chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: After the second dose had fever and chills for a day and a half; After the second dose had fever and chills for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After the second dose had fever and chills for a day and a half) and CHILLS (After the second dose had fever and chills for a day and a half) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032m20a and 011m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (drug that was no longer in the Market). Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PYREXIA (After the second dose had fever and chills for a day and a half) and CHILLS (After the second dose had fever and chills for a day and a half). In March 2021, PYREXIA (After the second dose had fever and chills for a day and a half) and CHILLS (After the second dose had fever and chills for a day and a half) had resolved.            No treatment information was provided.  After the second dose, patient had fever and chills for a day and a half.   This case was linked to MOD-2022-474179 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (covid). At the time of the report, COVID-19 (covid) 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.   Concomitant medications were not provided Treatment medications were not provided Company comment This spontaneous case concerns a patient of unknown gender and age with no medical history, who experienced the unexpected non serious AESI event of COVID19, after receiving a dose of mRNA-1273 Vaccine. Current pandemic situation of COVID 19 can be risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown gender and age with no medical history, who experienced the unexpected non serious AESI event of COVID19, after receiving a dose of mRNA-1273 Vaccine. Current pandemic situation of COVID 19 can be risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patients received a dose vial an expired vial, a vial which had been punctured on 30Jan2022 (more than 12 hours).) 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 medications were reported. No treatment medications were reported.  It was reported by practice administrator that on 01-Feb-2022 three female patients received a dose vial an expired vial, a vial which had been punctured on 30-Jan-2022 (more than 12 hours).   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up received includes no new information.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Product storage error
Clinical narrative: Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients; Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients; 2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients), PRODUCT STORAGE ERROR (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients) and EXTRA DOSE ADMINISTERED (2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients), PRODUCT STORAGE ERROR (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients) and EXTRA DOSE ADMINISTERED (2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients), PRODUCT STORAGE ERROR (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients) and EXTRA DOSE ADMINISTERED (2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was given as 03-FEB-2022 Date vial moved from freezer to refrigerator was mentioned as 03-FEB-2022 Proposed desired Use by Date was given as 03-FEB-2022 Excursion duration-12 hrs. (greater than 24 hrs.)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the first dose of Moderna Covid-19 vaccine in the left arm shoulder deltoid muscle.  The treatment information was not reported.  No concomitant medication was reported.   This case was linked to MOD-2022-474520 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Swollen tongue
Clinical narrative: Itching all over the body; Red Blotches under the skin; Her tongue was swollen; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body), RASH MACULAR (Red Blotches under the skin), SWOLLEN TONGUE (Her tongue was swollen) and RASH (Rash all over the body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A, 006M20A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced PRURITUS (Itching all over the body). 18-Oct-2021, the patient experienced RASH MACULAR (Red Blotches under the skin), SWOLLEN TONGUE (Her tongue was swollen) and RASH (Rash all over the body). At the time of the report, PRURITUS (Itching all over the body), RASH MACULAR (Red Blotches under the skin), SWOLLEN TONGUE (Her tongue was swollen) and RASH (Rash all over the body) outcome was unknown.            No concomitant medications were reported.  Patient had to visit emergency room and took 3 unknown medications as treatment.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer  a puncture vial after 24hs.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer  a puncture vial after 24hs.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033h21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer  a puncture vial after 24hs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer  a puncture vial after 24hs.) 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 provided  The Patient stated that it was a Booster dose.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).; a vial which had also been punctured on 30Jan2022 (more than 12 hours).; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).) and PRODUCT STORAGE ERROR (a vial which had also been punctured on 30Jan2022 (more than 12 hours).) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).) and PRODUCT STORAGE ERROR (a vial which had also been punctured on 30Jan2022 (more than 12 hours).). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).) and PRODUCT STORAGE ERROR (a vial which had also been punctured on 30Jan2022 (more than 12 hours).) 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 medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up contain fax no which is added.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I was diagnosed with covid in November 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I was diagnosed with covid in November 2021) 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.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COVID-19 (I was diagnosed with covid in November 2021). At the time of the report, COVID-19 (I was diagnosed with covid in November 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, COVID-19: result not provided Result not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. I  was diagnosed with covid in November 2021  Company comment: This case concerns a patient of unknown age and gender with no medical history, who experienced the unexpected non serious AESI event of Covid 19, unspecified days after receiving second dose of mRNA-1273 Vaccine. Current pandemic can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history, who experienced the unexpected non serious AESI event of Covid 19, unspecified days after receiving second dose of mRNA-1273 Vaccine. Current pandemic can be a risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bedridden, Dizziness, Eructation, Gait disturbance
