chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Seborrhoeic dermatitis, Skin discolouration, Urticaria
Clinical narrative: Seborrheic Dermatitis; Pinkish area of my face after doses/Pink patches on face, hairline; Hives on neck; This spontaneous case was reported by a nurse and describes the occurrence of SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 032L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Perimenopause.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-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 SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck). At the time of the report, SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: it came back seborrheic dermatitis it came back Seborrheic Dermatitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SEBORRHOEIC DERMATITIS (Seborrheic Dermatitis), SKIN DISCOLOURATION (Pinkish area of my face after doses/Pink patches on face, hairline) and URTICARIA (Hives on neck) to be related.    No concomitant medications were reported.  The patient undergone a lot of hormonal changes.  It was reported that, the events got much worsen after the booster dose.  It was also reported that, the immune system and the vaccine caused the event.  The patient used Topical Roslumilast Foam (ARQ-154) (instead of the placebo) as a treatment medication which was used in COPD in a pill form.   This case was linked to MOD-2022-516171 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat
Clinical narrative: cold sweats  after the first or the second dose of vaccine; got chills  after the first or the second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats  after the first or the second dose of vaccine) and CHILLS (got chills  after the first or the second dose of vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026521A, 021C21A and 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-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 COLD SWEAT (cold sweats  after the first or the second dose of vaccine) and CHILLS (got chills  after the first or the second dose of vaccine). At the time of the report, COLD SWEAT (cold sweats  after the first or the second dose of vaccine) and CHILLS (got chills  after the first or the second dose of vaccine) outcome was unknown.            No concomitant medication information provided.  It was reported that patient was having trouble reading the writing on the card. The patient did not remember after which vaccine that she had these reactions.  The patient did not remember which arm she had received the first, second and booster dose.   The patient reported no adverse reactions or side effects after booster dose.  Expiration date was not available for first, second and booster dose.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: She took a home covid-19 test and it was positive.; This morning she has a lump underneath the armpit; 101F Fever; convulsions; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Mar-2022, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant) and PYREXIA (101F Fever). On 21-Mar-2022, the patient experienced COVID-19 (She took a home covid-19 test and it was positive.) and AXILLARY MASS (This morning she has a lump underneath the armpit). At the time of the report, SEIZURE (convulsions), COVID-19 (She took a home covid-19 test and it was positive.), AXILLARY MASS (This morning she has a lump underneath the armpit) and PYREXIA (101F Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2022, Body temperature: 101f (abnormal) 101F Fever. On 21-Mar-2022, SARS-CoV-2 test positive: positive (Positive) She took a home covid-19 test and it was positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided  Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced first the unexpected and serious (medically significant) event of seizure and then the unexpected AESI COVID-19, along with the non-serious events of pyrexia and axillary mass, starting the following day a dose of mRNA-1273 vaccine was administered. Patient experienced fever of 101F and had a lump underneath the armpit; she took home a COVID-19 test, and it was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced first the unexpected and serious (medically significant) event of seizure and then the unexpected AESI COVID-19, along with the non-serious events of pyrexia and axillary mass, starting the following day a dose of mRNA-1273 vaccine was administered. Patient experienced fever of 101F and had a lump underneath the armpit; she took home a COVID-19 test, and it was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: She took a home covid-19 test and it was positive.; This morning she has a lump underneath the armpit; 101F Fever; convulsions; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Mar-2022, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant) and PYREXIA (101F Fever). On 21-Mar-2022, the patient experienced COVID-19 (She took a home covid-19 test and it was positive.) and AXILLARY MASS (This morning she has a lump underneath the armpit). At the time of the report, SEIZURE (convulsions), COVID-19 (She took a home covid-19 test and it was positive.), AXILLARY MASS (This morning she has a lump underneath the armpit) and PYREXIA (101F Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2022, Body temperature: 101f (abnormal) 101F Fever. On 21-Mar-2022, SARS-CoV-2 test positive: positive (Positive) She took a home covid-19 test and it was positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided  Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced first the unexpected and serious (medically significant) event of seizure and then the unexpected AESI COVID-19, along with the non-serious events of pyrexia and axillary mass, starting the following day a dose of mRNA-1273 vaccine was administered. Patient experienced fever of 101F and had a lump underneath the armpit; she took home a COVID-19 test, and it was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced first the unexpected and serious (medically significant) event of seizure and then the unexpected AESI COVID-19, along with the non-serious events of pyrexia and axillary mass, starting the following day a dose of mRNA-1273 vaccine was administered. Patient experienced fever of 101F and had a lump underneath the armpit; she took home a COVID-19 test, and it was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, SARS-CoV-2 test
