chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin mass, Sleep deficit
Clinical narrative: Bumps on the trunk of body; woke up early this morning; Itching/She states she started itching last night; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Bumps on the trunk of body), SLEEP DEFICIT (woke up early this morning) and PRURITUS (Itching/She states she started itching last night) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced SKIN MASS (Bumps on the trunk of body), SLEEP DEFICIT (woke up early this morning) and PRURITUS (Itching/She states she started itching last night). At the time of the report, SKIN MASS (Bumps on the trunk of body), SLEEP DEFICIT (woke up early this morning) and PRURITUS (Itching/She states she started itching last night) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported.  Patient experienced bumps on the trunk of her body. She states it's not like a rash, but just bumps on her body, almost like bed bugs or a mild reaction.   This case was linked to MOD-2021-081206 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Slight temp elevation; Dose 2- 30-Nov-21 and Dose 3 08-Dec-21; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Slight temp elevation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2- 30-Nov-21 and Dose 3 08-Dec-21) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012h21b, 012h21b and j07bx03) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Dec-2021 at 10:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2- 30-Nov-21 and Dose 3 08-Dec-21). On 09-Dec-2021, the patient experienced PYREXIA (Slight temp elevation). On 08-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2- 30-Nov-21 and Dose 3 08-Dec-21) had resolved. At the time of the report, PYREXIA (Slight temp elevation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, Body temperature: increased (High) Increased, slight temp elevation. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive, Tested positive for antibodies in country.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-405907 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Stretching in a way that is not normal for her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Stretching in a way that is not normal for her) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 021B21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Stretching in a way that is not normal for her). At the time of the report, VACCINATION COMPLICATION (Stretching in a way that is not normal for her) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.  The patient was running and she experienced stretching in a way that was not normal for her.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Plantar fasciitis
Clinical narrative: I have it on my right heel plantar fasciitis; This spontaneous case was reported by a consumer and describes the occurrence of PLANTAR FASCIITIS (I have it on my right heel plantar fasciitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 030M20A and 026A21A.) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PLANTAR FASCIITIS (I have it on my right heel plantar fasciitis). At the time of the report, PLANTAR FASCIITIS (I have it on my right heel plantar fasciitis) outcome was unknown.    Concomitant medications was not provided by the reporter.Treatment information was not provided. This case was linked to MOD-2021-408523, MOD-2021-408471, MOD-2021-408563 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, Hordeolum, Myalgia
Clinical narrative: Woke up with stye on her left eye; Left eye was itchy; Left eye swollen; Left eye sore; Left arm hurt really bad; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Woke up with stye on her left eye), EYE PRURITUS (Left eye was itchy), EYE SWELLING (Left eye swollen), EYE PAIN (Left eye sore) and PAIN IN EXTREMITY (Left arm hurt really bad) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J&J's vaccine (she developed a stye on her left eye). Past adverse reactions to the above products included Stye with J&J's vaccine.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurt really bad), PYREXIA (Fever) and MYALGIA (Body aches). On 09-Dec-2021, the patient experienced EYE PRURITUS (Left eye was itchy), EYE SWELLING (Left eye swollen) and EYE PAIN (Left eye sore). On 10-Dec-2021, the patient experienced HORDEOLUM (Woke up with stye on her left eye). At the time of the report, HORDEOLUM (Woke up with stye on her left eye), EYE PRURITUS (Left eye was itchy), EYE SWELLING (Left eye swollen), EYE PAIN (Left eye sore), PAIN IN EXTREMITY (Left arm hurt really bad), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication details was reported.  No treatment medication details was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Woke up with stye on her left eye; Left eye was itchy; Left eye swollen; Left eye sore; Left arm hurt really bad; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HORDEOLUM (Woke up with stye on her left eye), EYE PRURITUS (Left eye was itchy), EYE SWELLING (Left eye swollen), EYE PAIN (Left eye sore) and PAIN IN EXTREMITY (Left arm hurt really bad) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J&J's vaccine (she developed a stye on her left eye). Past adverse reactions to the above products included Stye with J&J's vaccine.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurt really bad), PYREXIA (Fever) and MYALGIA (Body aches). On 09-Dec-2021, the patient experienced EYE PRURITUS (Left eye was itchy), EYE SWELLING (Left eye swollen) and EYE PAIN (Left eye sore). On 10-Dec-2021, the patient experienced HORDEOLUM (Woke up with stye on her left eye). At the time of the report, HORDEOLUM (Woke up with stye on her left eye), EYE PRURITUS (Left eye was itchy), EYE SWELLING (Left eye swollen), EYE PAIN (Left eye sore), PAIN IN EXTREMITY (Left arm hurt really bad), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication details was reported.  No treatment medication details was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Induration, Pyrexia, Vascular pain