Clinical narrative: Had reactions; Sick to her stomach; Felt like she was going to get a sore throat; It felt like something was stuck in her throat; She could barely walk back & forth to the bathroom; Had dizzy spells to the point where she could barely walk back & forth to the bathroom; Was nauseated; Head hurt; Left arm hurt really bad & it felt beat to a pulp; Had excessive air coming up & was burping; Was in bed for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping) and OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy and Allergy to antibiotic (Allergic to antibiotics).    On 29-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp), NAUSEA (Was nauseated) and HEADACHE (Head hurt). At the time of the report, VACCINATION COMPLICATION (Had reactions), ABDOMINAL DISCOMFORT (Sick to her stomach), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), NAUSEA (Was nauseated) and HEADACHE (Head hurt) outcome was unknown and BEDRIDDEN (Was in bed for 4 days), ERUCTATION (Had excessive air coming up & was burping) and VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Before getting the dose the patient had tested positive for Covid..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-474388 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal discomfort, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Had reactions; Sick to her stomach; Felt like she was going to get a sore throat; It felt like something was stuck in her throat; She could barely walk back & forth to the bathroom; Had dizzy spells to the point where she could barely walk back & forth to the bathroom; Was nauseated; Head hurt; Left arm hurt really bad & it felt beat to a pulp; Had excessive air coming up & was burping; Was in bed for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping) and OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy and Allergy to antibiotic (Allergic to antibiotics).    On 29-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp), NAUSEA (Was nauseated) and HEADACHE (Head hurt). At the time of the report, VACCINATION COMPLICATION (Had reactions), ABDOMINAL DISCOMFORT (Sick to her stomach), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), NAUSEA (Was nauseated) and HEADACHE (Head hurt) outcome was unknown and BEDRIDDEN (Was in bed for 4 days), ERUCTATION (Had excessive air coming up & was burping) and VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Before getting the dose the patient had tested positive for Covid..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-474388 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Had reactions; Sick to her stomach; Felt like she was going to get a sore throat; It felt like something was stuck in her throat; She could barely walk back & forth to the bathroom; Had dizzy spells to the point where she could barely walk back & forth to the bathroom; Was nauseated; Head hurt; Left arm hurt really bad & it felt beat to a pulp; Had excessive air coming up & was burping; Was in bed for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping) and OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy and Allergy to antibiotic (Allergic to antibiotics).    On 29-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp), NAUSEA (Was nauseated) and HEADACHE (Head hurt). At the time of the report, VACCINATION COMPLICATION (Had reactions), ABDOMINAL DISCOMFORT (Sick to her stomach), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), NAUSEA (Was nauseated) and HEADACHE (Head hurt) outcome was unknown and BEDRIDDEN (Was in bed for 4 days), ERUCTATION (Had excessive air coming up & was burping) and VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Before getting the dose the patient had tested positive for Covid..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-474388 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dyspnoea, Fluid retention, Heart rate, Ultrasound Doppler
Clinical narrative: terrible reaction after she got the 2nd dose of the vaccine; fluid retention; Bloatingness; difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), DYSPNOEA (difficulty of breathing), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (NOS) in 2018 and Atrial fibrillation in 2018. Concurrent medical conditions included Penicillin allergy. Concomitant products included METOPROLOL, LISINOPRIL and RIVAROXABAN (XARELTO) for Atrial fibrillation and Heart failure (NOS).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (difficulty of breathing). On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness). At the time of the report, VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), DYSPNOEA (difficulty of breathing), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: normal (normal) normal. On an unknown date, Ultrasound Doppler: heart was fine and healthy (normal) heart was fine and healthy.         Patient was quite hesitant to take the booster dose. She reports that on the night after she got the 2nd dose (10-Mar-20221), she had difficulty of breathing. She went to her PCP who ignored it and then 2 weeks later she went to her cardiologist. Symptoms started on the night when 2nd dose of the Moderna Covid-19 vaccine was given and symptoms resolved after taking diuretics.  There was no history of COVID-19 infection nor Myocarditis and pericarditis  For treatment diuretics was taken.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: terrible reaction after she got the 2nd dose of the vaccine; fluid retention; Bloatingness; difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), DYSPNOEA (difficulty of breathing), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (NOS) in 2018 and Atrial fibrillation in 2018. Concurrent medical conditions included Penicillin allergy. Concomitant products included METOPROLOL, LISINOPRIL and RIVAROXABAN (XARELTO) for Atrial fibrillation and Heart failure (NOS).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (difficulty of breathing). On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness). At the time of the report, VACCINATION COMPLICATION (terrible reaction after she got the 2nd dose of the vaccine), DYSPNOEA (difficulty of breathing), FLUID RETENTION (fluid retention) and ABDOMINAL DISTENSION (Bloatingness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: normal (normal) normal. On an unknown date, Ultrasound Doppler: heart was fine and healthy (normal) heart was fine and healthy.         Patient was quite hesitant to take the booster dose. She reports that on the night after she got the 2nd dose (10-Mar-20221), she had difficulty of breathing. She went to her PCP who ignored it and then 2 weeks later she went to her cardiologist. Symptoms started on the night when 2nd dose of the Moderna Covid-19 vaccine was given and symptoms resolved after taking diuretics.  There was no history of COVID-19 infection nor Myocarditis and pericarditis  For treatment diuretics was taken.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a dose from an expired vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired vial.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired vial.). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up information included no new information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine expired on 22-JAN-2022 and administered on 24-JAN-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine expired on 22-JAN-2022 and administered on 24-JAN-2022) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine expired on 22-JAN-2022 and administered on 24-JAN-2022). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine expired on 22-JAN-2022 and administered on 24-JAN-2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. It as given as a booster dose.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Immunocompromised patient received 0.25 ml for third dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Immunocompromised patient received 0.25 ml for third dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Immunocompromised patient received 0.25 ml for third dose). On 10-Sep-2021, INCORRECT DOSE ADMINISTERED (Immunocompromised patient received 0.25 ml for third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medications were not reported.  The patient was due for his fourth dose on 07-Feb-2022 and the nurse enquired whether the patient can be given the booster dose 3 days earlier.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination complication