Clinical narrative: after receiving the second dose, he started experiencing a lot of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (after receiving the second dose, he started experiencing a lot of symptoms) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity (Trobanil) and Asthma (didn´t bother him for years).    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (after receiving the second dose, he started experiencing a lot of symptoms). At the time of the report, VACCINATION COMPLICATION (after receiving the second dose, he started experiencing a lot of symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient reported that his Asthma had gotten worse. Concomitant medications reported were Diabetes medicine, Blood pressure medicine, Heart medicine. No treatment medications was provided.   This case was linked to MOD-2022-516898, MOD-2022-516904 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I couldn't move my arms, I couldn't move my legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    In April 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2020, the patient experienced MOBILITY DECREASED (I couldn't move my arms,I couldn't move my legs). At the time of the report, MOBILITY DECREASED (I couldn't move my arms,I couldn't move my legs) outcome was unknown.            No concomitant medications were reported. After vaccination it was mentioned that patient couldn't move her arms and legs. No treatment medications were reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered with the vaccine beyond the 30 day use by date; administered with the vaccine beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date) in a 25-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022 at 9:21 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022 at 9:21 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported  A nurse practitioner reports a vaccine administration error. They state that they received a Moderna Covid-19 vaccine vial on 31Jan2021 and the placed it in the refrigerator on the same day (specific time unknown).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received a Moderna Covid-19 vaccine vial on 31 Jan 2021 and the placed it in the refrigerator on the same day and administered on 10 Mar 2022; Administered with the vaccine beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received a Moderna Covid-19 vaccine vial on 31 Jan 2021 and the placed it in the refrigerator on the same day and administered on 10 Mar 2022) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022 at 4:59 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022 at 4:59 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a Moderna Covid-19 vaccine vial on 31 Jan 2021 and the placed it in the refrigerator on the same day and administered on 10 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received a Moderna Covid-19 vaccine vial on 31 Jan 2021 and the placed it in the refrigerator on the same day and administered on 10 Mar 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. A nurse practitioner reported a vaccine administration error. They stated that they received a Moderna Covid-19 vaccine vial on 31 Jan 2021 and placed it in the refrigerator on the same day ,specific time was unknown. They administered the vaccine to patient beyond the 30 days use by date. The patient did not reported any adverse events. Treatment information was not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Hypogeusia, Hyposmia
Clinical narrative: breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right; minimum smell; minimum taste; freaking dying because of the vaccine; his legs will give up, so he has to lay down; he feels like he is going to pass out; all his face gets numb; he throws up; headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right), HYPOSMIA (minimum smell), HYPOGEUSIA (minimum taste), VACCINATION COMPLICATION (freaking dying because of the vaccine) and MUSCULAR WEAKNESS (his legs will give up, so he has to lay down) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Trobanil) and Asthma (didn´t bother him for years).    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right), HYPOSMIA (minimum smell), HYPOGEUSIA (minimum taste), VACCINATION COMPLICATION (freaking dying because of the vaccine), MUSCULAR WEAKNESS (his legs will give up, so he has to lay down), PRESYNCOPE (he feels like he is going to pass out), HYPOAESTHESIA (all his face gets numb), VOMITING (he throws up) and HEADACHE (headaches). At the time of the report, DYSPNOEA (breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right), HYPOSMIA (minimum smell), HYPOGEUSIA (minimum taste), VACCINATION COMPLICATION (freaking dying because of the vaccine), MUSCULAR WEAKNESS (his legs will give up, so he has to lay down), PRESYNCOPE (he feels like he is going to pass out), HYPOAESTHESIA (all his face gets numb), VOMITING (he throws up) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient reported his asthma had gotten worse. Patient stayed in the ER for a day because they could not get his breathing right. The patient went to the ER with Covid-19 symptoms and was tested for Covid-19 numerous times. Concomitant medications reported were Diabetes medicine, Blood pressure medicine, Heart medicine. Treatment included Breathing treatments, oxygen and other medications.   This case was linked to MOD-2022-516667, MOD-2022-516904 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Muscular weakness, Presyncope, SARS-CoV-2 test, Vomiting
