chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Limb discomfort, Movement disorder, Paraesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of paresthesia (tingling in his left arm), movement disorder (left arm does not swing when walking), limb discomfort (left arm felt weird) and illness (severely sick the next day) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 044B21A and 016B21A) for COVID-19 immunization. No medical history reported. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On May 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On May 11, 2021, patient experienced limb discomfort (left arm felt weird). On May 12, 2021, patient experienced illness (severely sick the next day). On an unknown date, patient experienced paresthesia (tingling in his left arm) and movement disorder (left arm does not swing when walking). At the time of the report, paresthesia (tingling in his left arm), movement disorder (left arm does not swing when walking), limb discomfort (left arm felt weird) and illness (severely sick the next day) outcome: unknown. The patient already consulted his physician and CT scan done. They are going to do nerve conduction study as well. No concomitant medications or treatment information provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 030L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The vial was initially stored in the refrigerator on 22Oct2021
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-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. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Maternal exposure during pregnancy, Myalgia, Nausea
Clinical narrative: bad reaction; really sick; achy; bad nausea; headache; got booster shot while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got booster shot while pregnant). On 25-Oct-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache). On 24-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (got booster shot while pregnant) had resolved. At the time of the report, VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment information was reported. It was said that no any of the questions related to AE and consent was not obtained either as denied to contact.  This is a spontaneous case concerning an unknown age, female, pregnant patient with no relevant history reported, who experienced  maternal exposure during pregnancy and the unexpected non-serious events of vaccination complication and illness, and expected non-serious events of headache, nausea and myalgia. The events occurred approximately 2 days after the boost dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an unknown age, female, pregnant patient with no relevant history reported, who experienced  maternal exposure during pregnancy and the unexpected non-serious events of vaccination complication and illness, and expected non-serious events of headache, nausea and myalgia. The events occurred approximately 2 days after the boost dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad reaction; really sick; achy; bad nausea; headache; got booster shot while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got booster shot while pregnant). On 25-Oct-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache). On 24-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (got booster shot while pregnant) had resolved. At the time of the report, VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment information was reported. It was said that no any of the questions related to AE and consent was not obtained either as denied to contact.  This is a spontaneous case concerning an unknown age, female, pregnant patient with no relevant history reported, who experienced  maternal exposure during pregnancy and the unexpected non-serious events of vaccination complication and illness, and expected non-serious events of headache, nausea and myalgia. The events occurred approximately 2 days after the boost dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an unknown age, female, pregnant patient with no relevant history reported, who experienced  maternal exposure during pregnancy and the unexpected non-serious events of vaccination complication and illness, and expected non-serious events of headache, nausea and myalgia. The events occurred approximately 2 days after the boost dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: white blood cells increasing; This spontaneous case was reported by a pharmacist and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (white blood cells increasing) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (has leukemia (cancer) since even before receiving Moderna vaccine.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (white blood cells increasing). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (white blood cells increasing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) The latest blood work showed white blood cells increasing..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had not yet been started on Calquence treatment but was going to start it, because the patient's white blood cells are increasing. Concomitant medications were not provided by the reporter. Treatment information was not provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 INTERCHANGE OF VACCINE PRODUCTS (1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer). On 25-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (1st & 2nd doses (2nd dose on 27Feb2021) of the Covid-19 Vaccine from Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not specified
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Illness, Myalgia, Nasal congestion
Clinical narrative: stuffed noses; not hungry; felt under the weather like they really needed to stay in bed.; very fatigued; a little soreness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffed noses), DECREASED APPETITE (not hungry), ILLNESS (felt under the weather like they really needed to stay in bed.), FATIGUE (very fatigued) and MYALGIA (a little soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030M20A) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MYALGIA (a little soreness). On 04-Mar-2021, the patient experienced NASAL CONGESTION (stuffed noses), DECREASED APPETITE (not hungry), ILLNESS (felt under the weather like they really needed to stay in bed.) and FATIGUE (very fatigued). On 06-Mar-2021, NASAL CONGESTION (stuffed noses), DECREASED APPETITE (not hungry), ILLNESS (felt under the weather like they really needed to stay in bed.) and FATIGUE (very fatigued) had resolved. At the time of the report, MYALGIA (a little soreness) outcome was unknown.            No concomitant medications were reported   No treatment information was provided  The patient and her husband had the same reaction, and received the vaccine on the same dates with the same lots. Patient husband attributes his symptoms to the immune response of the vaccine. They did not took any medications or treatments for their symptoms.   This case was linked to MOD-2021-363423 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Somnolence
