chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Confusional state, Delirium, Dizziness, Feeling abnormal
Clinical narrative: NOT FEELING RIGHT; HIGH BLOOD PRESSURE; DIZZINESS,  LIGHTHEADEDNESS; MILD CONFUSION; SEVERE MIGRAINE, HEADACHE; HEART POUNDING; NOT FEELING WELL; DELIRIOUS; This spontaneous report received from a patient concerned a 42 year old female of an unspecified ethnic origin. The patient's weight was 173 pounds, and height was 67 inches. The patient's past medical history included: car accident, and concurrent conditions included: traumatic brain injury approximately 2 years due to the car accident, non smoker, and non alcohol user. The patient had no prior cardiac history and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered at right deltoid on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, Since she had taken vaccination the patient experienced not feeling well ( for 3 weeks now), on the same day she experienced light headedness and it kept getting worst with other developing symptoms included dizziness, mild confusion, severe migraine, headache, delirious and heart pounding. On 25-AUG-2021, the patient experienced episode of high blood pressure (1.5 days after the vaccination). It was also reported that she was driving and she was not feeling well, an ambulance was called and took blood pressure which read 176/100 mmHg. On 13-SEP-2021, she experienced that she was not feeling well and her customer, who was a nurse, took her blood pressure and read 165/92 mmHg at 14:00. During her physical therapy session at 18:00, she mentioned that she was not feeling right, and her blood pressure read 165/100 mmHg. On 14-Sep-2021, patient also reported that she was having her first appointment with her primary health care provider (PHCP) regarding this concern. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, dizziness, lightheadedness, mild confusion, severe migraine, headache, delirious, heart pounding, not feeling well, and not feeling right. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210926256-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  delirious -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).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Malaise, Migraine, Palpitations
Clinical narrative: NOT FEELING RIGHT; HIGH BLOOD PRESSURE; DIZZINESS,  LIGHTHEADEDNESS; MILD CONFUSION; SEVERE MIGRAINE, HEADACHE; HEART POUNDING; NOT FEELING WELL; DELIRIOUS; This spontaneous report received from a patient concerned a 42 year old female of an unspecified ethnic origin. The patient's weight was 173 pounds, and height was 67 inches. The patient's past medical history included: car accident, and concurrent conditions included: traumatic brain injury approximately 2 years due to the car accident, non smoker, and non alcohol user. The patient had no prior cardiac history and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered at right deltoid on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, Since she had taken vaccination the patient experienced not feeling well ( for 3 weeks now), on the same day she experienced light headedness and it kept getting worst with other developing symptoms included dizziness, mild confusion, severe migraine, headache, delirious and heart pounding. On 25-AUG-2021, the patient experienced episode of high blood pressure (1.5 days after the vaccination). It was also reported that she was driving and she was not feeling well, an ambulance was called and took blood pressure which read 176/100 mmHg. On 13-SEP-2021, she experienced that she was not feeling well and her customer, who was a nurse, took her blood pressure and read 165/92 mmHg at 14:00. During her physical therapy session at 18:00, she mentioned that she was not feeling right, and her blood pressure read 165/100 mmHg. On 14-Sep-2021, patient also reported that she was having her first appointment with her primary health care provider (PHCP) regarding this concern. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, dizziness, lightheadedness, mild confusion, severe migraine, headache, delirious, heart pounding, not feeling well, and not feeling right. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210926256-JANSSEN COVID-19 VACCINE Ad26.COV2.S-  delirious -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: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected Covid-19 infection and suspected clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. 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: 90000193347; Sender's Comments: V0:20210926597-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
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Glomerular filtration rate, Medication error, Protein urine, SARS-CoV-2 antibody test