Clinical narrative: breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right; minimum smell; minimum taste; freaking dying because of the vaccine; his legs will give up, so he has to lay down; he feels like he is going to pass out; all his face gets numb; he throws up; headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right), HYPOSMIA (minimum smell), HYPOGEUSIA (minimum taste), VACCINATION COMPLICATION (freaking dying because of the vaccine) and MUSCULAR WEAKNESS (his legs will give up, so he has to lay down) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Trobanil) and Asthma (didn´t bother him for years).    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right), HYPOSMIA (minimum smell), HYPOGEUSIA (minimum taste), VACCINATION COMPLICATION (freaking dying because of the vaccine), MUSCULAR WEAKNESS (his legs will give up, so he has to lay down), PRESYNCOPE (he feels like he is going to pass out), HYPOAESTHESIA (all his face gets numb), VOMITING (he throws up) and HEADACHE (headaches). At the time of the report, DYSPNOEA (breathing issues/his breathing, it´s so bad, he can´t breath and it´s getting worse/couldn´t get his breathing right), HYPOSMIA (minimum smell), HYPOGEUSIA (minimum taste), VACCINATION COMPLICATION (freaking dying because of the vaccine), MUSCULAR WEAKNESS (his legs will give up, so he has to lay down), PRESYNCOPE (he feels like he is going to pass out), HYPOAESTHESIA (all his face gets numb), VOMITING (he throws up) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient reported his asthma had gotten worse. Patient stayed in the ER for a day because they could not get his breathing right. The patient went to the ER with Covid-19 symptoms and was tested for Covid-19 numerous times. Concomitant medications reported were Diabetes medicine, Blood pressure medicine, Heart medicine. Treatment included Breathing treatments, oxygen and other medications.   This case was linked to MOD-2022-516667, MOD-2022-516904 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Latex allergy, Multiple sclerosis since 1995 and Heart disease, unspecified. Concomitant products included ACEBUTOLOL for Heart disease, unspecified, OCRELIZUMAB (OCREVUS) for Infusion, GABAPENTIN, ROPINIROLE, BACLOFEN, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HCTZ), DICYCLOMINE HCL, PROMETHAZINE and MELOXICAM (MOBIC) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient never had COVID-19 positive test or diagnosis. The patient did not have a history of Myocarditis/pericarditis. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. Concomitant products included Pantoprazole for her Stomach. Treatment information was unknown.   This case was linked to MOD-2022-517704 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy, Latex allergy and Multiple sclerosis since 1995. Concomitant products included OCRELIZUMAB (OCREVUS), GABAPENTIN, ROPINIROLE, BACLOFEN, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), DICYCLOMINE [DICYCLOVERINE], PROMETHAZINE and MELOXICAM (MOBIC) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concurrent conditions also included heart problems. No treatment medications were reported for second dose.   This case was linked to MOD-2022-517704, MOD-2022-517635 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: weakness; fever for a day; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (She had the flu vaccine sometime in Oct or Nov2021.) in 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Chronic arthritis, Hypertension and High cholesterol. Concomitant products included ATENOLOL, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired). In February 2021, PYREXIA (fever for a day) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown and FATIGUE (felt tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had no history of COVID-19 infection. Patient height was reported as  5' 2 2/1"-3". No treatment information was reported.   This case was linked to MOD-2022-517821 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary mass, Pyrexia
