chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: ARM IN A KNOT; 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 blood clot. 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 reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm in a knot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm in a knot was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint swelling, Paraesthesia, Poor peripheral circulation, Rash macular
Clinical narrative: POOR CIRCULATION (IN FINGERS, FOOT, ANKLES, ARMS); BLOTCHY RASH WHICH GOES UP THE ANKLE AND LEG ABOUT 2 INCHES; TINGLING DOWN LEFT ARM AND IN FINGERS; LEFT ARM AND FINGERS ARE NUMB; RIGHT ANKLE SWELLS AT NIGHT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced poor circulation (in fingers, foot, ankles, arms). On 26-MAR-2021, the subject experienced blotchy rash which goes up the ankle and leg about 2 inches. On 26-MAR-2021, the subject experienced tingling down left arm and in fingers. On 26-MAR-2021, the subject experienced left arm and fingers are numb. On 26-MAR-2021, the subject experienced right ankle swells at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor circulation (in fingers, foot, ankles, arms), blotchy rash which goes up the ankle and leg about 2 inches, tingling down left arm and in fingers, left arm and fingers are numb, and right ankle swells at night. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain in extremity
Clinical narrative: BACK PAIN; ARM PAIN; FATIGUE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced back pain. On APR-2021, the subject experienced arm pain. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, arm pain and back pain was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Sleep disorder
Clinical narrative: FLU-LIKE SYMPTOMS; LACK OF SLEEP; LOW GRADE HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included herniated disc, and nerve pain, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A211A, and batch number: 207A211A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for nerve pain, and herniated disc. On 12-APR-2021, the subject experienced flu-like symptoms. On 12-APR-2021, the subject experienced lack of sleep. On 12-APR-2021, the subject experienced low grade headache. On 12-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 13-APR-2021, had not recovered from low grade headache, and tiredness, and the outcome of lack of sleep was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Hyperhidrosis, Off label use
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; GENERALIZED WEAKNESS; ACHY; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 16 year old male. 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 patient had no known drug allergies or drug abuse/illicit drug usage. patient denied history of reactions to vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021 21:00, the subject experienced achy. On 12-APR-2021 21:00, the subject experienced generalized weakness. On an unspecified date, the subject experienced product administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, generalized weakness, fever, chills, and sweating, and the outcome of product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; GENERALIZED WEAKNESS; ACHY; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 16 year old male. 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 patient had no known drug allergies or drug abuse/illicit drug usage. patient denied history of reactions to vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 12:45 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. On 12-APR-2021 21:00, the subject experienced achy. On 12-APR-2021 21:00, the subject experienced generalized weakness. On an unspecified date, the subject experienced product administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, generalized weakness, fever, chills, and sweating, and the outcome of product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; 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, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.   No concomitant medications were reported. On an unspecified date, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dizziness, Feeling cold, Feeling hot
Clinical narrative: BLURRY VISION; UNCONTROLLABLE SHAKING; JAW PAIN; PAIN ON LEFT SIDE NEAR KIDNEY; FELT BODY HOT/BODY BURNING HOT; DIZZY; PAIN IN BONES ALL OVER BODY; FREEZING COLD; CHILLS; PAIN IN LEFT ARM WHERE INJECTED; HEADACHE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,  expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism, and insulin for type 1 diabetes.  On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced uncontrollable shaking. On 11-APR-2021, the subject experienced jaw pain. On 11-APR-2021, the subject experienced pain on left side near kidney. On 11-APR-2021, the subject experienced felt body hot/body burning hot. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced pain in bones all over body. On 11-APR-2021, the subject experienced freezing cold. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain in left arm where injected. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking, and chills on 11-APR-2021, jaw pain on 12-APR-2021, and felt body hot/body burning hot, freezing cold, pain in left arm where injected, headache, and fever on 13-APR-2021, was recovering from blurry vision, and pain on left side near kidney, and the outcome of dizzy and pain in bones all over body was not reported. This report was non-serious.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain in jaw, Pyrexia, Renal pain
Clinical narrative: BLURRY VISION; UNCONTROLLABLE SHAKING; JAW PAIN; PAIN ON LEFT SIDE NEAR KIDNEY; FELT BODY HOT/BODY BURNING HOT; DIZZY; PAIN IN BONES ALL OVER BODY; FREEZING COLD; CHILLS; PAIN IN LEFT ARM WHERE INJECTED; HEADACHE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,  expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism, and insulin for type 1 diabetes.  On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced uncontrollable shaking. On 11-APR-2021, the subject experienced jaw pain. On 11-APR-2021, the subject experienced pain on left side near kidney. On 11-APR-2021, the subject experienced felt body hot/body burning hot. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced pain in bones all over body. On 11-APR-2021, the subject experienced freezing cold. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain in left arm where injected. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking, and chills on 11-APR-2021, jaw pain on 12-APR-2021, and felt body hot/body burning hot, freezing cold, pain in left arm where injected, headache, and fever on 13-APR-2021, was recovering from blurry vision, and pain on left side near kidney, and the outcome of dizzy and pain in bones all over body was not reported. This report was non-serious.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: BLURRY VISION; UNCONTROLLABLE SHAKING; JAW PAIN; PAIN ON LEFT SIDE NEAR KIDNEY; FELT BODY HOT/BODY BURNING HOT; DIZZY; PAIN IN BONES ALL OVER BODY; FREEZING COLD; CHILLS; PAIN IN LEFT ARM WHERE INJECTED; HEADACHE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,  expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for hypothyroidism, and insulin for type 1 diabetes.  On 11-APR-2021, the subject experienced blurry vision. On 11-APR-2021, the subject experienced uncontrollable shaking. On 11-APR-2021, the subject experienced jaw pain. On 11-APR-2021, the subject experienced pain on left side near kidney. On 11-APR-2021, the subject experienced felt body hot/body burning hot. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced pain in bones all over body. On 11-APR-2021, the subject experienced freezing cold. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced pain in left arm where injected. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking, and chills on 11-APR-2021, jaw pain on 12-APR-2021, and felt body hot/body burning hot, freezing cold, pain in left arm where injected, headache, and fever on 13-APR-2021, was recovering from blurry vision, and pain on left side near kidney, and the outcome of dizzy and pain in bones all over body was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: EXPECTED SIDE EFFECTS; This spontaneous report received from a consumer concerned a 34 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On an unspecified date, the subject experienced expected side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expected side effects was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: BRAIN FOG; ARM  TINGLING; SORE ARM; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a parent concerned a 25 year old female. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced brain fog. On 01-APR-2021, the subject experienced arm tingling. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, and fever on 02-APR-2021, arm tingling on 01-APR-2021, and sore arm on 04-APR-2021, and the outcome of headache and fatigue was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: BRAIN FOG; ARM  TINGLING; SORE ARM; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a parent concerned a 25 year old female. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced brain fog. On 01-APR-2021, the subject experienced arm tingling. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, and fever on 02-APR-2021, arm tingling on 01-APR-2021, and sore arm on 04-APR-2021, and the outcome of headache and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Somnolence
Clinical narrative: DIZZINESS; SLEEPINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 51 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: 201A21A, and  expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced dizziness. On 06-APR-2021, the subject experienced sleepiness. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, dizziness, nausea, and sleepiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Headache, Pyrexia
Clinical narrative: COULDNT GET OUT OF BED; SEVERE HEADACHE; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 31-MAR-2021, the subject experienced couldn't get out of bed. On 31-MAR-2021, the subject experienced severe headache. On 31-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 38.2 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't get out of bed, severe headache, and fever. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: CHILLS; MILD FEVER; DULL HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid type symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced mild fever. On 08-APR-2021, the subject experienced dull headache. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, mild fever, and dull headache on 09-APR-2021, and fatigue on 10-APR-2021. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: ITCHY RASH  ALL OVER THE BODY; FEVER; This spontaneous report received from a patient concerned a 38 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced itchy rash all over the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, and had not recovered from itchy rash all over the body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lymphatic system neoplasm
