chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose 8 months apart from 1st; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 months apart from 1st) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 months apart from 1st). On 29-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 months apart from 1st) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, OLMESARTAN, AMLODIPINE, DULOXETINE and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.   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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-369137 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: I felt like I got run over by a truck; My arm was hard; trouble walking; My arm was swollen; Muscle pain; Next day I had joint pain; headache; chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), GAIT DISTURBANCE (trouble walking), VACCINATION SITE SWELLING (My arm was swollen) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026DZ1A, 032MZCA and 024MZCA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, IRBESARTAN, DILTIAZEM, PRAVASTATIN and EZETIMIBE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, 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 experienced FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), GAIT DISTURBANCE (trouble walking), VACCINATION SITE SWELLING (My arm was swollen), MYALGIA (Muscle pain), ARTHRALGIA (Next day I had joint pain), HEADACHE (headache), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), VACCINATION SITE SWELLING (My arm was swollen) and ARTHRALGIA (Next day I had joint pain) outcome was unknown and GAIT DISTURBANCE (trouble walking), MYALGIA (Muscle pain), HEADACHE (headache), CHILLS (chills) and FATIGUE (Fatigue) was resolving.            No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site induration, Vaccination site swelling
Clinical narrative: I felt like I got run over by a truck; My arm was hard; trouble walking; My arm was swollen; Muscle pain; Next day I had joint pain; headache; chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), GAIT DISTURBANCE (trouble walking), VACCINATION SITE SWELLING (My arm was swollen) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026DZ1A, 032MZCA and 024MZCA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, IRBESARTAN, DILTIAZEM, PRAVASTATIN and EZETIMIBE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, 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 experienced FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), GAIT DISTURBANCE (trouble walking), VACCINATION SITE SWELLING (My arm was swollen), MYALGIA (Muscle pain), ARTHRALGIA (Next day I had joint pain), HEADACHE (headache), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (I felt like I got run over by a truck), VACCINATION SITE INDURATION (My arm was hard), VACCINATION SITE SWELLING (My arm was swollen) and ARTHRALGIA (Next day I had joint pain) outcome was unknown and GAIT DISTURBANCE (trouble walking), MYALGIA (Muscle pain), HEADACHE (headache), CHILLS (chills) and FATIGUE (Fatigue) was resolving.            No treatment medications were provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Swelling, Vaccination site pain
Clinical narrative: his right elbow and the muscle of his right forearm is swollen; right arm is sore today/right elbow sore to the touch; Right arm cramp; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Right arm cramp), SWELLING (his right elbow and the muscle of his right forearm is swollen) and VACCINATION SITE PAIN (right arm is sore today/right elbow sore to the touch) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced MUSCLE SPASMS (Right arm cramp). On 29-Oct-2021, the patient experienced SWELLING (his right elbow and the muscle of his right forearm is swollen). 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (right arm is sore today/right elbow sore to the touch). At the time of the report, MUSCLE SPASMS (Right arm cramp), SWELLING (his right elbow and the muscle of his right forearm is swollen) and VACCINATION SITE PAIN (right arm is sore today/right elbow sore to the touch) outcome was unknown.            Concomitant and Treatment medications were not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-368757, MOD-2021-368774 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site discolouration
Clinical narrative: Report reaction; Arm turn yellow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report reaction) and VACCINATION SITE DISCOLOURATION (Arm turn yellow) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) 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 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE DISCOLOURATION (Arm turn yellow). On an unknown date, the patient experienced VACCINATION COMPLICATION (Report reaction). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Report reaction) and VACCINATION SITE DISCOLOURATION (Arm turn yellow) outcome was unknown.            No concomitant medication was provided.   This case was linked to MOD-2021-368986 (Parent-Child Link).   See case MOD-2021-368986 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2021: Follow up document received on 31 OCT 2021 contains report contact information added, Patient demographic details added, additional events added.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: patient is claiming it was given subconsciously because she has no reaction to it; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (patient is claiming it was given subconsciously because she has no reaction to it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (patient is claiming it was given subconsciously because she has no reaction to it). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (patient is claiming it was given subconsciously because she has no reaction to it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Is a hot; injection site has a big swollen area; Is itching really bad; It's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Is a hot), VACCINATION SITE SWELLING (injection site has a big swollen area), VACCINATION SITE PRURITUS (Is itching really bad) and VACCINATION SITE PAIN (It's sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 016M20A and 004M20A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Is a hot), VACCINATION SITE SWELLING (injection site has a big swollen area), VACCINATION SITE PRURITUS (Is itching really bad) and VACCINATION SITE PAIN (It's sore). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Is a hot), VACCINATION SITE SWELLING (injection site has a big swollen area), VACCINATION SITE PRURITUS (Is itching really bad) and VACCINATION SITE PAIN (It's sore) had resolved.            Other treatment medicines included OTC medicine.   This case was linked to MOD-2021-368828 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: "got the 2 shots and still got COVID"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ("got the 2 shots and still got COVID") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 ("got the 2 shots and still got COVID"). At the time of the report, COVID-19 ("got the 2 shots and still got COVID") outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: This case concerns a patient with unknown age and gender, no relevant medical history, who experienced the non-serious event of special interest of COVID-19. The event occurred on an unknown date after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Spikevax is not affected by this report. Although referred that COVID-19 is diagnosed being fully vaccinated, the information regarding vaccination dates is incomplete, so lack of efficacy situation cannot be properly assessed.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: terrible joint pain,lasted for a week; muscle pain,This has lasted for a week; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (terrible joint pain,lasted for a week) and MYALGIA (muscle pain,This has lasted for a week) 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.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (terrible joint pain,lasted for a week) and MYALGIA (muscle pain,This has lasted for a week). At the time of the report, ARTHRALGIA (terrible joint pain,lasted for a week) and MYALGIA (muscle pain,This has lasted for a week) had resolved.            No concomitant medications provided. The patient stated that after vaccination she did not have these events and after 6 months now is she experienced those events.The patient wants to know if that could be from the vaccine because it's been over 6 months. The patient states she had a test done (unspecified), but she doesn't understand what it means. No treatment medications provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Arm as if I have fire; It hurts but not to the level of my arm; Extreme tiredness; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Arm as if I have fire), PAIN IN EXTREMITY (It hurts but not to the level of my arm), FATIGUE (Extreme tiredness) and MYALGIA (Body ache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ARIPIPRAZOLE (ABILIFY) for Blood pressure abnormal.  On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced BURNING SENSATION (Arm as if I have fire), PAIN IN EXTREMITY (It hurts but not to the level of my arm), FATIGUE (Extreme tiredness) and MYALGIA (Body ache). At the time of the report, BURNING SENSATION (Arm as if I have fire), PAIN IN EXTREMITY (It hurts but not to the level of my arm), FATIGUE (Extreme tiredness) and MYALGIA (Body ache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication reported. No treatment information provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-369020, MOD-2021-369053, MOD-2021-368935, MOD-2021-369022 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: Legs from the knees down were itching horribly; Such an itchy itchy spot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Legs from the knees down were itching horribly) and VACCINATION SITE PRURITUS (Such an itchy itchy spot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRURITUS (Legs from the knees down were itching horribly). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Such an itchy itchy spot). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Legs from the knees down were itching horribly) and VACCINATION SITE PRURITUS (Such an itchy itchy spot) had resolved.            Other concomitant product use included nasal spray.  Other treatment product use included OTC medicine.  It was reported that the medications that the patient used to treat adverse event didn't worked and those  adverse events experienced by her went away eventually.   This case was linked to MOD-2021-368798 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection site left arm) in a 50-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. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in injection site left arm). At the time of the report, VACCINATION SITE PAIN (Soreness in injection site left arm) 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 was reported.  No treatment medications were reported.   This case was linked to MOD-2021-368929, MOD-2021-368930 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: A metallic taste; 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 DYSGEUSIA (A metallic taste) 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 DYSGEUSIA (A metallic taste). At the time of the report, DYSGEUSIA (A metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medication were provided.  The patient heard about a metallic taste after Moderna Covid-19 Vaccine.  No treatment medication were provided.   This case was linked to MOD-2021-369093, MOD-2021-368867 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: The patient reported to get the Moderna booster 3 day ago, in subconscious tissue and not the deltoid muscle/does not think the shot was given to her intramuscularly instead the shot was given subcutaneously; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient reported to get the Moderna booster 3 day ago, in subconscious tissue and not the deltoid muscle/does not think the shot was given to her intramuscularly instead the shot was given subcutaneously) 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.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. In October 2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient reported to get the Moderna booster 3 day ago, in subconscious tissue and not the deltoid muscle/does not think the shot was given to her intramuscularly instead the shot was given subcutaneously). In October 2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient reported to get the Moderna booster 3 day ago, in subconscious tissue and not the deltoid muscle/does not think the shot was given to her intramuscularly instead the shot was given subcutaneously) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was a nurse and experienced no adverse effects. The patient would like another booster shot.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Reporter contact information was added and vaccination details was updated.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: a metallic taste; 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 DYSGEUSIA (a metallic taste) 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 DYSGEUSIA (a metallic taste). At the time of the report, DYSGEUSIA (a metallic taste) 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-2021-368853 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Influenza like illness, Pyrexia
Clinical narrative: got pretty sick; felt like the flu; felt pretty bad; had fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got pretty sick), INFLUENZA LIKE ILLNESS (felt like the flu), FEELING ABNORMAL (felt pretty bad) and PYREXIA (had fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (underlying condition).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 ILLNESS (got pretty sick), INFLUENZA LIKE ILLNESS (felt like the flu), FEELING ABNORMAL (felt pretty bad) and PYREXIA (had fever). At the time of the report, ILLNESS (got pretty sick), INFLUENZA LIKE ILLNESS (felt like the flu) and FEELING ABNORMAL (felt pretty bad) outcome was unknown and PYREXIA (had fever) had resolved.            No concomitant medication information was provided. No treatment medication information was provided. This case pertains to patient 2. Patient got pretty sick after the  second Moderna dose. They felt like the flu, they felt pretty bad, and had fever, for 3 days.   This case was linked to MOD-2021-272492 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Under the arm and around the injection site is kind of blueish , Bruising because of the injection; there's also some swelling; Itchy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Under the arm and around the injection site is kind of blueish , Bruising because of the injection), VACCINATION SITE SWELLING (there's also some swelling) and VACCINATION SITE PRURITUS (Itchy) 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 VACCINATION SITE BRUISING (Under the arm and around the injection site is kind of blueish , Bruising because of the injection), VACCINATION SITE SWELLING (there's also some swelling) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE BRUISING (Under the arm and around the injection site is kind of blueish , Bruising because of the injection), VACCINATION SITE SWELLING (there's also some swelling) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Patient asked the Pharmacist about the reaction and they said it was probably bruising because of the injection. Patient would like to know when it will go away.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Pain in extremity
Clinical narrative: I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest; I had a slight sore arm; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest), PAIN IN EXTREMITY (I had a slight sore arm), CHILLS (Chills) and FATIGUE (Fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 011L20A and 031620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, VALSARTAN, FOLIC ACID, METOPROLOL SUCCINATE (TOPROL XL), ROSUVASTATIN CALCIUM (CRESTOR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced HEART RATE INCREASED (I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest), PAIN IN EXTREMITY (I had a slight sore arm), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, HEART RATE INCREASED (I had a really hard/fast heart beat it was frightening/I had high heart rate, could feel heart in throat and chest), PAIN IN EXTREMITY (I had a slight sore arm), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-368784 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: 6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases; This spontaneous case was reported by a physician and describes the occurrence of TACHYCARDIA (6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced TACHYCARDIA (6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases). The patient was treated with MAGNESIUM for Tachycardia, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (6 weeks after getting the second dose of the vaccine, they experienced tachycardia/ This repeated on 08Jun2021, but since 3 months ago it started to happen on a regular bases) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site is warm to the touch; Injection site swollen to the size of a golf ball; Injection site is painful; Injection site is red; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE SWELLING (Injection site swollen to the size of a golf ball), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, J20-2A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE SWELLING (Injection site swollen to the size of a golf ball), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE SWELLING (Injection site swollen to the size of a golf ball), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Heart rate: heart rate increased to 100 (High) Heart rate increased to 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-368920 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia, Neck pain
