chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Confusional state, Heart rate irregular, Hypertension
Clinical narrative: IRREGULAR HEART BEAT; STAGE 1 HYPERTENSION/HEADACHE/LIGHTHEADEDNESS; FEELING LITTLE BIT CLOUDY AND CONFUSION; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feeling little bit cloudy and confusion. On 06-MAY-2021, the subject experienced irregular heart beat. On 06-MAY-2021, the subject experienced stage 1 hypertension/headache/lightheadedness. Laboratory data included: Blood pressure (NR: not provided) HYPERTENSION. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irregular heart beat, stage 1 hypertension/headache/lightheadedness, and feeling little bit cloudy and confusion. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; LOW GRADE FEVER OF 99.1; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and low grade fever of 99.1.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever of 99.1 and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: BLEEDING NOSE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bleeding nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bleeding nose was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included cancer, and other pre-existing medical conditions included patient takes oral, targeted medicine (unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED  VACCINE TO A PATIENT; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported. On 26-APR-2021, the subject experienced administration of expired vaccine to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine to a patient was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: ITCHING AT INJECTION SITE; HURTING RIGHT ARM; FATIGUE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAY-2021, the subject experienced itching at injection site. On 03-MAY-2021, the subject experienced hurting right arm. On 03-MAY-2021, the subject experienced fatigue. On 03-MAY-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hurting right arm, fatigue, itching at injection site and swelling at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: TESTED NEGATIVE FOR IGG  ANTIBODIES; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced tested negative for igg antibodies. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) tested negative for spike specific IgG antibodies at Lab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested negative for igg antibodies was not reported. This report was non-serious.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Oropharyngeal pain, Pain in extremity, Vomiting
Clinical narrative: VOMITING; SORE THROAT; DIARRHEA; SORE ARMS; MINOR HEADACHES; This spontaneous report received from a patient concerned an 18 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vomiting. On 06-MAY-2021, the subject experienced sore throat. On 06-MAY-2021, the subject experienced diarrhea. On 06-MAY-2021, the subject experienced sore arms. On 06-MAY-2021, the subject experienced minor headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and the outcome of sore throat, diarrhea, minor headaches and sore arms was not reported. This report was non-serious
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, and the outcome of headache and nausea was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Heart rate, Pain
Clinical narrative: BODY ACHES; FATIGUE; LOW-GRADE FEVER; RAPID HEART RACING; CHILLS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with ergocalciferol; and experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rapid heart racing. On 31-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.1 F, and Heart rate (NR: not provided) 120 bpm. Treatment medications included: ibuprofen. On 31-MAR-2021 16:00, the subject experienced low-grade fever. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 90 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, rapid heart racing, and fatigue on 01-APR-2021, and chills, and low-grade fever on 31-MAR-2021. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: BODY ACHES; FATIGUE; LOW-GRADE FEVER; RAPID HEART RACING; CHILLS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with ergocalciferol; and experienced hives when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rapid heart racing. On 31-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.1 F, and Heart rate (NR: not provided) 120 bpm. Treatment medications included: ibuprofen. On 31-MAR-2021 16:00, the subject experienced low-grade fever. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 90 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, rapid heart racing, and fatigue on 01-APR-2021, and chills, and low-grade fever on 31-MAR-2021. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RED RASH ALL OVER BODY EXCEPT  FACE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, sulfa allergy, and lobster allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced red rash all over body except face. Treatment medications included: menthol/zinc oxide, and triamcinolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash all over body except face. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: BODY PAIN; ARM PAIN; TIREDNESS SENSATION; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body pain, arm pain, tiredness sensation, and headache. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, arm pain, tiredness sensation, and headache. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Feeling hot, Muscle spasms
Clinical narrative: CHEST TIGHTNESS; MUSCLE SPASM; BODY ACHE; LEG AND ARM WARM TO TOUCH; SORE LEG AND ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no previous cardiac issues and was felt fine before receiving janssen covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced body ache. On 06-MAY-2021, the subject experienced leg and arm warm to touch. On 06-MAY-2021, the subject experienced sore leg and arm. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 - 101.5. On 06-MAY-2021 21:00, the subject experienced chest tightness. On 06-MAY-2021 21:00, the subject experienced muscle spasm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness, muscle spasm, fever, chills, body ache, leg and arm warm to touch and sore leg and arm was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: CHEST TIGHTNESS; MUSCLE SPASM; BODY ACHE; LEG AND ARM WARM TO TOUCH; SORE LEG AND ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no previous cardiac issues and was felt fine before receiving janssen covid-19 vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced body ache. On 06-MAY-2021, the subject experienced leg and arm warm to touch. On 06-MAY-2021, the subject experienced sore leg and arm. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 - 101.5. On 06-MAY-2021 21:00, the subject experienced chest tightness. On 06-MAY-2021 21:00, the subject experienced muscle spasm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest tightness, muscle spasm, fever, chills, body ache, leg and arm warm to touch and sore leg and arm was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: BOTH ARMS HURT IN THE SHOULDERS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced both arms hurt in the shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of both arms hurt in the shoulders was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: STOMACH ACHE; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis with rheumatoid factor of multiple site. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, Expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced stomach ache, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness and stomach ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered to patient of inappropriate age was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: WHOLE BODY HURT; CHILLS; FEVER; BAD HEADACHE; PAIN MOVING DOWN ARM AS THE SHOT GIVEN; This spontaneous report received from a patient via a company representative concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced pain moving down arm as the shot given. On 07-APR-2021, the subject experienced whole body hurt. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced bad headache. On 07-APR-2021 18:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body hurt, pain moving down arm as the shot given, chills, fever, and bad headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OLU PATIENT POPULATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced OLU  - subject population. On 06-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the OLU - patient population and off label use was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Fatigue, Illness
Clinical narrative: felt like she couldn't breath; Congestion nasal; a crackling cough; was very sick after receiving the first dose; described as having pain in the arm which had been injected.; sometimes gets lightheaded or dizzy; being very tired a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (felt like she couldn't breath) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Hypertension since an unknown date.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSPNOEA (felt like she couldn't breath) (seriousness criterion medically significant), NASAL CONGESTION (Congestion nasal), COUGH (a crackling cough), ILLNESS (was very sick after receiving the first dose), VACCINATION SITE PAIN (described as having pain in the arm which had been injected.), DIZZINESS (sometimes gets lightheaded or dizzy) and FATIGUE (being very tired a lot). At the time of the report, DYSPNOEA (felt like she couldn't breath), ILLNESS (was very sick after receiving the first dose) and DIZZINESS (sometimes gets lightheaded or dizzy) outcome was unknown, NASAL CONGESTION (Congestion nasal) had not resolved, COUGH (a crackling cough) was resolving and VACCINATION SITE PAIN (described as having pain in the arm which had been injected.) and FATIGUE (being very tired a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs included blood pressure medication.  Treatment Her local pharmacist suggested her to take Mucinex DM for the symptom. She started taking the suggested Mucinex DM therapy three nights ago.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Vaccination site pain
Clinical narrative: felt like she couldn't breath; Congestion nasal; a crackling cough; was very sick after receiving the first dose; described as having pain in the arm which had been injected.; sometimes gets lightheaded or dizzy; being very tired a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (felt like she couldn't breath) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Hypertension since an unknown date.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSPNOEA (felt like she couldn't breath) (seriousness criterion medically significant), NASAL CONGESTION (Congestion nasal), COUGH (a crackling cough), ILLNESS (was very sick after receiving the first dose), VACCINATION SITE PAIN (described as having pain in the arm which had been injected.), DIZZINESS (sometimes gets lightheaded or dizzy) and FATIGUE (being very tired a lot). At the time of the report, DYSPNOEA (felt like she couldn't breath), ILLNESS (was very sick after receiving the first dose) and DIZZINESS (sometimes gets lightheaded or dizzy) outcome was unknown, NASAL CONGESTION (Congestion nasal) had not resolved, COUGH (a crackling cough) was resolving and VACCINATION SITE PAIN (described as having pain in the arm which had been injected.) and FATIGUE (being very tired a lot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs included blood pressure medication.  Treatment Her local pharmacist suggested her to take Mucinex DM for the symptom. She started taking the suggested Mucinex DM therapy three nights ago.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Body temperature, Delirium, Feeling cold, Feeling hot
Clinical narrative: Felt sore all over; Mild temperature of 100.4 F; Delirious; Soreness of arm; Talking out of his head; Shaking; Was very cold; Got real hot; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reports that the patient had done regeneron infusion on 02 Feb 2021).    On 27-Apr-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold) and FEELING HOT (Got real hot). On 27-Apr-2021 at 11:00 PM, the patient experienced PYREXIA (Mild temperature of 100.4 F). On 28-Apr-2021, the patient experienced MYALGIA (Felt sore all over). At the time of the report, DELIRIUM (Delirious), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold), FEELING HOT (Got real hot), PYREXIA (Mild temperature of 100.4 F) and MYALGIA (Felt sore all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 100.4 Mild temperature of 100.4 F was reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included the use of acetaminophen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Felt sore all over; Mild temperature of 100.4 F; Delirious; Soreness of arm; Talking out of his head; Shaking; Was very cold; Got real hot; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reports that the patient had done regeneron infusion on 02 Feb 2021).    On 27-Apr-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold) and FEELING HOT (Got real hot). On 27-Apr-2021 at 11:00 PM, the patient experienced PYREXIA (Mild temperature of 100.4 F). On 28-Apr-2021, the patient experienced MYALGIA (Felt sore all over). At the time of the report, DELIRIUM (Delirious), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold), FEELING HOT (Got real hot), PYREXIA (Mild temperature of 100.4 F) and MYALGIA (Felt sore all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 100.4 Mild temperature of 100.4 F was reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included the use of acetaminophen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharitis, Dry eye, Ear discomfort, Eye swelling, Headache
Clinical narrative: little bumps all over her face and body which are like measles; swollen eyes; watery eyes; Runny nose; Sneezing; Congestion on her chest; Dry eye socket; dry eye socket with crust on eyelashes; Headache; allergic reaction for a week/allergic reactions keep coming back; Ear feels full; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy. Concomitant products included LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced EAR DISCOMFORT (Ear feels full). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back). On an unknown date, the patient experienced PULMONARY CONGESTION (Congestion on her chest) (seriousness criterion medically significant), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (Congestion on her chest), HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), EAR DISCOMFORT (Ear feels full), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache) had not resolved.            Treatments provided were 25mg diphenhydramine, 16mg Hydrocortisone cream, Metoprolol steroid, and Doxycycline for 7 days given by her HCP. Action taken with mRNA in respect to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.   This case was linked to MOD-2021-095202 (Patient Link); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased, Pulmonary congestion, Rash papular, Rhinorrhoea
Clinical narrative: little bumps all over her face and body which are like measles; swollen eyes; watery eyes; Runny nose; Sneezing; Congestion on her chest; Dry eye socket; dry eye socket with crust on eyelashes; Headache; allergic reaction for a week/allergic reactions keep coming back; Ear feels full; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy. Concomitant products included LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced EAR DISCOMFORT (Ear feels full). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back). On an unknown date, the patient experienced PULMONARY CONGESTION (Congestion on her chest) (seriousness criterion medically significant), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (Congestion on her chest), HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), EAR DISCOMFORT (Ear feels full), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache) had not resolved.            Treatments provided were 25mg diphenhydramine, 16mg Hydrocortisone cream, Metoprolol steroid, and Doxycycline for 7 days given by her HCP. Action taken with mRNA in respect to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.   This case was linked to MOD-2021-095202 (Patient Link); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: little bumps all over her face and body which are like measles; swollen eyes; watery eyes; Runny nose; Sneezing; Congestion on her chest; Dry eye socket; dry eye socket with crust on eyelashes; Headache; allergic reaction for a week/allergic reactions keep coming back; Ear feels full; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy. Concomitant products included LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced EAR DISCOMFORT (Ear feels full). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back). On an unknown date, the patient experienced PULMONARY CONGESTION (Congestion on her chest) (seriousness criterion medically significant), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (Congestion on her chest), HYPERSENSITIVITY (allergic reaction for a week/allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), EAR DISCOMFORT (Ear feels full), DRY EYE (Dry eye socket), BLEPHARITIS (dry eye socket with crust on eyelashes) and HEADACHE (Headache) had not resolved.            Treatments provided were 25mg diphenhydramine, 16mg Hydrocortisone cream, Metoprolol steroid, and Doxycycline for 7 days given by her HCP. Action taken with mRNA in respect to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.   This case was linked to MOD-2021-095202 (Patient Link); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events. However, the patient's past medical history of food allergies remains a risk factor for these events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Ear discomfort, Eye swelling, Eyelid margin crusting, Headache
Clinical narrative: congestion on her chest; having allergic reaction for a week.allergic reactions keep coming back; little bumps all over her face and body which are like measles after the vaccine; swollen eyes; watery eyes; runny nose; sneezing; ear feels full; dry eye socket with crust on eyelashes; Crust on eyelashes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Food allergy since an unknown date. Concomitant products included LIRAGLUTIDE, INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PULMONARY CONGESTION (congestion on her chest) (seriousness criterion medically significant), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (congestion on her chest), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Treatment medications Provided were 25 mg Benadryl. 16 mg hydrocortisone cream. metoprolol steroid, and Doxycycline for 7 days given by her HCP.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-095089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased, Pulmonary congestion, Rash papular, Rhinorrhoea
Clinical narrative: congestion on her chest; having allergic reaction for a week.allergic reactions keep coming back; little bumps all over her face and body which are like measles after the vaccine; swollen eyes; watery eyes; runny nose; sneezing; ear feels full; dry eye socket with crust on eyelashes; Crust on eyelashes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (congestion on her chest) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Food allergy since an unknown date. Concomitant products included LIRAGLUTIDE, INSULIN GLARGINE (LANTUS), VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and LOSARTAN for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PULMONARY CONGESTION (congestion on her chest) (seriousness criterion medically significant), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache). At the time of the report, PULMONARY CONGESTION (congestion on her chest), HYPERSENSITIVITY (having allergic reaction for a week.allergic reactions keep coming back), RASH PAPULAR (little bumps all over her face and body which are like measles after the vaccine), EYE SWELLING (swollen eyes), LACRIMATION INCREASED (watery eyes), RHINORRHOEA (runny nose), SNEEZING (sneezing), EAR DISCOMFORT (ear feels full), DRY EYE (dry eye socket with crust on eyelashes), EYELID MARGIN CRUSTING (Crust on eyelashes) and HEADACHE (Headache) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.  Treatment medications Provided were 25 mg Benadryl. 16 mg hydrocortisone cream. metoprolol steroid, and Doxycycline for 7 days given by her HCP.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-095089 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.