chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got / shot #1 / 16 months ago / appointment to receive / shot #2 / 01-Jul-2021 / pharmacist told / to start the series over; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose intramuscularly on upper arm 16 months ago.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The reporter was a patient.  The age at vaccination was not applicable for this report. The reporter did not have a computer (no email). She did not have the exact date of the 1st dose of Shingrix vaccine administered. She did not have the lot number available. She provided the contact information of the pharmacy where the 1st shot was given.  She had an appointment to receive Shingrix 2nd dose on 01st July 2021. She stated that pharmacist told her that since it has been 16 months, she had to start the series over. It was not confirmed, if the patient received 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced off label use. On 07-APR-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate age at vaccine administration was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VIAL INITIALLY PUNCTURED AND HAD BEEN MAINTAINED IN THE REFRIGERATOR FROM THE TIME OF INITIAL PUNCTURE; This spontaneous report received from a pharmacist concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: 15-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vial initially punctured and had been maintained in the refrigerator from the time of initial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial initially punctured and had been maintained in the refrigerator from the time of initial puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210703146.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Arthralgia, Hyperaesthesia, Influenza like illness, Muscle spasms
Clinical narrative: BLURRED VISION; TOE CRAMPING; FACE BROKE OUT/PIMPLES; NIPPLE HYPERSENSITIVITY; JOINT PAIN; FLU LIKE SYMPTOM,FEVER,HEADACHE,CHILLS,FATIGUE; This spontaneous report received from a patient concerned a 50 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: 1808986, and expiry: 18-AUG-2021) dose was not reported, administered on 28-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced flu like symptom, fever, headache, chills, fatigue. On 28-JUN-2021, the subject experienced joint pain. On 29-JUN-2021, the subject experienced nipple hypersensitivity. Treatment medications included: paracetamol. On 30-JUN-2021, the subject experienced toe cramping. On 30-JUN-2021, the subject experienced face broke out/pimples. On 03-JUL-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from face broke out/pimples, and had not recovered from joint pain, flu like symptom, fever, headache, chills, fatigue, blurred vision, toe cramping, and nipple hypersensitivity. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; TOE CRAMPING; FACE BROKE OUT/PIMPLES; NIPPLE HYPERSENSITIVITY; JOINT PAIN; FLU LIKE SYMPTOM,FEVER,HEADACHE,CHILLS,FATIGUE; This spontaneous report received from a patient concerned a 50 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: 1808986, and expiry: 18-AUG-2021) dose was not reported, administered on 28-JUN-2021 09:30:00 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced flu like symptom, fever, headache, chills, fatigue. On 28-JUN-2021, the subject experienced joint pain. On 29-JUN-2021, the subject experienced nipple hypersensitivity. Treatment medications included: paracetamol. On 30-JUN-2021, the subject experienced toe cramping. On 30-JUN-2021, the subject experienced face broke out/pimples. On 03-JUL-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from face broke out/pimples, and had not recovered from joint pain, flu like symptom, fever, headache, chills, fatigue, blurred vision, toe cramping, and nipple hypersensitivity. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site plaque, Psoriasis
Clinical narrative: PLAQUE FORMED AT THE INJECTION SITE; PSORIASIS OUTBREAK; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced plaque formed at the injection site, and psoriasis outbreak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the plaque formed at the injection site and psoriasis outbreak was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, Pollakiuria
Clinical narrative: UP EVERY 2 HOURS TO GO TO THE WASHROOM; PRESSURE UNDER THE SKIN; ARM HURT A LITTLE; This spontaneous report received from a patient concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included gout, blood pressure, and cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 22A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUN-2021, the subject experienced pressure under the skin. On 28-JUN-2021, the subject experienced arm hurt a little. On 01-JUL-2021, the subject experienced up every 2 hours to go to the washroom. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure under the skin on 28-JUN-2021, and arm hurt a little on 29-JUN-2021, and had not recovered from up every 2 hours to go to the washroom. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Anaemia
Clinical narrative: ANEMIA; EXCESSIVE HAIR LOSS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known history of drug abuse or illicit drug usage .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 26-MAR-2021, the subject experienced anemia. On 26-MAR-2021, the subject experienced excessive hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anemia, and excessive hair loss. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: ITCHINESS; RED BUMPS ALL OVER  BODY (ON CHEST, STOMACH, BACK, AND LEFT, RIGHT ARM/UNDERARM, WHICH  VACCINE WAS ADMINISTERED); This spontaneous report received from a patient concerned a 34 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included terbinafine for drug used for unknown indication. On 24-JUN-2021, the subject experienced itchiness. On 24-JUN-2021, the subject experienced red bumps all over body (on chest, stomach, back, and left, right arm/underarm, which vaccine was administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchiness and red bumps all over body (on chest, stomach, back, and left, right arm/underarm, which vaccine was administered) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Headache, Peripheral swelling
