chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: VACCINE KICKING HIS ASS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 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 vaccine kicking his ass. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine kicking his ass was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Odynophagia, Oropharyngeal pain, Productive cough
Clinical narrative: SORE THROAT; LEFT SIDE OF NECK PAIN; PAINFUL SWALLOWING; LOT OF PHLEGM; This spontaneous report received from a patient concerned an 89 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, gout in left foot, split nails issue, seasonal allergies, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included biotin for split nails issue. On 18-MAR-2021, the subject experienced sore throat. On 18-MAR-2021, the subject experienced left side of neck pain. On 18-MAR-2021, the subject experienced painful swallowing. On 18-MAR-2021, the subject experienced lot of phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, left side of neck pain, painful swallowing, and lot of phlegm. This report was non-serious.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: HEART POUNDING; ELEVATED HEART RATE; This spontaneous report received from a patient concerned a 69 year old of unspecified sex. The patient's height, and weight were not reported.  The patient's past medical history included unexplained lips swellings, and premature ventricular contraction, and concurrent conditions included allergic to several antibiotics, and other pre-existing medical conditions included patient was on small dose of beta blocker that was tapered off over a month period.  The patient experienced drug allergy when treated with rosuvastatin calcium, and atorvastatin calcium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 17-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 85-95 BPM. On 17-MAR-2021 20, the subject experienced heart pounding. On 17-MAR-2021 20, the subject experienced elevated heart rate. On 18-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 70 BPM, 60-65 BPM. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding, and elevated heart rate on 18-MAR-2021 05. 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: Dizziness, Headache, Nausea
Clinical narrative: DIZZINESS; HEADACHE (PRESSURE ON HEAD); NAUSEA OFF AND ON; 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced dizziness. On 15-MAR-2021, the subject experienced headache (pressure on head). On 15-MAR-2021, the subject experienced nausea off and on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, headache (pressure on head), and nausea off and on. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, SARS-CoV-2 test positive
Clinical narrative: ITCHING; REDNESS; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, blood pressure, and rheumatoid arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered in left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 PCR test positive (NR: not provided) Positive. On 12-MAR-2021, the patient experienced itching. On 12-MAR-2021, the patient experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching, and had not recovered from redness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Myalgia, Nausea
Clinical narrative: CHEST TIGHTNESS; MUSCLE PAIN; NAUSEA; HEADACHE; 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 the patient did not had known allergies. no diagnostic data available.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 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced muscle pain. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, was recovering from nausea, and had not recovered from muscle pain, and chest tightness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site rash, Nodule, Pain in extremity
Clinical narrative: FATIGUE; HEADACHE; KNOT ON ARM; RASH AT INJECTION SITE; SORE 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced knot on arm. On 16-MAR-2021, the subject experienced rash at injection site. On 16-MAR-2021, the subject experienced sore arm. On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from knot on arm, rash at injection site, sore arm, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: UNDERDOSED; This spontaneous report received from a physician 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) .4 ml, start therapy date was 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 underdosed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of underdosed was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pyrexia
Clinical narrative: LOWER BACK PAIN (KIDNEYS); CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 53 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021 10:30, the subject experienced lower back pain (kidneys). On 13-MAR-2021 10:30, the subject experienced chills. On 13-MAR-2021 10:30, the subject experienced fever. On 13-MAR-2021 10:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache on MAR-2021, and had not recovered from lower back pain (kidneys). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: ARM WAS SORE A LITTLE FOR A DAY; HAD A FEW ACHES; 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, expiry date: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced arm was sore a little for a day. On MAR-2021, the subject experienced had a few aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore a little for a day, and had a few aches on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fear, Feeling of body temperature change, Headache, Nausea
