chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Injection site swelling, redness, tightness sensation  Headache, body chill, flush facial region Took extra strength Tylenol and introduced fluids.  COVID arm remained for twelve days. I took pictures with my cell phone.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disorientation, Heart rate increased, Impaired driving ability
Clinical narrative: Difficulty operating a motor vehicle at speeds over about 45 mph. I drove to the first vaccination appointment that morning (3/2/2021) and everything was fine. Driving home from the jab I started to experience trouble driving my car when crossing a major bridge in Pittsburgh. The feeling was akin to the anticipatory feeling of being on a climbing roller coaster or drop ride in an amusement park. Elevated heart rate; disorientation and a sort of adrenaline like rush. The feeling returns every time I attempt to drive on a freeway/bridge/etc though local driving is fine. (I was driven to the 2nd jab.) The issue continues now, close to 2 months after it began 45 minutes after receiving the 1st jab. In the several months prior to the jab I was driving extensively with no issues.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agitation, Disorientation, Heart rate increased, Impaired driving ability
Clinical narrative: Difficulty operating a motor vehicle at speeds over about 45 mph. I drove to the first vaccination appointment that morning (3/2/2021) and everything was fine. Driving home from the jab I started to experience trouble driving my car when crossing a major bridge in Pittsburgh. The feeling was akin to the anticipatory feeling of being on a climbing roller coaster or drop ride in an amusement park. Elevated heart rate; disorientation and a sort of adrenaline like rush. The feeling returns every time I attempt to drive on a freeway/bridge/etc though local driving is fine. (I was driven to the 2nd jab.) The issue continues now, close to 2 months after it began 45 minutes after receiving the 1st jab. In the several months prior to the jab I was driving extensively with no issues.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine
Clinical narrative: Daily migraines for 6 days, treated with prescribed migraine med and ibprofren
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Mild to medium voice hoarseness. It has been continuous since vaccine 1 even with vocal rest and nutrients/nourishment. I have not yet visited a doctor but will reach out now.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itching, similar in appearance to ringworm. Appearing in multiple locations: hands, arms, legs, feet. Treating symptoms with prednisone and antihistamines. Treatment started today (4/28) and as of now, the condition is ongoing and seems to be intensifying.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Herpes zoster
Clinical narrative: Headache, Swelling around my left eye, diagnosed with shingles in left eye lid
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: REPORTED BECAUSE PT IS NOT 18 YRS. PATIENT ONLY HAD MINOR SORNESS IN ARM FOR 2 DAYS
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: Noticed a increase in tinitus.  Making it difficult to sleep   no hearing loss.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Dizziness, Influenza like illness, Palpitations
Clinical narrative: DIFFICULTY IN BENDING RIGHT KNEES; SEVERE RIGHT KNEE PAIN AND JOINT PAIN; HEART PALPITATIONS; DIZZINESS; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 220 pounds, and height was 5.9 inches. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergies and did not had any history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced heart palpitations. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced flu like symptoms. On 24-APR-2021, the subject experienced difficulty in bending right knees. On 24-APR-2021, the subject experienced severe right knee pain and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations on 07-APR-2021, and dizziness, and flu like symptoms on 24-APR-2021, and had not recovered from difficulty in bending right knees, and severe right knee pain and joint pain. This report was non-serious.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Developmental delay, Dyskinesia, Electroencephalogram normal, Laboratory test normal, Magnetic resonance imaging head normal
Clinical narrative: Within days of this vaccination, Patient developed abnormal movements and halted developmental progression.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blood uric acid, Gout, X-ray
Clinical narrative: Developed gout in right foot on 4/25. Treated with prednisone for three days and  symptoms have mostly resolved by 4/28.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Ultrasound scan, X-ray
Clinical narrative: Severe arthritic pain in full body. Notably in left calf. Negative ultrasound for blood clot in leg.  Intermediate burning sensation is limbs.  Prednisone issued by Rheumatologist for 6 days beginning 4/27/21.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak on face snd in left eye. Being treated currently with Valtrex and Lotemax SE.  I am generally very healthy. Suspect a correlation.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Headache, Lip pruritus, Oral pruritus, Pruritus
