chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Flank pain, Nausea, Renal pain
Clinical narrative: KIDNEY PAIN; LOWER BACK PAIN; PAIN IN LEFT SIDE; DIZZY; VOMITING BILE; NAUSEA; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallbladder removed, and concurrent conditions included anxiety, and post-traumatic stress disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced dizzy. On 22-MAR-2021, the subject experienced vomiting bile. On 22-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced kidney pain. On 26-MAR-2021, the subject experienced lower back pain. On 26-MAR-2021, the subject experienced pain in left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting bile, had not recovered from nausea, kidney pain, lower back pain, and pain in left side, and the outcome of dizzy was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: KIDNEY PAIN; LOWER BACK PAIN; PAIN IN LEFT SIDE; DIZZY; VOMITING BILE; NAUSEA; This spontaneous report received from a consumer concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included gallbladder removed, and concurrent conditions included anxiety, and post-traumatic stress disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced dizzy. On 22-MAR-2021, the subject experienced vomiting bile. On 22-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced kidney pain. On 26-MAR-2021, the subject experienced lower back pain. On 26-MAR-2021, the subject experienced pain in left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting bile, had not recovered from nausea, kidney pain, lower back pain, and pain in left side, and the outcome of dizzy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Spontaneous penile erection
Clinical narrative: ERECTION WITH DISCHARGE WHILE SLEEPING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the subject experienced erection with discharge while sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the erection with discharge while sleeping and erection with discharge while sleeping was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: EARS TO ROAR VERY LOUDLY AND CAUSE EXTREME BAD TINNITUS; EXTREME VERTIGO; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced ears to roar very loudly and cause extreme bad tinnitus. On MAY-2021, the subject experienced extreme vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ears to roar very loudly and cause extreme bad tinnitus and extreme vertigo was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: SORE ARM; SLIGHT HEADACHE; LITTLE FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 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 20-MAR-2021, the subject experienced sore arm. On 20-MAR-2021, the subject experienced slight headache. On 20-MAR-2021, the subject experienced little fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, slight headache, and little fatigue on 21-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Discomfort, Fatigue, Gait disturbance
Clinical narrative: DIFFICULTY MOVING AND GETTING OUT OF CHAIRS; SLEEP DEPRIVATION; PHYSICAL DISCOMFORT; DIFFICULTY WALKING; STIFFNESS; JOINT ACHES; WEAKNESS; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced difficulty moving and getting out of chairs. On 12-APR-2021, the subject experienced sleep deprivation. On 12-APR-2021, the subject experienced physical discomfort. On 12-APR-2021, the subject experienced difficulty walking. On 12-APR-2021, the subject experienced stiffness. On 12-APR-2021, the subject experienced joint aches. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from muscle aches, joint aches, fatigue, weakness, difficulty moving and getting out of chairs, sleep deprivation, physical discomfort, difficulty walking, and stiffness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypokinesia, Musculoskeletal stiffness, Myalgia, Sleep deficit
Clinical narrative: DIFFICULTY MOVING AND GETTING OUT OF CHAIRS; SLEEP DEPRIVATION; PHYSICAL DISCOMFORT; DIFFICULTY WALKING; STIFFNESS; JOINT ACHES; WEAKNESS; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced difficulty moving and getting out of chairs. On 12-APR-2021, the subject experienced sleep deprivation. On 12-APR-2021, the subject experienced physical discomfort. On 12-APR-2021, the subject experienced difficulty walking. On 12-APR-2021, the subject experienced stiffness. On 12-APR-2021, the subject experienced joint aches. On 12-APR-2021, the subject experienced weakness. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from muscle aches, joint aches, fatigue, weakness, difficulty moving and getting out of chairs, sleep deprivation, physical discomfort, difficulty walking, and stiffness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER 99F TO 102.7F; BAD HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included COPD, type-2 diabetes, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced fever 99F to 102.7F. On 05-MAY-2021, the subject experienced bad headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99F to 102.7F. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 99F to 102.7F, chills, and bad headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Oxygen saturation, Sensation of foreign body
Clinical narrative: SHORTNESS OF BREATH; FLUSHED FACE; FEELING OF SOMETHING STUCK IN THROAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAY-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been request. No concomitant medications were reported. On 09-MAY-2021, the subject experienced shortness of breath. On 09-MAY-2021, the subject experienced flushed face. On 09-MAY-2021, the subject experienced feeling of something stuck in throat. Laboratory data included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, flushed face and feeling of something stuck in throat was not reported. This report was non-serious.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE OF VACCINE ADMINISTERED TO INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced off label use of vaccine administered to inappropriate age. The action taken with covid-19 vaccine  was not applicable. The outcome of off label use of vaccine administered to inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20210517564.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VIAL WAS PUNCTURED AT 932AM AND DOSE WAS GIVEN AT 5:25 PM TODAY; This spontaneous report received from a pharmacist concerned a 21 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced vial was punctured at 932am and dose was given at 5:25 pm today. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial was punctured at 932am and dose was given at 5:25 pm today was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site pain, Nausea
