chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Muscle spasms
Clinical narrative: HEADACHE; CHILLS; BODY ACHES; FATIGUE; STABBING PAIN IN JAW AND CHEEK BONE; MUSCLE SPASMS IN LEFT LEG; PAIN AT INJECTION SITE AT THE TIME OF WHEN INJECTION WAS ADMINISTERED/SORENESS AT INJECTION SITE THE DAY AFTER INJECTION; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 63.5 kilograms, and height was 170.18 centimeters. The patient's past medical history included covid infection, and viral infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ascorbic acid, biotin, sambucus nigra, and zinc acetate/zinc gluconate. On 04-MAR-2021, the subject experienced pain at injection site at the time of when injection was administered/soreness at injection site the day after injection. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced body aches. On 05-MAR-2021, the subject experienced fatigue. On 05-MAR-2021, the subject experienced stabbing pain in jaw and cheek bone. On 05-MAR-2021, the subject experienced muscle spasms in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, body aches, fatigue, pain at injection site at the time of when injection was administered/soreness at injection site the day after injection, stabbing pain in jaw and cheek bone, and muscle spasms in left leg. This report was non-serious.    Version created to amend previously reported information on 05-Mar-2021. Upon review the following information was amended: Labeling of event muscle spasms, body ache and chills updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: HEADACHE; CHILLS; BODY ACHES; FATIGUE; STABBING PAIN IN JAW AND CHEEK BONE; MUSCLE SPASMS IN LEFT LEG; PAIN AT INJECTION SITE AT THE TIME OF WHEN INJECTION WAS ADMINISTERED/SORENESS AT INJECTION SITE THE DAY AFTER INJECTION; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 63.5 kilograms, and height was 170.18 centimeters. The patient's past medical history included covid infection, and viral infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ascorbic acid, biotin, sambucus nigra, and zinc acetate/zinc gluconate. On 04-MAR-2021, the subject experienced pain at injection site at the time of when injection was administered/soreness at injection site the day after injection. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced body aches. On 05-MAR-2021, the subject experienced fatigue. On 05-MAR-2021, the subject experienced stabbing pain in jaw and cheek bone. On 05-MAR-2021, the subject experienced muscle spasms in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, body aches, fatigue, pain at injection site at the time of when injection was administered/soreness at injection site the day after injection, stabbing pain in jaw and cheek bone, and muscle spasms in left leg. This report was non-serious.    Version created to amend previously reported information on 05-Mar-2021. Upon review the following information was amended: Labeling of event muscle spasms, body ache and chills updated.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Ocular discomfort, Vomiting
Clinical narrative: NAUSEA; HEADACHE; PRESSURE IN THE EYE; VOMITING; 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 ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced pressure in the eye. On 06-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, pressure in the eye and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 at 10:00 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.  On 06-MAR-2021, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle tightness, Paraesthesia, Sensation of foreign body
Clinical narrative: JAW AND EAR AREA TIGHTNESS; TINGLING OF THE JAW AND EAR AREA; FEELING OF SOMETHING STUCK IN THE BACK OF THE MOUTH; PRESSURE IN JAW AND EAR AREA; 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, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced jaw and ear area tightness. On 05-MAR-2021, the subject experienced tingling of the jaw and ear area. On 05-MAR-2021, the subject experienced feeling of something stuck in the back of the mouth. On 05-MAR-2021, the subject experienced pressure in jaw and ear area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from jaw and ear area tightness, tingling of the jaw and ear area, and feeling of something stuck in the back of the mouth, and the outcome of pressure in jaw and ear area was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Headache, Muscular weakness
Clinical narrative: WEAK MUSCLES; CHILLS; HEADACHE; FEVER OF 102; NAUSEA; DID NOT EAT MUCH; This spontaneous report received from a consumer concerned a male of unspecified age. 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 05-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 did not eat much. On 05-MAR-2021, the subject experienced weak muscles. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced fever of 102. On 05-MAR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not eat much on MAR-2021, and weak muscles, chills, headache from hell, fever of 102, and nausea on 07-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: WEAK MUSCLES; CHILLS; HEADACHE; FEVER OF 102; NAUSEA; DID NOT EAT MUCH; This spontaneous report received from a consumer concerned a male of unspecified age. 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 05-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 did not eat much. On 05-MAR-2021, the subject experienced weak muscles. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced fever of 102. On 05-MAR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not eat much on MAR-2021, and weak muscles, chills, headache from hell, fever of 102, and nausea on 07-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; MASSIVE HEADACHE; VERY TIRED; NAUSEA; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 05-MAR-2021 13:00 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021 17:00, the subject experienced chills. On 05-MAR-2021 17:00, the subject experienced massive headache. On 05-MAR-2021 17:00, the subject experienced very tired. On 05-MAR-2021 17:00, the subject experienced nausea. On 05-MAR-2021 17:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, massive headache, very tired, nausea, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Contact lens intolerance, Eye infection, Eye irritation, Frequent bowel movements