Clinical narrative: About 15 minutes after my vaccine my lips, tongue, gums, and inside of mouth were itching. I notified the nurse immediately. By the time I was administered a shot of 50mg Benadryl, I had started a slight itching on my arm and legs. My oxygen saturation level (read with meter on finder) was 99%. The nurse listened to my breathing to ensure I was not wheezing. My throat did not swell and neither did my tongue. I was monitored for about 30-45 minutes longer and released with instruction to take Tylenol as needed and Benadryl if needed again. I was instructed to call 911 with any sign of anaphylaxis. I napped during the day but have had no other symptoms other than a mild headache. I had some slight confusion on the way home but that occurs with any dose of Benadryl I take, so the shot of Benadryl could have caused that.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: REPORTING BECAUSE PATIENT 16 YRS OLD, WHICH IS LESS THAN THE RECOMMENDED AGE OF  18 YRS. PATIENT HAD MINOR SORE ARM FOR 2 DAYS FOLLOWING VACCINATION
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Alopecia, Back pain, Decreased appetite, Diarrhoea
Clinical narrative: Headache first,  motion sickness,  Severe lower back pain to where I can't do anything,  Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk  6ft then pain becomes unbearable, Loss of appetite and thirst ,  extreme bloating and weight gain,  Hardly urinate and diarrhea,  Side aches,  chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs   unless I lay down all the time,  Whole body feels swollen and puffy, losing hair,  trouble sleeping,  severe  drooling, eyes burn and hard to focus even with glasses
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Drooling, Dyspnoea, Dysuria, Eye irritation, Flank pain
Clinical narrative: Headache first,  motion sickness,  Severe lower back pain to where I can't do anything,  Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk  6ft then pain becomes unbearable, Loss of appetite and thirst ,  extreme bloating and weight gain,  Hardly urinate and diarrhea,  Side aches,  chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs   unless I lay down all the time,  Whole body feels swollen and puffy, losing hair,  trouble sleeping,  severe  drooling, eyes burn and hard to focus even with glasses
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Mobility decreased, Motion sickness, Muscular weakness
Clinical narrative: Headache first,  motion sickness,  Severe lower back pain to where I can't do anything,  Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk  6ft then pain becomes unbearable, Loss of appetite and thirst ,  extreme bloating and weight gain,  Hardly urinate and diarrhea,  Side aches,  chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs   unless I lay down all the time,  Whole body feels swollen and puffy, losing hair,  trouble sleeping,  severe  drooling, eyes burn and hard to focus even with glasses
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Peripheral swelling, Swelling, Thirst decreased, Vision blurred
Clinical narrative: Headache first,  motion sickness,  Severe lower back pain to where I can't do anything,  Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk  6ft then pain becomes unbearable, Loss of appetite and thirst ,  extreme bloating and weight gain,  Hardly urinate and diarrhea,  Side aches,  chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs   unless I lay down all the time,  Whole body feels swollen and puffy, losing hair,  trouble sleeping,  severe  drooling, eyes burn and hard to focus even with glasses
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Headache first,  motion sickness,  Severe lower back pain to where I can't do anything,  Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk  6ft then pain becomes unbearable, Loss of appetite and thirst ,  extreme bloating and weight gain,  Hardly urinate and diarrhea,  Side aches,  chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs   unless I lay down all the time,  Whole body feels swollen and puffy, losing hair,  trouble sleeping,  severe  drooling, eyes burn and hard to focus even with glasses
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Depression, Heavy menstrual bleeding, Lymphadenopathy, Menstruation irregular
Clinical narrative: menorrhagia for 1 week following vaccine accompanied by 'blues' or mild depression and significant cramping; recurred with second shot as well and menstrual bleeding has been irregular  swollen lymph nodes on left side painful breasts
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: menorrhagia for 1 week following vaccine accompanied by 'blues' or mild depression and significant cramping; recurred with second shot as well and menstrual bleeding has been irregular  swollen lymph nodes on left side painful breasts
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF cell count normal, Electromyogram abnormal, Endotracheal intubation, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Muscular weakness, Paraesthesia, Quadriplegia, Subacute inflammatory demyelinating polyneuropathy
Clinical narrative: Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Intensive care, Lumbar puncture, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis, Plasmapheresis, X-ray
Clinical narrative: Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Albumin CSF increased, CSF immunoglobulin increased, Gastrostomy, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mechanical ventilation, Plasmapheresis, Tracheostomy
Clinical narrative: Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Decreased appetite, Fatigue