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; MEDICATION ERROR; This spontaneous report was received from literature. This report concerned an 80 year old female of unspecified ethnicity. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: Microscopic polyangiitis phenotype and and ANCA (anti-neutrophil cytoplasmic antibody) vasculitis. The patient was previously (5 month before vaccine first dose) treated with rituximab and steroids for microscopic polyangiitis. The patient had no previous COVID-19 infection or did not required dialysis during periods of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Moderna covid-19 vaccine (mRNA) for prophylactic vaccination. On an unspecified date, the patient experienced confirmed immunological vaccine failure and medication error. Laboratory data (dates unspecified) included: Estimated GFR (Glomerular filtration rate) at the time of booster dose of vaccine was 34 mL/min/(1.73 x m2), Proteinuria was 304 mg, ANCA (titer myeloperoxidase) was less than 9 u/ml, SARS-CoV-2 IgG antibody test was less than 12 AU (arbitrary units) and CD19 count less than 20 cell/ml. Immunoglobulin G antibodies to spike protein S1 subunit of on SARS-CoV-2 were measured using ELISA (Enzyme-linked immunosorbent assay) at least one month post completion of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and medication error was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case associated with product quality complaint.; Sender's Comments: V0 20210927182- COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; MEDICATION ERROR; This spontaneous report was received from literature. This report concerned an 80 year old female of unspecified ethnicity. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: Microscopic polyangiitis phenotype and and ANCA (anti-neutrophil cytoplasmic antibody) vasculitis. The patient was previously (5 month before vaccine first dose) treated with rituximab and steroids for microscopic polyangiitis. The patient had no previous COVID-19 infection or did not required dialysis during periods of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Moderna covid-19 vaccine (mRNA) for prophylactic vaccination. On an unspecified date, the patient experienced confirmed immunological vaccine failure and medication error. Laboratory data (dates unspecified) included: Estimated GFR (Glomerular filtration rate) at the time of booster dose of vaccine was 34 mL/min/(1.73 x m2), Proteinuria was 304 mg, ANCA (titer myeloperoxidase) was less than 9 u/ml, SARS-CoV-2 IgG antibody test was less than 12 AU (arbitrary units) and CD19 count less than 20 cell/ml. Immunoglobulin G antibodies to spike protein S1 subunit of on SARS-CoV-2 were measured using ELISA (Enzyme-linked immunosorbent assay) at least one month post completion of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and medication error was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case associated with product quality complaint.; Sender's Comments: V0 20210927182- COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fear, Paralysis
Clinical narrative: FULL BODY PARALYSIS; IT WAS FRIGHTENING; This spontaneous report received from a patient concerned a 64 year old male of unspecified ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: nonsmoker, and non-alcohol user, and other pre-existing medical conditions included: The patient had no known allergies, no history of drug abuse or illicit drug usage. The patient was pretty healthy and was not on medicine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: unknown) dose was not reported, 1 total administered on 31-AUG-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 14-SEP-2021 in night, patient reported that he believed he had stroke, he was sitting down listening to music when his body stopped responding, mostly right arm was totally not responsive but did not affect heart, lungs or brain. He had this episode which did not last that long, only lasted a minute but it was frightening. According to patient after 30-40 second he began to have some animation on his right hand, he was able to take off his shirt to help cool off and eventually everything turned back to normal. He took acetylsalicylic acid (Aspirin) as it would eliminate or minimized "long term side" (sic) and did not seek medical attention as it was only lasted a few seconds and they were most likely going to give him aspirin anyways. The patient said he thought it was probably something autonomic in the cerebellum, might a bit like sleep paralysis and later stated he thought it was probably the vaccine as he had not done anything different. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from full body paralysis, and it was frightening on 14-SEP-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210929008-COVID-19 VACCINE Ad26.COV2.S-Full Body Paralysis. This event is considered un-assessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS REPORTED IN MEDIA; This spontaneous report received from a consumer via social media concerned multiple female patients of unspecified age, race, and ethnicity. 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 administration not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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, blood clots were experienced by some female patients as reported in the media. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots reported in media was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210928678, 20210928799 and 20210929648.; Sender's Comments: V0- 20210929077-Covid-19 vaccine ad26.cov2.s- Blood clots reported in media. 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).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcohol user, and non-smoker. The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-SEP-2021, the patient underwent COV 19 IGG AB test (SARS-COV-2 IGG antibody test) which showed IgG antibody 0.1 non-reactive and COV 19 IGM AB test (SARS-COV-2 IGM antibody test) which showed IgM antibody0.2 non-reactive (confirmed immunological vaccine failure was not reported). On 14-SEP-2021, the patient underwent COVID 19 AB test (COVID-19 antibody test) and result was not reported. The patient described tests as blood tests. The patient reported that, according to the doctor test results showed that he did not have antibodies against COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210929231-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Neuralgia, Pain
