chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site hypersensitivity
Clinical narrative: Hypersensitivity reaction localized to the injection site on the same arm of the injection; She says that the rash got very big but went away on its own after 2 to 3 days; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (She says that the rash got very big but went away on its own after 2 to 3 days) and VACCINATION SITE HYPERSENSITIVITY (Hypersensitivity reaction localized to the injection site on the same arm of the injection) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026Z20A) for COVID-19 vaccination.     Concomitant products included COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE HYPERSENSITIVITY (Hypersensitivity reaction localized to the injection site on the same arm of the injection). In January 2021, the patient experienced RASH (She says that the rash got very big but went away on its own after 2 to 3 days). On 11-Jan-2021, VACCINATION SITE HYPERSENSITIVITY (Hypersensitivity reaction localized to the injection site on the same arm of the injection) had resolved. In January 2021, RASH (She says that the rash got very big but went away on its own after 2 to 3 days) 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 medical history was provided by the reporter. Other concomitant medications included birth control pills Treatment medication included unspecified topical cream.  The patient stated that the rash got very big but went away on its own after 2 to 3 days and also she has no known allergies.   This case was linked to MOD-2022-461882 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Spec of blood when blowing nose; Congestion; Headache; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), EPISTAXIS (Spec of blood when blowing nose), NASAL CONGESTION (Congestion) and HEADACHE (Headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 028A21A and 103A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and IRON for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2022, the patient experienced COUGH (Coughing), NASAL CONGESTION (Congestion) and HEADACHE (Headache). On 26-Jan-2022, the patient experienced EPISTAXIS (Spec of blood when blowing nose). The patient was treated with GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. On 26-Jan-2022, NASAL CONGESTION (Congestion) and HEADACHE (Headache) had resolved. At the time of the report, COUGH (Coughing) and EPISTAXIS (Spec of blood when blowing nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative.,Result received on 26-JAN-2022.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a booster to a 5 year old) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a booster to a 5 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a booster to a 5 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022) 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 20-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna COVID-19 vaccine beyond 12 hours after it was firstpunctured on 19-Jan-2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medications was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing), VOMITING (Vomiting most of the night) and PYREXIA (100.1 temperature) 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 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing) and PYREXIA (100.1 temperature). On 25-Jan-2022, the patient experienced VOMITING (Vomiting most of the night). At the time of the report, PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing), VOMITING (Vomiting most of the night) and PYREXIA (100.1 temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 100.1 (High) 100.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The case was reported by patient's mother. No concomitant medication information was provided. No treatment medications were provided. The reporter wanted to know if the symptoms were related to the vaccine. Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing), VOMITING (Vomiting most of the night) and PYREXIA (100.1 temperature) 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 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing) and PYREXIA (100.1 temperature). On 25-Jan-2022, the patient experienced VOMITING (Vomiting most of the night). At the time of the report, PAIN IN EXTREMITY (Arm is very sore), PAIN (Has body ache), COUGH (Coughing), VOMITING (Vomiting most of the night) and PYREXIA (100.1 temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 100.1 (High) 100.1. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The case was reported by patient's mother. No concomitant medication information was provided. No treatment medications were provided. The reporter wanted to know if the symptoms were related to the vaccine. Reporter did not allow further contact.
Age: 49.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart Attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 total. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria death and medically significant). The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            Concomitant drug details not provided. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) after receiving COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE). On an unspecified date, following vaccination with mRNA-1273, the patient had a heart attack. On the next day (after vaccination) the patient died due to heart attack. No treatment information was provided.  Company Comment -  This case concerns a 49 year old patient of unknown gender with no relevant medical history, who experienced the serious unexpected event of myocardial infarction. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The outcome was fatal , with death occurring 1 day after receiving a dose of mRNA-1273 vaccine. The reported cause of death was heart attack. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 49 year old patient of unknown gender with no relevant medical history, who experienced the serious unexpected event of myocardial infarction. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The outcome was fatal , with death occurring 1 day after receiving a dose of mRNA-1273 vaccine. The reported cause of death was heart attack. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Heart Attack
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia
Clinical narrative: Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA); This literature-non-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AUTOIMMUNE HAEMOLYTIC ANAEMIA (Moderate IgG-mediated Autoimmune Hemolytic Anemia (AIHA)) to be related.    No concomitant and treatment medications reported.  Company comment: This case concerns a 66-year-old female patient with no medical history provided, who experienced serious unexpected event of  moderate Autoimmune Hemolytic Anemia (IgG-mediated). The event occurred after the administration of the second dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown. The rechallenge is not applicable as the event occurred after the second vaccination and the outcome was unknown at the time of this report. No additional details regarding the clinical course of the event was provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 66-year-old female patient with no medical history provided, who experienced serious unexpected event of  moderate Autoimmune Hemolytic Anemia (IgG-mediated). The event occurred after the administration of the second dose of the mRNA-1273 vaccine, however, the precise temporal relationship cannot be determined as the date of vaccination and start date of the event were not provided. At the time of this report, the outcome of the event remained unknown. The rechallenge is not applicable as the event occurred after the second vaccination and the outcome was unknown at the time of this report. No additional details regarding the clinical course of the event was provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus disorder. Concomitant products included CETIRIZINE for Sinus disorder.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced COVID-19 (Got COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Got COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      Company comment: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID 19. Drug ineffective was also captured as event. The event occurred approximately 7.5 months after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.    No medical history information for patient was reported.   This case was linked to MOD-2022-461890 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID 19. Drug ineffective was also captured as event. The event occurred approximately 7.5 months after the second dose of mRNA-1273. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus, Visual impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Losing sight), PAIN (Sore), PRURITUS (Severe itching) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VISUAL IMPAIRMENT (Losing sight), PAIN (Sore), PRURITUS (Severe itching) and HEADACHE (Headache). At the time of the report, VISUAL IMPAIRMENT (Losing sight), PAIN (Sore), PRURITUS (Severe itching) and HEADACHE (Headache) had not resolved. No Concomitant product use was reported. The reporter was calling on behalf of their wife who was the patient who received the second shot in Apr-2021. The patient was experiencing sore, losing sight, headache, and severe itching. The patient went to doctor and they confirmed that the reactions were caused by the vaccine. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experienced site injection pain for 1-2 days afterward) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (experienced site injection pain for 1-2 days afterward). At the time of the report, VACCINATION SITE PAIN (experienced site injection pain for 1-2 days afterward) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information provided. No treatment medication information provided. The patient only experienced site injection pain for 1 to 2 days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No Concomitant product use was reported. No treatment information was provided. This case was linked to MOD-2022-462269, MOD-2022-462295 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered 2 doses of the Moderna COVID-19 vaccine 5 days past the expiration date) had resolved.        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. The patient was administered with Moderna COVID-19 vaccine 5 days past the expiration date and had no other symptoms experienced.Date the vial was initially stored in the refrigerator was on 10 Jan 2022 and there were no temperature excursions.   This case was linked to MOD-2022-462697 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered to 2 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to 2 patients) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to 2 patients). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered to 2 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient received his booster vaccine after 5 days of its expiry and had no other symptoms experienced. It was also stated that the vial was initially stored in the refrigerator and there were no temperature excursions. Concomitant and treatment medication information was not reported.    This case was linked to MOD-2022-462691 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of accidental underdose (immunocompromised patient received a 0.25mL dose as the third dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included immunocompromised status. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 0.25 milliliter. On an unknown date, patient experienced accidental underdose (immunocompromised patient received a 0.25mL dose as the third dose). At the time of the report, accidental underdose (immunocompromised patient received a 0.25mL dose as the third dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (swollen painful lymph nodes, archness), lymphadenopathy, lymph node pain and headache in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 21, 2022, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In January 2022, patient experienced pain (swollen painful lymph nodes, archness), lymphadenopathy, lymph node pain and headache. At the time of the report, pain (swollen painful lymph nodes, archness), lymphadenopathy, lymph node pain and headache: not resolved. No concomitant and treatment medications reported. After 5-6 days of receiving the booster, patient had a headache.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.  Company Comment: This spontaneous case concerns a patient with unknown age and gender with no medical history reported, who experienced Serious ( medically significant ) , expected event of myocarditis which occurred on an unknown  date with an unknown dose number of mRNA-1273 vaccine ( Moderna covid 19 vaccine ) , date of vaccination is also unknown. Details re:  laboratories , diagnostics and treatment for this event was not reported. The re-challenge for this case is not applicable since the dose details was not reported and the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with unknown age and gender with no medical history reported, who experienced Serious ( medically significant ) , expected event of myocarditis which occurred on an unknown  date with an unknown dose number of mRNA-1273 vaccine ( Moderna covid 19 vaccine ) , date of vaccination is also unknown. Details re:  laboratories , diagnostics and treatment for this event was not reported. The re-challenge for this case is not applicable since the dose details was not reported and the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to lisinopril) and Knee pain. Concomitant products included HCTZ for Blood pressure management.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness on the arm). At the time of the report, VACCINATION SITE PAIN (Soreness on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had steriod injection yesterday for right knee pain of kenolog brand.   This case was linked to MOD-2022-462970 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Somnolence
Clinical narrative: It gave severe cramps and muscle spasms; sleepiness; pain; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE SPASMS (It gave severe cramps and muscle spasms), SOMNOLENCE (sleepiness) and PAIN (pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (It gave severe cramps and muscle spasms), SOMNOLENCE (sleepiness) and PAIN (pain). At the time of the report, MUSCLE SPASMS (It gave severe cramps and muscle spasms), SOMNOLENCE (sleepiness) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with an expired dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with an expired dose). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (vaccinated with an expired dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Follow up received: No new information was received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster more than 12 hours post puncture) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster more than 12 hours post puncture). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired booster more than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Bone pain, Breast pain, Chest pain
Clinical narrative: Pain; pain under chest pain in middle of chest; pain in breast bone; pain at end of both breasts; not comfortable; She has high blood pressure/Her blood pressure is elevated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHEST PAIN (pain under chest pain in middle of chest), BONE PAIN (pain in breast bone), BREAST PAIN (pain at end of both breasts) and DISCOMFORT (not comfortable) in a 62-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.     Concurrent medical conditions included Blood pressure high, Diabetes and Hypercholesterolaemia.   On 26-Jan-2022 at 1:45 PM, 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 27-Jan-2022, the patient experienced CHEST PAIN (pain under chest pain in middle of chest), BONE PAIN (pain in breast bone), BREAST PAIN (pain at end of both breasts), DISCOMFORT (not comfortable) and BLOOD PRESSURE INCREASED (She has high blood pressure/Her blood pressure is elevated). On 27-Jan-2022 at 11:00 AM, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved and CHEST PAIN (pain under chest pain in middle of chest), BONE PAIN (pain in breast bone), BREAST PAIN (pain at end of both breasts), DISCOMFORT (not comfortable) and BLOOD PRESSURE INCREASED (She has high blood pressure/Her blood pressure is elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: 132/81. (High) 132/81.. In January 2022, Heart rate: 91 (High) 91.         Concomitant medication includes Blood pressure medication Diabetes medication High cholesterol medications.   Patient had reported that she has high blood pressure, but she took medicine today.  Her blood pressure was elevated. Her blood pressure was 132/81. Her pulse was 91.  No treatment information provided.   This case was linked to MOD-2022-463099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: added Reporter details, Patient demographics, Medical history,lab data, Product details added, concomitant medication added in I narrative.new events added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Heart rate, Pain
Clinical narrative: Pain; pain under chest pain in middle of chest; pain in breast bone; pain at end of both breasts; not comfortable; She has high blood pressure/Her blood pressure is elevated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHEST PAIN (pain under chest pain in middle of chest), BONE PAIN (pain in breast bone), BREAST PAIN (pain at end of both breasts) and DISCOMFORT (not comfortable) in a 62-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.     Concurrent medical conditions included Blood pressure high, Diabetes and Hypercholesterolaemia.   On 26-Jan-2022 at 1:45 PM, 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 27-Jan-2022, the patient experienced CHEST PAIN (pain under chest pain in middle of chest), BONE PAIN (pain in breast bone), BREAST PAIN (pain at end of both breasts), DISCOMFORT (not comfortable) and BLOOD PRESSURE INCREASED (She has high blood pressure/Her blood pressure is elevated). On 27-Jan-2022 at 11:00 AM, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved and CHEST PAIN (pain under chest pain in middle of chest), BONE PAIN (pain in breast bone), BREAST PAIN (pain at end of both breasts), DISCOMFORT (not comfortable) and BLOOD PRESSURE INCREASED (She has high blood pressure/Her blood pressure is elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood pressure measurement: 132/81. (High) 132/81.. In January 2022, Heart rate: 91 (High) 91.         