chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Pain, Rash pruritic
Clinical narrative: Itchy Rash all over body; Very Tired; Body Aches; clammy hot and cold; headache; This spontaneous report received from a patient concerned a 59 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 not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced itchy rash all over body. On MAR-2021, the subject experienced very tired. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced clammy hot and cold. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash all over body, very tired, body aches, clammy hot and cold, and headache. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Chills, Electrocardiogram, Epistaxis
Clinical narrative: TACHYCARDIA; SLIGHTLY LOW WHITE BLOOD CELL COUNT; CHEST PAIN; BLOODY NOSE; HIVES IN BACK (RED AND ELEVATED); ACHINESS; PRE MENSTRUAL BLEEDING; NAUSEA; FATIGUE; HEADACHE; MINOR CHILLS; This spontaneous report received from a physician concerned a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and relatively healthy individual. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 07:00 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and ECG (NR: not provided) Normal. On 25-MAR-2021, the subject experienced minor chills. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced achiness. On 26-MAR-2021, the subject experienced pre menstrual bleeding. On 26-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 69 {beats}/min. On 27-MAR-2021, the subject experienced tachycardia. On 27-MAR-2021, the subject experienced slightly low white blood cell count. On 27-MAR-2021, the subject experienced chest pain. On 27-MAR-2021, the subject experienced bloody nose. On 27-MAR-2021, the subject experienced hives in back (red and elevated). Laboratory data included: Decreased hemoglobin (NR: not provided) 1.9 (unspecified unit), Heart rate (NR: not provided) 90 {beats}/min, 106 {beats}/min, and White blood cell count (NR: not provided) 3.6 (unspecified unit). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 29-MAR-2021, achiness, bloody nose, hives in back (red and elevated), and fatigue on 27-MAR-2021, and pre menstrual bleeding, minor chills, and headache on 28-MAR-2021, was recovering from tachycardia, and the outcome of slightly low white blood cell count and nausea 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemoglobin decreased, Headache, Heart rate, Menstrual disorder
Clinical narrative: TACHYCARDIA; SLIGHTLY LOW WHITE BLOOD CELL COUNT; CHEST PAIN; BLOODY NOSE; HIVES IN BACK (RED AND ELEVATED); ACHINESS; PRE MENSTRUAL BLEEDING; NAUSEA; FATIGUE; HEADACHE; MINOR CHILLS; This spontaneous report received from a physician concerned a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and relatively healthy individual. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 07:00 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and ECG (NR: not provided) Normal. On 25-MAR-2021, the subject experienced minor chills. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced achiness. On 26-MAR-2021, the subject experienced pre menstrual bleeding. On 26-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 69 {beats}/min. On 27-MAR-2021, the subject experienced tachycardia. On 27-MAR-2021, the subject experienced slightly low white blood cell count. On 27-MAR-2021, the subject experienced chest pain. On 27-MAR-2021, the subject experienced bloody nose. On 27-MAR-2021, the subject experienced hives in back (red and elevated). Laboratory data included: Decreased hemoglobin (NR: not provided) 1.9 (unspecified unit), Heart rate (NR: not provided) 90 {beats}/min, 106 {beats}/min, and White blood cell count (NR: not provided) 3.6 (unspecified unit). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 29-MAR-2021, achiness, bloody nose, hives in back (red and elevated), and fatigue on 27-MAR-2021, and pre menstrual bleeding, minor chills, and headache on 28-MAR-2021, was recovering from tachycardia, and the outcome of slightly low white blood cell count and nausea 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Tachycardia, Urticaria, White blood cell count
Clinical narrative: TACHYCARDIA; SLIGHTLY LOW WHITE BLOOD CELL COUNT; CHEST PAIN; BLOODY NOSE; HIVES IN BACK (RED AND ELEVATED); ACHINESS; PRE MENSTRUAL BLEEDING; NAUSEA; FATIGUE; HEADACHE; MINOR CHILLS; This spontaneous report received from a physician concerned a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and relatively healthy individual. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 07:00 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and ECG (NR: not provided) Normal. On 25-MAR-2021, the subject experienced minor chills. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced achiness. On 26-MAR-2021, the subject experienced pre menstrual bleeding. On 26-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 69 {beats}/min. On 27-MAR-2021, the subject experienced tachycardia. On 27-MAR-2021, the subject experienced slightly low white blood cell count. On 27-MAR-2021, the subject experienced chest pain. On 27-MAR-2021, the subject experienced bloody nose. On 27-MAR-2021, the subject experienced hives in back (red and elevated). Laboratory data included: Decreased hemoglobin (NR: not provided) 1.9 (unspecified unit), Heart rate (NR: not provided) 90 {beats}/min, 106 {beats}/min, and White blood cell count (NR: not provided) 3.6 (unspecified unit). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 29-MAR-2021, achiness, bloody nose, hives in back (red and elevated), and fatigue on 27-MAR-2021, and pre menstrual bleeding, minor chills, and headache on 28-MAR-2021, was recovering from tachycardia, and the outcome of slightly low white blood cell count and nausea 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: TACHYCARDIA; SLIGHTLY LOW WHITE BLOOD CELL COUNT; CHEST PAIN; BLOODY NOSE; HIVES IN BACK (RED AND ELEVATED); ACHINESS; PRE MENSTRUAL BLEEDING; NAUSEA; FATIGUE; HEADACHE; MINOR CHILLS; This spontaneous report received from a physician concerned a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and relatively healthy individual. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 07:00 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and ECG (NR: not provided) Normal. On 25-MAR-2021, the subject experienced minor chills. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced achiness. On 26-MAR-2021, the subject experienced pre menstrual bleeding. On 26-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 69 {beats}/min. On 27-MAR-2021, the subject experienced tachycardia. On 27-MAR-2021, the subject experienced slightly low white blood cell count. On 27-MAR-2021, the subject experienced chest pain. On 27-MAR-2021, the subject experienced bloody nose. On 27-MAR-2021, the subject experienced hives in back (red and elevated). Laboratory data included: Decreased hemoglobin (NR: not provided) 1.9 (unspecified unit), Heart rate (NR: not provided) 90 {beats}/min, 106 {beats}/min, and White blood cell count (NR: not provided) 3.6 (unspecified unit). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 29-MAR-2021, achiness, bloody nose, hives in back (red and elevated), and fatigue on 27-MAR-2021, and pre menstrual bleeding, minor chills, and headache on 28-MAR-2021, was recovering from tachycardia, and the outcome of slightly low white blood cell count and nausea 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: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: HEADACHE; UPSET STOMACH; FEVER; This spontaneous report received from a vaccine facility 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: unknown) dose was not reported, administered on 25-MAR-2021 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 25-MAR-2021, the subject experienced upset stomach. On 25-MAR-2021, the  subject experienced fever. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fever and upset stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Heart rate increased, Pharyngeal swelling
Clinical narrative: THROAT SWELLING; RAPID HEART BEAT; DRY MOUTH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included history of allergies.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. Batch number was not reported and same has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced throat swelling, rapid heart beat, and dry mouth. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, acetylsalicylic acid, and lorazepam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, rapid heart beat, and dry mouth. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Dyspnoea, Headache, Myalgia
Clinical narrative: LOWER PART OF LEFT LEG FROM ANKLE UP TO KNEE PERIODICALLY PAINFUL- NOT SHARP PAIN JUST AN ACHE; HEADACHE; FEVER 106 DEGREES; MUSCLE ACHE; STOMACH CRAMPS; SEVERE RINGING IN EARS; RUNNY NOSE; STUFFY NOSE; TROUBLE BREATHING IN MORNING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included asymptomatic covid, and concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at  right arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced stomach cramps. On 27-MAR-2021, the subject experienced severe ringing in ears. On 27-MAR-2021, the subject experienced runny nose. On 27-MAR-2021, the subject experienced stuffy nose. On 27-MAR-2021, the subject experienced trouble breathing in morning. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever 106 degrees. On 27-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 106 F. On 28-MAR-2021, the subject experienced lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach cramps, severe ringing in ears, trouble breathing in morning, headache, and fever 106 degrees on 27-MAR-2021, had not recovered from runny nose, stuffy nose, and lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache, and the outcome of muscle ache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Pyrexia, Rhinorrhoea, Tinnitus
