chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: RESTORED TO CIRCULATION PATTERNS AND  COMFORTABLE NERVE RESPONSES IN BACK AND LEGS ALONG WITH A GENERALLY GOOD FEELING OF NORMAL SELF FROM WHAT SEEMS LIKE YEARS AGO; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included sciatica, and general pain in spine. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced restored to circulation patterns and comfortable nerve responses in back and legs along with a generally good feeling of normal self from what seems like years ago. The action taken with covid-19 vaccine was not applicable. The outcome of restored to circulation patterns and comfortable nerve responses in back and legs along with a generally good feeling of normal self from what seems like years ago was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; SWEATING PROFUSELY; ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On MAY-2021, the subject experienced sweating profusely. On MAY-2021, the subject experienced ache. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the sweating profusely, ache, fever and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient got tested for antibodies (specifically antibodies to the spike protein) for travel purposes. The patient's other option was to got a negative covid-19 test. As per the patient, the antibody test was valid for 4 months while negative covid-19 test was only valid for 5 days from travel. Patient opted for antibody testing. Test for covid-19 vaccine antibodies came back negative. So, patient did not had antibodies to the spike protein. The patient tested for S1-RBD Antibodies (S), or worse case scenario patient did not develop antibodies to the spike protein. The action taken with covid-19 vaccine was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine. Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Influenza like illness
Clinical narrative: DIARRHEA/MUSHY POOP; CRAMPING IN STOMACH WHEN EATS; DIDN'T EAT; SORE ARM; FEELS DIZZY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced feels dizzy. On 28-MAY-2021, the subject experienced flu like symptoms. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced diarrhea/mushy poop. On 29-MAY-2021, the subject experienced cramping in stomach when eats. On 29-MAY-2021, the subject experienced didn't eat. The action taken with covid-19 vaccine was not applicable. The patient was recovering from diarrhea/mushy poop, cramping in stomach when eats, and sore arm, had not recovered from feels dizzy, and flu like symptoms, and the outcome of didn't eat was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: DIARRHEA/MUSHY POOP; CRAMPING IN STOMACH WHEN EATS; DIDN'T EAT; SORE ARM; FEELS DIZZY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced feels dizzy. On 28-MAY-2021, the subject experienced flu like symptoms. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced diarrhea/mushy poop. On 29-MAY-2021, the subject experienced cramping in stomach when eats. On 29-MAY-2021, the subject experienced didn't eat. The action taken with covid-19 vaccine was not applicable. The patient was recovering from diarrhea/mushy poop, cramping in stomach when eats, and sore arm, had not recovered from feels dizzy, and flu like symptoms, and the outcome of didn't eat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: ITCHING OFF AND ON TO ARM; A LITTLE REDNESS TO ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JUN-2021, the subject experienced itching off and on to arm. On 01-JUN-2021, the subject experienced a little redness to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching off and on to arm, and a little redness to arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180501A expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced expired product administered. The outcome of expired product administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA AFTER STARTING TO EAT A LITTLE BIT; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced nausea after starting to eat a little bit. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from nausea after starting to eat a little bit. This report was non-serious.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 1-AUG-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: SLEEPY; This spontaneous report received from a patient via a company representative . The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sleepy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Sluggishness
Clinical narrative: COUGHING; SORE THROAT; SLUGGISH; HEADACHE; This spontaneous report received from a patient concerned a 53 year old of unspecified sex. The patient's weight was 215 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol consumer, and cigarette smoker, and other pre-existing medical conditions included patient have no known allergies and no drug abuse or illicit drug use.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041a21a, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced coughing. On 28-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced sluggish. On 28-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 2021, was recovering from sluggish, and had not recovered from coughing, and sore throat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: VACCINE ADMINISTERED AFTER  TRANSPORTATION OF THE  PREFILLED SYRINGE OUTSIDE OF  THE ACCEPTABLE LIMIT; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered after transportation of the prefilled syringe outside of the acceptable limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after transportation of the prefilled syringe outside of the acceptable limit was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies and has not had covid or been tested positive for covid. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: PRODUCT TEMPERATURE EXCURSION ISSUE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.. No concomitant medications were reported. On an unspecified date, the subject experienced product temperature excursion issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product temperature excursion issue was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diverticulitis, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: Diverticulitis; cannot lift anything up or drive; painful arm between the elbow and shoulder; muscle spasms; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms) and ABDOMINAL PAIN UPPER (stomach pain). On an unknown date, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) had resolved, MUSCLE SPASMS (muscle spasms), ABDOMINAL PAIN UPPER (stomach pain) and MUSCULAR WEAKNESS (cannot lift anything up or drive) outcome was unknown and MYALGIA (painful arm between the elbow and shoulder) had not resolved.            No concomitant medication were provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Action taken with mRNA-1273 Moderna vaccine was Not applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up was accepted on 27-May-2021 On 26-May-2021: Non significant follow up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Paraesthesia, Swelling face, Vision blurred
