chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: really dizzy and felt like she could pass out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (really dizzy and felt like she could pass out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 023M20A and 013L20B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure low.   On 24-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-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 DIZZINESS (really dizzy and felt like she could pass out). At the time of the report, DIZZINESS (really dizzy and felt like she could pass out) outcome was unknown.            Concomitant medication included Blood pressure medication. No treatment reported.  First dose of the suspect product was administered on 27Jan2021 with batch number 013L20B Second dose of the suspect product was administered on 24Jan2021 with batch number 023M20A   This case was linked to MOD-2021-413990 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Just usual soreness/ Pain went away; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Just usual soreness/ Pain went away) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Just usual soreness/ Pain went away). At the time of the report, MYALGIA (Just usual soreness/ Pain went away) had resolved. Not Provided          No concomitant medication was reported. No treatment medication was reported. The patient had usual soreness and no medication was needed with no swelling. The pain went away in about two days.   This case was linked to MOD-2021-411485, MOD-2021-406511 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: he developed chest pain after 2nd Moderna COVID-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (he developed chest pain after 2nd Moderna COVID-19 vaccine.) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (he developed chest pain after 2nd Moderna COVID-19 vaccine.). At the time of the report, CHEST PAIN (he developed chest pain after 2nd Moderna COVID-19 vaccine.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chills, Intentional dose omission, Irritability
Clinical narrative: I have not taken dose 2 of moderna yet; It is very irritating; Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (It is very irritating), CHILLS (Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current) and INTENTIONAL DOSE OMISSION (I have not taken dose 2 of moderna yet) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced IRRITABILITY (It is very irritating) and CHILLS (Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (I have not taken dose 2 of moderna yet). At the time of the report, IRRITABILITY (It is very irritating) and CHILLS (Chills feeling inside my body which did not go away/sometimes it happens my chest, sometimes inside my back, hips/so the chills feeling is running around inside my body like a current) had not resolved and INTENTIONAL DOSE OMISSION (I have not taken dose 2 of moderna yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) All the results are normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Eight months later the patient still had the same chills feeling. The chills feeling was not very serious, the patient do not feel cold and do not need to add cloths, but it ws very irritating. The chills feeling was not a full body one but localized. Sometime it happens inside body like a current. At each location of my body, the chills feeling remain for ten, twenty minutes each times and then moves to other location. Because of this situation, the patient have not taken second dose of moderna yet. No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Pain in neck; Shoulder Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in neck) and ARTHRALGIA (Shoulder Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Immunisation.     Concomitant products included ABALOPARATIDE (TYMLOS) from 28-Oct-2021 to an unknown date for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced NECK PAIN (Pain in neck) and ARTHRALGIA (Shoulder Joint pain). At the time of the report, NECK PAIN (Pain in neck) and ARTHRALGIA (Shoulder Joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Hypoaesthesia, Lymphadenopathy, Pain
Clinical narrative: Burning sensation in left hand fingertips; Achy; numbness sensation in left hand fingertips; Swollen lymph nodes in left armpit; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in left hand fingertips), PAIN (Achy), HYPOAESTHESIA (numbness sensation in left hand fingertips), LYMPHADENOPATHY (Swollen lymph nodes in left armpit ) and FATIGUE (Tired) in a 61-year-old patient of an unknown 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. In December 2021, the patient experienced BURNING SENSATION (Burning sensation in left hand fingertips), HYPOAESTHESIA (numbness sensation in left hand fingertips) and LYMPHADENOPATHY (Swollen lymph nodes in left armpit ). December 2021, the patient experienced PAIN (Achy) and FATIGUE (Tired). In December 2021, BURNING SENSATION (Burning sensation in left hand fingertips), PAIN (Achy), HYPOAESTHESIA (numbness sensation in left hand fingertips), LYMPHADENOPATHY (Swollen lymph nodes in left armpit ) and FATIGUE (Tired) had resolved.            No concomitant medication information was provided. No treatment medication were provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received booster dose from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster dose from an expired vial ) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster dose from an expired vial ). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received booster dose from an expired vial ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expiration date of the vial was reported as 13 Dec 2021.  No concomitant medications were reported. No treatment medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Myalgia, Swelling, Tenderness
Clinical narrative: bruise in the left hand over their ring finger knuckle and the middle ginger knuckle; very tender to the touch; a little swollen; a little body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise in the left hand over their ring finger knuckle and the middle ginger knuckle), TENDERNESS (very tender to the touch), SWELLING (a little swollen), MYALGIA (a little body aches) and CHILLS (chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced MYALGIA (a little body aches) and CHILLS (chills). On 15-Dec-2021, the patient experienced CONTUSION (bruise in the left hand over their ring finger knuckle and the middle ginger knuckle), TENDERNESS (very tender to the touch) and SWELLING (a little swollen). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 14-Dec-2021, MYALGIA (a little body aches) and CHILLS (chills) had resolved. At the time of the report, CONTUSION (bruise in the left hand over their ring finger knuckle and the middle ginger knuckle), TENDERNESS (very tender to the touch) and SWELLING (a little swollen) outcome was unknown.      Concomitant included medications for birth control.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Fear, Hypokinesia, Nightmare, Product dose omission issue
Clinical narrative: skipped the second Moderna dose; The caller reported four days later she had a bad dream that she couldn't get out; sort of like a psychotic thing; mind wouldn't let her get out of the bed/ couldn't move; it scared her; she was crying when she told her husband about the events; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (The caller reported four days later she had a bad dream that she couldn't get out), PSYCHOTIC DISORDER (sort of like a psychotic thing), HYPOKINESIA (mind wouldn't let her get out of the bed/ couldn't move), FEAR (it scared her) and CRYING (she was crying when she told her husband about the events) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced NIGHTMARE (The caller reported four days later she had a bad dream that she couldn't get out), PSYCHOTIC DISORDER (sort of like a psychotic thing), HYPOKINESIA (mind wouldn't let her get out of the bed/ couldn't move), FEAR (it scared her) and CRYING (she was crying when she told her husband about the events). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (skipped the second Moderna dose). At the time of the report, NIGHTMARE (The caller reported four days later she had a bad dream that she couldn't get out), PSYCHOTIC DISORDER (sort of like a psychotic thing), HYPOKINESIA (mind wouldn't let her get out of the bed/ couldn't move), FEAR (it scared her) and CRYING (she was crying when she told her husband about the events) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (skipped the second Moderna dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: skipped the second Moderna dose; The caller reported four days later she had a bad dream that she couldn't get out; sort of like a psychotic thing; mind wouldn't let her get out of the bed/ couldn't move; it scared her; she was crying when she told her husband about the events; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (The caller reported four days later she had a bad dream that she couldn't get out), PSYCHOTIC DISORDER (sort of like a psychotic thing), HYPOKINESIA (mind wouldn't let her get out of the bed/ couldn't move), FEAR (it scared her) and CRYING (she was crying when she told her husband about the events) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced NIGHTMARE (The caller reported four days later she had a bad dream that she couldn't get out), PSYCHOTIC DISORDER (sort of like a psychotic thing), HYPOKINESIA (mind wouldn't let her get out of the bed/ couldn't move), FEAR (it scared her) and CRYING (she was crying when she told her husband about the events). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (skipped the second Moderna dose). At the time of the report, NIGHTMARE (The caller reported four days later she had a bad dream that she couldn't get out), PSYCHOTIC DISORDER (sort of like a psychotic thing), HYPOKINESIA (mind wouldn't let her get out of the bed/ couldn't move), FEAR (it scared her) and CRYING (she was crying when she told her husband about the events) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (skipped the second Moderna dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin). At the time of the report, ALOPECIA (thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-414611 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pruritus, Tongue discomfort, Urticaria