Clinical narrative: SWOLLEN LEG; BRUISE GREEN PURPLE BRUISE, IT HURTS UPON TOUCHING, ON THE INNER THIGH , LEFT SIDE , BIG SIZE, ABOVE THE KNEE AND ALL THE WAY TO THE TOP; HEADACHE (BUT SHE THINKS IT WAS HANGOVER FROM LAST NIGHT'S DRINKS); FELL DOWN ON BACK NOT RELATED TO SIGHT OF PROBLEM; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known health issue, no known allergies and no drug abuse or illict drug usage, patient was not pregnant at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 07:00 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced fell down on back not related to sight of problem. On 03-JUL-2021, the subject experienced bruise green purple bruise, it hurts upon touching, on the inner thigh, left side, big size, above the knee and all the way to the top. On 03-JUL-2021, the subject experienced headache (but she thinks it was hangover from last night's drinks). On an unspecified date, the subject experienced swollen leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise green purple bruise, it hurts upon touching, on the inner thigh , left side , big size, above the knee and all the way to the top, and headache (but she thinks it was hangover from last night's drinks), and the outcome of swollen leg and fell down on back not related to sight of problem was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: MIGRAINE; NUMB TO FINGERS; ARM SWOLLEN; PRESSURE IN ARM/ARM TIGHTNESS; CHILLS; HEADACHE; FELT FEVERISH; INJECTION SITE TINGLING (DOWN THE ARMS TO THE FINGERS AND UP TO THE SHOULDER BLADE); FELT HOT; DIZZINESS; This spontaneous report received from a patient concerned a 32 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: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced injection site tingling (down the arms to the fingers and up to the shoulder blade). On 28-JUN-2021, the subject experienced felt hot. On 28-JUN-2021, the subject experienced dizziness. On 28-JUN-2021, the subject experienced numb to fingers. On 28-JUN-2021, the subject experienced arm swollen. On 28-JUN-2021, the subject experienced pressure in arm/arm tightness. On 28-JUN-2021, the subject experienced chills. On 28-JUN-2021, the subject experienced headache. On 28-JUN-2021, the subject experienced felt feverish. On 29-JUN-2021, the subject experienced migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, dizziness, chills, and felt feverish on 30-JUN-2021, was recovering from headache, had not recovered from injection site tingling (down the arms to the fingers and up to the shoulder blade), pressure in arm/arm tightness, numb to fingers, and arm swollen, and the outcome of migraine was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Limb discomfort, Migraine, Peripheral swelling, Pyrexia
Clinical narrative: MIGRAINE; NUMB TO FINGERS; ARM SWOLLEN; PRESSURE IN ARM/ARM TIGHTNESS; CHILLS; HEADACHE; FELT FEVERISH; INJECTION SITE TINGLING (DOWN THE ARMS TO THE FINGERS AND UP TO THE SHOULDER BLADE); FELT HOT; DIZZINESS; This spontaneous report received from a patient concerned a 32 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: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced injection site tingling (down the arms to the fingers and up to the shoulder blade). On 28-JUN-2021, the subject experienced felt hot. On 28-JUN-2021, the subject experienced dizziness. On 28-JUN-2021, the subject experienced numb to fingers. On 28-JUN-2021, the subject experienced arm swollen. On 28-JUN-2021, the subject experienced pressure in arm/arm tightness. On 28-JUN-2021, the subject experienced chills. On 28-JUN-2021, the subject experienced headache. On 28-JUN-2021, the subject experienced felt feverish. On 29-JUN-2021, the subject experienced migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, dizziness, chills, and felt feverish on 30-JUN-2021, was recovering from headache, had not recovered from injection site tingling (down the arms to the fingers and up to the shoulder blade), pressure in arm/arm tightness, numb to fingers, and arm swollen, and the outcome of migraine was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ON AND OFF TINNITUS; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included gall bladder surgery, and cataract extraction, and concurrent conditions included hypertension, general osteoarthritis, high cholesterol, osteopenia, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced on and off tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on and off tinnitus. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Feeling abnormal, Hypersensitivity
Clinical narrative: FELT KIND OF YUCKY; BURNED A LITTLE; MALAISE/DON'T FEEL GOOD; SORE ARM; FELT LIKE ALLERGIES; COLD; FATIGUE/TIRED/FEELING RUN DOWN; SHIVERING/CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hip and knee pain arthritis, and other pre-existing medical conditions included consumer took an antidepressant and blood pressure medicine and centrum multivitamin when she could afford it. The patient was previously treated with pneumococcal vaccine, influenza vaccine, and varicella zoster vaccine rge (cho) for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hip and left knee arthritis, and paracetamol for to prevent headaches. On 29-MAR-2021, the subject experienced shivering/chills. On 29-MAR-2021, the subject experienced fatigue/tired/feeling run down. On 30-MAR-2021, the subject experienced cold. On 30-MAR-2021, the subject experienced felt like allergies. On an unspecified date, the subject experienced felt kind of yucky, burned a little, malaise/don't feel good, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, felt kind of yucky, malaise/don't feel good, sore arm, shivering/chills, felt like allergies, and fatigue/tired/feeling run down, and the outcome of burned a little was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain in extremity
Clinical narrative: FELT KIND OF YUCKY; BURNED A LITTLE; MALAISE/DON'T FEEL GOOD; SORE ARM; FELT LIKE ALLERGIES; COLD; FATIGUE/TIRED/FEELING RUN DOWN; SHIVERING/CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hip and knee pain arthritis, and other pre-existing medical conditions included consumer took an antidepressant and blood pressure medicine and centrum multivitamin when she could afford it. The patient was previously treated with pneumococcal vaccine, influenza vaccine, and varicella zoster vaccine rge (cho) for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hip and left knee arthritis, and paracetamol for to prevent headaches. On 29-MAR-2021, the subject experienced shivering/chills. On 29-MAR-2021, the subject experienced fatigue/tired/feeling run down. On 30-MAR-2021, the subject experienced cold. On 30-MAR-2021, the subject experienced felt like allergies. On an unspecified date, the subject experienced felt kind of yucky, burned a little, malaise/don't feel good, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, felt kind of yucky, malaise/don't feel good, sore arm, shivering/chills, felt like allergies, and fatigue/tired/feeling run down, and the outcome of burned a little was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Fatigue, Headache
Clinical narrative: SIDE EFFECTS; MAJOR HEADACHE; SOME FATIGUE; This spontaneous report received from a patient via a company representative concerned a 21 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: Unknown dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effects, major headache, and some fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects, major headache, and some fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: ITCHY, RED RASHES ALL OVER BODY INCLUDING LEGS, ARMS, STOMACH, CHEST AND BACK.; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 06-JUL-2021, the subject experienced itchy, red rashes all over body including legs, arms, stomach, chest and back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy, red rashes all over body including legs, arms, stomach, chest and back. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FELT KINDA SICK THE NEXT DAY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 felt kinda sick the next day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt kinda sick the next day was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Headache, Lacrimation increased, Rhinorrhoea
Clinical narrative: hearing loss; Roaring in ear; Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat; Nose has been running; Eyes tearing up; Headache that felt like severe pressure; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a 62-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.     Concurrent medical conditions included Rheumatoid arthritis since 30-Oct-2015. Concomitant products included VITAMIN D NOS from 01-Jan-2010 to an unknown date and CALCIUM from 01-Jan-2010 to an unknown date for Bone disorder, ZEAXANTHIN (LUTEIN [ZEAXANTHIN]) from 01-Jan-2008 to an unknown date for Eye disorder, MAGNESIUM from 01-Jan-2010 to an unknown date for Muscle disorder.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), TINNITUS (Roaring in ear), EAR DISCOMFORT (Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat), RHINORRHOEA (Nose has been running), LACRIMATION INCREASED (Eyes tearing up) and HEADACHE (Headache that felt like severe pressure). At the time of the report, DEAFNESS (hearing loss), TINNITUS (Roaring in ear), EAR DISCOMFORT (Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat), RHINORRHOEA (Nose has been running), LACRIMATION INCREASED (Eyes tearing up) and HEADACHE (Headache that felt like severe pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. Very limited information regarding the date of the events in relation to the date of vaccine administration have been provided. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient demographics updated. Patient medical history updated. concomitant medications added. Start date for the events were added. Outcome for the events updated ( from unknown to not resolved) On 30-Jun-2021: Follow up information was received from initial reporter: New event Deafness was added.  This case was upgraded from non-serious to serious due to the addition of new event Deafness; Sender's Comments: Very limited information regarding the date of the events in relation to the date of vaccine administration have been provided. Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: hearing loss; Roaring in ear; Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat; Nose has been running; Eyes tearing up; Headache that felt like severe pressure; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a 62-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.     Concurrent medical conditions included Rheumatoid arthritis since 30-Oct-2015. Concomitant products included VITAMIN D NOS from 01-Jan-2010 to an unknown date and CALCIUM from 01-Jan-2010 to an unknown date for Bone disorder, ZEAXANTHIN (LUTEIN [ZEAXANTHIN]) from 01-Jan-2008 to an unknown date for Eye disorder, MAGNESIUM from 01-Jan-2010 to an unknown date for Muscle disorder.