chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Pain, Vomiting, Weight decreased
Clinical narrative: BARELY WALK; LOST A LOT OF WEIGHT; SEVERE PHYSICAL PAIN; BARELY STAND; THROWING UP; This spontaneous report received from a parent 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: 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 patient experienced barely walk, lost a lot of weight, severe physical pain, barely stand, and throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the barely walk, throwing up, lost a lot of weight, severe physical pain and barely stand was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Hypoaesthesia oral, Nasal discomfort, Paraesthesia
Clinical narrative: NUMB IN UPPER CHEST; LOT OF NUMBNESS IN LIPS ROOF OF MOUTH; NUMBNESS IN THE RIGHT SIDE OF FACE AND JAW/ THE NUMBNESS WAS SPREADING TO OTHER AREAS OF FACE/HEAD/NECK/NUMBNESS OF NOSE WHERE IT ATTACHED TO LIPS; NUMBNESS THROAT; BURNING IN THAT AREA OF NOSE WHICH WAS VERY UNCOMFORTABLE; HARD TO SWALLOW; TINGLING IN THAT AREA OF NOSE WHICH WAS WEIRD FEELING/ TINGLING IN UPPER CHEST; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, non alcohol user, penicillin allergy, degenerative at herniated disc, arthritis, asthma, and macular degeneration, and other pre-existing medical conditions included: Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, cetirizine hydrochloride for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, diphenhydramine hydrochloride/paracetamol for drug used for unknown indication, montelukast sodium for drug used for unknown indication, nabumetone for drug used for unknown indication, and bevacizumab for macular degeneration. On 07-AUG-2021, the patient experienced burning in that area of nose which was very uncomfortable. On 07-AUG-2021, the patient experienced hard to swallow. On 07-AUG-2021, the patient experienced numbness in the right side of face and jaw/ the numbness was spreading to other areas of face/head/neck/numbness of nose where it attached to lips. On 07-AUG-2021, the patient experienced numbness throat. On 07-AUG-2021, the patient experienced tingling in that area of nose which was weird feeling/ tingling in upper chest. On 07-SEP-2021, the patient experienced lot of numbness in lips roof of mouth. On 05-OCT-2021, the patient experienced numb in upper chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lot of numbness in lips roof of mouth, numbness in the right side of face and jaw/ the numbness was spreading to other areas of face/head/neck/numbness of nose where it attached to lips, numbness throat, numb in upper chest, burning in that area of nose which was very uncomfortable, hard to swallow, and tingling in that area of nose which was weird feeling/ tingling in upper chest. This report was non-serious. This case, from the same reporter is linked to 20211017044.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: NUMB IN UPPER CHEST; LOT OF NUMBNESS IN LIPS ROOF OF MOUTH; NUMBNESS IN THE RIGHT SIDE OF FACE AND JAW/ THE NUMBNESS WAS SPREADING TO OTHER AREAS OF FACE/HEAD/NECK/NUMBNESS OF NOSE WHERE IT ATTACHED TO LIPS; NUMBNESS THROAT; BURNING IN THAT AREA OF NOSE WHICH WAS VERY UNCOMFORTABLE; HARD TO SWALLOW; TINGLING IN THAT AREA OF NOSE WHICH WAS WEIRD FEELING/ TINGLING IN UPPER CHEST; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, non alcohol user, penicillin allergy, degenerative at herniated disc, arthritis, asthma, and macular degeneration, and other pre-existing medical conditions included: Patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, cetirizine hydrochloride for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, diphenhydramine hydrochloride/paracetamol for drug used for unknown indication, montelukast sodium for drug used for unknown indication, nabumetone for drug used for unknown indication, and bevacizumab for macular degeneration. On 07-AUG-2021, the patient experienced burning in that area of nose which was very uncomfortable. On 07-AUG-2021, the patient experienced hard to swallow. On 07-AUG-2021, the patient experienced numbness in the right side of face and jaw/ the numbness was spreading to other areas of face/head/neck/numbness of nose where it attached to lips. On 07-AUG-2021, the patient experienced numbness throat. On 07-AUG-2021, the patient experienced tingling in that area of nose which was weird feeling/ tingling in upper chest. On 07-SEP-2021, the patient experienced lot of numbness in lips roof of mouth. On 05-OCT-2021, the patient experienced numb in upper chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lot of numbness in lips roof of mouth, numbness in the right side of face and jaw/ the numbness was spreading to other areas of face/head/neck/numbness of nose where it attached to lips, numbness throat, numb in upper chest, burning in that area of nose which was very uncomfortable, hard to swallow, and tingling in that area of nose which was weird feeling/ tingling in upper chest. This report was non-serious. This case, from the same reporter is linked to 20211017044.