Clinical narrative: extreme hives; tongue related adverse event; itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over; tightness in chest near esophagus; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in chest near esophagus), URTICARIA (extreme hives), TONGUE DISCOMFORT (tongue related adverse event) and PRURITUS (itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 039B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced CHEST DISCOMFORT (tightness in chest near esophagus), TONGUE DISCOMFORT (tongue related adverse event) and PRURITUS (itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over). On 17-Nov-2021, the patient experienced URTICARIA (extreme hives). The patient was treated with PREDNISOLONE for Adverse event, at a dose of 5 day pack; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of during day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of at night. At the time of the report, CHEST DISCOMFORT (tightness in chest near esophagus), URTICARIA (extreme hives), TONGUE DISCOMFORT (tongue related adverse event) and PRURITUS (itching started on scalp which spread to torso to groin to under the breast to waistline, kind of all over) outcome was unknown.            It was reported while being evaluated by healthcare professional  (HCP),  patient mentioned eating little sushi, scallops, and shrimp for about 4 days. Patient mentioned her tightness in chest was related to  allergic. On 20 Nov 2021, patient visited healthcare professional and HCP said she maybe having a mild allergic reaction.  It was reported that the patient has been eating the same seafood products with no problems anymore. Patient did not had any similar or other events after 1st and 2nd dose of moderna COVID-19 vaccine.  No concomitant medications use were reported. Treatment activities for event was done with Steroid Shot.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine given when it was expired on 05OCT2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given when it was expired on 05OCT2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given when it was expired on 05OCT2021). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine given when it was expired on 05OCT2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment was reported by the reporter.  Patient has not reported any side effects following the vaccination.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discharge, Breast disorder, Eczema, Nipple exudate bloody, Rash pruritic
Clinical narrative: The rashes from it were scabby, oval shaped, and itchy; Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp; Got bloody discharge twice from left nipple,blood from the scabs; If she itched too much, clear liquid would come out; Duct in breast is enlarged; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp), NIPPLE EXUDATE BLOODY (Got bloody discharge twice from left nipple,blood from the scabs), BREAST DISCHARGE (If she itched too much, clear liquid would come out), BREAST DISORDER (Duct in breast is enlarged) and RASH PRURITIC (The rashes from it were scabby, oval shaped, and itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Asthma. Concomitant products included MOMETASONE FUROATE (NASONEX) for Allergy, LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) for Asthma.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ECZEMA (Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp), NIPPLE EXUDATE BLOODY (Got bloody discharge twice from left nipple,blood from the scabs), BREAST DISCHARGE (If she itched too much, clear liquid would come out) and BREAST DISORDER (Duct in breast is enlarged). On 19-Feb-2021, the patient experienced RASH PRURITIC (The rashes from it were scabby, oval shaped, and itchy). At the time of the report, ECZEMA (Had eczema all over the place/eczema presented grossly/eczema at that point was around her breast and scalp), NIPPLE EXUDATE BLOODY (Got bloody discharge twice from left nipple,blood from the scabs), BREAST DISCHARGE (If she itched too much, clear liquid would come out), BREAST DISORDER (Duct in breast is enlarged) and RASH PRURITIC (The rashes from it were scabby, oval shaped, and itchy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided  The patient stated that 3 weeks after she received the 1st dose, she had to be seen by a dermatologist as well as a breast care specialist. She states that she had to get mammograms and ultrasound of the breast done because her duct was enlarged and also stated that the eczema at that point was around her breast and scalp.   This case was linked to MOD-2021-414693 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were accidentally administered to patients from the punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were accidentally administered to patients from the punctured vial) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) and Pfizer (2nd dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were accidentally administered to patients from the punctured vial). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Doses were accidentally administered to patients from the punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.  The caller reported that, on 13-Dec-2021 a vial of the Moderna vaccine was opened and was not disposed of properly. And on 14-Dec-2021, 3 doses were accidently administered to patients from he punctured vial. She reported that the vial was refrigerated the entire time but it was administered approximately 18 hours post puncture. The caller stated that none of the patients have reported adverse reactions to this expired dose.   This case was linked to MOD-2021-414582 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, SARS-CoV-2 test positive
