chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: SWELLING OF LYMPH NODE ON RIGHT SIDE OF NECK; This spontaneous report received from a pharmacist 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the patient experienced swelling of lymph node on right side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of lymph node on right side of neck. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: REDNESS; SWELLING; SORENESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number:  UNKNOWN) dose was not reported, administered on 08-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced soreness. On 09-MAR-2021, the subject experienced redness. On 09-MAR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from redness, and swelling on 11-MAR-2021, and was recovering from soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: FEELING UNWELL; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) 1 in total, dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced feeling unwell. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and feeling unwell was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOT SPECIFIED (NOS); This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received j and j baby shampoo (shampoo, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; and j and j baby powder (powder, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. 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 is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event not specified (nos). The action taken with covid-19 vaccine ad26.cov2.s, j and j baby shampoo, and j and j baby powder was not applicable. The outcome of adverse event not specified (nos) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Feeling cold
Clinical narrative: DIZZINESS; VERY COLD; LACK OF APPETITE; WEAKNESS; VERY TIRED; SERIOUS HEADACHE; PAIN AT INJECTION SITE; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced very cold. On 16-MAR-2021, the subject experienced lack of appetite. On 16-MAR-2021, the subject experienced weakness. On 16-MAR-2021, the subject experienced very tired. On 16-MAR-2021, the subject experienced serious headache. On 16-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious headache, very tired, very cold, dizziness, weakness, pain at injection site, and lack of appetite. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: DIZZINESS; VERY COLD; LACK OF APPETITE; WEAKNESS; VERY TIRED; SERIOUS HEADACHE; PAIN AT INJECTION SITE; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced very cold. On 16-MAR-2021, the subject experienced lack of appetite. On 16-MAR-2021, the subject experienced weakness. On 16-MAR-2021, the subject experienced very tired. On 16-MAR-2021, the subject experienced serious headache. On 16-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious headache, very tired, very cold, dizziness, weakness, pain at injection site, and lack of appetite. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: HEADACHE; JOINT PAIN; CHILLS; FEVER; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 17-MAR-2021, and had not recovered from headache, and joint pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: FEELING A LITTLE NAUSEOUS BUT NOT BAD; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 17-MAR-2021, the subject experienced feeling a little nauseous but not bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling a little nauseous but not bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: LUMP AT INJECTION SITE; PAIN AT INJECTION SITE; WARM AT INJECTION SITE; This spontaneous report received from a consumer concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced lump at injection site. On 13-MAR-2021, the subject experienced pain at injection site. On 13-MAR-2021, the subject experienced warm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at injection site, pain at injection site, and warm at injection site. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Hypoaesthesia
Clinical narrative: HEADACHE; Chills; FACIAL NUMBNESS; DIZZINESS; ACHES; JOINT PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 165 pounds, and height was 66.5 inches. The patient's concurrent conditions included penicillin allergy, walnut allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced facial numbness. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced aches. On 12-MAR-2021, the subject experienced joint pain. On 12-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and joint pain on 13-MAR-2021, and headache on 14-MAR-2021, was recovering from dizziness, had not recovered from facial numbness, and the outcome of chills was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: HEADACHE; Chills; FACIAL NUMBNESS; DIZZINESS; ACHES; JOINT PAIN; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 165 pounds, and height was 66.5 inches. The patient's concurrent conditions included penicillin allergy, walnut allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced facial numbness. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced aches. On 12-MAR-2021, the subject experienced joint pain. On 12-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and joint pain on 13-MAR-2021, and headache on 14-MAR-2021, was recovering from dizziness, had not recovered from facial numbness, and the outcome of chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Exposure during pregnancy, Fatigue, Feeling cold
