chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Headache, Injection site pain, Pyrexia
Clinical narrative: Anemia; ringing in ear; left arm redness; pain at injection site; fever 102-101.7 range; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site) and PYREXIA (fever 102-101.7 range) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (she had a cancer diagnosis and is in remission.).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site), PYREXIA (fever 102-101.7 range), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site), PYREXIA (fever 102-101.7 range), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Full blood count: (normal) conducted baseline CBC prior to the vaccine and blood was normal. On an unknown date, Blood alkaline phosphatase: (abnormal) blood test done with several markers outside the range of normal. On an unknown date, Body temperature: 102 (High) Fever 102-101.7 range. On an unknown date, C-reactive protein: (abnormal) blood test done with several markers outside the range of normal. On an unknown date, Red blood cell sedimentation rate: (High) elevated sedimentation rates.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information is provided.  Patient stated that he consulted three HCP. Patient stated that his 2nd dose was taken on 11-May-2021 with Lot #002C21A.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains non-significant information. NNI
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Tinnitus
Clinical narrative: Anemia; ringing in ear; left arm redness; pain at injection site; fever 102-101.7 range; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site) and PYREXIA (fever 102-101.7 range) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (she had a cancer diagnosis and is in remission.).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site), PYREXIA (fever 102-101.7 range), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site), PYREXIA (fever 102-101.7 range), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Full blood count: (normal) conducted baseline CBC prior to the vaccine and blood was normal. On an unknown date, Blood alkaline phosphatase: (abnormal) blood test done with several markers outside the range of normal. On an unknown date, Body temperature: 102 (High) Fever 102-101.7 range. On an unknown date, C-reactive protein: (abnormal) blood test done with several markers outside the range of normal. On an unknown date, Red blood cell sedimentation rate: (High) elevated sedimentation rates.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information is provided.  Patient stated that he consulted three HCP. Patient stated that his 2nd dose was taken on 11-May-2021 with Lot #002C21A.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains non-significant information. NNI
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Excessive cerumen production
Clinical narrative: Weakness Worsened; Ear Wax; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (Weakness Worsened) and EXCESSIVE CERUMEN PRODUCTION (Ear Wax) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes since 2000, Emphysema since 2009, Tobacco user in 2009 and Chronic pain (fell from stairs nd injured at work) since an unknown date. Concurrent medical conditions included Drug allergy (manifested by frequent visits to the bathroom). Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Back pain, LISINOPRIL and ATENOLOL for Blood pressure, PRAVASTATIN for Cholesterol, METFORMIN for Diabetes, SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]) for Emphysema, RANITIDINE for Heartburn, GABAPENTIN for Pain, ADALIMUMAB (HUMIRA) and PANTOPRAZOLE for Ulcerative colitis, RISPERIDONE (RISPERDAL CONSTA) for mental illness, vitamin d and IRON for supplement.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. In May 2021, the patient experienced ASTHENIA (Weakness Worsened) and EXCESSIVE CERUMEN PRODUCTION (Ear Wax). The patient was treated with IBUPROFEN at an unspecified dose and frequency; AMOXICILLIN at an unspecified dose and frequency and CELECOXIB (DEBROX [CELECOXIB]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness Worsened) and EXCESSIVE CERUMEN PRODUCTION (Ear Wax) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-131958, MOD-2021-131958 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: big red Bruise on my arm; area is very hot; area itches; 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 SITE WARMTH (big red Bruise on my arm), VACCINATION SITE PRURITUS (area is very hot) and PRURITUS (area itches) 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 13-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 WARMTH (big red Bruise on my arm), VACCINATION SITE PRURITUS (area is very hot) and PRURITUS (area itches). At the time of the report, VACCINATION SITE WARMTH (big red Bruise on my arm), VACCINATION SITE PRURITUS (area is very hot) and PRURITUS (area itches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: On 25-May-2021, follow up document was attached which contains no new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (sore  arm), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (Hot arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and VITAMINS NOS for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). In February 2021, the patient experienced VACCINATION SITE WARMTH (sore  arm). On an unknown date, the patient experienced VACCINATION SITE PAIN (Hot arm). At the time of the report, VACCINATION SITE WARMTH (sore  arm), VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE PAIN (Hot arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was cholestrol pills. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant follow up case has  no new information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Exhausted with GI symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Exhausted with GI symptoms) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 14-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 ABDOMINAL DISCOMFORT (Exhausted with GI symptoms). At the time of the report, ABDOMINAL DISCOMFORT (Exhausted with GI symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  Patient had  first Moderna shot on 05-14 and the next day was exhausted with GI symptoms   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pin and needle like feelings in both arms and hands; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pin and needle like feelings in both arms and hands) 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 PARAESTHESIA (Pin and needle like feelings in both arms and hands). At the time of the report, PARAESTHESIA (Pin and needle like feelings in both arms and hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    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 ARTHRALGIA (Shoulder pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain). The patient was treated with PARACETAMOL (TYLENOL ) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-may-2021,contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (covid vaccine cause you to have hot flashes) 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 HOT FLUSH (covid vaccine cause you to have hot flashes). At the time of the report, HOT FLUSH (covid vaccine cause you to have hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally gave the First dose of the Moderna Covid-19 Vaccine to a 15 year old female patient today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally gave the First dose of the Moderna Covid-19 Vaccine to a 15 year old female patient today) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Unknown. On 25-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally gave the First dose of the Moderna Covid-19 Vaccine to a 15 year old female patient today). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidentally gave the First dose of the Moderna Covid-19 Vaccine to a 15 year old female patient today) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-MAY-2021 does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose on day 38; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on day 38) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events since an unknown date.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 mg. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on day 38). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose on day 38) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       there is no concomitant medications given in the treatement   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurts at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm hurts at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No significant follow up; Reporter's Comments: N/A; Sender's Comments: N/A
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 100.9; 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 PYREXIA (Fever of 100.9) in a patient of an unknown age and 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 100.9). At the time of the report, PYREXIA (Fever of 100.9) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.  Patient reported fever of 100.9.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Myalgia
Clinical narrative: achiness; light red area below the injection site; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (light red area below the injection site), FATIGUE (tiredness) and MYALGIA (achiness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis and Osteoarthritis. Concomitant products included RITUXIMAB (RITUXAN), METHOTREXATE, METOPROLOL, VALSARTAN, AMLODIPINE, FOLIC ACID and Nolaxican.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced ERYTHEMA (light red area below the injection site) and FATIGUE (tiredness). On an unknown date, the patient experienced MYALGIA (achiness). On 26-Feb-2021, ERYTHEMA (light red area below the injection site) and FATIGUE (tiredness) had resolved. At the time of the report, MYALGIA (achiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Rheumatologist stated it would be okay to get revaccinated because their Antibody test (SARS COvid-2 IG antibody) shows negative.   Treatment information was unknown   This case was linked to MOD-2021-169526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Live follow up, medication history added , second dose added
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 26-MAY-2021 contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. Not Provided      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 25-May-2021: Follow up received on 25 May 2021 contains non-significant information.; Reporter's Comments: N/A
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Vaccination site pain
Clinical narrative: shortness of breath; sore left injection site arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) in a 55-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Pain in extremity
Clinical narrative: Pain in Legs; Pain in her abdomen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in Legs) and ABDOMINAL PAIN (Pain in her abdomen) 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 PAIN IN EXTREMITY (Pain in Legs) and ABDOMINAL PAIN (Pain in her abdomen). At the time of the report, PAIN IN EXTREMITY (Pain in Legs) and ABDOMINAL PAIN (Pain in her abdomen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient received vaccine at 17 years old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received vaccine at 17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 immunisation.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received vaccine at 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient received vaccine at 17 years old) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Have a rash were i got the shot; Med Info Agent:  Have a rash were i got the shot does happen  often.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: lost smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost smell) in a 50-year-old male 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 19-May-2021, the patient experienced ANOSMIA (lost smell). At the time of the report, ANOSMIA (lost smell) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended to AER
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was not administered over 4-5 months) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 (Second dose was not administered over 4-5 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was not administered over 4-5 months) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.      Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 and contains non significant information.; Reporter's Comments: NA; Sender's Comments: NA
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Rash erythematous, Rash pruritic
Clinical narrative: Red, some small and some big splotches; Itchy, some small and some big splotches; Flu-like symptoms 10 days before second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu-like symptoms 10 days before second dose), RASH ERYTHEMATOUS (Red, some small and some big splotches) and RASH PRURITIC (Itchy, some small and some big splotches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included LORATADINE and FLUTICASONE for Allergy.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INFLUENZA (Flu-like symptoms 10 days before second dose). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red, some small and some big splotches) and RASH PRURITIC (Itchy, some small and some big splotches). At the time of the report, INFLUENZA (Flu-like symptoms 10 days before second dose), RASH ERYTHEMATOUS (Red, some small and some big splotches) and RASH PRURITIC (Itchy, some small and some big splotches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The patient reports that she suspects she is now dealing with shingles, although not diagnosed by a doctor. The patient thinks that she overlooked the onset of the shingles flare up that started on her leg (after the first dose), and progressively spread to her arm, neck and back.   This case was linked to MOD-2021-169634 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash; 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 RASH (Skin 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 25-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Skin rash). At the time of the report, RASH (Skin rash) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 27-MAY-2021 contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Muscle spasms, Myalgia, Nausea
Clinical narrative: i feel like im gonna die; shot in the arm is really painful; great pain in my arm and muscles are cramping all over; running a temp of 101.6; Nauseous; have throw up; muscles are cramping all over; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6) and NAUSEA (Nauseous) 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 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 FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6), NAUSEA (Nauseous), VOMITING (have throw up) and MUSCLE SPASMS (muscles are cramping all over). At the time of the report, FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6), NAUSEA (Nauseous), VOMITING (have throw up) and MUSCLE SPASMS (muscles are cramping all over) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6. (Inconclusive) 101.6..         no treatment information was provided no concomitant medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: i feel like im gonna die; shot in the arm is really painful; great pain in my arm and muscles are cramping all over; running a temp of 101.6; Nauseous; have throw up; muscles are cramping all over; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6) and NAUSEA (Nauseous) 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 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 FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6), NAUSEA (Nauseous), VOMITING (have throw up) and MUSCLE SPASMS (muscles are cramping all over). At the time of the report, FEELING ABNORMAL (i feel like im gonna die), VACCINATION SITE PAIN (shot in the arm is really painful), MYALGIA (great pain in my arm and muscles are cramping all over), PYREXIA (running a temp of 101.6), NAUSEA (Nauseous), VOMITING (have throw up) and MUSCLE SPASMS (muscles are cramping all over) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.6. (Inconclusive) 101.6..         no treatment information was provided no concomitant medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Her hair is falling out after receiving second shot; 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 ALOPECIA (Her hair is falling out after receiving second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Her hair is falling out after receiving second shot). At the time of the report, ALOPECIA (Her hair is falling out after receiving second shot) outcome was unknown. Not Provided          no concomitant medications are reported. treatment to the events not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up case booked in
