chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Vaccination complication
Clinical narrative: I think he had covid but did not get tested; He got sick like I did a week before me; He had a reaction to the vaccine really bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ILLNESS (He got sick like I did a week before me) and VACCINATION COMPLICATION (He had a reaction to the vaccine really bad). On an unknown date, the patient experienced COVID-19 (I think he had covid but did not get tested). At the time of the report, ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a reaction to the vaccine really bad.  No concomitant medications were reported.                   No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered greater than 12 hours after initial vial puncture; Vial was not stored in refrigerator and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesteremia, Osteoarthritis, Anxiety, Blood pressure and Insomnia. Concomitant products included SPIRONOLACTONE, CARVEDILOL and AMLODIPINE for Blood pressure, ROSUVASTATIN for Cholesterol high, ALPRAZOLAM for Insomnia.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient). On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) and PRODUCT STORAGE ERROR (Vial was not stored in refrigerator and administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Updated reporter information, patient demographics, Added past relevant history, and updated vaccine dose details, and added concomitant medications.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product dose omission issue
Clinical narrative: Has not received her 2nd dose; Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) in a 31-year-old female patient 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. Last menstrual period and estimated date of delivery were not provided. In January 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose). In January 2021, MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was still currently pregnant. She has 3 possible due dates were 11 Oct 2021, 18 Oct 2021 and 19 Oct 2021. The patient do not have information on her last period since she was on birth control, she did not have period.   Treatment information was not provided.  This is a case of product exposure during pregnancy and product dose omission issue with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy and product dose omission issue with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Dental operation, Product dose omission issue
Clinical narrative: Emergency dental surgery; caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL OPERATION (Emergency dental surgery) and PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia and Immunocompromised.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose). On an unknown date, the patient experienced DENTAL OPERATION (Emergency dental surgery). The patient was treated with Surgery for Dental operation. On 20-May-2021, PRODUCT DOSE OMISSION ISSUE (caller received the 1st Moderna vaccine on 20Apr2021 and didn't receive 2nd dose) had resolved. At the time of the report, DENTAL OPERATION (Emergency dental surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information was not provided by reporter.  company comment:Very limited information regarding this event Dental Operation has been provided at this time.  Further information has been requested. The event Product Dose Omission Issue was not accompanied by any adverse event. A causality assessment is not applicable.; Sender's Comments: Very limited information regarding this event Dental Operation has been provided at this time.  Further information has been requested. The event Product Dose Omission Issue was not accompanied by any adverse event. A causality assessment is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Eye irritation, Feeling abnormal
Clinical narrative: Lots of pain/Severe pain; She cold hardly walk; Back hurts; Collar bone hurts; Legs hurts; Eyes are burning (like where the socket is); Feels like something is wrong; Pain at the site of injection; Wrist hurts/Ankles hurts; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts) and PAIN IN EXTREMITY (Legs hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 003B21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN (Lots of pain/Severe pain). 27-Aug-2021, the patient experienced HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain) had not resolved.      No concomitant medication information was provided. Patient did not have this experience with the 1st two doses.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Lots of pain/Severe pain; She cold hardly walk; Back hurts; Collar bone hurts; Legs hurts; Eyes are burning (like where the socket is); Feels like something is wrong; Pain at the site of injection; Wrist hurts/Ankles hurts; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts) and PAIN IN EXTREMITY (Legs hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A, 003B21A and 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN (Lots of pain/Severe pain). 27-Aug-2021, the patient experienced HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, PAIN (Lots of pain/Severe pain), HYPOKINESIA (She cold hardly walk), BACK PAIN (Back hurts), BONE PAIN (Collar bone hurts), PAIN IN EXTREMITY (Legs hurts), EYE IRRITATION (Eyes are burning (like where the socket is)), FEELING ABNORMAL (Feels like something is wrong), VACCINATION SITE PAIN (Pain at the site of injection), ARTHRALGIA (Wrist hurts/Ankles hurts) and MYALGIA (Muscle pain) had not resolved.      