Clinical narrative: LOWER BACK PAIN THAT KEPT HER UP ALL NIGHT; PEEING A LOT; SENSITIVE SKIN / SORE SKIN WORSE ON THE ARM THAT HAD VACCINE AND ALSO IN OTHER ARM TO A LESSER DEGREE; SWEATY; FEELING COLD; SHIVERS; HURTS TO MOVE ARM; FEVER; HEADACHE; VACCINE EXPOSURE DURING PREGNANCY; FEELING TIRED; This spontaneous pregnancy 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 headache. It was not reported whether the patient had been pregnant before. 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 left arm on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Pregnancy test (NR: not provided) POSITIVE. On 16-MAR-2021, the subject experienced lower back pain that kept her up all night. On 16-MAR-2021, the subject experienced peeing a lot. On 16-MAR-2021, the subject experienced sensitive skin / sore skin worse on the arm that had vaccine and also in other arm to a lesser degree. On 16-MAR-2021, the subject experienced sweaty. On 16-MAR-2021, the subject experienced feeling cold. On 16-MAR-2021, the subject experienced shivers. On 16-MAR-2021, the subject experienced hurts to move arm. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced vaccine exposure during pregnancy. On 16-MAR-2021, the subject experienced feeling tired. The date of the subject's last menstrual period was not reported and expected delivery date was 01-OCT-2021. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, feeling cold, shivers, and fever on 16-MAR-2021, was recovering from headache, had not recovered from lower back pain that kept her up all night, peeing a lot, sensitive skin / sore skin worse on the arm that had vaccine and also in other arm to a lesser degree, hurts to move arm, and feeling tired, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Pollakiuria, Pregnancy test
Clinical narrative: LOWER BACK PAIN THAT KEPT HER UP ALL NIGHT; PEEING A LOT; SENSITIVE SKIN / SORE SKIN WORSE ON THE ARM THAT HAD VACCINE AND ALSO IN OTHER ARM TO A LESSER DEGREE; SWEATY; FEELING COLD; SHIVERS; HURTS TO MOVE ARM; FEVER; HEADACHE; VACCINE EXPOSURE DURING PREGNANCY; FEELING TIRED; This spontaneous pregnancy 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 headache. It was not reported whether the patient had been pregnant before. 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 left arm on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Pregnancy test (NR: not provided) POSITIVE. On 16-MAR-2021, the subject experienced lower back pain that kept her up all night. On 16-MAR-2021, the subject experienced peeing a lot. On 16-MAR-2021, the subject experienced sensitive skin / sore skin worse on the arm that had vaccine and also in other arm to a lesser degree. On 16-MAR-2021, the subject experienced sweaty. On 16-MAR-2021, the subject experienced feeling cold. On 16-MAR-2021, the subject experienced shivers. On 16-MAR-2021, the subject experienced hurts to move arm. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced vaccine exposure during pregnancy. On 16-MAR-2021, the subject experienced feeling tired. The date of the subject's last menstrual period was not reported and expected delivery date was 01-OCT-2021. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, feeling cold, shivers, and fever on 16-MAR-2021, was recovering from headache, had not recovered from lower back pain that kept her up all night, peeing a lot, sensitive skin / sore skin worse on the arm that had vaccine and also in other arm to a lesser degree, hurts to move arm, and feeling tired, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: LOWER BACK PAIN THAT KEPT HER UP ALL NIGHT; PEEING A LOT; SENSITIVE SKIN / SORE SKIN WORSE ON THE ARM THAT HAD VACCINE AND ALSO IN OTHER ARM TO A LESSER DEGREE; SWEATY; FEELING COLD; SHIVERS; HURTS TO MOVE ARM; FEVER; HEADACHE; VACCINE EXPOSURE DURING PREGNANCY; FEELING TIRED; This spontaneous pregnancy 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 headache. It was not reported whether the patient had been pregnant before. 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 left arm on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Pregnancy test (NR: not provided) POSITIVE. On 16-MAR-2021, the subject experienced lower back pain that kept her up all night. On 16-MAR-2021, the subject experienced peeing a lot. On 16-MAR-2021, the subject experienced sensitive skin / sore skin worse on the arm that had vaccine and also in other arm to a lesser degree. On 16-MAR-2021, the subject experienced sweaty. On 16-MAR-2021, the subject experienced feeling cold. On 16-MAR-2021, the subject experienced shivers. On 16-MAR-2021, the subject experienced hurts to move arm. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced vaccine exposure during pregnancy. On 16-MAR-2021, the subject experienced feeling tired. The date of the subject's last menstrual period was not reported and expected delivery date was 01-OCT-2021. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty, feeling cold, shivers, and fever on 16-MAR-2021, was recovering from headache, had not recovered from lower back pain that kept her up all night, peeing a lot, sensitive skin / sore skin worse on the arm that had vaccine and also in other arm to a lesser degree, hurts to move arm, and feeling tired, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: HEADACHE; ACHINESS OF MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced achiness of muscles. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and achiness of muscles. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a vaccine facility 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 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. Treatment medications included: ibuprofen. 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: Pain in extremity
Clinical narrative: PAIN TO LEFT ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered in right arm on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced pain to left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain to left arm. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 16-MAR-2021, the subject experienced swelling at injection site. On 16-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling at injection site, and pain at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Headache, Injection site pain
Clinical narrative: BODY PAIN; LOW BACK PAIN; CHILLS; HEADACHE; FEVER; PAIN AT INJECTION SITE; 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 17-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 2021, the subject experienced pain at injection site. On an unspecified date, the subject experienced body pain, low back pain, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at injection site, body pain, chills, headache, low back pain and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY PAIN; LOW BACK PAIN; CHILLS; HEADACHE; FEVER; PAIN AT INJECTION SITE; 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 17-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 2021, the subject experienced pain at injection site. On an unspecified date, the subject experienced body pain, low back pain, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain at injection site, body pain, chills, headache, low back pain and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: ABDOMINAL PAIN AND CRAMPING; SWEATING; VOMITING; DIFFICULTY BREATHING; FATIGUE; HEADACHE; NAUSEA; 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: 1802072) dose was not reported, Vaccinated at on left deltoid once a total administered on 16-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021 01:30, the subject experienced abdominal pain and cramping. On 17-MAR-2021 01:30, the subject experienced sweating. On 17-MAR-2021 01:30, the subject experienced vomiting. On 17-MAR-2021 01:30, the subject experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain and cramping, vomiting, difficulty breathing, and nausea on 17-MAR-2021, had not recovered from fatigue, and headache, and the outcome of sweating 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: Nausea, Vomiting
Clinical narrative: ABDOMINAL PAIN AND CRAMPING; SWEATING; VOMITING; DIFFICULTY BREATHING; FATIGUE; HEADACHE; NAUSEA; 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: 1802072) dose was not reported, Vaccinated at on left deltoid once a total administered on 16-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021 01:30, the subject experienced abdominal pain and cramping. On 17-MAR-2021 01:30, the subject experienced sweating. On 17-MAR-2021 01:30, the subject experienced vomiting. On 17-MAR-2021 01:30, the subject experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain and cramping, vomiting, difficulty breathing, and nausea on 17-MAR-2021, had not recovered from fatigue, and headache, and the outcome of sweating was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and as per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, low grade fever and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Delusion, Disorientation, Dysphagia
Clinical narrative: DISORIENTED; DELUSION; VOMITING; SLEEPINESS; LOSS OF APPETITE; COULD NOT DRINK LIQUIDS; LETHARGIC; HEADACHE; FEVER 99; TIRED; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced sleepiness. On 16-MAR-2021, the subject experienced loss of appetite. On 16-MAR-2021, the subject experienced could not drink liquids. On 16-MAR-2021, the subject experienced lethargic. On 16-MAR-2021, the subject experienced vomiting. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fever 99. Laboratory data included: Body temperature (NR: not provided) 99 deg. On 17-MAR-2021, the subject experienced delusion. On an unspecified date, the subject experienced disoriented. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and disoriented on 18-MAR-2021, was recovering from headache, could not drink liquids, lethargic, and fever 99, had not recovered from delusion, and the outcome of sleepiness, tired and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Pyrexia, Somnolence
Clinical narrative: DISORIENTED; DELUSION; VOMITING; SLEEPINESS; LOSS OF APPETITE; COULD NOT DRINK LIQUIDS; LETHARGIC; HEADACHE; FEVER 99; TIRED; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced sleepiness. On 16-MAR-2021, the subject experienced loss of appetite. On 16-MAR-2021, the subject experienced could not drink liquids. On 16-MAR-2021, the subject experienced lethargic. On 16-MAR-2021, the subject experienced vomiting. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fever 99. Laboratory data included: Body temperature (NR: not provided) 99 deg. On 17-MAR-2021, the subject experienced delusion. On an unspecified date, the subject experienced disoriented. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and disoriented on 18-MAR-2021, was recovering from headache, could not drink liquids, lethargic, and fever 99, had not recovered from delusion, and the outcome of sleepiness, tired and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DISORIENTED; DELUSION; VOMITING; SLEEPINESS; LOSS OF APPETITE; COULD NOT DRINK LIQUIDS; LETHARGIC; HEADACHE; FEVER 99; TIRED; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced sleepiness. On 16-MAR-2021, the subject experienced loss of appetite. On 16-MAR-2021, the subject experienced could not drink liquids. On 16-MAR-2021, the subject experienced lethargic. On 16-MAR-2021, the subject experienced vomiting. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fever 99. Laboratory data included: Body temperature (NR: not provided) 99 deg. On 17-MAR-2021, the subject experienced delusion. On an unspecified date, the subject experienced disoriented. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and disoriented on 18-MAR-2021, was recovering from headache, could not drink liquids, lethargic, and fever 99, had not recovered from delusion, and the outcome of sleepiness, tired and vomiting was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product container issue
Clinical narrative: NO ILL EFFECTS/ISSUES SINCE BEING  VACCINATED; PATIENT RECEIVED VACCINE AFTER VIAL WAS PUNCTURED; This spontaneous report received from a physician concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and abstain from alcohol, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: 25-MAY-2021) 0.5 ml, once a total administered on 09/Mar/2021;10:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced subject received vaccine after vial was punctured. On an unspecified date, the subject experienced no ill effects/issues since being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from patient received vaccine after vial was punctured on MAR-2021, and the outcome of no ill effects/issues since being vaccinated was not reported. This report was non-serious.  Additional information was received from physician on 17-MAR-2021. The following information was updated and incorporated into case narrative. The patient's pregnancy status, suspect drug details (expiry date, start date time, the needle length/ gauge size and storage information) and other reference number.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pain
Clinical narrative: BODY ACHES; DIZZINESS; FEELING WEAK; HEADACHE; 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: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 16-MAR-2021, the subject experienced body aches. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced feeling weak. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling weak, headache, body aches, and dizziness. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: FULL BODY RASH WHICH WAS DESCRIBED AS ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerned a 67 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no preexisting condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced full body rash which was described as allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body rash which was described as allergic reaction on 16-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Injection site irritation, Injection site pain, Myalgia
Clinical narrative: IRRITATION AT INJECTION SITE; UNCOMFORTABLE; PAIN DURING INJECTION; VERY SORE MUSCLE; 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced irritation at injection site, uncomfortable, pain during injection, and very sore muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain during injection, irritation at injection site, uncomfortable and very sore muscle was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; 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 and expiry: unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Batch no.is not reported and it is requested. No concomitant medications were reported.  On an unspecified date, the subject experienced bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Eye contusion, Fall, Limb injury
Clinical narrative: FALL; BRUISED SHOULDER FROM FALL; BRUISED HIP FROM FALL; BLACK EYE FROM FALL; 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, 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 fall, bruised shoulder from fall, bruised hip from fall, and black eye from fall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fall, bruised shoulder from fall, bruised hip from fall and black eye from fall was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: ALLERGIC REACTION ON THE WHOLE BODY, MORE INTENSIVE ON THE HANDS AND FOOTS/SKIN FEELS ITCHES; FEVER; This spontaneous report received from a patient via a company representative concerned a 23 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: 1802072, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced allergic reaction on the whole body, more intensive on the hands and foots/skin feels itches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 11-MAR-2021, and had not recovered from allergic reaction on the whole body, more intensive on the hands and foots/skin feels itches. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Nausea, Pyrexia
Clinical narrative: CHARLEY HORSES/MUSCLE SPASMS ON HER LEGS, NECK AND SHOULDER; MILD TO SEVERE HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 55 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) dose was not reported, administered on 14-MAR-2021 in right arm (deltoid) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the patient experienced charley horses/muscle spasms on her legs, neck and shoulder, mild to severe headache, nausea, fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild to severe headache, charley horses/muscle spasms on her legs, neck and shoulder, nausea, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Pain, Pyrexia
Clinical narrative: VERY SICK; ACHES; TERRIBLE CHILLS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced very sick, aches, terrible chills, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from terrible chills, fever, aches, fatigue, and very sick. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Erythema, Gait disturbance
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021 22:00, the subject experienced body pains. On 15-MAR-2021 22:00, the subject experienced head felt like a giant balloon. On 15-MAR-2021 22:00, the subject experienced light headed and super woozy. On 15-MAR-2021 22:00, the subject experienced trouble walking. On 15-MAR-2021 22:00, the subject experienced arm has a big circle. On 15-MAR-2021 22:00, the subject experienced couldn't rest. On 15-MAR-2021 22:00, the subject experienced every joint was throbbing. On 15-MAR-2021 22:00, the subject experienced sore arm. On 15-MAR-2021 22:00, the subject experienced chills (superduper chills/vibrating). On 15-MAR-2021 22:00, the subject experienced hard knot at the injection site. On 15-MAR-2021 22:00, the subject experienced mild fever. On 15-MAR-2021 22:00, the subject experienced arm red. On 15-MAR-2021 22:00, the subject experienced serious headache. On 16-MAR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pains, head felt like a giant balloon, light headed and super woozy, trouble walking, couldn't rest, every joint was throbbing, chills (superduper chills/vibrating), mild fever, and serious headache on 16-MAR-2021, and had not recovered from arm has a big circle, arm red, sore arm, and hard knot at the injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Injection site reaction, Pain, Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021 22:00, the subject experienced body pains. On 15-MAR-2021 22:00, the subject experienced head felt like a giant balloon. On 15-MAR-2021 22:00, the subject experienced light headed and super woozy. On 15-MAR-2021 22:00, the subject experienced trouble walking. On 15-MAR-2021 22:00, the subject experienced arm has a big circle. On 15-MAR-2021 22:00, the subject experienced couldn't rest. On 15-MAR-2021 22:00, the subject experienced every joint was throbbing. On 15-MAR-2021 22:00, the subject experienced sore arm. On 15-MAR-2021 22:00, the subject experienced chills (superduper chills/vibrating). On 15-MAR-2021 22:00, the subject experienced hard knot at the injection site. On 15-MAR-2021 22:00, the subject experienced mild fever. On 15-MAR-2021 22:00, the subject experienced arm red. On 15-MAR-2021 22:00, the subject experienced serious headache. On 16-MAR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pains, head felt like a giant balloon, light headed and super woozy, trouble walking, couldn't rest, every joint was throbbing, chills (superduper chills/vibrating), mild fever, and serious headache on 16-MAR-2021, and had not recovered from arm has a big circle, arm red, sore arm, and hard knot at the injection site. This report was non-serious.