Clinical narrative: PAIN IN WHOLE BODY; NERVE PAIN IN JOINTS; COULD NOT GET OUT OF BED; CHRONIC, SEVERE JOINT PAIN(SHOULDERS, HIPS, AND KNEES); This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient had received 3 rounds of steroids. On 01-SEP-2021, patient tested negative for rheumatoid arthritis, lyme disease, and west nile. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced pain in whole body. On MAR-2021, the patient experienced nerve pain in joints. On MAR-2021, the patient experienced could not get out of bed. On MAR-2021, the patient experienced chronic, severe joint pain (shoulders, hips, and knees). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from chronic, severe joint pain(shoulders, hips, and knees), pain in whole body, nerve pain in joints, and could not get out of bed. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Renal function test, Renal impairment
Clinical narrative: KIDNEY FUNCTION ISSUES; This spontaneous report received from a patient concerned a 34 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on unspecified date of MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date of JUN-2021, the patient discovered that he had kidney function issues (not assuming it was the vaccine but he was researching to see if it might have a link with the vaccine administration). The patient had lab investigations done frequently which showed elevated kidney function rate and it continued through the summer. He tried medication, change of diet but kidney function rate was still high.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidney function issues. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210929343-covid-19 vaccine ad26.cov2.s -Kidney function issues. 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).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Malignant melanoma
Clinical narrative: MELANOMA; This spontaneous report received from a patient concerned a 57 year old male, white, not hispanic or latino. The patient's height, and weight were not reported. The patient had no known drug allergies, no previous medical conditions, and no current medication usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 15-SEP-2021, the patient was diagnosed with melanoma and the stage was not reported. The action taken with covid-19 vaccine was not applicable. The outcome of melanoma was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210929761-covid-19 vaccine-Melanoma. 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).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Taste disorder
Clinical narrative: ALTERED TASTE, TASTED EVERYTHING FISHY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAR-2021, the patient experienced chills. On 24-MAR-2021, the patient experienced fever. On 24-MAR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.8 Max. On 25-MAR-2021, the patient experienced altered taste, tasted everything fishy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from altered taste, tasted everything fishy on 26-MAR-2021, and chills, fever, and headache on 25-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEGS GIVING A LOT OF TROUBLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced legs giving a lot of trouble. The action taken with covid-19 vaccine was not applicable. The outcome of legs giving a lot of trouble was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe headache. This report was non-serious. This case, from the same reporter is linked to 20210932604.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Blood test
Clinical narrative: ALT (ALANINE AMINOTRANSFERASE) LIVER ENZYMES WERE ELEVATED HIGHER THAN NORMAL ABOUT 152-153; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure abnormal. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 07-SEP-2021) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced alt (alanine aminotransferase) liver enzymes were elevated higher than normal about 152-153. Laboratory data included: ALT increased (NR: not provided) ALT liver enzymes were elevated higher than normal about 152-153., and Blood test (NR: not provided) not reported. The action taken with covid-19 vaccine was not applicable. The outcome of alt (alanine aminotransferase) liver enzymes were elevated higher than normal about 152-153 was not reported. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: RECEIVED AN EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 32 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced received an expired vaccine. On 27-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the received an expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931982, 20210932036, 20210931844, 20210931951, 20210932240, 20210932593, 20210932567, 20210932874, 20210933129 and 20210933076.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED ON 26-AUG-2021 (VACCINE WAS EXPIRED ON 24-AUG-2021); This spontaneous report received from a health care professional concerned a 25 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced expired vaccine administered on 26-AUG-2021 (vaccine was expired on 24-AUG-2021). The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered on 26-AUG-2021 (vaccine was expired on 24-AUG-2021) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931951, 20210931982, 20210932036, 20210931810, 20210932240, 20210932593, 20210932567, 20210932874, 20210933076 and 20210933129.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORENESS ALL OF HER RIGHT ARM IMMEDIATELY AS SHE WAS GETTING THE NEEDLE/PUNCHED IN THE ARM A FEW TIMES; LITTLE HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-SEP-2021, the patient experienced soreness all of her right arm immediately as she was getting the needle/punched in the arm a few times. On 16-SEP-2021, the patient experienced little headache. The action taken with covid-19 vaccine was not applicable. The patient was recovering from little headache, and soreness all of her right arm immediately as she was getting the needle/punched in the arm a few times. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Fibromyalgia, Headache, Malaise
