chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: PHARMACIST ADMINISTERED VACCINE FROM PUNCTURED VIAL 28 HRS AFTER OPENING THE VIAL (RECOMMENDED 6 HOURS); 6HR EXCURSION IN THE FRIDGE; VACCINE GIVEN FROM PUNCTURED VACCINE VIAL (28HRS AFTER OPENING); This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced pharmacist administered vaccine from punctured vial 28 hrs after opening the vial (recommended 6 hours). On 25-MAY-2021, the subject experienced 6hr excursion in the fridge. On 25-MAY-2021, the subject experienced vaccine given from punctured vaccine vial (28hrs after opening). The action taken with covid-19 vaccine was not applicable. The outcome of the pharmacist administered vaccine from punctured vial 28 hrs after opening the vial (recommended 6 hours), 6hr excursion in the fridge and vaccine given from punctured vaccine vial (28hrs after opening) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vasculitis, Vertigo
Clinical narrative: VASCULAR INFLAMMATION; VERTIGO; DEBILITATING HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced vascular inflammation, vertigo, and debilitating headaches. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from vascular inflammation, debilitating headaches, and vertigo. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN ON THE OPPOSITE ARM/LEG FOOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disease, high blood pressure, depression, asthma, sleep apnea, grass allergy, cat allergy, tree allergy, dust allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for sleep apnea, amlodipine, and losartan potassium. On 24-MAY-2021, the subject experienced pain on the opposite arm/leg foot. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain on the opposite arm/leg foot. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) 1 total, dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient's wife reported that, on 20-MAY-2021, the patient's antibody test was negative with score less than 1 (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210551477 and 20210550960.; Sender's Comments: V0:20210551575-covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Influenza like illness, Pain in extremity
Clinical narrative: A LARGE (ABOUT 4 INCHES IN LENGTH) PAIN FULL BRUISE APPEARED ABOVE THE RIGHT KNEE; PAIN AND SWELLING DOWN THE LEG, ANKLE AND  FOOT SWELLING; MILD FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-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 mild flu like symptoms. On 24-MAY-2021, the subject experienced a large (about 4 inches in length) pain full bruise appeared above the right knee. On 24-MAY-2021, the subject experienced pain and swelling down the leg, ankle and foot swelling. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from pain and swelling down the leg, ankle and foot swelling, and the outcome of mild flu like symptoms and a large (about 4 inches in length) pain full bruise appeared above the right knee was not reported. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: SUSPECTED  COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 24 year old male. The patient's weight was 195 pounds, and height was 72 inches. The patient's past medical history included exposed to covid 19.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 21-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On FEB-2021, Laboratory data included: Antibody test (NR: not provided) High Antibodies. On 21-MAY-2021, the subject experienced suspected covid-19 infection. On 24-MAY-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE GIVEN POST EXPIRATION; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced vaccine given post expiration. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine given post expiration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced incorrect storage of vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and incorrect storage of vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Gait disturbance, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: SWELLING; DIFFICULTY IN WALKING; STIFFNESS; PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriatic arthritis, and other pre-existing medical conditions included the patient had no known allergies. 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. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced swelling, difficulty in walking, stiffness, and pain. The action taken with covid-19 vaccine  was not applicable; and action taken with adalimumab was not reported. The outcome of the swelling, difficulty in walking, stiffness and pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Limb discomfort, Neck pain
Clinical narrative: DISCOMFORT IN LEGS AND ARMS GOES UPTO ELBOW AND ARMPIT/IN THIGH OF THE LEFT LEG; TINGLING/ NUMBNESS IN LEG/ARM/IN THE FINGERS; PAIN IN NECK; WHOLE WEEK SLEEPINESS; PAIN IN LEFT ARM; DISCOMFORT IN ARMS; TIREDNESS; PAIN IN HEAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the subject experienced discomfort in legs and arms goes upto elbow and armpit/in thigh of the left leg. On 15-MAY-2021, the subject experienced tingling/ numbness in leg/arm/in the fingers. On 15-MAY-2021, the subject experienced pain in neck. On 15-MAY-2021, the subject experienced whole week sleepiness. On 15-MAY-2021, the subject experienced pain in left arm. On 15-MAY-2021, the subject experienced discomfort in arms. On 15-MAY-2021, the subject experienced tiredness. On 15-MAY-2021, the subject experienced pain in head. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pain in neck, pain in left arm, and pain in head on MAY-2021, and the outcome of discomfort in legs and arms goes upto elbow and armpit/in thigh of the left leg, tiredness, whole week sleepiness, tingling/ numbness in leg/arm/in the fingers and discomfort in arms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Somnolence