Clinical narrative: 4 small lung nodules; fever for a day; felt tired/tiredness persisted; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PULMONARY MASS (4 small lung nodules), PYREXIA (fever for a day) and FATIGUE (felt tired/tiredness persisted) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Vaccine (Took flu vaccine sometime in Oct or Nov2021). Past adverse reactions to the above products included No adverse reaction with Flu Vaccine. Concurrent medical conditions included Chronic arthritis, Hypertension and High cholesterol. Concomitant products included ATENOLOL, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired/tiredness persisted). In May 2021, the patient experienced PULMONARY MASS (4 small lung nodules). In March 2021, PYREXIA (fever for a day) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown and PULMONARY MASS (4 small lung nodules) and FATIGUE (felt tired/tiredness persisted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: 4 small lung nodules possible problem in the aorta and they found 4 small lung nodules.. On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Immunology test: 495 level at the last test was 495.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that she did not have a medical history of Covid-19 infection.  The patient stated that she was asymptomatic (pulmonary-wise) and was not having any kind of respiratory illness for the past 5 years. For this reason, she was referred to a pulmonologist by her internist and she would have a CT Scan every 5 months. The patient's son was a radiologist and she was afraid that the nodules might migrate to other organs. The patient was not saying that the nodules was from the vaccine but they just want to know if there had been reports of indeterminate lung nodules such as from people who had received the Moderna vaccine. Patient mentioned that she read an article that some patient who had gotten the Pfizer vaccine had interstitial lung disease hence, she was wondering if Moderna had something similar. Patient stated not to get the booster dose because of the lung nodule.  Patient height was reported as  5' 2 2/1"-3".  No treatment information was reported.   This case was linked to MOD-2022-517797, MOD-2022-517950 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: 4 small lung nodules; fever for a day; felt tired/tiredness persisted; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PULMONARY MASS (4 small lung nodules), PYREXIA (fever for a day) and FATIGUE (felt tired/tiredness persisted) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Vaccine (Took flu vaccine sometime in Oct or Nov2021). Past adverse reactions to the above products included No adverse reaction with Flu Vaccine. Concurrent medical conditions included Chronic arthritis, Hypertension and High cholesterol. Concomitant products included ATENOLOL, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired/tiredness persisted). In May 2021, the patient experienced PULMONARY MASS (4 small lung nodules). In March 2021, PYREXIA (fever for a day) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown and PULMONARY MASS (4 small lung nodules) and FATIGUE (felt tired/tiredness persisted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: 4 small lung nodules possible problem in the aorta and they found 4 small lung nodules.. On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Immunology test: 495 level at the last test was 495.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that she did not have a medical history of Covid-19 infection.  The patient stated that she was asymptomatic (pulmonary-wise) and was not having any kind of respiratory illness for the past 5 years. For this reason, she was referred to a pulmonologist by her internist and she would have a CT Scan every 5 months. The patient's son was a radiologist and she was afraid that the nodules might migrate to other organs. The patient was not saying that the nodules was from the vaccine but they just want to know if there had been reports of indeterminate lung nodules such as from people who had received the Moderna vaccine. Patient mentioned that she read an article that some patient who had gotten the Pfizer vaccine had interstitial lung disease hence, she was wondering if Moderna had something similar. Patient stated not to get the booster dose because of the lung nodule.  Patient height was reported as  5' 2 2/1"-3".  No treatment information was reported.   This case was linked to MOD-2022-517797, MOD-2022-517950 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Fatigue, Immunology test
Clinical narrative: Weakness; Felt tired; Fever for a day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day). In February 2021, PYREXIA (Fever for a day) had resolved. At the time of the report, ASTHENIA (Weakness) and FATIGUE (Felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported.  Doctor advised to not to get the booster dose yet.  No Treatment information was reported.    This case was linked to MOD-2022-517968, MOD-2022-517821 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary mass, Pyrexia
Clinical narrative: Weakness; Felt tired; Fever for a day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day). In February 2021, PYREXIA (Fever for a day) had resolved. At the time of the report, ASTHENIA (Weakness) and FATIGUE (Felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported.  Doctor advised to not to get the booster dose yet.  No Treatment information was reported.    This case was linked to MOD-2022-517968, MOD-2022-517821 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: Weakness; Felt tired; Fever for a day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Felt tired) and PYREXIA (Fever for a day). In February 2021, PYREXIA (Fever for a day) had resolved. At the time of the report, ASTHENIA (Weakness) and FATIGUE (Felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported.  Doctor advised to not to get the booster dose yet.  No Treatment information was reported.    This case was linked to MOD-2022-517968, MOD-2022-517821 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Immunisation reaction
Clinical narrative: Bad reaction; Discomfort in her chest; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), CHEST DISCOMFORT (Discomfort in her chest) and CHEST PAIN (Chest pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction), CHEST DISCOMFORT (Discomfort in her chest) and CHEST PAIN (Chest pain). At the time of the report, VACCINATION COMPLICATION (Bad reaction), CHEST DISCOMFORT (Discomfort in her chest) and CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Caller stated that patient experienced events for almost 2 months and because of fear she only received one dose of the Moderna COVID19 vaccine. No treatment information was given.   This case was linked to MOD-2022-517778 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Fatigue, Pyrexia
Clinical narrative: weakness; fever for a day; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3 (He had chronic kidney disease, stage 3 which was diagnosed before he got the vaccine.).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired). At the time of the report, ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, Antibody test: 2500 greater that 2500.         Patient was 5'10" or 11" tall.  Concomitant medications was not provided by the reporter.  Patient's immunity level was greater that 2500 in Dec2021, so they were advised by their doctor not to get the booster dose yet.  Treatment information was not provided.   This case was linked to MOD-2022-517950, MOD-2022-517821, MOD-2022-517797 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness
Clinical narrative: flu like symptoms after her third dose; chills after her third dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms after her third dose) and CHILLS (chills after her third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms after her third dose) and CHILLS (chills after her third dose). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms after her third dose) and CHILLS (chills after her third dose) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Immunisation reaction
Clinical narrative: Long time effects including loss of appetite after receiving the Moderna vaccine; Long time effects; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Long time effects including loss of appetite after receiving the Moderna vaccine) and VACCINATION COMPLICATION (Long time effects) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Long time effects including loss of appetite after receiving the Moderna vaccine) and VACCINATION COMPLICATION (Long time effects). At the time of the report, DECREASED APPETITE (Long time effects including loss of appetite after receiving the Moderna vaccine) and VACCINATION COMPLICATION (Long time effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm was sore after receiving the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was sore after receiving the first vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Patient's medical history was not reported.  Concomitant products included BISOPROLOL FUMARATE for Blood pressure high, LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) for Epilepsy, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation, CLOPIDOGREL, PHENYTOIN (DILANTIN [PHENYTOIN]) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (left arm was sore after receiving the first vaccine). At the time of the report, VACCINATION SITE PAIN (left arm was sore after receiving the first vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2022-517834 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received half dose for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for 3rd 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.  It was reported that patient received a 0.25 mL dose for their 3rd dose, instead of a full dose   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave doses from a vial 1 day past the beyond use date; Date the vial was initially stored in the refrigerator: 18-Feb-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave doses from a vial 1 day past the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 18-Feb-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 18-Feb-2022). On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave doses from a vial 1 day past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave doses from a vial 1 day past the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 18-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vail did not undergo any temperature excursions. No treatment medication was provided by reporter.   This case was linked to MOD-2022-518738 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2022: Follow-up received with non significant information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date vial was initially stored in the refrigerator 18-FEB-2022; Gave doses from a vial 1 day past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave doses from a vial 1 day past the beyond use date) and PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator 18-FEB-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave doses from a vial 1 day past the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator 18-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave doses from a vial 1 day past the beyond use date) and PRODUCT STORAGE ERROR (Date vial was initially stored in the refrigerator 18-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. Paitent gave dose from a vial 1 day past the beyond use date 20-MAR-2022. It had been reported that  Date the vial was initially stored in the refrigerator 18-FEB-2022. The vial did not undergo any temperature excursions. No treatment medication reported.   This case was linked to MOD-2022-518727 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2022: Follow up received contain Non-significant information.