chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral venous disease, Urine abnormality
Clinical narrative: SHORTNESS OF BREATH (FEELING CONSTRICTED BUT NOT COMPLETE LOSS OF BREATH); LEFT NECK LYMPH NODE SWELLING (NOW DECREASED IN SIZE, STILL PALPABLE AND INFLAMED); FEELS HYPOSTATIC; LIGHT HEADED; FEELING BACKED UP; CLOUDINESS IN URINE; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included fever, tinnitus, and drug induced hypertension, and concurrent conditions included autoimmune disease -psoriatic arthritis, and other pre-existing medical conditions included the patient had experienced many adverse experiences with other vaccines/medications in the past. the patient had received steroids that resulted in bright pink torso and was aware about the steroid allergy. the patient thinks he had covid-19 back in december because he loss his sense of smell for 2 to 3 weeks. patient received a vaccine 10 years ago that gave him a fever for 10 days straight. The patient experienced hypertensive when treated with salbutamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04A21A, and expiry: 05/AUG/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced cloudiness in urine. On 21-MAY-2021, the subject experienced shortness of breath (feeling constricted but not complete loss of breath). On 21-MAY-2021, the subject experienced left neck lymph node swelling (now decreased in size, still palpable and inflamed). On 21-MAY-2021, the subject experienced feels hypostatic. On 21-MAY-2021, the subject experienced light headed. On 21-MAY-2021, the subject experienced feeling backed up. On 01-JUN-2021, Laboratory data included: Blood test (NR: not provided) all clear. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 111/63. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (feeling constricted but not complete loss of breath), left neck lymph node swelling (now decreased in size, still palpable and inflamed), feels hypostatic, light headed, cloudiness in urine, and feeling backed up. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Ear pain, Headache, Lacrimation increased, Muscle spasms
Clinical narrative: LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AND FOOT CRAMPING; INTERMITTENT HEAD ACHES; PAIN BEHIND BOTH EAR; SWELLING IN BOTH ARMPIT, BEHIND BOTH EAR; WATERY EYES; DRIPPY NOSE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to mold.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced watery eyes. On 15-MAY-2021, the subject experienced drippy nose. On 17-MAY-2021, the subject experienced pain behind both ear. On 17-MAY-2021, the subject experienced swelling in both armpit, behind both ear. On 17-MAY-2021, the subject experienced intermittent head aches. On 19-MAY-2021, the subject experienced left hand and foot cramping. On 23-MAY-2021, the subject experienced left and right armpit pain. On 30-MAY-2021, the subject experienced left hand stiffness. On 30-MAY-2021, the subject experienced left hand soreness and fingertip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from watery eyes, and drippy nose on 16-MAY-2021, and left hand and foot cramping on 30-MAY-2021, and had not recovered from left hand soreness and fingertip pain, left hand stiffness, pain behind both ear, swelling in both armpit, behind both ear, intermittent head aches, and left and right armpit pain. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Rhinorrhoea, Swelling
Clinical narrative: LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AND FOOT CRAMPING; INTERMITTENT HEAD ACHES; PAIN BEHIND BOTH EAR; SWELLING IN BOTH ARMPIT, BEHIND BOTH EAR; WATERY EYES; DRIPPY NOSE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to mold.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced watery eyes. On 15-MAY-2021, the subject experienced drippy nose. On 17-MAY-2021, the subject experienced pain behind both ear. On 17-MAY-2021, the subject experienced swelling in both armpit, behind both ear. On 17-MAY-2021, the subject experienced intermittent head aches. On 19-MAY-2021, the subject experienced left hand and foot cramping. On 23-MAY-2021, the subject experienced left and right armpit pain. On 30-MAY-2021, the subject experienced left hand stiffness. On 30-MAY-2021, the subject experienced left hand soreness and fingertip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from watery eyes, and drippy nose on 16-MAY-2021, and left hand and foot cramping on 30-MAY-2021, and had not recovered from left hand soreness and fingertip pain, left hand stiffness, pain behind both ear, swelling in both armpit, behind both ear, intermittent head aches, and left and right armpit pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM HURTING; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.   On an unspecified date, the subject experienced arm hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurting was not reported. This report was non-serious. This case, from the same reporter is linked to 20210637808.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINES WERE OUTSIDE THE RECOMMENDED STORED TEMPERATURE; POOR QUALITY VACCINE ADMINISTERED; 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: Unknown) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-JUN-2021, the subject experienced vaccines were outside the recommended stored temperature. On 17-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccines were outside the recommended stored temperature and poor quality vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY ACHE; MILD FEVER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 body ache, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and mild fever. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chills, Dizziness, Eructation
