chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Felt a little achy; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) and FATIGUE (Extremely tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for Prophylaxis.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (Felt a little achy) and FATIGUE (Extremely tired). On 16-Mar-2021, PAIN (Felt a little achy) and FATIGUE (Extremely tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-390023 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (MULTIPLE VITAMIN), TOCOPHEROL (VITAMIN E [TOCOPHEROL]) and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.    On 18-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 (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) 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.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-390052 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal
Clinical narrative: COVID-19; foggy and tired in the head; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and FEELING ABNORMAL (foggy and tired in the head) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COVID-19 (COVID-19) and FEELING ABNORMAL (foggy and tired in the head). At the time of the report, COVID-19 (COVID-19) and FEELING ABNORMAL (foggy and tired in the head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.            No treatment information was provided.; Sender's Comments: This case concerns a 69-year-old, female patient, with no known medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  approximately 2 months after an unspecified dose of mRNA 1273 vaccine. The patient had Covid-19 and felt foggy and tired in the head, outcome of events are unknown. The rechallenge is not applicable as there is no information regarding the dose number.The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin test
Clinical narrative: Rash on face, leg, back, spread throughout their body/Rash arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on face, leg, back, spread throughout their body/Rash arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Allergic to formaldehyde). Concomitant products included VITAMINS NOS, VITAMIN E NOS and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash on face, leg, back, spread throughout their body/Rash arm). The patient was treated with PREDNISONE (oral) for Rash, at a dose of twice steroid pills. At the time of the report, RASH (Rash on face, leg, back, spread throughout their body/Rash arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test: positive (Positive) Positive- allergic to formaldehyde.      After the second dose of the Moderna COVID-19 vaccine the broke out with a rash that has spreaded from their face to their leg, arm, and back. Patient has been following up with the Dermatologist. Dermatologist had prescribed 3 different steroid ointment and twice steroid pills called Prednisone. The Prednisone had help calm down the rash. Couple months ago, the rash on the face had cleared up but the rash on the hand, leg, and arm has progressed. Dermatologist also suggested to stop taking concomitant medicine to see if the rash goes away. Patient stated that even stopping their concomitant medicine did not help.   This case was linked to MOD-2021-390034 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Got the second dose of the Moderna Covid-19 vaccine and was 16 years old; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got the second dose of the Moderna Covid-19 vaccine and was 16 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 058A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got the second dose of the Moderna Covid-19 vaccine and was 16 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got the second dose of the Moderna Covid-19 vaccine and was 16 years old) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-390030 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Vaccination site pain
Clinical narrative: would not want no one to touch her after second dose; sore arm after every shot; body hurting after second dose/very achy after second dose; light chills after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (would not want no one to touch her after second dose), VACCINATION SITE PAIN (sore arm after every shot), MYALGIA (body hurting after second dose/very achy after second dose) and CHILLS (light chills after second dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ESCITALOPRAM OXALATE (LEXAPRO), IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] 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 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (would not want no one to touch her after second dose), VACCINATION SITE PAIN (sore arm after every shot), MYALGIA (body hurting after second dose/very achy after second dose) and CHILLS (light chills after second dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of UNK UNK, qd. At the time of the report, PAIN (would not want no one to touch her after second dose), VACCINATION SITE PAIN (sore arm after every shot), MYALGIA (body hurting after second dose/very achy after second dose) and CHILLS (light chills after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Tylenol reported as both concomitant and treatment medication.   This case was linked to MOD-2021-390091, MOD-2021-390060 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Muscle pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle pain) had not resolved.            Patient used heat packs to treat muscle pain. Concomitant medications were not provided. Patient has been experiencing ongoing muscle pain for about 3 weeks Tylenol and heat packs on his arm for treatment which has not helped to improve the symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Low-grade fever (around 99° F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low-grade fever (around 99° F)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Low-grade fever (around 99° F)). On 03-Apr-2021, PYREXIA (Low-grade fever (around 99° F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 99 (Low) low-grade fever (around 99° F).         No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-390249 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain in extremity, Paraesthesia oral
Clinical narrative: Couldn't sleep; Arm hurt/very sore/pain was pretty intense; Tired; Lip was tingling; Tongue was tingling a few hours; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue was tingling a few hours), PARAESTHESIA ORAL (Lip was tingling), INSOMNIA (Couldn't sleep), PAIN IN EXTREMITY (Arm hurt/very sore/pain was pretty intense) and FATIGUE (Tired) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 026A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PARAESTHESIA ORAL (Tongue was tingling a few hours). On 06-Apr-2021, the patient experienced PARAESTHESIA ORAL (Lip was tingling). On an unknown date, the patient experienced INSOMNIA (Couldn't sleep), PAIN IN EXTREMITY (Arm hurt/very sore/pain was pretty intense) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Tongue was tingling a few hours), PARAESTHESIA ORAL (Lip was tingling), INSOMNIA (Couldn't sleep), PAIN IN EXTREMITY (Arm hurt/very sore/pain was pretty intense) and FATIGUE (Tired) outcome was unknown.            This case was linked to MOD-2021-390119 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) 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. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired). In October 2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on  09-Oct-2021. Vaccine was administered from 11-Oct-2021 to 26-Oct-2021. No concomitant or treatment medications of any patient reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Feeling hot, Pyrexia
Clinical narrative: felt kind of weird; warm; temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt kind of weird), FEELING HOT (warm) and PYREXIA (temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 028A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced FEELING ABNORMAL (felt kind of weird) and PYREXIA (temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either). 09-Nov-2021, the patient experienced FEELING HOT (warm). At the time of the report, FEELING ABNORMAL (felt kind of weird) and FEELING HOT (warm) outcome was unknown and PYREXIA (temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: 100.1 (High) 100.1 degree F.         Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-390214 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;) in a 55-year-old male patient who received Moderna COVID-19 Vaccine (batch nos. 037C21A, 024C21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety since 11-Jan-2018, GERD since 10-Nov-2017, Hypertension since 10-Nov-2017, Hyperlipidemia since 10-Nov-2017 and Myocardial infarction (myocardial infarction/CABGx2) since 11-Aug-2018. Concomitant products included ATORVASTATIN and FENOFIBRATE for Cholesterol, LOSARTAN and METOPROLOL SUCCINATE for Hypertension, ACETYLSALICYLIC ACID (ASPIRIN 81) for Myocardial infarction.   On 01-Apr-2021, the patient received first dose of Moderna COVID-19 Vaccine (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of Moderna COVID-19 Vaccine (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021 at 12:30 PM, received third dose of Moderna COVID-19 Vaccine (unknown route) dosage was changed to .25 milliliter. On 15-Nov-2021,  after starting Moderna COVID-19 Vaccine, the patient experienced PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;). On 15-Nov-2021, PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial/the booster dose was the 22nd punctured dose from the Moderna vial;) had resolved. Not Provided      For Moderna COVID-19 Vaccine (Intramuscular), the reporter did not provide any causality assessments.   COVID-19 vaccine - body site- Deltoid  No treatment medications were provided.  The booster dose vial should be used beyond 02-Dec-2022. The vial was stored in the refrigerator between two to eight degree Celsius. The patient reported no symptoms following the booster dose.   This case was linked to MOD-2021-387978 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mouth swelling, Oral discomfort, Swollen tongue, Tongue discomfort
Clinical narrative: Mouth swelling; Burning mouth; Lip swelling; Burning lips; Swelling of toungue; Burning tongue; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Mouth swelling), ORAL DISCOMFORT (Burning mouth), LIP SWELLING (Lip swelling), ORAL DISCOMFORT (Burning lips) and SWOLLEN TONGUE (Swelling of toungue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 MOUTH SWELLING (Mouth swelling), ORAL DISCOMFORT (Burning mouth), LIP SWELLING (Lip swelling), ORAL DISCOMFORT (Burning lips), SWOLLEN TONGUE (Swelling of toungue) and TONGUE DISCOMFORT (Burning tongue). At the time of the report, MOUTH SWELLING (Mouth swelling), ORAL DISCOMFORT (Burning mouth), LIP SWELLING (Lip swelling), ORAL DISCOMFORT (Burning lips), SWOLLEN TONGUE (Swelling of toungue) and TONGUE DISCOMFORT (Burning tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00721A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.). On 17-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.) had resolved.      No relevant concomitant medications was reported. Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 5 patients received a Moderna booster shot of 0.5ml (not 0.25ml); This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)). At the time of the report, ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. This is a spontaneous case concerning a 40-year-old, female patient with no relevant medical history, who experienced the non serious event of accidental overdose. The event accidental overdose occurred right after the booster dose of mRNA-1273 vaccine administration. The patient received the full dose of 0.5 mL of mRNA-1273 vaccine instead of the recommended 0.25 mL of booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 40-year-old, female patient with no relevant medical history, who experienced the non serious event of accidental overdose. The event accidental overdose occurred right after the booster dose of mRNA-1273 vaccine administration. The patient received the full dose of 0.5 mL of mRNA-1273 vaccine instead of the recommended 0.25 mL of booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Confusional state, Hypertension, Hypotension, Lethargy
Clinical narrative: Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities; Hypertension of 158/108; Hypotension of 95.5F; Moderate agitation; Lethargy; Moderate to severe confusion.  Patient thought she was at the bank; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities) (seriousness criterion medically significant), HYPERTENSION (Hypertension of 158/108), HYPOTENSION (Hypotension of 95.5F), AGITATION (Moderate agitation), LETHARGY (Lethargy) and CONFUSIONAL STATE (Moderate to severe confusion.  Patient thought she was at the bank). At the time of the report, SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities), HYPERTENSION (Hypertension of 158/108), HYPOTENSION (Hypotension of 95.5F), AGITATION (Moderate agitation), LETHARGY (Lethargy) and CONFUSIONAL STATE (Moderate to severe confusion.  Patient thought she was at the bank) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were reported. No concomitant drugs reported.  Company comment: This case concerns a 64-year-old, female patient with no medical history reported, who experienced the unexpected event of seizure. The event occurred 1-2 minutes after receiving third dose of mRNA-1273. The patient experienced seizure activities. She experienced hypertension of 158/108, moderate agitation, lethargy and moderate to severe confusion. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no medical history reported, who experienced the unexpected event of seizure. The event occurred 1-2 minutes after receiving third dose of mRNA-1273. The patient experienced seizure activities. She experienced hypertension of 158/108, moderate agitation, lethargy and moderate to severe confusion. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities; Hypertension of 158/108; Hypotension of 95.5F; Moderate agitation; Lethargy; Moderate to severe confusion.  Patient thought she was at the bank; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities) (seriousness criterion medically significant), HYPERTENSION (Hypertension of 158/108), HYPOTENSION (Hypotension of 95.5F), AGITATION (Moderate agitation), LETHARGY (Lethargy) and CONFUSIONAL STATE (Moderate to severe confusion.  Patient thought she was at the bank). At the time of the report, SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities), HYPERTENSION (Hypertension of 158/108), HYPOTENSION (Hypotension of 95.5F), AGITATION (Moderate agitation), LETHARGY (Lethargy) and CONFUSIONAL STATE (Moderate to severe confusion.  Patient thought she was at the bank) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were reported. No concomitant drugs reported.  Company comment: This case concerns a 64-year-old, female patient with no medical history reported, who experienced the unexpected event of seizure. The event occurred 1-2 minutes after receiving third dose of mRNA-1273. The patient experienced seizure activities. She experienced hypertension of 158/108, moderate agitation, lethargy and moderate to severe confusion. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no medical history reported, who experienced the unexpected event of seizure. The event occurred 1-2 minutes after receiving third dose of mRNA-1273. The patient experienced seizure activities. She experienced hypertension of 158/108, moderate agitation, lethargy and moderate to severe confusion. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Axillary pain, Chills
Clinical narrative: Her right knee hurt as much as her left knee did; sick to her stomach; Has had stabbing pain in her legs/painful; weak; A goose egg at the injection site; verbally whelped due to the needle that has the cover; it's bright red; under her left armpit hurts; very tired; Body aches/left arm soreness; cold chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Has had stabbing pain in her legs/painful), ASTHENIA (weak), VACCINATION SITE MASS (A goose egg at the injection site) and VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 030A21A and 09K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (replaced 8 weeks ago) and Lymph node excision (removed in the past). Previously administered products included for Product used for unknown indication: flu vaccine (from a flu shot 10 years ago). Past adverse reactions to the above products included Guillain-Barre syndrome with flu vaccine.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (weak), VACCINATION SITE MASS (A goose egg at the injection site), VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover), VACCINATION SITE ERYTHEMA (it's bright red), AXILLARY PAIN (under her left armpit hurts), FATIGUE (very tired), MYALGIA (Body aches/left arm soreness) and CHILLS (cold chills). November 2021, the patient experienced PAIN (Has had stabbing pain in her legs/painful). On 16-Nov-2021, the patient experienced ARTHRALGIA (Her right knee hurt as much as her left knee did). At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Has had stabbing pain in her legs/painful), ASTHENIA (weak), VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover), VACCINATION SITE ERYTHEMA (it's bright red), AXILLARY PAIN (under her left armpit hurts), FATIGUE (very tired), MYALGIA (Body aches/left arm soreness), CHILLS (cold chills) and ARTHRALGIA (Her right knee hurt as much as her left knee did) outcome was unknown and VACCINATION SITE MASS (A goose egg at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided.   This case was linked to MOD-2021-390449, MOD-2021-390455 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Vaccination site erythema, Vaccination site mass
Clinical narrative: Her right knee hurt as much as her left knee did; sick to her stomach; Has had stabbing pain in her legs/painful; weak; A goose egg at the injection site; verbally whelped due to the needle that has the cover; it's bright red; under her left armpit hurts; very tired; Body aches/left arm soreness; cold chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Has had stabbing pain in her legs/painful), ASTHENIA (weak), VACCINATION SITE MASS (A goose egg at the injection site) and VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 030A21A and 09K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (replaced 8 weeks ago) and Lymph node excision (removed in the past). Previously administered products included for Product used for unknown indication: flu vaccine (from a flu shot 10 years ago). Past adverse reactions to the above products included Guillain-Barre syndrome with flu vaccine.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (weak), VACCINATION SITE MASS (A goose egg at the injection site), VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover), VACCINATION SITE ERYTHEMA (it's bright red), AXILLARY PAIN (under her left armpit hurts), FATIGUE (very tired), MYALGIA (Body aches/left arm soreness) and CHILLS (cold chills). November 2021, the patient experienced PAIN (Has had stabbing pain in her legs/painful). On 16-Nov-2021, the patient experienced ARTHRALGIA (Her right knee hurt as much as her left knee did). At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Has had stabbing pain in her legs/painful), ASTHENIA (weak), VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover), VACCINATION SITE ERYTHEMA (it's bright red), AXILLARY PAIN (under her left armpit hurts), FATIGUE (very tired), MYALGIA (Body aches/left arm soreness), CHILLS (cold chills) and ARTHRALGIA (Her right knee hurt as much as her left knee did) outcome was unknown and VACCINATION SITE MASS (A goose egg at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided.   This case was linked to MOD-2021-390449, MOD-2021-390455 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her right knee hurt as much as her left knee did; sick to her stomach; Has had stabbing pain in her legs/painful; weak; A goose egg at the injection site; verbally whelped due to the needle that has the cover; it's bright red; under her left armpit hurts; very tired; Body aches/left arm soreness; cold chills; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Has had stabbing pain in her legs/painful), ASTHENIA (weak), VACCINATION SITE MASS (A goose egg at the injection site) and VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 030A21A and 09K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (replaced 8 weeks ago) and Lymph node excision (removed in the past). Previously administered products included for Product used for unknown indication: flu vaccine (from a flu shot 10 years ago). Past adverse reactions to the above products included Guillain-Barre syndrome with flu vaccine.