Clinical narrative: FEELING FEAR; HEADACHE; NAUSEA; FEELING HOT AND COLD; 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 the patient was not pregnant at the time of event reporting.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 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot and cold. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced feeling fear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 16-MAR-2021, and had not recovered from feeling hot and cold, nausea, and feeling fear. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Inflammation, Injection site swelling, Injection site warmth
Clinical narrative: FEEL LUMP; LYMPH NODES (BREAST TISSUE AND ARMPIT SWOLLEN); SWELLING MOVED TO SIDE OF BREAST TISSUE (SWOLLEN ARMPIT) AND FELT HEAT UNDER ARMPIT; BODY ACHE; JOINT ACHE; MUSCLE ACHE; SWELLING ON ARM WHERE INJECTION WAS GIVEN; INJECTION SITE HEAT; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination at her right arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced swelling moved to side of breast tissue (swollen armpit) and felt heat under armpit. On 14-MAR-2021, the subject experienced body ache. On 14-MAR-2021, the subject experienced joint ache. On 14-MAR-2021, the subject experienced muscle ache. On 14-MAR-2021, the subject experienced swelling on arm where injection was given. On 14-MAR-2021, the subject experienced injection site heat. On an unspecified date, the subject experienced feel lump, and lymph nodes (breast tissue and armpit swollen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, joint ache, muscle ache, swelling on arm where injection was given, and injection site heat, had not recovered from swelling moved to side of breast tissue (swollen armpit) and felt heat under armpit, and the outcome of feel lump and lymph nodes (breast tissue and armpit swollen) was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain
Clinical narrative: FEEL LUMP; LYMPH NODES (BREAST TISSUE AND ARMPIT SWOLLEN); SWELLING MOVED TO SIDE OF BREAST TISSUE (SWOLLEN ARMPIT) AND FELT HEAT UNDER ARMPIT; BODY ACHE; JOINT ACHE; MUSCLE ACHE; SWELLING ON ARM WHERE INJECTION WAS GIVEN; INJECTION SITE HEAT; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination at her right arm. No concomitant medications were reported. On 14-MAR-2021, the subject experienced swelling moved to side of breast tissue (swollen armpit) and felt heat under armpit. On 14-MAR-2021, the subject experienced body ache. On 14-MAR-2021, the subject experienced joint ache. On 14-MAR-2021, the subject experienced muscle ache. On 14-MAR-2021, the subject experienced swelling on arm where injection was given. On 14-MAR-2021, the subject experienced injection site heat. On an unspecified date, the subject experienced feel lump, and lymph nodes (breast tissue and armpit swollen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, joint ache, muscle ache, swelling on arm where injection was given, and injection site heat, had not recovered from swelling moved to side of breast tissue (swollen armpit) and felt heat under armpit, and the outcome of feel lump and lymph nodes (breast tissue and armpit swollen) was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: WEAKNESS IN THE LEFT ARM; This spontaneous report received from a patient concerned an 83 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced weakness in the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness in the left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: DIARRHEA; VOMITING; FEVER FOR ONE DAY; NAUSEA; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry:, and 2022) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced fever for one day. On 10-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever for one day, diarrhea, vomiting, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FELT LIKE HAD THE FLU; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced felt like had the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like had the flu was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Gait disturbance, Lymphadenopathy, Malaise
Clinical narrative: SWOLLEN LYMPH NODES; DIZZY; VOMITING; NAUSEA; FEVER; DON'T FEEL 100% CORRECT; COULD NOT WALK; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to MIR contrast, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse, illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, 1802070 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 11:30 to left arm for prophylactic vaccination. Concomitant medications included diet formulations for treatment of obesity for diet pill, and spironolactone for diuretic.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 17-MAR-2021, the subject experienced swollen lymph nodes. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced vomiting. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced could not walk, and don't feel 100% correct. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 17-MAR-2021, was recovering from dizzy, had not recovered from swollen lymph nodes, and fever, and the outcome of could not walk and don't feel 100% correct 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 assessed non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: SWOLLEN LYMPH NODES; DIZZY; VOMITING; NAUSEA; FEVER; DON'T FEEL 100% CORRECT; COULD NOT WALK; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to MIR contrast, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse, illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, 1802070 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 11:30 to left arm for prophylactic vaccination. Concomitant medications included diet formulations for treatment of obesity for diet pill, and spironolactone for diuretic.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 17-MAR-2021, the subject experienced swollen lymph nodes. On 17-MAR-2021, the subject experienced dizzy. On 17-MAR-2021, the subject experienced vomiting. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced could not walk, and don't feel 100% correct. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 17-MAR-2021, was recovering from dizzy, had not recovered from swollen lymph nodes, and fever, and the outcome of could not walk and don't feel 100% correct 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 assessed non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: FLU-LIKE SYMPTOMS CHILLS, MUSCLE SORENESS, HEADACHE AND ACHY SKIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included clotting disorder (unknown cause, with two episodes of clot prior), chronic migraine, celiac disease, penicillin allergy, cephalosporin allergy, sulfa drugs allergy, and social drinker (once every few months). The patient experienced drug allergy when treated with tetracycline, and vancomycin non-company for drug used for unknown indication. 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 15-MAR-2021 14:15 in left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. On 15-MAR-2021 22:00, the subject experienced flu-like symptoms chills, muscle soreness, headache and achy skin. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient was recovering from flu-like symptoms chills, muscle soreness, headache and achy skin, and injection site pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Musculoskeletal stiffness
Clinical narrative: STIFF NECK; DRY MOUTH; HEADACHE; 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, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 09:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021 11:00, the subject experienced stiff neck. On 18-MAR-2021 11:00, the subject experienced dry mouth. On 18-MAR-2021 11:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck, headache, and dry mouth. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: BODY ACHE; SORE THROAT; HEADACHE; NAUSEA; 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, and batch number: UNKNOWN) dose was not reported, administered on 17-MAR-2021 08:00 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-MAR-2021, the subject experienced body ache. On 17-MAR-2021, the subject experienced sore throat. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, nausea, and sore throat, and had not recovered from headache. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a 66 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) 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 patient experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FATIGUE; FEVER; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced fatigue. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Dyspnoea, Feeding disorder
Clinical narrative: BACK PAIN; LEGS PAIN; HIPS PAIN; RED WELTS RAISED AND UNDERNEATH THE SKIN/ WELTS ITCHES/ PAINFUL TO A LIGHT TOUCH (WELT); "BUG BITE" LIKE RED DOT ON LEFT LEG; BODY CRAMPS; PAINFUL POINT OF INJECTION ON TOUCH; NAUSEA; FEVER OF 102.8F; HEADACHE; FEELING UNWELL; UNABLE TO EAT; SWEATY; TROUBLE BREATHING; BODY ACHES; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 77.11 kilograms, and height was 170.18 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 13:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced unable to eat. On 15-MAR-2021, the subject experienced sweaty. On 15-MAR-2021, the subject experienced trouble breathing. On 15-MAR-2021, the subject experienced body aches. On 15-MAR-2021, the subject experienced body cramps. On 15-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced painful point of injection on touch. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced fever of 102.8f. On 15-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.8 F. On an unspecified date, the subject experienced "bug bite" like red dot on left leg, back pain, legs pain, hips pain, and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, loratadine, calamine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing, body aches, and body cramps on 17-MAR-2021, was recovering from unable to eat, fever of 102.8f, sweaty, headache, feeling unwell, nausea, and painful point of injection on touch, had not recovered from legs pain, back pain, and hips pain, and the outcome of "bug bite" like red dot on left leg and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site pain, Malaise, Muscle spasms
Clinical narrative: BACK PAIN; LEGS PAIN; HIPS PAIN; RED WELTS RAISED AND UNDERNEATH THE SKIN/ WELTS ITCHES/ PAINFUL TO A LIGHT TOUCH (WELT); "BUG BITE" LIKE RED DOT ON LEFT LEG; BODY CRAMPS; PAINFUL POINT OF INJECTION ON TOUCH; NAUSEA; FEVER OF 102.8F; HEADACHE; FEELING UNWELL; UNABLE TO EAT; SWEATY; TROUBLE BREATHING; BODY ACHES; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 77.11 kilograms, and height was 170.18 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 13:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced unable to eat. On 15-MAR-2021, the subject experienced sweaty. On 15-MAR-2021, the subject experienced trouble breathing. On 15-MAR-2021, the subject experienced body aches. On 15-MAR-2021, the subject experienced body cramps. On 15-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced painful point of injection on touch. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced fever of 102.8f. On 15-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.8 F. On an unspecified date, the subject experienced "bug bite" like red dot on left leg, back pain, legs pain, hips pain, and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, loratadine, calamine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing, body aches, and body cramps on 17-MAR-2021, was recovering from unable to eat, fever of 102.8f, sweaty, headache, feeling unwell, nausea, and painful point of injection on touch, had not recovered from legs pain, back pain, and hips pain, and the outcome of "bug bite" like red dot on left leg and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: BACK PAIN; LEGS PAIN; HIPS PAIN; RED WELTS RAISED AND UNDERNEATH THE SKIN/ WELTS ITCHES/ PAINFUL TO A LIGHT TOUCH (WELT); "BUG BITE" LIKE RED DOT ON LEFT LEG; BODY CRAMPS; PAINFUL POINT OF INJECTION ON TOUCH; NAUSEA; FEVER OF 102.8F; HEADACHE; FEELING UNWELL; UNABLE TO EAT; SWEATY; TROUBLE BREATHING; BODY ACHES; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 77.11 kilograms, and height was 170.18 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 13:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced unable to eat. On 15-MAR-2021, the subject experienced sweaty. On 15-MAR-2021, the subject experienced trouble breathing. On 15-MAR-2021, the subject experienced body aches. On 15-MAR-2021, the subject experienced body cramps. On 15-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced painful point of injection on touch. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced fever of 102.8f. On 15-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.8 F. On an unspecified date, the subject experienced "bug bite" like red dot on left leg, back pain, legs pain, hips pain, and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, loratadine, calamine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing, body aches, and body cramps on 17-MAR-2021, was recovering from unable to eat, fever of 102.8f, sweaty, headache, feeling unwell, nausea, and painful point of injection on touch, had not recovered from legs pain, back pain, and hips pain, and the outcome of "bug bite" like red dot on left leg and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: BACK PAIN; LEGS PAIN; HIPS PAIN; RED WELTS RAISED AND UNDERNEATH THE SKIN/ WELTS ITCHES/ PAINFUL TO A LIGHT TOUCH (WELT); "BUG BITE" LIKE RED DOT ON LEFT LEG; BODY CRAMPS; PAINFUL POINT OF INJECTION ON TOUCH; NAUSEA; FEVER OF 102.8F; HEADACHE; FEELING UNWELL; UNABLE TO EAT; SWEATY; TROUBLE BREATHING; BODY ACHES; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 77.11 kilograms, and height was 170.18 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 15-MAR-2021 13:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced unable to eat. On 15-MAR-2021, the subject experienced sweaty. On 15-MAR-2021, the subject experienced trouble breathing. On 15-MAR-2021, the subject experienced body aches. On 15-MAR-2021, the subject experienced body cramps. On 15-MAR-2021, the subject experienced feeling unwell. On 15-MAR-2021, the subject experienced painful point of injection on touch. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced fever of 102.8f. On 15-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.8 F. On an unspecified date, the subject experienced "bug bite" like red dot on left leg, back pain, legs pain, hips pain, and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, loratadine, calamine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing, body aches, and body cramps on 17-MAR-2021, was recovering from unable to eat, fever of 102.8f, sweaty, headache, feeling unwell, nausea, and painful point of injection on touch, had not recovered from legs pain, back pain, and hips pain, and the outcome of "bug bite" like red dot on left leg and red welts raised and underneath the skin/ welts itches/ painful to a light touch (welt) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Pain, Toothache
Clinical narrative: PAIN IN TEETH; RIGHT BREAST SORENESS; MILD GENERALIZED ACHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 11-MAR-2021, the subject experienced pain in teeth. On 11-MAR-2021, the subject experienced right breast soreness. On 11-MAR-2021, the subject experienced mild generalized aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in teeth on 18-MAR-2021, and right breast soreness on 17-MAR-2021, and was recovering from mild generalized aching. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and company unable to perform follow-up. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eye pain, Headache, Nausea
Clinical narrative: SEVERE BACK PAIN IN BETWEEN THE BLADES AND LOWER BACK; EYES HURT; CHILLS; FEVER; NAUSEA; HEADACHE; 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 covid-19 infection, and concurrent conditions included fibromyalgia, lupus, left bundle branch block, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient was not pregnant at the time of reporting. The patient was previously treated with ivermectin for covid-19 infection; and experienced drug allergy when treated with pethidine hydrochloride, morphine, and oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced severe back pain in between the blades and lower back. On 18-MAR-2021, the subject experienced eyes hurt. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced nausea. On 18-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 fever, and nausea, and the outcome of chills, headache, severe back pain in between the blades and lower back and eyes hurt was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SEVERE BACK PAIN IN BETWEEN THE BLADES AND LOWER BACK; EYES HURT; CHILLS; FEVER; NAUSEA; HEADACHE; 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 covid-19 infection, and concurrent conditions included fibromyalgia, lupus, left bundle branch block, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient was not pregnant at the time of reporting. The patient was previously treated with ivermectin for covid-19 infection; and experienced drug allergy when treated with pethidine hydrochloride, morphine, and oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced severe back pain in between the blades and lower back. On 18-MAR-2021, the subject experienced eyes hurt. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced nausea. On 18-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 fever, and nausea, and the outcome of chills, headache, severe back pain in between the blades and lower back and eyes hurt was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site bruising
Clinical narrative: BRUISE APPEARANCE AROUND SITE OF INJECTION; LOSS OF APPETITE; CHILLS; FEVER; HEADACHE; FATIGUE; 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 was not reported, administered on 15-MAR-2021 at right deltoid 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 bruise appearance around site of injection, loss of appetite, chills, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, bruise appearance around site of injection, headache, loss of appetite and fatigue was not reported. This report was non-serious. The case is associated with Product Quality Complaint number # 90000173359. The suspected product quality complaint has been confirmed to be voided (does not meet PQC criteria) based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BRUISE APPEARANCE AROUND SITE OF INJECTION; LOSS OF APPETITE; CHILLS; FEVER; HEADACHE; FATIGUE; 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 was not reported, administered on 15-MAR-2021 at right deltoid 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 bruise appearance around site of injection, loss of appetite, chills, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, bruise appearance around site of injection, headache, loss of appetite and fatigue was not reported. This report was non-serious. The case is associated with Product Quality Complaint number # 90000173359. The suspected product quality complaint has been confirmed to be voided (does not meet PQC criteria) based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Burning sensation, Dry mouth, Fatigue, Headache
Clinical narrative: MOUTH DRYNESS/THRUSHY FEELING IN MOUTH; ACHES; PAIN; FATIGUE; HEADACHE; SKIN BURNING ESPECIALLY ON THE FACE, ALSO ON BACK; EXTREME SENSITIVITY ON SKIN; HYPED-UP FEELING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced skin burning especially on the face, also on back. On 13-MAR-2021, the subject experienced extreme sensitivity on skin. On 13-MAR-2021, the subject experienced hyped-up feeling. On 13-MAR-2021, the subject experienced aches. On 13-MAR-2021, the subject experienced pain. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced mouth dryness/thrushy feeling in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, pain, fatigue, and headache, and the outcome of skin burning especially on the face, also on back, extreme sensitivity on skin, hyped-up feeling and mouth dryness/thrushy feeling in mouth was not reported. This report was non-serious.