Clinical narrative: LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; 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 past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia, Muscle spasms, Pain in extremity
Clinical narrative: LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; 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 past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SKULL ACHE (INTERMITTENTLY DIRECTLY ON THE TOP OF HEAD); This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's past medical history included front subdural hematoma, and concurrent conditions included bees allergy, horse allergy, alcohol user (15 drinks per week), and cigarette smoker (quarter of pack per day since 17 years), and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced skull ache (intermittently directly on the top of head). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skull ache (intermittently directly on the top of head). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Swelling of eyelid
Clinical narrative: HEADACHE; RIGHT EYELID SWELLING; This spontaneous report received from a parent concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gluten intolerant, and allergy to antibiotics.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced right eyelid swelling. On 08-JUN-2021, Laboratory data included: MRI (NR: not provided) No tumors. On 16-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right eyelid swelling, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME FATIGUE; 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. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: SLIGHT FEVER; JUST TIRED; 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) 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 slight fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOW GRADE 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 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low grade fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTION; 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 numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Computerised tomogram, Dizziness, Headache
Clinical narrative: Blood pressure skyrocketed from 100/50 normally to 179/110; Dizziness/Dizzy; Vision was blurry; Headaches; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B211A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for High cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for Prophylaxis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) (seriousness criterion medically significant). In April 2021, the patient experienced DIZZINESS (Dizziness/Dizzy), VISION BLURRED (Vision was blurry) and HEADACHE (Headaches). The patient was treated with LOSARTAN POTASSIUM for Blood pressure high, at a dose of 50 mg twice a day. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) had not resolved, DIZZINESS (Dizziness/Dizzy) outcome was unknown and VISION BLURRED (Vision was blurry) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 179/110 (High) skyrocketed from 100/50 normally to 179/110 and after sometimes it was  down to 167/106. On 02-Apr-2021, Computerised tomogram: negative (Negative) Negative. On 02-Apr-2021, Magnetic resonance imaging: negative (Negative) Negative.         Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-213201 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vision blurred
Clinical narrative: Blood pressure skyrocketed from 100/50 normally to 179/110; Dizziness/Dizzy; Vision was blurry; Headaches; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B211A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for High cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for Prophylaxis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) (seriousness criterion medically significant). In April 2021, the patient experienced DIZZINESS (Dizziness/Dizzy), VISION BLURRED (Vision was blurry) and HEADACHE (Headaches). The patient was treated with LOSARTAN POTASSIUM for Blood pressure high, at a dose of 50 mg twice a day. At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure skyrocketed from 100/50 normally to 179/110) had not resolved, DIZZINESS (Dizziness/Dizzy) outcome was unknown and VISION BLURRED (Vision was blurry) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 179/110 (High) skyrocketed from 100/50 normally to 179/110 and after sometimes it was  down to 167/106. On 02-Apr-2021, Computerised tomogram: negative (Negative) Negative. On 02-Apr-2021, Magnetic resonance imaging: negative (Negative) Negative.         Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-213201 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: 6/18 chills, headache, nausea 6/19 chills, fatigue, nausea, headache, brain fog 6/20 fatigue, brain fog 6/21 fatigue, brain fog
Age: 102.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Atrial fibrillation, Autonomic nervous system imbalance, Blood culture negative, Blood thyroid stimulating hormone normal
Clinical narrative: Pt received his 2nd pfizer covid 19 vaccine on March 11 (the lot number was not written on the card unfortunately) and was hospitalized from 5/21-6/4 with new onset profound hypotension and new onset atrial fibrillation with a bradycardic rate.,requiring ICU admission and pressor support. He presented with a fall and was found to be profoundly hypotensive. Sepsis was ruled out and the cause was unclear. He was eventually started on midodrine . He did not require any rate controlling medication. His daughter did not want anticoagulation ordered due to risk outweighing benefit. He was diagnosed with new autonomic dysfunction and new atrial fibrillation and discharged home on 6/4/21
Age: 102.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Cortisol normal, Culture urine negative, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Pt received his 2nd pfizer covid 19 vaccine on March 11 (the lot number was not written on the card unfortunately) and was hospitalized from 5/21-6/4 with new onset profound hypotension and new onset atrial fibrillation with a bradycardic rate.,requiring ICU admission and pressor support. He presented with a fall and was found to be profoundly hypotensive. Sepsis was ruled out and the cause was unclear. He was eventually started on midodrine . He did not require any rate controlling medication. His daughter did not want anticoagulation ordered due to risk outweighing benefit. He was diagnosed with new autonomic dysfunction and new atrial fibrillation and discharged home on 6/4/21
Age: 102.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Fibrin D dimer increased, Hypotension, Intensive care, Mitral valve incompetence
Clinical narrative: Pt received his 2nd pfizer covid 19 vaccine on March 11 (the lot number was not written on the card unfortunately) and was hospitalized from 5/21-6/4 with new onset profound hypotension and new onset atrial fibrillation with a bradycardic rate.,requiring ICU admission and pressor support. He presented with a fall and was found to be profoundly hypotensive. Sepsis was ruled out and the cause was unclear. He was eventually started on midodrine . He did not require any rate controlling medication. His daughter did not want anticoagulation ordered due to risk outweighing benefit. He was diagnosed with new autonomic dysfunction and new atrial fibrillation and discharged home on 6/4/21
Age: 102.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary mass, SARS-CoV-2 test negative, Tricuspid valve incompetence
Clinical narrative: Pt received his 2nd pfizer covid 19 vaccine on March 11 (the lot number was not written on the card unfortunately) and was hospitalized from 5/21-6/4 with new onset profound hypotension and new onset atrial fibrillation with a bradycardic rate.,requiring ICU admission and pressor support. He presented with a fall and was found to be profoundly hypotensive. Sepsis was ruled out and the cause was unclear. He was eventually started on midodrine . He did not require any rate controlling medication. His daughter did not want anticoagulation ordered due to risk outweighing benefit. He was diagnosed with new autonomic dysfunction and new atrial fibrillation and discharged home on 6/4/21
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Injection site erythema, Injection site pain
Clinical narrative: Large red spot 4 inches below injection site, slightly sore.  Also burning chest sensations. As of today spot is gone. Chest burning is not.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap, Anti-GAD antibody, Anti-islet cell antibody, Blood glucose increased, Blood insulin
Clinical narrative: pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions secondary to new onset type 1 diabetes. she has had no recent illnesses or infections. she takes no medications and has no known medical problems. she sees her primary care regularly and never had problems with her blood sugars before. she is very active and eats well. she has never smoked. she noticed about 2 months ago not feeling herself. she noticed 2 scabs and sores on the outside of her ears that would not heal and sudden weight loss. she then noticed polydipsia, polyuria and polyphagia and thrush in her mouth. she went to urgent care on 6/19 and her blood sugar was 474 and she was directed to the ER for evaluation where she was found to be in DKA with new type 1 diabetes and admitted to the icu on an insulin drip. She had her covid 19 vaccines on 3/3 and 3/31. No hx illnesses or infections. she takes no medications. she has never had covid 19 to her knowledge. with iv fluids, insulin and treatment for her thrush her blood sugars were better controlled and she was transferred out of the icu to the medical floor for further education on management of new diabetes and placed on lantus, humalog with meals and sliding scale. she was seen by the diabetes educator and will be following up with endocrinology after discharge. autoimmune antibody panel for LADA pending.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pH decreased, Blood phosphorus, Carbon dioxide, Diabetic ketoacidosis, Differential white blood cell count normal
Clinical narrative: pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions secondary to new onset type 1 diabetes. she has had no recent illnesses or infections. she takes no medications and has no known medical problems. she sees her primary care regularly and never had problems with her blood sugars before. she is very active and eats well. she has never smoked. she noticed about 2 months ago not feeling herself. she noticed 2 scabs and sores on the outside of her ears that would not heal and sudden weight loss. she then noticed polydipsia, polyuria and polyphagia and thrush in her mouth. she went to urgent care on 6/19 and her blood sugar was 474 and she was directed to the ER for evaluation where she was found to be in DKA with new type 1 diabetes and admitted to the icu on an insulin drip. She had her covid 19 vaccines on 3/3 and 3/31. No hx illnesses or infections. she takes no medications. she has never had covid 19 to her knowledge. with iv fluids, insulin and treatment for her thrush her blood sugars were better controlled and she was transferred out of the icu to the medical floor for further education on management of new diabetes and placed on lantus, humalog with meals and sliding scale. she was seen by the diabetes educator and will be following up with endocrinology after discharge. autoimmune antibody panel for LADA pending.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count normal, Hyperphagia, Infusion, Intensive care
Clinical narrative: pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions secondary to new onset type 1 diabetes. she has had no recent illnesses or infections. she takes no medications and has no known medical problems. she sees her primary care regularly and never had problems with her blood sugars before. she is very active and eats well. she has never smoked. she noticed about 2 months ago not feeling herself. she noticed 2 scabs and sores on the outside of her ears that would not heal and sudden weight loss. she then noticed polydipsia, polyuria and polyphagia and thrush in her mouth. she went to urgent care on 6/19 and her blood sugar was 474 and she was directed to the ER for evaluation where she was found to be in DKA with new type 1 diabetes and admitted to the icu on an insulin drip. She had her covid 19 vaccines on 3/3 and 3/31. No hx illnesses or infections. she takes no medications. she has never had covid 19 to her knowledge. with iv fluids, insulin and treatment for her thrush her blood sugars were better controlled and she was transferred out of the icu to the medical floor for further education on management of new diabetes and placed on lantus, humalog with meals and sliding scale. she was seen by the diabetes educator and will be following up with endocrinology after discharge. autoimmune antibody panel for LADA pending.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Oral candidiasis, Polydipsia, Polyuria, SARS-CoV-2 test negative
Clinical narrative: pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions secondary to new onset type 1 diabetes. she has had no recent illnesses or infections. she takes no medications and has no known medical problems. she sees her primary care regularly and never had problems with her blood sugars before. she is very active and eats well. she has never smoked. she noticed about 2 months ago not feeling herself. she noticed 2 scabs and sores on the outside of her ears that would not heal and sudden weight loss. she then noticed polydipsia, polyuria and polyphagia and thrush in her mouth. she went to urgent care on 6/19 and her blood sugar was 474 and she was directed to the ER for evaluation where she was found to be in DKA with new type 1 diabetes and admitted to the icu on an insulin drip. She had her covid 19 vaccines on 3/3 and 3/31. No hx illnesses or infections. she takes no medications. she has never had covid 19 to her knowledge. with iv fluids, insulin and treatment for her thrush her blood sugars were better controlled and she was transferred out of the icu to the medical floor for further education on management of new diabetes and placed on lantus, humalog with meals and sliding scale. she was seen by the diabetes educator and will be following up with endocrinology after discharge. autoimmune antibody panel for LADA pending.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Scab, Skin lesion, Type 1 diabetes mellitus, Urine analysis, Urine ketone body present
Clinical narrative: pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions secondary to new onset type 1 diabetes. she has had no recent illnesses or infections. she takes no medications and has no known medical problems. she sees her primary care regularly and never had problems with her blood sugars before. she is very active and eats well. she has never smoked. she noticed about 2 months ago not feeling herself. she noticed 2 scabs and sores on the outside of her ears that would not heal and sudden weight loss. she then noticed polydipsia, polyuria and polyphagia and thrush in her mouth. she went to urgent care on 6/19 and her blood sugar was 474 and she was directed to the ER for evaluation where she was found to be in DKA with new type 1 diabetes and admitted to the icu on an insulin drip. She had her covid 19 vaccines on 3/3 and 3/31. No hx illnesses or infections. she takes no medications. she has never had covid 19 to her knowledge. with iv fluids, insulin and treatment for her thrush her blood sugars were better controlled and she was transferred out of the icu to the medical floor for further education on management of new diabetes and placed on lantus, humalog with meals and sliding scale. she was seen by the diabetes educator and will be following up with endocrinology after discharge. autoimmune antibody panel for LADA pending.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions secondary to new onset type 1 diabetes. she has had no recent illnesses or infections. she takes no medications and has no known medical problems. she sees her primary care regularly and never had problems with her blood sugars before. she is very active and eats well. she has never smoked. she noticed about 2 months ago not feeling herself. she noticed 2 scabs and sores on the outside of her ears that would not heal and sudden weight loss. she then noticed polydipsia, polyuria and polyphagia and thrush in her mouth. she went to urgent care on 6/19 and her blood sugar was 474 and she was directed to the ER for evaluation where she was found to be in DKA with new type 1 diabetes and admitted to the icu on an insulin drip. She had her covid 19 vaccines on 3/3 and 3/31. No hx illnesses or infections. she takes no medications. she has never had covid 19 to her knowledge. with iv fluids, insulin and treatment for her thrush her blood sugars were better controlled and she was transferred out of the icu to the medical floor for further education on management of new diabetes and placed on lantus, humalog with meals and sliding scale. she was seen by the diabetes educator and will be following up with endocrinology after discharge. autoimmune antibody panel for LADA pending.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nervousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient nervous/anxiety about shot, patient received shot. Approximately 5 min after vaccine, during patient's 15 min, patient became lightheaded, then fainted. Patient then became responsive less than a minute after fainting. 911 was called at 6:58pm. EMT arrived, took over and patient/mother declined to hospital transportation. Patient left pharmacy on own.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Systemic: red raised rash appearing minutes after injection and still present-Mild, Additional Details: Patient states her boyfriend noticed the rash within minutes of injection.  small raised red bumps on chest extending just below collar bone and on back of neck extending to the shoulder blades.  not itchy
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumothorax
Clinical narrative: Systemic: Pneumothorax-Severe
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red area about the size of golf ball on injection site; Itching on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red area about the size of golf ball on injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red area about the size of golf ball on injection site) (seriousness criterion medically significant) and VACCINATION SITE PRURITUS (Itching on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red area about the size of golf ball on injection site) and VACCINATION SITE PRURITUS (Itching on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided. Treatment medication information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: U
Vaccine: BCG, TDAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: Six staff members were administered Adacel 0.1mL in the right forearm instead of the TB (tuberculosis) shot, no AE; Six staff members were administered Adacel 0.1mL in the right forearm instead of the TB (tuberculosis) shot, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00636207) and transmitted to Sanofi on 10-Jun-2021.  This case involves 6 patients (demographics unknown) who were administered 0.1ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in the right forearm for prophylactic vaccination on an unknown date (Underdose and Wrong product administered) instead of Tuberculosis shot (TB, not Sanofi's)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Wrong vaccine administered and Underdose (latency same day).  At the time of report, no adverse event was reported.  Nurse stated that 6 staff members were administered Adacel 0.1mL in the right forearm instead of the TB shot. The nurse asked if there are any side effects/interactions that they should be aware of and if the vaccine was valid. The nurse declined to provide any adverse event (AE) information on all 6 staff members until she could get permission from her boss and the 6 staff members to provide the AE information  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 1.42
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 17 month old patient was administered Quadracel/no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Global Medical Information (GMI) (Reference number- 00636504) and transmitted to Sanofi on 10-Jun-2021.  This case involves a 17 months old female patient who received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA, expiry date: 26-Aug-2022, (fourth dose DTAP, fourth Ipol)) via intramuscular route in the left thigh for prophylactic vaccination on 09-Jun-2021 (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  Medical assistance (MA) reported a 17 month old who was behind on vaccine schedule and was administered Quadracel. She asked for an appropriate follow-up.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: vaccines were given after a temperature excursion > 77F with no reported adverse event; refrigerator containing vaccines reached a low temp of 32.2F before thermometer was adjusted upward for 1 hour 15 minutes and reached a high temp of 91.2F for about 2 hours after thermometer was adjusted upward with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a physician via Agency (Reference number- 00636513) and transmitted to Sanofi on 10-Jun-2021 from.  This case involves a 02-months old male patient for whom it was reported that refrigerator containing vaccines reached a low temp of 32.2f before thermometer was adjusted upward for 1 hour 15 minutes and reached a high temp of 91.2f (Fahrenheit) for about 2 hours after thermometer was adjusted upward (product temperature excursion issue) and vaccines were given after a temperature excursion > 77f (off label use), while she received DIPHTHERIA/TETANUS/2 AC PERT/IPV/HIB/HEP B (HANSENULA) VACCINE [HEXYON], ROTAVIRUS VACCINE LIVE ORAL 1V [ROTARIX] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVENAR 13].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6874AB and expiration date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 31-Mar-2021, the patient developed a non-serious. refrigerator containing vaccines reached a low temp of 32.2f before thermometer was adjusted upward for 1 hour 15 minutes and reached a high temp of 91.2f for about 2 hours after thermometer was adjusted upward (product temperature excursion issue), (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On an unknown date, the patient developed a non-serious, vaccines were given after a temperature excursion > 77f (off label use), (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired ADACEL with no adverse event; Initial information regarding an unsolicited valid non-serious case from a pharmacist via Medical Information (Reference number- 00638033) and transmitted to Sanofi on 11-Jun-2021.  This case involves a 49-year old male patient who received an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] On 11-Jun-2021 [lot number: U6214AA and expiration date: 14-Mar-2021] via intramuscular route in the left arm for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.