chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: covid arm that is itchy; covid arm that is red; covid arm that is hot; covid arm that is swollen; covid arm that is painful and sore; covid arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (covid arm that is itchy), VACCINATION SITE ERYTHEMA (covid arm that is red), VACCINATION SITE WARMTH (covid arm that is hot), VACCINATION SITE SWELLING (covid arm that is swollen) and VACCINATION SITE PAIN (covid arm that is painful and sore) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 irms for an unknown indication.    On 26-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 VACCINATION SITE PRURITUS (covid arm that is itchy), VACCINATION SITE ERYTHEMA (covid arm that is red), VACCINATION SITE WARMTH (covid arm that is hot), VACCINATION SITE SWELLING (covid arm that is swollen), VACCINATION SITE PAIN (covid arm that is painful and sore) and VACCINATION SITE REACTION (covid arm). The patient was treated with irms at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (sore arm after the 1st dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 27, 2021, patient experienced myalgia (sore arm after the 1st dose). At the time of the report, myalgia (sore arm after the 1st dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication use and treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. Diagnostic results: On an unknown date, body temperature: inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of chest pain in a 31-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 9 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced chest pain. At the time of the report, chest pain outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (experienced side effects after vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (experienced side effects after vaccination). At the time of the report, vaccination complication (experienced side effects after vaccination) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema infectiosum, Myalgia
Clinical narrative: feeling better like old self before being diagnosed with fifth persons syndrome; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) and ERYTHEMA INFECTIOSUM (feeling better like old self before being diagnosed with fifth persons syndrome) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included DIAZEPAM, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) and CANNABIS for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (muscle pain). On 28-Apr-2021, the patient experienced ERYTHEMA INFECTIOSUM (feeling better like old self before being diagnosed with fifth persons syndrome). On 28-Apr-2021, MYALGIA (muscle pain) had resolved. On 08-May-2021, ERYTHEMA INFECTIOSUM (feeling better like old self before being diagnosed with fifth persons syndrome) 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 medicine : Pain medicine.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: low grade fever; aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) and MYALGIA (aches) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PYREXIA (low grade fever) and MYALGIA (aches). At the time of the report, PYREXIA (low grade fever) and MYALGIA (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No concomitant medication reported by the reporter.; 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: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (vaccination site pruritus) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus). At the time of the report, VACCINATION SITE PRURITUS (vaccination site pruritus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever is 102.8; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever is 102.8) 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 PYREXIA (Fever is 102.8). At the time of the report, PYREXIA (Fever is 102.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.8 (High) Fever is 102.8.     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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Arm has lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Arm has lump) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Arm has lump). At the time of the report, VACCINATION SITE MASS (Arm has lump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that the event was still present after 4 weeks of vaccination. No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up received is non significant and only the contact information is updated. The event LLT/PT/ changed to Vaccination site mass as per MSA Comment. On 02-Aug-2021: Possible NNI.; Sender's Comments: Very limited information regarding the event have been provided at this time. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extrasystoles, Fatigue, Feeling abnormal, Headache
Clinical narrative: A couple of days after that I started experiencing skipping of heart beat; my heart would beat real fast for 3 times and there would be a break.I had irregular heart beat.; I had headache; chills; soreness at the site; after the shot I was fatigued; I could hardly stay awake; first night I had a rapid heart beat; I didn't feel right; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued) and INSOMNIA (I could hardly stay awake) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Declined) 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 CARVEDILOL for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued), INSOMNIA (I could hardly stay awake), HEART RATE INCREASED (first night I had a rapid heart beat) and FEELING ABNORMAL (I didn't feel right). On 24-Apr-2021, the patient experienced EXTRASYSTOLES (A couple of days after that I started experiencing skipping of heart beat) and HEART RATE IRREGULAR (my heart would beat real fast for 3 times and there would be a break.I had irregular heart beat.). On 24-Apr-2021, HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued), INSOMNIA (I could hardly stay awake), HEART RATE INCREASED (first night I had a rapid heart beat) and FEELING ABNORMAL (I didn't feel right) had resolved. On 04-Jun-2021, EXTRASYSTOLES (A couple of days after that I started experiencing skipping of heart beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular, Insomnia, Vaccination site pain