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash spread for whole body- breast, legs, chest , back; "bad rash" non stopping spreading; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash spread for whole body- breast, legs, chest , back) and RASH ("bad rash" non stopping spreading) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MAGNESIUM OXIDE for Product used for unknown indication, QUETIAPINE FUMARATE (SEROQUEL), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), ATORVASTATIN CALCIUM (LIPITOR), MIRABEGRON (MYRBETRIQ), CALCIUM CITRATE (CALCITRATE), VITAMIN B12 [VITAMIN B12 NOS], LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), VITAMIN D NOS, MESO ZEAXANTHIN, XANTOFYL, ZEAXANTHIN (MACUHEALTH WITH LMZ3), ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) and ZEAXANTHIN for an unknown indication, Meso-zeaxanthin.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash spread for whole body- breast, legs, chest , back) and RASH ("bad rash" non stopping spreading). At the time of the report, RASH (rash spread for whole body- breast, legs, chest , back) and RASH ("bad rash" non stopping spreading) outcome was unknown. Not Provided      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.   This case was linked to MOD-2021-169553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021. contain non significant information
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Illness, Pruritus, Rash macular
Clinical narrative: shingles that progressively spread; red/itchy/small and big splotchy areas on leg, back, arm; red/itchy/small and big splotchy areas on leg, back, arm; red/itchy/small and big splotchy areas on leg, back, arm; very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), HERPES ZOSTER (shingles that progressively spread), ERYTHEMA (red/itchy/small and big splotchy areas on leg, back, arm), PRURITUS (red/itchy/small and big splotchy areas on leg, back, arm) and RASH MACULAR (red/itchy/small and big splotchy areas on leg, back, arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 011A21A) for COVID-19 vaccination.     No medical history reported by the patient.  Concomitant products included LORATADINE and FLUTICASONE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (very sick). On an unknown date, the patient experienced HERPES ZOSTER (shingles that progressively spread), ERYTHEMA (red/itchy/small and big splotchy areas on leg, back, arm), PRURITUS (red/itchy/small and big splotchy areas on leg, back, arm) and RASH MACULAR (red/itchy/small and big splotchy areas on leg, back, arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Apr-2021, ILLNESS (very sick) had resolved. At the time of the report, HERPES ZOSTER (shingles that progressively spread), ERYTHEMA (red/itchy/small and big splotchy areas on leg, back, arm), PRURITUS (red/itchy/small and big splotchy areas on leg, back, arm) and RASH MACULAR (red/itchy/small and big splotchy areas on leg, back, arm) outcome was unknown. Not Provided          This case was linked to MOD-2021-169604  (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Heart rate increased, Hypertension
Clinical narrative: Client reports received 1st Moderna dose at pharmacy and within minutes began feeling dizzy, fast heart rated and high blood pressure. Per client was kept 40 mins in observation and left home. Client reported that same night symptoms returned and went to urgent care. Per client EKG was normal and was kept 3hrs until blood pressure stabilized.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Ear pain, Hypoacusis, Tinnitus
Clinical narrative: Ringing in both ears with intermittent pain in both ears. Treated with Prednisone and Famciclovir.  Course of treatment 14 days.  After treatment, ringing in both ears remain. Occasional pain in right ear.  Decrease hearing in both ears.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cold sweat, Confusional state, Delirium, Differential white blood cell count normal
Clinical narrative: Extreme tiredness, fever and cold sweats during the night. I got up to use the bathroom (~5:30am), had lots of nausea. After using, I stood and started to make way to bedroom. Nausea became intense, pain and tightness swelled through my torso as well. Breathing became tight, vision was fading, and I was losing balance. My wife heard a thud from the bedroom and came out to find me collapsed against the wall, covered in cold sweat, and delirious. I don't remember falling or passing out, I remember her concerned voice and her dabbing my face with a wet cloth. I was very confused, frightened. After getting me seated okay couch and talking through what happened, my symptoms were very similar to a heart attack, which is a personal concern of mine, so she took me to the ER (~6:15am).  At the ER they performed (~7:00-7:30am): - CBC with differential - Comprehensive Metabolic Panel - Extra Gold Top Tube - Extra Green Top Tube - Extra Lavender Top Tube - Troponin 1 - ECG 12 Lead  All tests came back within normal limits. Doctor believes it was Vasovagal syncope.  Current outcome is near full recovery (as of 7:00pm 8/22).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Fatigue, Fear, Full blood count normal