Clinical narrative: PINS AND NEEDLES FEELING TO HIS RIGHT ARM AND HAND; NUMBNESS IN RIGHT ARM; SORENESS OF THE ARM AT THE  MUSCLE IT WAS INJECTED; FATIGUE; HEADACHE; NAUSEA; 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  (suspension for injection, route of admin not reported, batch number: 205a21a, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced soreness of the arm at the muscle it was injected. On 06-MAY-2021, the subject experienced fatigue. On 06-MAY-2021, the subject experienced headache. On 06-MAY-2021, the subject experienced nausea. On 07-MAY-2021 08:00, the subject experienced pins and needles feeling to his right arm and hand. On 07-MAY-2021 08:00, the subject experienced numbness in right arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from soreness of the arm at the muscle it was injected, fatigue, headache, nausea, numbness in right arm, and pins and needles feeling to his right arm and hand. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: PINS AND NEEDLES FEELING TO HIS RIGHT ARM AND HAND; NUMBNESS IN RIGHT ARM; SORENESS OF THE ARM AT THE  MUSCLE IT WAS INJECTED; FATIGUE; HEADACHE; NAUSEA; 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  (suspension for injection, route of admin not reported, batch number: 205a21a, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced soreness of the arm at the muscle it was injected. On 06-MAY-2021, the subject experienced fatigue. On 06-MAY-2021, the subject experienced headache. On 06-MAY-2021, the subject experienced nausea. On 07-MAY-2021 08:00, the subject experienced pins and needles feeling to his right arm and hand. On 07-MAY-2021 08:00, the subject experienced numbness in right arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from soreness of the arm at the muscle it was injected, fatigue, headache, nausea, numbness in right arm, and pins and needles feeling to his right arm and hand. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine  was not applicable. The outcome of not feeling well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: EPISODES OF HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 24-MAY-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced episodes of headache. The action taken with covid-19 vaccine  was not applicable. The outcome of episodes of headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue discomfort, Tongue disorder
Clinical narrative: TONGUE SWOLLEN; TONGUE WITH SPOTS; TONGUE WITH BURNS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On 2021, the subject experienced tongue swollen. On 2021, the subject experienced tongue with spots. On 2021, the subject experienced tongue with burns. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tongue swollen, tongue with spots and tongue with burns was not reported. This report was non-serious. This case, from the same reporter is linked to 20210516288.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test positive
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included sars-cov-2 semi quantitative total antibody test, and concurrent conditions included flu vaccine allergy, ciprofloxacin allergy, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (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 08-APR-2021, the subject experienced headache. On 07-MAY-2021, Laboratory data included: SARS-CoV-2 test positive (NR: not provided) 2500 U/mL. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: MILD PAIN IN THE ANKLE AND BELOW RIGHT ANKLE ON AND OFF; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety disorder. 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-MAY-2021 14:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021, the subject experienced sore arm. On 10-MAY-2021, the subject experienced mild pain in the ankle and below right ankle on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and had not recovered from mild pain in the ankle and below right ankle on and off. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Condition aggravated, Dizziness
Clinical narrative: VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACHES /LITTLE SORE; FEELING WORSE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 13:00 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for depression.  On MAY-2021, the subject experienced body aches /little sore. On MAY-2021, the subject experienced feeling worse. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced muscle soreness. On 08-MAY-2021, the subject experienced very low temperature. On 08-MAY-2021, the subject experienced very light-headed. On 08-MAY-2021, the subject experienced lips were cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94 F. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, muscle soreness, body aches /little sore, lips were cold, very low temperature, very light-headed and feeling worse was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Myalgia, Pain
