chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: DOES NOT FEEL VERY WELL; NAUSEA; CHILLS; HEADACHE; LOW FEVER; 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 concurrent conditions included coronary artery disease, non-alcohol user, non-smoker, sulfa allergy, and penicillin 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, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced low fever. On 28-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced does not feel very well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and low fever on 28-MAR-2021, and had not recovered from headache, nausea, and does not feel very well. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: VACCINE ADMINISTERED AFTER TEMPERATURE EXCURSION; 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 patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 25-MAR-2021, 26-MAR-2021, and 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patients experienced vaccine administered after temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after temperature excursion was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Discomfort, Fatigue, Feeling abnormal
Clinical narrative: SORE; LOSS OF APPETITE; FEELING TERRIBLE; ACHING JOINTS; INCREDIBLE FEVER; TIRED; 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: not reported) dose was not reported, once a total administered on 28-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 sore. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced feeling terrible. On MAR-2021, the subject experienced aching joints. On MAR-2021, the subject experienced incredible fever. On MAR-2021, the subject experienced tired. Laboratory data included: Lab test (NR: not provided) 8/10 recommended (units unspecified). The action taken with covid-19 vaccine was not applicable. The outcome of the tired, loss of appetite, incredible fever, aching joints, feeling terrible and sore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test, Pyrexia
Clinical narrative: SORE; LOSS OF APPETITE; FEELING TERRIBLE; ACHING JOINTS; INCREDIBLE FEVER; TIRED; 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: not reported) dose was not reported, once a total administered on 28-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 sore. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced feeling terrible. On MAR-2021, the subject experienced aching joints. On MAR-2021, the subject experienced incredible fever. On MAR-2021, the subject experienced tired. Laboratory data included: Lab test (NR: not provided) 8/10 recommended (units unspecified). The action taken with covid-19 vaccine was not applicable. The outcome of the tired, loss of appetite, incredible fever, aching joints, feeling terrible and sore was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Nausea, Pruritus, Rash, Rash macular
Clinical narrative: EARACHE; SINUS BLOCKAGE; FACIAL PUFFINESS; ITCHY; RASH ON FACE; RED SPOTS ON FACE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included rosacea, and concurrent conditions included osteoporosis, alcohol use, and non-smoker, and other 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at 10:40 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced earache. On 19-MAR-2021, the subject experienced sinus blockage. On 19-MAR-2021, the subject experienced facial puffiness. On 19-MAR-2021, the subject experienced itchy. On 19-MAR-2021, the subject experienced rash on face. On 19-MAR-2021, the subject experienced red spots on face. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from earache, sinus blockage, and nausea on 20-MAR-2021, had not recovered from rash on face, facial puffiness, and red spots on face, and the outcome of itchy was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sinonasal obstruction, Swelling face
Clinical narrative: EARACHE; SINUS BLOCKAGE; FACIAL PUFFINESS; ITCHY; RASH ON FACE; RED SPOTS ON FACE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included rosacea, and concurrent conditions included osteoporosis, alcohol use, and non-smoker, and other 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at 10:40 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced earache. On 19-MAR-2021, the subject experienced sinus blockage. On 19-MAR-2021, the subject experienced facial puffiness. On 19-MAR-2021, the subject experienced itchy. On 19-MAR-2021, the subject experienced rash on face. On 19-MAR-2021, the subject experienced red spots on face. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from earache, sinus blockage, and nausea on 20-MAR-2021, had not recovered from rash on face, facial puffiness, and red spots on face, and the outcome of itchy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Fatigue, Glossodynia, Hypersomnia, Ocular hyperaemia
Clinical narrative: STICKY AND OOZY EYES; HER EYES BECAME BLOOD SHOT; HER EYES BECAME RED; WHITE PATCHES IN MOUTH; VERY SENSITIVE TONGUE/TONGUE WAS VERY SENSITIVE; RUNNING NOSE WITH A CONSTANT NASAL DRIP; FATIGUE; HER EYES BECAME OOZY; SLEPT ALL DAY; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Sjogren's disease, rheumatoid arthritis, odours,environmental allergies, and had problems with eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced her eyes became oozy. On 27-MAR-2021, the subject experienced slept all day. On 27-MAR-2021, the subject experienced fatigue. On 27-MAR-2021 17:30, the subject experienced running nose with a constant nasal drip. On 29-MAR-2021, the subject experienced very sensitive tongue/tongue was very sensitive. On 30-MAR-2021, the subject experienced white patches in mouth. On an unspecified date, the subject experienced her eyes became blood shot, her eyes became red, and sticky and oozy eyes. Treatment medications (dates unspecified) included: allergy medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from her eyes became blood shot, sticky and oozy eyes, her eyes became oozy, and her eyes became red, had not recovered from running nose with a constant nasal drip, fatigue, and white patches in mouth, and the outcome of very sensitive tongue/tongue was very sensitive and slept all day 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: F
