chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: ADMINISTRATION ERROR/INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; TEMPERATURE EXCURSION; This spontaneous report received from a physician concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-OCT-2021, the patient experienced administration error/incorrectly stored vaccine administered. On 18-OCT-2021, the patient experienced vaccine stored outside of the acceptable limits. On 18-OCT-2021, the patient experienced temperature excursion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error/incorrectly stored vaccine administered, temperature excursion, and vaccine stored outside of the acceptable limits was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Headache, Injection site pain, Oropharyngeal pain
Clinical narrative: CHEST PAIN; BLURRED VISION; LEG SWELLING (STARTED IN LEFT LEG NOW IN BOTH LEGS); ARM HURTS AT THE INJECTION SITE LIKE AN OLD BRUISE IF RUBS IT; HEADACHE; DIARRHEA; ALTERNATE CHILLS AND FEVER; THROAT HURTING; SWOLLEN TONSILS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, copd, and back problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) she had covid antibodies. On SEP-2021, the patient experienced throat hurting. On SEP-2021, the patient experienced swollen tonsils. On an unspecified date, the patient experienced chest pain, blurred vision, leg swelling (started in left leg now in both legs), arm hurts at the injection site like an old bruise if rubs it, headache, diarrhea, and alternate chills and fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, headache, blurred vision, leg swelling, started in left leg now in both legs, arm hurts at the injection site like an old bruise if rubs it, swollen tonsils, diarrhea, alternate chills and fever and throat hurting was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test, Tonsillar hypertrophy
Clinical narrative: CHEST PAIN; BLURRED VISION; LEG SWELLING (STARTED IN LEFT LEG NOW IN BOTH LEGS); ARM HURTS AT THE INJECTION SITE LIKE AN OLD BRUISE IF RUBS IT; HEADACHE; DIARRHEA; ALTERNATE CHILLS AND FEVER; THROAT HURTING; SWOLLEN TONSILS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, copd, and back problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) she had covid antibodies. On SEP-2021, the patient experienced throat hurting. On SEP-2021, the patient experienced swollen tonsils. On an unspecified date, the patient experienced chest pain, blurred vision, leg swelling (started in left leg now in both legs), arm hurts at the injection site like an old bruise if rubs it, headache, diarrhea, and alternate chills and fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, headache, blurred vision, leg swelling, started in left leg now in both legs, arm hurts at the injection site like an old bruise if rubs it, swollen tonsils, diarrhea, alternate chills and fever and throat hurting was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: CHEST PAIN; BLURRED VISION; LEG SWELLING (STARTED IN LEFT LEG NOW IN BOTH LEGS); ARM HURTS AT THE INJECTION SITE LIKE AN OLD BRUISE IF RUBS IT; HEADACHE; DIARRHEA; ALTERNATE CHILLS AND FEVER; THROAT HURTING; SWOLLEN TONSILS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, copd, and back problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) she had covid antibodies. On SEP-2021, the patient experienced throat hurting. On SEP-2021, the patient experienced swollen tonsils. On an unspecified date, the patient experienced chest pain, blurred vision, leg swelling (started in left leg now in both legs), arm hurts at the injection site like an old bruise if rubs it, headache, diarrhea, and alternate chills and fever. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, headache, blurred vision, leg swelling, started in left leg now in both legs, arm hurts at the injection site like an old bruise if rubs it, swollen tonsils, diarrhea, alternate chills and fever and throat hurting was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: ACHES AND PAINS; VERY TIRED/ FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-OCT-2021, the patient experienced aches and pains. On 18-OCT-2021, the patient experienced very tired/ fatigue. On 18-OCT-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of very tired/ fatigue and aches and pains was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Migraine, Pain in extremity, Peripheral swelling
Clinical narrative: SERIOUS MIGRAINE EVER SINCE; FOOT SWELLING; AREAS FELT REALLY HOT; SEVERE PAIN IN CALF MUSCLE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 18-OCT-2021, the patient experienced foot swelling. On 18-OCT-2021, the patient experienced areas felt really hot. On 18-OCT-2021, the patient experienced severe pain in calf muscle. On an unspecified date, the patient experienced serious migraine ever since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious migraine ever since, and the outcome of foot swelling, severe pain in calf muscle and areas felt really hot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dysphagia, Fatigue, Pain of skin
Clinical narrative: SMALL CIRCULAR RED RASH 2-3 INCHES IN PATCHES ON LOWER CALF WITH SMALL BUMPS ,POPPED UP ON THIGH COMING AND GOING WITH SKIN RAISED UP; FEELING TIRED; WELTS AND HIVES ON PALM OF RIGHT HAND AS RAISED, ITCHY, AND TENDER; FELT LIKE THROAT WAS SWELLING SHUT; FELT TIGHTNESS HIGH IN THE CENTER OF CHEST; HARD TO SWALLOW; FINGERS TENDER LIKE HAD BEEN DOING WORK/ SKIN TINDER; ITCHING ON LEG AREA  AND STOMACH; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: enlarged prostate, premature ventricular contractions, gluten allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient does not think he was exposed to poison ivy. On 05-OCT-2021 patient had visited doctor. The patient did not have any 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, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 13-OCT-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 05-OCT-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 15-OCT-2021, the patient experienced itching on leg area and stomach. On 16-OCT-2021, the patient experienced felt like throat was swelling shut. On 16-OCT-2021, the patient experienced felt tightness high in the center of chest. On 16-OCT-2021, the patient experienced hard to swallow. On 16-OCT-2021, the patient experienced fingers tender like had been doing work/ skin tinder. On 16-OCT-2021, the patient experienced welts and hives on palm of right hand as raised, itchy, and tender. Treatment medications included: diphenhydramine hydrochloride. On 19-OCT-2021, the patient experienced small circular red rash 2-3 inches in patches on lower calf with small bumps, popped up on thigh coming and going with skin raised up. On 19-OCT-2021, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on leg area and stomach, welts and hives on palm of right hand as raised, itchy, and tender, felt like throat was swelling shut, felt tightness high in the center of chest, hard to swallow, small circular red rash 2-3 inches in patches on lower calf with small bumps ,popped up on thigh coming and going with skin raised up, fingers tender like had been doing work/ skin tinder, and feeling tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash erythematous, Urticaria
Clinical narrative: SMALL CIRCULAR RED RASH 2-3 INCHES IN PATCHES ON LOWER CALF WITH SMALL BUMPS ,POPPED UP ON THIGH COMING AND GOING WITH SKIN RAISED UP; FEELING TIRED; WELTS AND HIVES ON PALM OF RIGHT HAND AS RAISED, ITCHY, AND TENDER; FELT LIKE THROAT WAS SWELLING SHUT; FELT TIGHTNESS HIGH IN THE CENTER OF CHEST; HARD TO SWALLOW; FINGERS TENDER LIKE HAD BEEN DOING WORK/ SKIN TINDER; ITCHING ON LEG AREA  AND STOMACH; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: enlarged prostate, premature ventricular contractions, gluten allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient does not think he was exposed to poison ivy. On 05-OCT-2021 patient had visited doctor. The patient did not have any 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, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 13-OCT-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 05-OCT-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 15-OCT-2021, the patient experienced itching on leg area and stomach. On 16-OCT-2021, the patient experienced felt like throat was swelling shut. On 16-OCT-2021, the patient experienced felt tightness high in the center of chest. On 16-OCT-2021, the patient experienced hard to swallow. On 16-OCT-2021, the patient experienced fingers tender like had been doing work/ skin tinder. On 16-OCT-2021, the patient experienced welts and hives on palm of right hand as raised, itchy, and tender. Treatment medications included: diphenhydramine hydrochloride. On 19-OCT-2021, the patient experienced small circular red rash 2-3 inches in patches on lower calf with small bumps, popped up on thigh coming and going with skin raised up. On 19-OCT-2021, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on leg area and stomach, welts and hives on palm of right hand as raised, itchy, and tender, felt like throat was swelling shut, felt tightness high in the center of chest, hard to swallow, small circular red rash 2-3 inches in patches on lower calf with small bumps ,popped up on thigh coming and going with skin raised up, fingers tender like had been doing work/ skin tinder, and feeling tired. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Dysphagia, Feeling abnormal
Clinical narrative: DIFFICULTY IN SWALLOWING; VOMITING; LIGHT HEADNESS; FEELING OF SKIN VIBRATION; EXCESSIVE SLEEP AND FEELING OF TIREDNESS; BAD COUGH; CLOUDINESS IN THE HEAD; CRAMPING IN FORE ARM AND PINK FINGER OF LEFT ARM; LEFT ARM PAIN; SHARP PAIN AND PRESSURE IN THE LEFT SHOULDER THAT SETTLED AND SPREAD.; STIFFNESS IN WHOLE BODY; LESS SENSATION ON BODY; DIFFICULTY TO MOVE THE BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: smoker, and concurrent conditions included: alcohol user, and other pre-existing medical conditions included: Patient have not known allergies. patient did not had any 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: Unk) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On 30-SEP-2021, the patient experienced stiffness in whole body. On 30-SEP-2021, the patient experienced less sensation on body. On 30-SEP-2021, the patient experienced difficulty to move the body. On 30-SEP-2021, the patient experienced cramping in fore arm and pink finger of left arm. On 30-SEP-2021, the patient experienced left arm pain. On 30-SEP-2021, the patient experienced sharp pain and pressure in the left shoulder that settled and spread. On 01-OCT-2021, the patient experienced light headness. On 01-OCT-2021, the patient experienced feeling of skin vibration. On 01-OCT-2021, the patient experienced excessive sleep and feeling of tiredness. On 01-OCT-2021, the patient experienced bad cough. On 01-OCT-2021, the patient experienced cloudiness in the head. On 04-OCT-2021, the patient experienced difficulty in swallowing. On 04-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, sharp pain and pressure in the left shoulder that settled and spread., left arm pain, stiffness in whole body, less sensation on body, difficulty to move the body, light headness, feeling of skin vibration, excessive sleep and feeling of tiredness, bad cough, cloudiness in the head, cramping in fore arm and pink finger of left arm, and difficulty in swallowing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Muscle spasms, Musculoskeletal stiffness, Pain in extremity, Sensory loss
Clinical narrative: DIFFICULTY IN SWALLOWING; VOMITING; LIGHT HEADNESS; FEELING OF SKIN VIBRATION; EXCESSIVE SLEEP AND FEELING OF TIREDNESS; BAD COUGH; CLOUDINESS IN THE HEAD; CRAMPING IN FORE ARM AND PINK FINGER OF LEFT ARM; LEFT ARM PAIN; SHARP PAIN AND PRESSURE IN THE LEFT SHOULDER THAT SETTLED AND SPREAD.; STIFFNESS IN WHOLE BODY; LESS SENSATION ON BODY; DIFFICULTY TO MOVE THE BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: smoker, and concurrent conditions included: alcohol user, and other pre-existing medical conditions included: Patient have not known allergies. patient did not had any 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: Unk) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On 30-SEP-2021, the patient experienced stiffness in whole body. On 30-SEP-2021, the patient experienced less sensation on body. On 30-SEP-2021, the patient experienced difficulty to move the body. On 30-SEP-2021, the patient experienced cramping in fore arm and pink finger of left arm. On 30-SEP-2021, the patient experienced left arm pain. On 30-SEP-2021, the patient experienced sharp pain and pressure in the left shoulder that settled and spread. On 01-OCT-2021, the patient experienced light headness. On 01-OCT-2021, the patient experienced feeling of skin vibration. On 01-OCT-2021, the patient experienced excessive sleep and feeling of tiredness. On 01-OCT-2021, the patient experienced bad cough. On 01-OCT-2021, the patient experienced cloudiness in the head. On 04-OCT-2021, the patient experienced difficulty in swallowing. On 04-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, sharp pain and pressure in the left shoulder that settled and spread., left arm pain, stiffness in whole body, less sensation on body, difficulty to move the body, light headness, feeling of skin vibration, excessive sleep and feeling of tiredness, bad cough, cloudiness in the head, cramping in fore arm and pink finger of left arm, and difficulty in swallowing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Tremor, Vomiting
Clinical narrative: DIFFICULTY IN SWALLOWING; VOMITING; LIGHT HEADNESS; FEELING OF SKIN VIBRATION; EXCESSIVE SLEEP AND FEELING OF TIREDNESS; BAD COUGH; CLOUDINESS IN THE HEAD; CRAMPING IN FORE ARM AND PINK FINGER OF LEFT ARM; LEFT ARM PAIN; SHARP PAIN AND PRESSURE IN THE LEFT SHOULDER THAT SETTLED AND SPREAD.; STIFFNESS IN WHOLE BODY; LESS SENSATION ON BODY; DIFFICULTY TO MOVE THE BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: smoker, and concurrent conditions included: alcohol user, and other pre-existing medical conditions included: Patient have not known allergies. patient did not had any 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: Unk) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On 30-SEP-2021, the patient experienced stiffness in whole body. On 30-SEP-2021, the patient experienced less sensation on body. On 30-SEP-2021, the patient experienced difficulty to move the body. On 30-SEP-2021, the patient experienced cramping in fore arm and pink finger of left arm. On 30-SEP-2021, the patient experienced left arm pain. On 30-SEP-2021, the patient experienced sharp pain and pressure in the left shoulder that settled and spread. On 01-OCT-2021, the patient experienced light headness. On 01-OCT-2021, the patient experienced feeling of skin vibration. On 01-OCT-2021, the patient experienced excessive sleep and feeling of tiredness. On 01-OCT-2021, the patient experienced bad cough. On 01-OCT-2021, the patient experienced cloudiness in the head. On 04-OCT-2021, the patient experienced difficulty in swallowing. On 04-OCT-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, sharp pain and pressure in the left shoulder that settled and spread., left arm pain, stiffness in whole body, less sensation on body, difficulty to move the body, light headness, feeling of skin vibration, excessive sleep and feeling of tiredness, bad cough, cloudiness in the head, cramping in fore arm and pink finger of left arm, and difficulty in swallowing. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced hair is falling out in bunches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair is falling out in bunches. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Myocardial necrosis marker, Tachycardia
Clinical narrative: rapid heart beat; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Out of breath) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DYSPNOEA (Out of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (rapid heart beat). At the time of the report, DYSPNOEA (Out of breath) had not resolved and TACHYCARDIA (rapid heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: increased (High) Rapid heart beats. On an unknown date, Myocardial necrosis marker: normal (normal) bloodwork returned normal showed no elevated cardiac enzymes..         No concomitant medication details were provided. No treatment information was mentioned. It was reported that patient received his second Moderna Covid-19 vaccine 4 weeks after his first Moderna Covid-19 vaccine. Patients Mother states that her son was not diagnosed with myocarditis or pericarditis. After receiving his second Moderna covid-19 vaccine in April 2021 patient was out of breath, experienced a rapid heart beat and felt as though he was experiencing a heart attack. Cardiac Lab values, electrocardiogram, cardiac test, cardiac enzymes were performed. The bloodwork returned normal. The patient would be going to cardiac computed tomography positron emission tomography scan on 13 Oct 2021.  Company comment -This case concerns a 35-year-old, male patient with no relevant medical history, who experienced the serious event of dyspnoea. The date of onset was not reported, neither vaccination date. The rechallenge was not applicable as no additional dose is expected to be given, and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-350433 (Patient Link).; Sender's Comments: This case concerns a 35-year-old, male patient with no relevant medical history, who experienced the serious event of dyspnoea. The date of onset was not reported, neither vaccination date. The rechallenge was not applicable as no additional dose is expected to be given, and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: gave doses from an open vial over approximately 2-3 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (gave doses from an open vial over approximately 2-3 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (gave doses from an open vial over approximately 2-3 days). At the time of the report, PRODUCT STORAGE ERROR (gave doses from an open vial over approximately 2-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Red rash about 3 inch wide, 4 inch long right at injection site; It was red; It was itchy; It was a little tender presses or pushes the area it hurts; A spontaneous report was received from a reporter and other HCP concerning a 50-year-old, female patient, who was pregnant participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced    red rash about 3 inches wide and 4 inches long right at the injection site, and it is red and itchy.  The patient's medical history, as provided by the reporter, included type-1 diabetes. Concomitant medications reported included insulin and lisinopril.   The patient received their first of two planned dose of mRNA-1273 on 13jan2021. On 13 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.     After a week  of  receiving mRNA-1273, the patient got a red rash about 3 inches wide and 4 inches long right at the injection site, and it is red and itchy.       Action taken with mRNA-1273 in response to the events was not reported.     The events, injection site rash, injection site erythema, injection site pruritus and injection site pain were considered not resolved at the time of report.   The reporter did not provide an assessment for the events, injection site rash, erythema, pruritus and pain.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Bradykinesia, Burning sensation, Dyskinesia
