chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Pain
Clinical narrative: MOUTH DRYNESS/THRUSHY FEELING IN MOUTH; ACHES; PAIN; FATIGUE; HEADACHE; SKIN BURNING ESPECIALLY ON THE FACE, ALSO ON BACK; EXTREME SENSITIVITY ON SKIN; HYPED-UP FEELING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced skin burning especially on the face, also on back. On 13-MAR-2021, the subject experienced extreme sensitivity on skin. On 13-MAR-2021, the subject experienced hyped-up feeling. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced pain. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced mouth dryness/thrushy feeling in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, pain, fatigue, and headache, and the outcome of skin burning especially on the face, also on back, extreme sensitivity on skin, hyped-up feeling and mouth dryness/thrushy feeling in mouth was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Pyrexia
Clinical narrative: FEVER; INCREASED HEART RATE; CHEST PRESSURE AND CHEST PAIN; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, and inflammation of the sternum.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for inflammation of the sternum, and propranolol for inflammation of the sternum. On 15-MAR-2021, the subject experienced increased heart rate. On 15-MAR-2021, the subject experienced chest pressure and chest pain. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, and fever on 16-MAR-2021, and had not recovered from chest pressure and chest 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: U
Vaccine: COVID19
Symptoms: Adverse event, Influenza like illness
Clinical narrative: FELT LIKE THE FLU; BAD RESULT; This spontaneous report received from a patient via a company representative 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, expiry: 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 subject experienced felt like the flu, and bad result. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like the flu and bad result was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED ADVERSE EVENTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disorder. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced unspecified adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse events was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: BODY ACHES; CHILLS; FATIGUE; This spontaneous report received from a health care professional 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 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 body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, body aches and chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative 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 17-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 fever, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: DIARRHEA; FELT TIRED; FEELING QUEASY; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 14:30 on right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced slight headache. On 18-MAR-2021 05:00, the subject experienced diarrhea. On 18-MAR-2021 05:00, the subject experienced felt tired. On 18-MAR-2021 05:00, the subject experienced feeling queasy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 10-MAR-2021, and had not recovered from felt tired, diarrhea, and feeling queasy. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: CHILLS; ARM TENDER/SORE ARM; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, high blood pressure, high cholesterol, and seasonal (dust and pollen) allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced arm tender/sore arm. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm tender/sore arm, headache, and fatigue on 10-MAR-2021. The reporter causality between JNJ-78436735 and chills, arm tender/sore arm, headache, and fatigue was related. Company causality between JNJ-78436735 and chills, arm tender/sore arm, headache, and fatigue was possible. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood glucose abnormal, Blood glucose decreased, Blood glucose fluctuation, Chest pain
Clinical narrative: FLUCTUATING BLOOD SUGAR; BLOOD SUGAR IS LOWER; CHILLS; TROUBLE BREATHING; BACK PAIN; PUKING; CHEST PAIN; NO APETITE; EXTREMELY TIRED; FELT LIKE CRAP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  and batch number: 1805031) dose was not reported, administered on 11-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced no apetite. On MAR-2021, the subject experienced felt like crap. On MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced puking. On 11-MAR-2021, the subject experienced chest pain. On 11-MAR-2021, the subject experienced trouble breathing. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fluctuating blood sugar. On 16-MAR-2021, the subject experienced blood sugar is lower. Laboratory data included: Blood sugar abnormal (NR: not provided) FLUCTUATING AND LOWER. Treatment medications (dates unspecified) included: codeine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puking, chest pain, extremely tired, no apetite, fluctuating blood sugar, back pain, and blood sugar is lower, and the outcome of trouble breathing, chills and felt like crap was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Malaise
Clinical narrative: FLUCTUATING BLOOD SUGAR; BLOOD SUGAR IS LOWER; CHILLS; TROUBLE BREATHING; BACK PAIN; PUKING; CHEST PAIN; NO APETITE; EXTREMELY TIRED; FELT LIKE CRAP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  and batch number: 1805031) dose was not reported, administered on 11-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced no apetite. On MAR-2021, the subject experienced felt like crap. On MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced puking. On 11-MAR-2021, the subject experienced chest pain. On 11-MAR-2021, the subject experienced trouble breathing. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fluctuating blood sugar. On 16-MAR-2021, the subject experienced blood sugar is lower. Laboratory data included: Blood sugar abnormal (NR: not provided) FLUCTUATING AND LOWER. Treatment medications (dates unspecified) included: codeine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puking, chest pain, extremely tired, no apetite, fluctuating blood sugar, back pain, and blood sugar is lower, and the outcome of trouble breathing, chills and felt like crap was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: FLUCTUATING BLOOD SUGAR; BLOOD SUGAR IS LOWER; CHILLS; TROUBLE BREATHING; BACK PAIN; PUKING; CHEST PAIN; NO APETITE; EXTREMELY TIRED; FELT LIKE CRAP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  and batch number: 1805031) dose was not reported, administered on 11-MAR-2021 on Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced no apetite. On MAR-2021, the subject experienced felt like crap. On MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced puking. On 11-MAR-2021, the subject experienced chest pain. On 11-MAR-2021, the subject experienced trouble breathing. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fluctuating blood sugar. On 16-MAR-2021, the subject experienced blood sugar is lower. Laboratory data included: Blood sugar abnormal (NR: not provided) FLUCTUATING AND LOWER. Treatment medications (dates unspecified) included: codeine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puking, chest pain, extremely tired, no apetite, fluctuating blood sugar, back pain, and blood sugar is lower, and the outcome of trouble breathing, chills and felt like crap was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling cold, Oropharyngeal pain, Productive cough
Clinical narrative: PAIN UNDER LEFT EAR; LOT OF PHLEGM; PAIN IN THROAT WHEN SWALLOWS; COLD IN THROAT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, once a total administered, start therapy date not reported for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced pain under left ear. On 18-MAR-2021, the subject experienced lot of phlegm. On 18-MAR-2021, the subject experienced pain in throat when swallows. On 18-MAR-2021, the subject experienced cold in throat. Treatment medications included: isopropanol/menthol/thymol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain under left ear, lot of phlegm, pain in throat when swallows and cold in throat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: ARM SORENESS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 arm soreness, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, arm soreness and headache was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Migraine, Nausea
Clinical narrative: VOMITING; NO HUNGER; "NOT ALL THERE" FOGGY; NAUSEA; FATIGUE; HIGH FEVER/BURNING UP; SEVERE HEADACHE CALLED AS MIGRAINE; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 68 kilograms, and height was 164.59 centimeters. The patient's concurrent conditions included back pain, neck pain, and methadone allergy, and other pre-existing medical conditions included the patient had no illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 14-MAR-2021, the subject experienced severe headache called as migraine. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced no hunger. On 14-MAR-2021, the subject experienced "not all there" foggy. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced high fever/burning up. On 16-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache called as migraine, and high fever/burning up on 17-MAR-2021, and vomiting on MAR-2021, and was recovering from body aches, nausea, no hunger, "not all there" foggy, and fatigue. This report was non-serious.  The additional information was received from consumer/non health care professional on 23-Mar-2021. The following information was updated and incorporated into case narrative- patient demographics (patient height, weight, age at the time of vaccination and age group), methadone allergy, and no illness at the time of vaccination were added.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: VOMITING; NO HUNGER; "NOT ALL THERE" FOGGY; NAUSEA; FATIGUE; HIGH FEVER/BURNING UP; SEVERE HEADACHE CALLED AS MIGRAINE; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 68 kilograms, and height was 164.59 centimeters. The patient's concurrent conditions included back pain, neck pain, and methadone allergy, and other pre-existing medical conditions included the patient had no illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 14-MAR-2021, the subject experienced severe headache called as migraine. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced no hunger. On 14-MAR-2021, the subject experienced "not all there" foggy. On 14-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced high fever/burning up. On 16-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache called as migraine, and high fever/burning up on 17-MAR-2021, and vomiting on MAR-2021, and was recovering from body aches, nausea, no hunger, "not all there" foggy, and fatigue. This report was non-serious.  The additional information was received from consumer/non health care professional on 23-Mar-2021. The following information was updated and incorporated into case narrative- patient demographics (patient height, weight, age at the time of vaccination and age group), methadone allergy, and no illness at the time of vaccination were added.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: NAUSEA; HEADACHE; INTENSE DIZZINESS WHICH FEELS LESS DIZZY WHEN STANDING ON SOLID FLOOR OR NOT MOVING; 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: Unknown) dose was not reported, administered on 12-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced intense dizziness which feels less dizzy when standing on solid floor or not moving. On 13-MAR-2021, the subject experienced nausea. On 13-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 intense dizziness which feels less dizzy when standing on solid floor or not moving, nausea, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Sinus headache, Vomiting