Clinical narrative: side effects; in pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) and PAIN (in pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects) and PAIN (in pain). At the time of the report, VACCINATION COMPLICATION (side effects) and PAIN (in pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up appended contains No new information.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna expired on 01/22/22 and was administered to the patient on Mon. 01/24/22.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna expired on 01/22/22 and was administered to the patient on Mon. 01/24/22.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna expired on 01/22/22 and was administered to the patient on Mon. 01/24/22.). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna expired on 01/22/22 and was administered to the patient on Mon. 01/24/22.) had resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Lot # 048F21A expired on 01/22/22. This lot number was administered to the patient on 01/24/22.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Lot # 048F21A expired on 01/22/22. This lot number was administered to the patient on 01/24/22.) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Lot # 048F21A expired on 01/22/22. This lot number was administered to the patient on 01/24/22.). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna Lot # 048F21A expired on 01/22/22. This lot number was administered to the patient on 01/24/22.) had resolved. Not applicable      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 medication was reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past it's beyond use date of 06 JAN 2022 for a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Patient received booster dose vaccine past it's beyond use date of 06 Jan 2022 and does not reported any other adverse events.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up received, contains non significant information. On 07-Feb-2022: Follow up received, contact information updated.
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccination to an 11 year old as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination to an 11 year old as their first dose) in an 11-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 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination to an 11 year old as their first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination to an 11 year old as their first dose) 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.   Reporter did not allow further contact
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used\233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used\233 Patients given expired doses) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021 at 1:24 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used\233 Patients given expired doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used\233 Patients given expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient was not immunocompromised.This expiration date was mistakenly thought as 07-Apr-2022. However, on 04-Feb- 2022 it realized that the expiration date was on 07-Nov-2021. Started using this lot on 19-Nov-2021 until 04-Feb-2022, administered the Booster dose of the Moderna Covid-19 vaccine to 236 people. 14 vials were utilized. All vials were stored in a vaccine freezer set to -20C. Depending on number of patients signed up for that day, either 1 or 2 vials were removed from the freezer and placed on counter at room temperature for 30 minutes to thaw. Temperature readings of fridge were at either 3.8C or 5.6C. No temperature excursions were noted at any time during the administration of the vaccine.  Treatment medications were not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used / 233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used / 233 Patients given expired doses) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021 at 1:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used / 233 Patients given expired doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used / 233 Patients given expired doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  14 vials were utilized. All vials were stored in a vaccine freezer set to -20C. At the date and times of our vaccine clinic, depending on how many signed up for that day, either 1 or 2 vials were removed from the freezer and placed on counter at room temperature for 30 minutes. The vaccine was drawn up and then placed in vaccine fridge for the duration of the clinic, taken out when patient was ready to receive. Temperature readings of fridge were at either 3.8C or 5.6C depending on the date (we had received and set up a new vaccine fridge between 23-Dec-2021 and 07-Jan-2022). No temperature excursions were noted at any time during the administration of the vaccine.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had arm pain for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had arm pain for 1 day) 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 PAIN IN EXTREMITY (had arm pain for 1 day). At the time of the report, PAIN IN EXTREMITY (had arm pain for 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication information was not reported.   This case was linked to MOD-2022-474275 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Vaccination site pain
Clinical narrative: Lost strength on his arm. Started to get a lot worse after getting the booster shot; Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-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 MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot). At the time of the report, MUSCULAR WEAKNESS (Lost strength on his arm. Started to get a lot worse after getting the booster shot) and VACCINATION SITE PAIN (Arm at the injection site is hurting/ hurting at the injection site in the muscles down to the bone/ The pain is stabbing/ very painful/ started to get a lot worse after getting the booster shot) had not resolved.            No Concomitant information was reported. No Treatment information was reported.  It was reported that arm at the injection site is hurting and hurting at the injection site in the muscles down to the bone and it's been months. The pain is constantly there during the day and it becomes more intense during night time when he is resting.  Started a couple of days after the 2nd dose and it started to get a lot worse after getting the booster shot.   This case was linked to MOD-2022-474346 (Patient Link).