Clinical narrative: RASH; MUSCLE CRAMPS; CHILLS; FEVER; HEADACHE; NAUSEA; MUSCLE ACHES; JOINT PAIN; FATIGUE; VOMITING; INSOMNIA; LACK OF APPETITE; STOMACH CRAMPS; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and occasional alcohol drinking, and other pre-existing medical conditions included no 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced insomnia. On 12-APR-2021, the subject experienced lack of appetite. On 12-APR-2021, the subject experienced stomach cramps. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced muscle aches. On 12-APR-2021, the subject experienced joint pain. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced muscle cramps. On 20-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, insomnia, chills, headache, and nausea on 13-APR-2021, lack of appetite, muscle aches, and fatigue on 19-APR-2021, stomach cramps on 16-APR-2021, and fever on 14-APR-2021, was recovering from rash, and had not recovered from joint pain, and muscle cramps. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Muscle spasms, Myalgia, Nausea
Clinical narrative: RASH; MUSCLE CRAMPS; CHILLS; FEVER; HEADACHE; NAUSEA; MUSCLE ACHES; JOINT PAIN; FATIGUE; VOMITING; INSOMNIA; LACK OF APPETITE; STOMACH CRAMPS; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and occasional alcohol drinking, and other pre-existing medical conditions included no 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced insomnia. On 12-APR-2021, the subject experienced lack of appetite. On 12-APR-2021, the subject experienced stomach cramps. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced muscle aches. On 12-APR-2021, the subject experienced joint pain. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced muscle cramps. On 20-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, insomnia, chills, headache, and nausea on 13-APR-2021, lack of appetite, muscle aches, and fatigue on 19-APR-2021, stomach cramps on 16-APR-2021, and fever on 14-APR-2021, was recovering from rash, and had not recovered from joint pain, and muscle cramps. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: RASH; MUSCLE CRAMPS; CHILLS; FEVER; HEADACHE; NAUSEA; MUSCLE ACHES; JOINT PAIN; FATIGUE; VOMITING; INSOMNIA; LACK OF APPETITE; STOMACH CRAMPS; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non smoker, and occasional alcohol drinking, and other pre-existing medical conditions included no 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen. On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced insomnia. On 12-APR-2021, the subject experienced lack of appetite. On 12-APR-2021, the subject experienced stomach cramps. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced muscle aches. On 12-APR-2021, the subject experienced joint pain. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced muscle cramps. On 20-APR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, insomnia, chills, headache, and nausea on 13-APR-2021, lack of appetite, muscle aches, and fatigue on 19-APR-2021, stomach cramps on 16-APR-2021, and fever on 14-APR-2021, was recovering from rash, and had not recovered from joint pain, and muscle cramps. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Eye pain, Headache, Migraine, Nasal discomfort
Clinical narrative: MIGRAINE TYPE HEADACHE; PAIN IN NOSE; FEELING OF PIMPLE INSIDE NOSE; PAIN IN EYES; PRESSURE IN LEFT EYE; BLINKING LIGHT AURA IN LEFT EYE; NASAL PRESSURE; FEELING OF BUMPS INSIDE NOSE; PAIN IN FOREHEAD/A LOT OF HEADACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient have no known drug allergies, 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol. On 05-APR-2021, the subject experienced migraine type headache. On 05-APR-2021, the subject experienced pain in nose. On 05-APR-2021, the subject experienced feeling of pimple inside nose. On 05-APR-2021, the subject experienced pain in eyes. On 05-APR-2021, the subject experienced pressure in left eye. On 05-APR-2021, the subject experienced blinking light aura in left eye. On 05-APR-2021, the subject experienced nasal pressure. On 05-APR-2021, the subject experienced feeling of bumps inside nose. On 05-APR-2021, the subject experienced pain in forehead/a lot of headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in nose, feeling of pimple inside nose, and feeling of bumps inside nose on 07-APR-2021, had not recovered from pain in forehead/a lot of headaches, migraine type headache, pain in eyes, pressure in left eye, and blinking light aura in left eye, and the outcome of nasal pressure was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Ocular discomfort, Photopsia, Rhinalgia
Clinical narrative: MIGRAINE TYPE HEADACHE; PAIN IN NOSE; FEELING OF PIMPLE INSIDE NOSE; PAIN IN EYES; PRESSURE IN LEFT EYE; BLINKING LIGHT AURA IN LEFT EYE; NASAL PRESSURE; FEELING OF BUMPS INSIDE NOSE; PAIN IN FOREHEAD/A LOT OF HEADACHES; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient have no known drug allergies, 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol. On 05-APR-2021, the subject experienced migraine type headache. On 05-APR-2021, the subject experienced pain in nose. On 05-APR-2021, the subject experienced feeling of pimple inside nose. On 05-APR-2021, the subject experienced pain in eyes. On 05-APR-2021, the subject experienced pressure in left eye. On 05-APR-2021, the subject experienced blinking light aura in left eye. On 05-APR-2021, the subject experienced nasal pressure. On 05-APR-2021, the subject experienced feeling of bumps inside nose. On 05-APR-2021, the subject experienced pain in forehead/a lot of headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in nose, feeling of pimple inside nose, and feeling of bumps inside nose on 07-APR-2021, had not recovered from pain in forehead/a lot of headaches, migraine type headache, pain in eyes, pressure in left eye, and blinking light aura in left eye, and the outcome of nasal pressure was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION TO VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2020, treatment medications included: prednisone. On MAR-2021, treatment medications included: cetirizine hydrochloride. On 09-MAR-2021, the subject experienced allergic reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic reaction to vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: SORE ARM; BRUISE ON CALF; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-APR-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 APR-2021, the subject experienced bruise on calf. On 15-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and bruise on calf was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Gait disturbance, Hypoaesthesia, Oedema peripheral, Pyrexia
Clinical narrative: NUMBNESS IN LEFT ARM FROM SHOULDER DOWN TO FINDERS AND IN BOTH LEGS; SWOLLEN RIGHT FOOT 2X BIGGER; LOSS OF COORDINATION; HARD TO WALK; LITTLE FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of diabetes except family history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced little fever. On 15-APR-2021, the subject experienced numbness in left arm from shoulder down to finders and in both legs. On 15-APR-2021, the subject experienced swollen right foot 2x bigger. On 15-APR-2021, the subject experienced loss of coordination. On 15-APR-2021, the subject experienced hard to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fever on 03-APR-2021, and had not recovered from numbness in left arm from shoulder down to finders and in both legs, swollen right foot 2x bigger, loss of coordination, and hard to walk. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: SWOLLEN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Chills, Contusion, Headache
Clinical narrative: BRUISE AT THE INJECTION SITE; SIDE EFFECTS; PAIN IN LEGS AND ARM PAIN; CHILLS; FEELING OF WEAKNESS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included lyme disease. 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 08-APR-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 APR-2021, the subject experienced bruise at the injection site. On APR-2021, the subject experienced side effects. On APR-2021, the subject experienced pain in legs and arm pain. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced feeling of weakness. On APR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in legs and arm pain, and the outcome of bruise at the injection site, slight headache, chills, feeling of weakness and side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: BRUISE AT THE INJECTION SITE; SIDE EFFECTS; PAIN IN LEGS AND ARM PAIN; CHILLS; FEELING OF WEAKNESS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included lyme disease. 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 08-APR-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 APR-2021, the subject experienced bruise at the injection site. On APR-2021, the subject experienced side effects. On APR-2021, the subject experienced pain in legs and arm pain. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced feeling of weakness. On APR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in legs and arm pain, and the outcome of bruise at the injection site, slight headache, chills, feeling of weakness and side effects was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: FELT OFF; FEVER; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included sulfa allergy, and concurrent conditions included nonsmoker. 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 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine sodium for drug use for unknown indication, linaclotide, melatonin, and zolpidem tartrate. On 14-MAR-2021, the subject experienced felt off. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off, and fever on 14-MAR-2021. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthcare professional advised patient to visit emergency room but patient did not want to go.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain at injection site. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Coordination abnormal, Dizziness, Hypoaesthesia
Clinical narrative: DIZZY; CRYSTALS IN THE EAR CREATING IMBALANCE PROBLEMS; NUMB HEAD; RHINORRHEA; NASAL DISCHARGE; INJECTION SITE PAIN; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced crystals in the ear creating imbalance problems. On APR-2021, the subject experienced numb head. On APR-2021, the subject experienced rhinorrhea. On APR-2021, the subject experienced nasal discharge. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) came out to be clear., and COVID-19 (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever, had not recovered from nausea, dizzy, crystals in the ear creating imbalance problems, and rhinorrhea, and the outcome of numb head and nasal discharge was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: DIZZY; CRYSTALS IN THE EAR CREATING IMBALANCE PROBLEMS; NUMB HEAD; RHINORRHEA; NASAL DISCHARGE; INJECTION SITE PAIN; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and alcohol use, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced crystals in the ear creating imbalance problems. On APR-2021, the subject experienced numb head. On APR-2021, the subject experienced rhinorrhea. On APR-2021, the subject experienced nasal discharge. On APR-2021, the subject experienced injection site pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Blood test (NR: not provided) came out to be clear., and COVID-19 (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and fever, had not recovered from nausea, dizzy, crystals in the ear creating imbalance problems, and rhinorrhea, and the outcome of numb head and nasal discharge was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: BROKE OUT WITH  SHINGLES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced broke out with shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out with shingles was not reported. This report was non-serious.  .