No concomitant medication information was provided. Patient did not have this experience with the 1st two doses.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Maternal exposure during pregnancy; really bad headache/headache; arm is sore and hurting; feel exhausted; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore and hurting), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), FATIGUE (feel exhausted) and HEADACHE (really bad headache/headache) in a 91-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache). In August 2021, the patient experienced VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Headache, at an unspecified dose and frequency. On 04-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and HEADACHE (really bad headache/headache) had resolved. At the time of the report, VACCINATION SITE PAIN (arm is sore and hurting) and FATIGUE (feel exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Patient was pregnant before she received her vaccination and currently, she was 32 weeks pregnant. Her second dose would be due on 30-Aug-2021. She had headache on the 1st day and went away. That evening, she got really bad headache and took some Tylenol, and she thinks it had gone now. On the second day and third day, she felt exhausted. Her arm was sore and hurting. She read about Moderna COVID 19 vaccine and that people can get blood clot. Although she didn't get blood clot with her first dose, she was worried that she can get it with the second dose. She asked if she could get blood clot with the second dose. Also, she wants information on blood clot like what types of people can get it and why. She was frustrated that agent didn't have information on this, and she didn't feel comfortable about providing further information about herself. She disconnected the call immediately after agent sated no information.; Sender's Comments: This is a case of product exposure during pregnancy with associated adverse events for this 91-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events headache, vaccination site pain and fatigue, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring during the pregnancy. Patient´s date of birth confirmation has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate
Clinical narrative: feeling of tightness in her chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (feeling of tightness in her chest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (feeling of tightness in her chest). At the time of the report, CHEST DISCOMFORT (feeling of tightness in her chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 50 (Low) below 50.         Treatment information was not provided by reporter.  Patient went to the emergency room where she stayed overnight due to the feeling of tightness in her chest and low heart rate below 50. Patient stated that she has developed bradycardia with heart rate of 45 to 50 pulse per minute after the first dose and still having episodes of it ever since.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-299694 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment information not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-300239 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Poisoning, Rash
Clinical narrative: Intoxication; Rash in all over her Body; This spontaneous case was reported by a consumer and describes the occurrence of POISONING (Intoxication) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced RASH (Rash in all over her Body). On an unknown date, the patient experienced POISONING (Intoxication) (seriousness criterion medically significant). At the time of the report, POISONING (Intoxication) and RASH (Rash in all over her Body) outcome was unknown.            The patient used unidentified medicament to alleviate rash.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Follow up information received 29 August 2021 does not change company causality, however a new event of "intoxication" was reported and added to the case.   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2021: Route of administration suspected product  and event added.; 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. Follow up information received 29 August 2021 does not change company causality, however a new event of "intoxication" was reported and added to the case.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Ear discomfort, Hyperhidrosis, Neck mass, Swelling face
Clinical narrative: sweating Profusely; lump on the right side of neck; swelling on the right side of face; pressure in ears; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump on the right side of neck), SWELLING FACE (swelling on the right side of face), EAR DISCOMFORT (pressure in ears) and HYPERHIDROSIS (sweating Profusely) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced NECK MASS (lump on the right side of neck) (seriousness criterion medically significant), SWELLING FACE (swelling on the right side of face) (seriousness criterion medically significant) and EAR DISCOMFORT (pressure in ears) (seriousness criterion medically significant). In August 2021, the patient experienced HYPERHIDROSIS (sweating Profusely) (seriousness criterion medically significant). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency; CEFALEXIN (CEPHALEXINE) for Adverse event, at an unspecified dose and frequency and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Ear discomfort, at an unspecified dose and frequency. At the time of the report, NECK MASS (lump on the right side of neck), SWELLING FACE (swelling on the right side of face), EAR DISCOMFORT (pressure in ears) and HYPERHIDROSIS (sweating Profusely) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood test: positive (Positive) Antibodies for the Epstein Barre virus.         Relevant concomitant product usage were not reported by the reporter. On an unknown date, patient underwent CT Scan to rule out Cancer. Results were not received. Biopsy of the lymph nodes was also planned.  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.  No further information is expected.; 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.  No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute leukaemia, Blood test, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Acute leukemia; Light headedness; Too week to walk; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE LEUKAEMIA (Acute leukemia) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high (High blood pressure). Concomitant products included ATENOLOL for Blood pressure high.   On 11-May-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. In 2021, the patient experienced DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue). On 26-Aug-2021, the patient experienced ACUTE LEUKAEMIA (Acute leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 26-Aug-2021 due to ACUTE LEUKAEMIA. At the time of the report, ACUTE LEUKAEMIA (Acute leukemia), DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) normal. On 26-Aug-2021, Haemoglobin: 5.5 (Low) Decreased. On 26-Aug-2021, White blood cell count: 0.2 (Low) Decreased.         No treatment medications were reported. Patient was hospitalized with acute leukemia with 5.5 hemoglobin and 0.2 white blood count and was complaining of fatigue and light headedness for the last month. For past two weeks he has been too week to walk. Patient's last bloodwork up in February 2021 was normal.  Patient does have high blood pressure and takes Atenolol.  Patient was not sure the vaccine was related and did not know exact date of first dose and did not have lot numbers.  Company Comment: Very limited information regarding this events has been provided at this time. However, 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.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, White blood cell count
Clinical narrative: Acute leukemia; Light headedness; Too week to walk; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE LEUKAEMIA (Acute leukemia) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high (High blood pressure). Concomitant products included ATENOLOL for Blood pressure high.   On 11-May-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. In 2021, the patient experienced DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue). On 26-Aug-2021, the patient experienced ACUTE LEUKAEMIA (Acute leukemia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 26-Aug-2021 due to ACUTE LEUKAEMIA. At the time of the report, ACUTE LEUKAEMIA (Acute leukemia), DIZZINESS (Light headedness), GAIT DISTURBANCE (Too week to walk) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) normal. On 26-Aug-2021, Haemoglobin: 5.5 (Low) Decreased. On 26-Aug-2021, White blood cell count: 0.2 (Low) Decreased.         No treatment medications were reported. Patient was hospitalized with acute leukemia with 5.5 hemoglobin and 0.2 white blood count and was complaining of fatigue and light headedness for the last month. For past two weeks he has been too week to walk. Patient's last bloodwork up in February 2021 was normal.  Patient does have high blood pressure and takes Atenolol.  Patient was not sure the vaccine was related and did not know exact date of first dose and did not have lot numbers.  Company Comment: Very limited information regarding this events has been provided at this time. However, 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.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, 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: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Vaccination complication
Clinical narrative: Severe reaction to the vaccine; Lips swollen completely; Lips and eyes are swollen completely; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lip cosmetic procedure (Had lip filler about a year ago.) in 2020.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely). At the time of the report, VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided  Patient received first dose of Moderna COVID-19 Vaccine on a Saturday.  This is a spontaneous report received by phone call of a patient with antecedent of lip dermal filler who presented Lip/Eyes swelling of severe intensity after an unknown period of receiving an unknown dose of the product.  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.; Sender's Comments: This is a spontaneous report received by phone call of a patient with antecedent of lip dermal filler who presented Lip/Eyes swelling of severe intensity after an unknown period of receiving an unknown dose of the product.  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 will not be available as per patient did not consent follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures/ having seizures since the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures/ having seizures since the vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizure (Patient hadn't had any seizures since 6 months).