chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Dizziness, Headache, Hypertension
Clinical narrative: Dizziness; High blood pressure episode; headache; she had COVID; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERTENSION (High blood pressure episode), COVID-19 (she had COVID) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for Blood pressure high.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (she had COVID). On an unknown date, the patient experienced DIZZINESS (Dizziness), HYPERTENSION (High blood pressure episode) and HEADACHE (headache). At the time of the report, DIZZINESS (Dizziness), HYPERTENSION (High blood pressure episode), COVID-19 (she had COVID) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Reporter wanted to know if patient can take the booster dose before the second dose because the booster is only half a dose and she doesn´t want to feel those symptoms again.  Patient has not yet recievd the second dose of vaccine.  This case concerns a 71-year-old, female patient with no reported medical history, who experienced the unexpected, non- serious and AESI event of COVID-19. The event occurred approximately 6 months after first dose of Spikevax. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit risk relationship of vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 71-year-old, female patient with no reported medical history, who experienced the unexpected, non- serious and AESI event of COVID-19. The event occurred approximately 6 months after first dose of Spikevax. The rechallenge is not applicable, as the outcome of the event is unknown. The benefit risk relationship of vaccine is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Injection site erythema, Pyrexia, Vaccination site mass
Clinical narrative: She got sick; Swelling in her left arm at the injection site the size of a tennis ball, like a knot.; Swelling in her left arm at the injection site; fever; Chills; Injection site was red; Injection was sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She got sick), VACCINATION SITE MASS (Swelling in her left arm at the injection site the size of a tennis ball, like a knot.), VACCINATION SITE SWELLING (Swelling in her left arm at the injection site), PYREXIA (fever) and CHILLS (Chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ILLNESS (She got sick), VACCINATION SITE MASS (Swelling in her left arm at the injection site the size of a tennis ball, like a knot.), VACCINATION SITE SWELLING (Swelling in her left arm at the injection site), PYREXIA (fever), CHILLS (Chills), INJECTION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection was sore). At the time of the report, ILLNESS (She got sick), VACCINATION SITE MASS (Swelling in her left arm at the injection site the size of a tennis ball, like a knot.), VACCINATION SITE SWELLING (Swelling in her left arm at the injection site), PYREXIA (fever), CHILLS (Chills), INJECTION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection was sore) outcome was unknown.            No concomitant and treatment medications were provided. On the same evening (25-oct-2021), the patient got sick. The patient had a fever and chills, welling in her left arm at the injection site the size of a tennis ball, like a knot. The patient stated the injection site is red and sore.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: She got sick; Swelling in her left arm at the injection site the size of a tennis ball, like a knot.; Swelling in her left arm at the injection site; fever; Chills; Injection site was red; Injection was sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She got sick), VACCINATION SITE MASS (Swelling in her left arm at the injection site the size of a tennis ball, like a knot.), VACCINATION SITE SWELLING (Swelling in her left arm at the injection site), PYREXIA (fever) and CHILLS (Chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ILLNESS (She got sick), VACCINATION SITE MASS (Swelling in her left arm at the injection site the size of a tennis ball, like a knot.), VACCINATION SITE SWELLING (Swelling in her left arm at the injection site), PYREXIA (fever), CHILLS (Chills), INJECTION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection was sore). At the time of the report, ILLNESS (She got sick), VACCINATION SITE MASS (Swelling in her left arm at the injection site the size of a tennis ball, like a knot.), VACCINATION SITE SWELLING (Swelling in her left arm at the injection site), PYREXIA (fever), CHILLS (Chills), INJECTION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection was sore) outcome was unknown.            No concomitant and treatment medications were provided. On the same evening (25-oct-2021), the patient got sick. The patient had a fever and chills, welling in her left arm at the injection site the size of a tennis ball, like a knot. The patient stated the injection site is red and sore.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Influenza like illness, Insomnia, Pain
Clinical narrative: couldn't lift my arm over my head; excruciating pain.; very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night; dehydration; fever; chills; extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.) and INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), CALCIUM, ASCORBIC ACID (VIT C) and ZINC for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.), INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night) and DEHYDRATION (dehydration). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow) had not resolved and INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.), INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night), DEHYDRATION (dehydration), PYREXIA (fever) and CHILLS (chills) outcome was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site movement impairment
