chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Condition aggravated, Contusion, Fatigue
Clinical narrative: CHARLEY HORSE IN THE BACK; RASH ON FEET; SHOULDER PAIN; FATIGUE(FEELING VERY TIRED); NECK PAIN; COLD SORE WORSENED; WHOLE ARM HURT SO BAD IT WAS SCARY, PAIN IN THE LEFT ARM, RIGHT LEG, LEGS BURNING; BLEEDING STOPPED; BRUISE ON LEFT BREAST AND HAS BECAME BIGGER; SORENESS AND PAIN IN LEFT BREAST; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 190 pounds, and height was 67 inches. The patient's past medical history included cold sore. The patient was previously treated with progesterone for bleeding.  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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bruise on left breast and has became bigger. On 07-APR-2021, the subject experienced soreness and pain in left breast. On 07-APR-2021, the subject experienced bleeding stopped. On 08-APR-2021, the subject experienced neck pain. On 08-APR-2021, the subject experienced cold sore worsened. On 08-APR-2021, the subject experienced whole arm hurt so bad it was scary, pain in the left arm, right leg, legs burning. On 08-APR-2021, the subject experienced shoulder pain. On 08-APR-2021, the subject experienced fatigue (feeling very tired). On 11-APR-2021, the subject experienced rash on feet. On 13-APR-2021, the subject experienced muscle spasm in the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding stopped, was recovering from cold sore worsened, and had not recovered from bruise on left breast and has became bigger, soreness and pain in left breast, fatigue(feeling very tired), rash on feet, muscle spasm in the back, whole arm hurt so bad it was scary, pain in the left arm, right leg, legs burning, shoulder pain, and neck pain. This report was non-serious.; Sender's Comments: V0; MAC comment is not required for non-serious cases as per standard protocol
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Pain in extremity, Rash, Withdrawal bleed
Clinical narrative: CHARLEY HORSE IN THE BACK; RASH ON FEET; SHOULDER PAIN; FATIGUE(FEELING VERY TIRED); NECK PAIN; COLD SORE WORSENED; WHOLE ARM HURT SO BAD IT WAS SCARY, PAIN IN THE LEFT ARM, RIGHT LEG, LEGS BURNING; BLEEDING STOPPED; BRUISE ON LEFT BREAST AND HAS BECAME BIGGER; SORENESS AND PAIN IN LEFT BREAST; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 190 pounds, and height was 67 inches. The patient's past medical history included cold sore. The patient was previously treated with progesterone for bleeding.  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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced bruise on left breast and has became bigger. On 07-APR-2021, the subject experienced soreness and pain in left breast. On 07-APR-2021, the subject experienced bleeding stopped. On 08-APR-2021, the subject experienced neck pain. On 08-APR-2021, the subject experienced cold sore worsened. On 08-APR-2021, the subject experienced whole arm hurt so bad it was scary, pain in the left arm, right leg, legs burning. On 08-APR-2021, the subject experienced shoulder pain. On 08-APR-2021, the subject experienced fatigue (feeling very tired). On 11-APR-2021, the subject experienced rash on feet. On 13-APR-2021, the subject experienced muscle spasm in the back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding stopped, was recovering from cold sore worsened, and had not recovered from bruise on left breast and has became bigger, soreness and pain in left breast, fatigue(feeling very tired), rash on feet, muscle spasm in the back, whole arm hurt so bad it was scary, pain in the left arm, right leg, legs burning, shoulder pain, and neck pain. This report was non-serious.; Sender's Comments: V0; MAC comment is not required for non-serious cases as per standard protocol
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH; PAIN IN BILATERAL LEGS; PAIN IN BILATERAL HIPS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 200 pounds, and height was 158 centimeters. The patient's concurrent conditions included hypothyroidism, high blood pressure, diabetes type 2(non-insulin dependent), hyperlipidemia, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0422A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced pain in bilateral legs. On 09-APR-2021, the subject experienced pain in bilateral hips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, pain in bilateral legs, and pain in bilateral hips on 11-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Headache, Hot flush
Clinical narrative: SHORTNESS OF BREATH; FEELING LIKE HEART WAS GOING TO  BEAT OUT OF CHEST; HOT FLASH ON FACE; HURTING LEG; TEETH SHATTERING CHILLS; STINGING AT INJECTION SITE; FEVER OF 103.7; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and did not had history of reactions to vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, expiry: Unknown) dose was not reported, administered on 10-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: ibuprofen. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced feeling like heart was going to beat out of chest. On 10-APR-2021, the subject experienced hot flash on face. On 10-APR-2021, the subject experienced hurting leg. On 10-APR-2021, the subject experienced teeth shattering chills. On 10-APR-2021, the subject experienced stinging at injection site. On 10-APR-2021, the subject experienced fever of 103.7. On 10-APR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 103.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like heart was going to beat out of chest, hot flash on face, hurting leg, teeth shattering chills, and fever of 103.7 on 11-APR-2021, and stinging at injection site on 10-APR-2021, was recovering from shortness of breath, and had not recovered from severe headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; FEELING LIKE HEART WAS GOING TO  BEAT OUT OF CHEST; HOT FLASH ON FACE; HURTING LEG; TEETH SHATTERING CHILLS; STINGING AT INJECTION SITE; FEVER OF 103.7; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and did not had history of reactions to vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, expiry: Unknown) dose was not reported, administered on 10-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: ibuprofen. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced feeling like heart was going to beat out of chest. On 10-APR-2021, the subject experienced hot flash on face. On 10-APR-2021, the subject experienced hurting leg. On 10-APR-2021, the subject experienced teeth shattering chills. On 10-APR-2021, the subject experienced stinging at injection site. On 10-APR-2021, the subject experienced fever of 103.7. On 10-APR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 103.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like heart was going to beat out of chest, hot flash on face, hurting leg, teeth shattering chills, and fever of 103.7 on 11-APR-2021, and stinging at injection site on 10-APR-2021, was recovering from shortness of breath, and had not recovered from severe headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: BODY ACHES; ABDOMINAL PAIN; NUMBNESS IN LEG; RIGHT LEG PAIN; HEADACHE; PAIN AT INJECTION SITE; FEELING TIRED; 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced feeling tired. On 07-APR-2021, the subject experienced pain at injection site. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced abdominal pain. On 08-APR-2021, the subject experienced numbness in leg. On 08-APR-2021, the subject experienced right leg pain. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and abdominal pain on 11-APR-2021, and right leg pain on 09-APR-2021, was recovering from pain at injection site, had not recovered from headache, and feeling tired, and the outcome of numbness in leg was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: BODY ACHES; ABDOMINAL PAIN; NUMBNESS IN LEG; RIGHT LEG PAIN; HEADACHE; PAIN AT INJECTION SITE; FEELING TIRED; 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced feeling tired. On 07-APR-2021, the subject experienced pain at injection site. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced abdominal pain. On 08-APR-2021, the subject experienced numbness in leg. On 08-APR-2021, the subject experienced right leg pain. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and abdominal pain on 11-APR-2021, and right leg pain on 09-APR-2021, was recovering from pain at injection site, had not recovered from headache, and feeling tired, and the outcome of numbness in leg was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: PAIN IN BOTH ARMS; HEADACHE; CHILLS; PAIN IN INJECTION ARM; FEVER; PAIN IN VEINS; 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 past medical history included thrombosis, and concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient was previously treated with rivaroxaban for thrombosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in veins. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced pain in injection arm. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced pain in both arms. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, pain in injection arm, fever, and headache on 19-MAR-2021, had not recovered from pain in both arms, and the outcome of pain in veins was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular pain
Clinical narrative: PAIN IN BOTH ARMS; HEADACHE; CHILLS; PAIN IN INJECTION ARM; FEVER; PAIN IN VEINS; 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 past medical history included thrombosis, and concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient was previously treated with rivaroxaban for thrombosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in veins. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced pain in injection arm. On 18-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced pain in both arms. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, pain in injection arm, fever, and headache on 19-MAR-2021, had not recovered from pain in both arms, and the outcome of pain in veins was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; INAPPROPRIATE AGE OF VACCINE ADMINISTRATION; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included pineapple allergy, allergy to dust mites, and azithromycin allergy. The patient was previously treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1808978, 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 inappropriate age of vaccine administration. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Dyspnoea, Fatigue