Clinical narrative: DISCOMFORT IN LEGS AND ARMS GOES UPTO ELBOW AND ARMPIT/IN THIGH OF THE LEFT LEG; TINGLING/ NUMBNESS IN LEG/ARM/IN THE FINGERS; PAIN IN NECK; WHOLE WEEK SLEEPINESS; PAIN IN LEFT ARM; DISCOMFORT IN ARMS; TIREDNESS; PAIN IN HEAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the subject experienced discomfort in legs and arms goes upto elbow and armpit/in thigh of the left leg. On 15-MAY-2021, the subject experienced tingling/ numbness in leg/arm/in the fingers. On 15-MAY-2021, the subject experienced pain in neck. On 15-MAY-2021, the subject experienced whole week sleepiness. On 15-MAY-2021, the subject experienced pain in left arm. On 15-MAY-2021, the subject experienced discomfort in arms. On 15-MAY-2021, the subject experienced tiredness. On 15-MAY-2021, the subject experienced pain in head. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pain in neck, pain in left arm, and pain in head on MAY-2021, and the outcome of discomfort in legs and arms goes upto elbow and armpit/in thigh of the left leg, tiredness, whole week sleepiness, tingling/ numbness in leg/arm/in the fingers and discomfort in arms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Contusion, Dizziness, Headache
Clinical narrative: BRUISING OF ARM; CHILLS; HEADACHE; DIZZY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The patient number not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced dizzy. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced bruising of arm. The action taken with covid-19 vaccine was not applicable. The outcome of the headache, dizzy, chills and bruising of arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: SWEATING PROFUSELY; ACHES; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported,) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sweating profusely, aches, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the sweating profusely, aches and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; LOW GRADE FEVER; MINOR HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm, low grade fever, and minor headache. The action taken with covid-19 vaccine s was not applicable. The outcome of the low grade fever, sore arm and minor headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE; SOME NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included digestive issues, and chronic headaches. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced headache, and some nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache and some nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS AND SHIVERS; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced chills and shivers. On 26-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the chills and shivers and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: FELT LIKE A COMBINATION OF DRUNK AND ON SLEEPING  MEDS; DRY MOUTH; SHIVERING; SORE ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt like a combination of drunk and on sleeping meds, dry mouth, shivering, sore arm, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the felt like a combination of drunk and on sleeping meds, shivering, dry mouth, fever and sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH PAINS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced stomach pains. The action taken with covid-19 vaccine  was not applicable. The outcome of stomach pains was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210551574 and 20210554431.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: HEART BURN; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Batch number is not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced heart burn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart burn was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a pharmacist concerned a 36 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced expired vaccine used. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210551574 and 20210554296.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Chills, Dizziness
Clinical narrative: STOMACH PAIN; SWEAT; DIZZY; CHILLS; JOINT ACHES; FEVER; HEADACHES; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 140 pounds, and height was 60 inches. The patient's concurrent conditions included lupus, rheumatoid arthritis, diabetes, latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included hydromorphone for drug used for unknown indication. On 24-MAY-2021, the subject experienced sweat. On 24-MAY-2021, the subject experienced dizzy. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced joint aches. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced headaches. On 24-MAY-2021, the subject experienced muscle aches. On 24-MAY-2021, the subject experienced fatigue. On 25-MAY-2021, the subject experienced stomach pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) highest was101F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, muscle aches, stomach pain, headaches, fatigue, chills, and sweat, and the outcome of joint aches and dizzy was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: STOMACH PAIN; SWEAT; DIZZY; CHILLS; JOINT ACHES; FEVER; HEADACHES; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 140 pounds, and height was 60 inches. The patient's concurrent conditions included lupus, rheumatoid arthritis, diabetes, latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included hydromorphone for drug used for unknown indication. On 24-MAY-2021, the subject experienced sweat. On 24-MAY-2021, the subject experienced dizzy. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced joint aches. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced headaches. On 24-MAY-2021, the subject experienced muscle aches. On 24-MAY-2021, the subject experienced fatigue. On 25-MAY-2021, the subject experienced stomach pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) highest was101F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, muscle aches, stomach pain, headaches, fatigue, chills, and sweat, and the outcome of joint aches and dizzy was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: HALO VISION; HORRIBLE FEELING; COUGH; FAST HEARTBEAT; FEVER; FATIGUED/EXHAUSTED; THROAT TIGHTNESS; DIZZY; FEELS PRESSURE INTERMITTENTLY; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced chest tightness. On MAY-2021, the subject experienced feels pressure intermittently. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. On 21-MAY-2021, the subject experienced throat tightness. On 21-MAY-2021, the subject experienced dizzy. On 21-MAY-2021, the subject experienced fatigued/exhausted. On 22-MAY-2021, the subject experienced fast heartbeat. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) Fast. On 23-MAY-2021, the subject experienced cough. On 27-MAY-2021, the subject experienced halo vision. On 27-MAY-2021, the subject experienced horrible feeling. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fast heartbeat on 22-MAY-2021, and feels pressure intermittently on 23-MAY-2021, had not recovered from cough, and dizzy, and the outcome of chest tightness, halo vision, throat tightness, fever, fatigued/exhausted and horrible feeling was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Halo vision, Headache, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: HALO VISION; HORRIBLE FEELING; COUGH; FAST HEARTBEAT; FEVER; FATIGUED/EXHAUSTED; THROAT TIGHTNESS; DIZZY; FEELS PRESSURE INTERMITTENTLY; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced chest tightness. On MAY-2021, the subject experienced feels pressure intermittently. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. On 21-MAY-2021, the subject experienced throat tightness. On 21-MAY-2021, the subject experienced dizzy. On 21-MAY-2021, the subject experienced fatigued/exhausted. On 22-MAY-2021, the subject experienced fast heartbeat. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) Fast. On 23-MAY-2021, the subject experienced cough. On 27-MAY-2021, the subject experienced halo vision. On 27-MAY-2021, the subject experienced horrible feeling. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fast heartbeat on 22-MAY-2021, and feels pressure intermittently on 23-MAY-2021, had not recovered from cough, and dizzy, and the outcome of chest tightness, halo vision, throat tightness, fever, fatigued/exhausted and horrible feeling was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: HALO VISION; HORRIBLE FEELING; COUGH; FAST HEARTBEAT; FEVER; FATIGUED/EXHAUSTED; THROAT TIGHTNESS; DIZZY; FEELS PRESSURE INTERMITTENTLY; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced chest tightness. On MAY-2021, the subject experienced feels pressure intermittently. Treatment medications included: diphenhydramine hydrochloride, and ibuprofen. On 21-MAY-2021, the subject experienced throat tightness. On 21-MAY-2021, the subject experienced dizzy. On 21-MAY-2021, the subject experienced fatigued/exhausted. On 22-MAY-2021, the subject experienced fast heartbeat. On 22-MAY-2021, the subject experienced fever. Laboratory data included: Heart rate (NR: not provided) Fast. On 23-MAY-2021, the subject experienced cough. On 27-MAY-2021, the subject experienced halo vision. On 27-MAY-2021, the subject experienced horrible feeling. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fast heartbeat on 22-MAY-2021, and feels pressure intermittently on 23-MAY-2021, had not recovered from cough, and dizzy, and the outcome of chest tightness, halo vision, throat tightness, fever, fatigued/exhausted and horrible feeling was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: BREAST PAIN (LYMPHATIC NODS BURNING); This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAY-2021, the subject experienced breast pain (lymphatic nods burning). The action taken with covid-19 vaccine  was not applicable. The outcome of breast pain (lymphatic nods burning) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE OF VACCINE GIVEN TO PATIENT GREATER THAN 20 HOURS, VIAL PUNCTURED ON 26/MAY/2021 AT 9:13; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced dose of vaccine given to subject greater than 20 hours, vial punctured on 26/may/2021 at 9:13. The action taken with covid-19 vaccine  was not applicable. The outcome of dose of vaccine given to patient greater than 20 hours, vial punctured on 26/may/2021 at 9:13 was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain, Rash
Clinical narrative: BODY ACHE; RASH; HEADACHE; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 71 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: 1808986, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced body ache. On 26-MAY-2021, the subject experienced rash. On 26-MAY-2021, the subject experienced headache. On 26-MAY-2021, the subject experienced fatigue. On 26-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body ache, fatigue, and muscle ache on 27-MAY-2021, and headache on 26-MAY-2021, and had not recovered from rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: ENTIRE VACCINE VIAL GIVEN TO A PATIENT; ENTIRE VIAL OF JANSSEN WAS GIVEN TO A PATIENT; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced entire vaccine vial given to a subject. The action taken with covid-19 vaccine  was not applicable. The outcome of the entire vaccine vial given to a patient was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: BODY ACHES; LEG PAIN; HEADACHES; 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 lymph node cancer. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown expiry date: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced body aches. On 26-MAY-2021, the subject experienced leg pain. On 26-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine  was not applicable. The patient recovered from leg pain on 27-MAY-2021, and had not recovered from body aches, and headaches. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Confusional state, Dyspnoea, Fatigue
Clinical narrative: difficulty breathing; still encountering vision issues; vomiting; feels weak at the moment; little headache; confusion; stomach cramps; fatigued; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing), VISUAL IMPAIRMENT (still encountering vision issues) and VOMITING (vomiting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Lupus erythematosus. Concomitant products included ALPRAZOLAM (XANAX), LISINOPRIL and EZETIMIBE (ZETIA) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced DYSPNOEA (difficulty breathing) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (still encountering vision issues) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On 27-Jan-2021, the patient experienced ASTHENIA (feels weak at the moment), HEADACHE (little headache), CONFUSIONAL STATE (confusion), ABDOMINAL PAIN UPPER (stomach cramps) and FATIGUE (fatigued). The patient was hospitalized on 31-Dec-2020 due to DYSPNOEA, VISUAL IMPAIRMENT and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; OXYGEN at an unspecified dose and frequency and MORPHINE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), VISUAL IMPAIRMENT (still encountering vision issues), ASTHENIA (feels weak at the moment), HEADACHE (little headache), CONFUSIONAL STATE (confusion), ABDOMINAL PAIN UPPER (stomach cramps) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-020166 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Visual impairment, Vomiting
Clinical narrative: difficulty breathing; still encountering vision issues; vomiting; feels weak at the moment; little headache; confusion; stomach cramps; fatigued; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing), VISUAL IMPAIRMENT (still encountering vision issues) and VOMITING (vomiting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Lupus erythematosus. Concomitant products included ALPRAZOLAM (XANAX), LISINOPRIL and EZETIMIBE (ZETIA) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced DYSPNOEA (difficulty breathing) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (still encountering vision issues) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On 27-Jan-2021, the patient experienced ASTHENIA (feels weak at the moment), HEADACHE (little headache), CONFUSIONAL STATE (confusion), ABDOMINAL PAIN UPPER (stomach cramps) and FATIGUE (fatigued). The patient was hospitalized on 31-Dec-2020 due to DYSPNOEA, VISUAL IMPAIRMENT and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; OXYGEN at an unspecified dose and frequency and MORPHINE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), VISUAL IMPAIRMENT (still encountering vision issues), ASTHENIA (feels weak at the moment), HEADACHE (little headache), CONFUSIONAL STATE (confusion), ABDOMINAL PAIN UPPER (stomach cramps) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-020166 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Oligomenorrhoea
Clinical narrative: The May's menstrual period has last for 16 days; The April's menstrual period came 2 weeks earlier; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy menstrual bleeding) and MENSTRUATION IRREGULAR  (menstruation irregular)(seriousness criterion medically significant), in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy menstrual bleeding) (seriousness criterion medically significant), and  MENSTRUATION IRREGULAR (menstruation irregular) (seriousness criterion medically significant) (The April's menstrual period came 2 weeks earlier) and OLIGOMENORRHOEA (The May's menstrual period has last for 16 days). At the time of the report, HEAVY MENSTRUAL BLEEDING (heavy menstrual bleeding), MENSTRUATION IRREGULAR (The April's menstrual period came 2 weeks earlier) and OLIGOMENORRHOEA (The May's menstrual period has last for 16 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reports her menstrual period came 2 week earlier than she was expected, and her May's menstrual period has lasted 16 days at the moment of this call with blood cloths.  Concomitant product use was not provided by the reporter.    Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anal haemorrhage, Diarrhoea, Fatigue, Haematochezia
Clinical narrative: fresh blood in the stool; Watery stool; Anal bleeding; felt tired; This spontaneous case was reported by a patient and describes the occurrence of HAEMATOCHEZIA (fresh blood in the stool) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced FATIGUE (felt tired). On 14-May-2021, the patient experienced HAEMATOCHEZIA (fresh blood in the stool) (seriousness criterion medically significant), DIARRHOEA (Watery stool) and ANAL HAEMORRHAGE (Anal bleeding). At the time of the report, HAEMATOCHEZIA (fresh blood in the stool), DIARRHOEA (Watery stool) and ANAL HAEMORRHAGE (Anal bleeding) had not resolved and FATIGUE (felt tired) outcome was unknown.            It was reported that the patient was not pregnant and not having her period. SD text:23-year-old female patient is calling to report that she received the SECOND dose of Moderna COVID-19 vaccine on 12MAY2021 (Lot#  023C21A) in the Right Arm. The Next Day on 13MAY2021, she felt Tired.  Today 14MAY2021, She is having Watery Stool and Anal Bleeding. She states that she is not pregnant and she is not having her period. There is fresh blood in the watery stool (Not Coffee ground stool).      Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded