chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: LARGE KNOT ABOUT 1/2 TO 1 INCH SURROUNDING THE INJECTION SITE; SEVERE/ BAD FLU-LIKE SYMPTOMS; PAINFULLY SORE AT THE INJECTION SITE/ TENDER ENOUGH; EXTREMELY SWOLLEN (INJECTION SITE); 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-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced large knot about 1/2 to 1 inch surrounding the injection site. On 13-MAY-2021, the subject experienced severe/ bad flu-like symptoms. On 13-MAY-2021, the subject experienced painfully sore at the injection site/ tender enough. On 13-MAY-2021, the subject experienced extremely swollen (injection site). The action taken with covid-19 vaccine was not applicable. The patient was recovering from severe/ bad flu-like symptoms, and had not recovered from painfully sore at the injection site/ tender enough, extremely swollen (injection site), and large knot about 1/2 to 1 inch surrounding the injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: ADMINISTRATION OF SECOND DOSE OF VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced administration of second dose of vaccine, and off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the administration of second dose of vaccine and off label use was not reported. This report was non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWOLLEN LEFT LEG, NO PAIN, NOTHING ELSE JUST BIG, REAL TIGHT, FELLS HARD, NOT HOT TO TOUCH; This spontaneous report received from a patient concerned a 76 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: 204azia, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swollen left leg, no pain, nothing else just big, real tight, fells hard, not hot to touch. The action taken with covid-19 vaccine  was not applicable. The outcome of swollen left leg, no pain, nothing else just big, real tight, fells hard, not hot to touch was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PEDIATRIC 16 YEAR OLD PATIENT RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 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 pediatric 16 year old subject received vaccine, and off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the pediatric 16 year old patient received vaccine and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: EQUILIBRIUM TROUBLE; DIZZINESS; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's past medical history included hot flashes, and previous dizziness., and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808609, and batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced dizziness. On an unspecified date, the subject experienced equilibrium trouble. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dizziness, and the outcome of equilibrium trouble was not reported. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain
Clinical narrative: HEADACHE; TIREDNESS; INJECTION SITE PAIN; This spontaneous report received from a patient via a company representative concerned a 27 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 204A21A) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, tiredness, and injection site pain. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache, tiredness and injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dizziness, Muscle spasms
Clinical narrative: LEG CRAMPS; STOMACH PAIN; ALMOST FAINTED AT WORK; 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: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced leg cramps. On MAY-2021, the subject experienced stomach pain. On MAY-2021, the subject experienced almost fainted at work. The action taken with covid-19 vaccine was not applicable. The outcome of the leg cramps, stomach pain and almost fainted at work was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Thrombosis
Clinical narrative: LEG CRAMPS; STOMACH PAIN; ALMOST FAINTED AT WORK; 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: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced leg cramps. On MAY-2021, the subject experienced stomach pain. On MAY-2021, the subject experienced almost fainted at work. The action taken with covid-19 vaccine was not applicable. The outcome of the leg cramps, stomach pain and almost fainted at work was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Malaise, Pyrexia
Clinical narrative: FEELING UNDER THE WEATHER; FEVER; COULDN'T FALL ASLEEP AND DIDN'T REST VERY WELL; This spontaneous report received from a patient concerned a 54 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: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced couldn't fall asleep and didn't rest very well. On 26-MAY-2021, the subject experienced feeling under the weather. On 26-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 degrees Fahrenheit. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from couldn't fall asleep and didn't rest very well, fever, and feeling under the weather. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Electric shock sensation, Feeling hot, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE (138/96 MMHG); FACIAL NUMBNESS; ELECTRIC SHOCK LIKE PAIN BEHIND BOTH EARS IN BRAIN; HEAT UP NECK; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included arm numbness, and concurrent conditions included penicillin allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no prior diagnosis of high blood pressure. The patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of vaccination. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced facial numbness. On 10-APR-2021, the subject experienced electric shock like pain behind both ears in brain. On 10-APR-2021, the subject experienced heat up neck. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 138/96 mmHg. On 12-MAY-2021, the subject experienced high blood pressure (138/96 mmHg). Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The patient was recovering from facial numbness, electric shock like pain behind both ears in brain, and heat up neck, and had not recovered from high blood pressure (138/96 mmHg). This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: HIGH BLOOD PRESSURE (138/96 MMHG); FACIAL NUMBNESS; ELECTRIC SHOCK LIKE PAIN BEHIND BOTH EARS IN BRAIN; HEAT UP NECK; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included arm numbness, and concurrent conditions included penicillin allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no prior diagnosis of high blood pressure. The patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of vaccination. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced facial numbness. On 10-APR-2021, the subject experienced electric shock like pain behind both ears in brain. On 10-APR-2021, the subject experienced heat up neck. On MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 138/96 mmHg. On 12-MAY-2021, the subject experienced high blood pressure (138/96 mmHg). Laboratory data (dates unspecified) included: CT scan (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The patient was recovering from facial numbness, electric shock like pain behind both ears in brain, and heat up neck, and had not recovered from high blood pressure (138/96 mmHg). This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Arthralgia, Body temperature, Gait inability, Headache
Clinical narrative: PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT  KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Muscular weakness, Night sweats, Oropharyngeal pain, Peripheral swelling
Clinical narrative: PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT  KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, SARS-CoV-2 test negative, Urinary tract infection
Clinical narrative: PAIN IN JOINTS; WEAKNESS IN ARMS; BUMPY RASH; SWELLING IN LEFT FOOT AND RIGHT FOOT; ITCHINESS THROUGHOUT BODY; SWELLING OF LEFT AND RIGHT  KNEE; FLUCTUATING FEVER; NIGHT SWEATS; HEADACHE; SORE THROAT; UNABLE TO WALK; BREAKOUT ON BACK OF HEAD; This spontaneous report received from a consumer concerned a 53 year old male. The patient's weight was 90.71 kilograms, and height was 179.832 centimeters. The patient's pre-existing medical conditions included the patient had no coughing, no nasal conjunction and no upper respiratory symptoms. The patient experienced drug allergy when treated with morphine, and sickness when treated with Demerol (pethidine hydrochloride). The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cetirizine hydrochloride. On MAY-2021, the subject experienced breakout on back of head. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced unable to walk. On 21-MAY-2021, the subject experienced night sweats. On 21-MAY-2021, the subject experienced headache. On 23-MAY-2021, the subject experienced swelling in left foot and right foot. On 23-MAY-2021, the subject experienced itchiness throughout body. On 23-MAY-2021, the subject experienced swelling of left and right knee. On 23-MAY-2021, the subject experienced bumpy rash. On 23-MAY-2021, the subject experienced fluctuating fever. Laboratory data included: Body temperature (NR: not provided) 97F to 101 F. On 24-MAY-2021, the subject experienced pain in joints. On 24-MAY-2021, the subject experienced weakness in arms. On 25-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative, and Recurrent urinary tract infection (NR: not provided) Negative. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, ibuprofen, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from swelling in left foot and right foot, itchiness throughout body, fluctuating fever, and bumpy rash, and the outcome of headache, night sweats, weakness in arms, pain in joints, swelling of left and right knee, sore throat, unable to walk and breakout on back of head was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORED AT INAPPROPRIATE STORAGE CONDITION; VACCINE SYRINGES WERE DRAWN AT AN UNKNOWN TIME AND WERE ADMINISTERED; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced product stored at inappropriate storage condition. On 26-MAY-2021, the subject experienced vaccine syringes were drawn at an unknown time and were administered. The action taken with covid-19 vaccine was not applicable. The outcome of the product stored at inappropriate storage condition and vaccine syringes were drawn at an unknown time and were administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Muscular weakness
Clinical narrative: ELEVATED CREATINE KINASE LEVEL; MUSCLE WEAKNESS; This spontaneous report received from a patient concerned a 42 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: 1802072 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for pain. On 21-MAR-2021, the subject experienced muscle weakness. On 24-MAY-2021, Laboratory data included: Creatine kinase high (NR: not provided) 210. On an unspecified date, the subject experienced elevated creatine kinase level. Laboratory data (dates unspecified) included: Creatine kinase high (NR: not provided) 150 or so, 160. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, and elevated creatine kinase level. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pyrexia, Tachycardia, Urticaria
Clinical narrative: Hypotension; Few episodes of hives each day/full body hives; Tachycardia; Low grade fever; This spontaneous case was reported by a nurse and describes the occurrence of HYPOTENSION (Hypotension) in a 32-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 History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (Hypotension) (seriousness criterion medically significant), URTICARIA (Few episodes of hives each day/full body hives), TACHYCARDIA (Tachycardia) and PYREXIA (Low grade fever). At the time of the report, HYPOTENSION (Hypotension), URTICARIA (Few episodes of hives each day/full body hives), TACHYCARDIA (Tachycardia) and PYREXIA (Low grade fever) had not resolved.        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.   Concomitant product use was not provided by the reporter. About 10 days after  injection, the patient began experiencing a few episodes of hives each day for 3 days. On day 4, she had full body hives with hypotension, tachycardia, and low-grade fever. It continued for the next 3 days. She had a couple days of getting better, then it got worse. Treatment for the event included IV fluid and steroid.  Company Comment: 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.; Sender's Comments: 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Diarrhoea, Diverticulitis, Erythema, Pyrexia