Concomitant medication includes Blood pressure medication Diabetes medication High cholesterol medications.   Patient had reported that she has high blood pressure, but she took medicine today.  Her blood pressure was elevated. Her blood pressure was 132/81. Her pulse was 91.  No treatment information provided.   This case was linked to MOD-2022-463099 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: added Reporter details, Patient demographics, Medical history,lab data, Product details added, concomitant medication added in I narrative.new events added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Lisinopril). Concomitant products included HYDROCHLOROTHIAZIDE (HCTZ) for Blood pressure.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the arm) outcome was unknown.            Treatment: Steroids  were taken for her pain on the right knee the brand is Kenolog.   This case was linked to MOD-2022-462888, MOD-2022-462971 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066, 013L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Pain in knee. Concurrent medical conditions included Drug allergy (Lisinopril) and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE (HCTZ) for Blood pressure high.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-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 experienced PAIN IN EXTREMITY (Soreness on the arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the arm) outcome was unknown.            The patient had Steroid injected for pain on the right knee and the brand was Kenalog. Treatment details were not given.   This case was linked to MOD-2022-462888, MOD-2022-462970 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: ringing in both of the ears; a little soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in both of the ears) and PAIN IN EXTREMITY (a little soreness in arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013FUA) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Acid reflux (esophageal). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in both of the ears) and PAIN IN EXTREMITY (a little soreness in arm). At the time of the report, TINNITUS (ringing in both of the ears) and PAIN IN EXTREMITY (a little soreness in arm) outcome was unknown.            Caller stated that she went to doctor and they checked her ears and it did not show any wax in ears.  Caller has taken ear drops for the ringing but it did not do anything.  Caller is currently taking medication for high blood pressure and acid reflux.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Follow-up contains non-significant information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chest pain, dyspnea (some trouble breathing) and vaccination site pain (left injection site arm hurts) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included COVID-19 in November 2021. On Jan 26, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Jan 26, 2022, patient experienced vaccination site pain (left injection site arm hurts). On Jan 27, 2022, patient experienced chest pain and dyspnea (some trouble breathing). At the time of the report, chest pain, dyspnea (some trouble breathing) and vaccination site pain (left injection site arm hurts): not resolved. Diagnostic results: November 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The patient received the vaccine in left arm shoulder deltoid muscle. It was reported as no cause determined. The patient has not received any treatment. The patient has not had any lab work or tests performed. Before receiving the Moderna COVID-19 vaccine, patient didn't experience any symptoms like this. The patient not hospitalized for COVID-19, and didn't receive treatment. Patient didn't have a history of myocarditis/pericarditis. Concomitant medications and treatment information not provided by reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose received on day 21 after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 21 after the first dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A and 028K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 21 after the first dose). On 27-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 21 after the first dose) had resolved.        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: 60.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Feeling cold, Mobility decreased, Pain
Clinical narrative: Had razor sharp freezing pain throughout my body the entire day and night. Put gloves on flannel pjs, heated blanket could not stop the pain or get warm the entire day and night.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 008B21-2A and 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients). On 25-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 2 of the patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. HCP, a local health nurse, called in and reported that an incident happened in their facility last 25Jan2022. Another nurse who was covering a shift, administered an expired vaccine last 25Jan2022 to 2 of their patients. The said vaccine was moved from the freezer to the refrigerator last 21Dec2021. Based on their knowledge, vials may be stored refrigerated between 2° to 8°C(36° to 46°F) for up to 30 days prior to first use. The vial that was moved from the freezer to the refrigerator was already expired last 20Jan2022 but they were still able to give it to 2 of their patients. Batch number: 067H21A. This case was linked to MOD-2022-463078 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Myalgia, Pain, Somnolence
Clinical narrative: Left armpit was completely swollen for 4 days. I have been extremely dehydrated since the booster shot. I've had body aches and muscle aches, also very tired and have not wanted to do anything but sleep.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Left armpit was completely swollen for 4 days. I have been extremely dehydrated since the booster shot. I've had body aches and muscle aches, also very tired and have not wanted to do anything but sleep.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever after 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PYREXIA (High fever after 2nd dose). At the time of the report, PYREXIA (High fever after 2nd dose) outcome was unknown.            Concomitant medication included blood pressure medication,diabetes medication and high cholesterol medication were reported. No treatment details were reported.   This case was linked to MOD-2022-462968 (Patient Link).