chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Asthenia, Blood pressure measurement, Chest pain
Clinical narrative: Sweety hand; Having trouble sleeping waking up every 3 hours; Sore throat; Cannot taste his food; Stomach hurt; Pain in the lower left chest; Pain that come and goes in the upper right side of the jaw; Dizziness; Not feeling well; Weakness; Extremely strong headache; Very very nauseous; General fatigue\ Tiredness; Muscle pain; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food) and ABDOMINAL PAIN UPPER (Stomach hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Past medical history includes in 2011 Patient had a minor brain stroke
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Heart rate, Hyperhidrosis
Clinical narrative: Sweety hand; Having trouble sleeping waking up every 3 hours; Sore throat; Cannot taste his food; Stomach hurt; Pain in the lower left chest; Pain that come and goes in the upper right side of the jaw; Dizziness; Not feeling well; Weakness; Extremely strong headache; Very very nauseous; General fatigue\ Tiredness; Muscle pain; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food) and ABDOMINAL PAIN UPPER (Stomach hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Past medical history includes in 2011 Patient had a minor brain stroke
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Oropharyngeal pain, Pain in jaw
Clinical narrative: Sweety hand; Having trouble sleeping waking up every 3 hours; Sore throat; Cannot taste his food; Stomach hurt; Pain in the lower left chest; Pain that come and goes in the upper right side of the jaw; Dizziness; Not feeling well; Weakness; Extremely strong headache; Very very nauseous; General fatigue\ Tiredness; Muscle pain; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food) and ABDOMINAL PAIN UPPER (Stomach hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Past medical history includes in 2011 Patient had a minor brain stroke
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: Sweety hand; Having trouble sleeping waking up every 3 hours; Sore throat; Cannot taste his food; Stomach hurt; Pain in the lower left chest; Pain that come and goes in the upper right side of the jaw; Dizziness; Not feeling well; Weakness; Extremely strong headache; Very very nauseous; General fatigue\ Tiredness; Muscle pain; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food) and ABDOMINAL PAIN UPPER (Stomach hurt) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweety hand), SLEEP DISORDER (Having trouble sleeping waking up every 3 hours), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (Cannot taste his food), ABDOMINAL PAIN UPPER (Stomach hurt), CHEST PAIN (Pain in the lower left chest), PAIN IN JAW (Pain that come and goes in the upper right side of the jaw), DIZZINESS (Dizziness), MALAISE (Not feeling well), ASTHENIA (Weakness), HEADACHE (Extremely strong headache), NAUSEA (Very very nauseous), FATIGUE (General fatigue\ Tiredness), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Normal. On an unknown date, Heart rate: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Past medical history includes in 2011 Patient had a minor brain stroke
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant woman received her 1st dose of vaccine; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Factor V Leiden mutation (Factor 5 Leiden Disorder (genetic Disorder)). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Jan-2021 and the estimated date of delivery was 22-Oct-2021. On 17-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant woman received her 1st dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Synthroid ,Prenatal Vitamins. No treatment information was reported. The reporter reported that the patient was pregnant and received her 1st dose of vaccine. Pregnancy was of 2nd trimester Last date of Menstruation was around 15-JAN-2021 (patient wasn't sure) Date of Conception reported as 25-JAN-2021.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting after 2nd dose) in an 18-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting after 2nd dose). At the time of the report, VOMITING (vomiting after 2nd dose) outcome was unknown. Not Provided          No concomitant medication was provided by the reporter. No treatment information was given by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: Arm is very swollen; Hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is very swollen) and MYALGIA (Hurts a lot) 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) (Intramuscular) 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 PERIPHERAL SWELLING (Arm is very swollen) and MYALGIA (Hurts a lot). At the time of the report, PERIPHERAL SWELLING (Arm is very swollen) and MYALGIA (Hurts a lot) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.  Action take with mRNA-1273 in response to the event was not applicable.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: swelling at the injection site; itch at the injection site; dark spot at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site) in a t-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced HEADACHE (headache). On 14-Jun-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site). At the time of the report, HEADACHE (headache), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE PRURITUS (itch at the injection site) and VACCINATION SITE RASH (dark spot at injection site) outcome was unknown.            No concomitant medications details provided. No treatment details provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) with response to events was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Illness