Clinical narrative: couldn't lift my arm over my head; excruciating pain.; very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night; dehydration; fever; chills; extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.) and INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), CALCIUM, ASCORBIC ACID (VIT C) and ZINC for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.), INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night) and DEHYDRATION (dehydration). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (extreme pain near my elbow/still had pain for about 6 weeks/excruciating pain/This was not at the injection site but 8 inches below near the elbow) had not resolved and INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm over my head), PAIN (excruciating pain.), INSOMNIA (very painful to sleep/wake me up in the middle of the night/couldn't sleep the whole night), DEHYDRATION (dehydration), PYREXIA (fever) and CHILLS (chills) outcome was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007MZ0A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-369017 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease; This spontaneous case was reported by a pharmacist and describes the occurrence of AUTOIMMUNE DISORDER (got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AUTOIMMUNE DISORDER (got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details provided.  Patient started a high dose steroid after diagnosed with autoimmune disease.  Company comment: This case concerns a  female patient (age not provided) with no relevant medical history, who experienced the unexpected event of Autoimmune Disorder. The event occurred approximately 1 week after the third dose  (booster) of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 Vaccine)  is not affected by this report.; Sender's Comments: This case concerns a  female patient (age not provided) with no relevant medical history, who experienced the unexpected event of Autoimmune Disorder. The event occurred approximately 1 week after the third dose  (booster) of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 Vaccine)  is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip swelling) 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 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced LIP SWELLING (Lip swelling). At the time of the report, LIP SWELLING (Lip swelling) outcome was unknown.            Patient  does have lip fillers but she does have some lip swelling. No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall
Clinical narrative: Lost of balance when standing, feel her balance go; she fell; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost of balance when standing, feel her balance go) and FALL (she fell) in a 90-year-old female patient 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 BALANCE DISORDER (Lost of balance when standing, feel her balance go) and FALL (she fell). At the time of the report, BALANCE DISORDER (Lost of balance when standing, feel her balance go) and FALL (she fell) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-373853 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Significant follow-up- Event (fall) added. On 04-Nov-2021: Non-significant follow up appended.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: follow-up document contains no new information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: full dose instead of a half dose; Five doses of the Moderna Covid-19 Vaccine were given to patients today,; Five doses of the Moderna Covid-19 Vaccine were given to patients today,29Oct2021, after being in the refrigerator starting on 8Sep2021; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses of the Moderna Covid-19 Vaccine were given to patients today,) and PRODUCT STORAGE ERROR (Five doses of the Moderna Covid-19 Vaccine were given to patients today,29Oct2021, after being in the refrigerator starting on 8Sep2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 012A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses of the Moderna Covid-19 Vaccine were given to patients today,) and PRODUCT STORAGE ERROR (Five doses of the Moderna Covid-19 Vaccine were given to patients today,29Oct2021, after being in the refrigerator starting on 8Sep2021). On 29-Oct-2021, ACCIDENTAL OVERDOSE (full dose instead of a half dose), EXPIRED PRODUCT ADMINISTERED (Five doses of the Moderna Covid-19 Vaccine were given to patients today,) and PRODUCT STORAGE ERROR (Five doses of the Moderna Covid-19 Vaccine were given to patients today,29Oct2021, after being in the refrigerator starting on 8Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Contact information fax was updated and event added Product storage error.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired second dose of Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired second dose of Moderna vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired second dose of Moderna vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired second dose of Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial (lot 047B21A) was placed in the fridge on 14-Oct-2021 (expired on 09Oct2021). The reporter reported that the vial was in the refrigerator and it had not been compromised. There was no temperatures excursion. The vaccine was injected into the muscle. It was reported that patient had not experienced side effects. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Followup received, updated patient information and narrative.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Muscle tightness, Neck pain
Clinical narrative: her arm is still very sore; neck is sore this time, very tight and sore; Fatigue; headache; Arm is still really sensitive; very bruised in her arm.; Neck is very sore.; Got like a very red; Seems like it must have been swollen; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), PAIN IN EXTREMITY (her arm is still very sore) and MUSCLE TIGHTNESS (neck is sore this time, very tight and sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A, 023M20A and 004M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), VACCINATION SITE ERYTHEMA (Got like a very red) and VACCINATION SITE SWELLING (Seems like it must have been swollen). On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (her arm is still very sore), MUSCLE TIGHTNESS (neck is sore this time, very tight and sore), FATIGUE (Fatigue) and HEADACHE (headache). At the time of the report, SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), PAIN IN EXTREMITY (her arm is still very sore), MUSCLE TIGHTNESS (neck is sore this time, very tight and sore), VACCINATION SITE ERYTHEMA (Got like a very red), VACCINATION SITE SWELLING (Seems like it must have been swollen), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.            The patient stated that the events fatigue, headache, the typical that they had the first time,but worse even which she didn't expect with booster because she received half dose  No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-369214 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sensitive skin, Vaccination site erythema, Vaccination site swelling