Clinical narrative: swelling; irritating; redness; fever; Diverticulitis attack; Diarrhea; Pain in lower abdomen on both sides; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis attack) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DIVERTICULITIS (Diverticulitis attack) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN LOWER (Pain in lower abdomen on both sides). On an unknown date, the patient experienced SWELLING (swelling), VACCINATION SITE IRRITATION (irritating), ERYTHEMA (redness) and PYREXIA (fever). At the time of the report, DIVERTICULITIS (Diverticulitis attack), SWELLING (swelling), VACCINATION SITE IRRITATION (irritating), ERYTHEMA (redness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN LOWER (Pain in lower abdomen on both sides) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was tested via CT scan and diagnosis of diverticulitis was made.  As treatment, the patient was put on antibiotics by her doctor and she was expected to have more tests done as well.  No concomitant medications were reported.  Company comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: significant follow: Additional events, treatment, Vaccine start date, lot number added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site irritation
Clinical narrative: swelling; irritating; redness; fever; Diverticulitis attack; Diarrhea; Pain in lower abdomen on both sides; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis attack) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DIVERTICULITIS (Diverticulitis attack) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and ABDOMINAL PAIN LOWER (Pain in lower abdomen on both sides). On an unknown date, the patient experienced SWELLING (swelling), VACCINATION SITE IRRITATION (irritating), ERYTHEMA (redness) and PYREXIA (fever). At the time of the report, DIVERTICULITIS (Diverticulitis attack), SWELLING (swelling), VACCINATION SITE IRRITATION (irritating), ERYTHEMA (redness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN LOWER (Pain in lower abdomen on both sides) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was tested via CT scan and diagnosis of diverticulitis was made.  As treatment, the patient was put on antibiotics by her doctor and she was expected to have more tests done as well.  No concomitant medications were reported.  Company comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: significant follow: Additional events, treatment, Vaccine start date, lot number added.; 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Limb discomfort, Muscle rupture, Musculoskeletal discomfort
Clinical narrative: Torn muscles; pain in the arm, elbows; discomfort in the legs, arm and hand; discomfort in the shoulders; Significant pain; Underarm seems to hurt; shoulder muscle pain; knees pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RUPTURE (Torn muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Torn muscle (Shoulder muscle tear). Concurrent medical conditions included Arthritis, Knee pain (Patient is experiencing knee pain due to Arthritis) and Muscle pain (Shoulder muscle pain).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced ARTHRALGIA (knees pain) and MYALGIA (shoulder muscle pain). On an unknown date, the patient experienced MUSCLE RUPTURE (Torn muscles) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in the arm, elbows), LIMB DISCOMFORT (discomfort in the legs, arm and hand), MUSCULOSKELETAL DISCOMFORT (discomfort in the shoulders), PAIN (Significant pain) and AXILLARY PAIN (Underarm seems to hurt). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ACTIV) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCLE RUPTURE (Torn muscles), PAIN IN EXTREMITY (pain in the arm, elbows), LIMB DISCOMFORT (discomfort in the legs, arm and hand), MUSCULOSKELETAL DISCOMFORT (discomfort in the shoulders), PAIN (Significant pain), ARTHRALGIA (knees pain), AXILLARY PAIN (Underarm seems to hurt) and MYALGIA (shoulder muscle pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Significant follow-up received on 18-May-2021: Seriousness. New Events added, Treatment drug added, Reporter information updated On 20-May-2021: Significant follow up received on 20-May-2021 :- Event underarm pain , torn muscles in the shoulder added.; 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: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Torn muscles; pain in the arm, elbows; discomfort in the legs, arm and hand; discomfort in the shoulders; Significant pain; Underarm seems to hurt; shoulder muscle pain; knees pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RUPTURE (Torn muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Torn muscle (Shoulder muscle tear). Concurrent medical conditions included Arthritis, Knee pain (Patient is experiencing knee pain due to Arthritis) and Muscle pain (Shoulder muscle pain).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced ARTHRALGIA (knees pain) and MYALGIA (shoulder muscle pain). On an unknown date, the patient experienced MUSCLE RUPTURE (Torn muscles) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in the arm, elbows), LIMB DISCOMFORT (discomfort in the legs, arm and hand), MUSCULOSKELETAL DISCOMFORT (discomfort in the shoulders), PAIN (Significant pain) and AXILLARY PAIN (Underarm seems to hurt). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ACTIV) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCLE RUPTURE (Torn muscles), PAIN IN EXTREMITY (pain in the arm, elbows), LIMB DISCOMFORT (discomfort in the legs, arm and hand), MUSCULOSKELETAL DISCOMFORT (discomfort in the shoulders), PAIN (Significant pain), ARTHRALGIA (knees pain), AXILLARY PAIN (Underarm seems to hurt) and MYALGIA (shoulder muscle pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Significant follow-up received on 18-May-2021: Seriousness. New Events added, Treatment drug added, Reporter information updated On 20-May-2021: Significant follow up received on 20-May-2021 :- Event underarm pain , torn muscles in the shoulder added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Loss of control of legs, Vaccination complication
