chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Stroke; Developed blood clots after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and THROMBOSIS (Developed blood clots after the second dose) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and THROMBOSIS (Developed blood clots after the second dose) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and THROMBOSIS (Developed blood clots after the second dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  It was stated that the patient  knows other women in their 60s who got blood clots after the second shot of Moderna and resulted in a stroke as well.  No treatment was reported.  Company comment: This spontaneous case concerns an adult female patient (in 60s) with no reported medical history, who experienced the unexpected serious (medically significant) AESIs of Cerebrovascular accident and Thrombosis unknown days after administration of second dose of mRNA-1273 vaccine. Details regarding age of the patient, dates of vaccination, date of onset of events, medical history, concomitant medications, clinical course, investigations, and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-566839, MOD-2022-566808 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Significant Information Added- Reporter Information Added & Event Added; Sender's Comments: This spontaneous case concerns an adult female patient (in 60s) with no reported medical history, who experienced the unexpected serious (medically significant) AESIs of Cerebrovascular accident and Thrombosis unknown days after administration of second dose of mRNA-1273 vaccine. Details regarding age of the patient, dates of vaccination, date of onset of events, medical history, concomitant medications, clinical course, investigations, and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Developed blood clots after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No concomitant medication provided.  No treatment information mentioned.  Patient was in her 60s. Patient got blood clots after the second shot of Moderna which resulted in a stroke as well.  Company Comment:  This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) adverse events of special interest Thrombosis (Developed blood clots after the second shot), and Cerebrovascular accident, that occurred on an unknown date after receiving second dose of mRNA-1273 vaccine (Latency between vaccine and events cannot be established).  Outcome of the events was reported as unknown. No information was provided on the first dose of COVID-19 vaccination. There is limited information for further medical review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-566808, MOD-2022-566718, MOD-2022-566814, MOD-2022-566839, MOD-2022-566821, MOD-2022-566822, MOD-2022-566828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Reporter Information and event was added.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) adverse events of special interest Thrombosis (Developed blood clots after the second shot), and Cerebrovascular accident, that occurred on an unknown date after receiving second dose of mRNA-1273 vaccine (Latency between vaccine and events cannot be established).  Outcome of the events was reported as unknown. No information was provided on the first dose of COVID-19 vaccination. There is limited information for further medical review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombotic stroke
Clinical narrative: blood clots/stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOTIC STROKE (blood clots/stroke) in a 62-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOTIC STROKE (blood clots/stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOTIC STROKE (blood clots/stroke) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 62 year old female patient with no reported medical history who experienced the unexpected, serious (medically significant) adverse event of special interest of Thrombotic Stroke that occurred on an unknown date after receiving a second dose of mRNA1273 as COVID-19 vaccine. No further details about the clinical course, diagnostic procedures and treatments were provided in the case.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-566820, MOD-2022-566822, MOD-2022-566821, MOD-2022-566718, MOD-2022-566814, MOD-2022-566808, MOD-2022-566839 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow up received included: Non-significant information.; Sender's Comments: This spontaneous case concerns a 62 year old female patient with no reported medical history who experienced the unexpected, serious (medically significant) adverse event of special interest of Thrombotic Stroke that occurred on an unknown date after receiving a second dose of mRNA1273 as COVID-19 vaccine. No further details about the clinical course, diagnostic procedures and treatments were provided in the case.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema) in a male patient of an unknown age 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 ANGIOEDEMA (angioedema) (seriousness criterion medically significant). At the time of the report, ANGIOEDEMA (angioedema) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  redness and swelling on arm down to fingers.  Company comment; This spontaneous case concerns a male patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Angioedema that occurred on an unknown date after receiving the mRNA-1273 vaccine on an unknown date. Patient reported redness and swelling on arm down to fingers. Clinical course and treatment details were not reported. The outcome of event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Angioedema that occurred on an unknown date after receiving the mRNA-1273 vaccine on an unknown date. Patient reported redness and swelling on arm down to fingers. Clinical course and treatment details were not reported. The outcome of event was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 29-Apr-2022, which was expired on 17-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the booster dose of Moderna vaccine (Expiry date: 17-Apr-2022). The vial was initially stored in the refrigerator on 29-Apr-2022. Vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site warmth