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), ASTHENIA (weak), VACCINATION SITE MASS (A goose egg at the injection site), VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover), VACCINATION SITE ERYTHEMA (it's bright red), AXILLARY PAIN (under her left armpit hurts), FATIGUE (very tired), MYALGIA (Body aches/left arm soreness) and CHILLS (cold chills). November 2021, the patient experienced PAIN (Has had stabbing pain in her legs/painful). On 16-Nov-2021, the patient experienced ARTHRALGIA (Her right knee hurt as much as her left knee did). At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Has had stabbing pain in her legs/painful), ASTHENIA (weak), VACCINATION SITE PAIN (verbally whelped due to the needle that has the cover), VACCINATION SITE ERYTHEMA (it's bright red), AXILLARY PAIN (under her left armpit hurts), FATIGUE (very tired), MYALGIA (Body aches/left arm soreness), CHILLS (cold chills) and ARTHRALGIA (Her right knee hurt as much as her left knee did) outcome was unknown and VACCINATION SITE MASS (A goose egg at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not provided.   This case was linked to MOD-2021-390449, MOD-2021-390455 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 5 patients received a Moderna booster shot of 0.5ml (not 0.25ml); This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)). On 29-Oct-2021, ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Incorrect dose administered
Clinical narrative: patient received a Moderna booster shot of 0.5ml (not 0.25ml); received a Moderna booster shot of 0.5ml; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received a Moderna booster shot of 0.5ml (not 0.25ml)) and ACCIDENTAL OVERDOSE (received a Moderna booster shot of 0.5ml) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received a Moderna booster shot of 0.5ml (not 0.25ml)) and ACCIDENTAL OVERDOSE (received a Moderna booster shot of 0.5ml). On 29-Oct-2021, INCORRECT DOSE ADMINISTERED (patient received a Moderna booster shot of 0.5ml (not 0.25ml)) and ACCIDENTAL OVERDOSE (received a Moderna booster shot of 0.5ml) 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.   This case concerns a 50-year-old, female patient, with no known medical history, who experienced the non-serious events of incorrect dose administered and accidental overdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was given 0.5ml of Moderna vaccine instead of 0.25ml for booster dose. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 50-year-old, female patient, with no known medical history, who experienced the non-serious events of incorrect dose administered and accidental overdose. The events occurred  on the same day after booster dose of mRNA 1273 vaccine. The patient was given 0.5ml of Moderna vaccine instead of 0.25ml for booster dose. The rechallenge is not applicable due to the nature of the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 5 patients received a Moderna booster shot of 0.5ml (not 0.25ml); This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)). On 29-Oct-2021, ACCIDENTAL OVERDOSE (5 patients received a Moderna booster shot of 0.5ml (not 0.25ml)) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Caller would like to report post vaccination adverse events; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Caller would like to report post vaccination adverse events) 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 VACCINATION COMPLICATION (Caller would like to report post vaccination adverse events). At the time of the report, VACCINATION COMPLICATION (Caller would like to report post vaccination adverse events) 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 was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired lot numbers administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired lot numbers administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 EXPIRED PRODUCT ADMINISTERED (expired lot numbers administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired lot numbers administered to patients) 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Taste disorder
Clinical narrative: Since she got her 2nd dose she has had her taste buds changing; got a stomach virus after her 1st dose & that's why she put the 2nd dose off by a couple of weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of TASTE DISORDER (Since she got her 2nd dose she has had her taste buds changing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a stomach virus after her 1st dose & that's why she put the 2nd dose off by a couple of weeks) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 09K20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (left knee problem) and Lymph node excision (lymph nodes removed in right arm). Previously administered products included for Product used for unknown indication: flu vaccine (10 years ago) in 2012. Past adverse reactions to the above products included Guillain-Barre syndrome with flu vaccine.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (Since she got her 2nd dose she has had her taste buds changing) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a stomach virus after her 1st dose & that's why she put the 2nd dose off by a couple of weeks). At the time of the report, TASTE DISORDER (Since she got her 2nd dose she has had her taste buds changing) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got a stomach virus after her 1st dose & that's why she put the 2nd dose off by a couple of weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.   This case was linked to MOD-2021-390449 (Patient Link).