Clinical narrative: LOWER PART OF LEFT LEG FROM ANKLE UP TO KNEE PERIODICALLY PAINFUL- NOT SHARP PAIN JUST AN ACHE; HEADACHE; FEVER 106 DEGREES; MUSCLE ACHE; STOMACH CRAMPS; SEVERE RINGING IN EARS; RUNNY NOSE; STUFFY NOSE; TROUBLE BREATHING IN MORNING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included asymptomatic covid, and concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at  right arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced stomach cramps. On 27-MAR-2021, the subject experienced severe ringing in ears. On 27-MAR-2021, the subject experienced runny nose. On 27-MAR-2021, the subject experienced stuffy nose. On 27-MAR-2021, the subject experienced trouble breathing in morning. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever 106 degrees. On 27-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 106 F. On 28-MAR-2021, the subject experienced lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach cramps, severe ringing in ears, trouble breathing in morning, headache, and fever 106 degrees on 27-MAR-2021, had not recovered from runny nose, stuffy nose, and lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache, and the outcome of muscle ache was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site pain, Pain in extremity
Clinical narrative: WARMTH IN THE ARM; ACHINESS AND PAIN IN THE ARM AROUND THE  INJECTION AREA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was not reported and height was 167 centimeters. The patient's concurrent conditions included penicillin allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 13:45 on left arm for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure. On 05-MAR-2021, the subject experienced injection site pain. On 23-MAR-2021, the subject experienced warmth in the arm. On 23-MAR-2021, the subject experienced achiness and pain in the arm around the injection area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from achiness and pain in the arm around the injection area, and warmth in the arm. This report was non-serious.  Additional information was received from patient on 31-MAR-2021.The following information was updated and incorporated into the case: Patient height, medical history (penicillin allergy) added, Concomitant product amlodipine added. Vaccination time added, Expiry date added.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: CHILLS; SORE ARM; SLIGHT HEADACHE; This spontaneous report received from a consumer 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: Unk) 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 chills, sore arm and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and slight headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: VOMITING; FEVER; HEADACHE; NAUSEA; FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 29 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: Unknown) dose was not reported, administered on 25-MAR-2021 at left deltoid muscle for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced vomiting. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 101-105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on MAR-2021, and had not recovered from headache, nausea, fever, and fatigue. 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: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: VOMITING; FEVER; HEADACHE; NAUSEA; FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 29 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: Unknown) dose was not reported, administered on 25-MAR-2021 at left deltoid muscle for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced vomiting. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 101-105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on MAR-2021, and had not recovered from headache, nausea, fever, and fatigue. 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: Asthenia, Axillary pain, Back pain, Headache
Clinical narrative: SHARP PAIN IN BACK; ARM PIT HURT; NO ENERGY TOO; HEADACHES; 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 (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, once a total administered, start therapy date 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 headaches, back pain, arm pit hurt, and no energy. The action taken with covid-19 vaccine was not applicable. The outcome of the headaches, back pain, arm pit hurt and no energy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RED RASH (STARTED ON FEET AND STOMACH BUT NOW EVERYWHERE)/ ITCHY/ ALLERGIC REACTION SOMETHING; This spontaneous report received from a patient concerned a 51 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: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced red rash (started on feet and stomach but now everywhere)/ itchy/ allergic reaction something. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, hydrocortisone, and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash (started on feet and stomach but now everywhere)/ itchy/ allergic reaction something. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS IN LEFT WRISTS WHICH MOVES TOWARDS LEFT  HAND; 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: Unknown) dose was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced numbness in left wrists which moves towards left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness in left wrists which moves towards left hand was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Breast pain, Breast swelling, Chills, Fatigue