Clinical narrative: Neck pain; Arms were getting hotter; Hands and arms getting redder and hotter.; middle/to extreme pain in the lower body,that then transferred to the upper body; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), FEELING HOT (Arms were getting hotter), ERYTHEMA (Hands and arms getting redder and hotter.) and MYALGIA (middle/to extreme pain in the lower body, that then transferred to the upper body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced FEELING HOT (Arms were getting hotter), ERYTHEMA (Hands and arms getting redder and hotter.) and MYALGIA (middle/to extreme pain in the lower body,that then transferred to the upper body). On 30-Oct-2021, the patient experienced NECK PAIN (Neck pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), FEELING HOT (Arms were getting hotter), ERYTHEMA (Hands and arms getting redder and hotter.) and MYALGIA (middle/to extreme pain in the lower body,that then transferred to the upper body) outcome was unknown.            Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 30 potential patients received thawed, refrozen, thawed again vaccine doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (30 potential patients received thawed, refrozen, thawed again vaccine doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (30 potential patients received thawed, refrozen, thawed again vaccine doses). At the time of the report, PRODUCT STORAGE ERROR (30 potential patients received thawed, refrozen, thawed again vaccine doses) 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 medications was provided by the reporter.  No treatment medications was provided by the reporter.  As the Source document product was removed from freezer and thawed and kept in refrigerator and again was replaced in freezer, sat for overnight later this product vaccine was administered to 30 patients.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 27 patients received expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (27 patients received expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (27 patients received expired doses). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (27 patients received expired doses) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test positive
Clinical narrative: Had covid 2 months ago in August; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Had covid 2 months ago in August) and DRUG INEFFECTIVE (Lack of drug effect) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011521A and 011520A) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE [VENLAFAXINE HYDROCHLORIDE]) and BUPROPION HYDROCHLORIDE for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Had covid 2 months ago in August) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Had covid 2 months ago in August) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test positive: positive (Positive) Positive.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown. This case concerns a 27 year old female with no reported medical history , who experienced non serious, unexpected events of Covid 19 and Drug ineffective which occurred approximately 6- 7 months after vaccination with the 2nd dose of mRNA-1273 (Moderna) vaccine. The re-challenge for this case is not applicable . The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.; Sender's Comments: This case concerns a 27 year old female with no reported medical history , who experienced non serious, unexpected events of Covid 19 and Drug ineffective which occurred approximately 6- 7 months after vaccination with the 2nd dose of mRNA-1273 (Moderna) vaccine. The re-challenge for this case is not applicable . The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We had an error where a vaccine was administered 3 weeks past; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had an error where a vaccine was administered 3 weeks past) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had an error where a vaccine was administered 3 weeks past). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had an error where a vaccine was administered 3 weeks past) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported. No concomitant medications was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Significant adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Significant adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Significant adverse reaction). At the time of the report, VACCINATION COMPLICATION (Significant adverse reaction) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given expired in December. But it turned out it expired on 27Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  No treatment drugs were reported.   This case was linked to MOD-2021-369020, MOD-2021-368822 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort
Clinical narrative: experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001a21a and 037a21b) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Product used for unknown indication, PRAVASTATIN, LEVOTHYROXINE, MONTELUKAST, LOSARTAN, DILTIAZEM, ALBUTEROL [SALBUTAMOL] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced NASAL DISCOMFORT (experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL DISCOMFORT (experiencing nose burn, nasal problems, nasal passages, sinuses and everything is burning) outcome was unknown.            Patient  states that on October or September their nasal passages were burning and went to the doctor them antibiotics and these happened twice.   This case was linked to MOD-2021-368964 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Didn't feel as well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel as well) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-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 MALAISE (Didn't feel as well). At the time of the report, MALAISE (Didn't feel as well) had resolved.            No concomitant medication was reported   No treatment medication was reported   This case was linked to MOD-2021-368921 (Patient Link).