Clinical narrative: VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACHES /LITTLE SORE; FEELING WORSE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 13:00 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for depression.  On MAY-2021, the subject experienced body aches /little sore. On MAY-2021, the subject experienced feeling worse. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced muscle soreness. On 08-MAY-2021, the subject experienced very low temperature. On 08-MAY-2021, the subject experienced very light-headed. On 08-MAY-2021, the subject experienced lips were cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94 F. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, muscle soreness, body aches /little sore, lips were cold, very low temperature, very light-headed and feeling worse was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Lymphadenopathy, Middle insomnia, Muscle spasms
Clinical narrative: SWOLLEN LYMPH NODES UNDER ARM AND BREAST; TIGHTNESS OF THE COLLAR BONE; CRAMPING OF MUSCLE; STOMACH CRAMPING; NIGHT SWEATS; DIZZY; NAUSEA; FEVER; WAKING UP OCCASIONALLY; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced waking up occasionally. On 08-MAR-2021, the subject experienced cramping of muscle. On 08-MAR-2021, the subject experienced stomach cramping. On 08-MAR-2021, the subject experienced night sweats. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced swollen lymph nodes under arm and breast. On 15-MAR-2021, the subject experienced tightness of the collar bone. The action taken with covid-19 vaccine  was not applicable. The patient recovered from cramping of muscle, stomach cramping, dizzy, nausea, and fever on 09-MAR-2021, had not recovered from night sweats, swollen lymph nodes under arm and breast, and tightness of the collar bone, and the outcome of waking up occasionally was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Night sweats, Pyrexia
Clinical narrative: SWOLLEN LYMPH NODES UNDER ARM AND BREAST; TIGHTNESS OF THE COLLAR BONE; CRAMPING OF MUSCLE; STOMACH CRAMPING; NIGHT SWEATS; DIZZY; NAUSEA; FEVER; WAKING UP OCCASIONALLY; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced waking up occasionally. On 08-MAR-2021, the subject experienced cramping of muscle. On 08-MAR-2021, the subject experienced stomach cramping. On 08-MAR-2021, the subject experienced night sweats. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced swollen lymph nodes under arm and breast. On 15-MAR-2021, the subject experienced tightness of the collar bone. The action taken with covid-19 vaccine  was not applicable. The patient recovered from cramping of muscle, stomach cramping, dizzy, nausea, and fever on 09-MAR-2021, had not recovered from night sweats, swollen lymph nodes under arm and breast, and tightness of the collar bone, and the outcome of waking up occasionally was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, General physical health deterioration
Clinical narrative: TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Musculoskeletal chest pain, Pain, Pharyngeal swelling, Pneumonitis
Clinical narrative: TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: TENDERNESS IN THE CHEST; LUNG INFLAMMATION; COUGHING; SORENESS; TROUBLE BREATHING; THROAT SWELLING; CHEST TIGHTNESS; GENERAL SWELLING; DETERIORATION; DID NOT FEEL WELL; TIRED/FATIGUE; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-APR-2021, the subject experienced tired/fatigue. On MAY-2021, the subject experienced deterioration. On MAY-2021, the subject experienced did not feel well. On 07-MAY-2021, the subject experienced soreness. On 07-MAY-2021, the subject experienced trouble breathing. On 07-MAY-2021, the subject experienced throat swelling. On 07-MAY-2021, the subject experienced chest tightness. On 07-MAY-2021, the subject experienced general swelling. On 07-MAY-2021, the subject experienced coughing. On 08-MAY-2021, the subject experienced tenderness in the chest. On 08-MAY-2021, the subject experienced lung inflammation. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from tired/fatigue, had not recovered from soreness, trouble breathing, throat swelling, chest tightness, general swelling, lung inflammation, and coughing, and the outcome of tenderness in the chest, did not feel well and deterioration was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin sensitisation
Clinical narrative: SENSITIVE ARM, ALMOST LIKE A SUNBURN WITH NO REDNESS OR SWELLING; ARM HURTS,  FROM ELBOW TO WRIST; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On MAY-2021, the subject experienced sensitive arm, almost like a sunburn with no redness or swelling. On MAY-2021, the subject experienced arm hurts, from elbow to wrist. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm hurts, from elbow to wrist, and the outcome of sensitive arm, almost like a sunburn with no redness or swelling was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Palpitations
Clinical narrative: RACING HEART; JOINT PAIN; FEVER; MUSCLE ACHES; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 49 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced racing heart. On 13-APR-2021, the subject experienced joint pain. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart on 24-APR-2021, joint pain, and muscle aches on 27-APR-2021, tired, and headache on 26-APR-2021, and fever on 16-APR-2021. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RACING HEART; JOINT PAIN; FEVER; MUSCLE ACHES; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 49 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced racing heart. On 13-APR-2021, the subject experienced joint pain. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart on 24-APR-2021, joint pain, and muscle aches on 27-APR-2021, tired, and headache on 26-APR-2021, and fever on 16-APR-2021. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia
Clinical narrative: PAIN IN SHOULDER; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was not reported and height was 51.5 inches. The patient's concurrent conditions included hypertension, obesity, arthritis, panic attacks, borderline diabetes, mold allergy, tree allergy, cat allergy, dog allergy, cipro allergy, and non smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced pain in shoulder. On 29-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pain in shoulder on 09-APR-2021. This report was non-serious.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Product storage error
