chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Eye pain
Clinical narrative: SHORT LASTING PAIN IN RIGHT EYE; SHARP SHORT LASTING PAIN IN LEFT EAR; This spontaneous report received from a patient concerned a 70 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left deltoid for prophylactic vaccination. Concomitant medications included aflibercept. On 20-MAR-2021, the subject experienced sharp short lasting pain in left ear. On 23-MAR-2021, the subject experienced short lasting pain in right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from short lasting pain in right eye, and sharp short lasting pain in left ear. This report was non-serious. This report was associated with a product quality complaint: 90000174005. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Flushing, Hypokinesia, Injection site pain, Joint swelling
Clinical narrative: SHOULDER SWELLING; SHOULDER PAIN; SHOT WAS EXTREMELY PAINFUL; FLUSHED FEELING; DIFFICULTY LIFTING THE ARM; This spontaneous report received from a patient concerned an 84 year old female. The patient's weight was 100 pounds, and height was 157.48 centimeters. The patient's concurrent conditions included arthritis in left shoulder and mammals allergy. The patient had no illness at the time of vaccination. The patient had no past history of similar event. the patient had no adverse event after any previous vaccination(s). The patient had no pre-existing acute illness 30 days prior to vaccination. The patient had no history of hospitalization or acute illness in last 30 days, with cause. The patient had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccine(s)/risk factors. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for left deltoid prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced flushed feeling. On MAR-2021, the patientexperienced difficulty lifting the arm. On 15-MAR-2021, the patient experienced shot was extremely painful. On 19-MAR-2021, the patient experienced shoulder swelling. On 19-MAR-2021, the patient experienced shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and shoulder swelling, and the outcome of flushed feeling, difficulty lifting the arm and shot was extremely painful 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Epistaxis, Influenza like illness, Nasopharyngitis
Clinical narrative: FLU LIKE SYMPTOMS/ TIREDNESS; COLD SYMPTOMS/ NASAL CONGESTION; RIGHT SIDE NOSE BLEEDS; RIGHT SIDE EAR ACHE; This spontaneous report received from a patient concerned a 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to Vectrum, Keflex. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced right side nose bleeds. On 18-MAR-2021, the subject experienced right side ear ache. On 18-MAR-2021, the subject experienced cold symptoms. On an unspecified date, the subject experienced flu like symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold symptoms, had not recovered from right side nose bleeds, and right side ear ache, and the outcome of flu like symptoms 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
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain in extremity, Pruritus, Rash
Clinical narrative: ITCHING ALL OVER BODY; RASH; SORE ARM; FAST HEART BEAT OF 140 BPM; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included vicodin drug allergy, and sulfa drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on left deltoid on 23-MAR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced fast heart beat of 140 bpm. On 23-MAR-2021, the subject experienced rash. On 23-MAR-2021, the subject experienced sore arm. Laboratory data included: Heart rate (NR: not provided) 140 pm. On 23-MAR-2021 16:15, the subject experienced itching all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from itching all over body, rash, and fast heart beat of 140 bpm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: SPONTANEOUS NOSE BLEEDS (GUSHING, ALSO LIKE STREAMS OF RIBBONS,THICK); This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pseudocholinesterase deficiency, scoliosis, ramsay hunt syndrome, diabetes, narcotics allergy, non alcholic, non smoker, and anaesthesia allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. he patient had no family history of any disease or allergy relevant to vaccination. the patient had no pre-existing acute illness in last 30 days prior to vaccination. the patient had no history of hospitalization in last 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 08:30 on left arm for prophylactic vaccination. Concomitant medications included glimepiride for diabetes. On 13-MAR-2021 12:30, the subject experienced spontaneous nose bleeds (gushing, also like streams of ribbons, thick). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from spontaneous nose bleeds (gushing, also like streams of ribbons, thick). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: SKIN ITCHINESS OF FACE, SCALP, EYES; VERY SLIGHT PUFFINESS OF UPPER CHEEKS AT BOTH SIDES OF NOSE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight was not reported and height was 185.42 centimeters. The patient's concurrent conditions included HIV, alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no known history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate for HIV.  On 15-MAR-2021, the subject experienced skin itchiness of face, scalp, eyes. On 15-MAR-2021, the subject experienced very slight puffiness of upper cheeks at both sides of nose. The patient was treated with antihistamines for itching.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin itchiness of face, scalp, eyes, and very slight puffiness of upper cheeks at both sides of nose. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Needle issue, Underdose
Clinical narrative: LEAK OF PRODUCT FROM NEEDLE; PARTIAL ADMINISTRATION OF THE VACCINE; LEAKING OF THE PRODUCT FROM THE NEEDLE AND THE PATIENT ARM; This spontaneous report received from a pharmacist concerned a patient of unspecified age and 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) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced leak of product from needle. On 23-MAR-2021, the subject experienced partial administration of the vaccine. On 23-MAR-2021, the subject experienced leaking of the product from the needle and the subject arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the partial administration of the vaccine, leak of product from needle and leaking of the product from the needle and the patient arm was not reported. The case is associated with Product Quality Complaint number 90000174117 This report was non-serious. 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: Arthralgia, Axillary pain, Breast pain, Chills, Contusion
Clinical narrative: SORE NECK; SENSITIVE TO TOUCH; ARM TINGLING ON LEFT ARM AND DOWN TO FINGER; PAIN UNDERNEATH BREAST; FEVER EPISODES; NAUSEA; CHILLS; STIFF NECK; ARMPIT PAIN; HOT; ELBOW  BRUISE AND LEFT BREAST BRUISE; INABILITY TO MOVE ARM / CANNOT RAISE ARM PAST BREAST LEVE; SORE SHOULDER/ELBOW PAIN; 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 pulmonary problems, depression, alcoholic, and smoker, and other pre-existing medical conditions included .patient had no drug abuse or illicit drug usage. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination on Left Arm. No concomitant medications were reported. On 21-MAR-2021, the subject experienced stiff neck. On 21-MAR-2021, the subject experienced armpit pain. On 21-MAR-2021, the subject experienced hot. On 21-MAR-2021, the subject experienced elbow bruise and left breast bruise. On 21-MAR-2021, the subject experienced inability to move arm / cannot raise arm past breast level  On 21-MAR-2021, the subject experienced sore shoulder/elbow pain. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced sore neck. On 22-MAR-2021, the subject experienced sensitive to touch. On 22-MAR-2021, the subject experienced arm tingling on left arm and down to finger. On 22-MAR-2021, the subject experienced pain underneath breast. On 22-MAR-2021, the subject experienced fever episodes. On 22-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 23-MAR-2021, was recovering from sore neck, had not recovered from arm tingling on left arm and down to finger, stiff neck, nausea, sore shoulder/elbow pain, chills, hot, armpit pain, pain underneath breast, elbow bruise and left breast bruise, sensitive to touch, and fever episodes, and the outcome of inability to move arm / cannot raise arm past breast level was not reported. This report was non-serious.  Additional information was received from reporter on 23-Mar-2021. The following information was updated and incorporated into the case narrative: patient medical history (pulmonary problem, depression, alcoholic, smoker)  additional events (sore neck, sensitive to touch, elbow bruise and left breast bruise, headache, nausea), causality (Dechallenge, rechallenge action taken) , past event  past product, was was added.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperaesthesia, Hypokinesia, Musculoskeletal stiffness
Clinical narrative: SORE NECK; SENSITIVE TO TOUCH; ARM TINGLING ON LEFT ARM AND DOWN TO FINGER; PAIN UNDERNEATH BREAST; FEVER EPISODES; NAUSEA; CHILLS; STIFF NECK; ARMPIT PAIN; HOT; ELBOW  BRUISE AND LEFT BREAST BRUISE; INABILITY TO MOVE ARM / CANNOT RAISE ARM PAST BREAST LEVE; SORE SHOULDER/ELBOW PAIN; 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 pulmonary problems, depression, alcoholic, and smoker, and other pre-existing medical conditions included .patient had no drug abuse or illicit drug usage. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination on Left Arm. No concomitant medications were reported. On 21-MAR-2021, the subject experienced stiff neck. On 21-MAR-2021, the subject experienced armpit pain. On 21-MAR-2021, the subject experienced hot. On 21-MAR-2021, the subject experienced elbow bruise and left breast bruise. On 21-MAR-2021, the subject experienced inability to move arm / cannot raise arm past breast level  On 21-MAR-2021, the subject experienced sore shoulder/elbow pain. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced sore neck. On 22-MAR-2021, the subject experienced sensitive to touch. On 22-MAR-2021, the subject experienced arm tingling on left arm and down to finger. On 22-MAR-2021, the subject experienced pain underneath breast. On 22-MAR-2021, the subject experienced fever episodes. On 22-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 23-MAR-2021, was recovering from sore neck, had not recovered from arm tingling on left arm and down to finger, stiff neck, nausea, sore shoulder/elbow pain, chills, hot, armpit pain, pain underneath breast, elbow bruise and left breast bruise, sensitive to touch, and fever episodes, and the outcome of inability to move arm / cannot raise arm past breast level was not reported. This report was non-serious.  Additional information was received from reporter on 23-Mar-2021. The following information was updated and incorporated into the case narrative: patient medical history (pulmonary problem, depression, alcoholic, smoker)  additional events (sore neck, sensitive to touch, elbow bruise and left breast bruise, headache, nausea), causality (Dechallenge, rechallenge action taken) , past event  past product, was was added.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Paraesthesia, Pyrexia