Clinical narrative: nodule under arm pit; warm to the touch; arm been hurting; hurts under arm pit; red mark further down arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (nodule under arm pit), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (arm been hurting), AXILLARY PAIN (hurts under arm pit) and VACCINATION SITE ERYTHEMA (red mark further down arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced VACCINATION SITE NODULE (nodule under arm pit), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (arm been hurting), AXILLARY PAIN (hurts under arm pit) and VACCINATION SITE ERYTHEMA (red mark further down arm). At the time of the report, VACCINATION SITE NODULE (nodule under arm pit), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (arm been hurting), AXILLARY PAIN (hurts under arm pit) and VACCINATION SITE ERYTHEMA (red mark further down arm) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2022-568203 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Miliaria, Myalgia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Body aches; I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh; I just thought it was a heat rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh), MILIARIA (I just thought it was a heat rash) and MYALGIA (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 025j20a) for COVID-19 vaccination.     Patient never been diagnosed with/ tested positive for COVID-19. Patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Hypertension since 2018, Anxiety, Cholesterol and Allergy NOS. Concomitant products included MONTELUKAST and LEVOCETIRIZINE DIHYDROCHLORIDE for Allergy NOS, ESCITALOPRAM for Anxiety, ATORVASTATIN CALCIUM for Blood cholesterol abnormal, HYDROCHLOROTHIAZIDE for Hypertension.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Feb-2021, the patient experienced MYALGIA (Body aches). In 2021, the patient experienced SKIN LESION (I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh) and MILIARIA (I just thought it was a heat rash). At the time of the report, SKIN LESION (I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh) and MILIARIA (I just thought it was a heat rash) outcome was unknown and MYALGIA (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Red blood cell sedimentation rate: elevated to 32 (High) Elevated to 32. On 05-Feb-2021, Rheumatoid factor: elevated to 116 (High) Elevated to 116. On 02-Aug-2021, C-reactive protein: elevated to 0.8 (High) Elevated to 0.8mg/dl.         On Feb-2021, the patient saw her primary care provider with some body aches.  On 05-Feb-2021, she had done lab test. Patient had lesion in upper part of her buttock a few different times in 2021 (unspecified date). Patient just thought it was a heat rash.  On 04-Aug-2021, patient had a lesion developed on the back of her right thigh and this made her take notice more. Patient stated she used over the counter medication (unspecified) for it.  On 13-Aug-2021, it returned again, and patient did a telehealth visit to her primary provider on 27-Aug-2021. Later, she was treated for a bacterial infection, which it was not.   It was reported that, patient had not experienced a similar event in the past.   This case was linked to MOD-2022-554962 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: Body aches; I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh; I just thought it was a heat rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh), MILIARIA (I just thought it was a heat rash) and MYALGIA (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004m20a and 025j20a) for COVID-19 vaccination.     Patient never been diagnosed with/ tested positive for COVID-19. Patient had no acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Hypertension since 2018, Anxiety, Cholesterol and Allergy NOS. Concomitant products included MONTELUKAST and LEVOCETIRIZINE DIHYDROCHLORIDE for Allergy NOS, ESCITALOPRAM for Anxiety, ATORVASTATIN CALCIUM for Blood cholesterol abnormal, HYDROCHLOROTHIAZIDE for Hypertension.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Feb-2021, the patient experienced MYALGIA (Body aches). In 2021, the patient experienced SKIN LESION (I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh) and MILIARIA (I just thought it was a heat rash). At the time of the report, SKIN LESION (I had lesion upper part of my buttock a few different times in 2021 /On 8/4/21, I had a lesion develop on the back of my right thigh) and MILIARIA (I just thought it was a heat rash) outcome was unknown and MYALGIA (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Red blood cell sedimentation rate: elevated to 32 (High) Elevated to 32. On 05-Feb-2021, Rheumatoid factor: elevated to 116 (High) Elevated to 116. On 02-Aug-2021, C-reactive protein: elevated to 0.8 (High) Elevated to 0.8mg/dl.         On Feb-2021, the patient saw her primary care provider with some body aches.  On 05-Feb-2021, she had done lab test. Patient had lesion in upper part of her buttock a few different times in 2021 (unspecified date). Patient just thought it was a heat rash.  On 04-Aug-2021, patient had a lesion developed on the back of her right thigh and this made her take notice more. Patient stated she used over the counter medication (unspecified) for it.  On 13-Aug-2021, it returned again, and patient did a telehealth visit to her primary provider on 27-Aug-2021. Later, she was treated for a bacterial infection, which it was not.   It was reported that, patient had not experienced a similar event in the past.   This case was linked to MOD-2022-554962 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick with the other doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with the other doses) in an elderly 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick with the other doses). At the time of the report, ILLNESS (sick with the other doses) outcome was unknown. No concomitant medications were reported by the reporter. Patient reports that she did not have side effect like second booster dose with the other doses, she was just very sick. No treatment medications were reported by the reporter. This case was linked to MOD-2022-568195 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection Site Right Arm after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection Site Right Arm after first shot) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 vaccination.     The patient's past medical history included Cat bite (on the left hand) on 28-Feb-2022 and Surgery (left hand) on 14-Mar-2022. Previously administered products included for Cat bite: Rabies shot (right arm). Past adverse reactions to the above products included No adverse event with Rabies shot. Concurrent medical conditions included Asthma.    On 09-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced VACCINATION SITE PAIN (Pain at injection Site Right Arm after first shot). In April 2022, VACCINATION SITE PAIN (Pain at injection Site Right Arm after first shot) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications included asthma medications.  At the beginning of Mar-2022, prior to vaccination, the patient was at hospital for cat bite.  The patient had pain at injection site and the pain lingered for about 2 weeks.  No treatment medication was provided.   Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022; 5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) in an 88-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired/vaccine was administered after published expiry date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-May-2022, expired on 25-Mar-2022 and administered on 13-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that their facility had an error where 5 doses of the Moderna COVID-19 vaccine was administered after the expiration date of 25-Mar-2022. The administration occurred on 13-May-2022. None of the 5 patients had reported any adverse reactions to this dose. Number of doses/vials: 5 doses, 1 vial. The vial was initially stored in the refrigerator on 02-May-2022 The vial did not undergo any temperature excursions. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow-up received contains no new information. On 16-May-2022: Live significant follow up: Patient information and dose number were added.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Myalgia, Pain, SARS-CoV-2 test
Clinical narrative: sleeps all the time; muscle pain in legs and shoulder; tired; bad aches all over the body; This spontaneous case was reported by a patient and describes the occurrence of PAIN (bad aches all over the body), SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PAIN (bad aches all over the body). On an unknown date, the patient experienced SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired). At the time of the report, PAIN (bad aches all over the body), SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: negative (Negative) all tests came back negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         Concomitant medication of the patient was not reported.  The patient received total 3 doses. The patient went to his primary care physician, all tests came back negative and the cause could not found.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleeps all the time; muscle pain in legs and shoulder; tired; bad aches all over the body; This spontaneous case was reported by a patient and describes the occurrence of PAIN (bad aches all over the body), SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PAIN (bad aches all over the body). On an unknown date, the patient experienced SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired). At the time of the report, PAIN (bad aches all over the body), SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: negative (Negative) all tests came back negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         Concomitant medication of the patient was not reported.  The patient received total 3 doses. The patient went to his primary care physician, all tests came back negative and the cause could not found.  No treatment information was provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information were provided.   This case was linked to MOD-2022-568302, MOD-2022-568301 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number: 2 administered on 17Feb2021 and 1st booster  administered on17Mar2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medication were provided.   This case was linked to MOD-2022-568302, MOD-2022-568300 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Had some chills; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (Had some chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-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 CHILLS (Had some chills). In 2021, CHILLS (Had some chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient stated that the patient had some chills for a day after their 2nd primary dose.  No treatment information was provided.   This case was linked to MOD-2022-568655 (Patient Link).   Reporter did not allow further contact
Age: 91.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 12May2022 expired on 02may22; We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12May2022 expired on 02may22) in a 91-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12May2022 expired on 02may22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 12May2022 expired on 02may22) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine 13May2022 - 4 doses administered with expiry date 04 Apr 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 13May2022 - 4 doses administered with expiry date 04 Apr 2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 13May2022 - 4 doses administered with expiry date 04 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine 13May2022 - 4 doses administered with expiry date 04 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  The vial was not stored in the refrigerator, directly it was thawed from the freezer before administration.  The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received and patient demographic details added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Head injury