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS/FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 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 subject experienced tiredness/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness/fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210452621.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Lethargy, Product dose omission issue
Clinical narrative: COVID positive; Missed second dose; Dry uncontrollable cough; Severe headache; Lethargic; Swelling at injection site; Fever; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID positive) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), POTASSIUM, RIFAMPIN, VITAMIN D NOS and PREDNISONE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced COUGH (Dry uncontrollable cough), HEADACHE (Severe headache), LETHARGY (Lethargic), VACCINATION SITE SWELLING (Swelling at injection site), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021, the patient experienced COVID-19 (COVID positive) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, COVID-19 (COVID positive), COUGH (Dry uncontrollable cough), HEADACHE (Severe headache), LETHARGY (Lethargic), VACCINATION SITE SWELLING (Swelling at injection site), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient concomitantly used some heart medications and allergy medication. On 11-Mar-2021, the patient developed shortness of breath within 20 minutes, dry uncontrollable cough, body aches, fever, severe headache, lethargy, pain at injection site, swelling at injection site. The patient was injected with antibodies on 12-Mar-2021. The patient took Tylenol (acetaminophen) as treatment. The patient is waiting for 90 days post antibodies injection to receive her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Tested positive for COVID-19. Treatment information updated.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # 030A21A, with associated Adverse Events of  cough, headache, COVID-19 , lethargy, vaccination site swelling , vaccination site pain and pyrexia.. Based on the current available information and temporal association between the use of the product and the start date of all the events except COVID-19, a causal relationship cannot be excluded.Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: COVID positive; Missed second dose; Dry uncontrollable cough; Severe headache; Lethargic; Swelling at injection site; Fever; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID positive) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), POTASSIUM, RIFAMPIN, VITAMIN D NOS and PREDNISONE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced COUGH (Dry uncontrollable cough), HEADACHE (Severe headache), LETHARGY (Lethargic), VACCINATION SITE SWELLING (Swelling at injection site), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021, the patient experienced COVID-19 (COVID positive) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, COVID-19 (COVID positive), COUGH (Dry uncontrollable cough), HEADACHE (Severe headache), LETHARGY (Lethargic), VACCINATION SITE SWELLING (Swelling at injection site), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient concomitantly used some heart medications and allergy medication. On 11-Mar-2021, the patient developed shortness of breath within 20 minutes, dry uncontrollable cough, body aches, fever, severe headache, lethargy, pain at injection site, swelling at injection site. The patient was injected with antibodies on 12-Mar-2021. The patient took Tylenol (acetaminophen) as treatment. The patient is waiting for 90 days post antibodies injection to receive her second dose.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Tested positive for COVID-19. Treatment information updated.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # 030A21A, with associated Adverse Events of  cough, headache, COVID-19 , lethargy, vaccination site swelling , vaccination site pain and pyrexia.. Based on the current available information and temporal association between the use of the product and the start date of all the events except COVID-19, a causal relationship cannot be excluded.Based on mechanism of action of mRNA -1273 vaccine, the event COVID-19 is assessed as unlikely related to mRNA-1273.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional adverse events; An expired Vaccine (VAQTA) was adminsitered to the patient; This spontaneous report was received from a register nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported      On 26-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # T014590, expiration date 15-APR-2021, 0.5 milliliter (route not reported) for prophylaxis. The vaccine had never undergone a temperature excursion. No additional adverse events. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability