chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 101F° after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101F° after the second vaccine) in a 60-year-old patient of an unknown 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 PYREXIA (fever of 101F° after the second vaccine). At the time of the report, PYREXIA (fever of 101F° after the second vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101f° (High) 101F°.         Concomitant medications details were not reported by the reporter  Treatment details was not reported by the reporter.    This case was linked to MOD-2021-398470 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        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 was linked to MOD-2021-398481 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (vomiting) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL (ADCIRCA), WARFARIN SODIUM and AMBRISENTAN for an unknown indication.   On 29-Nov-2007, the patient started TREPROSTINIL SODIUM (REMODULIN) (Subcutaneous) .112 microgram/kilogram. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (vomiting) was resolving.            No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hyperpyrexia, Pyrexia
Clinical narrative: fever 119; i got a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERPYREXIA (fever 119) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERPYREXIA (fever 119) (seriousness criterion medically significant) and PYREXIA (i got a fever). At the time of the report, HYPERPYREXIA (fever 119) and PYREXIA (i got a fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 119 (High) high and 98.6 (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided.  No treatment information was provided.  Company comment: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Hyperpyrexia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Hyperpyrexia. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Received Moderna covid19 vaccine and wants to Know if some of the symptoms that they are having if is normal if they are still going on; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Received Moderna covid19 vaccine and wants to Know if some of the symptoms that they are having if is normal if they are still going on) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Received Moderna covid19 vaccine and wants to Know if some of the symptoms that they are having if is normal if they are still going on). At the time of the report, VACCINATION COMPLICATION (Received Moderna covid19 vaccine and wants to Know if some of the symptoms that they are having if is normal if they are still going on) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Have a bad itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Have a bad itching) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056H21B) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder (Liver ailment).    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Nov-2021, the patient experienced PRURITUS (Have a bad itching). At the time of the report, PRURITUS (Have a bad itching) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient had a bad itching and not have any rash. She did not had any reaction with first and second dose.  She had liver ailment and still contacting her doctor if she can take allergy medicines.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Vaccination site rash
Clinical narrative: allergic reaction; rash all over her stomach, chest; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), RASH (rash all over her stomach, chest) and VACCINATION SITE RASH (Rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-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 HYPERSENSITIVITY (allergic reaction), RASH (rash all over her stomach, chest) and VACCINATION SITE RASH (Rash at injection site). At the time of the report, HYPERSENSITIVITY (allergic reaction), RASH (rash all over her stomach, chest) and VACCINATION SITE RASH (Rash at injection site) had resolved.            The patient was fine after the first dose. After the second dose, the patient had had an allergic reaction, had a rash all over her stomach, chest and injection site that went away with some cream. No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migraine; has a headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) and HEADACHE (has a headache) 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 24-Nov-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 MIGRAINE (Migraine) and HEADACHE (has a headache). At the time of the report, MIGRAINE (Migraine) and HEADACHE (has a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Patient wanted to know if they could take a natural aspirin, that's it was like a blood thinner, with magnesium, rosemary and curcuma, that was specific for migraines.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JJ (Patient received the JJ primary vaccination). Past adverse reactions to the above products included No adverse event with JJ. Concurrent medical conditions included Pulmonary arterial hypertension (PAH).    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HEART RATE INCREASED (Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138). The patient was treated with IBUPROFEN for Heart rate high, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (Heart rate of 209, It stayed high for quite a while/ The heart rate is now at 138) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Heart rate: 209 (High) 209. On 26-Nov-2021, Heart rate: 138 (High) 138.         No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects after booster dose) 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects after booster dose). At the time of the report, VACCINATION COMPLICATION (Side effects after booster dose) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-398716 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have some side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (have some side effects). At the time of the report, VACCINATION COMPLICATION (have some side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all around the body; It is itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all around the body) and PRURITUS (It is itchy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (Hives all around the body) and PRURITUS (It is itchy). At the time of the report, URTICARIA (Hives all around the body) and PRURITUS (It is itchy) outcome was unknown.            Concomitant product use included medication for anxiety but not all the time.  Treatment information included steroid and histamine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received full dose as booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received full dose as booster dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     The patient's past medical history included Heart disorder and Hypertension since an unknown date.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (received full dose as booster dose). On 27-Sep-2021, ACCIDENTAL OVERDOSE (received full dose as booster dose) had resolved.            No concomitant and treatment information were reported by the reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Nausea, Vaccination site pain, Vaccination site rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of asthenopia (tired eyes), vaccination site pain (sore injection arm), vaccination site rash (red rash at the injection site) and nausea (little nauseous) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011M20A) for COVID-19 immunization. No medical history reported. On Feb 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2021, patient experienced asthenopia (tired eyes), vaccination site pain (sore injection arm), vaccination site rash (red rash at the injection site) and nausea (little nauseous). In February 2021, asthenopia (tired eyes), vaccination site pain (sore injection arm), vaccination site rash (red rash at the injection site) resolved. At the time of the report, nausea (little nauseous) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case  linked to MOD-2021-398849 (patient link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Nausea
Clinical narrative: Feeling a bit nauseous; Vaccine which is already expired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Feeling a bit nauseous) and EXPIRED PRODUCT ADMINISTERED (Vaccine which is already expired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced NAUSEA (Feeling a bit nauseous) and EXPIRED PRODUCT ADMINISTERED (Vaccine which is already expired). On 28-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine which is already expired) had resolved. At the time of the report, NAUSEA (Feeling a bit nauseous) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Experienced some pain at the injection site after receiving the booster shoot on the right arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Experienced some pain at the injection site after receiving the booster shoot on the right arm.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (The lymph nodes of the under the arm removed due to cancer treatment a few year ago.). Concurrent medical conditions included Cancer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Experienced some pain at the injection site after receiving the booster shoot on the right arm.). At the time of the report, VACCINATION SITE PAIN (Experienced some pain at the injection site after receiving the booster shoot on the right arm.) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swollen lymph node; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) 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.   Concomitant medications were not reported. Treatment details not provided.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: was pretty sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was pretty sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Encephalitis (immunocompromised with chronic encephalitis).    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ILLNESS (was pretty sick). At the time of the report, ILLNESS (was pretty sick) had resolved.            Patient took Johnson and Johnson for the first 2 shots and then have a Moderna shot because he is immunocompromised with chronic encephalitis.  The concomitant medications were not reported.  Th treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021 at 1:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 28-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-398840, MOD-2021-398858 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            Patient was on chronic medications. No treatment medication was provided.   This case was linked to MOD-2021-398880 (Parent-Child Link).   See case MOD-2021-398880 for details regarding the child case.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-398854 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Ankles are swollen; Ankles are painful/left ankle is painful than the right; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Ankles are swollen) and ARTHRALGIA (Ankles are painful/left ankle is painful than the right) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced JOINT SWELLING (Ankles are swollen) and ARTHRALGIA (Ankles are painful/left ankle is painful than the right). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Nov-2021 for Adverse event, at a dose of 3 Benadryl. At the time of the report, JOINT SWELLING (Ankles are swollen) and ARTHRALGIA (Ankles are painful/left ankle is painful than the right) had not resolved.            Concomitant medication was not provided.  Patient does not had diabetes.  It was reported that the patient had his legs elevated as a part of treatment.   This case was linked to MOD-2021-398917, MOD-2021-398918 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse drug reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse drug 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse drug reaction). At the time of the report, VACCINATION COMPLICATION (adverse drug reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Swelling arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 PERIPHERAL SWELLING (Swelling arm) and RASH (Rash). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-398870, MOD-2021-398894 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Swelling arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm) and RASH (Rash). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and RASH (Rash) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-398870, MOD-2021-398893 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: I have a cold; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (I have a cold) 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 NASOPHARYNGITIS (I have a cold). At the time of the report, NASOPHARYNGITIS (I have a cold) 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 relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: slept on and off for 24 hours; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept on and off for 24 hours) and PAIN IN EXTREMITY (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic fatigue syndrome and Fibromyalgia. Concomitant products included NAPROXEN, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), ZOLPIDEM TARTRATE (AMBIEN) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    In March 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 INSOMNIA (slept on and off for 24 hours) and PAIN IN EXTREMITY (Sore arm). At the time of the report, INSOMNIA (slept on and off for 24 hours) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-399156 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue
Clinical narrative: Energy decreased; Joint aches/Pain in my joints (elbow, knees, lower back and hips); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Rocephin), Sulfonamide allergy and Drug allergy (Allergic to Morphine). Concomitant products included THERAWORX RELIEF for Muscle cramp, LEVOTHYROXINE SODIUM (SYNTHROID), ACYCLOVIR [ACICLOVIR], UBIDECARENONE (COQ-10), VITAMIN D3, FISH OIL, L-LYSINE [LYSINE], OCUVITE EXTRA and ASCORBIC ACID, BETACAROTENE, COPPER, DUNALIELLA SALINA, SELENIUM, XANTOFYL, ZEAXANTHIN, ZINC CHELATE (HEALTHY EYES) for an unknown indication.   On 15-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 9:30 AM, 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 ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN ongoing since an unknown date for Joint pain, at a dose of 360 milligram once a day. At the time of the report, ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ASTHENIA (Energy decreased), ARTHRALGIA (Joint aches/Pain in my joints (elbow, knees, lower back and hips)) and FATIGUE (Fatigue) to be possibly related.    Patient reported that prior to her vaccination she was a very high energy person with no joint pain.   This case was linked to MOD-2021-369104 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of low-grade headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine), for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In October 2021, patient developed a low-grade headache. At the time of the report, low-grade headache: not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertonic bladder, Pollakiuria
Clinical narrative: overactive bladder; frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTONIC BLADDER (overactive bladder) and POLLAKIURIA (frequent urination) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Clindamycin), Blood pressure high since 2000, Arthritis (arthritis in left shoulder) since 2016 and Arthritis (arthritis in right knee) since 2018. Concomitant products included LOSARTAN, HCTZ and ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure high.    On 13-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 HYPERTONIC BLADDER (overactive bladder) and POLLAKIURIA (frequent urination). At the time of the report, HYPERTONIC BLADDER (overactive bladder) and POLLAKIURIA (frequent urination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-377577 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain). The patient was treated with IBUPROFEN for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain) had not resolved.            No concomitant medications were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye pain, Feeling hot, Headache
Clinical narrative: felt hot; eyeball pain; painful headache/"odd little headache"; fever/99.8 Fahrenheit temperature; chills was shaking and teeth were chattering; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot), EYE PAIN (eyeball pain), HEADACHE (painful headache/"odd little headache"), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 014M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Laryngopharyngeal reflux (diagnosed with laryngopharynx reflux 17 years ago.). Concurrent medical conditions included Arthritis and Seafood allergy (allergic to mussels.).  Concomitant products included OMEPRAZOLE, METOCLOPRAMIDE HYDROCHLORIDE (VOMISTOP [METOCLOPRAMIDE HYDROCHLORIDE]), CELECOXIB, AZELASTINE and FLUTICASONE for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 27-Nov-2021 at 3:40 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced FEELING HOT (felt hot), EYE PAIN (eyeball pain), HEADACHE (painful headache/"odd little headache"), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form three times a day. At the time of the report, FEELING HOT (felt hot), EYE PAIN (eyeball pain), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering) outcome was unknown and HEADACHE (painful headache/"odd little headache") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Body temperature: 99.8 (High) 99.8 Fahrenheit.   It was reported that patient received half dose of Moderna booster.   This case was linked to MOD-2021-399992 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt hot; eyeball pain; painful headache/"odd little headache"; fever/99.8 Fahrenheit temperature; chills was shaking and teeth were chattering; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot), EYE PAIN (eyeball pain), HEADACHE (painful headache/"odd little headache"), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 014M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Laryngopharyngeal reflux (diagnosed with laryngopharynx reflux 17 years ago.). Concurrent medical conditions included Arthritis and Seafood allergy (allergic to mussels.).  Concomitant products included OMEPRAZOLE, METOCLOPRAMIDE HYDROCHLORIDE (VOMISTOP [METOCLOPRAMIDE HYDROCHLORIDE]), CELECOXIB, AZELASTINE and FLUTICASONE for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 27-Nov-2021 at 3:40 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced FEELING HOT (felt hot), EYE PAIN (eyeball pain), HEADACHE (painful headache/"odd little headache"), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form three times a day. At the time of the report, FEELING HOT (felt hot), EYE PAIN (eyeball pain), PYREXIA (fever/99.8 Fahrenheit temperature) and CHILLS (chills was shaking and teeth were chattering) outcome was unknown and HEADACHE (painful headache/"odd little headache") had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Body temperature: 99.8 (High) 99.8 Fahrenheit.   It was reported that patient received half dose of Moderna booster.   This case was linked to MOD-2021-399992 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Neutrophil count decreased, Rash, White blood cell count
Clinical narrative: low wbc / neutrophil labs; low wbc / neutrophil labs; had a lymph node appear on my mammo which they say is common but not 8 month later; got terrible rashes; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs), LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) and RASH (got terrible rashes) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs), LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) and RASH (got terrible rashes). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs) and RASH (got terrible rashes) outcome was unknown and LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) Patient reported had a lymph node appear on his/her mammo stated that it was mentioned as common but was not 8 months later. On an unknown date, White blood cell count: low (Low) low wbc / neutrophil labs.         Patient was due for the booster and stated that extremely worried about the potential of aggravating his/her immune system.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-399764 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: low wbc / neutrophil labs; low wbc / neutrophil labs; had a lymph node appear on my mammo which they say is common but not 8 month later; got terrible rashes; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs), LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) and RASH (got terrible rashes) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs), LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) and RASH (got terrible rashes). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (low wbc / neutrophil labs), NEUTROPHIL COUNT DECREASED (low wbc / neutrophil labs) and RASH (got terrible rashes) outcome was unknown and LYMPHADENOPATHY (had a lymph node appear on my mammo which they say is common but not 8 month later) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) Patient reported had a lymph node appear on his/her mammo stated that it was mentioned as common but was not 8 months later. On an unknown date, White blood cell count: low (Low) low wbc / neutrophil labs.         Patient was due for the booster and stated that extremely worried about the potential of aggravating his/her immune system.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-399764 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Muscular weakness, Myalgia
Clinical narrative: cramped legs and feet; tired legs and feet/ tired left arm; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramped legs and feet), MUSCULAR WEAKNESS (tired legs and feet/ tired left arm), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (cramped legs and feet), MUSCULAR WEAKNESS (tired legs and feet/ tired left arm), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MUSCLE SPASMS (cramped legs and feet), MUSCULAR WEAKNESS (tired legs and feet/ tired left arm), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.            No concomitant medications were reported   No treatment information was provided
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer vaccine (First dose, Lot number ER2613) on 17-Mar-2021, Pfizer vaccine (Second dose and Lot number EW0158) on 07-Apr-2021.Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (a patient got a booster dose of the Moderna Covid-19 Vaccine more that 12 hours after the 1st puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Symptoms: It was reported that the patient had received booster dose of Moderna vaccine 12 hours after first punctured, it was first punctured on 28-Nov-2021 at 03:22 pm and kept back into the refrigerator, then took out from refrigerator on 29-Nov-2021 at 09:15 am, kept at room temperature and was administered to patient at 11:49 am. Number of doses: 1dose/1vial, was initially stored in the refrigerator on 27-Nov-2021, and the vial did not undergo any temperature excursion,amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 2 hours 30 min No concomitant medications were reported. No treatment medications were reported.