Clinical narrative: INFLAMMATION IN THE URINARY TRACT; NOT FEELING WELL; CONSISTENT HEADACHE; EXTREME FATIGUE; NO ENERGY; INCREASE IN INTENSITY OF FIBROMYALGIA AT ALL TRIGGER POINTS QUADRUPLED IN SIZE AND VERY PAINFUL; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, irritable bowel syndrome, insomnia, penicillin allergy, social alcohol drinker, cigarette smoker, and cyclines allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the patient experienced increase in intensity of fibromyalgia at all trigger points quadrupled in size and very painful. On 19-JUN-2021, the patient experienced not feeling well. On 19-JUN-2021, the patient experienced consistent headache. On 19-JUN-2021, the patient experienced extreme fatigue. On 19-JUN-2021, the patient experienced no energy. On an unspecified date, the patient experienced inflammation in the urinary tract. Laboratory data (dates unspecified) included: Urine analysis (NR: not provided) Came back clear. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from consistent headache, increase in intensity of fibromyalgia at all trigger points quadrupled in size and very painful, extreme fatigue, no energy, inflammation in the urinary tract, and not feeling well. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract inflammation, Urine analysis
Clinical narrative: INFLAMMATION IN THE URINARY TRACT; NOT FEELING WELL; CONSISTENT HEADACHE; EXTREME FATIGUE; NO ENERGY; INCREASE IN INTENSITY OF FIBROMYALGIA AT ALL TRIGGER POINTS QUADRUPLED IN SIZE AND VERY PAINFUL; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, irritable bowel syndrome, insomnia, penicillin allergy, social alcohol drinker, cigarette smoker, and cyclines allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the patient experienced increase in intensity of fibromyalgia at all trigger points quadrupled in size and very painful. On 19-JUN-2021, the patient experienced not feeling well. On 19-JUN-2021, the patient experienced consistent headache. On 19-JUN-2021, the patient experienced extreme fatigue. On 19-JUN-2021, the patient experienced no energy. On an unspecified date, the patient experienced inflammation in the urinary tract. Laboratory data (dates unspecified) included: Urine analysis (NR: not provided) Came back clear. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from consistent headache, increase in intensity of fibromyalgia at all trigger points quadrupled in size and very painful, extreme fatigue, no energy, inflammation in the urinary tract, and not feeling well. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness, Somnolence
Clinical narrative: SLUGGISH; SLEEPY; 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 (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 patient experienced sluggish, and sleepy. The action taken with covid-19 vaccine was not applicable. The outcome of the sluggish and sleepy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210933142.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Paraesthesia, X-ray
Clinical narrative: SEVERE PAIN IN HIS KNEE; SHARP PAIN EVENTS; PINS, NEEDLES FEELING AND TINGLING AND WEIRD SENSATION ALL OVER BODY; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced pins, needles feeling and tingling and weird sensation all over body. On 09-SEP-2021, the patient experienced sharp pain events. On an unspecified date, the patient experienced severe pain in his knee. Laboratory data (dates unspecified) included: X-ray (NR: not provided) no blood clots was reported. The action taken with covid-19 vaccine was not applicable. The patient recovered from severe pain in his knee, and the outcome of pins, needles feeling and tingling and weird sensation all over body and sharp pain events was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844 and 20210931810.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced received an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of received an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931844, 20210931810, 20210932036, 20210932593, 20210932567, 20210931951, 20210932240, 20210932874 and 20210933076.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disorientation, Pain, Pollakiuria