Clinical narrative: Lost partial vision in her left eye; Tingling on the injection site; Swelling of the face; Blurred vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS UNILATERAL (Lost partial vision in her left eye) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PARAESTHESIA (Tingling on the injection site), SWELLING FACE (Swelling of the face) and VISION BLURRED (Blurred vision). On an unknown date, the patient experienced BLINDNESS UNILATERAL (Lost partial vision in her left eye) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. At the time of the report, BLINDNESS UNILATERAL (Lost partial vision in her left eye) had not resolved and PARAESTHESIA (Tingling on the injection site), SWELLING FACE (Swelling of the face) and VISION BLURRED (Blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient is immunocompromised. Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up received on 31-MAY-2021: New AEs were updated(Blurred vision,partial vision lost); Sender's Comments: Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depressed level of consciousness, Fatigue, Myalgia, Pyrexia
Clinical narrative: brain fog; left arm injection site was sore; fatigue; body aches; fever; chills; fatigued/Tired; body aches; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history per source document.). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced the first episode of VACCINATION SITE PAIN (left arm injection site was sore), FATIGUE (fatigued/Tired) and the first episode of MYALGIA (body aches). On 20-May-2021, the patient experienced FATIGUE (fatigue), the second episode of MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and the second episode of VACCINATION SITE PAIN (left arm injection site was sore). On 24-May-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) (seriousness criterion medically significant). On 27-Apr-2021, FATIGUE (fatigued/Tired) had resolved. On 23-May-2021, FATIGUE (fatigue), the last episode of MYALGIA (body aches) and the last episode of VACCINATION SITE PAIN (left arm injection site was sore) had resolved. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Patient received both Moderna Covid-19 vaccine in his left arm shoulder deltoid muscle.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: brain fog; left arm injection site was sore; fatigue; body aches; fever; chills; fatigued/Tired; body aches; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history per source document.). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced the first episode of VACCINATION SITE PAIN (left arm injection site was sore), FATIGUE (fatigued/Tired) and the first episode of MYALGIA (body aches). On 20-May-2021, the patient experienced FATIGUE (fatigue), the second episode of MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and the second episode of VACCINATION SITE PAIN (left arm injection site was sore). On 24-May-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) (seriousness criterion medically significant). On 27-Apr-2021, FATIGUE (fatigued/Tired) had resolved. On 23-May-2021, FATIGUE (fatigue), the last episode of MYALGIA (body aches) and the last episode of VACCINATION SITE PAIN (left arm injection site was sore) had resolved. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Patient received both Moderna Covid-19 vaccine in his left arm shoulder deltoid muscle.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: cant see; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (cant see) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (cant see) (seriousness criterion medically significant). At the time of the report, BLINDNESS (cant see) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Company Comment : This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time, and no reporter can be contacted for follow-up.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time, and no reporter can be contacted for follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Son died 10 days after his first moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Son died 10 days after his first moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  A male patient of an unknown age who received mRNA-1273 died 10 days after his first dose of vaccine. No medical conditions or conmeds were provided.  Very limited information regarding these events has been provided at this time. Further information is being pursued.; Sender's Comments: A male patient of an unknown age who received mRNA-1273 died 10 days after his first dose of vaccine. No medical conditions or conmeds were provided.  Very limited information regarding these events has been provided at this time. Further information is being pursued.; Reported Cause(s) of Death: Son died 10 days after his first moderna vaccine
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Cardiac disorder, Chest pain, Chills
Clinical narrative: heart disorder; Inappropriate schedule of vaccine administered; started feeling short of breath; pain in the back and chest; pain in the back and chest; pain bone; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (heart disorder) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high (Patient was diagnosed at the hospital) on 19-Mar-2021.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced BONE PAIN (pain bone) and CHILLS (chills). On 16-May-2021, the patient experienced DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest) and BACK PAIN (pain in the back and chest). On 19-May-2021, the patient experienced CARDIAC DISORDER (heart disorder) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered). The patient was hospitalized on 19-Mar-2021 due to CARDIAC DISORDER. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 06-Apr-2021, BONE PAIN (pain bone) and CHILLS (chills) had resolved. At the time of the report, CARDIAC DISORDER (heart disorder), DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest), BACK PAIN (pain in the back and chest) and PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received medications for diabetes and high blood pressure however, drug names were not provided.  Company comment: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was received.; Sender's Comments: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Product dose omission issue