Clinical narrative: SOME TYPE OF LYMPH NODE GROWTH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced lymph node growth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lymph node growth. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; BODY ACHES; HIVES ON FACE AND NECK; FATIGUE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's thyroiditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced fatigue. On 07-APR-2021 12:45, the subject experienced hives on face and neck. On 07-APR-2021 20:00, the subject experienced body aches. On 07-APR-2021 20:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 07-APR-2021 22:00, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 101.6 F.  Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives on face and neck, and the outcome of body aches, chills, fever and fatigue was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: CHILLS; FEVER; BODY ACHES; HIVES ON FACE AND NECK; FATIGUE; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's thyroiditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced fatigue. On 07-APR-2021 12:45, the subject experienced hives on face and neck. On 07-APR-2021 20:00, the subject experienced body aches. On 07-APR-2021 20:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 07-APR-2021 22:00, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 101.6 F.  Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives on face and neck, and the outcome of body aches, chills, fever and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN RIGHT ARM, HAND AND LEG; TINGLING IN RIGHT ARM, HAND AND LEG; 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: UNKNWON, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced numbness in right arm, hand and leg. On 10-APR-2021, the subject experienced tingling in right arm, hand and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in right arm, hand and leg and tingling in right arm, hand and leg was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle tightness, Pain in extremity
Clinical narrative: MUSCLE TIGHTNESS ON LEFT SIDE; SORENESS IN THE OPPOSITE ARM; HEADACHE; 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 codeine allergy. The patient was previously treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced soreness in the opposite arm. On 12-APR-2021, the subject experienced muscle tightness on left side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and muscle tightness on left side, and had not recovered from soreness in the opposite arm. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Rash pruritic
Clinical narrative: COULD NOT SLEEP; ITCHY RASH ON HIS ARMS AND LEGS WHICH WAS SPREADING UP; BODY ACHES; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included eosinophilic esophagitis. The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced could not sleep. On 11-APR-2021, the subject experienced itchy rash on his arms and legs which was spreading up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash on his arms and legs which was spreading up, and the outcome of body aches and could not sleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immune system disorder
Clinical narrative: ELEVATED IMMUNE RESPONSE; EXTREME EXHAUSTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the subject experienced Extreme exhaustion. On an unspecified date, the subject experienced Elevated immune response. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme exhaustion and elevated immune response was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Contusion, Musculoskeletal discomfort, Myalgia
Clinical narrative: SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. 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 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. 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 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Oropharyngeal pain
Clinical narrative: SORE THROAT; MORE RUNNY DIARRHEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced more runny diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 08-APR-2021, and the outcome of more runny diarrhea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional sinus headache on and off. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included prednisolone. On 12-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: guaifenesin/paracetamol/phenylephrine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Pyrexia, Urticaria
Clinical narrative: QUARTER SIZE WELT PAINFUL AND ITCHY; FEVER; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F.  On an unspecified date, the subject experienced quarter size welt painful and itchy, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quarter size welt painful and itchy, fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Muscle atrophy
Clinical narrative: QUARTER SIZE WELT PAINFUL AND ITCHY; FEVER; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F.  On an unspecified date, the subject experienced quarter size welt painful and itchy, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quarter size welt painful and itchy, fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: QUARTER SIZE WELT PAINFUL AND ITCHY; FEVER; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F.  On an unspecified date, the subject experienced quarter size welt painful and itchy, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the quarter size welt painful and itchy, fever and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Fatigue, Feeling of body temperature change
Clinical narrative: HOT AND COLD FLASHES; STOMACH PAINS; REALLY BAD BACK PAIN; NECK PAIN; CHILLS; REALLY BAD HEADACHE; EXHAUSTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach pains. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced hot and cold flashes. On 16-MAR-2021, the subject experienced stomach pains. On 16-MAR-2021, the subject experienced really bad back pain. On 16-MAR-2021, the subject experienced neck pain. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced really bad headache. On 16-MAR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes, and chills on 18-MAR-2021, had not recovered from really bad headache, exhaustion, really bad back pain, and neck pain, and the outcome of stomach pains was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: HOT AND COLD FLASHES; STOMACH PAINS; REALLY BAD BACK PAIN; NECK PAIN; CHILLS; REALLY BAD HEADACHE; EXHAUSTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach pains. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced hot and cold flashes. On 16-MAR-2021, the subject experienced stomach pains. On 16-MAR-2021, the subject experienced really bad back pain. On 16-MAR-2021, the subject experienced neck pain. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced really bad headache. On 16-MAR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold flashes, and chills on 18-MAR-2021, had not recovered from really bad headache, exhaustion, really bad back pain, and neck pain, and the outcome of stomach pains was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: LEG/FOOT CRAMPS; LEG/FOOT PAIN; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported.  The patient's concurrent conditions included leg cramps, and other pre-existing medical conditions included patient had no known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A,  expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced leg/foot cramps. On 13-APR-2021, the subject experienced leg/foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg/foot cramps, and leg/foot pain on 13-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; 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: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on MAR-2021. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Headache, Muscular weakness
Clinical narrative: HEAVINESS ON UPPER TORSO UPON STANDING / FELT LIKE LOWER SPINE OR BACK WAS COLLAPSING OR BUCKLING UNDER WEIGHT; MUSCLE WEAKNESS; JOINT PAIN IN LOWER BACK / KNEE AND RIGHT HAND KNUCKLES; CHILLS; MUSCLE ACHES; MILD HEADACHES; This spontaneous report received from a patient concerned a 51 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight. On APR-2021, the subject experienced muscle weakness. On APR-2021, the subject experienced joint pain in lower back, knee and right hand knuckles. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild headaches on APR-2021, and the outcome of muscle aches, muscle weakness, joint pain in lower back, knee and right hand knuckles and heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: HEAVINESS ON UPPER TORSO UPON STANDING / FELT LIKE LOWER SPINE OR BACK WAS COLLAPSING OR BUCKLING UNDER WEIGHT; MUSCLE WEAKNESS; JOINT PAIN IN LOWER BACK / KNEE AND RIGHT HAND KNUCKLES; CHILLS; MUSCLE ACHES; MILD HEADACHES; This spontaneous report received from a patient concerned a 51 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight. On APR-2021, the subject experienced muscle weakness. On APR-2021, the subject experienced joint pain in lower back, knee and right hand knuckles. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and mild headaches on APR-2021, and the outcome of muscle aches, muscle weakness, joint pain in lower back, knee and right hand knuckles and heaviness on upper torso upon standing//felt like lower spine or back was collapsing or buckling under weight was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Electrocardiogram, Full blood count, Potassium chloride sensitivity test, Salt intoxication
Clinical narrative: Patient is an otherwise healthy 41-year-old male who presents emergency department for evaluation of reaction after giving the 1st dose of a COVID vaccine.  Patient states he did not eat much for breakfast, drank 2 cups of coffee.  He got the vaccine and 5-10 minutes later began to feel lightheaded, flushed and warm.  He denies any difficulty breathing.  Denies any difficulty swallowing.  Denies any rash or itchiness.  Denies any nausea, vomiting or diarrhea.  Patient was brought to the emergency department for further evaluation.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate irregular, Ventricular extrasystoles
Clinical narrative: Received COVID shot #2 in the morning.  Went to a GI specialist appointment and noted irregular heart beat on exam.  Referred to see PCP that same day Saw pediatrician, did EKG and PVCs noted and heard. Referred to cardiologist
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Hallucination, Headache, Myalgia
Clinical narrative: Patient reported to medical clinic 24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration.  At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He planned to follow-up the next day.   The patient returned to  medical Clinic on 03/22/2021 with no specific symptoms. Previous symptoms from initial encounter resolved according to medical chart. Patient returned on 03/28/2021 with right upper arm DVT proven on U/S. He was seen at Primary Care Clinic beforehand where diagnosis of DVT was made. He was then started on anticoagulation therapy by MD in clinic after specialist phone consult, and will be closely followed. He was sent to Evacuation  to home station due to the complexity of the condition, medications, etc.