Clinical narrative: her arm is still very sore; neck is sore this time, very tight and sore; Fatigue; headache; Arm is still really sensitive; very bruised in her arm.; Neck is very sore.; Got like a very red; Seems like it must have been swollen; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), PAIN IN EXTREMITY (her arm is still very sore) and MUSCLE TIGHTNESS (neck is sore this time, very tight and sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A, 023M20A and 004M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), VACCINATION SITE ERYTHEMA (Got like a very red) and VACCINATION SITE SWELLING (Seems like it must have been swollen). On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (her arm is still very sore), MUSCLE TIGHTNESS (neck is sore this time, very tight and sore), FATIGUE (Fatigue) and HEADACHE (headache). At the time of the report, SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), PAIN IN EXTREMITY (her arm is still very sore), MUSCLE TIGHTNESS (neck is sore this time, very tight and sore), VACCINATION SITE ERYTHEMA (Got like a very red), VACCINATION SITE SWELLING (Seems like it must have been swollen), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.            The patient stated that the events fatigue, headache, the typical that they had the first time,but worse even which she didn't expect with booster because she received half dose  No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-369214 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Caller received a full dose for the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Caller received a full dose for the booster dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AC1AC3, 025A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (Diabetic).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Caller received a full dose for the booster dose). On 29-Oct-2021, ACCIDENTAL OVERDOSE (Caller received a full dose for the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  Patient reported the he did not know if he was immunocompromised, but he went for a booster dose  Patient stated that his daughter is immunocompromised and lives with them, and stated that they are considered health care providers because they take care of her daughter, who has down syndrome, and has had heart surgeries since before her vaccination  Patient also reported that he asked for Moderna but he doesn't know if the pharmacist gave her Moderna or maybe it was Pfizer, she said she gave him moderna but the lot number didn't look like the others and called was not sure if it was Moderna.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Vaccination complication
Clinical narrative: Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"; Aches of knees, elbows, hips and back; Joint aches of knees, elbows, hips and back; In beginning I noticed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"), BACK PAIN (Aches of knees, elbows, hips and back), ARTHRALGIA (Joint aches of knees, elbows, hips and back) and FATIGUE (In beginning I noticed fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (Aches of knees, elbows, hips and back), ARTHRALGIA (Joint aches of knees, elbows, hips and back) and FATIGUE (In beginning I noticed fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"). The patient was treated with IBUPROFEN in 2021 for Adverse event, at a dose of 1 dosage form and VITAMIN D [VITAMIN D NOS] in 2021 for Adverse event, at a dose of 4000. At the time of the report, VACCINATION COMPLICATION (Wants to follow up on some experiencing that they have  experienced following the vaccine"I was a young 78 year old before the vaccine"), BACK PAIN (Aches of knees, elbows, hips and back), ARTHRALGIA (Joint aches of knees, elbows, hips and back) and FATIGUE (In beginning I noticed fatigue) had not resolved.            Patients states that before vaccination she used to do activities like hiking, jump over streams and over the past 6 weeks she's experiencing the events.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Include patient contact information updated, dose 1 and dose 2 details, concomitant medication information,treatment medication details and events occurred and outcome was updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: I am having a reaction to the Moderna shot/ COVID-Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I am having a reaction to the Moderna shot/ COVID-Arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I am having a reaction to the Moderna shot/ COVID-Arm). At the time of the report, VACCINATION SITE REACTION (I am having a reaction to the Moderna shot/ COVID-Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medications were reported.  The patient had reaction to the Moderna shot and have been to the doctor. The patient believed about having COVID arm.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow-up received: Reporter's contact information and event verbatim was updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Muscular weakness, Nausea
Clinical narrative: dizziness; muscle weakness; er energy would just be zapped and she couldn't do much; even walking around was a lot; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness), ASTHENIA (er energy would just be zapped and she couldn't do much), GAIT DISTURBANCE (even walking around was a lot) and NAUSEA (nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness), ASTHENIA (er energy would just be zapped and she couldn't do much), GAIT DISTURBANCE (even walking around was a lot) and NAUSEA (nausea). In October 2021, GAIT DISTURBANCE (even walking around was a lot) had resolved. At the time of the report, DIZZINESS (dizziness), MUSCULAR WEAKNESS (muscle weakness) and NAUSEA (nausea) had not resolved and ASTHENIA (er energy would just be zapped and she couldn't do much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided.  No treatment medications were provided.  After she got the vaccine, she had dizziness, nausea, and muscle weakness. It was every day; she had to be on the couch. Even walking around was a lot. It lasted about two weeks, where her energy would just be zapped, and she couldn't do much. Now she still had the dizziness, nausea, and weakness, but It was just less than it was. It was not every day; It was more intermittent. Patient added that she had some muscle issues.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Candida infection, Genital discomfort, Genital erythema, Nausea, Oral candidiasis
