chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Influenza like illness
Clinical narrative: cough; backache on the right side; symptoms like the flu; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), BACK PAIN (backache on the right side) and INFLUENZA LIKE ILLNESS (symptoms like the flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D17F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough), BACK PAIN (backache on the right side) and INFLUENZA LIKE ILLNESS (symptoms like the flu). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (cough), BACK PAIN (backache on the right side) and INFLUENZA LIKE ILLNESS (symptoms like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.   This case was linked to MOD-2021-389907 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Injection site pain; very swollen lymph node for the same arm of vaccination; painful lymph node for the same arm of vaccination; Slightly Feverish; Fatiuge; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain), LYMPHADENOPATHY (very swollen lymph node for the same arm of vaccination), LYMPH NODE PAIN (painful lymph node for the same arm of vaccination), PYREXIA (Slightly Feverish) and FATIGUE (Fatiuge) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Nov-2021 at 11:00 AM, 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Nov-2021, the patient experienced INJECTION SITE PAIN (Injection site pain), LYMPHADENOPATHY (very swollen lymph node for the same arm of vaccination), LYMPH NODE PAIN (painful lymph node for the same arm of vaccination), PYREXIA (Slightly Feverish) and FATIGUE (Fatiuge). At the time of the report, INJECTION SITE PAIN (Injection site pain), LYMPHADENOPATHY (very swollen lymph node for the same arm of vaccination), LYMPH NODE PAIN (painful lymph node for the same arm of vaccination) and PYREXIA (Slightly Feverish) was resolving and FATIGUE (Fatiuge) outcome was unknown. Not Provided          No Concomitant medications were provided by the reporter. No Treatment information was reported. This case concerns a 24-year-old female patient with no relevant medical history, who experienced the expected events of Injection Site Pain, Lymphadenopathy, Lymph Node Pain, Pyrexia, and Fatigue. The events occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 24-year-old female patient with no relevant medical history, who experienced the expected events of Injection Site Pain, Lymphadenopathy, Lymph Node Pain, Pyrexia, and Fatigue. The events occurred 1 day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: I developed an irregular heartbeat; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE IRREGULAR (I developed an irregular heartbeat) 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 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 HEART RATE IRREGULAR (I developed an irregular heartbeat). At the time of the report, HEART RATE IRREGULAR (I developed an irregular heartbeat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported. With both moderna shots the patient  developed an irregular heartbeat and is afraid to get the booster This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected event of heart rate irregular. The event occurred on an unknown date after the second dose of mRNA-1273. The rechallenge was positive for first occurrence of event (described in linked case) since it was reported that the patient developed an irregular heartbeat with both moderna shots. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-390452 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected event of heart rate irregular. The event occurred on an unknown date after the second dose of mRNA-1273. The rechallenge was positive for first occurrence of event (described in linked case) since it was reported that the patient developed an irregular heartbeat with both moderna shots. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Limb discomfort
Clinical narrative: Soreness/cramping in arm/ arm pain; Couldn't lift her arm laterally; Sleep disturbance; Fatigue; Headache; Joint soreness; Muscle pain; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain), LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 039K20A and 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain), LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint soreness), MYALGIA (Muscle pain) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain) had not resolved and LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint soreness), MYALGIA (Muscle pain) and CHILLS (Chills) was resolving.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: Soreness/cramping in arm/ arm pain; Couldn't lift her arm laterally; Sleep disturbance; Fatigue; Headache; Joint soreness; Muscle pain; Chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain), LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 039K20A and 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain), LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint soreness), MYALGIA (Muscle pain) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness/cramping in arm/ arm pain) had not resolved and LIMB DISCOMFORT (Couldn't lift her arm laterally), SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint soreness), MYALGIA (Muscle pain) and CHILLS (Chills) was resolving.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder injury (In march 2021 had surgery to remove it.) from January 2021 to March 2021. Concurrent medical conditions included Asthma. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, PANTOPRAZOLE for Acid reflux (esophageal), APIXABAN (ELIQUIS) for Anticoagulant therapy, BUSPIRONE for Anxiety, LEVOTHYROXINE, ESTRADIOL, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ALBUTEROL [SALBUTAMOL] and BUDESONIDE (BUDESONIDE ALMUS) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had diagnosed with a heart condition except for a murmur as a child that was never an issue for them as adults.   This case was linked to MOD-2021-390775, MOD-2021-390776, MOD-2021-390776, MOD-2021-390775 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: diarrhea; shortness of breath; feeling very tired; dehydrated; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), DEHYDRATION (dehydrated), DYSPNOEA (shortness of breath) and FATIGUE (feeling very tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065f21a, 021b21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DEHYDRATION (dehydrated). On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath) and FATIGUE (feeling very tired). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), DEHYDRATION (dehydrated), DYSPNOEA (shortness of breath) and FATIGUE (feeling very tired) had resolved.            Patient reported that she takes medications for her thyroid. Patient took water as treatment for dehydration.   This case was linked to MOD-2021-390844 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: I am  experiencing little red itchy bumps all over body, some are patches some are hives; I am  experiencing little red itchy bumps all over body, some are patches some are hives; some are patches some are hives; I am  experiencing little red itchy bumps all over body, some are patches some are hives; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (I am  experiencing little red itchy bumps all over body, some are patches some are hives), ERYTHEMA (I am  experiencing little red itchy bumps all over body, some are patches some are hives), URTICARIA (some are patches some are hives) and PRURITUS (I am  experiencing little red itchy bumps all over body, some are patches some are hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.   On 02-Mar-2021, the patient received first 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULO-PAPULAR (I am  experiencing little red itchy bumps all over body, some are patches some are hives), ERYTHEMA (I am  experiencing little red itchy bumps all over body, some are patches some are hives), URTICARIA (some are patches some are hives) and PRURITUS (I am  experiencing little red itchy bumps all over body, some are patches some are hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULO-PAPULAR (I am  experiencing little red itchy bumps all over body, some are patches some are hives), ERYTHEMA (I am  experiencing little red itchy bumps all over body, some are patches some are hives), URTICARIA (some are patches some are hives) and PRURITUS (I am  experiencing little red itchy bumps all over body, some are patches some are hives) had not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Taste disorder
Clinical narrative: Peculiar taste in mouth/bitter taste in mouth; Altered taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Peculiar taste in mouth/bitter taste in mouth) and TASTE DISORDER (Altered taste in mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced DYSGEUSIA (Peculiar taste in mouth/bitter taste in mouth) and TASTE DISORDER (Altered taste in mouth). At the time of the report, DYSGEUSIA (Peculiar taste in mouth/bitter taste in mouth) and TASTE DISORDER (Altered taste in mouth) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that they received first, second and booster dose of Moderna COVID-19 vaccine and shortly after receiving the booster dose, they began to have peculiar taste in mouth, altered taste in mouth, and bitter taste in mouth.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: Stayed in bed for 5 days after booster; Diarrhea after booster; Fever after booster; Very fatigue after booster/ Drained; Nausea after booster; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed in bed for 5 days after booster), DIARRHOEA (Diarrhea after booster), PYREXIA (Fever after booster), FATIGUE (Very fatigue after booster/ Drained) and NAUSEA (Nausea after booster) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first 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 26-Oct-2021, the patient experienced BEDRIDDEN (Stayed in bed for 5 days after booster), DIARRHOEA (Diarrhea after booster), PYREXIA (Fever after booster), FATIGUE (Very fatigue after booster/ Drained) and NAUSEA (Nausea after booster). On 31-Oct-2021, BEDRIDDEN (Stayed in bed for 5 days after booster) had resolved. On 02-Nov-2021, PYREXIA (Fever after booster) and NAUSEA (Nausea after booster) had resolved. At the time of the report, DIARRHOEA (Diarrhea after booster) and FATIGUE (Very fatigue after booster/ Drained) had not resolved.            No concomitant medications were reported. Treatment medications were not provided by the reporter. Patient was healthy.  On 26-Oct-2021, seven months after second dose, patient received booster shot of Moderna COVID-19 vaccine. After the booster shot, patient had fatigue, nausea, diarrhea, and fever. Patient stayed in bed for 5 days.  Weeks later, patient was still feeling very fatigue, drained and still had a little diarrhea.   This case was linked to MOD-2021-390829 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Feeling abnormal
Clinical narrative: It was enough to keep him in bed all day; lessening of strength in his core; felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant), BEDRIDDEN (It was enough to keep him in bed all day) and ASTHENIA (lessening of strength in his core) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036H21A, 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant). On 17-Nov-2021, the patient experienced BEDRIDDEN (It was enough to keep him in bed all day) and ASTHENIA (lessening of strength in his core). At the time of the report, FEELING ABNORMAL (felt something was off in the evening. When he woke up, he did have the same symptoms as before but they weren't as severe,unpleasant), BEDRIDDEN (It was enough to keep him in bed all day) and ASTHENIA (lessening of strength in his core) outcome was unknown.            No concomitant medication information was provided  No treatment medication information was provided    This case was linked to MOD-2021-390838 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Skin fissures, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Her fingers are cracking due to the cold weather; Her hands got dry due to the cold weather; Arm is still red; Arm is still swelled; Hurts like a son of a gun; This spontaneous case was reported by a consumer and describes the occurrence of SKIN FISSURES (Her fingers are cracking due to the cold weather), DRY SKIN (Her hands got dry due to the cold weather), VACCINATION SITE ERYTHEMA (Arm is still red), VACCINATION SITE SWELLING (Arm is still swelled) and VACCINATION SITE PAIN (Hurts like a son of a gun) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN FISSURES (Her fingers are cracking due to the cold weather), DRY SKIN (Her hands got dry due to the cold weather), VACCINATION SITE ERYTHEMA (Arm is still red), VACCINATION SITE SWELLING (Arm is still swelled) and VACCINATION SITE PAIN (Hurts like a son of a gun). At the time of the report, SKIN FISSURES (Her fingers are cracking due to the cold weather) and DRY SKIN (Her hands got dry due to the cold weather) outcome was unknown and VACCINATION SITE ERYTHEMA (Arm is still red), VACCINATION SITE SWELLING (Arm is still swelled) and VACCINATION SITE PAIN (Hurts like a son of a gun) had not resolved.            