Clinical narrative: Hands and toes feel on fire; Rash and blisters on hands and toes; Arm was sore; blisters on top of my right middle finger and right middle toe; slowly spread to other fingers and toes; first one was about an inch and a half in diameter and the outer edge is more raised; little bit red and pink; blisters appear only on top of both my fingers and toes; blisters got worst; A spontaneous report was received from a reporter (consumer) concerning a patient of unspecified age and gender , who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant medications were also not provided by the reporter .   On an unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, after receiving the vaccine, patient experienced events, hands and toes on fire and rash and blisters on hands and toes.  Laboratory details was not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of report, outcome of events hands and toes on fire and rash and blisters on hands and toes were unknown.; Reporter'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: U
Vaccine: COVID19
Symptoms: Erythema, Rash vesicular
Clinical narrative: Hands and toes feel on fire; Rash and blisters on hands and toes; Arm was sore; blisters on top of my right middle finger and right middle toe; slowly spread to other fingers and toes; first one was about an inch and a half in diameter and the outer edge is more raised; little bit red and pink; blisters appear only on top of both my fingers and toes; blisters got worst; A spontaneous report was received from a reporter (consumer) concerning a patient of unspecified age and gender , who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant medications were also not provided by the reporter .   On an unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, after receiving the vaccine, patient experienced events, hands and toes on fire and rash and blisters on hands and toes.  Laboratory details was not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of report, outcome of events hands and toes on fire and rash and blisters on hands and toes were unknown.; Reporter'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: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Tenderness
Clinical narrative: Red knot at the injection site; Warm to the touch knot at the injection site; Itchy knot; Tender knot; swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red knot at the injection site), INJECTION SITE WARMTH (Warm to the touch knot at the injection site), PRURITUS (Itchy knot), TENDERNESS (Tender knot) and INJECTION SITE SWELLING (swollen at the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-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 INJECTION SITE ERYTHEMA (Red knot at the injection site), INJECTION SITE WARMTH (Warm to the touch knot at the injection site), PRURITUS (Itchy knot), TENDERNESS (Tender knot) and INJECTION SITE SWELLING (swollen at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red knot at the injection site), INJECTION SITE WARMTH (Warm to the touch knot at the injection site), PRURITUS (Itchy knot), TENDERNESS (Tender knot) and INJECTION SITE SWELLING (swollen at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Based on MSA comment,  INJECTION SITE WARMTH,  PRURITUS, TENDERNESS and INJECTION SITE SWELLING (MAH causality assessment should be changed from "Not Provided" to "possibly Related"
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: side of my face got warm, after 3 days it went away; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (side of my face got warm, after 3 days it went away) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (side of my face got warm, after 3 days it went away). At the time of the report, FEELING HOT (side of my face got warm, after 3 days it went away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Transient tachypnoea of the newborn
Clinical narrative: his spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     The patient's past medical history included Maternal exposure during pregnancy.    On 30-Dec-2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The mother's last menstrual period was on 02-Jul-2020 and the estimated date of delivery was 08-Apr-2021. The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy. The cesarean delivery occurred, which was reported as Full-term. For neonate 1, with an APGAR score of 7 and 7 at (1, 5 minutes). The outcome was reported as Term Birth w Complications. Retained fetal lung fluid.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   The Treatment information was not provided.   This case was linked to MOD-2021-006493, MOD-2020-006493 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: Her smell is off; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Her smell is off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Her smell is off). At the time of the report, ANOSMIA (Her smell is off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter.  No treatment information provided by reporter   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: Sore Arm; tested positive (after both doses); Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and COVID-19 (tested positive (after both doses)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No relevant medical history was provided.