chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Vascular pain
Clinical narrative: DIZZINESS; DEBILITATING HEAD PRESSURE; STRUGGLES TO FALL ASLEEP; TERRIBLE THROBBING HEADACHE; BURNING IN LEGS VEINS; THROBBING IN LEGS VEINS; BRUISING IN LEGS; RADIATING PAIN THROUGH HIPS; INJECTION SITE BRUISING; INJECTION SITE KNOT; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) Did not find anything abnormal, and MRI (NR: not provided) Did not find anything abnormal. On 30-MAR-2021, the subject experienced injection site bruising. On 30-MAR-2021, the subject experienced injection site knot. On 04-APR-2021, the subject experienced radiating pain through hips. On 10-APR-2021, the subject experienced bruising in legs. On 12-APR-2021, the subject experienced burning in legs veins. On 12-APR-2021, the subject experienced throbbing in legs veins. On 26-APR-2021, the subject experienced dizziness. On 26-APR-2021, the subject experienced debilitating head pressure. On 26-APR-2021, the subject experienced struggles to fall asleep. On 26-APR-2021, the subject experienced terrible throbbing headache. Treatment medications (dates unspecified) included: pseudoephedrine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 13-APR-2021, injection site knot on 31-MAR-2021, bruising in legs on 11-APR-2021, burning in legs veins, and throbbing in legs veins on 19-APR-2021, and radiating pain through hips on 08-APR-2021, was recovering from terrible throbbing headache, and had not recovered from dizziness, debilitating head pressure, and struggles to fall asleep. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accident, Contusion
Clinical narrative: DIZZINESS; DEBILITATING HEAD PRESSURE; STRUGGLES TO FALL ASLEEP; TERRIBLE THROBBING HEADACHE; BURNING IN LEGS VEINS; THROBBING IN LEGS VEINS; BRUISING IN LEGS; RADIATING PAIN THROUGH HIPS; INJECTION SITE BRUISING; INJECTION SITE KNOT; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) Did not find anything abnormal, and MRI (NR: not provided) Did not find anything abnormal. On 30-MAR-2021, the subject experienced injection site bruising. On 30-MAR-2021, the subject experienced injection site knot. On 04-APR-2021, the subject experienced radiating pain through hips. On 10-APR-2021, the subject experienced bruising in legs. On 12-APR-2021, the subject experienced burning in legs veins. On 12-APR-2021, the subject experienced throbbing in legs veins. On 26-APR-2021, the subject experienced dizziness. On 26-APR-2021, the subject experienced debilitating head pressure. On 26-APR-2021, the subject experienced struggles to fall asleep. On 26-APR-2021, the subject experienced terrible throbbing headache. Treatment medications (dates unspecified) included: pseudoephedrine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 13-APR-2021, injection site knot on 31-MAR-2021, bruising in legs on 11-APR-2021, burning in legs veins, and throbbing in legs veins on 19-APR-2021, and radiating pain through hips on 08-APR-2021, was recovering from terrible throbbing headache, and had not recovered from dizziness, debilitating head pressure, and struggles to fall asleep. This report was non-serious.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Nodule
Clinical narrative: SWELLING OF THE LEFT ELBOW; SOFT KNOT IN LEFT ELBOW; This spontaneous report received from a patient concerned an 81 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced swelling of the left elbow. On MAY-2021, the subject experienced soft knot in left elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of the left elbow and soft knot in left elbow was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: ITCHY; RASH ON BOTH LEGS, MORE ON THE LEFT AND ON BACK; BOUTS OF NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient experienced bouts of nausea. On 11-MAY-2021, the patient experienced itchy. On 11-MAY-2021, the patient experienced rash on both legs, more on the left and on back. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from rash on both legs, more on the left and on back, itchy, and bouts of nausea. This report was non-serious. This case, from the same reporter is linked to 20210521685.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, sulfa drug allergy, peanut and shell fish allergy, tree nuts allergy, mango allergy, chocolate allergy, allergic to color, allergic to flowers/ allergic to soil, allergic to horses, allergic to cats and dogs, and pecan tree allergy, and other pre-existing medical conditions included patient carries an epipen patient was tested for 48 things. The patient was previously treated with . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included azelastine for allergy, cetirizine hydrochloride for allergy, fluticasone propionate for allergy, and rosuvastatin calcium for high cholesterol. On 02-APR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheadedness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: TESTICULAR PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 testicular pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from testicular pain. This report was non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Electrocardiogram, Fatigue, Feeling cold, Heart rate increased
Clinical narrative: passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped out, Fatigue; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRAVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on). 30-Mar-2021, the patient experienced FATIGUE (Wiped out, Fatigue). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown and FATIGUE (Wiped out, Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: result not mentioned (Inconclusive) result not mentioned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included discontinuation of glipizide. Company comment: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-070319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information On 04-May-2021: Updated outcome of fatigue, added route of administration of suspect drug.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped out, Fatigue; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRAVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on). 30-Mar-2021, the patient experienced FATIGUE (Wiped out, Fatigue). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown and FATIGUE (Wiped out, Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: result not mentioned (Inconclusive) result not mentioned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included discontinuation of glipizide. Company comment: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-070319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information On 04-May-2021: Updated outcome of fatigue, added route of administration of suspect drug.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Gonarthrosis; Slept all day and night; Sick as a dog; Felt very Drained; Chills; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OSTEOARTHRITIS (Gonarthrosis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. The patient's past medical history included Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Non-tobacco user. Concomitant products included METHOTREXATE for Rheumatoid arthritis. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient experienced OSTEOARTHRITIS (Gonarthrotic) (seriousness criterion hospitalization), HYPERSOMNIA (Slept all day and night), ILLNESS (Sick as a dog), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Physical therapy (4 Physical therapy visits at home) for Osteoarthritis. At the time of the report, OSTEOARTHRITIS (Gonarthrotic), HYPERSOMNIA (Slept all day and night), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and ILLNESS (Sick as a dog) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Everything good. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had knee replacement on 10-Feb-2021.  She had to stopped Humira two week prior and two week after surgery then she went back to every two weeks dose. The Nurse was sent for first three days at home and they changed her bandages than was give four physical therapy visits at home. She said Humira helped her knee replacement. Her rheumatoid arthritis was also in control with Humira and she was able to move again and live normal life. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: patient demographics updated, medical history updated, concomitant  medications updated (Methotrexate), Humira therapy details updated, event term updated (total knee replacement to Gonarthrotic), seriousness criteria updated from non-serious to hospitalization for the event Gonarthrotic.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Osteoarthritis
Clinical narrative: Gonarthrosis; Slept all day and night; Sick as a dog; Felt very Drained; Chills; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OSTEOARTHRITIS (Gonarthrosis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. The patient's past medical history included Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Non-tobacco user. Concomitant products included METHOTREXATE for Rheumatoid arthritis. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient experienced OSTEOARTHRITIS (Gonarthrotic) (seriousness criterion hospitalization), HYPERSOMNIA (Slept all day and night), ILLNESS (Sick as a dog), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Physical therapy (4 Physical therapy visits at home) for Osteoarthritis. At the time of the report, OSTEOARTHRITIS (Gonarthrotic), HYPERSOMNIA (Slept all day and night), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and ILLNESS (Sick as a dog) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Everything good. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had knee replacement on 10-Feb-2021.  She had to stopped Humira two week prior and two week after surgery then she went back to every two weeks dose. The Nurse was sent for first three days at home and they changed her bandages than was give four physical therapy visits at home. She said Humira helped her knee replacement. Her rheumatoid arthritis was also in control with Humira and she was able to move again and live normal life. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: patient demographics updated, medical history updated, concomitant  medications updated (Methotrexate), Humira therapy details updated, event term updated (total knee replacement to Gonarthrotic), seriousness criteria updated from non-serious to hospitalization for the event Gonarthrotic.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Autonomic neuropathy, Gait disturbance, Head discomfort, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Day 50 and has not received second injection; Autonomic nervous system symptoms; Neurological pain in her legs making it difficult to walk; Unexplained, rapid heart rate; Pressure in her head; Ringing in her ears; Paresthesia in her tongue and throat; Paresthesia in her tongue and throat; Neurological pain all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) in a 36-year-old female patient who received mRNA-1273 (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) (seriousness criterion medically significant), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection). At the time of the report, AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       It was reported the patient has been to the emergency room 4 times and had a whole laundry list of tests and labs. Nothing has been successful. The symptoms began within the first 5 minutes after vaccination and had progressively gotten worse. She denies pregnancy.  Company comment: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Paraesthesia oral, Pharyngeal paraesthesia, Tinnitus
Clinical narrative: Day 50 and has not received second injection; Autonomic nervous system symptoms; Neurological pain in her legs making it difficult to walk; Unexplained, rapid heart rate; Pressure in her head; Ringing in her ears; Paresthesia in her tongue and throat; Paresthesia in her tongue and throat; Neurological pain all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) in a 36-year-old female patient who received mRNA-1273 (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) (seriousness criterion medically significant), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection). At the time of the report, AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       It was reported the patient has been to the emergency room 4 times and had a whole laundry list of tests and labs. Nothing has been successful. The symptoms began within the first 5 minutes after vaccination and had progressively gotten worse. She denies pregnancy.  Company comment: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pneumonia
Clinical narrative: headache; muscle aches and pains; pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) and MYALGIA (muscle aches and pains). On 01-May-2021, PNEUMONIA (pneumonia) had resolved. At the time of the report, HEADACHE (headache) and MYALGIA (muscle aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included IV (which may had antibiotics), doxycycline and its dose lasted till Wednesday last week (28Apr2021). Patient was not taking any other medications.  It was reported that on 14 Apr 2021, the patient had taken 1st dose of Moderna COVID-19 vaccine (Lot number 011M20A) in the right upper arm and 6 hours later patient was sick and had chills, fever. On 18 Apr 2021, the patient went to urgent care and diagnosed with pneumonia. On 01 May 2021 the event Pneumonia was resolved (Duration 14 days).  Patient was scheduled to get 2nd dose of vaccine on 12-May-2021.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Hip arthroplasty, Rash
Clinical narrative: Rash around neck; fatigue; hip replacement; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a physician and describes the occurrence of HIP ARTHROPLASTY (hip replacement) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 05-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2020, the patient experienced HIP ARTHROPLASTY (hip replacement) (seriousness criterion medically significant) and FATIGUE (fatigue). On an unknown date, the patient experienced RASH (Rash around neck). At the time of the report, HIP ARTHROPLASTY (hip replacement) had resolved and RASH (Rash around neck) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient was taking Humira medication but stopped in 2022 and restarted on 05-JAN-2021. No treatment information was provided.   there is no reasonable possibility that the events of hip replacement surgery, after First dose of covid vaccine developed rash around neck and after second dose of covid vaccine patient was fatigue are related to humira (adalimumab); Sender's Comments: Based on reporter's causality the hip replacement event is assessed as unlikely related to mRNA-1273, while fatigue and rash events are possibly related to mRNA-1273.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Head discomfort, Mental impairment, Visual impairment
Clinical narrative: Mild Brain pause; Unable to think clearly; Vision Problem; Pressure in her head; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Mild Brain pause) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical report provided by the reporter.  Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL for Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (Mild Brain pause) (seriousness criterion medically significant), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head). At the time of the report, MENTAL IMPAIRMENT (Mild Brain pause), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. The rechallenge was positive.   This case was linked to MOD-2021-114463 (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.
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash; Initial information regarding an unsolicited valid non-serious case was received from the Physician via Medical Information (Reference number- 00577192) and transmitted to Sanofi on 26-Apr-2021.  This case involves a  male patient (demographics not reported) who had rash while after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 08-May-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5654AA; expiry date: 27-Apr-2019) via unknown route in unknown administration site for prophylactic vaccination.  On 08-MAY-2018 the patient developed a non-serious rash on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  The reporter stated, the patient has had a rash ever since he received the vaccine and believed it may have been caused by the vaccine. The reporter wanted to know if there are any known issues with this vaccine.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the event was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiparesis
Clinical narrative: Patient woke up with right upper and lower extremity weakness on 4/27/2021. She did not go to the ER. I suspect stroke and have ordered CT brain.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cold sweat, Dyspnoea, Ear discomfort, Hyperhidrosis
Clinical narrative: SOB, ears clogged and sweaty.  Customer c/o sob, clammy skin.  Customer also c/ that her ears felt plugged for a second.  EMS and Nurse onsite responded..  B/P 160/80, HR 66.  On 96 cust stated she was fine, just had some anxiety. 1st dose.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury
Clinical narrative: N17.9 - Acute kidney failure, unspecified
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Tinnitus
Clinical narrative: Tinnitus started approximately 4 hours after receiving my first dose of the Pfizer COVID 19 vaccine.  Other symptoms include dizziness, fatigue, difficulty concentrating at times.  The tinnitus has been constant.  I saw my PCP, an ENT specialist, and an Audiologist.   There is no treatment for the tinnitus and it may be permanent.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Blood osmolarity decreased, Hyponatraemia
Clinical narrative: N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Productive cough, Rhinorrhoea
Clinical narrative: Sudden onset of sore throat coughing runny nose coughing up phlegm
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: N17.9 - Acute kidney failure, unspecified
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood osmolarity decreased, Hyponatraemia
Clinical narrative: E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: HE COMPLAINED OF CHEST PAIN. ON SITE EMS RESPONDED. VITALS LISTED BELOW. THE NON CARDIAC PAIN SUBSIDED AND HE WAS RELEASED TO HOME
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Lymph node pain
Clinical narrative: Lymph node Tenderness in armpit, chills
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary normal, Full blood count normal, Peripheral swelling, Pulmonary embolism
Clinical narrative: Saddle pulmonary embolus diagnosed 5/12/21 with unilateral leg swelling starting over one month prior.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Myalgia, Neuralgia, Pain
Clinical narrative: Minor symptoms immediately after vaccinations, including vertigo at first vaccine and brown out on second. Pain developed over a few hours, including a bad headache after first vaccine. In four days this moved to fairly severe whole body muscular and nerve pain. Had second vaccination 4/17/2021, lot number ER8731. Pain still persisting almost a month later. Myalgia?
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Minor symptoms immediately after vaccinations, including vertigo at first vaccine and brown out on second. Pain developed over a few hours, including a bad headache after first vaccine. In four days this moved to fairly severe whole body muscular and nerve pain. Had second vaccination 4/17/2021, lot number ER8731. Pain still persisting almost a month later. Myalgia?
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury
Clinical narrative: N17.9 - Acute kidney failure, unspecified
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Facial paresis
Clinical narrative: N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Non adverse events listed but tested positive for COVID-19 on 4/6/21
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Confusional state, Cough, Dizziness, Dyspnoea
Clinical narrative: -immediate headache 5 min post vaccination -dizziness 10 min post -fogginess and confusion 45 min post -increased mucus 1 hour post -flu-like symptoms in evening  (lasted 48 hours) -throat/trachea inflammation 10:00pm with wheezing, felt like throat closing and asthma attack (relieved w essential oil to open airways).   (lasted 48 hours) -woke up with swollen lips  & eyes and inflammation in tonsils & trachea, coughing, coughing up black mucus, felt like asthma attack and migraine, can?t take deep breath  (lasted 48 hours) -9:00am took 2 Advil -coughing & flu like symptoms continued -swollen tonsils & closing trachea as if having an asthma attack -enlarged lymph nodes (and above left clavicle) one week post vaccine (lasted almost 2 weeks)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Feeling abnormal, Headache, Influenza like illness, Lip swelling
Clinical narrative: -immediate headache 5 min post vaccination -dizziness 10 min post -fogginess and confusion 45 min post -increased mucus 1 hour post -flu-like symptoms in evening  (lasted 48 hours) -throat/trachea inflammation 10:00pm with wheezing, felt like throat closing and asthma attack (relieved w essential oil to open airways).   (lasted 48 hours) -woke up with swollen lips  & eyes and inflammation in tonsils & trachea, coughing, coughing up black mucus, felt like asthma attack and migraine, can?t take deep breath  (lasted 48 hours) -9:00am took 2 Advil -coughing & flu like symptoms continued -swollen tonsils & closing trachea as if having an asthma attack -enlarged lymph nodes (and above left clavicle) one week post vaccine (lasted almost 2 weeks)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pharyngeal swelling, Productive cough, Tonsillar hypertrophy, Wheezing
Clinical narrative: -immediate headache 5 min post vaccination -dizziness 10 min post -fogginess and confusion 45 min post -increased mucus 1 hour post -flu-like symptoms in evening  (lasted 48 hours) -throat/trachea inflammation 10:00pm with wheezing, felt like throat closing and asthma attack (relieved w essential oil to open airways).   (lasted 48 hours) -woke up with swollen lips  & eyes and inflammation in tonsils & trachea, coughing, coughing up black mucus, felt like asthma attack and migraine, can?t take deep breath  (lasted 48 hours) -9:00am took 2 Advil -coughing & flu like symptoms continued -swollen tonsils & closing trachea as if having an asthma attack -enlarged lymph nodes (and above left clavicle) one week post vaccine (lasted almost 2 weeks)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute myocardial infarction
Clinical narrative: I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe ringing in both ears. I have not sought treatment.  The ringing is a constant high pitch ring and throughout the day as the ringing gets worse it will also throb to the pace of my pulse.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Medium, Additional Details: Pt had fever for two days and bruise at injection site for two weeks.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute myocardial infarction
Clinical narrative: I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute renal injury (CMS/HCC)
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Blood osmolarity decreased, Hyponatraemia
Clinical narrative: E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: No adverse events listed - tested positive for COVID-19 on 4/16/21  04/16/21 1654  COVID-19 (SARS CoV-2,RNA Molecular Amplification)  Collected: 04/16/21 0818 | Final result | Specimen: Swab from Nares   COVID-19 SARS-CoV-2 Overall Result DetectedCritical