Clinical narrative: Normal symptoms of thrush/yeast thrush infection in mouth; Throat irritation; Itching in mouth; Crotch area is red; Irritation down in crotch area/down in crotch area; Thrush infection down in crotch area; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red) and GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red), GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area), CANDIDA INFECTION (Thrush infection down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with FLUCONAZOLE for Adverse event, at a dose of 1 tablet once a day for 10 days and FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red), GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area), CANDIDA INFECTION (Thrush infection down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Treatment information included fungal medication for months, on and off. Patient took Famotidine to treat throat irritation and itching in mouth.  Patient experienced the symptoms after the first dose which got bad after receiving the second dose of vaccination. Consumer did state he did not had these problems prior to vaccination.   This case was linked to MOD-2021-369271 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pruritus, Pyrexia, Throat irritation
Clinical narrative: Normal symptoms of thrush/yeast thrush infection in mouth; Throat irritation; Itching in mouth; Crotch area is red; Irritation down in crotch area/down in crotch area; Thrush infection down in crotch area; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red) and GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red), GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area), CANDIDA INFECTION (Thrush infection down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with FLUCONAZOLE for Adverse event, at a dose of 1 tablet once a day for 10 days and FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ORAL CANDIDIASIS (Normal symptoms of thrush/yeast thrush infection in mouth), THROAT IRRITATION (Throat irritation), ORAL PRURITUS (Itching in mouth), GENITAL ERYTHEMA (Crotch area is red), GENITAL DISCOMFORT (Irritation down in crotch area/down in crotch area), CANDIDA INFECTION (Thrush infection down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  Treatment information included fungal medication for months, on and off. Patient took Famotidine to treat throat irritation and itching in mouth.  Patient experienced the symptoms after the first dose which got bad after receiving the second dose of vaccination. Consumer did state he did not had these problems prior to vaccination.   This case was linked to MOD-2021-369271 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Had fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Had fatigue) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M2014) 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 an unknown date, the patient experienced FATIGUE (Had fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Had fatigue) and HEADACHE (Headache) 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.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-369087 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye movement disorder, Facial paralysis, Hypoaesthesia
Clinical narrative: This sensation expanded to her face where she developed some paralysis; Pain in the ear; Left eye unable to blink; Numb thumb/Her thumb started to fell numb; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (This sensation expanded to her face where she developed some paralysis) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced HYPOAESTHESIA (Numb thumb/Her thumb started to fell numb). On an unknown date, the patient experienced FACIAL PARALYSIS (This sensation expanded to her face where she developed some paralysis) (seriousness criterion medically significant), EAR PAIN (Pain in the ear) and EYE MOVEMENT DISORDER (Left eye unable to blink). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (This sensation expanded to her face where she developed some paralysis), HYPOAESTHESIA (Numb thumb/Her thumb started to fell numb), EAR PAIN (Pain in the ear) and EYE MOVEMENT DISORDER (Left eye unable to blink) outcome was unknown.     Shortly after the Moderna booster dose, patient's thumb started to felt numb, this sensation expanded to face and developed some paralysis there, left ear was on pain and left eye was unable to blink. The patient was not in any medication at the time of the vaccination.  The patient took some Tylenol trying to alleviate the symptoms.  Company Comment - This case concerns a 37 year-old male female patient with no reported medical history who experienced the unexpected serious adverse event of special interest of facial paralysis. The event occurred on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 37 year-old male female patient with no reported medical history who experienced the unexpected serious adverse event of special interest of facial paralysis. The event occurred on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired booster dose of Moderna vaccine; vial was in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine) and PRODUCT STORAGE ERROR (vial was in the refrigerator) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine) and PRODUCT STORAGE ERROR (vial was in the refrigerator). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired booster dose of Moderna vaccine) and PRODUCT STORAGE ERROR (vial was in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was in the refrigerator and had been compromised with no temperature excursion.  No concomitant medication were provided. Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received on 02-NOV-2021 contains ADR form added with HCP and race information added.