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures/ having seizures since the vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures/ having seizures since the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported No treatment medications provided  At this time, very limited information has been provided on this event, the start and end date, and the patient's vaccination date was not documented. Consent for safety to contact the patient was not obtained.   Reporter did not allow further contact; Sender's Comments: At this time, very limited information has been provided on this event, the start and end date, and the patient's vaccination date was not documented. Consent for safety to contact the patient was not obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Heart rate
Clinical narrative: Heart fluttering; Chest pain; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant) and CHEST PAIN (Chest pain). At the time of the report, CARDIAC FLUTTER (Heart fluttering) and CHEST PAIN (Chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided.  No treatment medication details was provided.   Patient did not confirm whether or not she had a history of myocarditis or pericarditis.  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.; 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: COVID-19, Hyperhidrosis, Malaise
Clinical narrative: Getting covid after vaccination series; perfusion sweating; didn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Getting covid after vaccination series), HYPERHIDROSIS (perfusion sweating) and MALAISE (didn't feel good) 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 COVID-19 (Getting covid after vaccination series) (seriousness criterion hospitalization), HYPERHIDROSIS (perfusion sweating) (seriousness criterion hospitalization) and MALAISE (didn't feel good) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Getting covid after vaccination series), HYPERHIDROSIS (perfusion sweating) and MALAISE (didn't feel good) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.  The patient was later discharged 4-58 hours later.  Company comment: Very limited information regarding this events has been provided at this time. This report refers to a case of Drug ineffective for mRNA-1273, lot numbers unspecified with AEs. There is no information on date of vaccine doses and start date of events, but case is processed assuming that the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events, based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this events has been provided at this time. This report refers to a case of Drug ineffective for mRNA-1273, lot numbers unspecified with AEs. There is no information on date of vaccine doses and start date of events, but case is processed assuming that the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events, based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: undisclosed number of patients were given expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (undisclosed number of patients were given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.  Action taken with vaccine was not applicable.   Reporter did not allow further contact
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: severe chills for several hours, moderate fever for several hours, mild fatigue and body aches for several hours
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain upper, Back pain, Diarrhoea
Clinical narrative: Since the 3rd of July which is the day of the 2nd administration of Pfizer, I have continuous nausea, vertigo to the point that I cannot drive my vehicle. Blurry vision, severe pain in the stomach area under the right breast height of liver. Radiates a little to the left. Strong diarrhea that comes and goes and is very clear. Severe pain in upper back area unable to sleep because of the pain. Pain in calves and sensation of heaviness in the legs. I noticed like a knot in my stomach and heaviness and my stomach is bloated. Sensation of indigestion. Reflux and burning esophagus. Rash on breasts and stomach and lichen planus on the foot and left leg. Before the vaccination I was doing very well. Except for a little lack of iron, mild hypertension controlled and ulcerative colitis mild (proctitis).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Impaired driving ability, Insomnia, Lichen planus
Clinical narrative: Since the 3rd of July which is the day of the 2nd administration of Pfizer, I have continuous nausea, vertigo to the point that I cannot drive my vehicle. Blurry vision, severe pain in the stomach area under the right breast height of liver. Radiates a little to the left. Strong diarrhea that comes and goes and is very clear. Severe pain in upper back area unable to sleep because of the pain. Pain in calves and sensation of heaviness in the legs. I noticed like a knot in my stomach and heaviness and my stomach is bloated. Sensation of indigestion. Reflux and burning esophagus. Rash on breasts and stomach and lichen planus on the foot and left leg. Before the vaccination I was doing very well. Except for a little lack of iron, mild hypertension controlled and ulcerative colitis mild (proctitis).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Oesophageal pain, Pain, Pain in extremity
