes on her stomach and back,rash sting; This spontaneous case was reported by a consumer and describes the occurrence of   in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     NO Treatment drug reported.  Patient reported she stayed in the observation room for 30 minutes &  she did not experience any reaction that time.  Patient is allergic to a lot of over the counter drugs, penicillin, sulfur.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment information was provided   This case was linked to MOD-2021-285598 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Lump under arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump under arm) 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 MASS (Lump under arm). At the time of the report, MASS (Lump under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: sore injection site left arm; Headache; Fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment details were reported.   This case was linked to MOD-2021-285675 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tremors in both hands and jaw; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors in both hands and jaw) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced TREMOR (Tremors in both hands and jaw). At the time of the report, TREMOR (Tremors in both hands and jaw) had not resolved.            No Concomitant medications were reported.  No Treatment information was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: sore injection site left arm; headache; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-285667 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site but not on the muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site but not on the muscle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site but not on the muscle). At the time of the report, VACCINATION SITE PAIN (pain at the injection site but not on the muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-285693.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: couldn't lift both arms and both legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (couldn't lift both arms and both legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.   Concomitant products included GABAPENTIN for Neuropathy, Blood pressure and Thyroid therapy.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 DYSKINESIA (couldn't lift both arms and both legs) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to 06-Apr-2021 due to DYSKINESIA. The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) at an unspecified dose and frequency. At the time of the report, DYSKINESIA (couldn't lift both arms and both legs) outcome was unknown.  Patient was having physical therapy due to too much of antibodies (unspecified) were damaging patient's muscle. The patient was hospitalized for 12 days.  Also patient was taking 2 infusions with rituxan caller does not know how to spell Rituxan, actual medicine could not be confirmed.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (a sore arm). At the time of the report, VACCINATION SITE PAIN (a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication include chemotherapy for a blood disorder. No Treatment information was reported.   This case was linked to MOD-2021-285685 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hypersomnia, Pyrexia
Clinical narrative: slept all day after the second dose; feeling bad; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (chemotherapy for a blood disorder.).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-285683 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning) in a 32-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning). At the time of the report, VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: lose strength/without strength/the muscle on the "rabbit" there is where lost strength; tried to lift the arm and the pain was strong; muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt; where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle; tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired). At the time of the report, ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-285679 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Achy for the day after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy for the day after first dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history information was reported.  Concomitant products included APIXABAN (ELIQUIS) and CLONIDINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achy for the day after first dose). At the time of the report, MYALGIA (Achy for the day after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication were provided.    This case was linked to MOD-2021-285702 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Dyspnoea, Eyelid function disorder, Injection site pain, Mobility decreased
Clinical narrative: Shortness of breath; Felt like a sinus infection; right eyelid is twitching; sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes; can't raise his left arm sometimes; Achy; the Injection site was aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes) and MOBILITY DECREASED (can't raise his left arm sometimes) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Retinal hole (Patient has hole in the retina in his left eye so he sees eye doctor for that, was diagnosed three years ago.). Concomitant products included APIXABAN (ELIQUIS) and CLONIDINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes), MYALGIA (Achy) and INJECTION SITE PAIN (the Injection site was aching). At the time of the report, DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection) and MYALGIA (Achy) had resolved and BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes) and INJECTION SITE PAIN (the Injection site was aching) had not resolved.            No treatment medicine was provided.   This case was linked to MOD-2021-285694 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sinusitis
Clinical narrative: Shortness of breath; Felt like a sinus infection; right eyelid is twitching; sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes; can't raise his left arm sometimes; Achy; the Injection site was aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes) and MOBILITY DECREASED (can't raise his left arm sometimes) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Retinal hole (Patient has hole in the retina in his left eye so he sees eye doctor for that, was diagnosed three years ago.). Concomitant products included APIXABAN (ELIQUIS) and CLONIDINE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes), MYALGIA (Achy) and INJECTION SITE PAIN (the Injection site was aching). At the time of the report, DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection) and MYALGIA (Achy) had resolved and BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning  /eyes feel heavy and sandy  /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes) and INJECTION SITE PAIN (the Injection site was aching) had not resolved.            No treatment medicine was provided.   This case was linked to MOD-2021-285694 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune inner ear disease, Vertigo
Clinical narrative: Auto immune disease in inner right ear; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) and VERTIGO (Vertigo) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Meniere's disease (In left ear) since 2019. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for Autoimmune inner ear disease, PREDNISONE, METOPROLOL TARTRATE (METOPROLOL XL), ROSUVASTATIN CALCIUM (CRESTOR), FAMOTIDINE (PEPCID [FAMOTIDINE]), LEVOTHYROXINE and DENOSUMAB (PROLIA) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) (seriousness criterion medically significant) and VERTIGO (Vertigo) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) and VERTIGO (Vertigo) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The treatment with Imuran for autoimmune ear disease was discontinued due to high liver enzymes. The patient received both of vaccinations in left arm shoulder deltoid muscle.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However patients' past history of Meniere's disease could be a confounding factor in the occurrence of events.   This case was linked to MOD-2021-285741 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However patients' past history of Meniere's disease could be a confounding factor in the occurrence of events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune inner ear disease, Vertigo
Clinical narrative: Auto  immuneinner  Ear Disease in her right ear.; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (Auto  immuneinner  Ear Disease in her right ear.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Meniere's disease (Left ear) in 2019. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), DENOSUMAB (PROLIA), PREDNISONE, LEVOTHYROXINE, METOPROLOL TARTRATE (METOPROLOL XL) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-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 AUTOIMMUNE INNER EAR DISEASE (Auto  immuneinner  Ear Disease in her right ear.) (seriousness criterion medically significant) and VERTIGO (Vertigo). The patient was treated with AZATHIOPRINE (IMURAN [AZATHIOPRINE]) at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE INNER EAR DISEASE (Auto  immuneinner  Ear Disease in her right ear.) and VERTIGO (Vertigo) outcome was unknown.            Patient was treated with Imuran and was discontinued due to high Liver Enzymes and then patient was  placed on Cellcept .   This case was linked to MOD-2021-285739 (Patient Link).; Sender's Comments: This case concerns a 72-year-old female, with a history of Meniere's disease (left ear), who developed serious unexpected events of autoimmune inner ear disease (right ear) with associated vertigo. Event latency 2 weeks after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Chest pain, Heart rate, Pneumonia, Pyrexia
Clinical narrative: pneumonia; chest hurt; asthma; and fever since the end of May.; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant), CHEST PAIN (chest hurt), ASTHMA (asthma) and PYREXIA (and fever since the end of May.). At the time of the report, PNEUMONIA (pneumonia), CHEST PAIN (chest hurt), ASTHMA (asthma) and PYREXIA (and fever since the end of May.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: high (High) increased.         No concomitant medication information was provided No treatment product information was provided  Company comment: Very limited information regarding these events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on both legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both legs and arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MELOXICAM from 18-Feb-2021 to an unknown date for Pain.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on both legs and arms). At the time of the report, RASH (rash on both legs and arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not provided.  treatment medications included steroid cream for rash.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286241 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.