Clinical narrative: FELT FATIGUE; SHORTNESS OF BREATH; BLURRY VISION; HEART PALPITATIONS; DIZZINESS; VACCINATION SITE IS HARD THE SIZE OF A SILVER DOLLAR; SWEATING PROFUSELY; DIFFICULTY GOING UP THE STAIRS; WEAKNESS LIKE PASSING OUT; FEVER; 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 11-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 shortness of breath. On APR-2021, the subject experienced blurry vision. On APR-2021, the subject experienced heart palpitations. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced vaccination site is hard the size of a silver dollar. On APR-2021, the subject experienced sweating profusely. On APR-2021, the subject experienced difficulty going up the stairs. On APR-2021, the subject experienced weakness like passing out. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-APR-2021, the subject experienced felt fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt fatigue, fever, blurry vision, heart palpitations, dizziness, weakness like passing out, shortness of breath, vaccination site is hard the size of a silver dollar, sweating profusely and difficulty going up the stairs was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site reaction, Mobility decreased, Palpitations, Pyrexia
Clinical narrative: FELT FATIGUE; SHORTNESS OF BREATH; BLURRY VISION; HEART PALPITATIONS; DIZZINESS; VACCINATION SITE IS HARD THE SIZE OF A SILVER DOLLAR; SWEATING PROFUSELY; DIFFICULTY GOING UP THE STAIRS; WEAKNESS LIKE PASSING OUT; FEVER; 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 11-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 shortness of breath. On APR-2021, the subject experienced blurry vision. On APR-2021, the subject experienced heart palpitations. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced vaccination site is hard the size of a silver dollar. On APR-2021, the subject experienced sweating profusely. On APR-2021, the subject experienced difficulty going up the stairs. On APR-2021, the subject experienced weakness like passing out. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-APR-2021, the subject experienced felt fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt fatigue, fever, blurry vision, heart palpitations, dizziness, weakness like passing out, shortness of breath, vaccination site is hard the size of a silver dollar, sweating profusely and difficulty going up the stairs was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: FELT FATIGUE; SHORTNESS OF BREATH; BLURRY VISION; HEART PALPITATIONS; DIZZINESS; VACCINATION SITE IS HARD THE SIZE OF A SILVER DOLLAR; SWEATING PROFUSELY; DIFFICULTY GOING UP THE STAIRS; WEAKNESS LIKE PASSING OUT; FEVER; 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 11-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 shortness of breath. On APR-2021, the subject experienced blurry vision. On APR-2021, the subject experienced heart palpitations. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced vaccination site is hard the size of a silver dollar. On APR-2021, the subject experienced sweating profusely. On APR-2021, the subject experienced difficulty going up the stairs. On APR-2021, the subject experienced weakness like passing out. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-APR-2021, the subject experienced felt fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt fatigue, fever, blurry vision, heart palpitations, dizziness, weakness like passing out, shortness of breath, vaccination site is hard the size of a silver dollar, sweating profusely and difficulty going up the stairs was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210437834.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Exercise tolerance decreased, Hyperhidrosis, Nausea
Clinical narrative: DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating.  On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DIFFICULTY BREATHING; CANNOT FINISH EXERCISES; WEAKNESS; SWEATING; NAUSEA (FELT LIKE VOMITING); FEVER; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included stage 3 colon cancer, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse/illicit drug use. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sweating.  On 10-APR-2021, the subject experienced nausea (felt like vomiting). On 13-APR-2021, the subject experienced difficulty breathing. On 13-APR-2021, the subject experienced cannot finish exercises. On 13-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, difficulty breathing, weakness, sweating, nausea (felt like vomiting), and cannot finish exercises. 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pruritus, Rash papular
Clinical narrative: ?Covid arm? large raised bump, warm to touch, itchy and painfuk
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Motor dysfunction, Paranasal sinus discomfort, Vision blurred
Clinical narrative: Starting 8 days after injection I will go into a brain fog for several hours mid morning. Difficulty concentrating and motor function seems mildly  impaired.  Visuon is slightly blurred. Also slight pressure across sinuses.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Pain assessment
Clinical narrative: HIGH BLOOD PRESSURE; HEADACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 140 pounds, and height was 152 centimeters.  The patient's past medical history included depression, and migraine, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1A02072, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 20-MAR-2021, the subject experienced high blood pressure. On 20-MAR-2021, the subject experienced headache.  Laboratory data included: Pain scale (NR: not provided) 10/10. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 6/10. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and high blood pressure. 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Fatigue, Headache
Clinical narrative: Next morning severe headache to the point of delirium....2nd day a little better...headache gone....fatigue...3rd day still tired..got up in late afternoon....tiredness lasted about 5days
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Blood test normal, Chest discomfort, Chills, Dyspnoea
Clinical narrative: *4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day.  Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening  and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good  on 4/7  but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I  called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Gait disturbance, Heart rate increased, Hyperhidrosis, Lymphadenopathy
Clinical narrative: *4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day.  Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening  and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good  on 4/7  but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I  called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pyrexia, Skin warm, Tremor
Clinical narrative: *4/4 Morning felt like I couldn't walk, knew my feet were their, but couldn't register to move for hr and then got up, EXTREME pain in center of my left armpit (to point of almost crying and it was worse than my kidney stone pain I had for a week) and all over pain in body-hard to even move much this day...I slept in 12 hr increments till next day.  Noticed my Heart rate was very high constantly between 100-115 ( on my wrist monitor) * On 4/5 Woke up and told myself to get moving for day, arm was turning very red at this point and swelling bad along with armpit along edge and was hot and still painful. Was up for 7 hr.. I got in shower that evening  and felt weird midway and my head felt like a whoosh and thought I was going to pass out (normal temp in shower) held onto shower got out was fine for about 20 min and then I started extreme shaking uncontrollably and teeth were chattering from chills. Went to get a Tylenol because I knew something was not right and within 30 min started sweating profusely with fever (I didn't even get up because I felt so crappy) *4/6 Woke up, felt a little better, arm, armpit and side of armpit red, hot and swollen still. Was up for 9 hrs, but when I went to bed and laid down, I felt like I couldn't breathe well...something told me to take a deep breath and I felt something like a pop in chest and then I felt like I was breathing better. Was not still feeling good  on 4/7  but went back to work, on 4/8 felt a lot better, then woke 4/9 with Migraine and felt terrible and my heart felt weird...I  called the Health Department and asked what to do and they recommended going to doctor... but a Nurse followed up with me which was very nice. Went to doctor and my Blood Pressure was 179/98 at that time. They ran blood work and prescribed me a antibiotic for my arm and armpit area. I want to add as well, not sure if this matters, but my shot was not in center of arm...it was closer to inner part of upper shoulder closer to chest.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection sight was sore for 2 days after shot
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Diarrhoea, Feeling abnormal, Pyrexia
Clinical narrative: Fever up to 102 for 2 days and periodically for 2 weeks after bone ache for first two days and a severe flare up 2 weeks later diarrhea for first week Chills for two days and off and on after Brain fog ongoing since shot
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depression, Rhinorrhoea
Clinical narrative: Runny Nose, Chills, Depression
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Lymphadenopathy, Pyrexia
Clinical narrative: 102 fever Every lymph node in body sore and swollen  Chills Insomnia
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Joint stiffness, Limb discomfort
Clinical narrative: Immediately after getting the shot, I felt a heaviness on the arm (left) that was given the shot.  Then, that heaviness moved to my left leg, thighs, and calf.  My joints (knees, elbows, etc.)  are stiff and sore.  My left calf feels numb and stiff like after getting a nasty leg cramp.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Immediately after getting the shot, I felt a heaviness on the arm (left) that was given the shot.  Then, that heaviness moved to my left leg, thighs, and calf.  My joints (knees, elbows, etc.)  are stiff and sore.  My left calf feels numb and stiff like after getting a nasty leg cramp.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: DIZZINESS; JOINT PAIN; ARM SORENESS; CHILLS; MUSCLE PAIN; NAUSEA; FEVER; FATIGUE; 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: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced arm soreness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced muscle pain. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, chills, muscle pain, and fever on 12-APR-2021, and fatigue, and headache on 13-APR-2021, was recovering from dizziness, and had not recovered from nausea, and arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210430703.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: DIZZINESS; JOINT PAIN; ARM SORENESS; CHILLS; MUSCLE PAIN; NAUSEA; FEVER; FATIGUE; 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: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced joint pain. On 11-APR-2021, the subject experienced arm soreness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced muscle pain. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, chills, muscle pain, and fever on 12-APR-2021, and fatigue, and headache on 13-APR-2021, was recovering from dizziness, and had not recovered from nausea, and arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210430703.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Burning sensation, Chest discomfort, Dyspnoea, Facial pain
Clinical narrative: ABDOMINAL PAIN; JAW PAIN; FACIAL PAIN; PRESSURE IN LEG; LEG PAIN; BURNING FROM BRA STRAP TO BRAIN; CHEST PRESSURE AND PAIN; NAUSEA; SEVERE HEADACHE; ACHE; SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 038A21A expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced ache. On 31-MAR-2021, the subject experienced shortness of breath. On 31-MAR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 31-MAR-2021 21:00, the subject experienced severe headache. On 04-APR-2021, the subject experienced burning from bra strap to brain. On 04-APR-2021, the subject experienced chest pressure and pain. On 04-APR-2021, the subject experienced pressure in leg. On 04-APR-2021, the subject experienced leg pain. On 04-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced abdominal pain. On 13-APR-2021, the subject experienced jaw pain. On 13-APR-2021, the subject experienced facial pain. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and the outcome of severe headache, fatigue, ache, shortness of breath, burning from bra strap to brain, chest pressure and pain, pressure in leg, nausea, abdominal pain, jaw pain and facial pain was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Nausea, Pain
Clinical narrative: ABDOMINAL PAIN; JAW PAIN; FACIAL PAIN; PRESSURE IN LEG; LEG PAIN; BURNING FROM BRA STRAP TO BRAIN; CHEST PRESSURE AND PAIN; NAUSEA; SEVERE HEADACHE; ACHE; SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 038A21A expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced ache. On 31-MAR-2021, the subject experienced shortness of breath. On 31-MAR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 31-MAR-2021 21:00, the subject experienced severe headache. On 04-APR-2021, the subject experienced burning from bra strap to brain. On 04-APR-2021, the subject experienced chest pressure and pain. On 04-APR-2021, the subject experienced pressure in leg. On 04-APR-2021, the subject experienced leg pain. On 04-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced abdominal pain. On 13-APR-2021, the subject experienced jaw pain. On 13-APR-2021, the subject experienced facial pain. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and the outcome of severe headache, fatigue, ache, shortness of breath, burning from bra strap to brain, chest pressure and pain, pressure in leg, nausea, abdominal pain, jaw pain and facial pain was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: ABDOMINAL PAIN; JAW PAIN; FACIAL PAIN; PRESSURE IN LEG; LEG PAIN; BURNING FROM BRA STRAP TO BRAIN; CHEST PRESSURE AND PAIN; NAUSEA; SEVERE HEADACHE; ACHE; SHORTNESS OF BREATH; FATIGUE; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 038A21A expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced ache. On 31-MAR-2021, the subject experienced shortness of breath. On 31-MAR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 31-MAR-2021 21:00, the subject experienced severe headache. On 04-APR-2021, the subject experienced burning from bra strap to brain. On 04-APR-2021, the subject experienced chest pressure and pain. On 04-APR-2021, the subject experienced pressure in leg. On 04-APR-2021, the subject experienced leg pain. On 04-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced abdominal pain. On 13-APR-2021, the subject experienced jaw pain. On 13-APR-2021, the subject experienced facial pain. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain, and the outcome of severe headache, fatigue, ache, shortness of breath, burning from bra strap to brain, chest pressure and pain, pressure in leg, nausea, abdominal pain, jaw pain and facial pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Fatigue, Folate deficiency
Clinical narrative: LEG CRAMPS; CHEST PAIN; RUNNY NOSE; FOLATE DEFICIENCY; VITAMIN D DEFICIENCY; RASH; FEELING UNWELL; LACK OF ENERGY; CHILLS; HEADACHE; BEING WIPED OUT; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included orthopedic problems, asthma, attention deficit hyperactivity disorder, allergic to house dust, allergic to dog hair, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and also not pregnant at the time of vaccination. The patient received Pfizer vaccine on January 14, 2021 and February 4, 2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced leg cramps. On 2021, the subject experienced chest pain. On 2021, the subject experienced runny nose. On 2021, the subject experienced folate deficiency. On 2021, the subject experienced vitamin d deficiency. On 2021, the subject experienced rash. On 2021, the subject experienced feeling unwell. On 2021, the subject experienced lack of energy. On 2021, the subject experienced chills. On 2021, the subject experienced headache. On 2021, the subject experienced being wiped out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, leg cramps, rash, runny nose, feeling unwell, lack of energy, folate deficiency, vitamin d deficiency, and being wiped out, and the outcome of chest pain was not reported. This report was non-serious.