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 15-Aug-2021, SARS-CoV-2 test positive.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-400101, MOD-2021-400101 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) 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 details reported.   This case was linked to MOD-2021-400101, MOD-2021-400101 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered to patient 12 hours post puncture; the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient 12 hours post puncture) and PRODUCT STORAGE ERROR (the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture). On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient 12 hours post puncture). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient 12 hours post puncture) and PRODUCT STORAGE ERROR (the pre-drawn syringe was stored in the fridge for more than 12 hours as the dose was administered 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided. The vial was initially stored in the refrigerator on 14-Dec-2021 and was first punctured at 8:00 am or 9:00 am.Pre-drawn syringe was refrigerated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 0.5mL dose administered to patient as booster dose instead of 0.25mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (0.5mL dose administered to patient as booster dose instead of 0.25mL) in a 70-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) (Intramuscular) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 15-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5mL dose administered to patient as booster dose instead of 0.25mL). On 15-Dec-2021, ACCIDENTAL OVERDOSE (0.5mL dose administered to patient as booster dose instead of 0.25mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided The pharmacist stated that the patient was fine after the dose was administered. Patient received total of 1.5mL of moderna vaccine for all 3 doses combined.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pruritus, Rash, Skin reaction
Clinical narrative: Skin reaction; Rash all over the body; Headaches; Low energy; Itching; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (Low energy), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH (Rash all over the body) and HEADACHE (Headaches) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for an unknown indication.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced SKIN REACTION (Skin reaction). In November 2021, the patient experienced ASTHENIA (Low energy), PRURITUS (Itching), RASH (Rash all over the body) and HEADACHE (Headaches). The patient was treated with CYPROHEPTADINE for Itching, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Low energy), PRURITUS (Itching), SKIN REACTION (Skin reaction), RASH (Rash all over the body) and HEADACHE (Headaches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not required hospitalization.   This case was linked to MOD-2021-414620 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Feeling cold, Feeling hot, Myalgia
Clinical narrative: Bone pain; Feels cold; Then gets hot; It has been a lousy week; Bad rash; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), FEELING COLD (Feels cold), FEELING HOT (Then gets hot), FEELING ABNORMAL (It has been a lousy week) and RASH (Bad rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 013A219 and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced BONE PAIN (Bone pain), FEELING COLD (Feels cold), FEELING HOT (Then gets hot), FEELING ABNORMAL (It has been a lousy week), RASH (Bad rash) and MYALGIA (Muscle pain). At the time of the report, BONE PAIN (Bone pain), FEELING COLD (Feels cold), FEELING HOT (Then gets hot), FEELING ABNORMAL (It has been a lousy week), RASH (Bad rash) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bone pain; Feels cold; Then gets hot; It has been a lousy week; Bad rash; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), FEELING COLD (Feels cold), FEELING HOT (Then gets hot), FEELING ABNORMAL (It has been a lousy week) and RASH (Bad rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 013A219 and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced BONE PAIN (Bone pain), FEELING COLD (Feels cold), FEELING HOT (Then gets hot), FEELING ABNORMAL (It has been a lousy week), RASH (Bad rash) and MYALGIA (Muscle pain). At the time of the report, BONE PAIN (Bone pain), FEELING COLD (Feels cold), FEELING HOT (Then gets hot), FEELING ABNORMAL (It has been a lousy week), RASH (Bad rash) and MYALGIA (Muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Ultrasound scan, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling in upper arm over the side vaccine was administered/Pain resolved but there is still residual swelling/fell a tiny bit swollen/quarter of inch swollen; hurting/very painful; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (swelling in upper arm over the side vaccine was administered/Pain resolved but there is still residual swelling/fell a tiny bit swollen/quarter of inch swollen) and VACCINATION SITE PAIN (hurting/very painful) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE SWELLING (swelling in upper arm over the side vaccine was administered/Pain resolved but there is still residual swelling/fell a tiny bit swollen/quarter of inch swollen) and VACCINATION SITE PAIN (hurting/very painful). In 2021, VACCINATION SITE PAIN (hurting/very painful) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling in upper arm over the side vaccine was administered/Pain resolved but there is still residual swelling/fell a tiny bit swollen/quarter of inch swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound Doppler: result not reported (Inconclusive) Result not reported. On an unknown date, Ultrasound scan: result not reported (Inconclusive) Result not reported.