Clinical narrative: PRODUCT GIVEN AFTER EIGHT TO NINE HOURS AFTER FIRST PUNCTURE; FLU LIKE SYMPTOMS; SORE ARM; This spontaneous report received from a pharmacist concerned a 41 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 08-MAY-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced product given after eight to nine hours after first puncture, flu like symptoms, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product given after eight to nine hours after first puncture, sore arm and flu like symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Tenderness
Clinical narrative: LITTLE LETHARGIC; TENDERNESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced little lethargic. On 08-MAY-2021, the subject experienced tenderness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little lethargic and tenderness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210518102.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: LEFT KIDNEY PAIN; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced left kidney pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left kidney pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT/SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch unknown) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced unspecified adverse event/symtoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event/symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: DIARRHEA; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-MAY-2021, the subject experienced diarrhea. On 06-MAY-2021, the subject experienced vomiting. On 06-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: loperamide hydrochloride, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, vomiting, and nausea on 08-MAY-2021. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: SWELLING/TIGHTNESS ON LEFT SIDE OF FACE; ACHE; LEFT ARM PAIN; FEVER; This spontaneous report received from a parent concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to penicillin, alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A,  expiry: 23-JUN-2021) dose was not reported, administered on 09-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced swelling/tightness on left side of face. On 09-MAY-2021, the subject experienced ache. On 09-MAY-2021, the subject experienced left arm pain. On 09-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling/tightness on left side of face, left arm pain, ache, and fever. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Pain, Peripheral swelling
Clinical narrative: Forearm elbow down to hand has been swollen/puffy; Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Pacemaker insertion (cardiac).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (Sore arm). On 15-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Forearm elbow down to hand has been swollen/puffy). At the time of the report, CELLULITIS (Diagnosed as left arm Cellulitis of unspecified cause for the left arm swelling), PAIN (Sore arm) and PERIPHERAL SWELLING (Forearm elbow down to hand has been swollen/puffy) outcome was unknown.            No concomitant medications mentioned.  Treatment for the events included Clindamycin hydrochloride 300mg.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The Urgent Care, diagnosed patient left upper arm swollen twice the size from elbow down to finger, as Cellulitis of Unspecified cause left upper limb. The Urgent Care prescribed Clindamycin HCL 300mg antibiotics every 6 hourly for 7 days and patient symptoms improving after starting the treatment, according to the patient.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Mentioned confirmation of visiting Urgent care and diagnosis from Urgent Care; Events updated. 2nd dose information mentioned; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immobile, Limb discomfort, Muscle contractions involuntary
Clinical narrative: Can't move it independently and states it is immobile; Muscles contractions between her shoulder and her arm, the big part or arm of completely seized/patient is almost still completely unable to lift her arm.; Patient is almost still completely unable to lift her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMOBILE (Can't move it independently and states it is immobile) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced IMMOBILE (Can't move it independently and states it is immobile) (seriousness criterion medically significant), MUSCLE CONTRACTIONS INVOLUNTARY (Muscles contractions between her shoulder and her arm, the big part or arm of completely seized/patient is almost still completely unable to lift her arm.) and LIMB DISCOMFORT (Patient is almost still completely unable to lift her arm). At the time of the report, IMMOBILE (Can't move it independently and states it is immobile) and LIMB DISCOMFORT (Patient is almost still completely unable to lift her arm) outcome was unknown and MUSCLE CONTRACTIONS INVOLUNTARY (Muscles contractions between her shoulder and her arm, the big part or arm of completely seized/patient is almost still completely unable to lift her arm.) was resolving. Not Provided          Relevant concomitant medications were not reported. Treatment information were included ibuprofen, acetaminophen and diphenhydramine recommended by her doctor but the patient took lower than recommended doses: 800mg ibuprofen, 25mg diphenhydramine and 800 mg acetaminophen.  Action taken with mRNA-1273 in response to the event was not applicable.  Company Comment: This case concerns a 31-year-old female with a serious unexpected event of immobile, and nonserious unexpected muscle contractions involuntary and limb discomfort. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 31-year-old female with a serious unexpected event of immobile, and nonserious unexpected muscle contractions involuntary and limb discomfort. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.