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: FEVER; LYMPH NODE PAIN; BODY ACHES/GENERALIZED BODY ACHES; SHIVERS/FEELING COLD; SWOLLEN LYMPH NODE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 168 pounds, and height was 74 inches. The patient's past medical history included: penicillin allergy, and other pre-existing medical conditions included: The patient had no known medical history and no daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced lymph node pain. On 06-OCT-2021, the patient experienced body aches/generalized body aches. On 06-OCT-2021, the patient experienced shivers/feeling cold. On 06-OCT-2021, the patient experienced swollen lymph node. On 07-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches/generalized body aches, and fever on 07-OCT-2021, and shivers/feeling cold on 06-OCT-2021, and had not recovered from swollen lymph node, and lymph node pain. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; LYMPH NODE PAIN; BODY ACHES/GENERALIZED BODY ACHES; SHIVERS/FEELING COLD; SWOLLEN LYMPH NODE; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 168 pounds, and height was 74 inches. The patient's past medical history included: penicillin allergy, and other pre-existing medical conditions included: The patient had no known medical history and no daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: UNKNOWN) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced lymph node pain. On 06-OCT-2021, the patient experienced body aches/generalized body aches. On 06-OCT-2021, the patient experienced shivers/feeling cold. On 06-OCT-2021, the patient experienced swollen lymph node. On 07-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches/generalized body aches, and fever on 07-OCT-2021, and shivers/feeling cold on 06-OCT-2021, and had not recovered from swollen lymph node, and lymph node pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dehydration, Movement disorder, Musculoskeletal stiffness, Neuralgia, Pyrexia
Clinical narrative: NERVE PAINS THROUGHOUT THE BODY; DEHYDRATED; NOT BEING ABLE TO MOVE TO GET A DRINK; LIMBS WERE TOO STIFF AND STUCK TO SIDES; SEIZING UP AND SHAKING REAL BAD FOR  5 TO 10 MIN; FEVER SO BAD; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced nerve pains throughout the body, dehydrated, not being able to move to get a drink, limbs were too stiff and stuck to sides, seizing up and shaking real bad for 5 to 10 min, and fever so bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever so bad, nerve pains throughout the body, dehydrated, not being able to move to get a drink, limbs were too stiff and stuck to sides and seizing up and shaking real bad for 5 to 10 min was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: NERVE PAINS THROUGHOUT THE BODY; DEHYDRATED; NOT BEING ABLE TO MOVE TO GET A DRINK; LIMBS WERE TOO STIFF AND STUCK TO SIDES; SEIZING UP AND SHAKING REAL BAD FOR  5 TO 10 MIN; FEVER SO BAD; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced nerve pains throughout the body, dehydrated, not being able to move to get a drink, limbs were too stiff and stuck to sides, seizing up and shaking real bad for 5 to 10 min, and fever so bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever so bad, nerve pains throughout the body, dehydrated, not being able to move to get a drink, limbs were too stiff and stuck to sides and seizing up and shaking real bad for 5 to 10 min was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient 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: unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211017191.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; INAPPROPRIATE AGE AT VACCINATION ADMINISTRATION; This spontaneous report received from a health care professional concerned a 15 year old of unspecified 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 was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced off label use. On 08-OCT-2021, the patient experienced inappropriate age at vaccination administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccination administration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac monitoring, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, ethnicity and race. 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 and expiry date: unknown) dose was not reported, 1 total, administered on 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 an unspecified date of AUG-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (coronavirus 19 infection). As per the reporter "I had J&J vaccine in March, got COVID in August, got real sick but not hospitalized for COVID but stayed one night monitoring my heart. Had infusion of monoclonal antibodies." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality complaint: 90000196798.; Sender's Comments: V0: 20211017004-Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination 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  20211017344-Covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: METALLIC TASTE; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a 3 decade 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced metallic taste, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metallic taste and slight headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED TO 3 PATIENTS; This spontaneous report received from a health care professional concerned multiple patients.  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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-OCT-2021, the patient experienced expired vaccine administered to 3 patients. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered to 3 patients was not reported. This report was non-serious. This case, from the same reporter is linked to 20211017517.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Hypoaesthesia, Hypoaesthesia oral, Muscle twitching
Clinical narrative: TWITCHING OF THE EYES; NUMBNESS IN HIS MOUTH; PAIN IN HIS FACE AND JAW; NUMBNESS ON LEFT SIDE OF FACE; This spontaneous report received from a consumer concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: enlarged prostate, high blood pressure, non alcoholic, and smoker, and other pre-existing medical conditions included: Patient had no known allergies. No drug abuse or illicit drug usage at the time of vaccination. Doctor prescribed anti-viral for numbness on the left side of his face thinking possible bells palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included finasteride for enlarged prostate, morniflumate for enlarged prostate, and losartan for high blood pressure.  On 26-JUL-2021, the patient experienced pain in his face and jaw. On 26-JUL-2021, the patient experienced numbness on left side of face. On 07-OCT-2021, the patient experienced twitching of the eyes. On 07-OCT-2021, the patient experienced numbness in his mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on left side of face, pain in his face and jaw, numbness in his mouth, and twitching of the eyes. This report was non-serious. This case, from the same reporter is linked to 20211016889.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Head discomfort, Headache, Pyrexia
Clinical narrative: BURNING SENSATION IN FACE AND NECK; HEAD PRESSURE; LOW FEVER; HEADACHE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A,  expiry: 14-DEC-2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient experienced burning sensation in face and neck. On 07-OCT-2021, the patient experienced head pressure. On 07-OCT-2021, the patient experienced low fever. On 07-OCT-2021, the patient experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low fever, and had not recovered from burning sensation in face and neck, head pressure, and headache. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED JANSEEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 50 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced administered expired janseen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired janseen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211017536, 20211017519 and 20211017116.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Glomerular filtration rate, Glomerular filtration rate decreased
Clinical narrative: DECLINE IN GLOMERULAR FILTRATION RATE; This spontaneous report received from a consumer concerned a 73 year old male. The patient's weight was 207 pounds, and height was 66 inches. The patient's concurrent conditions included: chronic kidney disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 18-AUG-2021) dose was not reported, administered on 21-JUL-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, the patient experienced decline in glomerular filtration rate. Laboratory data included: Glomerular filtration rate (NR: not provided) 20. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, and Glomerular filtration rate (NR: not provided) 24. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from decline in glomerular filtration rate. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 28 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Pyrexia
Clinical narrative: INSTANCES SOB; NAUSEA; LOW-GRADE FEVER; LOW GFR; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 186 pounds, and height was 64 inches. The patient's past medical history included: depression, and anxiety, and concurrent conditions included: chronic kidney disease (ckd), hypertension (htn), thyroid condition, gerd, grass allergy, mold allergy, pet dander allergy, dust allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 18-AUG-2021) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. Concomitant medications included clonazepam for drug used for unknown indication, famotidine for drug used for unknown indication, fluoxetine for drug used for unknown indication, hydralazine for drug used for unknown indication, lamotrigine for drug used for unknown indication, levothyroxine for drug used for unknown indication, and liothyronine for drug used for unknown indication. On 26-JUL-2021, the patient experienced low gfr. Laboratory data included: GFR (NR: not provided) 15. On an unspecified date, the patient experienced instances sob, nausea, and low-grade fever. Laboratory data (dates unspecified) included: GFR (NR: not provided) 20, 16. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low gfr, and the outcome of instances sob, nausea and low-grade fever was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased, Biopsy, Inflammatory marker increased, Inflammatory marker test
Clinical narrative: ANA ELEVATED; INFLAMMATORY MARKERS ELEVATED; INVASIVE DUCTAL CARCINOMA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's medical history included: ductal carcinoma, double mastectomy, implantation, surgery on foot, artificial cartilage, broke ankle, persistent postural perceptual dizziness, head injury, and arthritis in big toe. Concurrent conditions included: juvenile arthritis, allergy to sulfa, alcohol user, and non smoker. The patient had no drug abuse or illicit use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after vaccination), she had a little to no issue. In JUL-2021, she was feeling uncomfortable in the area. She visited to physician office and her plastic surgeon was suggested a magnetic resonance imaging (MRI). Later, her MRI, ultrasound and biopsy were performed (result not reported). In SEP-2021 (Last week or the week before the report), she was diagnosed with an invasive ductal carcinoma. On an unspecified date, her inflammatory markers (NR: not reported) and her antinuclear antibodies (ANA) (NR: not reported) was performed and found elevated. Her primary care provided (PCP) wanted to send her to a rheumatologist but she put them on hold because of the new finding. In next week of this report, her surgery was scheduled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of invasive ductal carcinoma, ANA elevated and inflammatory markers elevated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211017130-Covid-19 vaccine ad26.cov2.s- Invasive ductal carcinoma. 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: MEDICAL HISTORY
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Invasive ductal breast carcinoma, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: ANA ELEVATED; INFLAMMATORY MARKERS ELEVATED; INVASIVE DUCTAL CARCINOMA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's medical history included: ductal carcinoma, double mastectomy, implantation, surgery on foot, artificial cartilage, broke ankle, persistent postural perceptual dizziness, head injury, and arthritis in big toe. Concurrent conditions included: juvenile arthritis, allergy to sulfa, alcohol user, and non smoker. The patient had no drug abuse or illicit use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after vaccination), she had a little to no issue. In JUL-2021, she was feeling uncomfortable in the area. She visited to physician office and her plastic surgeon was suggested a magnetic resonance imaging (MRI). Later, her MRI, ultrasound and biopsy were performed (result not reported). In SEP-2021 (Last week or the week before the report), she was diagnosed with an invasive ductal carcinoma. On an unspecified date, her inflammatory markers (NR: not reported) and her antinuclear antibodies (ANA) (NR: not reported) was performed and found elevated. Her primary care provided (PCP) wanted to send her to a rheumatologist but she put them on hold because of the new finding. In next week of this report, her surgery was scheduled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of invasive ductal carcinoma, ANA elevated and inflammatory markers elevated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211017130-Covid-19 vaccine ad26.cov2.s- Invasive ductal carcinoma. 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product storage error
Clinical narrative: FROZEN VACCINE ADMINISTERED; EXPIRED VACCINE USED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  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: 042A21A expiry: 19-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced frozen vaccine administered, expired vaccine used, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the frozen vaccine administered, expired vaccine used and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: ARM WAS STILL PURPLE; PAIN WAS UNBEARABLE FOR A WHOLE WEEK; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced arm was still purple, and pain was unbearable for a whole week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm was still purple, and the outcome of pain was unbearable for a whole week was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the health care professional (HCP) reported that patient (co-worker) underwent laboratory test for COVID-19 antibody test which was found to be negative (suspected immunological vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196839 This case, from the same reporter is linked to 20211017311, 20210445531 and 20211007061.; Sender's Comments: V0: 20211017208- COVID-19 VACCINE AD26.COV2.S-Suspected immunological vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Injection site bruising, Injection site erythema
Clinical narrative: Fatigue, muscle aches, chills, diarrhea, redness/swelling/bruising at injection site.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Fatigue, muscle aches, chills, diarrhea, redness/swelling/bruising at injection site.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic shock
Clinical narrative: anaphylactic shock.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope
Clinical narrative: Fainting spells and seizures that began on March 27, and also occurred on April 2 and June 8.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Hyperhidrosis, Hypertension
Clinical narrative: Flu like symptoms; fever; chills; sweating; body aches; headache; increased heart rate; high blood pressure (160/93)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; fever; chills; sweating; body aches; headache; increased heart rate; high blood pressure (160/93)
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen and sore lymph nodes in right armpit
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Pharyngeal swelling, Swelling
Clinical narrative: Patient was administered the vaccine IM into her left deltoid at 4:45pm and instructed to stay on site for 15 minutes. Patient left and said she started feeling symptoms around 5:10pm. She presented back at the pharmacy between 5:20 and 5:25pm complaining of chest pressure, difficulty swallowing, and swelling neck / throat. She was offered to have 911 called, but turned it down saying she would have her boyfriend drive her to an ER or Urgent care. She was offered and took two, 12.5mg chewable tablets along with a small amount of water. She was observed for a few more minutes and said she wasn't feeling any worse but wasn't feeling any better and said she would have her boyfriend drive her to an ER. She was escorted from the pharmacy to the parking garage by a technician. The patient was contacted by the pharmacist at 5:40pm via phone and she said she was on her way to urgent care and wasn't feeling any worse. Rph offered to have 911 called for her again if she wanted to return to the pharmacy, but the patient again declined.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling pain itching injection site
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: Fatigue, runny nose, mild fever
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbing of both of my arms,  hands, and fingers on both hands.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling hot, Headache, Muscle twitching, Pain
Clinical narrative: About 36 hours after getting the Pfizer covid vaccine, I woke up in the morning with a terrible pain on my right cheek bone.  It was very painful and hot feeling.  The pain lasted the full day.  It felt like it was also in my right temple area and at times would also radiate up into my right forehead.  I wanted to take pain medicine, but I remembered that I was told not to take ibuprofen for a little while after the vaccine because it could inactivate it.  So I just used an ice pack on my face.  The following day a good amount of the pain subsided but it turned into a dull headache in my right temple.  I kept hoping the headache would eventually go away. I did eventually take some ibuprofen about 5 days in which helped a bit.  On Aug 28th I got some tingling in my left toes, felt like my foot fell asleep for a minute or so.  I tried to walk it off and then it turned into a dull aching in my left calf which lasted a couple hours.  The headache continued for about 10 days before I called my dr and tried to get an appointment.  I got an appointment first with a nurse practitioner on Aug 31st  she gave me two injections (decadron and toradol) IM to try to break up the headaches. That sort of helped for a day or two. She helped me get a sooner appointment with doctor for Sept 10th.  Around 10pm on 9/5 I had an episode of blurred vision which lasted about an hour.  I saw  doctor on 9/10 (1st time seeing him to establish care) He said my face pain sounded a lot like trigeminal neuralgia. Did not give me any treatment for that visit.  The headaches mostly stopped until October 14th in the PM.  I?ve had a temple headache in my right temple for 24 hours now and decided to fill out this report. Also for the last few weeks now I?ve been having my feet and fingers fall asleep or get a tingling sensation every day.  (Also occasional leg twitching and aching.)  This never happened before I had this vaccine.  One day I grabbed my bag quickly and 3 of the fingers in my left hand went to sleep for a couple minutes.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Trigeminal neuralgia, Vision blurred
Clinical narrative: About 36 hours after getting the Pfizer covid vaccine, I woke up in the morning with a terrible pain on my right cheek bone.  It was very painful and hot feeling.  The pain lasted the full day.  It felt like it was also in my right temple area and at times would also radiate up into my right forehead.  I wanted to take pain medicine, but I remembered that I was told not to take ibuprofen for a little while after the vaccine because it could inactivate it.  So I just used an ice pack on my face.  The following day a good amount of the pain subsided but it turned into a dull headache in my right temple.  I kept hoping the headache would eventually go away. I did eventually take some ibuprofen about 5 days in which helped a bit.  On Aug 28th I got some tingling in my left toes, felt like my foot fell asleep for a minute or so.  I tried to walk it off and then it turned into a dull aching in my left calf which lasted a couple hours.  The headache continued for about 10 days before I called my dr and tried to get an appointment.  I got an appointment first with a nurse practitioner on Aug 31st  she gave me two injections (decadron and toradol) IM to try to break up the headaches. That sort of helped for a day or two. She helped me get a sooner appointment with doctor for Sept 10th.  Around 10pm on 9/5 I had an episode of blurred vision which lasted about an hour.  I saw  doctor on 9/10 (1st time seeing him to establish care) He said my face pain sounded a lot like trigeminal neuralgia. Did not give me any treatment for that visit.  The headaches mostly stopped until October 14th in the PM.  I?ve had a temple headache in my right temple for 24 hours now and decided to fill out this report. Also for the last few weeks now I?ve been having my feet and fingers fall asleep or get a tingling sensation every day.  (Also occasional leg twitching and aching.)  This never happened before I had this vaccine.  One day I grabbed my bag quickly and 3 of the fingers in my left hand went to sleep for a couple minutes.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest X-ray, Computerised tomogram neck, Dysphagia, Dysphonia
Clinical narrative: Anaphylactic reaction, started approx 25mins after administration.  Rash, swelling, airway concerns. Emergency telephoned by facility; transfer to ED.  Multiple epinephrine injections, steroids, Benadryl, breathing treatments, approx 6 days in ICU and further hospitalization.  Continued issues with shortness of breath, voice and swallowing problems.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Intensive care, Laboratory test, Rash, Swallow study
Clinical narrative: Anaphylactic reaction, started approx 25mins after administration.  Rash, swelling, airway concerns. Emergency telephoned by facility; transfer to ED.  Multiple epinephrine injections, steroids, Benadryl, breathing treatments, approx 6 days in ICU and further hospitalization.  Continued issues with shortness of breath, voice and swallowing problems.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Anaphylactic reaction, started approx 25mins after administration.  Rash, swelling, airway concerns. Emergency telephoned by facility; transfer to ED.  Multiple epinephrine injections, steroids, Benadryl, breathing treatments, approx 6 days in ICU and further hospitalization.  Continued issues with shortness of breath, voice and swallowing problems.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had made an appointment for a dose of Janssen. Patient received the dose of Janssen, but system would only allow Pfizer vaccine to be selected. On further investigation, system showed that PT received a dose of Pfizer vaccine on 8/7/21. On the paper screening form that we used, he attested that he had not received a previous dose of any COVID vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Fever (101.7), body aches, sweats/chills, headache, tiredness - Flu-like symptoms. Began same day as booster. Symptoms still occurring Day 2.  Taking extra strength Tylenol to relieve symptoms. No medical attention at this time.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (101.7), body aches, sweats/chills, headache, tiredness - Flu-like symptoms. Began same day as booster. Symptoms still occurring Day 2.  Taking extra strength Tylenol to relieve symptoms. No medical attention at this time.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: There was no adverse event. The patient is currently fine with no symptoms. The patient received a Pfizer dose which I thought was the patient's first dose. The caregiver of the patient was also unaware the patient previously received 2 doses of Moderna, 1st dose on 1/30/2021 and 2nd on 2/27/2021. He is a new patient of that caregiver and the caregiver was given instruction by case management to get his covid vaccinations started. This vaccination error was only identified when I was logging the vaccination on a database.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Chest X-ray abnormal, Cough
Clinical narrative: Coughing within 24 hours of second dose of vaccine. Coughing continued for 6 weeks until I went to the doctor and was diagnosed with Asthma and put on a daily asthma medication.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: This spontaneous report received from a health care professional concerned multiple patients of an unspecified sex, age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  "Reporter (Health Care Professional) stated that, on an unspecified date, one of his clients had done a antibody testing (COVID-19 antibody test) to all of their employees. From that testing, 'multiple people' that took J&J tested negative for antibodies (suspected immunological vaccine failure). It was unknown how long after vaccination testing was done". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211017208, 20210445531 and 20211007061. This report was associated with product RA: 90000196841.; Sender's Comments: V0: 20211017311-COVID-19 VACCINE AD26.COV2.S-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity
Clinical narrative: After one month, I used my left arm to carry grocery's home 4 blocks. My arm got sore again that night and felt the same soreness as it did after getting the first two shots. The next day it was not sore anymore. I've experienced soreness with my body the same way ever since the first month after getting the shots. It's all over my body and I get sore after walking and it feels sore like it should feel sore maybe the next day but.it feels sore that day, it is not normal to get sore this way from such little.excercise for me. My joints hurt as well for 3 months but that has gone away. When I feel sore the day of walking, by tomorrow the soreness will go away but it hurts in every muscle in my body. It's not normal to feel this way, I walk a half mile then I'm sore.all day as I walk around and I have to take frequent rests to stop the sore feeling of pain.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen under arm lymph nodes, as big as 1/2 tennis ball size, mild pain