Clinical narrative: SORE NECK; SENSITIVE TO TOUCH; ARM TINGLING ON LEFT ARM AND DOWN TO FINGER; PAIN UNDERNEATH BREAST; FEVER EPISODES; NAUSEA; CHILLS; STIFF NECK; ARMPIT PAIN; HOT; ELBOW  BRUISE AND LEFT BREAST BRUISE; INABILITY TO MOVE ARM / CANNOT RAISE ARM PAST BREAST LEVE; SORE SHOULDER/ELBOW PAIN; 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 pulmonary problems, depression, alcoholic, and smoker, and other pre-existing medical conditions included .patient had no drug abuse or illicit drug usage. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination on Left Arm. No concomitant medications were reported. On 21-MAR-2021, the subject experienced stiff neck. On 21-MAR-2021, the subject experienced armpit pain. On 21-MAR-2021, the subject experienced hot. On 21-MAR-2021, the subject experienced elbow bruise and left breast bruise. On 21-MAR-2021, the subject experienced inability to move arm / cannot raise arm past breast level  On 21-MAR-2021, the subject experienced sore shoulder/elbow pain. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced chills. On 22-MAR-2021, the subject experienced sore neck. On 22-MAR-2021, the subject experienced sensitive to touch. On 22-MAR-2021, the subject experienced arm tingling on left arm and down to finger. On 22-MAR-2021, the subject experienced pain underneath breast. On 22-MAR-2021, the subject experienced fever episodes. On 22-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 23-MAR-2021, was recovering from sore neck, had not recovered from arm tingling on left arm and down to finger, stiff neck, nausea, sore shoulder/elbow pain, chills, hot, armpit pain, pain underneath breast, elbow bruise and left breast bruise, sensitive to touch, and fever episodes, and the outcome of inability to move arm / cannot raise arm past breast level was not reported. This report was non-serious.  Additional information was received from reporter on 23-Mar-2021. The following information was updated and incorporated into the case narrative: patient medical history (pulmonary problem, depression, alcoholic, smoker)  additional events (sore neck, sensitive to touch, elbow bruise and left breast bruise, headache, nausea), causality (Dechallenge, rechallenge action taken) , past event  past product, was was added.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Pharyngeal swelling, Swollen tongue, Tremor
Clinical narrative: SHORTNESS OF BREATH; THROAT SWELLING; TONGUE SWELLING; UNCONTROLLED SHAKING; LEG NUMBNESS; This spontaneous report received from a patient concerned a 40 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, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Vaccinated on Left arm. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced throat swelling. On 09-MAR-2021, the subject experienced tongue swelling. On 09-MAR-2021, the subject experienced uncontrolled shaking. On 09-MAR-2021, the subject experienced leg numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, and tongue swelling on 14-MAR-2021, and uncontrolled shaking on 11-MAR-2021, and had not recovered from shortness of breath, and leg numbness. 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, Headache, Hyperhidrosis
Clinical narrative: SWEATS WORSENED; CHILLS; HEADACHE; 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 was not pregnant at the time of reporting. of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, vaccinate at left arm, once a total administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient began with a headache. It was reported that she had night sweats since giving birth but chills were new which also began on 17-MAR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, and sweats worsened. This report was non-serious. This parent/child case is linked; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Body temperature decreased, Chills, Diarrhoea
Clinical narrative: BODY TEMPERATURE GET LOW; CHILLS; HEADACHE; NAUSEA; DRUG USE VIA UNAPPROVED ADMINISTRATION ROUTE; OFF-LABEL USE; TIREDNESS; MUSCLE PAIN INCLUDING CHEST AND BACK; STOMACH ACHE; DIARRHOEA; BODY ACHES; SORE THROAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 158 pounds, and height was 62 inches. The patient's past medical history included rash, vomiting, nauseas, pass out, and tachycardia, and concurrent conditions included non-alcohol user, non-smoker, latex allergy, clindamycin allergy, and hydrocodone allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. the patient did not have acute illness 30 days prior to vaccination. the patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 18:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach ache. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle pain including chest and back. On 12-MAR-2021 18:45, the subject experienced drug use via unapproved administration route. On 12-MAR-2021 18:45, the subject experienced off-label use. On 12-MAR-2021 18:55, the subject experienced body temperature get low. On 12-MAR-2021 18:55, the subject experienced chills. On 12-MAR-2021 18:55, the subject experienced headache. On 12-MAR-2021 18:55, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Done, COVID-19 PCR test (NR: not provided) Negative, Negative, Negative, Urine analysis (NR: not provided) Done, and X-ray (NR: not provided) Done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, chills, and body temperature get low, and the outcome of stomach ache, diarrhea, sore throat, tiredness, muscle pain including chest and back, body aches, drug use via unapproved administration route and off-label use was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Off label use
Clinical narrative: BODY TEMPERATURE GET LOW; CHILLS; HEADACHE; NAUSEA; DRUG USE VIA UNAPPROVED ADMINISTRATION ROUTE; OFF-LABEL USE; TIREDNESS; MUSCLE PAIN INCLUDING CHEST AND BACK; STOMACH ACHE; DIARRHOEA; BODY ACHES; SORE THROAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 158 pounds, and height was 62 inches. The patient's past medical history included rash, vomiting, nauseas, pass out, and tachycardia, and concurrent conditions included non-alcohol user, non-smoker, latex allergy, clindamycin allergy, and hydrocodone allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. the patient did not have acute illness 30 days prior to vaccination. the patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 18:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach ache. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle pain including chest and back. On 12-MAR-2021 18:45, the subject experienced drug use via unapproved administration route. On 12-MAR-2021 18:45, the subject experienced off-label use. On 12-MAR-2021 18:55, the subject experienced body temperature get low. On 12-MAR-2021 18:55, the subject experienced chills. On 12-MAR-2021 18:55, the subject experienced headache. On 12-MAR-2021 18:55, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Done, COVID-19 PCR test (NR: not provided) Negative, Negative, Negative, Urine analysis (NR: not provided) Done, and X-ray (NR: not provided) Done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, chills, and body temperature get low, and the outcome of stomach ache, diarrhea, sore throat, tiredness, muscle pain including chest and back, body aches, drug use via unapproved administration route and off-label use was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Product use issue, SARS-CoV-2 test, Urine analysis
Clinical narrative: BODY TEMPERATURE GET LOW; CHILLS; HEADACHE; NAUSEA; DRUG USE VIA UNAPPROVED ADMINISTRATION ROUTE; OFF-LABEL USE; TIREDNESS; MUSCLE PAIN INCLUDING CHEST AND BACK; STOMACH ACHE; DIARRHOEA; BODY ACHES; SORE THROAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 158 pounds, and height was 62 inches. The patient's past medical history included rash, vomiting, nauseas, pass out, and tachycardia, and concurrent conditions included non-alcohol user, non-smoker, latex allergy, clindamycin allergy, and hydrocodone allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. the patient did not have acute illness 30 days prior to vaccination. the patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 18:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach ache. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle pain including chest and back. On 12-MAR-2021 18:45, the subject experienced drug use via unapproved administration route. On 12-MAR-2021 18:45, the subject experienced off-label use. On 12-MAR-2021 18:55, the subject experienced body temperature get low. On 12-MAR-2021 18:55, the subject experienced chills. On 12-MAR-2021 18:55, the subject experienced headache. On 12-MAR-2021 18:55, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Done, COVID-19 PCR test (NR: not provided) Negative, Negative, Negative, Urine analysis (NR: not provided) Done, and X-ray (NR: not provided) Done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, chills, and body temperature get low, and the outcome of stomach ache, diarrhea, sore throat, tiredness, muscle pain including chest and back, body aches, drug use via unapproved administration route and off-label use was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: BODY TEMPERATURE GET LOW; CHILLS; HEADACHE; NAUSEA; DRUG USE VIA UNAPPROVED ADMINISTRATION ROUTE; OFF-LABEL USE; TIREDNESS; MUSCLE PAIN INCLUDING CHEST AND BACK; STOMACH ACHE; DIARRHOEA; BODY ACHES; SORE THROAT; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 158 pounds, and height was 62 inches. The patient's past medical history included rash, vomiting, nauseas, pass out, and tachycardia, and concurrent conditions included non-alcohol user, non-smoker, latex allergy, clindamycin allergy, and hydrocodone allergy, and other pre-existing medical conditions included the patient had no history of drug abuse. the patient did not have acute illness 30 days prior to vaccination. the patient did not have significant family history of diseases or hospitalizations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 12-MAR-2021 18:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stomach ache. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle pain including chest and back. On 12-MAR-2021 18:45, the subject experienced drug use via unapproved administration route. On 12-MAR-2021 18:45, the subject experienced off-label use. On 12-MAR-2021 18:55, the subject experienced body temperature get low. On 12-MAR-2021 18:55, the subject experienced chills. On 12-MAR-2021 18:55, the subject experienced headache. On 12-MAR-2021 18:55, the subject experienced nausea. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Done, COVID-19 PCR test (NR: not provided) Negative, Negative, Negative, Urine analysis (NR: not provided) Done, and X-ray (NR: not provided) Done. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, chills, and body temperature get low, and the outcome of stomach ache, diarrhea, sore throat, tiredness, muscle pain including chest and back, body aches, drug use via unapproved administration route and off-label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported ,The company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Feeling hot, Headache
Clinical narrative: HEART RACING  (ALMOST LIKE FLUTTERING OR TWITCHING; SLEPT UNTIL NOON; HEART FEELS LIKE BEATING FAST; COUGH; HEADACHE; FEELING HOT / CHEEKS FEELING WARM UNDER; FELT OFF; CHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned an adult 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination to the Left Arm.  No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling hot / cheeks feeling warm under. On 20-MAR-2021, the subject experienced felt off. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced heart feels like beating fast. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced slept until noon. On 21-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced heart racing (almost like fluttering or twitching. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide, loratadine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, feeling hot / cheeks feeling warm under, felt off, muscle aches, headache, cough, heart racing (almost like fluttering or twitching, slept until noon and heart feels like beating fast was not reported. This report was non-serious.    .; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Palpitations, Somnolence
Clinical narrative: HEART RACING  (ALMOST LIKE FLUTTERING OR TWITCHING; SLEPT UNTIL NOON; HEART FEELS LIKE BEATING FAST; COUGH; HEADACHE; FEELING HOT / CHEEKS FEELING WARM UNDER; FELT OFF; CHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned an adult 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination to the Left Arm.  No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling hot / cheeks feeling warm under. On 20-MAR-2021, the subject experienced felt off. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced muscle aches. On 21-MAR-2021, the subject experienced heart feels like beating fast. On 21-MAR-2021, the subject experienced cough. On 21-MAR-2021, the subject experienced slept until noon. On 21-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced heart racing (almost like fluttering or twitching. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide, loratadine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, feeling hot / cheeks feeling warm under, felt off, muscle aches, headache, cough, heart racing (almost like fluttering or twitching, slept until noon and heart feels like beating fast was not reported. This report was non-serious.    .; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Electrocardiogram, Headache, Pain
Clinical narrative: HEART PALPITATION; BODY ACHES; CHILLS; HEADACHE; CHEST TIGHTNESS; 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 digestive problem, anxiety, penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced chest tightness. On 18-MAR-2021 18:00, the subject experienced body aches. On 18-MAR-2021 18:00, the subject experienced chills. On 18-MAR-2021 18:00, the subject experienced headache. On 20-MAR-2021, the subject experienced heart palpitation. Laboratory data (dates unspecified) included: EKG (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and the outcome of headache, chills, chest tightness and heart palpitation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: HEART PALPITATION; BODY ACHES; CHILLS; HEADACHE; CHEST TIGHTNESS; 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 digestive problem, anxiety, penicillin allergy, and sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced chest tightness. On 18-MAR-2021 18:00, the subject experienced body aches. On 18-MAR-2021 18:00, the subject experienced chills. On 18-MAR-2021 18:00, the subject experienced headache. On 20-MAR-2021, the subject experienced heart palpitation. Laboratory data (dates unspecified) included: EKG (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and the outcome of headache, chills, chest tightness and heart palpitation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: RASH ON HER WRIST; TIRED; This spontaneous report received from a patient via a company representative concerned a 70 year old female (Patient 1). 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) once a total dose was not reported, administered on 18-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 rash on her wrist. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on her wrist on MAR-2021, and the outcome of tired was not reported. This report was non-serious. This case, from the same reporter is linked to 20210342307.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Herpes zoster, Musculoskeletal stiffness, Myalgia
Clinical narrative: SHINGLES; FEELING LIKE CRAP; ITCHING ON LEFT ARM; NECK WAS VERY STIFF; NECK WAS SORE; HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 57 year old female. 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 on left arm (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feeling like crap. On MAR-2021, the subject experienced itching on left arm. On MAR-2021, the subject experienced neck was very stiff. On MAR-2021, the subject experienced neck was sore. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced muscle pain. On 23-MAR-2021, the subject experienced shingles. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck was very stiff on MAR-2021, was recovering from headache, had not recovered from shingles, muscle pain, itching on left arm, and neck was sore, and the outcome of feeling like crap was not reported.  This report was non-serious.  Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into case narrative: Reporter (details), due diligence, events (neck was sore and neck was very stiff), outcome (shingles and headache), shingles, muscle pain and neck was sore (treatment information),  product (neurontin), labeling and causality updated, narrative updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pruritus
Clinical narrative: SHINGLES; FEELING LIKE CRAP; ITCHING ON LEFT ARM; NECK WAS VERY STIFF; NECK WAS SORE; HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 57 year old female. 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 on left arm (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feeling like crap. On MAR-2021, the subject experienced itching on left arm. On MAR-2021, the subject experienced neck was very stiff. On MAR-2021, the subject experienced neck was sore. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced muscle pain. On 23-MAR-2021, the subject experienced shingles. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck was very stiff on MAR-2021, was recovering from headache, had not recovered from shingles, muscle pain, itching on left arm, and neck was sore, and the outcome of feeling like crap was not reported.  This report was non-serious.  Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into case narrative: Reporter (details), due diligence, events (neck was sore and neck was very stiff), outcome (shingles and headache), shingles, muscle pain and neck was sore (treatment information),  product (neurontin), labeling and causality updated, narrative updated.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: LOST APPETITE; STOMACH HURTS; SHORTNESS OF BREATH; HEADACHE; NAUSEA; FATIGUE /  VERY TIRED; 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 concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. 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 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 20-MAR-2021, the subject experienced lost appetite. On 20-MAR-2021, the subject experienced stomach hurts. On 20-MAR-2021, the subject experienced shortness of breath. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 23-MAR-2021, and had not recovered from lost appetite, nausea, stomach hurts, fatigue, and shortness of breath. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: LOST APPETITE; STOMACH HURTS; SHORTNESS OF BREATH; HEADACHE; NAUSEA; FATIGUE /  VERY TIRED; 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 concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage. 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 18-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 20-MAR-2021, the subject experienced lost appetite. On 20-MAR-2021, the subject experienced stomach hurts. On 20-MAR-2021, the subject experienced shortness of breath. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 23-MAR-2021, and had not recovered from lost appetite, nausea, stomach hurts, fatigue, and shortness of breath. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Chills, Fatigue, Pain, Pruritus
Clinical narrative: ITCHINESS STARTED ON THE CHEST AND STOMACH AND THEN SPREAD THROUGHOUT THE BODY.; RASH THAT STARTED ON THE CHEST AND STOMACH AND THEN SPREAD THROUGHOUT THE BODY; CHILLS; FATIGUE; BODY ACHES; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nickel, ore allergy. 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 14-MAR-2021 at left deltoid 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 fatigue. On 16-MAR-2021, the subject experienced itchiness started on the chest and stomach and then spread throughout the body. On 16-MAR-2021, the subject experienced rash that started on the chest and stomach and then spread throughout the body. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and fatigue on 15-MAR-2021, and had not recovered from itchiness started on the chest and stomach and then spread throughout the body., and rash that started on the chest and stomach and then spread throughout the body. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.