Clinical narrative: Extreme tiredness, fever and cold sweats during the night. I got up to use the bathroom (~5:30am), had lots of nausea. After using, I stood and started to make way to bedroom. Nausea became intense, pain and tightness swelled through my torso as well. Breathing became tight, vision was fading, and I was losing balance. My wife heard a thud from the bedroom and came out to find me collapsed against the wall, covered in cold sweat, and delirious. I don't remember falling or passing out, I remember her concerned voice and her dabbing my face with a wet cloth. I was very confused, frightened. After getting me seated okay couch and talking through what happened, my symptoms were very similar to a heart attack, which is a personal concern of mine, so she took me to the ER (~6:15am).  At the ER they performed (~7:00-7:30am): - CBC with differential - Comprehensive Metabolic Panel - Extra Gold Top Tube - Extra Green Top Tube - Extra Lavender Top Tube - Troponin 1 - ECG 12 Lead  All tests came back within normal limits. Doctor believes it was Vasovagal syncope.  Current outcome is near full recovery (as of 7:00pm 8/22).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test normal, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Extreme tiredness, fever and cold sweats during the night. I got up to use the bathroom (~5:30am), had lots of nausea. After using, I stood and started to make way to bedroom. Nausea became intense, pain and tightness swelled through my torso as well. Breathing became tight, vision was fading, and I was losing balance. My wife heard a thud from the bedroom and came out to find me collapsed against the wall, covered in cold sweat, and delirious. I don't remember falling or passing out, I remember her concerned voice and her dabbing my face with a wet cloth. I was very confused, frightened. After getting me seated okay couch and talking through what happened, my symptoms were very similar to a heart attack, which is a personal concern of mine, so she took me to the ER (~6:15am).  At the ER they performed (~7:00-7:30am): - CBC with differential - Comprehensive Metabolic Panel - Extra Gold Top Tube - Extra Green Top Tube - Extra Lavender Top Tube - Troponin 1 - ECG 12 Lead  All tests came back within normal limits. Doctor believes it was Vasovagal syncope.  Current outcome is near full recovery (as of 7:00pm 8/22).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Troponin I normal, Visual impairment
Clinical narrative: Extreme tiredness, fever and cold sweats during the night. I got up to use the bathroom (~5:30am), had lots of nausea. After using, I stood and started to make way to bedroom. Nausea became intense, pain and tightness swelled through my torso as well. Breathing became tight, vision was fading, and I was losing balance. My wife heard a thud from the bedroom and came out to find me collapsed against the wall, covered in cold sweat, and delirious. I don't remember falling or passing out, I remember her concerned voice and her dabbing my face with a wet cloth. I was very confused, frightened. After getting me seated okay couch and talking through what happened, my symptoms were very similar to a heart attack, which is a personal concern of mine, so she took me to the ER (~6:15am).  At the ER they performed (~7:00-7:30am): - CBC with differential - Comprehensive Metabolic Panel - Extra Gold Top Tube - Extra Green Top Tube - Extra Lavender Top Tube - Troponin 1 - ECG 12 Lead  All tests came back within normal limits. Doctor believes it was Vasovagal syncope.  Current outcome is near full recovery (as of 7:00pm 8/22).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram head, Full blood count normal, Metabolic function test, Muscular weakness
Clinical narrative: full body tremors, left-sided muscle weakness - ongoing and currently 10 days post vaccine
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, Tremor
Clinical narrative: full body tremors, left-sided muscle weakness - ongoing and currently 10 days post vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: 12 hours after - chills, sweating, fainted/seizure, fatigue, headache, body aches, rash at chest and arms. Lasted 24 hours. Rash is still visible after 24 hours
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Seizure, Syncope
Clinical narrative: 12 hours after - chills, sweating, fainted/seizure, fatigue, headache, body aches, rash at chest and arms. Lasted 24 hours. Rash is still visible after 24 hours
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: Starting the next morning and continuing for a total of 3 days /72 hours: chills and shaking with no relief. No amount antiinflammatories helped, no ammount of layered clothing assisted with the feeling of freezing. This also occurred in mid 80s-low 90 degree weather.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Tremor, Vomiting
Clinical narrative: Evening of same day dose given: Chills with intense shaking 11:00 pm -3:15 am Nausea 11:30 pm-3:15 am Vomiting 1:15 am-3:15 am Headache  1:30 am 8/21/2020 to present; treated with ibuprofen and excedrin