Clinical narrative: BOOBS WERE FILLED WITH CYSTS; PAINFUL BOOBS; SWOLLEN BOOBS; NIGHT SWEATS; LITTLE FAINT; GOT PERIODS EARLY/IMPACTING CYCLE; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned multiple patients. 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced boobs were filled with cysts, painful boobs, swollen boobs, night sweats, little faint, got periods early/impacting cycle, chills, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, little faint, and tired, had not recovered from fever, and chills, and the outcome of painful boobs, swollen boobs, boobs were filled with cysts and got periods early/impacting cycle was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Polymenorrhoea, Presyncope, Pyrexia
Clinical narrative: BOOBS WERE FILLED WITH CYSTS; PAINFUL BOOBS; SWOLLEN BOOBS; NIGHT SWEATS; LITTLE FAINT; GOT PERIODS EARLY/IMPACTING CYCLE; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned multiple patients. 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced boobs were filled with cysts, painful boobs, swollen boobs, night sweats, little faint, got periods early/impacting cycle, chills, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, little faint, and tired, had not recovered from fever, and chills, and the outcome of painful boobs, swollen boobs, boobs were filled with cysts and got periods early/impacting cycle was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: BODY ACHES; CHILLS; LEG PAIN; HEADACHE; This spontaneous report received from a parent 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, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced body aches. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced leg pain. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and leg pain, and had not recovered from chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Appetite disorder, Dry mouth, Pain
Clinical narrative: EXTREMELY HUNGRY; BODY ACHES; COTTON MOUTH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included drug allergy, smoker, and non alcoholic, and other pre-existing medical conditions included drug abuse/illicit - no. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) vaccinated at right deltoid ,dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced cotton mouth. On 24-MAR-2021, the subject experienced extremely hungry and body aches. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cotton mouth, extremely hungry, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 37 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: 1805025, and  expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site pain, Limb discomfort
Clinical narrative: FATIGUE; LEGS WITH A HEAVY FEELING; LOSS OF APPETITE; ITCHINESS; RASH; ACHING OF LEGS; INJECTION ARM SORENESS; CHILLS; This spontaneous report received from a patient concerned a 49 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 not reported) once a total  dose was not reported, administered on 05-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced legs with a heavy feeling. On 05-MAR-2021, the subject experienced loss of appetite. On 05-MAR-2021, the subject experienced itchiness. On 05-MAR-2021, the subject experienced aching of legs. On 05-MAR-2021, the subject experienced injection arm soreness. On 05-MAR-2021, the subject experienced rash. On 05-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fatigue. Treatment medication (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs with a heavy feeling, aching of legs, and chills on 06-MAR-2021, and itchiness on 24-MAR-2021, was recovering from rash, and injection arm soreness, and the outcome of fatigue and loss of appetite was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: FATIGUE; LEGS WITH A HEAVY FEELING; LOSS OF APPETITE; ITCHINESS; RASH; ACHING OF LEGS; INJECTION ARM SORENESS; CHILLS; This spontaneous report received from a patient concerned a 49 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 not reported) once a total  dose was not reported, administered on 05-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced legs with a heavy feeling. On 05-MAR-2021, the subject experienced loss of appetite. On 05-MAR-2021, the subject experienced itchiness. On 05-MAR-2021, the subject experienced aching of legs. On 05-MAR-2021, the subject experienced injection arm soreness. On 05-MAR-2021, the subject experienced rash. On 05-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fatigue. Treatment medication (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs with a heavy feeling, aching of legs, and chills on 06-MAR-2021, and itchiness on 24-MAR-2021, was recovering from rash, and injection arm soreness, and the outcome of fatigue and loss of appetite was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest X-ray, Chest pain, Gait disturbance, Headache
Clinical narrative: CHEST PAIN WHEN BREATHING; INCREASED HEART RATE UPTO 150; TROUBLE SITTING; TROUBLE LAYING DOWN; EXTREME BODY PAIN; TROUBLE WALKING; BACK PAIN; SORENESS AT INJECTION SITE; NAUSEA; THROBBING HEADACHE; This spontaneous report received from a patient 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, intramuscular, batch number: 1805029 expiry: unknown) dose was not reported, administered on 24-MAR-2021 10:35 on left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced chest pain when breathing. On 24-MAR-2021, the subject experienced increased heart rate upto 150. On 24-MAR-2021, the subject experienced trouble sitting. On 24-MAR-2021, the subject experienced trouble laying down. On 24-MAR-2021, the subject experienced extreme body pain. On 24-MAR-2021, the subject experienced trouble walking. On 24-MAR-2021, the subject experienced back pain. On 24-MAR-2021, the subject experienced soreness at injection site. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced throbbing headache. Laboratory data included: Heart rate (NR: not provided) 150 (units unspecified). Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) UNKNOWN (units unspecified). Treatment medications (dates unspecified) included: ondansetron, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing headache, nausea, extreme body pain, increased heart rate upto 150, soreness at injection site, trouble walking, trouble sitting, trouble laying down, chest pain when breathing, and back pain. 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: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Injection site pain, Movement disorder, Nausea
Clinical narrative: CHEST PAIN WHEN BREATHING; INCREASED HEART RATE UPTO 150; TROUBLE SITTING; TROUBLE LAYING DOWN; EXTREME BODY PAIN; TROUBLE WALKING; BACK PAIN; SORENESS AT INJECTION SITE; NAUSEA; THROBBING HEADACHE; This spontaneous report received from a patient 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, intramuscular, batch number: 1805029 expiry: unknown) dose was not reported, administered on 24-MAR-2021 10:35 on left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced chest pain when breathing. On 24-MAR-2021, the subject experienced increased heart rate upto 150. On 24-MAR-2021, the subject experienced trouble sitting. On 24-MAR-2021, the subject experienced trouble laying down. On 24-MAR-2021, the subject experienced extreme body pain. On 24-MAR-2021, the subject experienced trouble walking. On 24-MAR-2021, the subject experienced back pain. On 24-MAR-2021, the subject experienced soreness at injection site. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced throbbing headache. Laboratory data included: Heart rate (NR: not provided) 150 (units unspecified). Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) UNKNOWN (units unspecified). Treatment medications (dates unspecified) included: ondansetron, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing headache, nausea, extreme body pain, increased heart rate upto 150, soreness at injection site, trouble walking, trouble sitting, trouble laying down, chest pain when breathing, and back pain. 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: M
Vaccine: COVID19
Symptoms: Pain, Restlessness
Clinical narrative: CHEST PAIN WHEN BREATHING; INCREASED HEART RATE UPTO 150; TROUBLE SITTING; TROUBLE LAYING DOWN; EXTREME BODY PAIN; TROUBLE WALKING; BACK PAIN; SORENESS AT INJECTION SITE; NAUSEA; THROBBING HEADACHE; This spontaneous report received from a patient 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, intramuscular, batch number: 1805029 expiry: unknown) dose was not reported, administered on 24-MAR-2021 10:35 on left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced chest pain when breathing. On 24-MAR-2021, the subject experienced increased heart rate upto 150. On 24-MAR-2021, the subject experienced trouble sitting. On 24-MAR-2021, the subject experienced trouble laying down. On 24-MAR-2021, the subject experienced extreme body pain. On 24-MAR-2021, the subject experienced trouble walking. On 24-MAR-2021, the subject experienced back pain. On 24-MAR-2021, the subject experienced soreness at injection site. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced throbbing headache. Laboratory data included: Heart rate (NR: not provided) 150 (units unspecified). Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) UNKNOWN (units unspecified). Treatment medications (dates unspecified) included: ondansetron, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throbbing headache, nausea, extreme body pain, increased heart rate upto 150, soreness at injection site, trouble walking, trouble sitting, trouble laying down, chest pain when breathing, and back pain. 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: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Hypoaesthesia, Paraesthesia
Clinical narrative: SHORTNESS OF BREATH; PARAESTHESIA; CANNOT STAND; HYPOAESTHESIA; This spontaneous report received from a parent 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, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 24-MAR-2021, the subject experienced shortness of breath. On 24-MAR-2021, the subject experienced Paraesthesia. On 24-MAR-2021, the subject experienced cannot stand. On 24-MAR-2021, the subject experienced Hypoaesthesia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, Paraesthesia, and Hypoaesthesia, and the outcome of cannot stand 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.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Pyrexia, Tachycardia
Clinical narrative: HEART RATE OF 120; FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) once a total dose was not reported, administered on 26-MAR-2021 08:40 at right deltoid for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced heart rate of 120.  On 26-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2, and Heart rate (NR: not provided) 120. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and heart rate of 120. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Nausea, Pain
Clinical narrative: SYMPOTMS SUCH AS STUFF NOSE THAT PROGRESSED TO LOSS OF TASTE AND SMELL; CHILLS; ACHEY ALL OVER BODY; FEVER; NAUSEA; REALLY TIRED; SWELLING OF LYMPHOCYTES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dry cough, and other pre-existing medical conditions included has a dry cough from taking lisinopril, starting medication about a week before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril. On 25-MAR-2021, the subject experienced swelling of lymphocytes. On 25-MAR-2021 16:00, the subject experienced really tired. On 25-MAR-2021 22:00, the subject experienced achey all over body. On 25-MAR-2021 22:00, the subject experienced chills. On 25-MAR-2021 22:00, the subject experienced fever. On 25-MAR-2021 22:00, the subject experienced nausea. On 26-MAR-2021, the subject experienced symptoms such as stuff nose that progressed to loss of taste and smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from really tired, fever, chills, and swelling of lymphocytes, and the outcome of nausea, sympotms such as stuff nose that progressed to loss of taste and smell and achey all over body was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis
Clinical narrative: SYMPOTMS SUCH AS STUFF NOSE THAT PROGRESSED TO LOSS OF TASTE AND SMELL; CHILLS; ACHEY ALL OVER BODY; FEVER; NAUSEA; REALLY TIRED; SWELLING OF LYMPHOCYTES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dry cough, and other pre-existing medical conditions included has a dry cough from taking lisinopril, starting medication about a week before getting the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) 1 total, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril. On 25-MAR-2021, the subject experienced swelling of lymphocytes. On 25-MAR-2021 16:00, the subject experienced really tired. On 25-MAR-2021 22:00, the subject experienced achey all over body. On 25-MAR-2021 22:00, the subject experienced chills. On 25-MAR-2021 22:00, the subject experienced fever. On 25-MAR-2021 22:00, the subject experienced nausea. On 26-MAR-2021, the subject experienced symptoms such as stuff nose that progressed to loss of taste and smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from really tired, fever, chills, and swelling of lymphocytes, and the outcome of nausea, sympotms such as stuff nose that progressed to loss of taste and smell and achey all over body was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: CHILLS AROUND 5 PM; AROUND 5 PM FEVER; FATIGUE AND TIRED ALL DAY; SEVERE HEADACHE; This spontaneous report received from a patient 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on  right arm. for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 99 F, 101 F, 99.5 F. On 26-MAR-2021, the subject experienced around 5 pm fever. On 26-MAR-2021, the subject experienced chills around 5 pm. On 26-MAR-2021, the subject experienced fatigue and tired all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the around 5 pm fever, chills around 5 pm, fatigue and tired all day and severe headache was not reported. This report was non-serious.