chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia oral, Vaccination site pain
Clinical narrative: tip of her tongue numb; elevate heart rate; her left arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tip of her tongue numb), HEART RATE INCREASED (elevate heart rate) and VACCINATION SITE PAIN (her left arm is sore) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced HYPOAESTHESIA ORAL (tip of her tongue numb), HEART RATE INCREASED (elevate heart rate) and VACCINATION SITE PAIN (her left arm is sore). At the time of the report, HYPOAESTHESIA ORAL (tip of her tongue numb), HEART RATE INCREASED (elevate heart rate) and VACCINATION SITE PAIN (her left arm is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.  Patient reported that the paramedic had to come and medicate her,after these she felt sleep for a bit.   This case was linked to MOD-2021-069952 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness, Impaired work ability, Influenza like illness
Clinical narrative: friends got sick,  after second dose; flu like symptoms; some couldn't go to work for a few days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (friends got sick,  after second dose), INFLUENZA LIKE ILLNESS (flu like symptoms) and IMPAIRED WORK ABILITY (some couldn't go to work for a few days.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (friends got sick,  after second dose), INFLUENZA LIKE ILLNESS (flu like symptoms) and IMPAIRED WORK ABILITY (some couldn't go to work for a few days.). At the time of the report, ILLNESS (friends got sick,  after second dose) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown and IMPAIRED WORK ABILITY (some couldn't go to work for a few days.) had resolved.            No concomitant medication were given.  No treatment information were given.  Caller mention that their friends got sick, after second dose, like flu like symptoms ,and some couldn't go to work for a few days.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06SF21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2021, Body temperature: 102.2 (High) 102.2 fever.         Patient takes a lot of different concomitant medications (Not specified)
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: got the first dose lower that the deltoid muscle,; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the first dose lower that the deltoid muscle,) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the first dose lower that the deltoid muscle,). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (got the first dose lower that the deltoid muscle,) had resolved.            Concomitant and treatment medication was not provided. Patient had no adverse events.   Reporter did not allow further contact
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Swollen tongue
Clinical narrative: swelling of the tongue; sensitivity of the tongue is like you don't get your tastes buds properly; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (swelling of the tongue) and GLOSSODYNIA (sensitivity of the tongue is like you don't get your tastes buds properly) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031b21a and 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (pressure pill), Blood cholesterol abnormal (cholesterol pill), Acid reflux (oesophageal) (Acid reflux pill) and Denture wearer. Concomitant products included VITAMIN D [VITAMIN D NOS] and TOCOPHERYL ACETATE, UBIDECARENONE (COENZYME Q10 [TOCOPHERYL ACETATE;UBIDECARENONE]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced SWOLLEN TONGUE (swelling of the tongue) and GLOSSODYNIA (sensitivity of the tongue is like you don't get your tastes buds properly). At the time of the report, SWOLLEN TONGUE (swelling of the tongue) and GLOSSODYNIA (sensitivity of the tongue is like you don't get your tastes buds properly) had not resolved.            The patient stated that since 07-Oct-2021, she had swelling of the tongue and sensitivity of the tongue, was like you don't get your tastes buds properly. She was treating it by rinsing her mouth. She got vaccine on her left non dominant arm. The patient was worried because she didn't get any side effect until October. She was taking concomitant medications as vitamin D, Coenzyme Q10, pressure pill, cholesterol pill and acid reflux pill. She also mentioned that she wears dentures.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain
Clinical narrative: she has a red rush; a little sore on the injection site of her left non dominant arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (she has a red rush) and VACCINATION SITE PAIN (a little sore on the injection site of her left non dominant arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b21a and 025a21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced RASH ERYTHEMATOUS (she has a red rush) and VACCINATION SITE PAIN (a little sore on the injection site of her left non dominant arm). At the time of the report, RASH ERYTHEMATOUS (she has a red rush) and VACCINATION SITE PAIN (a little sore on the injection site of her left non dominant arm) outcome was unknown.            No  treatment medications were reported. Concomitant medication takes high blood pressure (unspecified). The patient had a red rush, and a little sore on the injection site of her left.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Myalgia, Pruritus, Pyrexia