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and SERTRALINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Oct-2021. On 07-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and COVID-19 (tested positive (after both doses)). On 07-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) and COVID-19 (tested positive (after both doses)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     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.   No treatment information was provided.  Company Comment: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy, Covid-19 and pain in extremity. The patient received the first dose of the Moderna Covid-19 vaccine at unknown age of gestation. The event pain in extremity occurred also on an unknown date. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-253146 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-OCT-2021 includes reporters contact details, changes from the initial version include update in coding of event, start date, stop date and outcome of event.; Sender's Comments: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy, Covid-19 and pain in extremity. The patient received the first dose of the Moderna Covid-19 vaccine at unknown age of gestation. The event pain in extremity occurred also on an unknown date. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Neuralgia, Paraesthesia
Clinical narrative: severe nerve pain on upper limbs and torso; Constant tingling sensation on fingers/Tingling sensation on the palm; Odd sensation on the torso; ischemic sensation and cold sensation; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (severe nerve pain on upper limbs and torso), PARAESTHESIA (Constant tingling sensation on fingers/Tingling sensation on the palm), FEELING ABNORMAL (Odd sensation on the torso) and FEELING COLD (ischemic sensation and cold sensation) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Allergy to antibiotic (cephalosporins), Latex allergy, Allergy to nuts, Asthma and Stenosis. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and MONTELUKAST for Asthma, ALENDRONATE SODIUM (ALENDRONATE) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Osteoporosis.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (severe nerve pain on upper limbs and torso), PARAESTHESIA (Constant tingling sensation on fingers/Tingling sensation on the palm), FEELING ABNORMAL (Odd sensation on the torso) and FEELING COLD (ischemic sensation and cold sensation). The patient was treated with TRAMADOL for Pain, at a dose of 3 dosage. On 01-Sep-2020, NEURALGIA (severe nerve pain on upper limbs and torso) had resolved. At the time of the report, PARAESTHESIA (Constant tingling sensation on fingers/Tingling sensation on the palm) and FEELING ABNORMAL (Odd sensation on the torso) had not resolved and FEELING COLD (ischemic sensation and cold sensation) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant reported include Kevoceturuzine 5mg,1d through oral route for allegy.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Significant follow up appended
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so). At the time of the report, EXPOSURE DURING PREGNANCY (May have received the Moderna COVID-19 vaccine while pregnant or may be planning to do so) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during possible pregnancy with no associated AEs for this female patient of unknown age. Patient declined further contact.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose past 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose past 36 days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-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 (Second dose past 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided by the reporter.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered  the  1 st dose of the Moderna COVID-19 Vaccine to a 12 years old female patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered  the  1 st dose of the Moderna COVID-19 Vaccine to a 12 years old female patient) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered  the  1 st dose of the Moderna COVID-19 Vaccine to a 12 years old female patient). On 13-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered  the  1 st dose of the Moderna COVID-19 Vaccine to a 12 years old female patient) had 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 information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up Information received contains No Significant Information
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain in the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain in the site of the injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain in the site of the injection). At the time of the report, VACCINATION SITE PAIN (Arm pain in the site of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact