chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain in extremity
Clinical narrative: Congested headache, stuffy nose and arm pain onset at 5 hours post injection
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal pain, Urinary tract infection
Clinical narrative: Kidney pain and UTI began day after first injection.  Diagnosed and treated for 5 UTIs since initial vaccine.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Tinnitus
Clinical narrative: I am updating report # 608369.  Historically my blood pressures had been normal until receiving covid vaccine. Apart from ringing in my ears now I also have high blood pressure.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Breast pain, Breast swelling, Discomfort, Lymphadenopathy
Clinical narrative: My breasts became swollen and painful, and I noticed raised bumps which were probably lymph nodes on the side, under my arm, and also a few inches down on the side.  This lasted a few days, and was very uncomfortable and worrisome.   By the time I got the doctor appointment on Feb 17, the condition was a little better.   The doctor examined me and said that she now did not feel anything that would be cause for alarm.   She recommended that I wait two months, and then go for a mammogram and sonogram.   I did that on May 19.   I told the radiologist about this experience, and she told me that my test results were good, but that I should be vigilant because I had that experience.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram normal, Ultrasound scan normal
Clinical narrative: My breasts became swollen and painful, and I noticed raised bumps which were probably lymph nodes on the side, under my arm, and also a few inches down on the side.  This lasted a few days, and was very uncomfortable and worrisome.   By the time I got the doctor appointment on Feb 17, the condition was a little better.   The doctor examined me and said that she now did not feel anything that would be cause for alarm.   She recommended that I wait two months, and then go for a mammogram and sonogram.   I did that on May 19.   I told the radiologist about this experience, and she told me that my test results were good, but that I should be vigilant because I had that experience.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid positive
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Rash, Rash erythematous
Clinical narrative: Left side of chin/neck developed a red rash with a yellow pimple on them. My wife compared them to fire ant bites. Researching on line it looks like erythema multi forms which is apparently being investigated as a possible side effect.  It is getting better but the redness is still there but not as many yellow pimples. I saw no reason to go to the doctor but obviously do not think it wise to get second dose as could trigger worse case or reactions. I have no allergies per say but am very sensitive to poison ivy. This is not poison ivy though.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac flutter, Chest discomfort, Chest pain, Hypoaesthesia
Clinical narrative: Initial feeling of vaccine through my veins.  Then heart tightness on first day.  Also pains near left chest near arm pit.   In the last 30 days heart palpitations, fluttering and sharper pains.  Uncomfortable to sleep or rest laying down.  Getting progressively worse.  Now some left arm numbness.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Sleep disorder
Clinical narrative: Initial feeling of vaccine through my veins.  Then heart tightness on first day.  Also pains near left chest near arm pit.   In the last 30 days heart palpitations, fluttering and sharper pains.  Uncomfortable to sleep or rest laying down.  Getting progressively worse.  Now some left arm numbness.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain
Clinical narrative: Ambulatory c/o headache, vomiting, body aches/fatigue and fever ever since receiving J&J vaccine last Thursday. Denies COVID contacts. PMH DM, taking Zofran w/ poor relief. 52 y/o M presents for evaluation of persistent nausea and vomiting s/p receiving the Johnson and Johnson COVID vaccination on 6/24/21. Pt endorses a 5 day hx of myalgias, nausea, and vomiting. He has not been drinking much water over the past couple days. He has not been checking his sugars regularly. Reports associated myalgias.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Ambulatory c/o headache, vomiting, body aches/fatigue and fever ever since receiving J&J vaccine last Thursday. Denies COVID contacts. PMH DM, taking Zofran w/ poor relief. 52 y/o M presents for evaluation of persistent nausea and vomiting s/p receiving the Johnson and Johnson COVID vaccination on 6/24/21. Pt endorses a 5 day hx of myalgias, nausea, and vomiting. He has not been drinking much water over the past couple days. He has not been checking his sugars regularly. Reports associated myalgias.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle ache in arms and legs, fever 100.3, chills, headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus, Injection site rash
Clinical narrative: Arm rash, itchiness, redness, hard knot at injection site. No fever.
Age: 52.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Injection site rash, Pain, Rash erythematous, Skin warm, Tenderness
Clinical narrative: patient developed a rash that appeared to look like a viral rash.  flat and red. not raised.  warm to touch.  rash went from right arm at injection site, to shoulder, front neck down to bra line, and posterior neck and down back to back of pants waist area. tender and painful.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid Positive
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Dyspnoea exertional, Electrocardiogram normal
Clinical narrative: 61 y/o F, BIB ALS, with hx of asthma, presents for evaluation of worsening shortness of breath beginning 1 month ago. Pt has been evaluated by his PMD multiple times and had a chest x-ray done with no clear etiology for her sx, but found something cardiovascular related and had an EKG done which came back normal. Pt used her inhaler at home with minimal sx improvement yesterday. Sx aggravated with any exertion/ambulation. Reports associated intermittent cough. Denies chest pain, LE edema, or fever. Pt is fully Pfizer COVID-19 vaccinated in May 2021.  PMH: Asthma, HTN  Social Hx: Denies tobacco use.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: COLD CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cold chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site erythema, Insomnia, Pain in extremity
Clinical narrative: CANT SLEEP; WOKE UP HURTING RIGHT ARM; WEAK; SPOTTING AND REDNESS AROUND  WHERE HE RECEIVED VACCINE; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic pain, fibromyalgia, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, administered on 03-AUG-2021 for prophylactic vaccination. Concomitant medications included for chronic pain. The batch number was not reported and has been requested. On 03-AUG-2021, the patient experienced cant sleep. On 03-AUG-2021, the patient experienced woke up hurting right arm. On 03-AUG-2021, the patient experienced weak. On 03-AUG-2021, the patient experienced spotting and redness around where he received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from woke up hurting right arm, and weak, and the outcome of cant sleep and spotting and redness around where he received vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000188853. The suspected product quality complaint has been confirmed to be voided(did not meet a product quality complaint criteria as reported complaints were adverse events) based on the Agency evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Fatigue, Feeling jittery, Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; SHAKES MAINLY IN HANDS MORE WHEN READS OR TRY TO CONCENTRATE; JITTERS; FELT TIRED/FATIGUE; SUGAR RUSH FEELING; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcoholic, non smoker, and low testosterone, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced sugar rush feeling. On 20-JUL-2021, the patient experienced felt tired/fatigue. On 21-JUL-2021, the patient experienced shakes mainly in hands more when reads or try to concentrate. On 21-JUL-2021, the patient experienced jitters. On an unspecified date, the patient experienced sore arm, and headache. Laboratory data (dates unspecified) included: Testosterone (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, headache, and felt tired/fatigue, was recovering from sugar rush feeling, and had not recovered from shakes mainly in hands more when reads or try to concentrate, and jitters. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Tremor
Clinical narrative: SORE ARM; HEADACHE; SHAKES MAINLY IN HANDS MORE WHEN READS OR TRY TO CONCENTRATE; JITTERS; FELT TIRED/FATIGUE; SUGAR RUSH FEELING; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcoholic, non smoker, and low testosterone, and other pre-existing medical conditions included: Patient had no known drug allergies and did not had any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the patient experienced sugar rush feeling. On 20-JUL-2021, the patient experienced felt tired/fatigue. On 21-JUL-2021, the patient experienced shakes mainly in hands more when reads or try to concentrate. On 21-JUL-2021, the patient experienced jitters. On an unspecified date, the patient experienced sore arm, and headache. Laboratory data (dates unspecified) included: Testosterone (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, headache, and felt tired/fatigue, was recovering from sugar rush feeling, and had not recovered from shakes mainly in hands more when reads or try to concentrate, and jitters. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, age group, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome-CoV-2) test (NR: not provided) diagnosed with a breakthrough case of covid. The patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210818073.; Sender's Comments: V0: 20210817422-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy partial responder
Clinical narrative: TITRES OF ANTIBODY RESULT IS LOW; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced titres of antibody result is low. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibody levels low was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817934-covid-19 vaccine ad26.cov2.s- titres of antibody result is low. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm at injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818227, 20210818021, 20210817805, 20210818401 and 20210820974.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diverticulitis, Eye haemorrhage, Iritis
Clinical narrative: DIVERTICULITIS; STROKE; BLEEDING IN THE BACK OF LEFT EYE; IRITIS; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight was 245 pounds, and height was 66 inches. The patient was in perfect health prior to the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total administered to right arm deltoid on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the patient experienced stroke and was hospitalized overnight and was discharged the following day (21-May-2021). Per patient stroke had caused her to lose sight of the left eye and her right eye had changed to 20-20 vision. On 05-JUL-2021, the patient was diagnosed with iritis. On 16-JUL-2021, the patient experienced diverticulitis and hospitalized for a day. On an unspecified date, the patient experienced bleeding in the back of left eye. Treatment medications (dates unspecified) included: acetylsalicylic acid (Aspirin), and atorvastatin calcium (Lipitor). The duration of hospitalization was 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from diverticulitis, and the outcome of iritis, stroke and bleeding in the back of left eye was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210819912- Covid-19 vaccine ad26.cov2.s- Stroke, diverticulitis, bleeding in the back of left eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervous system disorder, Paraesthesia
Clinical narrative: RIGHT FOOT AND LEG NERVE SYMPTOMS; RIGHT FOOT NUMB; RIGHT FOOT TINGLING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 AUG-2021, the patient experienced right foot numb. On AUG-2021, the patient experienced right foot tingling. On an unspecified date, the patient experienced right foot and leg nerve symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right foot and leg nerve symptoms, and the outcome of right foot numb and right foot tingling was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 49 year old male of unknown ethnicity. The patient's weight was 280 pounds, and height was 78 inches. The patient's concurrent conditions included: penicillin allergy, non alcohol user, and non smoker. Consumer was healthy and had no primary care physician. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: 23-JUN-2021),dose was not reported,1 total, administered on 03-JUN-2021 for prophylactic vaccination to right arm. No concomitant medications were reported.  On 09-AUG-2021, the patient tested Positive for COVID-19 antigen test and found to have suspected covid-19 infection (suspected clinical vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210820111-Covid-19 vaccine ad26.cov2. s-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN LUNGS; This spontaneous report received from a consumer concerned a 5 decade old (around 45 years) White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: blood clots from 2016. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced blood clot in lungs and on the same day, the patient was hospitalized. On 07-AUG-2021, the patient was discharged from hospital. According to the patient it did not have anything to do with the vaccine. The patient was hospitalized for 3 days. The patient was currently receiving unspecified blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in lungs was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210820320-covid-19 vaccine ad26.cov2.s-blood clot in lungs. This case concerned to a 5 decade old (around 45 years) White and not Hispanic or Latino male. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Cardiac monitoring, Cardiac stress test, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: BLOOD PRESSURE WENT UP; TOO MUCH HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced blood pressure went up, and too much headache. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) not reported, EKG (NR: not provided) cardio doctor saw something in it, normal, Echocardiogram (NR: not provided) not reported, and Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the too much headache and blood pressure went up was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: BLOOD PRESSURE WENT UP; TOO MUCH HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 patient experienced blood pressure went up, and too much headache. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) not reported, EKG (NR: not provided) cardio doctor saw something in it, normal, Echocardiogram (NR: not provided) not reported, and Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the too much headache and blood pressure went up was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: SLEPT  MORE THAN USUAL; SLIGHT FEVER 99F; INCREASED TIREDNESS/FEELING  DRAINED; This spontaneous report received from a consumer concerned a 38 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 patient experienced slept more than usual, slight fever 99f, and increased tiredness/feeling drained. Laboratory data (dates unspecified) included: Fever (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever 99f, increased tiredness/feeling drained and slept more than usual was not reported. This report was non-serious. This case, from the same reporter is linked to 20210818227, 20210817805, 20210818021, 20210818107 and 20210818401..
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: HAD THE SAME SYMPTOMS AS DENGUE FEVER; THE ARM ACHED FOR ALMOST FIVE DAYS WHERE THE SHOT WAS TAKEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced had the same symptoms as dengue fever, and the arm ached for almost five days where the shot was taken. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from the arm ached for almost five days where the shot was taken, and the outcome of had the same symptoms as dengue fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: VOMITED FOR ABOUT 8 HOURS; A VERY HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vomited for about 8 hours, and a very high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited for about 8 hours, and a very high fever. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Chills, Depression, Fear, Headache
Clinical narrative: BODY ACHE; HOT FLUSHES; MOOD SWING; VERY FEARFUL; FEELING VERY AGITATED; DEPRESSED; MALAISE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression. 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 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Lab test (NR: not provided) negative for UTI. On 09-AUG-2021, the patient experienced body ache. On 09-AUG-2021, the patient experienced hot flushes. On 09-AUG-2021, the patient experienced mood swing. On 09-AUG-2021, the patient experienced very fearful. On 09-AUG-2021, the patient experienced feeling very agitated. On 09-AUG-2021, the patient experienced depressed. On 09-AUG-2021, the patient experienced malaise. On 09-AUG-2021, the patient experienced chills. On 09-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, body ache, hot flushes, mood swing, very fearful, feeling very agitated, depressed, and malaise. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Laboratory test, Malaise, Mood swings, Pain
