chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Nasopharyngitis, Pyrexia
Clinical narrative: ROUGH NIGHTS SLEEP; DRY MOUTH; HEADCOLD; BREATHING ISSUES; SWEATING; FEVER; CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had drug abuse/illicit drug use. not necessarily takes cholesterol pill.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced rough nights sleep. On MAR-2021, the subject experienced dry mouth. On MAR-2021, the subject experienced headcold. On MAR-2021, the subject experienced breathing issues. On MAR-2021, the subject experienced sweating. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 12-MAR-2021, had not recovered from dry mouth, headcold, and breathing issues, and the outcome of rough nights sleep, mild headache and sweating was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inflammation, Injection site pain, Injection site reaction, Pain
Clinical narrative: FEELING TINGLING IN THIGH; BURNING PAIN; VACCINE DESTROYING BODY; PAIN IN FEET; INJECTION SITE VERY PAINFUL; MUSCLE STIFFNESS AT INJECTION SITE; INFLAMMATION IN THIGHS, BILATERAL FEET, ANKLES AND ARCH OF FEET; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included plantar fasciitis, prp in bilateral feet, and surgery, and concurrent conditions included carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left deltoid arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle stiffness at injection site. On MAR-2021, the subject experienced inflammation in thighs, bilateral feet, ankles and arch of feet. On MAR-2021, the subject experienced burning pain. On MAR-2021, the subject experienced vaccine destroying body. On MAR-2021, the subject experienced pain in feet. On MAR-2021, the subject experienced injection site very painful. On 06-MAR-2021, the subject experienced feeling tingling in thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in feet, feeling tingling in thigh, inflammation in thighs, bilateral feet, ankles and arch of feet, burning pain, vaccine destroying body, muscle stiffness at injection site, and injection site very painful. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: FEELING TINGLING IN THIGH; BURNING PAIN; VACCINE DESTROYING BODY; PAIN IN FEET; INJECTION SITE VERY PAINFUL; MUSCLE STIFFNESS AT INJECTION SITE; INFLAMMATION IN THIGHS, BILATERAL FEET, ANKLES AND ARCH OF FEET; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included plantar fasciitis, prp in bilateral feet, and surgery, and concurrent conditions included carpal tunnel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left deltoid arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced muscle stiffness at injection site. On MAR-2021, the subject experienced inflammation in thighs, bilateral feet, ankles and arch of feet. On MAR-2021, the subject experienced burning pain. On MAR-2021, the subject experienced vaccine destroying body. On MAR-2021, the subject experienced pain in feet. On MAR-2021, the subject experienced injection site very painful. On 06-MAR-2021, the subject experienced feeling tingling in thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in feet, feeling tingling in thigh, inflammation in thighs, bilateral feet, ankles and arch of feet, burning pain, vaccine destroying body, muscle stiffness at injection site, and injection site very painful. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: RED SKIN AREA IN THE SHOT; 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) 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 13-MAR-2021, the subject experienced red skin area in the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red skin area in the shot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Hyperhidrosis
Clinical narrative: SWEATY (HOT DURING THE NIGHT); TIRED; POOR SLEEP; BAD HEADACHE; SHOULDER PAIN (LEFT ARM); LITTLE SORENESS AT SITE OF VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and anxiety, 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 17:15 for prophylactic vaccination. Concomitant medications included sertraline hydrochloride for anxiety, and depression, and zolpidem tartrate for insomnia. On MAR-2021, the subject experienced shoulder pain (left arm). On MAR-2021, the subject experienced little soreness at site of vaccination. On 12-MAR-2021, the subject experienced poor sleep. On 12-MAR-2021, the subject experienced bad headache. On 13-MAR-2021, the subject experienced sweaty (hot during the night). On 13-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty (hot during the night) on 13-MAR-2021, was recovering from bad headache, had not recovered from tired, and the outcome of poor sleep, shoulder pain (left arm) and little soreness at site of vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: SWEATY (HOT DURING THE NIGHT); TIRED; POOR SLEEP; BAD HEADACHE; SHOULDER PAIN (LEFT ARM); LITTLE SORENESS AT SITE OF VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and anxiety, 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 17:15 for prophylactic vaccination. Concomitant medications included sertraline hydrochloride for anxiety, and depression, and zolpidem tartrate for insomnia. On MAR-2021, the subject experienced shoulder pain (left arm). On MAR-2021, the subject experienced little soreness at site of vaccination. On 12-MAR-2021, the subject experienced poor sleep. On 12-MAR-2021, the subject experienced bad headache. On 13-MAR-2021, the subject experienced sweaty (hot during the night). On 13-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty (hot during the night) on 13-MAR-2021, was recovering from bad headache, had not recovered from tired, and the outcome of poor sleep, shoulder pain (left arm) and little soreness at site of vaccination was not reported. This report was non-serious.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned an 87 year old male. The patient's height, and weight were not reported. The patient's past medical history included copd, and concurrent conditions included streptomycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: 25-MAY-2021) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Heart rate increased, Ocular hyperaemia, Pyrexia
Clinical narrative: INCREASED HEART RATE; RED EYES; SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included immunodeficient, recurrent infections, chronic inflammation, asthma, cat allergy, dog allergy, and seasonal allergies. The patient experienced drug allergy when treated with azithromycin non-company, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever. On 12-MAR-2021, the subject experienced increased heart rate. On 12-MAR-2021, the subject experienced red eyes. On 12-MAR-2021, the subject experienced severe chills. On 12-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.7 (not reported), 101.6 (not reported), 102.3-102.5 (not reported), 101.7 (not reported), and Heart rate increased (NR: not provided) over 100 (not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from red eyes, severe chills, fever, and increased heart rate. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment is not required per standard   procedure as the case includes non-serious event.
