chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Chills, Confusional state, Diarrhoea, Dyspepsia
Clinical narrative: CHILLS; NAUSEA; HEADACHE; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; VOMITING; DIARRHEA; CONFUSION; MILD BODY ACHE; NOISE SENSITIVITY; FEVER; BURNING SENSATION IN STOMACH; VOMITED BILE AND FOAM; NOT STAY AWAKE; SLIGHT HEART MURMUR; SENSITIVE BODY; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included heart murmur, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:50 for prophylactic vaccination. Concomitant medications included pantoprazole sodium sesquihydrate for heart murmur. On 14-APR-2021, treatment medications included: bismuth subsalicylate. On an unspecified date, the subject experienced chills, nausea, headache, pain at injection site, swelling at injection site, vomiting, diarrhea, confusion, mild body ache, noise sensitivity, fever, burning sensation in stomach, vomited bile and foam, not stay awake, slight heart murmur, and sensitive body. Additional treatment medications (dates unspecified) included: paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from noise sensitivity, vomited bile and foam, not stay awake, and slight heart murmur, and had not recovered from chills, nausea, headache, pain at injection site, swelling at injection site, vomiting, diarrhea, confusion, mild body ache, fever, burning sensation in stomach, and sensitive body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperacusis, Hyperaesthesia, Injection site pain, Injection site swelling
Clinical narrative: CHILLS; NAUSEA; HEADACHE; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; VOMITING; DIARRHEA; CONFUSION; MILD BODY ACHE; NOISE SENSITIVITY; FEVER; BURNING SENSATION IN STOMACH; VOMITED BILE AND FOAM; NOT STAY AWAKE; SLIGHT HEART MURMUR; SENSITIVE BODY; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included heart murmur, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:50 for prophylactic vaccination. Concomitant medications included pantoprazole sodium sesquihydrate for heart murmur. On 14-APR-2021, treatment medications included: bismuth subsalicylate. On an unspecified date, the subject experienced chills, nausea, headache, pain at injection site, swelling at injection site, vomiting, diarrhea, confusion, mild body ache, noise sensitivity, fever, burning sensation in stomach, vomited bile and foam, not stay awake, slight heart murmur, and sensitive body. Additional treatment medications (dates unspecified) included: paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from noise sensitivity, vomited bile and foam, not stay awake, and slight heart murmur, and had not recovered from chills, nausea, headache, pain at injection site, swelling at injection site, vomiting, diarrhea, confusion, mild body ache, fever, burning sensation in stomach, and sensitive body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Somnolence, Vomiting
Clinical narrative: CHILLS; NAUSEA; HEADACHE; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; VOMITING; DIARRHEA; CONFUSION; MILD BODY ACHE; NOISE SENSITIVITY; FEVER; BURNING SENSATION IN STOMACH; VOMITED BILE AND FOAM; NOT STAY AWAKE; SLIGHT HEART MURMUR; SENSITIVE BODY; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included heart murmur, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 13:50 for prophylactic vaccination. Concomitant medications included pantoprazole sodium sesquihydrate for heart murmur. On 14-APR-2021, treatment medications included: bismuth subsalicylate. On an unspecified date, the subject experienced chills, nausea, headache, pain at injection site, swelling at injection site, vomiting, diarrhea, confusion, mild body ache, noise sensitivity, fever, burning sensation in stomach, vomited bile and foam, not stay awake, slight heart murmur, and sensitive body. Additional treatment medications (dates unspecified) included: paracetamol, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from noise sensitivity, vomited bile and foam, not stay awake, and slight heart murmur, and had not recovered from chills, nausea, headache, pain at injection site, swelling at injection site, vomiting, diarrhea, confusion, mild body ache, fever, burning sensation in stomach, and sensitive body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced 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: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the subject experienced off label use, and product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Vision blurred
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-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 APR-2021, the subject experienced debilitating pain comparable to labor pain. On APR-2021, the subject experienced arms, feet and legs going numb. On APR-2021, the subject experienced can not see straight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arms, feet and legs going numb, debilitating pain comparable to labor pain and can not see straight was not reported. This report was non-serious. 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 10-APR-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 APR-2021, the subject experienced arms, feet and legs going numb. On 11-APR-2021, the subject experienced debilitating pain comparable to labor pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arms, feet and legs going numb and debilitating pain comparable to labor pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: EXCRUCIATING LOWER BACK PAIN; HOT AND COLD FLASHES; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced hot and cold flashes. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced excruciating lower back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes, tired, and headache on APR-2021, and had not recovered from excruciating lower back pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: LEFT ARM SORENESS; HEADACHES; HIGH FEVER; NAUSEA; CHILLS; SHAKING; ACHING; 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 pre-existing medical conditions included patient did not have any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced aching. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced shaking. On 20-MAR-2021, the subject experienced high fever. On 20-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. On an unspecified date, the subject experienced left arm soreness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching, shaking and chills on 20-MAR-2021, and high fever, and nausea, and the outcome of headaches and left arm soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: LEFT ARM SORENESS; HEADACHES; HIGH FEVER; NAUSEA; CHILLS; SHAKING; ACHING; 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 pre-existing medical conditions included patient did not have any medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced aching. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced shaking. On 20-MAR-2021, the subject experienced high fever. On 20-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. On an unspecified date, the subject experienced left arm soreness, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching, shaking and chills on 20-MAR-2021, and high fever, and nausea, and the outcome of headaches and left arm soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: ABDOMINAL PAIN DESCRIBES AS A GRABBING ACUTE PAIN; 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced abdominal pain describes as a grabbing acute pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain describes as a grabbing acute pain. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Hyperhidrosis, Hypoaesthesia
Clinical narrative: SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATIGUE; LUNG PAIN; LUNG WEIGHT/PINCH IN THE HEART/CHEST DISCOMFORT; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lung pain. On 24-MAR-2021, the subject experienced lung weight/pinch in the heart/chest discomfort. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced extremely thirsty. On 24-MAR-2021, the subject experienced left arm pain/legs burning. On 24-MAR-2021, the subject experienced left arm numbness. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced sweaty. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung pain, lung weight/pinch in the heart/chest discomfort, headache, fatigue, sweaty, body aches, extremely thirsty, left arm pain/legs burning, and left arm numbness. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pulmonary pain, Thirst
Clinical narrative: SWEATY; BODY ACHES; EXTREMELY THIRSTY; LEFT ARM PAIN/LEGS BURNING; LEFT ARM NUMBNESS; HEADACHE; FATIGUE; LUNG PAIN; LUNG WEIGHT/PINCH IN THE HEART/CHEST DISCOMFORT; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lung pain. On 24-MAR-2021, the subject experienced lung weight/pinch in the heart/chest discomfort. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced extremely thirsty. On 24-MAR-2021, the subject experienced left arm pain/legs burning. On 24-MAR-2021, the subject experienced left arm numbness. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced sweaty. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung pain, lung weight/pinch in the heart/chest discomfort, headache, fatigue, sweaty, body aches, extremely thirsty, left arm pain/legs burning, and left arm numbness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Haematoma
Clinical narrative: HEMATOMA; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced hematoma. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hematoma was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS IN HAND AND ARM; 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced numbness in hand and arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in hand and arm. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Injection site pain, Pain in extremity
Clinical narrative: HEADACHE; INJECTION SITE PAIN; PAIN IN RIGHT ARM; ANXIETY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, diabetes, glaucoma, neuropathy, high blood pressure, depression, anxiety, venous insufficiency of both lower extremities, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with amlodipine, and lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On 10-APR-2021, the subject experienced pain in right arm. On 10-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, pain in right arm, and injection site pain, and the outcome of anxiety was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Scratch, Swelling, Urticaria
Clinical narrative: ITCHING; REDNESS OF SCRATCHES; WELT ON ARM; SWELLING; This spontaneous report received from a patient concerned a 71 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced redness of scratches. On APR-2021, the subject experienced welt on arm. On APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, redness of scratches, and welt on arm, and the outcome of swelling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: SEVERE VOMITING; DRY HEAVING; SWEATS; CHILLS; NAUSEA; FATIGUE; RED ARM; SWOLLEN ARM; 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced red arm. On APR-2021, the subject experienced swollen arm. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced severe vomiting. On 10-APR-2021, the subject experienced dry heaving. On 10-APR-2021, the subject experienced sweats.  On 10-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vomiting, dry heaving, sweats, and chills on 10-APR-2021, and nausea, and fatigue, and the outcome of red arm and swollen arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Retching, Vomiting
Clinical narrative: SEVERE VOMITING; DRY HEAVING; SWEATS; CHILLS; NAUSEA; FATIGUE; RED ARM; SWOLLEN ARM; 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On APR-2021, the subject experienced red arm. On APR-2021, the subject experienced swollen arm. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced severe vomiting. On 10-APR-2021, the subject experienced dry heaving. On 10-APR-2021, the subject experienced sweats.  On 10-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vomiting, dry heaving, sweats, and chills on 10-APR-2021, and nausea, and fatigue, and the outcome of red arm and swollen arm was not reported. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Headache, Injection site bruising, Injection site pain
Clinical narrative: SWOLLEN AT INJECTION SITE; INJECTION SITE GREENISH PURPLE BRUISE COLOR; ABDOMINAL PAIN AND PRESSURE; INJECTION SITE SORE/TENDERNESS AT INJECTION SITE; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced abdominal pain and pressure. On 11-APR-2021, the subject experienced injection site sore/tenderness at injection site. On 12-APR-2021, the subject experienced injection site greenish purple bruise color. On 12-APR-2021, the subject experienced swollen at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, abdominal pain and pressure, injection site sore/tenderness at injection site, swollen at injection site, injection site greenish purple bruise color, and headache. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: SWOLLEN AT INJECTION SITE; INJECTION SITE GREENISH PURPLE BRUISE COLOR; ABDOMINAL PAIN AND PRESSURE; INJECTION SITE SORE/TENDERNESS AT INJECTION SITE; FEVER; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced abdominal pain and pressure. On 11-APR-2021, the subject experienced injection site sore/tenderness at injection site. On 12-APR-2021, the subject experienced injection site greenish purple bruise color. On 12-APR-2021, the subject experienced swollen at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, abdominal pain and pressure, injection site sore/tenderness at injection site, swollen at injection site, injection site greenish purple bruise color, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Vomiting
Clinical narrative: NEEDLES SUCK IT BURNED; VOMITED; ACHY; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced burned, vomited, achy, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burned, chills, vomited and achy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature decreased, Diarrhoea, Pain in extremity
Clinical narrative: DECREASE LEG TEMPERATURE; PAIN IN LEFT ARM/LEG; DIARRHOEA WITH LOOSE STOOLS; STOMACH ACHE; This spontaneous report received from a patient concerned a 28 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced pain in left arm. On 11-APR-2021, the subject experienced left leg pain. On 11-APR-2021, the subject experienced Diarrhea with loose stools. On 11-APR-2021, the subject experienced stomach ache. On 13-APR-2021, the subject experienced decrease leg temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in left arm, left leg pain, and decrease leg temperature, and had not recovered from stomach ache, and Diarrhea with loose stools. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Influenza like illness, Insomnia, Pain in extremity
Clinical narrative: FLU LIKE SYMPTOMS; INSOMNIA; PAINS IN LEGS; HEADACHE; This spontaneous report received from a consumer concerned an 86 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, insomnia, pains in legs, and headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) not reported, and Doppler scan (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, headache, pains in legs and insomnia was not reported. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: FLU LIKE SYMPTOMS; INSOMNIA; PAINS IN LEGS; HEADACHE; This spontaneous report received from a consumer concerned an 86 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, insomnia, pains in legs, and headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) not reported, and Doppler scan (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, headache, pains in legs and insomnia was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 26 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, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 13-APR-2021, was recovering from headache, and had not recovered from body aches. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling abnormal, Feeling jittery, Headache
Clinical narrative: THROBBING IN MIDDLE FINGER; DIARRHEA; JITTERS; FELT LIKE DYING; LEG PAIN AND NUMBNESS, LEFT ARM AND RIGHT ARM PAIN; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's concurrent conditions included spinal stenosis, lumbar deteriorating disc disease, deteriorating disease, alcohol user, smoker, cholesterol, and blood pressure, 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, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol for cholesterol, gabapentin for epilepsy, and fentanyl citrate. On 10-APR-2021, the subject experienced jitters. On 10-APR-2021, the subject experienced felt like dying. On 10-APR-2021, the subject experienced leg pain and numbness, left arm and right arm pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced throbbing in middle finger. On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing in middle finger, diarrhea, jitters, felt like dying, chills, and fever on 12-APR-2021, was recovering from leg pain and numbness, left arm and right arm pain, and had not recovered from headache. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: THROBBING IN MIDDLE FINGER; DIARRHEA; JITTERS; FELT LIKE DYING; LEG PAIN AND NUMBNESS, LEFT ARM AND RIGHT ARM PAIN; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's concurrent conditions included spinal stenosis, lumbar deteriorating disc disease, deteriorating disease, alcohol user, smoker, cholesterol, and blood pressure, 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, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included tramadol for cholesterol, gabapentin for epilepsy, and fentanyl citrate. On 10-APR-2021, the subject experienced jitters. On 10-APR-2021, the subject experienced felt like dying. On 10-APR-2021, the subject experienced leg pain and numbness, left arm and right arm pain. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced throbbing in middle finger. On 11-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throbbing in middle finger, diarrhea, jitters, felt like dying, chills, and fever on 12-APR-2021, was recovering from leg pain and numbness, left arm and right arm pain, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Lymphadenopathy, Pain
Clinical narrative: INSOMNIA; ENLARGED LYMPH NODES; BODY ACHES; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 insomnia, enlarged lymph nodes, body aches, fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, enlarged lymph nodes, fatigue, insomnia, body aches and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: INSOMNIA; ENLARGED LYMPH NODES; BODY ACHES; FEVER; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 insomnia, enlarged lymph nodes, body aches, fever, fatigue, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, enlarged lymph nodes, fatigue, insomnia, body aches and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Pyrexia
Clinical narrative: DIZZINESS; FELT BAD; FEVER; HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included pain issues before, and other pre-existing medical conditions included patient had no known allergies. 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced felt bad. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and dizziness, and the outcome of felt bad was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: HEADACHE; HAD A ROUGH NIGHT; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 12-APR-2021, the subject experienced had a rough night. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a rough night and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: ARM SORENESS; CHILLS; FEVER; 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm soreness, chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, chills, and fever. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Tinnitus, Tremor
Clinical narrative: HEADACHE; TIRED; RINGING IN EARS; SHAKING IN ARM; PAIN IN BOTH LEGS; This spontaneous report received from a consumer concerned a 61 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced ringing in ears. On 08-APR-2021, the subject experienced shaking in arm. On 08-APR-2021, the subject experienced pain in both legs. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, headache, shaking in arm, and tired, and the outcome of pain in both legs was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot, Hyperventilation
Clinical narrative: FEELING CLAMMY; FEELING WARM; HYPERVENTILATION; FATIGUE; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 160 pounds, and height was 160 centimeters. The patient's past medical history included blood clot on both lungs, and blood clot on legs, and concurrent conditions included alcohol user, cigarette smoker, seasonal allergy, penicillin allergy, and sulfa drugs allergy, and other pre-existing medical conditions included patient had no drug abuse and drug illicit usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for prevention of blood clot.  On 08-APR-2021, the subject experienced feeling clammy. On 08-APR-2021, the subject experienced feeling warm. On 08-APR-2021, the subject experienced hyperventilation. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hyperventilation on 08-APR-2021, and had not recovered from feeling clammy, feeling warm, and fatigue. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hyperhidrosis, Nasopharyngitis, Pain
Clinical narrative: BODY PAIN; SHOOTING PAIN; COLD; PERSPIRING; HEADACHE; SLEEPY; WEAK; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included hodgkin lymphoma, and back surgery, and concurrent conditions included lung diseases, heart diseases, and arthritis, and other pre-existing medical conditions included patient had no spleen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sleepy. On MAR-2021, the subject experienced weak. On 27-MAR-2021, the subject experienced body pain. On 27-MAR-2021, the subject experienced shooting pain. On 27-MAR-2021, the subject experienced cold. On 27-MAR-2021, the subject experienced perspiring. On 27-MAR-2021, the subject experienced headache. Treatment medications included: clonazepam, hydrocodone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, shooting pain, and headache on 2021, and the outcome of cold, perspiring, weak and sleepy was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: BODY PAIN; SHOOTING PAIN; COLD; PERSPIRING; HEADACHE; SLEEPY; WEAK; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included hodgkin lymphoma, and back surgery, and concurrent conditions included lung diseases, heart diseases, and arthritis, and other pre-existing medical conditions included patient had no spleen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sleepy. On MAR-2021, the subject experienced weak. On 27-MAR-2021, the subject experienced body pain. On 27-MAR-2021, the subject experienced shooting pain. On 27-MAR-2021, the subject experienced cold. On 27-MAR-2021, the subject experienced perspiring. On 27-MAR-2021, the subject experienced headache. Treatment medications included: clonazepam, hydrocodone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, shooting pain, and headache on 2021, and the outcome of cold, perspiring, weak and sleepy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain, Pruritus
Clinical narrative: DIZZINESS/SUNLIGHT MAKES FEEL DIZZIER; ITCHY; ARM HURTS 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm hurts at injection site. On 08-APR-2021, the subject experienced dizziness/sunlight makes feel dizzier. On 08-APR-2021, the subject experienced itchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm hurts at injection site, and itchy, and had not recovered from dizziness/sunlight makes feel dizzier. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: FAST HEART BEAT; 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: 805020, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 03:00 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart beat on 09-MAR-2021. This report was non-serious. This case, from the Others is linked to .