Clinical narrative: BODY ACHE; HOT FLUSHES; MOOD SWING; VERY FEARFUL; FEELING VERY AGITATED; DEPRESSED; MALAISE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression. 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 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Lab test (NR: not provided) negative for UTI. On 09-AUG-2021, the patient experienced body ache. On 09-AUG-2021, the patient experienced hot flushes. On 09-AUG-2021, the patient experienced mood swing. On 09-AUG-2021, the patient experienced very fearful. On 09-AUG-2021, the patient experienced feeling very agitated. On 09-AUG-2021, the patient experienced depressed. On 09-AUG-2021, the patient experienced malaise. On 09-AUG-2021, the patient experienced chills. On 09-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, body ache, hot flushes, mood swing, very fearful, feeling very agitated, depressed, and malaise. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Paraesthesia, Peripheral swelling
Clinical narrative: TINGLING SENSATION IN LEFT ARM AND LEFT LEG; SWELLING OF EYES; SWELLING OF LEGS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced swelling of eyes. On 09-AUG-2021, the patient experienced swelling of legs. On 11-AUG-2021, the patient experienced tingling sensation in left arm and left leg. The action taken with covid-19 vaccine was not applicable. The outcome of the swelling of legs, tingling sensation in left arm and left leg and swelling of eyes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Nonspecific reaction
Clinical narrative: FELT AWFUL; UNSPECIFIED SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-JUL-2021, the patient experienced unspecified symptoms. On 23-JUL-2021, the patient experienced felt awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt awful, and the outcome of unspecified symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: STILL PAINFUL HAND; SWOLLEN FEET; ZERO PERCENT TASTE BUDS; NAUSEATED; EXTREME EXHAUSTION; SLEEPY; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-AUG-2021, the patient experienced sleepy. On 06-AUG-2021, the patient experienced headache. On 07-AUG-2021, the patient experienced swollen feet. On 07-AUG-2021, the patient experienced zero percent taste buds. On 07-AUG-2021, the patient experienced nauseated. On 07-AUG-2021, the patient experienced extreme exhaustion. On an unspecified date, the patient experienced still painful hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme exhaustion, and still painful hand, and the outcome of sleepy, headache, swollen feet, nauseated and zero percent taste buds was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence
Clinical narrative: STILL PAINFUL HAND; SWOLLEN FEET; ZERO PERCENT TASTE BUDS; NAUSEATED; EXTREME EXHAUSTION; SLEEPY; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-AUG-2021, the patient experienced sleepy. On 06-AUG-2021, the patient experienced headache. On 07-AUG-2021, the patient experienced swollen feet. On 07-AUG-2021, the patient experienced zero percent taste buds. On 07-AUG-2021, the patient experienced nauseated. On 07-AUG-2021, the patient experienced extreme exhaustion. On an unspecified date, the patient experienced still painful hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme exhaustion, and still painful hand, and the outcome of sleepy, headache, swollen feet, nauseated and zero percent taste buds was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: BODY RASH STARTED ON LEFT ARM AND  SPREAD ON TORSO AND DOWN THE ARM, UNDERNEATH THE ARMS, TOWARDS THE BREAST AND WHOLE BACK THEN GOING DOWN TO LEGS, INNER THIGHS AND TUMMY; BODY ACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lyme disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced body aches. On 10-AUG-2021, the patient experienced body rash started on left arm and spread on torso and down the arm, underneath the arms, towards the breast and whole back then going down to legs, inner thighs and tummy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 10-AUG-2021, and had not recovered from body rash started on left arm and spread on torso and down the arm, underneath the arms, towards the breast and whole back then going down to legs, inner thighs and tummy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Breastfeeding; This spontaneous report was received from a nurse practitioner, who was also the patient, who received Moderna's COVID-19 (mRNA-1273) vaccine while breastfeeding.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, the patient reported that she was a breastfeeding mother to a 4.5 month old baby.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome for the event breast feeding was resolved on 22 Dec 2020.  Follow-up received on 28 Dec 2020 had no new information.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot #unknown), reporting Maternal exposure during breast feeding without any associated adverse events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Malaise, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: feels truly awful; severe congestion; cough; sore throat; body aches; This spontaneous report was received from a Dietician concerning a 50-year-old, female patient who received Moderna's COVID-19 Vaccine, and experienced the events severe congestion, cough, body aches, sore throat and feels truly awful.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received her first of two planned doses of mRNA-1273 on 26-Dec-2020 intramuscularly for prophylaxis of COVID-19 infection.   On 26-Dec-2020, the date of injection, caller reported that patient had severe congestion, cough, body aches, sore throat and the symptoms of Covid-19.  The patient was tested for Covid-19 on an undisclosed date.  Test results were pending at the time report was received.  By 28-Dec-2020, caller reported that the patient stated she felt truly awful. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided  The outcome of the events severe congestion, cough, body aches, sore throat and feels truly awful were unknown.; Reporter's Comments: This case concerns a 50-year-old, female patient, who experienced  non-serious unexpected events of Nasal congestion, Cough, Oropharyngeal pain, Malaise and non-serious expected event of Myalgia . The events of Nasal congestion, Cough, Oropharyngeal pain and Myalgia occurred 1 day (same day) after the first dose of mRNA-1273, COVID-19 vaccine. The event of Malaise occurred 2 days  after the first dose of mRNA-1273, COVID-19 vaccine. Based on the current available information and temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Neuralgia, Pain
Clinical narrative: Pain in her entire left deltoid muscle and goes from middle of armpit radiating to the elbow; Nerve pain; hot and painful; A spontaneous report was received from a consumer who was a 36-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain in her entire left deltoid muscle and goes from middle of armpit radiating to the elbow, nerve pain and hot and painful.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020 at around 14:30, approximately 7 hours prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Dec 2020 at around 21:30, the patient experienced a lot of pain in her entire deltoid muscle going from the middle of her armpit to the elbow in the left arm. She clarified that it felt like nerve pain and it was hot and painful. It got progressively worse and she stated it was so bad. Her healthcare provider was closed and not responding to her calls. She wrapped her arm in an ice pack.  On 24 Dec 2020 around 13:30, she took extra strength paracetamol and was considering visiting the emergency room.   Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, pain in her entire left deltoid muscle and goes from middle of armpit radiating to the elbow, nerve pain and hot and painful, were not reported.   The reporter assessed the events, pain in her entire left deltoid muscle and goes from middle of armpit radiating to the elbow, nerve pain and hot and painful, as related to study drug.; Reporter's Comments: This case concerns a 36 year-old, female patient, who experienced events of pain in her entire left deltoid muscle and goes from middle of armpit radiating to the elbow and nerve pain and it is hot and painful. The events occurred 7 hours after the first dose of COVID 19 vaccine administration. Due to possible temporal association, the events are considered as related to COVID 19 vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Musculoskeletal stiffness, Neck pain, Pyrexia
Clinical narrative: Can't turn neck (stiffed); Slight Fever; Left shoulder to neck pain; Neck Pain; Feels like someone is punching on her middle back; Initial MOD-2020-001518  A spontaneous report was received from a 59-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced left shoulder to neck pain, a feeling of somebody punching on her middle back, a stiff neck, slight fever and shoulder soreness that was getting worse.  The patient's medical history, as provided by the reporter, included high blood pressure. Concomitant medications reported included irbesartan.   On 23 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) for prophylaxis of COVID-19 infection.     On 24 Dec 2020, the patient experienced left shoulder to neck pain, a feeling of somebody punching on her middle back, stiff neck, slight fever and shoulder soreness that was getting worse. Treatment for the events included Tylenol on 25 Dec 2020.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events left shoulder to neck pain, a feeling of somebody punching on her middle back, a stiff neck, slight fever and shoulder soreness that was getting worse were considered not recovered.; Reporter's Comments: This case concerns a 59 year old female with medical history of hypertension, who experienced nonserious unexpected events of back pain, neck pain, and neck stiffness and nonserious expected events of pyrexia and shoulder pain. The events occurred 1 day after first dose of mRNA-1273, and were treated with Tylenol. All events were ongoing at the time of this report. 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.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity
Clinical narrative: A bit stuffy or stuffiness; Sore arm; A spontaneous report was received from  healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who developed a sore arm and a bit stuffy or stuffiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 24 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.  On 24 Dec 2020, the patient received her first dose of the Moderna vaccine. On 25 Dec 2020, the patient notified a company representative via text message that she had a sore arm and was a bit stuffy or  stuffiness.  She had no dizziness or nausea in general. The patient does not consent to Safety follow-up.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, sore arm and a bit stuffy or stuffiness, were unknown.; Reporter's Comments: This case concerns a female patient in mid 50s, who experienced an unexpected non-serious event of Nasal congestion and an expected non-serious event of Pain in extremity. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Heart rate from 58 that went up to 90; A spontaneous report was received from a nurse, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart rate from 58 that went up to 90.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date in Dec 2020, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date in Dec 2020, the patient experienced a heart rate from 58 that went up to 90. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, heart rate from 58 that went up to 90, was reported as resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.