Clinical narrative: VOMITING; HEADACHE; NAUSEA; SINUS HEADACHE ACROSS NOSE; 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced sinus headache. On 17-MAR-2021, the subject experienced nausea. On an unspecified date, the subject experienced vomiting, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, headache, and nausea on 17-MAR-2021, and sinus headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; UPSET STOMACH; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805026 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, Laboratory data included: COVID-19 (NR: not provided) Positive. On 15-MAR-2021, the subject experienced upset stomach. On 17-MAR-2021, the subject experienced suspected covid-19 infection( Symptoms included headache, tiredness, chills, sweating, weakness, tiredness, runny nose, and sore throat) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from upset stomach, and the outcome of suspected covid-19 infection was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria based on the PQC evaluation/investigation performed. This case is associated with PQC number: 90000173441; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient via a company representative 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 15-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 MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue, fever, body aches and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210329989.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness
Clinical narrative: WORSE SIDE EFFECTS AND FOR A LONGER PERIOD OF TIME; REALLY SICK FOR A WEEK; 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced worse side effects and for a longer period of time, and really sick for a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worse side effects and for a longer period of time and really sick for a week was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: BREATHING IS HARSH; SICK; VOMITING; DIARRHEA; CHEST FEELS TIGHT SOMETIMES; FEEL BAD; SEVERE CHILLS; FEELING RUN DOWN; NAUSEA; This spontaneous report received from a patient concerned a 56 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced breathing is harsh. On 16-MAR-2021, the subject experienced sick. On 16-MAR-2021, the subject experienced vomiting. On 16-MAR-2021, the subject experienced diarrhea. On 16-MAR-2021, the subject experienced chest feels tight sometimes. On 16-MAR-2021, the subject experienced feel bad. On 16-MAR-2021, the subject experienced severe chills. On 16-MAR-2021, the subject experienced feeling run down. On 16-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 17-MAR-2021, was recovering from chest feels tight sometimes, had not recovered from feeling run down, sick, vomiting, diarrhea, breathing is harsh, and nausea, and the outcome of feel bad 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: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Nausea, Vomiting
Clinical narrative: BREATHING IS HARSH; SICK; VOMITING; DIARRHEA; CHEST FEELS TIGHT SOMETIMES; FEEL BAD; SEVERE CHILLS; FEELING RUN DOWN; NAUSEA; This spontaneous report received from a patient concerned a 56 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced breathing is harsh. On 16-MAR-2021, the subject experienced sick. On 16-MAR-2021, the subject experienced vomiting. On 16-MAR-2021, the subject experienced diarrhea. On 16-MAR-2021, the subject experienced chest feels tight sometimes. On 16-MAR-2021, the subject experienced feel bad. On 16-MAR-2021, the subject experienced severe chills. On 16-MAR-2021, the subject experienced feeling run down. On 16-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills on 17-MAR-2021, was recovering from chest feels tight sometimes, had not recovered from feeling run down, sick, vomiting, diarrhea, breathing is harsh, and nausea, and the outcome of feel bad 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: SWEATY; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's weight was 240 pounds, and height was 74 inches. 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: 1805029 -last # unclear to caller, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 15:30 hours to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced sweaty. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, chills, and fatigue on 14-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Migraine, Pyrexia, Vomiting
Clinical narrative: STOMACH UPSET; MIGRAINE; VOMITING; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced stomach upset. On 04-MAR-2021, the subject experienced migraine. On 04-MAR-2021, the subject experienced vomiting. On 04-MAR-2021, the subject experienced feeling weak. On 04-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, vomiting, feeling weak, and fever, and had not recovered from stomach upset. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No concurrent conditions were reported. The patient's parent's medical history unknown.  The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported.  In MAR-2021, the subject experienced breastfeeding exposure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breastfeeding exposure was not reported. This report was non-serious. This parent/child case is linked to 20210332395.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODYACHE; FEVER; .This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bodyache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bodyache and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: HAND AND ARM WENT A LITTLE NUMB; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 hand and arm went a little numb, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand and arm went a little numb, and the outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Eye pruritus, Fatigue, Headache