Clinical narrative: Hard to press; Has a bruise there; Sore; Chills; A little bit of fever; And it was red compare to the other blood vessel; A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything; This spontaneous case was reported by a patient and describes the occurrence of INDURATION (Hard to press), CONTUSION (Has a bruise there), VEIN DISORDER (A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything), VASCULAR PAIN (Sore) and VEIN DISCOLOURATION (And it was red compare to the other blood vessel) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced VEIN DISORDER (A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything) and VEIN DISCOLOURATION (And it was red compare to the other blood vessel). On 10-Dec-2021, the patient experienced INDURATION (Hard to press), CONTUSION (Has a bruise there), VASCULAR PAIN (Sore), CHILLS (Chills) and PYREXIA (A little bit of fever). At the time of the report, INDURATION (Hard to press), CONTUSION (Has a bruise there), VEIN DISORDER (A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything), VASCULAR PAIN (Sore), VEIN DISCOLOURATION (And it was red compare to the other blood vessel), CHILLS (Chills) and PYREXIA (A little bit of fever) outcome was unknown.            Concomitant medications included Antacids(unspecified). No treatment medications were provided.  On 10-Dec-2021, the patient had a bruise and she did not know if it was a clot or not and the affected area was tinkle, sore and hard to press.   This case was linked to MOD-2021-408560 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vein discolouration, Vein disorder
Clinical narrative: Hard to press; Has a bruise there; Sore; Chills; A little bit of fever; And it was red compare to the other blood vessel; A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything; This spontaneous case was reported by a patient and describes the occurrence of INDURATION (Hard to press), CONTUSION (Has a bruise there), VEIN DISORDER (A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything), VASCULAR PAIN (Sore) and VEIN DISCOLOURATION (And it was red compare to the other blood vessel) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced VEIN DISORDER (A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything) and VEIN DISCOLOURATION (And it was red compare to the other blood vessel). On 10-Dec-2021, the patient experienced INDURATION (Hard to press), CONTUSION (Has a bruise there), VASCULAR PAIN (Sore), CHILLS (Chills) and PYREXIA (A little bit of fever). At the time of the report, INDURATION (Hard to press), CONTUSION (Has a bruise there), VEIN DISORDER (A Vein  in foot popped up/ Like it was like it had a busted blood vessel, but she didn't hit anything), VASCULAR PAIN (Sore), VEIN DISCOLOURATION (And it was red compare to the other blood vessel), CHILLS (Chills) and PYREXIA (A little bit of fever) outcome was unknown.            Concomitant medications included Antacids(unspecified). No treatment medications were provided.  On 10-Dec-2021, the patient had a bruise and she did not know if it was a clot or not and the affected area was tinkle, sore and hard to press.   This case was linked to MOD-2021-408560 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: sore arm; felt a little tired for 1 day; had a low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (sore arm), FATIGUE (felt a little tired for 1 day) and PYREXIA (had a low grade fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (sore arm), FATIGUE (felt a little tired for 1 day) and PYREXIA (had a low grade fever). At the time of the report, MYALGIA (sore arm), FATIGUE (felt a little tired for 1 day) and PYREXIA (had a low grade fever) 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 concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-408555 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Decreased appetite, Pain, Pyrexia
Clinical narrative: worry about dying; on and off again not to much appetite; he is in a lot of pain; definitely a high fever of 104°F/High temperature; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (worry about dying), DECREASED APPETITE (on and off again not to much appetite), PAIN (he is in a lot of pain) and PYREXIA (definitely a high fever of 104°F/High temperature) 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 ANXIETY (worry about dying), DECREASED APPETITE (on and off again not to much appetite), PAIN (he is in a lot of pain) and PYREXIA (definitely a high fever of 104°F/High temperature). At the time of the report, ANXIETY (worry about dying), DECREASED APPETITE (on and off again not to much appetite) and PAIN (he is in a lot of pain) outcome was unknown and PYREXIA (definitely a high fever of 104°F/High temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) high fever of 104°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vomiting
Clinical narrative: Patient began to felt chest pain; Patient began to vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Patient began to felt chest pain) and VOMITING (Patient began to vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced CHEST PAIN (Patient began to felt chest pain) and VOMITING (Patient began to vomiting). At the time of the report, CHEST PAIN (Patient began to felt chest pain) and VOMITING (Patient began to vomiting) had not resolved.            No concomitant drug details were reported. No treatment details were reported.  Treatment details include Diuretic.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: sore arm; chills; low grade fever; tired; 2 vials of vaccine had doses which were administered after 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (low grade fever), FATIGUE (tired) and EXPIRED PRODUCT ADMINISTERED (2 vials of vaccine had doses which were administered after 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) 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 PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (low grade fever) and FATIGUE (tired). an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 vials of vaccine had doses which were administered after 12 hours post puncture). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills), PYREXIA (low grade fever) and FATIGUE (tired) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (2 vials of vaccine had doses which were administered after 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter. .   This case was linked to MOD-2021-408462 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: After the 1st dose of the Moderna vaccine in the left arm, patient has not been able to lift or mover her left arm.; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (After the 1st dose of the Moderna vaccine in the left arm, patient has not been able to lift or mover her left arm.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01417201A) 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) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MOVEMENT DISORDER (After the 1st dose of the Moderna vaccine in the left arm, patient has not been able to lift or mover her left arm.