Clinical narrative: Yesterday slept all day.; Headaches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Yesterday slept all day.), HEADACHE (Headaches) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced SOMNOLENCE (Yesterday slept all day.), HEADACHE (Headaches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Yesterday slept all day.), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.            Concomitant medication reported included high blood pressure medicine.  The reporter stated that the patient's symptoms started about the next morning post the booster dose. The patient developed head aches and chills and it was reported that the patient slept all day yesterday. The lot number for the booster dose was unclear to the reporter and they provided lot number as 017F21A or 012F21A.   This case was linked to MOD-2021-363397, MOD-2021-363015 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of nasopharyngitis (cold symptoms) and headache in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nasopharyngitis (cold symptoms) an headache. At the time of the report, nasopharyngitis (cold symptoms) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant product use or treatment information provided. The reporter called on behalf of wife who felt cold symptoms post first Moderna COVID-19 vaccination and also had a headache.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little soreness,arm was sore a little bit; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (a little soreness,arm was sore a little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis and Irritable bowel syndrome. Concomitant products included MELATONIN for Sleep disorder.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little soreness,arm was sore a little bit). The patient was treated with IBUPROFEN ongoing since an unknown date for Diverticulitis, at an unspecified dose and frequency and HYDROCODONE ongoing since an unknown date for Diverticulitis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little soreness,arm was sore a little bit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-363553, MOD-2021-363555 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 027A20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) 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 medication was reported.  The patient received an expired dose of the Moderna COVID-19 Vaccine as a booster dose. The vaccine was initially stored in 22-Oct-2021 and expired on 24-Oct-2021 and was administered to the patient on 25-Oct-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-363183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-363183:Cross linked case/ Master case
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced adverse reaction) 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 COMPLICATION (experienced adverse reaction). At the time of the report, VACCINATION COMPLICATION (experienced adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received and patient demographics updated(Email address added)
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired third dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired third dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-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 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired third dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient was given the Moderna COVID19 vaccine dose past the 30 days in the refrigerator.   This case was linked to US-MODERNATX, INC.-MOD-2021-362998 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-362998:MOD21-156364(crosslink) (Master Case)
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Malaise, Nausea, Pain
Clinical narrative: Achy; Fever; Some nausea; Had a bad reaction to that dose; Sick for 3-4 days; Not feeling good for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction to that dose), ILLNESS (Sick for 3-4 days), MALAISE (Not feeling good for 3-4 days), PAIN (Achy) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) 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 HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), METFORMIN, OMEPRAZOLE, ROSUVASTATIN, TADALAFIL (CIALIS) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (Had a bad reaction to that dose), ILLNESS (Sick for 3-4 days) and MALAISE (Not feeling good for 3-4 days). On 21-Aug-2021, the patient experienced PAIN (Achy), PYREXIA (Fever) and NAUSEA (Some nausea). On 25-Aug-2021, PAIN (Achy), PYREXIA (Fever) and NAUSEA (Some nausea) had resolved. At the time of the report, VACCINATION COMPLICATION (Had a bad reaction to that dose) outcome was unknown and ILLNESS (Sick for 3-4 days) and MALAISE (Not feeling good for 3-4 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 100 (High) Temperature never went above 100 degrees Fahrenheit.         Patient stated that he may have taken Ibuprofen but does not remember. Patient weight was reported as 215.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Achy; Fever; Some nausea; Had a bad reaction to that dose; Sick for 3-4 days; Not feeling good for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction to that dose), ILLNESS (Sick for 3-4 days), MALAISE (Not feeling good for 3-4 days), PAIN (Achy) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) 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 HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), METFORMIN, OMEPRAZOLE, ROSUVASTATIN, TADALAFIL (CIALIS) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (Had a bad reaction to that dose), ILLNESS (Sick for 3-4 days) and MALAISE (Not feeling good for 3-4 days). On 21-Aug-2021, the patient experienced PAIN (Achy), PYREXIA (Fever) and NAUSEA (Some nausea). On 25-Aug-2021, PAIN (Achy), PYREXIA (Fever) and NAUSEA (Some nausea) had resolved. At the time of the report, VACCINATION COMPLICATION (Had a bad reaction to that dose) outcome was unknown and ILLNESS (Sick for 3-4 days) and MALAISE (Not feeling good for 3-4 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 100 (High) Temperature never went above 100 degrees Fahrenheit.         Patient stated that he may have taken Ibuprofen but does not remember. Patient weight was reported as 215.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore right injection site arm after his second Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore right injection site arm after his second Moderna vaccination) in a 46-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (sore right injection site arm after his second Moderna vaccination). At the time of the report, INJECTION SITE PAIN (sore right injection site arm after his second Moderna vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-363447 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported by patient.  Concomitant products included BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALEVE) for Pain, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN), RAMIPRIL, OXCARBAZEPINE, METOPROLOL, UBIDECARENONE (COQ10 [UBIDECARENONE]), MULTI VITAMINS & MINERALS, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLE FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE;METHYLSULFONYLMETHANE]), VITAMIN C [ASCORBIC ACID], multivitamin ADULTS 50+ and LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) for an unknown indication.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the arm). At the time of the report, VACCINATION SITE PAIN (Soreness in the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information includes for the concomitant information where patient had reported of taking Astioviflex for an unknown indication. Patient reported steroids as treatment medication.   