Clinical narrative: both of her legs became like jelly/jelly like feeling in both legs; unable to move,unable to get up/ can not reposition herself,spends many nights on floor; same feeling every night since the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONTROL OF LEGS (both of her legs became like jelly/jelly like feeling in both legs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 032120A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASENAPINE MALEATE (SAPHRIS), ZOLPIDEM TARTRATE (AMBIEN), CARBAMAZEPINE (TEGRETOL), DISULFIRAM (ANTABUSE), VALBENAZINE TOSILATE (INGREZZA), TRAZODONE, CLONIDINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and CHLORPROMAZINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced LOSS OF CONTROL OF LEGS (both of her legs became like jelly/jelly like feeling in both legs) (seriousness criterion medically significant), GAIT INABILITY (unable to move,unable to get up/ can not reposition herself,spends many nights on floor) and VACCINATION COMPLICATION (same feeling every night since the vaccine). At the time of the report, LOSS OF CONTROL OF LEGS (both of her legs became like jelly/jelly like feeling in both legs), GAIT INABILITY (unable to move,unable to get up/ can not reposition herself,spends many nights on floor) and VACCINATION COMPLICATION (same feeling every night since the vaccine) had not resolved.            Patient was fine during the day however, after taking her evening medications she experiences the same jelly like feeling in both legs.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-125373 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Skin laceration
Clinical narrative: horrible itching for 6 weeks with no relief after second dose of Moderna COVID-19 vaccine; big bruises from itching; skin tears from itching; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (horrible itching for 6 weeks with no relief after second dose of Moderna COVID-19 vaccine), CONTUSION (big bruises from itching) and SKIN LACERATION (skin tears from itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 031L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PREDNISONE for Itching.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (horrible itching for 6 weeks with no relief after second dose of Moderna COVID-19 vaccine) (seriousness criterion intervention required), CONTUSION (big bruises from itching) (seriousness criterion intervention required) and SKIN LACERATION (skin tears from itching) (seriousness criterion intervention required). At the time of the report, PRURITUS (horrible itching for 6 weeks with no relief after second dose of Moderna COVID-19 vaccine), CONTUSION (big bruises from itching) and SKIN LACERATION (skin tears from itching) outcome was unknown.            Treatment details not provided.  Patient stated that she had been to the doctor several times and was prescribed two separate rounds of a medrol dose pack, benadryl every four hours, and cortisone cream. She also stated that she had to take a sleeping pill at night to get any sleep because of the itching. Patient stated she had skin tears from itching so bad and sometimes wakes up with big bruises from itching in her sleep. She did not had a rash or hives, just itching for six weeks.  Action taken on mRNA-1273 in response to the events, was considered, not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy; This spontaneous case was reported by a pharmacist and describes the occurrence of BELL'S PALSY (Bells palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Pharmacist wanted to know if they should receive the second dose of the vaccine.  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection) (seriousness criterion medically significant). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Node; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Node) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen Lymph Node) outcome was unknown.        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 is treated with Tylenol. No concomitant list is provided. Event developed 10 days later.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Choking, Dysphagia, Dyspnoea
Clinical narrative: Had problems with throat getting stuck/Heimlich to get food out; Sweating; Would drink water and have problems getting it down throat/Heimlich to get food out; Had problems breathing; can't think straight; Fever; Chills; Muscle soreness in back/Muscle soreness in legs; Muscle soreness in ankle; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Had problems with throat getting stuck/Heimlich to get food out) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle). On an unknown date, the patient experienced CHOKING (Had problems with throat getting stuck/Heimlich to get food out) (seriousness criterion medically significant). At the time of the report, CHOKING (Had problems with throat getting stuck/Heimlich to get food out), HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle) outcome was unknown.            Concominant medications included unknown cancer medications.  On an unknown date, treatment included the Heimlich maneuver.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.