Vaccine: COVID19
Symptoms: Oral mucosal discolouration, Rhinorrhoea
Clinical narrative: STICKY AND OOZY EYES; HER EYES BECAME BLOOD SHOT; HER EYES BECAME RED; WHITE PATCHES IN MOUTH; VERY SENSITIVE TONGUE/TONGUE WAS VERY SENSITIVE; RUNNING NOSE WITH A CONSTANT NASAL DRIP; FATIGUE; HER EYES BECAME OOZY; SLEPT ALL DAY; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Sjogren's disease, rheumatoid arthritis, odours,environmental allergies, and had problems with eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced her eyes became oozy. On 27-MAR-2021, the subject experienced slept all day. On 27-MAR-2021, the subject experienced fatigue. On 27-MAR-2021 17:30, the subject experienced running nose with a constant nasal drip. On 29-MAR-2021, the subject experienced very sensitive tongue/tongue was very sensitive. On 30-MAR-2021, the subject experienced white patches in mouth. On an unspecified date, the subject experienced her eyes became blood shot, her eyes became red, and sticky and oozy eyes. Treatment medications (dates unspecified) included: allergy medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from her eyes became blood shot, sticky and oozy eyes, her eyes became oozy, and her eyes became red, had not recovered from running nose with a constant nasal drip, fatigue, and white patches in mouth, and the outcome of very sensitive tongue/tongue was very sensitive and slept all day 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: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 43 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: not reported) dose was not reported, once a total administered, on 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 fever. Laboratory data included: Body temperature (NR: not provided) 106 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Headache, Injection site swelling, Nausea
Clinical narrative: CHEST PAIN; BODY ACHES; ITCHING TO ARM AND NECK; DIZZY; VOMITING; NAUSEA; HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotics (unspecified) drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 09:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced chest pain. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced itching to arm and neck. On 30-MAR-2021, the subject experienced dizzy. On 30-MAR-2021, the subject experienced vomiting. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, swelling at injection site, itching to arm and neck, nausea, chest pain, dizzy, body aches and vomiting was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vomiting
Clinical narrative: CHEST PAIN; BODY ACHES; ITCHING TO ARM AND NECK; DIZZY; VOMITING; NAUSEA; HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included antibiotics (unspecified) drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 09:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced chest pain. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced itching to arm and neck. On 30-MAR-2021, the subject experienced dizzy. On 30-MAR-2021, the subject experienced vomiting. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced headache. On 30-MAR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, swelling at injection site, itching to arm and neck, nausea, chest pain, dizzy, body aches and vomiting was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Headache, Hyperhidrosis, Incorrect dose administered
Clinical narrative: SWELLING OF THE THROAT; HIVES OF THROAT; FEVER; HEADACHE; SHORTNESS OF BREATH; SWEATING; LEFTOVER 6TH DOSE WAS ADMINISTERED TO PATIENT; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 29-MAR-2021 14:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 93. Treatment medications included: acetylsalicylic acid, diphenhydramine hydrochloride, and paracetamol. On 29-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 104 F. On 29-MAR-2021 14:00, the subject experienced leftover 6th dose was administered to subject. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.9 F. On 30-MAR-2021 04:00, the subject experienced shortness of breath. On 30-MAR-2021 04:00, the subject experienced sweating. On 30-MAR-2021 04:00, the subject experienced swelling of the throat. On 30-MAR-2021 04:00, the subject experienced hives of throat. On 30-MAR-2021 04:00, the subject experienced fever. On 30-MAR-2021 04:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the throat, and hives of throat on 30-MAR-2021 at around 10:00, was recovering from shortness of breath, had not recovered from headache, fever, and sweating, and the outcome of leftover 6th dose was administered to patient 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pharyngeal swelling, Pyrexia, SARS-CoV-2 test positive, Urticaria
Clinical narrative: SWELLING OF THE THROAT; HIVES OF THROAT; FEVER; HEADACHE; SHORTNESS OF BREATH; SWEATING; LEFTOVER 6TH DOSE WAS ADMINISTERED TO PATIENT; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 29-MAR-2021 14:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 93. Treatment medications included: acetylsalicylic acid, diphenhydramine hydrochloride, and paracetamol. On 29-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 104 F. On 29-MAR-2021 14:00, the subject experienced leftover 6th dose was administered to subject. On 30-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.9 F. On 30-MAR-2021 04:00, the subject experienced shortness of breath. On 30-MAR-2021 04:00, the subject experienced sweating. On 30-MAR-2021 04:00, the subject experienced swelling of the throat. On 30-MAR-2021 04:00, the subject experienced hives of throat. On 30-MAR-2021 04:00, the subject experienced fever. On 30-MAR-2021 04:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the throat, and hives of throat on 30-MAR-2021 at around 10:00, was recovering from shortness of breath, had not recovered from headache, fever, and sweating, and the outcome of leftover 6th dose was administered to patient 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: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODYACHE; CHILL; FEVER; HEADACHE; This spontaneous report received from a consumer 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: 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 bodyache, chill, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chill, headache and bodyache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210359266.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Influenza like illness, Vascular rupture