Clinical narrative: Could not keep his balance; Fell down; Hit his head; Dizziness after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Could not keep his balance), FALL (Fell down), HEAD INJURY (Hit his head) and DIZZINESS (Dizziness after 2nd booster) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, the patient experienced BALANCE DISORDER (Could not keep his balance), FALL (Fell down), HEAD INJURY (Hit his head) and DIZZINESS (Dizziness after 2nd booster). On 14-May-2022, BALANCE DISORDER (Could not keep his balance), FALL (Fell down), HEAD INJURY (Hit his head) and DIZZINESS (Dizziness after 2nd booster) had resolved.            No relevant concomitant medications were reported.  The patient had received First booster dose of Moderna vaccine on 26OCT2021. The patient had received Second booster dose of Moderna vaccine on 13MAY2022  Patient wife called EMS and the ambulance came. Everything was fine so they did not transport patient to the hospital. Patient also mentioned that he did not report his adverse event to VAERS.  No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Monocyte count increased, Prostatic specific antigen increased
Clinical narrative: elevated PSA of about 2 points compared with a test he had 8 months ago; slight elevation in the monocyte level; This spontaneous case was reported by an other health care professional and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (elevated PSA of about 2 points compared with a test he had 8 months ago) and MONOCYTE COUNT INCREASED (slight elevation in the monocyte level) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 026L20A, 032L20A and 019F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-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. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (elevated PSA of about 2 points compared with a test he had 8 months ago) and MONOCYTE COUNT INCREASED (slight elevation in the monocyte level). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (elevated PSA of about 2 points compared with a test he had 8 months ago) and MONOCYTE COUNT INCREASED (slight elevation in the monocyte level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, Blood test: elevated psa of about 2 points compared with a tes (abnormal) elevated PSA of about 2 points compared with a test he had 8 months ago & a slight elevation in the monocyte level..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The caller stated that in a news report a urologist saying it's possible for PSAs to be elevated short term after the Moderna Covid-19 Vaccine. No treatment information was provided.   This case was linked to MOD-2022-568625.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022; I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (manufacturer date of expiry 3-apr-2022 and vail initialy stored in refrigerator on 15-apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergone any temperature excursion. No treatment medication was reported.  It was unknown if patient had allergies to medications, food and other products. It was unknown if patient  ever had COVID positive test or diagnosis. It was unknown if patient had history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.Other vaccines given within 1 month prior to Moderna COVID-19 vaccine were unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Weight
Clinical narrative: felt yucky for 2 to 3 days; had arm pain that lasted for 4 to 5 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt yucky for 2 to 3 days) and PAIN IN EXTREMITY (had arm pain that lasted for 4 to 5 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19.  No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Ovarian cancer stage IV (had the Ovarian peritoneal cancer for a while but it was diagnosed more recently in Feb-2022), Penicillin allergy, Allergy to antibiotic (Keflex allergy), Drug allergy (Sulfur allergy) and Allergy to chemicals (environmental sensitivity to different chemicals). Concomitant products included PACLITAXEL (TAXOL) and CARBOPLATIN for Ovarian cancer, COLECALCIFEROL (VITAMIN D3), IP-6, INOSITOL, ZINC PICOLINATE, MAGNESIUM L-THREONATE (MAGTEIN), MAGNESIUM TAURATE and MAGNESIUM GLYCINATE for an unknown indication.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (had arm pain that lasted for 4 to 5 days). On 01-Oct-2021, the patient experienced FEELING ABNORMAL (felt yucky for 2 to 3 days). In October 2021, FEELING ABNORMAL (felt yucky for 2 to 3 days) and PAIN IN EXTREMITY (had arm pain that lasted for 4 to 5 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: lost 18 pounds (Low) had lost 18 pounds since the fall of 2021.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications also included high dosage probiotic and IP-6 inositol.  Treatment information was not reported for events that occurred after first dose vaccination.   This case was linked to MOD-2022-568683 (Patient Link).
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .; I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I administered 2 doses of expired Moderna Covid-19 vaccine on 15Apr2022.) and PRODUCT STORAGE ERROR (Manufacture date of expiry 3-apr-2022 ,  Vial stored in the refrigerator 15-Apr-2022 .) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided. The vial did not undergo any temperature excursion.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Had hives for going on 3 months now; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Had hives for going on 3 months now) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031120A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced URTICARIA (Had hives for going on 3 months now). At the time of the report, URTICARIA (Had hives for going on 3 months now) had not resolved. No concomitant medications were provided. Patient reported his experiences after receiving 2 primary doses (2nd dose lot number 027L20A on 12Mar2021) of the Moderna Covid-19 Vaccine. The patient has had hives for going on 3 months at the time of report. No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: an expired dose is given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose is given) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose is given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose is given) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 16MAY2022. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022; Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 9 doses of expired Moderna Covid-19 vaccine on 13May2022.) and PRODUCT STORAGE ERROR (The vaccine expired on 02-May-2022 and was initially stored in the refrigerator on 12-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The vial was initially stored in refrigerator on 12-May-2022.  The vial did not undergo any temperature excursion.  No treatment medication was provided.