Sex: U
Vaccine: COVID19
Symptoms: Injection site infection, Wrong technique in product usage process
Clinical narrative: INJECTION SITE INFECTION; WRONG ADMINISTERED INJECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stage 4 lung cancer.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 10-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site infection, and wrong administered injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site infection and wrong administered injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Palpitations
Clinical narrative: HEART RACING; DIZZINESS; CHILLS; WEAKNESS; FEVER (102.4 F); 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 10:14 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4 F. On 12-MAR-2021, treatment medications included: paracetamol. On 12-MAR-2021 14:00, the subject experienced heart racing. On 12-MAR-2021 14:00, the subject experienced dizziness. On 12-MAR-2021 14:00, the subject experienced chills. On 12-MAR-2021 14:00, the subject experienced weakness. On 12-MAR-2021 14:00, the subject experienced fever (102.4 f). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (102.4 f), chills, weakness, dizziness, and heart racing. This report was non-serious. This parent/child case is linked to .; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEART RACING; DIZZINESS; CHILLS; WEAKNESS; FEVER (102.4 F); 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 10:14 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4 F. On 12-MAR-2021, treatment medications included: paracetamol. On 12-MAR-2021 14:00, the subject experienced heart racing. On 12-MAR-2021 14:00, the subject experienced dizziness. On 12-MAR-2021 14:00, the subject experienced chills. On 12-MAR-2021 14:00, the subject experienced weakness. On 12-MAR-2021 14:00, the subject experienced fever (102.4 f). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever (102.4 f), chills, weakness, dizziness, and heart racing. This report was non-serious. This parent/child case is linked to .; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Insomnia
Clinical narrative: FAST HEARTBEAT; DIZZINESS; TROUBLE SLEEPING; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 10-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 fast heartbeat. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced trouble sleeping. On MAR-2021, the subject experienced weakness. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fast heartbeat, dizziness, weakness and trouble sleeping was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Dizziness, Dyspnoea, Feeling cold
Clinical narrative: DIFFICULTY BREATHING; FEELING DISORIENTED; DIZZY; VERY COLD; CHILLS; NAUSEOUS; 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, and batch number: 1805022 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 difficulty breathing. On 13-MAR-2021, the subject experienced feeling disoriented. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced very cold. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling disoriented, dizzy, nauseous, very cold, chills and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: DIFFICULTY BREATHING; FEELING DISORIENTED; DIZZY; VERY COLD; CHILLS; NAUSEOUS; 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, and batch number: 1805022 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 difficulty breathing. On 13-MAR-2021, the subject experienced feeling disoriented. On 13-MAR-2021, the subject experienced dizzy. On 13-MAR-2021, the subject experienced very cold. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling disoriented, dizzy, nauseous, very cold, chills and difficulty breathing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Sinus disorder, Throat irritation
Clinical narrative: MID CHEST COLD VOICE; SCRATCHY THROAT; SINUS ISSUES; 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, route of admin 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 14-MAR-2021, the subject experienced mid chest cold voice. On 14-MAR-2021, the subject experienced scratchy throat. On 14-MAR-2021, the subject experienced sinus issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scratchy throat, sinus issues and mid chest cold voice was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; 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, 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 unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: SICK ALL DAY; This spontaneous report received from a patient via a company representative concerned a 96 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 14-MAR-2021, the subject experienced sick all day. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of sick all day was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ARM OF VACCINATION; 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, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced pain in arm of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm of vaccination was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; HEADACHE; PAIN AT INJECTION SITE; 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: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, body ache and pain at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: ACHES AND PAIN ALL OVER BODY; SORE ARM; 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 concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included patient had no known allergies and had no drug abuse and illicit drug usage. 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-MAR-2021 for prophylactic vaccination. Batch Number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced aches and pain all over body. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, sore arm, and aches and pain all over body. The reporter causality between JNJ-78436735 and headache, sore arm, and aches and pain all over body was not related. Company causality between JNJ-78436735 and headache, sore arm, and aches and pain all over body was possible. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin discolouration, Tremor