Clinical narrative: Felt like garbage /like i got ran over by a truck; Got sick; Woke up drenched in sweat; Chills; Violent headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like garbage /like i got ran over by a truck), ILLNESS (Got sick), HYPERHIDROSIS (Woke up drenched in sweat), CHILLS (Chills) and HEADACHE (Violent headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for Hypertension, DUPILUMAB (DUPIXENT) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced FEELING ABNORMAL (Felt like garbage /like i got ran over by a truck), ILLNESS (Got sick), HYPERHIDROSIS (Woke up drenched in sweat), CHILLS (Chills) and HEADACHE (Violent headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Apr-2021, FEELING ABNORMAL (Felt like garbage /like i got ran over by a truck), ILLNESS (Got sick), HYPERHIDROSIS (Woke up drenched in sweat), CHILLS (Chills) and HEADACHE (Violent headache) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  It was reported that patient messed with doses of Dupixent and skipped a couple doses before and after the vaccine was received.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Intense muscle paid the next day/ ongoing muscle aches and pains; felt terrible/ difficulty focusing and foggy; tiredness/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Intense muscle paid the next day/ ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible/ difficulty focusing and foggy) and FATIGUE (tiredness/ fatigue) outcome was unknown.            The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (low grade fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 65-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. In February 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 FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown.            Upon internal review on 04-Aug-2021, the age was corrected to 65 years.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First shot on April 27th, but never got my second dose./ am 2 months overdue for my second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Vaccination complication
Clinical narrative: Effects; I had the injection (2nd dose - first was a Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Effects) and INTERCHANGE OF VACCINE PRODUCTS (I had the injection (2nd dose - first was a Pfizer) 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 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (I had the injection (2nd dose - first was a Pfizer). On an unknown date, the patient experienced VACCINATION COMPLICATION (Effects). At the time of the report, VACCINATION COMPLICATION (Effects) and INTERCHANGE OF VACCINE PRODUCTS (I had the injection (2nd dose - first was a Pfizer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On 01 Apr 2021, the patient received the first dose of the Pfizer vaccine.  No treatment information was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: noticeable bruise at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (noticeable bruise at the injection site) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical history was provided by the Reporter.  Concomitant products included LORATADINE for an unknown indication.    On 19-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 CONTUSION (noticeable bruise at the injection site). At the time of the report, CONTUSION (noticeable bruise at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-229987 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up  received on 30-JUN-2021 and Updated secondary Reporter details and patient initials and updated suspect vaccine Lot number and Updated new Concomitant medication details.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days after the first dose without receiving the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) 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 treatment medications were provided. No concomitant medication information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: 2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient; it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured). On 17-Jun-2021, EXPOSURE DURING PREGNANCY (2nd dose of the Moderna COVID-19 vaccine was administered to a pregnant patient) and EXPIRED PRODUCT ADMINISTERED (it was given from pre-loaded syringe 12 hours past expiration and 24 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 Contains No significant information
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: rash all over; red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over) and RASH ERYTHEMATOUS (red rash) 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 21-Jun-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 21-Jun-2021, the patient experienced RASH (rash all over) and RASH ERYTHEMATOUS (red rash). At the time of the report, RASH (rash all over) and RASH ERYTHEMATOUS (red rash) outcome was unknown.            No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness at injection site,about 3 inches around, and not as severe in intensity.; swelling at injection site,about 3 inches around, and not as severe in intensity.; Itching at injection site,about 3 inches around, and not as severe in intensity.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 18-Feb-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.). At the time of the report, INJECTION SITE ERYTHEMA (redness at injection site,about 3 inches around, and not as severe in intensity.), INJECTION SITE SWELLING (swelling at injection site,about 3 inches around, and not as severe in intensity.) and INJECTION SITE PRURITUS (Itching at injection site,about 3 inches around, and not as severe in intensity.) outcome was unknown. Not Provided          No treatment medications were reported.  Patient height was reported as 5'7 and weight was reported as 150.   This case was linked to MOD-2021-027223 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Great pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Great 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 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 MYALGIA (Great pain). At the time of the report, MYALGIA (Great pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information given.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long side effects last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long side effects last) 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 VACCINATION COMPLICATION (How long side effects last). At the time of the report, VACCINATION COMPLICATION (How long side effects last) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products reported.  No treatment products reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant after 1st dose / Planning to get the 2nd one; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant after 1st dose / Planning to get the 2nd one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Jan-2021 and the estimated date of delivery was 10-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant after 1st dose / Planning to get the 2nd one). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant after 1st dose / Planning to get the 2nd one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received. Vaccine and reporter information updated
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Stomatitis, Vomiting