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), TINNITUS (Roaring in ear), EAR DISCOMFORT (Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat), RHINORRHOEA (Nose has been running), LACRIMATION INCREASED (Eyes tearing up) and HEADACHE (Headache that felt like severe pressure). At the time of the report, DEAFNESS (hearing loss), TINNITUS (Roaring in ear), EAR DISCOMFORT (Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat), RHINORRHOEA (Nose has been running), LACRIMATION INCREASED (Eyes tearing up) and HEADACHE (Headache that felt like severe pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. Very limited information regarding the date of the events in relation to the date of vaccine administration have been provided. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient demographics updated. Patient medical history updated. concomitant medications added. Start date for the events were added. Outcome for the events updated ( from unknown to not resolved) On 30-Jun-2021: Follow up information was received from initial reporter: New event Deafness was added.  This case was upgraded from non-serious to serious due to the addition of new event Deafness; Sender's Comments: Very limited information regarding the date of the events in relation to the date of vaccine administration have been provided. Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac failure, Hypertension, Peripheral swelling
Clinical narrative: Heart failure sent to ICU; legs swelled; had high blood pressure and her legs swelled; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE (Heart failure sent to ICU) in a 70-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.     Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FAILURE (Heart failure sent to ICU) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelled) and HYPERTENSION (had high blood pressure and her legs swelled). The patient was hospitalized from 11-May-2021 to 14-May-2021 due to CARDIAC FAILURE. At the time of the report, CARDIAC FAILURE (Heart failure sent to ICU) had resolved with sequelae and PERIPHERAL SWELLING (legs swelled) and HYPERTENSION (had high blood pressure and her legs swelled) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: high (High) high.         Treatment medication was not provided.  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 30-Jun-2021: ADR form received: Suspect drug details updated, Concomitant  medications added, New serious event added, event details updated; 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: COVID19
Symptoms: Product dose omission issue
Clinical narrative: My brother had a Moderna 1st vaccination early in March and has not had one since; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My brother had a Moderna 1st vaccination early in March and has not had one since) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 PRODUCT DOSE OMISSION ISSUE (My brother had a Moderna 1st vaccination early in March and has not had one since). At the time of the report, PRODUCT DOSE OMISSION ISSUE (My brother had a Moderna 1st vaccination early in March and has not had one since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No allergies, current illness, lab data and medical history was provide by patient. No concomitant and treatment medication was provide by patient.  Patient brother reported that patient had only one dose of Moderna in early march and had not taken one since.; Sender's Comments: This report refers to a case of Product dose omission for mRNA-1273 with no reported adverse events.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Impaired work ability, Mobility decreased, Myalgia
Clinical narrative: Breathing difficult; Parsonage-Turner Syndrome; cant workand is unable to use arms; numbness in left arm; sharp pain in  left arm; She can't work; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Breathing difficult), HYPOAESTHESIA (numbness in left arm), MYALGIA (sharp pain in  left arm), NEURALGIC AMYOTROPHY (Parsonage-Turner Syndrome) and MOBILITY DECREASED (cant workand is unable to use arms) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in left arm) (seriousness criterion hospitalization) and MYALGIA (sharp pain in  left arm) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced IMPAIRED WORK ABILITY (She can't work). On 29-Jun-2021, the patient experienced MOBILITY DECREASED (cant workand is unable to use arms) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (Breathing difficult) (seriousness criterion hospitalization) and NEURALGIC AMYOTROPHY (Parsonage-Turner Syndrome) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Breathing difficult), HYPOAESTHESIA (numbness in left arm), MYALGIA (sharp pain in  left arm), NEURALGIC AMYOTROPHY (Parsonage-Turner Syndrome) and MOBILITY DECREASED (cant workand is unable to use arms) outcome was unknown and IMPAIRED WORK ABILITY (She can't work) had not resolved.        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. 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 events, a causal relationship cannot be excluded.  Further information has been requested-.; 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.  Further information has been requested-.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy
Clinical narrative: Breathing difficult; Parsonage-Turner Syndrome; cant workand is unable to use arms; numbness in left arm; sharp pain in  left arm; She can't work; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Breathing difficult), HYPOAESTHESIA (numbness in left arm), MYALGIA (sharp pain in  left arm), NEURALGIC AMYOTROPHY (Parsonage-Turner Syndrome) and MOBILITY DECREASED (cant workand is unable to use arms) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in left arm) (seriousness criterion hospitalization) and MYALGIA (sharp pain in  left arm) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced IMPAIRED WORK ABILITY (She can't work). On 29-Jun-2021, the patient experienced MOBILITY DECREASED (cant workand is unable to use arms) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (Breathing difficult) (seriousness criterion hospitalization) and NEURALGIC AMYOTROPHY (Parsonage-Turner Syndrome) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Breathing difficult), HYPOAESTHESIA (numbness in left arm), MYALGIA (sharp pain in  left arm), NEURALGIC AMYOTROPHY (Parsonage-Turner Syndrome) and MOBILITY DECREASED (cant workand is unable to use arms) outcome was unknown and IMPAIRED WORK ABILITY (She can't work) had not resolved.        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. 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 events, a causal relationship cannot be excluded.  Further information has been requested-.; 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.  Further information has been requested-.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to RASH. At the time of the report, RASH (Rash) had resolved.            Patient is on some concomitant medications but no information provided. No concomitant medication information was provided No treatment product 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 event, a causal relationship cannot be excluded. Further information has been requested.; 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. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Computerised tomogram, Dizziness, Lacrimation increased, Ocular discomfort
Clinical narrative: Blockage in artery around the neck; Dizzniess; Eyes Watered Profusely; Eyes dont feel right; This spontaneous case was reported by a consumer and describes the occurrence of ARTERIAL OCCLUSIVE DISEASE (Blockage in artery around the neck), DIZZINESS (Dizzniess), LACRIMATION INCREASED (Eyes Watered Profusely) and OCULAR DISCOMFORT (Eyes dont feel right) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced DIZZINESS (Dizzniess), LACRIMATION INCREASED (Eyes Watered Profusely) and OCULAR DISCOMFORT (Eyes dont feel right). On 10-Jun-2021, the patient experienced ARTERIAL OCCLUSIVE DISEASE (Blockage in artery around the neck). At the time of the report, ARTERIAL OCCLUSIVE DISEASE (Blockage in artery around the neck), DIZZINESS (Dizzniess), LACRIMATION INCREASED (Eyes Watered Profusely) and OCULAR DISCOMFORT (Eyes dont feel right) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jun-2021, Computerised tomogram: abnormal (abnormal) Patient detected with blockages in arteries around the neck.         No concomitant medication reported.  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-2021-079223 (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: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Hospice care, Malaise, SARS-CoV-2 test
Clinical narrative: didn't know anyone around her; very weak; not feeling well; failure to survive complications from COVID-19; Hospice care; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (failure to survive complications from COVID-19), MALAISE (not feeling well), CONFUSIONAL STATE (didn't know anyone around her) and ASTHENIA (very weak) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criteria death and hospitalization). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (didn't know anyone around her) (seriousness criteria death and hospitalization) and ASTHENIA (very weak) (seriousness criteria death and hospitalization). On 26-Mar-2021, the patient experienced HOSPICE CARE (Hospice care). On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (failure to survive complications from COVID-19) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was failure to survive complications from covid-19 vaccine. It is unknown if an autopsy was performed. At the time of death, HOSPICE CARE (Hospice care) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         Patient was concomitantly taking blood pressure medications.   Patient received IV fluids as corrective treatment.  Company Comment : Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: failure to survive complications from COVID-19 vaccine
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: didn't know anyone around her; very weak; not feeling well; failure to survive complications from COVID-19; Hospice care; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (failure to survive complications from COVID-19), MALAISE (not feeling well), CONFUSIONAL STATE (didn't know anyone around her) and ASTHENIA (very weak) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criteria death and hospitalization). On 06-Mar-2021, the patient experienced CONFUSIONAL STATE (didn't know anyone around her) (seriousness criteria death and hospitalization) and ASTHENIA (very weak) (seriousness criteria death and hospitalization). On 26-Mar-2021, the patient experienced HOSPICE CARE (Hospice care). On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (failure to survive complications from COVID-19) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was failure to survive complications from covid-19 vaccine. It is unknown if an autopsy was performed. At the time of death, HOSPICE CARE (Hospice care) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         Patient was concomitantly taking blood pressure medications.   Patient received IV fluids as corrective treatment.  Company Comment : Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Reported Cause(s) of Death: failure to survive complications from COVID-19 vaccine