Clinical narrative: heart disorder; Inappropriate schedule of vaccine administered; started feeling short of breath; pain in the back and chest; pain in the back and chest; pain bone; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (heart disorder) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high (Patient was diagnosed at the hospital) on 19-Mar-2021.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced BONE PAIN (pain bone) and CHILLS (chills). On 16-May-2021, the patient experienced DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest) and BACK PAIN (pain in the back and chest). On 19-May-2021, the patient experienced CARDIAC DISORDER (heart disorder) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered). The patient was hospitalized on 19-Mar-2021 due to CARDIAC DISORDER. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 06-Apr-2021, BONE PAIN (pain bone) and CHILLS (chills) had resolved. At the time of the report, CARDIAC DISORDER (heart disorder), DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest), BACK PAIN (pain in the back and chest) and PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received medications for diabetes and high blood pressure however, drug names were not provided.  Company comment: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was received.; Sender's Comments: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Confusional state, Infection, Malaise
Clinical narrative: Infection; Confusion; Could not get out of the bed; Very sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (Infection) and CONFUSIONAL STATE (Confusion) in a 90-year-old male patient 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 provided.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick). At the time of the report, INFECTION (Infection), CONFUSIONAL STATE (Confusion), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick) had not resolved.            Concomitant product use was not provided. Treatment information was not provided.  Company Comment: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Seizure, Vaccination site pain, Vomiting
Clinical narrative: Seizure; Vomiting; Muscle aches; Chills; Pain in my arm from shot; 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 SEIZURE (Seizure) in a patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), VOMITING (Vomiting), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in my arm from shot). At the time of the report, SEIZURE (Seizure), VOMITING (Vomiting), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in my arm from shot) outcome was unknown. Not Provided          The case pertains to one patient from chatbot. No concomitant medications were reported. The patient had these symptoms after second dose. Treatment information was not provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pneumonia
Clinical narrative: in the hospital for pneumonia; first dose on 22Mar2021 (no second dose); This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (in the hospital for pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. WSY86RS56) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (in the hospital for pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 22Mar2021 (no second dose)). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (in the hospital for pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 22Mar2021 (no second dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug information provided. No concomitant drug information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0470 2orZ 1A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tachyarrhythmia
Clinical narrative: Tachyarrhythmia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYARRHYTHMIA (Tachyarrhythmia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 TACHYARRHYTHMIA (Tachyarrhythmia) (seriousness criterion hospitalization). At the time of the report, TACHYARRHYTHMIA (Tachyarrhythmia) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested..; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested..
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Dyspnoea, Pain in extremity, Pyrexia
Clinical narrative: Woke up in the middle of the night and she was choking; Not able to breath; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Woke up in the middle of the night and she was choking) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). On 09-May-2021, the patient experienced CHOKING (Woke up in the middle of the night and she was choking) (seriousness criterion medically significant) and DYSPNOEA (Not able to breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Apr-2021, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved. On 09-May-2021, CHOKING (Woke up in the middle of the night and she was choking) and DYSPNOEA (Not able to breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Reportedly, the patient woke up in the middle of the night and was choking. Patient was not able to breath. All of a sudden the patient was fine and went back to sleep. It was for a few seconds.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident, Diplopia
Clinical narrative: Stroke; Lost sight in one eye; Double vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (Lost sight in one eye) in a 74-year-old female patient 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 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 15-May-2021, the patient experienced BLINDNESS UNILATERAL (Lost sight in one eye) (seriousness criterion medically significant) and DIPLOPIA (Double vision). On 16-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 16-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), BLINDNESS UNILATERAL (Lost sight in one eye) and DIPLOPIA (Double vision) outcome was unknown.            Concomitant product use was not provided.  It was reported that the patient is planning to go to rehab center from Hospital.  Treatment information was unknown.  Very limited information regarding these events has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: Surgery after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (Surgery after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (Surgery after 1st dose). At the time of the report, SURGERY (Surgery after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment medications were reported.  Patient had a surgery after first vaccination so patient wanted to reschedule the second dose of vaccine  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Headache, Pain in extremity, Product dose omission issue
Clinical narrative: Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.