Clinical narrative: Since the 3rd of July which is the day of the 2nd administration of Pfizer, I have continuous nausea, vertigo to the point that I cannot drive my vehicle. Blurry vision, severe pain in the stomach area under the right breast height of liver. Radiates a little to the left. Strong diarrhea that comes and goes and is very clear. Severe pain in upper back area unable to sleep because of the pain. Pain in calves and sensation of heaviness in the legs. I noticed like a knot in my stomach and heaviness and my stomach is bloated. Sensation of indigestion. Reflux and burning esophagus. Rash on breasts and stomach and lichen planus on the foot and left leg. Before the vaccination I was doing very well. Except for a little lack of iron, mild hypertension controlled and ulcerative colitis mild (proctitis).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vertigo, Vision blurred
Clinical narrative: Since the 3rd of July which is the day of the 2nd administration of Pfizer, I have continuous nausea, vertigo to the point that I cannot drive my vehicle. Blurry vision, severe pain in the stomach area under the right breast height of liver. Radiates a little to the left. Strong diarrhea that comes and goes and is very clear. Severe pain in upper back area unable to sleep because of the pain. Pain in calves and sensation of heaviness in the legs. I noticed like a knot in my stomach and heaviness and my stomach is bloated. Sensation of indigestion. Reflux and burning esophagus. Rash on breasts and stomach and lichen planus on the foot and left leg. Before the vaccination I was doing very well. Except for a little lack of iron, mild hypertension controlled and ulcerative colitis mild (proctitis).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Mood altered, Nasopharyngitis
Clinical narrative: Fatigue, cold, sore throat and swollen tonsils, confusion, dizziness, gertie, vomiting, sinusitis, moodiness
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Sinusitis, Tonsillar hypertrophy, Vomiting
Clinical narrative: Fatigue, cold, sore throat and swollen tonsils, confusion, dizziness, gertie, vomiting, sinusitis, moodiness
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Lung neoplasm malignant
Clinical narrative: Surgery to take out 2 encapsulated cancer tumors of his left lung; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (because he is taking Tagrisso) and Lung cancer. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for Lung cancer, MULTIVITAMIN [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID), SODIUM BICARBONATE, AMLODIPINE and DOXYCYCLINE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) (seriousness criterion medically significant). The patient was treated with Surgery (On 03-May-2021 he got surgery to take out 2 encapsulated cancer tumors of his left lung) for Lung neoplasm malignant. At the time of the report, LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) to be unlikely related.    Treatment medication was not provided.  Company comment: Based on information provide and considering that the patient had medical history of lung cancer for which the patient underwent surgery the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on information provide and considering that the patient had medical history of lung cancer for which the patient underwent surgery the event is assessed as unlikely related to mRNA-1273.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dehydration, Dizziness, Fatigue, Haematochezia
Clinical narrative: After the first dose he complained of bloody stool, severe vomiting, high fever and flu-like symptoms.   His symptoms occurred within a few hours of receiving his first dose and lasted approximately 21 days. He said he felt ?run down,? and similar feelings of dehydration and exhaustion.  He had the above side effects with second dose but complained that the magnitude of symptoms were much worse and bloody stool increased. He complained of feeling as if he was going to ?pass out,? upon instances of brief aerobic activity.   Upon the
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pyrexia, Urine analysis, Vomiting
Clinical narrative: After the first dose he complained of bloody stool, severe vomiting, high fever and flu-like symptoms.   His symptoms occurred within a few hours of receiving his first dose and lasted approximately 21 days. He said he felt ?run down,? and similar feelings of dehydration and exhaustion.  He had the above side effects with second dose but complained that the magnitude of symptoms were much worse and bloody stool increased. He complained of feeling as if he was going to ?pass out,? upon instances of brief aerobic activity.   Upon the
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Fatigue; Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 54-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not provided, Expiry date: Unknown, Age at vaccination: 54) via an unspecified route of administration in Arm Right on 07Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history included ongoing diabetes mellitus, it was controlled with diet, ongoing hypothyroidism and high cholesterol. Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing; pravastatin (PRAVASTATIN) taken for blood cholesterol increased from an unspecified start date and ongoing; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced fatigue and joint pain on an unspecified date. She has had fatigue for the last 2 or 3 days. Joint pain started 3 or 4 days ago. The seriousness of the events was non-serious. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.er has been requested.