Clinical narrative: SHAKING REALLY BAD; RED NECK; RED SPOT ON NECK; RED SPOT ON CHEST; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, sulphur allergy, shellfish allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced shaking really bad. On 12-MAR-2021, the subject experienced red neck. On 12-MAR-2021, the subject experienced red spot on neck. On 12-MAR-2021, the subject experienced red spot on chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking really bad, red spot on chest, and red spot on neck, and the outcome of red neck was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Fatigue, Fibromyalgia
Clinical narrative: HEAVINESS IN CHEST; DIZZY/FEELING LIKE SHE WOULD PASS OUT; COUGHING; FEVER; TIREDNESS; MUSCLE ACHES; PROFUSE SWEATING; NOT FEELING WELL; OUT OF WORK SICK; FIBROMYALGIA WORSENED PAIN; 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 past medical history included covid-19 disease, ear ringing, headache, fatigue, muscle aches, fibromyalgia pain, and celiac disease, and concurrent conditions included alcohol consumption, and other pre-existing medical conditions included patient felt fullness, tried lyrica, flu shot 2020 and the patient eats gluten free. The patient was previously treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fibromyalgia worsened pain. On MAR-2021, the subject experienced not feeling well. On MAR-2021, the subject experienced out of work sick. On 11-MAR-2021, the subject experienced muscle aches. On 11-MAR-2021, the subject experienced profuse sweating. On 11-MAR-2021, the subject experienced tiredness. On 11-MAR-2021 01:00, the subject experienced fever. On 13-MAR-2021, the subject experienced coughing. On 14-MAR-2021, the subject experienced heaviness in chest. On 14-MAR-2021, the subject experienced dizzy/feeling like she would pass out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, profuse sweating, fever, and tiredness on 12-MAR-2021, was recovering from coughing, had not recovered from heaviness in chest, and dizzy/feeling like she would pass out, and the outcome of not feeling well, fibromyalgia worsened pain and out of work sick 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Malaise, Myalgia, Pyrexia
Clinical narrative: HEAVINESS IN CHEST; DIZZY/FEELING LIKE SHE WOULD PASS OUT; COUGHING; FEVER; TIREDNESS; MUSCLE ACHES; PROFUSE SWEATING; NOT FEELING WELL; OUT OF WORK SICK; FIBROMYALGIA WORSENED PAIN; 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 past medical history included covid-19 disease, ear ringing, headache, fatigue, muscle aches, fibromyalgia pain, and celiac disease, and concurrent conditions included alcohol consumption, and other pre-existing medical conditions included patient felt fullness, tried lyrica, flu shot 2020 and the patient eats gluten free. The patient was previously treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fibromyalgia worsened pain. On MAR-2021, the subject experienced not feeling well. On MAR-2021, the subject experienced out of work sick. On 11-MAR-2021, the subject experienced muscle aches. On 11-MAR-2021, the subject experienced profuse sweating. On 11-MAR-2021, the subject experienced tiredness. On 11-MAR-2021 01:00, the subject experienced fever. On 13-MAR-2021, the subject experienced coughing. On 14-MAR-2021, the subject experienced heaviness in chest. On 14-MAR-2021, the subject experienced dizzy/feeling like she would pass out. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, profuse sweating, fever, and tiredness on 12-MAR-2021, was recovering from coughing, had not recovered from heaviness in chest, and dizzy/feeling like she would pass out, and the outcome of not feeling well, fibromyalgia worsened pain and out of work sick 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: M
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Decreased appetite, Feeling abnormal, Pyrexia
Clinical narrative: FEVER; CAN'T HOLD FOOD DOWN; DROWSY; CONFUSION; LOSS OF APPETITE; FEELING BAD; 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, intramuscular, batch number: L-1802072, and batch number: L-1802072 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced can't hold food down. On MAR-2021, the subject experienced drowsy. On MAR-2021, the subject experienced confusion. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced feeling bad. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, can't hold food down, drowsy, confusion, loss of appetite and feeling bad was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: FEVER; CAN'T HOLD FOOD DOWN; DROWSY; CONFUSION; LOSS OF APPETITE; FEELING BAD; 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, intramuscular, batch number: L-1802072, and batch number: L-1802072 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced can't hold food down. On MAR-2021, the subject experienced drowsy. On MAR-2021, the subject experienced confusion. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced feeling bad. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, can't hold food down, drowsy, confusion, loss of appetite and feeling bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Headache, Oral pain, Pain, Pyrexia
Clinical narrative: HEADACHE; FEVER; BODY ACHE; TONGUE SOURED; MOUTH SOURED; 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; expiry: Unknown) dose was not reported, administered on 13-MAR-2021 14:00 for prophylactic vaccination. the batch number was not reported hence requested.No concomitant medications were reported.  On 14-MAR-2021 07:00, the subject experienced mouth soured. On an unspecified date, the subject experienced headache, fever, body ache, and tongue soured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache, fever, mouth soured and tongue soured was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: STOMACH BUBBLING; STOMACH ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included acid reflux. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown). The batch nunmber was not reported and has been requested. On 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced stomach bubbling. On 11-MAR-2021, the subject experienced stomach ache. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach bubbling and stomach ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Malaise, Pyrexia
Clinical narrative: DIZZINESS; NOT FEELING WELL; CHILLS; FEVER OF 100.7; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autism.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced not feeling well. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever of 100.7. Laboratory data included: Body temperature (NR: not provided) 100.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 100.7, dizziness, not feeling well, and chills. This report was non-serious.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: 17 YEAR OLD MINOR WAS ADMINISTERED VACCINE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 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 12-MAR-2021, the subject experienced 17 year old minor was administered vaccine. On 12-MAR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 17 year old minor was administered vaccine and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: FEVER; CHILLS; HEADACHE; UPSET STOMACH; 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, 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 fever, chills, headache, and upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and upset stomach was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: BODY ACHES; CHILLS; TIREDNESS; This spontaneous report received from a consumer concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and tiredness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Myalgia, Nasopharyngitis, Pain in extremity
Clinical narrative: CRAMPS IN TOES; LITTLE COLD; SORE LEGS, SORE FEET; SORE KNEES; SORE THIGHS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced cramps in toes. On 13-MAR-2021, the subject experienced little cold. On 13-MAR-2021, the subject experienced sore legs, sore feet. On 13-MAR-2021, the subject experienced sore knees. On 13-MAR-2021, the subject experienced sore thighs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore legs, sore feet, cramps in toes, little cold, sore knees, and sore thighs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Pain, Pyrexia
Clinical narrative: BODY ACHES; EXPIRED VACCINE ADMINISTERED; 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, intramuscular, batch number: Unknown, expiry date: 13-MAR-2021) dose was not reported, administered on left arm on 13-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 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced expired vaccine administered. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and expired vaccine administered was not reported. This report was non-serious.
Age: 17.0
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 pharmacist concerned a 17 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, 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 off label use. On 14-MAR-2021, the subject experienced product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Palpitations
Clinical narrative: HEART PALPITATIONS; DIZZINESS; NAUSEA; HEADACHE; BURNING IN SKIN ON THE NECK; BODY ACHES; GENERALIZED ITCHINESS; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine, and penicillin allergy. The patient was previously treated with topiramate for migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced burning in skin on the neck. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced generalized itchiness. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning in skin on the neck on 12-MAR-2021, and body aches, heart palpitations, generalized itchiness, fever, nausea, and headache on 13-MAR-2021, and had not recovered from dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Skin burning sensation
Clinical narrative: HEART PALPITATIONS; DIZZINESS; NAUSEA; HEADACHE; BURNING IN SKIN ON THE NECK; BODY ACHES; GENERALIZED ITCHINESS; FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraine, and penicillin allergy. The patient was previously treated with topiramate for migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced burning in skin on the neck. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced generalized itchiness. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning in skin on the neck on 12-MAR-2021, and body aches, heart palpitations, generalized itchiness, fever, nausea, and headache on 13-MAR-2021, and had not recovered from dizziness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: BODY ACHES; SWEATING; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced body aches, sweating, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sweating, chills, fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: STIFF NECK; 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: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced stiff neck. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stiff neck and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: SHORT TERM MEMORY LOSS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced short term memory loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of short term memory loss was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.