Clinical narrative: A couple of days after that I started experiencing skipping of heart beat; my heart would beat real fast for 3 times and there would be a break.I had irregular heart beat.; I had headache; chills; soreness at the site; after the shot I was fatigued; I could hardly stay awake; first night I had a rapid heart beat; I didn't feel right; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued) and INSOMNIA (I could hardly stay awake) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Declined) 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 CARVEDILOL for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued), INSOMNIA (I could hardly stay awake), HEART RATE INCREASED (first night I had a rapid heart beat) and FEELING ABNORMAL (I didn't feel right). On 24-Apr-2021, the patient experienced EXTRASYSTOLES (A couple of days after that I started experiencing skipping of heart beat) and HEART RATE IRREGULAR (my heart would beat real fast for 3 times and there would be a break.I had irregular heart beat.). On 24-Apr-2021, HEADACHE (I had headache), CHILLS (chills), VACCINATION SITE PAIN (soreness at the site), FATIGUE (after the shot I was fatigued), INSOMNIA (I could hardly stay awake), HEART RATE INCREASED (first night I had a rapid heart beat) and FEELING ABNORMAL (I didn't feel right) had resolved. On 04-Jun-2021, EXTRASYSTOLES (A couple of days after that I started experiencing skipping of heart beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. Action taken with mRNA-1273 in response to the events were not Applicable
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Head discomfort, Headache, Influenza like illness, Pyrexia
Clinical narrative: Pins in the top of your head; Flu like symptoms; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pins in the top of your head), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Pins in the top of your head), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, HEAD DISCOMFORT (Pins in the top of your head), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Moderna to be given 57 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna to be given 57 days after the first dose) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna to be given 57 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna to be given 57 days after the first dose) 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 medications were not provided
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: contracted shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (contracted shingles) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HERPES ZOSTER (contracted shingles). At the time of the report, HERPES ZOSTER (contracted shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 03-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 medications were mentioned. Treatment medications were not reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 68 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (68 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence, Therapeutic response unexpected
Clinical narrative: several test done and it has come back that her rare condition is in remission.; Sleeping more; Pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021. The most recent information was received on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping more), PAIN (Pain) and THERAPEUTIC RESPONSE UNEXPECTED (several test done and it has come back that her rare condition is in remission.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Stiff person syndrome (Movement disorder). Concomitant products included DIAZEPAM, CANNABIS and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced SOMNOLENCE (Sleeping more) and PAIN (Pain). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (several test done and it has come back that her rare condition is in remission.). On 24-May-2021, SOMNOLENCE (Sleeping more) and PAIN (Pain) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (several test done and it has come back that her rare condition is in remission.) outcome was unknown.            Treatment medications included pain medicines.  Reportedly, the patient had seen three different doctors for her rare disease Stiff Person Syndrome and had several tests done. The test results showed that her rare condition was in remission.   This case was linked to MOD-2021-208973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up information received, included medical history and additional event.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: very bad nausey; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (very bad nausey) in a 31-year-old patient of an unknown 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 NAUSEA (very bad nausey). At the time of the report, NAUSEA (very bad nausey) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) 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 provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Protein total increased
Clinical narrative: elevated protein in my blood; 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 PROTEIN TOTAL INCREASED (elevated protein in my blood) 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 PROTEIN TOTAL INCREASED (elevated protein in my blood). At the time of the report, PROTEIN TOTAL INCREASED (elevated protein in my blood) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Inconclusive) Patient reported elevated protein in blood.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant an treatment information was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after second dose). At the time of the report, VACCINATION COMPLICATION (Side effects after second dose) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Depression, Erythema, Gait disturbance, Insomnia
Clinical narrative: Actually getting her depressed.; Feet constantly burning; Feet constantly aching; Can't sleep; Red bump on feet; Red bump on feet; In pain; Can't walk; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Can't walk), DEPRESSION (Actually getting her depressed.), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching) and INSOMNIA (Can't sleep) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced GAIT DISTURBANCE (Can't walk), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching), INSOMNIA (Can't sleep), MASS (Red bump on feet), ERYTHEMA (Red bump on feet) and PAIN (In pain). On 04-Jun-2021, the patient experienced DEPRESSION (Actually getting her depressed.). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and ZOLPIDEM TARTRATE (AMBIEN) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (Can't walk), DEPRESSION (Actually getting her depressed.), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching), INSOMNIA (Can't sleep), MASS (Red bump on feet), ERYTHEMA (Red bump on feet) and PAIN (In pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Two weeks after receiving the 2nd dose on 07-Apr-2021, she developed a red bump on her feet to an extent that she can't walk. She had been referred to 2 different specialists and they said it's from the COVID 19 vaccine. They told her to take Ibuprofen but today they prescribed generic Ambien (zolpidem) because she was unable to sleep due to her feet constantly burning and aching. She has been in pain since 07-Apr-2021 and she was actually getting her depressed.  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. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: report contained no new information; 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. Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain, Pain in extremity
Clinical narrative: Actually getting her depressed.; Feet constantly burning; Feet constantly aching; Can't sleep; Red bump on feet; Red bump on feet; In pain; Can't walk; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Can't walk), DEPRESSION (Actually getting her depressed.), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching) and INSOMNIA (Can't sleep) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced GAIT DISTURBANCE (Can't walk), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching), INSOMNIA (Can't sleep), MASS (Red bump on feet), ERYTHEMA (Red bump on feet) and PAIN (In pain). On 04-Jun-2021, the patient experienced DEPRESSION (Actually getting her depressed.). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and ZOLPIDEM TARTRATE (AMBIEN) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (Can't walk), DEPRESSION (Actually getting her depressed.), BURNING SENSATION (Feet constantly burning), PAIN IN EXTREMITY (Feet constantly aching), INSOMNIA (Can't sleep), MASS (Red bump on feet), ERYTHEMA (Red bump on feet) and PAIN (In pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Two weeks after receiving the 2nd dose on 07-Apr-2021, she developed a red bump on her feet to an extent that she can't walk. She had been referred to 2 different specialists and they said it's from the COVID 19 vaccine. They told her to take Ibuprofen but today they prescribed generic Ambien (zolpidem) because she was unable to sleep due to her feet constantly burning and aching. She has been in pain since 07-Apr-2021 and she was actually getting her depressed.  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. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: report contained no new information; 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. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; 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) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant information was provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: had a allergic reaction to the first Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (had a allergic reaction to the first Moderna shot) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 ALLERGY TO VACCINE (had a allergic reaction to the first Moderna shot). At the time of the report, ALLERGY TO VACCINE (had a allergic reaction to the first Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. Treatment medications were not provided
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in the arm he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm he got the shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm he got the shot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm he got the shot) had not resolved.            No concomitant medications were reported.  Treatment medications included heating pad, anti-inflammatory medications.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine adinistered after the vaccine's storage viability had been exceeded; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine adinistered after the vaccine's storage viability had been exceeded) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-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 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine adinistered after the vaccine's storage viability had been exceeded). On 03-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine adinistered after the vaccine's storage viability had been exceeded) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Eating disorder, Fatigue, Feeling abnormal
Clinical narrative: Get full with little food; Feels like a zombie; Not well; Cannot work; Pain in the arms; Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired; Pain in the arms; Face is hot and getting hard; Muscles are tense, like balls in her thighs and arms; Chest feels like paralyzed; Lost of apetite/no hungry; Cramps in the muscles of the pelvic area; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed) and DECREASED APPETITE (Lost of apetite/no hungry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced MUSCLE SPASMS (Cramps in the muscles of the pelvic area), DECREASED APPETITE (Lost of apetite/no hungry) and NAUSEA (Nausea). On an unknown date, the patient experienced HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), CHEST DISCOMFORT (Chest feels like paralyzed), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired) and MYALGIA (Pain in the arms). At the time of the report, HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed), DECREASED APPETITE (Lost of apetite/no hungry), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired), MYALGIA (Pain in the arms) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Additional information received on 06-Jun- 2021 contains significant information added new events and updated reporter information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Impaired work ability, Malaise, Muscle spasms, Muscle tightness
Clinical narrative: Get full with little food; Feels like a zombie; Not well; Cannot work; Pain in the arms; Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired; Pain in the arms; Face is hot and getting hard; Muscles are tense, like balls in her thighs and arms; Chest feels like paralyzed; Lost of apetite/no hungry; Cramps in the muscles of the pelvic area; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed) and DECREASED APPETITE (Lost of apetite/no hungry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced MUSCLE SPASMS (Cramps in the muscles of the pelvic area), DECREASED APPETITE (Lost of apetite/no hungry) and NAUSEA (Nausea). On an unknown date, the patient experienced HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), CHEST DISCOMFORT (Chest feels like paralyzed), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired) and MYALGIA (Pain in the arms). At the time of the report, HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed), DECREASED APPETITE (Lost of apetite/no hungry), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired), MYALGIA (Pain in the arms) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Additional information received on 06-Jun- 2021 contains significant information added new events and updated reporter information.