This case was linked to MOD-2021-363342, MOD-2021-363478 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-Oct-2021 is non-Significant Follow up- Earlier missed details of concomitant and treatment medication is updated.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: she's had to take an inhaler after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she's had to take an inhaler after the first dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (she's had to take an inhaler after the first dose). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (she's had to take an inhaler after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-362537 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow up received and fax number of Reporter was  updated.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5 mL instead of 0.25 mL for booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 mL instead of 0.25 mL for booster dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 mL instead of 0.25 mL for booster dose). On 22-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5 mL instead of 0.25 mL for booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received single dose of Johnson and Johnson vaccine.  No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Patient received 3rd dose and they were not immunocompromised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received 3rd dose and they were not immunocompromised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Patient received 3rd dose and they were not immunocompromised). At the time of the report, OFF LABEL USE (Patient received 3rd dose and they were not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 043L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 19-Apr-2021 and the estimated date of delivery was 01-Feb-2022. On 22-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 22-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            No concomitant medications was reported. No treatment information was provided.  This case concerns a 31-year-old, female patient with no known  medical history, who experienced the non-serious event of Maternal exposure during pregnancy. The patient received the third dose of vaccine at 26 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Followup information was received on 28-Oct-2021 contains no new information.; Sender's Comments: This case concerns a 31-year-old, female patient with no known  medical history, who experienced the non-serious event of Maternal exposure during pregnancy. The patient received the third dose of vaccine at 26 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain
Clinical narrative: Not feeling good after the booster; Kind of achy after the booster; kind of  tired after the booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good after the booster), PAIN (Kind of achy after the booster) and FATIGUE (kind of  tired after the booster) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FEELING ABNORMAL (Not feeling good after the booster), PAIN (Kind of achy after the booster) and FATIGUE (kind of  tired after the booster). At the time of the report, FEELING ABNORMAL (Not feeling good after the booster), PAIN (Kind of achy after the booster) and FATIGUE (kind of  tired after the booster) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: administered with 0.5 ml for booster dose instead of 0.25ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (administered with 0.5 ml for booster dose instead of 0.25ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (administered with 0.5 ml for booster dose instead of 0.25ml). At the time of the report, PRODUCT ADMINISTRATION ERROR (administered with 0.5 ml for booster dose instead of 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients received expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5 ml dose instead of a 0.25 ml dose for their booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml dose instead of a 0.25 ml dose for their booster) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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) .5 milliliter. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 ml dose instead of a 0.25 ml dose for their booster). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5 ml dose instead of a 0.25 ml dose for their booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-363330 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Malaise, Vaccination site pain, Vertigo
Clinical narrative: not feeling good; loopy/a little dizzy, like she was in a dream; a little vertigo; more sore arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling good), DIZZINESS (loopy/a little dizzy, like she was in a dream), VERTIGO (a little vertigo), VACCINATION SITE PAIN (more sore arm) and FATIGUE (tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis and Irritable bowel syndrome. Concomitant products included MELATONIN for Sleep disorder NOS.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling good), DIZZINESS (loopy/a little dizzy, like she was in a dream), VERTIGO (a little vertigo), VACCINATION SITE PAIN (more sore arm) and FATIGUE (tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling good), DIZZINESS (loopy/a little dizzy, like she was in a dream), VERTIGO (a little vertigo) and FATIGUE (tired) outcome was unknown and VACCINATION SITE PAIN (more sore arm) had resolved.            Patient experienced the symptoms after her second dose of vaccine.   This case was linked to MOD-2021-363450, MOD-2021-363555 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID-19 Vaccine as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 Vaccine as a booster dose) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The vial was initially stored in the refrigerator on 22-Oct-2021. The vial did not undergo any temperature excursions.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: On 19 Oct 2021, the patient reported she had a reaction to the second dose of the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (On 19 Oct 2021, the patient reported she had a reaction to the second dose of the Moderna vaccine.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Malignant neoplasm of female breast.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On 19-Oct-2021, the patient experienced VACCINATION COMPLICATION (On 19 Oct 2021, the patient reported she had a reaction to the second dose of the Moderna vaccine.). At the time of the report, VACCINATION COMPLICATION (On 19 Oct 2021, the patient reported she had a reaction to the second dose of the Moderna vaccine.) outcome was unknown. Not Provided          Patient year of birth is 1960.  Concomitant medications were not provided  Treatment medications were not provided
Sex: U
Vaccine: COVID19
Symptoms: Cough, Vaccination complication
Clinical narrative: Bad reaction; Cough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction) and COUGH (Cough) 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 24-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. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction) and COUGH (Cough). At the time of the report, VACCINATION COMPLICATION (Bad reaction) and COUGH (Cough) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-363638 (Patient Link).   Reporter did not allow further contact