Clinical narrative: POPPED A BLOOD VESSEL; BRUISING OF ARM; FLU LIKE SYMPTOMS (FEVER AND BODY ACHES); 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 thyroid issues. 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 16:15 on left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced popped a blood vessel. On 27-MAR-2021, the subject experienced bruising of arm. On 27-MAR-2021 at around 2:30, the subject experienced flu like symptoms (fever and body aches). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms (fever and body aches) on 27-MAR-2021 07:30, and the outcome of popped a blood vessel and bruising of arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram, Heart rate increased, Incorrect route of product administration
Clinical narrative: KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site mass, Malaise, Nausea, Off label use, Pain in extremity
Clinical narrative: KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: KNOT ON LEFT ARM; OFF LABEL USE; INAPPROPRIATE ROUTE OF VACCINATION; INCREASED BP; INCREASED HEART RATE; DIZZINESS SUNDAY AND MONDAY; PAIN IN ARM; DONT FEEL WELL; SOME NAUSEA; TINGLING OF HAND; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 239 (unit unspecified), and height was 5 (unit unspecified). The patient's concurrent conditions included allergy, thyroid, sinus infection, elevated growth hormone, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tingling of hand. On 27-MAR-2021, the subject experienced off label use. On 27-MAR-2021, the subject experienced inappropriate route of vaccination. On 27-MAR-2021, the subject experienced increased blood pressure. On 27-MAR-2021, the subject experienced increased heart rate. On 27-MAR-2021, the subject experienced dizziness Sunday and Monday. On 27-MAR-2021, the subject experienced pain in arm. On 27-MAR-2021, the subject experienced don't feel well. On 27-MAR-2021, the subject experienced some nausea. On 28-MAR-2021, the subject experienced knot on left arm. Laboratory data (dates unspecified) included: EKG (NR: not provided) clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness Sunday and Monday, and had not recovered from knot on left arm, tingling of hand, pain in arm, some nausea, increased blood pressure, increased heart rate, don't feel well, inappropriate route of vaccination, and off label use. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: BODY ACHES; CHILLS; 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: 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 body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Oxygen saturation, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to insect bites, and other pre-existing medical conditions included the patient has suspected lupus but not diagnosed. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced tested positive for covid-19. Laboratory data included: Blood pressure (NR: not provided) NORMAL, COVID-19 virus test positive (NR: not provided) POSITIVE, and Oxygen saturation (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tested positive for covid-19. 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Flatulence
Clinical narrative: BODY ACHES; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; GASSY; SCRATCHY THROAT; JOINT PAIN; FEELING REALLY COLD/ CHILLS; FEVER (100-101.4F); MUSCLE PAIN; NAUSEA; TIRED; HEADACHE; This spontaneous report received from a consumer concerned a 16 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced body aches. On 27-MAR-2021, the subject experienced product administered to subject of inappropriate age. On 27-MAR-2021, the subject experienced product administered to subject of inappropriate age. On 27-MAR-2021, the subject experienced gassy. On 27-MAR-2021, the subject experienced scratchy throat. On 27-MAR-2021, the subject experienced joint pain. On 27-MAR-2021, the subject experienced feeling really cold/ chills. On 27-MAR-2021, the subject experienced fever (100-101.4f). On 27-MAR-2021, the subject experienced muscle pain. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced tired. On 27-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-101.4 F. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling really cold/ chills, fever (100-101.4f), body aches, muscle pain, joint pain, nausea, gassy, tired, and headache, and the outcome of scratchy throat, product administered to patient of inappropriate age and product administered to patient of inappropriate age 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: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Product administered to patient of inappropriate age
Clinical narrative: BODY ACHES; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; GASSY; SCRATCHY THROAT; JOINT PAIN; FEELING REALLY COLD/ CHILLS; FEVER (100-101.4F); MUSCLE PAIN; NAUSEA; TIRED; HEADACHE; This spontaneous report received from a consumer concerned a 16 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced body aches. On 27-MAR-2021, the subject experienced product administered to subject of inappropriate age. On 27-MAR-2021, the subject experienced product administered to subject of inappropriate age. On 27-MAR-2021, the subject experienced gassy. On 27-MAR-2021, the subject experienced scratchy throat. On 27-MAR-2021, the subject experienced joint pain. On 27-MAR-2021, the subject experienced feeling really cold/ chills. On 27-MAR-2021, the subject experienced fever (100-101.4f). On 27-MAR-2021, the subject experienced muscle pain. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced tired. On 27-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-101.4 F. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling really cold/ chills, fever (100-101.4f), body aches, muscle pain, joint pain, nausea, gassy, tired, and headache, and the outcome of scratchy throat, product administered to patient of inappropriate age and product administered to patient of inappropriate age 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: F
Vaccine: COVID19
Symptoms: Product use in unapproved indication, Pyrexia, SARS-CoV-2 test, Throat irritation
Clinical narrative: BODY ACHES; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; GASSY; SCRATCHY THROAT; JOINT PAIN; FEELING REALLY COLD/ CHILLS; FEVER (100-101.4F); MUSCLE PAIN; NAUSEA; TIRED; HEADACHE; This spontaneous report received from a consumer concerned a 16 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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced body aches. On 27-MAR-2021, the subject experienced product administered to subject of inappropriate age. On 27-MAR-2021, the subject experienced product administered to subject of inappropriate age. On 27-MAR-2021, the subject experienced gassy. On 27-MAR-2021, the subject experienced scratchy throat. On 27-MAR-2021, the subject experienced joint pain. On 27-MAR-2021, the subject experienced feeling really cold/ chills. On 27-MAR-2021, the subject experienced fever (100-101.4f). On 27-MAR-2021, the subject experienced muscle pain. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced tired. On 27-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-101.4 F. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling really cold/ chills, fever (100-101.4f), body aches, muscle pain, joint pain, nausea, gassy, tired, and headache, and the outcome of scratchy throat, product administered to patient of inappropriate age and product administered to patient of inappropriate age 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: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Illness
Clinical narrative: VERY SICK; TEMPERATURE OF 102; This spontaneous report received from a patient via a company representative concerned a 19 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.. No concomitant medications were reported.  On an unspecified date, the subject experienced temperature of 102, and very sick. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature of 102 and very sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient concerned a African/American Hispanic/Latino female of an unspecified age. 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, expiry date: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The outcome of chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nasopharyngitis, Pain in extremity
Clinical narrative: COLD; FEEL KIND OF BAD; SHIVERING; FINGERS HURT; HEAD HURT; 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 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 cold. On MAR-2021, the subject experienced feel kind of bad. On MAR-2021, the subject experienced shivering. On MAR-2021, the subject experienced fingers hurt. On MAR-2021, the subject experienced head hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head hurt, cold, shivering, fingers hurt and feel kind of bad was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: HIVES ON EAR AND HEAD; FEVER; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and heart problems, and concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced hives on ear and head. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on ear and head on 28-MAR-2021, and fever on 27-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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 chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: BAD FLU-LIKE SYMPTOMS; CHILLS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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: 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 MAR-2021, the subject experienced bad flu-like symptoms. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from bad flu-like symptoms, chills, and fever on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hepatic enzyme increased
Clinical narrative: ELEVATED LIVER ENZYMES; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 to left deltoid 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 elevated liver enzymes. On MAR-2021, the subject experienced headache. Laboratory data (dates unspecified) included: Elevated liver enzymes (NR: not provided) Liver enzymes elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and elevated liver enzymes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210403235.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Inflammation
Clinical narrative: BURNING SENSATION TO THE LEFT OF THE GROIN AREA AND LEGS; INFLAMED GROIN AREA AND LEGS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received COVID-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 13:00 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the patient experienced burning sensation to the left of the groin area and legs. On 27-MAR-2021, the patient experienced inflamed groin area and legs. The action taken with COVID-19 vaccine was not applicable. The patient had not recovered from burning sensation to the left of the groin area and legs and inflamed groin area and legs. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Hyperhidrosis
Clinical narrative: SLUGGISHNESS; HEAVINESS; PAIN; CHILLS; FEVER; HEADACHES; TIREDNESS; SWEATING; DROWSY; WALKING AROUND LIKE FOG; DID NOT REMEMBER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included normal headache. The patient was previously treated with paracetamol for headache. 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 20-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced walking around like fog. On MAR-2021, the subject experienced did not remember. On 21-MAR-2021, the subject experienced sweating. On 21-MAR-2021, the subject experienced drowsy. On 21-MAR-2021, the subject experienced sluggishness. On 21-MAR-2021, the subject experienced heaviness. On 21-MAR-2021, the subject experienced pain. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced headaches. On 21-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, drowsy, pain, chills, and fever on 22-MAR-2021, and walking around like fog, sluggishness, heaviness, did not remember, headaches, and tiredness on MAR-2021. This report was non-serious.