No relevant concomitant product were reported. No treatment medication was provided.  After getting booster dose, patient's arm was still red, still swelled and hurts like a son of a gun. Patient did not had a problem with first or second dose.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.). On 28-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I have a patient here that received his 1st dose of the Moderna Covid-19 vaccine on 28Oct2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 04-NOV-2021 vial was initially stored in the refrigerator. On 17-NOV-2021 10.00 AM vial was first punctured. Post puncture vial was stored under room temperature. Vial did not undergone any temperature excursions. Vial was exposed to room temperature range 46° to 77°F from 17-NOV-2021 10:53AM until 18NOV2021 11:00AM.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.  Additionally, as of 19-Nov-2021, no adverse reactions to the vaccine reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: In additional information included suspect administration date were updated On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Correct information about the dose administration received. On 22-Nov-2021: Follow up received with no new information
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.             No treatment information was provided.  The vaccine was manufactured on 09 Mar 2021. Delivered at vaccination center on 30 Sep 2021. Patient did not experienced adverse event and there was no product quality issues.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 48 patients received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment information was provided by the reporter.  The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Unfortunately we did use this beyond the use date of 10/9/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Unfortunately we did use this beyond the use date of 10/9/21) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Till date did not had any significant adverse events with all the vaccinations. There was no product quality issues.  Treatment information was not reported.   This case was linked to MOD-2021-391677 (Patient Link).
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 15-Oct-2021, the patient received vaccine with expiration date 09-Oct-2021.  No concomitant medications was reported. No treatment drug details was reported.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were experienced by the patient.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Illness, Insomnia
Clinical narrative: was not able to go into work today.; 12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so; over night she got really sick.; She could not sleep all night; body aches that were terrible; she had a really high fever of 105F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.), FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so), ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night) and MYALGIA (body aches that were terrible) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (same side effects as the booster). Past adverse reactions to the above products included Adverse event with JANSSEN COVID-19 VACCINE.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.), FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so), ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night), MYALGIA (body aches that were terrible), PYREXIA (she had a really high fever of 105F) and HEADACHE (Headache). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.) and FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so) had not resolved and ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night), MYALGIA (body aches that were terrible), PYREXIA (she had a really high fever of 105F) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Body temperature: 105 (High) high fever of 105F.         No concomitant medications  was provided.  No treatment medications was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: was not able to go into work today.; 12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so; over night she got really sick.; She could not sleep all night; body aches that were terrible; she had a really high fever of 105F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.), FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so), ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night) and MYALGIA (body aches that were terrible) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (same side effects as the booster). Past adverse reactions to the above products included Adverse event with JANSSEN COVID-19 VACCINE.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.), FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so), ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night), MYALGIA (body aches that were terrible), PYREXIA (she had a really high fever of 105F) and HEADACHE (Headache). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (was not able to go into work today.) and FEELING ABNORMAL (12 hours after her booster shot she felt funny, did not start to feel good until an hour ago or so) had not resolved and ILLNESS (over night she got really sick.), INSOMNIA (She could not sleep all night), MYALGIA (body aches that were terrible), PYREXIA (she had a really high fever of 105F) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Body temperature: 105 (High) high fever of 105F.         No concomitant medications  was provided.  No treatment medications was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: General Fatigue that lasted a few hours; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (General Fatigue that lasted a few hours) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (General Fatigue that lasted a few hours). In January 2021, FATIGUE (General Fatigue that lasted a few hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  The adverse reactions are lasted for few hours.   This case was linked to MOD-2021-391815, MOD-2021-391816 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received booster 5 months after second vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received booster 5 months after second vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.