Clinical narrative: Vomiting; Diarrhea; Mouth sores; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea) and STOMATITIS (Mouth sores) 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 at an unspecified dose. On an unknown date, the patient experienced VOMITING (Vomiting), DIARRHOEA (Diarrhea) and STOMATITIS (Mouth sores). At the time of the report, VOMITING (Vomiting), DIARRHOEA (Diarrhea) and STOMATITIS (Mouth sores) outcome was unknown.            No concomitant were provided. No treatment medication were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: intense muscle paid the next day/ongoing muscle aches and pains; felt terrible; tiredness/fatigue; difficulty focusing and foggy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (intense muscle paid the next day/ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible), FATIGUE (tiredness/fatigue) and DISTURBANCE IN ATTENTION (difficulty focusing and foggy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 MYALGIA (intense muscle paid the next day/ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible), FATIGUE (tiredness/fatigue) and DISTURBANCE IN ATTENTION (difficulty focusing and foggy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Took two. At the time of the report, MYALGIA (intense muscle paid the next day/ongoing muscle aches and pains), FEELING ABNORMAL (felt terrible), FATIGUE (tiredness/fatigue) and DISTURBANCE IN ATTENTION (difficulty focusing and foggy) outcome was unknown.            Concomitant product usage were also not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: sideeffect after my second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (sideeffect after my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (sideeffect after my second dose). At the time of the report, VACCINATION COMPLICATION (sideeffect after my second dose) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was considered to be not applicable.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Product administered to patient of inappropriate age
Clinical narrative: Past 35 days for the second dose; 17 yrs son received Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yrs son received Moderna) and INTENTIONAL PRODUCT USE ISSUE (Past 35 days for the second dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yrs son received Moderna). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Past 35 days for the second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yrs son received Moderna) and INTENTIONAL PRODUCT USE ISSUE (Past 35 days for the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  No treatment medication was reported.  Patient was not able to receive the second dose due to being under 18 years old. Caller wanted to know what to do because he is past the recommended time.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up received: Reporter slider first and second were added. Suspect action taken updated Not applicable from unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rhesus antigen negative
Clinical narrative: Black and blue arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Black and blue arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included Hypoglycemia, Hypothyroidism, Stent placement (Patient had three cardiac stents) and Arthrodesis. Concurrent medical conditions included Drug allergy, Allergic reaction to antibiotics (Levaquin), Shellfish allergy (shellfish), Coronary artery disease (have three cardiac stents), Asthma, Gastroesophageal reflux disease, Osteoarthritis, Osteoporosis, Epileptic seizure, Hypertension and Drug allergy (Vioxx). Concomitant products included ATENOLOL (TENORMIN) for Arrhythmia, GLYCERYL TRINITRATE (NITROGLYCERIN LINGUAL) for Coronary artery disease, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ10 [UBIDECARENONE]), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN (NEURONTIN), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LEVOSALBUTAMOL TARTRATE (XOPENEX HFA), EPINEPHRINE (EPIPEN), ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHYROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) for an unknown indication.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced CONTUSION (Black and blue arm). At the time of the report, CONTUSION (Black and blue arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Rhesus antigen negative: negative (Negative) Rh negative.     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.   Patient had concomitant medication Xopenex HFA for rescue inhaler  and sublingual Nitroglycerine.  No Treatment medications was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: befor she could get second shot she got covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (befor she could get second shot she got covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 COVID-19 (befor she could get second shot she got covid). At the time of the report, COVID-19 (befor she could get second shot she got covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus test positive, Fatigue, Lethargy, Malaise, Myalgia
Clinical narrative: Maybe had covid; lethargic; achy; Major abnormality positive for Epstein Barr virus identified; Incredibly fatigued; General malaise; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic), EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified) and MYALGIA (achy) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Loratadine (Claritin) for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced MALAISE (General malaise) and FATIGUE (Incredibly fatigued). On 02-Jul-2021, the patient experienced EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified). On an unknown date, the patient experienced SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (General malaise) and FATIGUE (Incredibly fatigued) had not resolved and SUSPECTED COVID-19 (Maybe had covid), LETHARGY (lethargic), EPSTEIN-BARR VIRUS TEST POSITIVE (Major abnormality positive for Epstein Barr virus identified) and MYALGIA (achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 24-jun-2021 patient's mother took her daughter to the pediatrician and he confirmed that the patient may have COVID so she had a lengthy response to vaccine. on 30-jun-2021 her mother also stated that she had not improved at all and which was the biggest complaint that that there was no improvement at day 14.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow-up added on 30-JUN-2021 and updated reporter information, patient  initials,age at vaccination,  start date of both doses of vaccine , batch number and anatomical location of vaccine administered , concomitant, treatment medications, events and outcome of the event were added. On 06-Jul-2021: Significant follow up received on 06-Jul-2021, new event added.