Clinical narrative: BODY ACHES AND PAINS; DISORIENTED AT TIMES; PEE A LOT; CHILLS THROUGH HER BODY; 103 FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) 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 body aches and pains, disoriented at times, pee a lot, chills through her body, and 103 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine was not applicable. The outcome of the 103 fever, chills through her body, body aches and pains, disoriented at times and pee a lot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES AND PAINS; DISORIENTED AT TIMES; PEE A LOT; CHILLS THROUGH HER BODY; 103 FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) 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 body aches and pains, disoriented at times, pee a lot, chills through her body, and 103 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine was not applicable. The outcome of the 103 fever, chills through her body, body aches and pains, disoriented at times and pee a lot was not reported. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED ON 27-AUG-2021 (VACCINE WAS EXPIRED ON 24-AUG-2021); This spontaneous report received from a health care professional concerned a 24 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced expired vaccine administered on 27-aug-2021 (vaccine was expired on 24-aug-2021). The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered on 27-aug-2021 (vaccine was expired on 24-aug-2021) was not reported. This report was non-serious. This case, involving the same patient is linked to 20210931844, 20210931810, 20210931982, 20210932593, 20210931951, 20210932240, 20210932567, 20210932874, 20210933076 and 20210933129.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Pain, Pyrexia
Clinical narrative: FEELING COLD AND HOT; ACHING/PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, the patient experienced feeling cold and hot. On 04-MAR-2021, the patient experienced aching/pain. On 04-MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from feeling cold and hot, aching/pain, and fever on 05-MAR-2021. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: DIZZY AT THE SAME TIME; BODY GOT HOT AND SWEATY AND GRADUALLY GOT WORSE OVERNIGHT; PROBLEM TALKING, WAS TRYING TO SAY WORDS AND COULD NOT GET THE WORDS FULLY OUT; BODY CHILLS; NAUSEOUS ALL DAY AND THREW UP A COUPLE OF TIMES LAST NIGHT; WHOLE HEAD HURT EVEN THE SLIGHTEST MOVEMENT; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included: abdominal blunt force trauma, and surgery for abdominal blunt force trauma, and concurrent conditions included: steroid allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced dizzy at the same time. On 15-SEP-2021, the patient experienced body got hot and sweaty and gradually got worse overnight. On 15-SEP-2021, the patient experienced problem talking, was trying to say words and could not get the words fully out. On 15-SEP-2021, the patient experienced body chills. On 15-SEP-2021, the patient experienced nauseous all day and threw up a couple of times last night. On 15-SEP-2021, the patient experienced whole head hurt even the slightest movement. The action taken with covid-19 vaccine was not applicable. The patient recovered from problem talking, was trying to say words and could not get the words fully out on 15-SEP-2021, and had not recovered from nauseous all day and threw up a couple of times last night, body chills, whole head hurt even the slightest movement, dizzy at the same time, and body got hot and sweaty and gradually got worse overnight. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: DIZZY AT THE SAME TIME; BODY GOT HOT AND SWEATY AND GRADUALLY GOT WORSE OVERNIGHT; PROBLEM TALKING, WAS TRYING TO SAY WORDS AND COULD NOT GET THE WORDS FULLY OUT; BODY CHILLS; NAUSEOUS ALL DAY AND THREW UP A COUPLE OF TIMES LAST NIGHT; WHOLE HEAD HURT EVEN THE SLIGHTEST MOVEMENT; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included: abdominal blunt force trauma, and surgery for abdominal blunt force trauma, and concurrent conditions included: steroid allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: UNKNOWN) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-SEP-2021, the patient experienced dizzy at the same time. On 15-SEP-2021, the patient experienced body got hot and sweaty and gradually got worse overnight. On 15-SEP-2021, the patient experienced problem talking, was trying to say words and could not get the words fully out. On 15-SEP-2021, the patient experienced body chills. On 15-SEP-2021, the patient experienced nauseous all day and threw up a couple of times last night. On 15-SEP-2021, the patient experienced whole head hurt even the slightest movement. The action taken with covid-19 vaccine was not applicable. The patient recovered from problem talking, was trying to say words and could not get the words fully out on 15-SEP-2021, and had not recovered from nauseous all day and threw up a couple of times last night, body chills, whole head hurt even the slightest movement, dizzy at the same time, and body got hot and sweaty and gradually got worse overnight. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: WORST MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-AUG-2021, the patient experienced worst muscle aches. Treatment medications (dates unspecified) included: cyclobenzaprine hydrochloride, paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from worst muscle aches. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: RECEIVED AN EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced received an expired vaccine. On 27-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the received an expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931810, 20210931844, 20210932593, 20210932036, 20210932567, 20210931951, 20210931982, 20210933076 and 20210933129.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID FOR 28 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-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 AUG-2021, the patient experienced COVID for 28 days. The action taken with COVID-19 vaccine was not applicable. The patient recovered from COVID for 28 days on AUG-2021. This report was non-serious. This report was associated with product quality complaint: 90000193650