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Nervousness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient received vaccine. Had not eaten anything that day prior to vaccination. Said he felt tired and closed his eyes for a minute but lost control of his bladder. Seemed shaky and sweaty. Blood pressure taken was low 90/50 initially at 222pm. Gave patient water and a protein bar. Blood pressure at 238pm 109/72. Blood pressure at 253pm 119/86. Seemed much improved after 30 minutes.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient received vaccine. Had not eaten anything that day prior to vaccination. Said he felt tired and closed his eyes for a minute but lost control of his bladder. Seemed shaky and sweaty. Blood pressure taken was low 90/50 initially at 222pm. Gave patient water and a protein bar. Blood pressure at 238pm 109/72. Blood pressure at 253pm 119/86. Seemed much improved after 30 minutes.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Muscular weakness, Walking aid user
Clinical narrative: Extreme muscle weakness especially in the legs, mainly quads. Need to use walker to stand and once, standing it's difficult to hold and upright position. This is mostly evident after raising from a sitting position.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Decreased appetite, Fatigue, Lip discolouration
Clinical narrative: Received vaccine at 0930 and was dismissed from waiting area at 0946 with no symptoms or reactions.  My husband and I stopped to do some errands on way home (car wash and store). We returned home  at 11:30 AM when I experienced pruritis and fatigue.  I looked at chest and abdomen and noted  reddened rash. My husband also noted rash on my back.  I went to sleep for 2 hours after taking a 25  mg. diphenhydramine tablet. When I awoke my husband confirmed I had urticaria all over the trunk of  my body and extending to my knees, elbows and chin line.l had severe pruritis with this We had family  arriving for a visit that evening (4/23), so I continued taking diphenhydramine 25mg and alternating  with Hydroxyzine 25 mg. for
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Mental disorder, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: Received vaccine at 0930 and was dismissed from waiting area at 0946 with no symptoms or reactions.  My husband and I stopped to do some errands on way home (car wash and store). We returned home  at 11:30 AM when I experienced pruritis and fatigue.  I looked at chest and abdomen and noted  reddened rash. My husband also noted rash on my back.  I went to sleep for 2 hours after taking a 25  mg. diphenhydramine tablet. When I awoke my husband confirmed I had urticaria all over the trunk of  my body and extending to my knees, elbows and chin line.l had severe pruritis with this We had family  arriving for a visit that evening (4/23), so I continued taking diphenhydramine 25mg and alternating  with Hydroxyzine 25 mg. for
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Throat tightness, Urticaria, Weight decreased
Clinical narrative: Received vaccine at 0930 and was dismissed from waiting area at 0946 with no symptoms or reactions.  My husband and I stopped to do some errands on way home (car wash and store). We returned home  at 11:30 AM when I experienced pruritis and fatigue.  I looked at chest and abdomen and noted  reddened rash. My husband also noted rash on my back.  I went to sleep for 2 hours after taking a 25  mg. diphenhydramine tablet. When I awoke my husband confirmed I had urticaria all over the trunk of  my body and extending to my knees, elbows and chin line.l had severe pruritis with this We had family  arriving for a visit that evening (4/23), so I continued taking diphenhydramine 25mg and alternating  with Hydroxyzine 25 mg. for
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache nagging at the start, then severe and then lessened and lingering nagging headache.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: Severe arm/ injection sight pain, dizziness, fatigue, nausea, chills, and body aches. The first wave came on around 11:00am and lasted until 2:00pm when they began to resolve. Then a second wave began around 5:00pm and didn?t fully resolve until 4:00pm the following day 5/12/2021
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe arm/ injection sight pain, dizziness, fatigue, nausea, chills, and body aches. The first wave came on around 11:00am and lasted until 2:00pm when they began to resolve. Then a second wave began around 5:00pm and didn?t fully resolve until 4:00pm the following day 5/12/2021
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest X-ray, Chills, Cough, Diarrhoea
Clinical narrative: Cough, shortness of breath fatigue, headaches, congestion or runny nose, lightheaded and sore throat, chills, fever, sinus pressure, sinus pain, diarrhea and nausea, back pain and myalgias