Clinical narrative: ITCHY EYES; EYELIDS SWELLED; HEADACHE; FATIGUE; TEMPERATURES UP TO 99 DEGREES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-MAR-2021, the subject experienced itchy eyes. On 17-MAR-2021, the subject experienced eyelids swelled. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced temperatures up to 99 degrees. On 18-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 degrees (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eyelids swelled, had not recovered from headache, fatigue, and temperatures up to 99 degrees, and the outcome of itchy eyes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: ITCHY EYES; EYELIDS SWELLED; HEADACHE; FATIGUE; TEMPERATURES UP TO 99 DEGREES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-MAR-2021, the subject experienced itchy eyes. On 17-MAR-2021, the subject experienced eyelids swelled. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced temperatures up to 99 degrees. On 18-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 degrees (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eyelids swelled, had not recovered from headache, fatigue, and temperatures up to 99 degrees, and the outcome of itchy eyes was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 101.3 F; This spontaneous report received from a consumer concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lactose intolerant, non-smoker, and non-alcoholic, and other pre-existing medical conditions included no known drug allergies and no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s on left arm (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever of 101.3 F. Laboratory data included: Body temperature (NR: not provided) 101.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 101.3 F. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH; 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 past medical history included COPD. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: VOMITING; CHILLS; HEADACHE; NAUSEA; ACHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 16-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 16-MAR-2021, the subject experienced achy. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced nausea. On 18-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 17-MAR-2021, and had not recovered from headache, nausea, vomiting, and achy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Somnolence
Clinical narrative: SOMNOLENCE; NOT FEELING RIGHT; HEADACHE; WEAKNESS; This spontaneous report received from a patient 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: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced somnolence, not feeling right, headache, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, somnolence, weakness and not feeling right was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 18-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Lymphadenopathy, Pain
Clinical narrative: RETURN OF SMELL; RETURN OF TASTE; TIGHTNESS/HEAVINESS IN CHEST UPON INJECTION "OVER THE HEART"; HEAVY BREATHING UPON INJECTION; FEET SWEATING; SWOLLEN FACE AND LIPS, LOCALIZED TO LOWER AREA OF FACE (NOT AFFECTING THE EYES); SWELLING OF RIGHT LYMPH NODE ("TURKEY NECK APPEARANCE); BODY ACHES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included cardio-hx of pvc, and soft murmur allergy, and concurrent conditions included non-alcoholic, non-smoker, pollen allergy, peanut allergy, bee sting allergy, capsaicin allergy, fungus/mushroom allergy, and tetracycline allergy, and other pre-existing medical conditions included no drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021,19:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced return of smell. On 17-MAR-2021, the subject experienced return of taste. On 17-MAR-2021, the subject experienced tightness/heaviness in chest upon injection "over the heart".  On 17-MAR-2021, the subject experienced heavy breathing upon injection. On 17-MAR-2021, the subject experienced feet sweating. On 17-MAR-2021, the subject experienced swollen face and lips, localized to lower area of face (not affecting the eyes). On 17-MAR-2021, the subject experienced swelling of right lymph node ("turkey neck appearance). On 17-MAR-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: magnesium sulfate, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness/heaviness in chest upon injection "over the heart", heavy breathing upon injection, feet sweating, swollen face and lips, localized to lower area of face (not affecting the eyes), and swelling of right lymph node ("turkey neck appearance) on 17-MAR-2021, was recovering from body aches, and had not recovered from return of smell, and return of taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Swelling face, Taste disorder
Clinical narrative: RETURN OF SMELL; RETURN OF TASTE; TIGHTNESS/HEAVINESS IN CHEST UPON INJECTION "OVER THE HEART"; HEAVY BREATHING UPON INJECTION; FEET SWEATING; SWOLLEN FACE AND LIPS, LOCALIZED TO LOWER AREA OF FACE (NOT AFFECTING THE EYES); SWELLING OF RIGHT LYMPH NODE ("TURKEY NECK APPEARANCE); BODY ACHES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included cardio-hx of pvc, and soft murmur allergy, and concurrent conditions included non-alcoholic, non-smoker, pollen allergy, peanut allergy, bee sting allergy, capsaicin allergy, fungus/mushroom allergy, and tetracycline allergy, and other pre-existing medical conditions included no drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021,19:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced return of smell. On 17-MAR-2021, the subject experienced return of taste. On 17-MAR-2021, the subject experienced tightness/heaviness in chest upon injection "over the heart".  On 17-MAR-2021, the subject experienced heavy breathing upon injection. On 17-MAR-2021, the subject experienced feet sweating. On 17-MAR-2021, the subject experienced swollen face and lips, localized to lower area of face (not affecting the eyes). On 17-MAR-2021, the subject experienced swelling of right lymph node ("turkey neck appearance). On 17-MAR-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: magnesium sulfate, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tightness/heaviness in chest upon injection "over the heart", heavy breathing upon injection, feet sweating, swollen face and lips, localized to lower area of face (not affecting the eyes), and swelling of right lymph node ("turkey neck appearance) on 17-MAR-2021, was recovering from body aches, and had not recovered from return of smell, and return of taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS CANNOT GET WARM; This spontaneous report received from a patient concerned a female 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, batch number: D10523P) dose was not reported, vaccinated at right arm, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced chills cannot get warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills cannot get warm was not reported. This report was non-serious.