Clinical narrative: patient's spleen enlarged 6 times the normal size; has had itching from head to toe; left arm pit is also swollen.; had fever,; arm of the injection has been red from her shoulder to her elbow; arm of the injection has been swollen from her shoulder to her elbow.; aches; joint pain; This spontaneous case was reported by a pharmacist and describes the occurrence of SPLENOMEGALY (patient's spleen enlarged 6 times the normal size), PRURITUS (has had itching from head to toe), LYMPHADENOPATHY (left arm pit is also swollen.), PYREXIA (had fever,) and VACCINATION SITE ERYTHEMA (arm of the injection has been red from her shoulder to her elbow) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced SPLENOMEGALY (patient's spleen enlarged 6 times the normal size), PRURITUS (has had itching from head to toe), LYMPHADENOPATHY (left arm pit is also swollen.), PYREXIA (had fever,), VACCINATION SITE ERYTHEMA (arm of the injection has been red from her shoulder to her elbow), VACCINATION SITE SWELLING (arm of the injection has been swollen from her shoulder to her elbow.), MYALGIA (aches) and ARTHRALGIA (joint pain). At the time of the report, SPLENOMEGALY (patient's spleen enlarged 6 times the normal size), LYMPHADENOPATHY (left arm pit is also swollen.), PYREXIA (had fever,), VACCINATION SITE ERYTHEMA (arm of the injection has been red from her shoulder to her elbow), VACCINATION SITE SWELLING (arm of the injection has been swollen from her shoulder to her elbow.), MYALGIA (aches) and ARTHRALGIA (joint pain) outcome was unknown and PRURITUS (has had itching from head to toe) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Splenomegaly, Vaccination site erythema, Vaccination site swelling
Clinical narrative: patient's spleen enlarged 6 times the normal size; has had itching from head to toe; left arm pit is also swollen.; had fever,; arm of the injection has been red from her shoulder to her elbow; arm of the injection has been swollen from her shoulder to her elbow.; aches; joint pain; This spontaneous case was reported by a pharmacist and describes the occurrence of SPLENOMEGALY (patient's spleen enlarged 6 times the normal size), PRURITUS (has had itching from head to toe), LYMPHADENOPATHY (left arm pit is also swollen.), PYREXIA (had fever,) and VACCINATION SITE ERYTHEMA (arm of the injection has been red from her shoulder to her elbow) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced SPLENOMEGALY (patient's spleen enlarged 6 times the normal size), PRURITUS (has had itching from head to toe), LYMPHADENOPATHY (left arm pit is also swollen.), PYREXIA (had fever,), VACCINATION SITE ERYTHEMA (arm of the injection has been red from her shoulder to her elbow), VACCINATION SITE SWELLING (arm of the injection has been swollen from her shoulder to her elbow.), MYALGIA (aches) and ARTHRALGIA (joint pain). At the time of the report, SPLENOMEGALY (patient's spleen enlarged 6 times the normal size), LYMPHADENOPATHY (left arm pit is also swollen.), PYREXIA (had fever,), VACCINATION SITE ERYTHEMA (arm of the injection has been red from her shoulder to her elbow), VACCINATION SITE SWELLING (arm of the injection has been swollen from her shoulder to her elbow.), MYALGIA (aches) and ARTHRALGIA (joint pain) outcome was unknown and PRURITUS (has had itching from head to toe) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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: little bit of reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (little bit of reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (little bit of reaction). At the time of the report, VACCINATION COMPLICATION (little bit of reaction) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-377770 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: got the booster the side effects were really bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got the booster the side effects were really bad) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (got the booster the side effects were really bad). At the time of the report, VACCINATION COMPLICATION (got the booster the side effects were really bad) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-377738 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter. This case concerns a 71-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 71-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: head to toe itching; visible rash in some places; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (head to toe itching) and RASH (visible rash in some places) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 026A21A and 030A20A) for COVID-19 vaccination.     The patient's past medical history included Eczema, Breast cancer and Parotid tumor. Concurrent medical conditions included Depression, Hives, Allergy to plants (allergic to leaf in falls), Allergy to chemicals (Allergy to sulpha) and Allergy to animals (allergic to horse and some dogs). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), CLONAZEPAM (KLONOPIN), COLECALCIFEROL (VITAMIN D3) and FISH OIL, TOCOPHERYL ACETATE (FISH OIL [FISH OIL;TOCOPHERYL ACETATE]) for an unknown indication, FEXOFENADINE HYDROCHLORIDE (ALLEGRATAB).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PRURITUS (head to toe itching) and RASH (visible rash in some places). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (head to toe itching) and RASH (visible rash in some places) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient reported of having Antihistamine from her doctor , but of no use.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: significant follow up appended Patient medical history ,allergic conditions, and dose details updated. On 10-Nov-2021: follow up received on 10-nov-2021, event outcome updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Head discomfort, Headache
Clinical narrative: Flu like symptoms; I have dizzy spells; Runny nose; Coughing; In my head, top of the skull I feel a pressure and its moving around; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing) and HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 085F21A, 030A21A and 213MC0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing), HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing), HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Rhinorrhoea
Clinical narrative: Flu like symptoms; I have dizzy spells; Runny nose; Coughing; In my head, top of the skull I feel a pressure and its moving around; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing) and HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 085F21A, 030A21A and 213MC0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing), HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (I have dizzy spells), RHINORRHOEA (Runny nose), COUGH (Coughing), HEAD DISCOMFORT (In my head, top of the skull I feel a pressure and its moving around), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Oropharyngeal pain, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: sore throats; Patient stated that he had the flu symptoms; Patient missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throats), INFLUENZA (Patient stated that he had the flu symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-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 OROPHARYNGEAL PAIN (sore throats), INFLUENZA (Patient stated that he had the flu symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (XL 3) for Flu symptoms, at an unspecified dose and frequency and NAPROXEN SODIUM, PARACETAMOL (FEBRAX) for Flu symptoms, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throats) had not resolved and INFLUENZA (Patient stated that he had the flu symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Nipple pain
Clinical narrative: Patient experienced pain underneath his nipples below the areola; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (Patient experienced pain underneath his nipples below the areola) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LOVASTATIN, FAMOTIDINE, SOTALOL, OXYBUTYNIN, PREDNISOLONE ACETATE and TIMOLOL MALEATE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NIPPLE PAIN (Patient experienced pain underneath his nipples below the areola). At the time of the report, NIPPLE PAIN (Patient experienced pain underneath his nipples below the areola) had not resolved.            No Treatment information was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Illness, Inappropriate schedule of product administration
Clinical narrative: felt pretty sick; pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg); Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (felt pretty sick), ACCIDENTAL OVERDOSE (pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F214) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (first dose) on 30-Dec-2020 and Pfizer (second dose) on 20-Jan-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer and Pfizer.    On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-Nov-2021, the patient experienced ILLNESS (felt pretty sick). On 07-Nov-2021, ACCIDENTAL OVERDOSE (pharmacist made a med error and give me a double dose/full dose of Moderna (100 mcg)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ILLNESS (felt pretty sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up - event added, patient demographics added, reporter detail updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling, Dehydration, Headache, Myalgia, Vaccination site pain
Clinical narrative: dehydration; swelling around her mouth.; Injection site sore; severe headache; Injection site swelling; muscle aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydration), CIRCUMORAL SWELLING (swelling around her mouth.), VACCINATION SITE PAIN (Injection site sore), HEADACHE (severe headache) and VACCINATION SITE SWELLING (Injection site swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 041L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ROSUVASTATIN and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (dehydration), CIRCUMORAL SWELLING (swelling around her mouth.), VACCINATION SITE PAIN (Injection site sore), HEADACHE (severe headache), VACCINATION SITE SWELLING (Injection site swelling) and MYALGIA (muscle aches and pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DEHYDRATION (dehydration), CIRCUMORAL SWELLING (swelling around her mouth.), VACCINATION SITE PAIN (Injection site sore), HEADACHE (severe headache), VACCINATION SITE SWELLING (Injection site swelling) and MYALGIA (muscle aches and pain) outcome was unknown.            This case was linked to MOD-2021-378320 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: dehydration; swelling around her mouth.; Injection site sore; severe headache; Injection site swelling; muscle aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydration), CIRCUMORAL SWELLING (swelling around her mouth.), VACCINATION SITE PAIN (Injection site sore), HEADACHE (severe headache) and VACCINATION SITE SWELLING (Injection site swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 041L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ROSUVASTATIN and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (dehydration), CIRCUMORAL SWELLING (swelling around her mouth.), VACCINATION SITE PAIN (Injection site sore), HEADACHE (severe headache), VACCINATION SITE SWELLING (Injection site swelling) and MYALGIA (muscle aches and pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DEHYDRATION (dehydration), CIRCUMORAL SWELLING (swelling around her mouth.), VACCINATION SITE PAIN (Injection site sore), HEADACHE (severe headache), VACCINATION SITE SWELLING (Injection site swelling) and MYALGIA (muscle aches and pain) outcome was unknown.            This case was linked to MOD-2021-378320 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: No appetite; Tired; Bad headache; High fever (102.8); Couldn't open eyes yesterday; Body doesn't like it very much; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Couldn't open eyes yesterday), FEELING ABNORMAL (Body doesn't like it very much), DECREASED APPETITE (No appetite), FATIGUE (Tired) and HEADACHE (Bad headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced FEELING ABNORMAL (Body doesn't like it very much). On 06-Nov-2021, the patient experienced SOMNOLENCE (Couldn't open eyes yesterday) and PYREXIA (High fever (102.8)). 06-Nov-2021, the patient experienced HEADACHE (Bad headache). On an unknown date, the patient experienced DECREASED APPETITE (No appetite) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Couldn't open eyes yesterday), FEELING ABNORMAL (Body doesn't like it very much), DECREASED APPETITE (No appetite) and HEADACHE (Bad headache) outcome was unknown, FATIGUE (Tired) had not resolved and PYREXIA (High fever (102.8)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 102.8 (High) High fever (102.8). On 07-Nov-2021, Body temperature: 102.0 (High) 102.0 when I woke up and 100.1 (High) Now it was 100.1.         It was reported that the patient was doing somewhat better after the booster dose comparing to the second dose  Also stated that the patient was still tired, but was able to function after Tylenol medication  Concomitant medication information was not reported   This case was linked to MOD-2021-378677 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: No appetite; Tired; Bad headache; High fever (102.8); Couldn't open eyes yesterday; Body doesn't like it very much; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Couldn't open eyes yesterday), FEELING ABNORMAL (Body doesn't like it very much), DECREASED APPETITE (No appetite), FATIGUE (Tired) and HEADACHE (Bad headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced FEELING ABNORMAL (Body doesn't like it very much). On 06-Nov-2021, the patient experienced SOMNOLENCE (Couldn't open eyes yesterday) and PYREXIA (High fever (102.8)). 06-Nov-2021, the patient experienced HEADACHE (Bad headache). On an unknown date, the patient experienced DECREASED APPETITE (No appetite) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Couldn't open eyes yesterday), FEELING ABNORMAL (Body doesn't like it very much), DECREASED APPETITE (No appetite) and HEADACHE (Bad headache) outcome was unknown, FATIGUE (Tired) had not resolved and PYREXIA (High fever (102.8)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 102.8 (High) High fever (102.8). On 07-Nov-2021, Body temperature: 102.0 (High) 102.0 when I woke up and 100.1 (High) Now it was 100.1.         It was reported that the patient was doing somewhat better after the booster dose comparing to the second dose  Also stated that the patient was still tired, but was able to function after Tylenol medication  Concomitant medication information was not reported   This case was linked to MOD-2021-378677 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: No appetite; couldn't open my eyes; high fever (102.8); Bad headache; tired; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), SOMNOLENCE (couldn't open my eyes), PYREXIA (high fever (102.8)), HEADACHE (Bad headache) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (No appetite), SOMNOLENCE (couldn't open my eyes), PYREXIA (high fever (102.8)), HEADACHE (Bad headache), FATIGUE (tired), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at a dose of 1 dosage form. At the time of the report, DECREASED APPETITE (No appetite), SOMNOLENCE (couldn't open my eyes), HEADACHE (Bad headache), FATIGUE (tired), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown and PYREXIA (high fever (102.8)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.8 (High) High, 102 (High) High and 100.1 (High) High.         No concomitant medications were given by the reporter.   This case was linked to MOD-2021-378646 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vomiting
Clinical narrative: No appetite; couldn't open my eyes; high fever (102.8); Bad headache; tired; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), SOMNOLENCE (couldn't open my eyes), PYREXIA (high fever (102.8)), HEADACHE (Bad headache) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (No appetite), SOMNOLENCE (couldn't open my eyes), PYREXIA (high fever (102.8)), HEADACHE (Bad headache), FATIGUE (tired), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at a dose of 1 dosage form. At the time of the report, DECREASED APPETITE (No appetite), SOMNOLENCE (couldn't open my eyes), HEADACHE (Bad headache), FATIGUE (tired), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown and PYREXIA (high fever (102.8)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.8 (High) High, 102 (High) High and 100.1 (High) High.         No concomitant medications were given by the reporter.   This case was linked to MOD-2021-378646 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling abnormal, Feeling cold, Hyperhidrosis
Clinical narrative: I felt like I was hit by a bus /Her whole body was in shock; was cold; My body was in shock and had loss of appetite; sweating; unable to sleep; throwing up; chills; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating) and INSOMNIA (unable to sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071721a, 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating), INSOMNIA (unable to sleep), VOMITING (throwing up), CHILLS (chills) and MYALGIA (muscle ache). At the time of the report, FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating), INSOMNIA (unable to sleep), VOMITING (throwing up), CHILLS (chills) and MYALGIA (muscle ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Vomiting
Clinical narrative: I felt like I was hit by a bus /Her whole body was in shock; was cold; My body was in shock and had loss of appetite; sweating; unable to sleep; throwing up; chills; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating) and INSOMNIA (unable to sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071721a, 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating), INSOMNIA (unable to sleep), VOMITING (throwing up), CHILLS (chills) and MYALGIA (muscle ache). At the time of the report, FEELING ABNORMAL (I felt like I was hit by a bus /Her whole body was in shock), FEELING COLD (was cold), DECREASED APPETITE (My body was in shock and had loss of appetite), HYPERHIDROSIS (sweating), INSOMNIA (unable to sleep), VOMITING (throwing up), CHILLS (chills) and MYALGIA (muscle ache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 used) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported  No treatment medication reported  This is a case of Expired Product Administered concerning a patient of unknown gender and age with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving an unknown dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no dosage numbers were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a patient of unknown gender and age with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving an unknown dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no dosage numbers were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.