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (After the 1st dose of the Moderna vaccine in the left arm, patient has not been able to lift or mover her left arm.) outcome was unknown.            No concomitant medications provided. Treatment included other pain medication.  She was seen by her doctor in September 2021 and has had an MRI and other tests done etc. A definite cause or diagnosis was not provided regarding her left arm. She is currently under doctor's care.   This case was linked to MOD-2021-408579 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A1, 04L20A and 044B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METHYLPREDNISOLONE and MUPIROCIN (BACTROBAN [MUPIROCIN]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include Flovent inhaler.  Treatment information was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: little itchy on injection site; little pain on injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (little itchy on injection site) and VACCINATION SITE PAIN (little pain on injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (little itchy on injection site) and VACCINATION SITE PAIN (little pain on injection site). On 26-Mar-2021, VACCINATION SITE PRURITUS (little itchy on injection site) and VACCINATION SITE PAIN (little pain on injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-408601 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm was sore; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm was sore). At the time of the report, VACCINATION SITE PAIN (Left arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-408553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Non-significant follow up appended.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: severe itching all over my body; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (severe itching all over my body) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (severe itching all over my body). At the time of the report, PRURITUS (severe itching all over my body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: little bit of body aches; low grade temperature; it was just an off day; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (little bit of body aches), PYREXIA (low grade temperature) and FEELING ABNORMAL (it was just an off day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included MS.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN (little bit of body aches), PYREXIA (low grade temperature) and FEELING ABNORMAL (it was just an off day). At the time of the report, PAIN (little bit of body aches), PYREXIA (low grade temperature) and FEELING ABNORMAL (it was just an off day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went off her immunosuppressant medication when Covid-19 first hit.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-408541, MOD-2021-408555 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised); Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 27-Oct-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 09-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 09-Dec-2021, ACCIDENTAL OVERDOSE (Patient administered full dose of Moderna COVID-19 vaccine for booster dose (not immunocompromised)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Reported stated that the Moderna COVID-19 vaccine was supposed to be a booster dose but HCP assumed that they were administering the first dose of a primary series.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm hurt for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurt for two days) 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 VACCINATION SITE PAIN (arm hurt for two days). At the time of the report, VACCINATION SITE PAIN (arm hurt for two days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pyrexia
Clinical narrative: heat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (heat) and PYREXIA (Fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006021A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (heat) and PYREXIA (Fever). At the time of the report, FEELING HOT (heat) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy arm after the shot) in a 100-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. In November 2021, the patient experienced PRURITUS (itchy arm after the shot). At the time of the report, PRURITUS (itchy arm after the shot) outcome was unknown. Not Provided          Treatment information was not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-405414 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I was given an expired booster shot ten days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I was given an expired booster shot ten days ago) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I was given an expired booster shot ten days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I was given an expired booster shot ten days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient received booster shot 10 days ago
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: HCP stated that a patient received half a dose , instead a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated that a patient received half a dose , instead a full 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 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated that a patient received half a dose , instead a full dose). On 08-Dec-2021, ACCIDENTAL UNDERDOSE (HCP stated that a patient received half a dose , instead a full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient received half a dose instead of full dose.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Myalgia, Nasal congestion, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (is very "nasely" and her nose is really stuffed.), SNEEZING (has been sneezing a lot), FEELING HOT (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever), RASH (rash on my face/rash in forehead around my eyes) and CHILLS (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: JandJ (first shot given in right dominant arm with lot number :1802070) on 14-Mar-2021.Past adverse reactions to the above products included No adverse event with JandJ. On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced FEELING HOT (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever), CHILLS (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever) and MYALGIA (on Thursday night, patient experienced body aches). On an unknown date, the patient experienced NASAL CONGESTION (is very "nasely" and her nose is really stuffed.), SNEEZING (has been sneezing a lot) and RASH (rash on my face/rash in forehead around my eyes). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 10-Dec-2021, FEELING HOT (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever), CHILLS (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever) and MYALGIA (on Thursday night, patient experienced body aches) had resolved. At the time of the report, NASAL CONGESTION (is very "nasely" and her nose is really stuffed.), SNEEZING (has been sneezing a lot) and RASH (rash on my face/rash in forehead around my eyes) outcome was unknown. Concomitant medications were not provided. Treatment medication also includes sinus medication and antihistamine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (is very "nasely" and her nose is really stuffed.), SNEEZING (has been sneezing a lot), FEELING HOT (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever), RASH (rash on my face/rash in forehead around my eyes) and CHILLS (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: JandJ (first shot given in right dominant arm with lot number :1802070) on 14-Mar-2021.Past adverse reactions to the above products included No adverse event with JandJ. On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced FEELING HOT (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever), CHILLS (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever) and MYALGIA (on Thursday night, patient experienced body aches). On an unknown date, the patient experienced NASAL CONGESTION (is very "nasely" and her nose is really stuffed.), SNEEZING (has been sneezing a lot) and RASH (rash on my face/rash in forehead around my eyes). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 10-Dec-2021, FEELING HOT (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever), CHILLS (on Thursday night, patient experienced body aches, chills and was hot but doesn't remember having a fever) and MYALGIA (on Thursday night, patient experienced body aches) had resolved. At the time of the report, NASAL CONGESTION (is very "nasely" and her nose is really stuffed.), SNEEZING (has been sneezing a lot) and RASH (rash on my face/rash in forehead around my eyes) outcome was unknown. Concomitant medications were not provided. Treatment medication also includes sinus medication and antihistamine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hangover, Malaise
Clinical narrative: A couple of hours after getting the Booster shot, she felt sick like with a minor hangover; A couple of hours after getting the Booster shot, she felt sick like with a minor hangover; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) and HANGOVER (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 001B21A and 016E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) and HANGOVER (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover). On 09-Dec-2021, MALAISE (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) and HANGOVER (A couple of hours after getting the Booster shot, she felt sick like with a minor hangover) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Vaccination complication, Vaccination site pain
Clinical narrative: Reactions after the vaccine; Feel sick; Headache; Hurt where it was injected; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Reactions after the vaccine), MALAISE (Feel sick), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurt where it was injected) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Hurt where it was injected). On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions after the vaccine) and MALAISE (Feel sick). At the time of the report, VACCINATION COMPLICATION (Reactions after the vaccine), MALAISE (Feel sick), HEADACHE (Headache) and VACCINATION SITE PAIN (Hurt where it was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.  Patient stated that she didn't get the second shot.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Reporter's contact details and additional event of Feeling sick were updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A sore arm after all doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm after all doses) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-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 PAIN IN EXTREMITY (A sore arm after all doses). At the time of the report, PAIN IN EXTREMITY (A sore arm after all doses) outcome was unknown.            No concomitant medications were reported. Treatment medication was reported as unknown.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Dec-2021: Follow up received includes treatment medication information (Unknown).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: Also a sore arm after all doses and was very cold for 3 days after first dose; Also a sore arm after all doses and was very cold for 3 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Also a sore arm after all doses and was very cold for 3 days after first dose) and NASOPHARYNGITIS (Also a sore arm after all doses and was very cold for 3 days after first dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Also a sore arm after all doses and was very cold for 3 days after first dose). an unknown date, the patient experienced NASOPHARYNGITIS (Also a sore arm after all doses and was very cold for 3 days after first dose). At the time of the report, PAIN IN EXTREMITY (Also a sore arm after all doses and was very cold for 3 days after first dose) and NASOPHARYNGITIS (Also a sore arm after all doses and was very cold for 3 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Provided picture of event. No concomitant medications and No treatment information were reported.   This case was linked to MOD-2021-408573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Dec-2021: Follow up received Provided pictures for safety.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia, Vaccination complication
Clinical narrative: the booster is killing him, a day a night and a day; felt horrible; ache; feverish; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (the booster is killing him, a day a night and a day), FEELING ABNORMAL (felt horrible), PAIN (ache) and PYREXIA (feverish) 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 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (the booster is killing him, a day a night and a day), FEELING ABNORMAL (felt horrible), PAIN (ache) and PYREXIA (feverish). At the time of the report, VACCINATION COMPLICATION (the booster is killing him, a day a night and a day), FEELING ABNORMAL (felt horrible), PAIN (ache) and PYREXIA (feverish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.