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Vaccination site erythema
Clinical narrative: small area of redness at the injection site; received the primary vaccine series dose instead of the booster dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (small area of redness at the injection site) and ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (small area of redness at the injection site) and ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose). In November 2021, VACCINATION SITE ERYTHEMA (small area of redness at the injection site) had resolved. On 19-Nov-2021, ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.  0.5ml were administered instead of 0.25ml doses to patient.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity
Clinical narrative: Pain in arm; Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). In November 2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided      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 information was provided by the reporter. Patient denied any side effects following vaccine at the time of report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Illness, Nausea
Clinical narrative: Blurry vision; Thought she was going to die; Headache; Nausea; Low grade fever 101.8; Got sick; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Got sick), VISION BLURRED (Blurry vision), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-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.     The patient's past medical history included Illness (was feeling ill after a procedure) on 09-Dec-2021, Fever (felt ill with a fever) on 10-Dec-2021 and Surgery. Previously administered products included for COVID-19 vaccination: COVID-19 Vaccine Pfizer (Patient received the first two doses of the Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine Pfizer. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension, MAGNESIUM and SODIUM POTASSIUM TARTRATE for an unknown indication.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced VISION BLURRED (Blurry vision). In December 2021, the patient experienced ILLNESS (Got sick), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever 101.8). On 15-Dec-2021, PYREXIA (Low grade fever 101.8) had resolved. At the time of the report, ILLNESS (Got sick), VISION BLURRED (Blurry vision), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 101.8 (High) Body temperature high. On 15-Dec-2021, SARS-CoV-2 test: results pending (Inconclusive) Waiting for the results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller did not take anything for the side effects because of the previous surgeries. It was reported that the patient had blurry vision so the patient did not drive the first two days,thought she was going to die.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vision blurred
Clinical narrative: Blurry vision; Thought she was going to die; Headache; Nausea; Low grade fever 101.8; Got sick; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Got sick), VISION BLURRED (Blurry vision), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-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.     The patient's past medical history included Illness (was feeling ill after a procedure) on 09-Dec-2021, Fever (felt ill with a fever) on 10-Dec-2021 and Surgery. Previously administered products included for COVID-19 vaccination: COVID-19 Vaccine Pfizer (Patient received the first two doses of the Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine Pfizer. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension, MAGNESIUM and SODIUM POTASSIUM TARTRATE for an unknown indication.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced VISION BLURRED (Blurry vision). In December 2021, the patient experienced ILLNESS (Got sick), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Low grade fever 101.8). On 15-Dec-2021, PYREXIA (Low grade fever 101.8) had resolved. At the time of the report, ILLNESS (Got sick), VISION BLURRED (Blurry vision), FEELING ABNORMAL (Thought she was going to die), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Body temperature: 101.8 (High) Body temperature high. On 15-Dec-2021, SARS-CoV-2 test: results pending (Inconclusive) Waiting for the results.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller did not take anything for the side effects because of the previous surgeries. It was reported that the patient had blurry vision so the patient did not drive the first two days,thought she was going to die.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).