Clinical narrative: EYE BURNS, MORE THE RIGHT EYE THAN THE LEFT BUT STARTING TO FEEL IT IN THE LEFT EYE TOO; UNABLE TO WEAR CONTACT LENSES; EYE FEELS INFECTED; HARD TO KEEP EYE OPEN; A LOT OF BOWEL MOVEMENTS, PATIENT WENT 3 TO 4 TIMES LAST NIGHT, WHICH IS UNUSUAL; RUNNY NOSE; CONGESTION (NOSE); 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) dose was not reported, administered on 07-MAR-2021 09:30:00 to 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 runny nose. On MAR-2021, the subject experienced congestion (nose). On 07-MAR-2021, the subject experienced a lot of bowel movements, subject went 3 to 4 times last night, which is unusual. On 08-MAR-2021, the subject experienced eye burns, more the right eye than the left but starting to feel it in the left eye too. On 08-MAR-2021, the subject experienced unable to wear contact lenses. On 08-MAR-2021, the subject experienced eye feels infected. On 08-MAR-2021, the subject experienced hard to keep eye open. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a lot of bowel movements, patient went 3 to 4 times last night, which is unusual, had not recovered from hard to keep eye open, eye burns, more the right eye than the left but starting to feel it in the left eye too, unable to wear contact lenses, runny nose, and congestion (nose), and the outcome of eye feels infected was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per the standard operating procedure as the case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: EYE BURNS, MORE THE RIGHT EYE THAN THE LEFT BUT STARTING TO FEEL IT IN THE LEFT EYE TOO; UNABLE TO WEAR CONTACT LENSES; EYE FEELS INFECTED; HARD TO KEEP EYE OPEN; A LOT OF BOWEL MOVEMENTS, PATIENT WENT 3 TO 4 TIMES LAST NIGHT, WHICH IS UNUSUAL; RUNNY NOSE; CONGESTION (NOSE); 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) dose was not reported, administered on 07-MAR-2021 09:30:00 to 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 runny nose. On MAR-2021, the subject experienced congestion (nose). On 07-MAR-2021, the subject experienced a lot of bowel movements, subject went 3 to 4 times last night, which is unusual. On 08-MAR-2021, the subject experienced eye burns, more the right eye than the left but starting to feel it in the left eye too. On 08-MAR-2021, the subject experienced unable to wear contact lenses. On 08-MAR-2021, the subject experienced eye feels infected. On 08-MAR-2021, the subject experienced hard to keep eye open. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a lot of bowel movements, patient went 3 to 4 times last night, which is unusual, had not recovered from hard to keep eye open, eye burns, more the right eye than the left but starting to feel it in the left eye too, unable to wear contact lenses, runny nose, and congestion (nose), and the outcome of eye feels infected was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per the standard operating procedure as the case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: FEVER; CHILLS; 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 AD26.COV2.S (suspension for injection, intramuscular) 0.5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain
Clinical narrative: DIZZY; BODY ACHE; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 06:07 to left arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body ache, and dizzy. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: LOW GRADE FEVER; BODY ACHES; 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, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced low grade fever. On 06-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Muscle twitching, Myalgia
Clinical narrative: CHILLS; BODY TWITCHING; ACHY BODY; 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, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:40 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98 F. On 06-MAR-2021 18:30, the subject experienced chills. On 06-MAR-2021 18:30, the subject experienced body twitching. On 06-MAR-2021 18:30, the subject experienced achy body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and body twitching, and had not recovered from achy body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PARTIAL INJECTION OF VACCINE DOSE; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. the batch lot number were not reported hence requested No concomitant medications were reported. On 06-MAR-2021, the subject experienced partial injection of vaccine dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial injection of vaccine dose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Nasopharyngitis, Pyrexia
Clinical narrative: FEVER (101F); COLD; FACE HOT; 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, intramuscular, batch number: 18020N, and batch number: 18020N expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 06-MAR-2021 17:00, the subject experienced fever (101f). On 06-MAR-2021 17:00, the subject experienced cold. On 06-MAR-2021 17:00, the subject experienced face hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (101f), cold, and face hot. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Dizziness
Clinical narrative: Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Injection site pain, Pain, Pyrexia
Clinical narrative: Achy; No appetite; Mild dizziness; Feeling flushed; Soreness at the vaccine site; Fever; MILD JOINT PAIN; Chills; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included liver disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 10:45 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced mild joint pain. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. On 05-MAR-2021 11:00, the subject experienced mild dizziness. On 05-MAR-2021 11:00, the subject experienced feeling flushed. On 05-MAR-2021 11:00, the subject experienced soreness at the vaccine site. On 06-MAR-2021, the subject experienced achy. On 06-MAR-2021, the subject experienced no appetite. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 (high fever). On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 98.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild joint pain, and fever, had not recovered from soreness at the vaccine site, and the outcome of mild dizziness, feeling flushed, chills, achy and no appetite was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Dyspnoea
Clinical narrative: HEART IS RACING FAST; HARD TO BREATHE; HOT FLASHES; BODY ACHE; DIZZINES; WEAKNESS; SNEEZING; COLD CHILLS; HEADACHE; 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, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 11:03 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101. On 08-MAR-2021 17:30, the subject experienced heart is racing fast. On 08-MAR-2021 17:30, the subject experienced hard to breathe. On 08-MAR-2021 17:30, the subject experienced hot flashes. On 08-MAR-2021 17:30, the subject experienced body ache. On 08-MAR-2021 17:30, the subject experienced dizzines. On 08-MAR-2021 17:30, the subject experienced weakness. On 08-MAR-2021 17:30, the subject experienced sneezing. On 08-MAR-2021 17:30, the subject experienced cold chills. On 08-MAR-2021 17:30, the subject experienced headache. On 08-MAR-2021 17:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 08-MAR-2021, and had not recovered from hot flashes, headache, body ache, dizzines, weakness, heart is racing fast, fever, hard to breathe, and sneezing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hot flush, Pain, Pyrexia
Clinical narrative: HEART IS RACING FAST; HARD TO BREATHE; HOT FLASHES; BODY ACHE; DIZZINES; WEAKNESS; SNEEZING; COLD CHILLS; HEADACHE; 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, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 11:03 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101. On 08-MAR-2021 17:30, the subject experienced heart is racing fast. On 08-MAR-2021 17:30, the subject experienced hard to breathe. On 08-MAR-2021 17:30, the subject experienced hot flashes. On 08-MAR-2021 17:30, the subject experienced body ache. On 08-MAR-2021 17:30, the subject experienced dizzines. On 08-MAR-2021 17:30, the subject experienced weakness. On 08-MAR-2021 17:30, the subject experienced sneezing. On 08-MAR-2021 17:30, the subject experienced cold chills. On 08-MAR-2021 17:30, the subject experienced headache. On 08-MAR-2021 17:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 08-MAR-2021, and had not recovered from hot flashes, headache, body ache, dizzines, weakness, heart is racing fast, fever, hard to breathe, and sneezing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: HEART IS RACING FAST; HARD TO BREATHE; HOT FLASHES; BODY ACHE; DIZZINES; WEAKNESS; SNEEZING; COLD CHILLS; HEADACHE; 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, intramuscular, batch number: UNKNOWN) .5 ml, administered on 08-MAR-2021 11:03 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101. On 08-MAR-2021 17:30, the subject experienced heart is racing fast. On 08-MAR-2021 17:30, the subject experienced hard to breathe. On 08-MAR-2021 17:30, the subject experienced hot flashes. On 08-MAR-2021 17:30, the subject experienced body ache. On 08-MAR-2021 17:30, the subject experienced dizzines. On 08-MAR-2021 17:30, the subject experienced weakness. On 08-MAR-2021 17:30, the subject experienced sneezing. On 08-MAR-2021 17:30, the subject experienced cold chills. On 08-MAR-2021 17:30, the subject experienced headache. On 08-MAR-2021 17:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold chills on 08-MAR-2021, and had not recovered from hot flashes, headache, body ache, dizzines, weakness, heart is racing fast, fever, hard to breathe, and sneezing. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Headache, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer 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: 1802072 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103. On 07-MAR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, fever and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING SICK; This spontaneous report received from a consumer 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, 1 total, administered on 05-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 an unspecified date, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Nausea
Clinical narrative: FATIGUE; NAUSEA; TEMPERATURE OF 100.6F; 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, intramuscular, batch number: 1805018, expiry: 25-MAY-2021) .5 ml, 1 total, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced fatigue, nausea, and temperature of 100.6F. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.6 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, nausea and temperature of 100.6F was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: BLOOD IN URINE; 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 concurrent conditions included non smoker, high blood pressure, and high cholesterol, and other pre-existing medical conditions included patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802025, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to Right Deltoid for prophylactic vaccination at noon.. No concomitant medications were reported. On 08-MAR-2021 16:15, the subject experienced blood in urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in urine. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; HEADACHES; JOINT PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included gastritis, and hypertension, 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headaches. On 09-MAR-2021, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 100.0-101 unknown unit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, headaches, and joint pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, 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 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Retching
Clinical narrative: DRY HEAVES; BODY ACHES; CHILLS; FEVER OF 103; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, high cholesterol, non-smoker, and non-alcoholic, and other pre-existing medical conditions included there was no drug abuse or illicit use. The patient experienced keflex allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805408) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced fever of 103. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced dry heaves. On 08-MAR-2021, the subject experienced body aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 103, chills, dry heaves, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: BURNING SENSATION ON BOTH BUTTOCKS; ITCHY SENSATION ON BOTH BUTTOCKS; This spontaneous report received from a patient . The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, NSAIDs, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced burning sensation on both buttocks, and itchy sensation on both buttocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation on both buttocks and itchy sensation on both buttocks was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Headache, Injection site pain, Pain
Clinical narrative: PAIN AT INJECTION SITE; CHILLS; BODY ACHES; HEADACHE; DULLED SENSE OF TASTE; This spontaneous report received from a patient concerned a 30 year old white male (Not Hispanic/Latino). The patient's height, and weight were not reported. The patient's concurrent conditions included obese, and no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) .5 ml, 1 total, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced pain at injection site, chills, body aches, headache and dulled sense of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site, and chills on 06-MAR-2021, and was recovering from body aches, headache, and dulled sense of taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOM; 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, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced flu like symptom. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptom was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Uterine pain
Clinical narrative: UTERUS AREA PAIN; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) 0.5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced uterus area pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and uterus area pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: CHILLS; HEADACHES; MUSCLE ACHES; 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 was not reported, administered on 09-MAR-2021 at around 5:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced headaches. On 09-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, muscle aches, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Myalgia
Clinical narrative: MUSCLE ACHES; TIRED; CRAMPS; 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 08-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced cramps. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, tired, and cramps. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: DIZZYNESS; WEAKNESS; FATIGUE; NAUSEA; TIREDNESS; 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 diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced dizziness. On 06-MAR-2021, the subject experienced weakness. On 06-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and nausea on 08-MAR-2021, and was recovering from weakness, fatigue, and tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Pyrexia, Tremor
Clinical narrative: HEADACHE; EXTREME CHILLS; VIOLENT SHAKING; FEVER; STIFFNESS/PAIN BACK OF NECK; This spontaneous report received from a consumer 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, intramuscular, batch number: Unknown, and batch number: not reported expiry: not reported) dose was not reported, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced headache,extreme chills ,violent shaking, fever and stiffness/pain back of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, extreme chills, violent shaking, fever, and stiffness/pain back of neck. This report was non-serious.  Version (1) created to amend previously reported information on 06-Mar-2021. Upon review the following information was amended: Labeling of event (headache) updated to labeled from unlabeled in CCDS and ,Labeling of event (fever) updated to labeled from unlabeled in CCDS and CCDS labeling for event chills was updated from unlabeled to labeled.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Pyrexia, SARS-CoV-2 test
Clinical narrative: CONSTANT COUGH; DIARRHEA; FEVER; FEELING WEAK; 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 past medical history included covid 19 infection, and concurrent conditions included diabetes, and obesity, and other pre-existing medical conditions included the patient is also on thyroid medication.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: C19185029) dose was not reported, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced constant cough. On 07-MAR-2021, the subject experienced diarrhea. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced feeling weak. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-MAR-2021, and fever on 09-MAR-2021, and had not recovered from feeling weak, and constant cough. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: INCOMPLETE DOSE(PERSON WHO GAVE VACCINE TO PATIENT MUST NOT HAVE STUCK THE NEEDLE IN FAR ENOUGH BECAUSE WHEN HE PULLED IT OUT ALL THE MEDICINE POURED OUT  OF ARM DOWN OFF ELBOW); POSSIBLE INCORRECT ADMINISTRATION(PERSON WHO GAVE VACCINE TO PATIENT MUST NOT HAVE STUCK THE NEEDLE IN FAR ENOUGH BECAUSE WHEN HE PULLED IT OUT ALL THE MEDICINE POURED OUT  OF ARM DOWN OFF ELBOW); 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced incomplete dose (person who gave vaccine to subject must not have stuck the needle in far enough because when he pulled it out all the medicine poured out of arm down off elbow), and possible incorrect administration (person who gave vaccine to subject must not have stuck the needle in far enough because when he pulled it out all the medicine poured out of arm down off elbow). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The outcome of the incomplete dose(person who gave vaccine to patient must not have stuck the needle in far enough because when he pulled it out all the medicine poured out of arm down off elbow) and possible incorrect administration(person who gave vaccine to patient must not have stuck the needle in far enough because when he pulled it out all the medicine poured out of arm down off elbow) was not reported. This report was non-serious.