chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Neuralgia, Oral herpes, Paraesthesia
Clinical narrative: SMALL COLD SORE ON CENTER OF TOP LIP; SWELLING ON LIP; NERVE PAIN ON LEFT SIDE OF FACE AND UP AROUND EYE; TINGLING; This spontaneous report received from a patient concerned a 55 year old of unspecified 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, and batch number were not reported) dose was not reported, administered on 31-MAR-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 an unspecified date, the subject experienced small cold sore on center of top lip, swelling on lip, nerve pain on left side of face and up around eye, and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small cold sore on center of top lip, swelling on lip, nerve pain on left side of face and up around eye and tingling was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Somnolence
Clinical narrative: LOSS OF APPETITE; GROGGY; FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced groggy. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, headache, nausea, loss of appetite, and groggy. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pyrexia
Clinical narrative: FEELING DIZZY; CHILLS; HEAD PAIN; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021 20:00, the subject experienced feeling dizzy. On 03-APR-2021 20:00, the subject experienced chills. On 03-APR-2021 20:00, the subject experienced head pain. On 03-APR-2021 20:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling dizzy, head pain, fever, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; STRONG HEADACHE; This spontaneous report received from a patient 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: UNKNOWN) dose was not reported, administered  on 02-APR-2021 14:56 to right arm 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 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced strong headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and strong headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; HEAVY CHESTED; CHILLS; 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-APR-2021, the subject experienced flu like symptoms. On 04-APR-2021, the subject experienced heavy chested. On 04-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, flu like symptoms, and heavy chested. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body mass index, Chills, Dizziness, Fatigue
Clinical narrative: RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. 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, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced racing heartbeat. On 01-APR-2021, the subject experienced dizzy. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced weakness. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heartbeats increased (NR: not provided) 144 /min. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 21 BMI. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heartbeat, weakness, fever, muscle ache, and nausea on 02-APR-2021, and headache on 03-APR-2021, was recovering from chills, and had not recovered from fatigue, and dizzy. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Nausea, Pyrexia
Clinical narrative: RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. 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, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced racing heartbeat. On 01-APR-2021, the subject experienced dizzy. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced weakness. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heartbeats increased (NR: not provided) 144 /min. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 21 BMI. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heartbeat, weakness, fever, muscle ache, and nausea on 02-APR-2021, and headache on 03-APR-2021, was recovering from chills, and had not recovered from fatigue, and dizzy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: PAIN IN THE ARM; FEVER; 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) 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 pain in the arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and pain in the arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Tremor
Clinical narrative: IRREGULAR HEART BEAT; TREMOR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included slight murmur, diabetes, chronic obstructive pulmonary disease, alcohol user, and non-smoker, and other pre-existing medical conditions included patient have no known allergies and there was 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced tremor. On 02-APR-2021, the subject experienced irregular heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tremor, and irregular heart beat. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE; 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 was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Hypokinesia, Injection site bruising, Injection site pain, Joint swelling
Clinical narrative: SORENESS IN ELBOW, WRIST AND KNUCKLES; SORENESS IN ARM, HAND AND FINGERS; INJECTION SITE SORENESS; DIFFICULTY USING HAND; SWOLLEN SHOULDER; INJECTION SITE BRUISING; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received Tylenol unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced injection site bruising. On 02-APR-2021, the patient experienced difficulty using hand. On 02-APR-2021, the patient experienced swollen shoulder. On 02-APR-2021, the patient experienced injection site soreness. On 03-APR-2021, the patient experienced soreness in arm, hand and fingers. On 04-APR-2021, the patient experienced soreness in elbow, wrist and knuckles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Tylenol unspecified was not reported. The patient had not recovered from injection site soreness, difficulty using hand, swollen shoulder, injection site bruising, soreness in elbow, wrist and knuckles, and soreness in arm, hand and fingers. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ELBOW, WRIST AND KNUCKLES; SORENESS IN ARM, HAND AND FINGERS; INJECTION SITE SORENESS; DIFFICULTY USING HAND; SWOLLEN SHOULDER; INJECTION SITE BRUISING; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received Tylenol unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced injection site bruising. On 02-APR-2021, the patient experienced difficulty using hand. On 02-APR-2021, the patient experienced swollen shoulder. On 02-APR-2021, the patient experienced injection site soreness. On 03-APR-2021, the patient experienced soreness in arm, hand and fingers. On 04-APR-2021, the patient experienced soreness in elbow, wrist and knuckles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Tylenol unspecified was not reported. The patient had not recovered from injection site soreness, difficulty using hand, swollen shoulder, injection site bruising, soreness in elbow, wrist and knuckles, and soreness in arm, hand and fingers. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pain, Pyrexia, Vomiting
Clinical narrative: VOMITING/ THREW UP FOR AT LEAST 6 TIMES; ACHES ALL OVER BODY; FEELING WEAK; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 10808978, and batch number: 10808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 14:00 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced vomiting/ threw up for at least 6 times. On 02-APR-2021, the subject experienced aches all over body. On 02-APR-2021, the subject experienced feeling weak. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 106 F. On 03-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting/ threw up for at least 6 times on APR-2021, and had not recovered from fever, aches all over body, and feeling weak. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Injection site pain
Clinical narrative: CHEST PAIN; INJECT SITE PAIN; FEELING WARM; This spontaneous report received from a patient concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient was asthmatic.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced chest pain. On 03-APR-2021, the subject experienced inject site pain. On 03-APR-2021, the subject experienced feeling warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from inject site pain, and feeling warm on 03-APR-2021, and had not recovered from chest pain. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patiennt concerned a 28 year old female. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30am in left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, chills and nausea was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: On April 5,2021 at 7AM both of my feet & ankles were severely swollen. I could not see my ankle bones or foot veins,  I was in no discomfort . The swelling started to decrease by noontime.  I had no treatment.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin discomfort
Clinical narrative: Rash across body, itchiness and discomfort across skin. No treatment yet.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Shakes/chills, Fever, Headache, Body ache, Extreme fatigue.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shakes/chills, Fever, Headache, Body ache, Extreme fatigue.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I got shingles 2 weeks after first dose. Doctors say get second dose 3 weeks later (today) but bc I have shingles I?m waiting a week or two. Listening to my two pharmacist friends and my gut/common sense. There are many people with my same story online who have gotten shingles after the first or second dose of the Covid vaccine. I don?t know how there can?t be a connection. My pharmacy?s and two doctors told me the vaccine lowers your immune system so it makes sense you would be more susceptible to getting shingles.    One pharmacist said this: The common thing is to wait till it?s gone before second dose because there have been no studies done with patients with shingles and so they say wait till it?s gone just to be safe. If you have active shingles, do not get vaccinated 2nd dose until healed. Even if it is past the 42 days, it?s still fine to get the next shot.  Another pharmacist said this: As of 4/8/21, the CDC does not state specifically that you cannot get the shot tomorrow due to taking valacyclovir or due to active shingles infection.  In my personal opinion,  If it were me I would wait until off the Valacyclovir and the shingles has gone away just to be sure your immune system is at full force. Hope that helps.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: DAY 6:  Hives - 2 spots on nape of neck, at hairline. First thought to be mosquito bites.   DAY 7;  Awoke with hives/welts across torso, especially along  underwear lines, not itchy, took 2 Benadry, faded away after a few hours. DAY 8: Same as Day 7, woke about 2 am.  DAY 9:  Woke up at 3am with more widely spread hives/welts. Now on lower back as well as more on front & sides of torso.  itchy. Have taken 2 Benedryl first thing on Days 8, & 9 also.   Have eliminated possibility of food or environmental causes, including possible changes in laundry detergents, etc. Don't recall ever having this type of reaction to anything previously.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Eye irritation, Fatigue, Headache, Nasal congestion
Clinical narrative: Covid-19 Infection. Symptoms included nasal congestion, headache, fatigue, and burning of eyes for 3 days. Treatment included symptomatic relief with Paracetamol 500mg thrice daily, Leveoceterizine and Vitamin C supplements.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid-19 Infection. Symptoms included nasal congestion, headache, fatigue, and burning of eyes for 3 days. Treatment included symptomatic relief with Paracetamol 500mg thrice daily, Leveoceterizine and Vitamin C supplements.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: body rash, bumps, severe itiching
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Influenza like illness, Injection site pain, Somnolence
Clinical narrative: Arm soreness itching at injection site. Extreme tiredness and sleepiness. Brain fog flu like symptoms chills.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: About 10 hours after receiving the vaccine, I had a fever. The fever only lasted about 4 hours after I took some Motrin.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test normal, Computerised tomogram abdomen normal, Demyelination, Discomfort
Clinical narrative: Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Gait inability, Hypoaesthesia, Incontinence, Lumbar puncture normal
Clinical narrative: Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Myelitis transverse, Pain, Sensory loss
Clinical narrative: Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal cord injury cervical, Spinal cord injury thoracic, Vaccination complication
Clinical narrative: Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test negative, Blood immunoglobulin G normal, Borrelia test negative, CSF culture negative, Gait disturbance
Clinical narrative: Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: HIV test negative, Hypoaesthesia, Magnetic resonance imaging spinal normal, Methylmalonic aciduria, Myelitis transverse
Clinical narrative: Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Vitamin B12 normal
Clinical narrative: Began with severe back pain on 3/04/21. I went to the ER and they checked heart because pain radiated to front. I went home and pain continued briefly the next day. By 3/6, I began to have numbness in my left leg, so again, I went to ER and they  prescribed oral steroids and recommended MRI to be scheduled in back. My Monday 3/8 I was unable to walk and had no sensation from mid chest down. I could feel Pressure, but had no sense of temperature or sharpness. From that point I was admitted to the hospital. I spent a week on the 6th floor and a week on the inpatient rehab floor. They ruled out demyelinating disease that could cause  the lesion that was found on my cervical spine from c6-T-2. The records indicate demyelinating disease vs post vaccine reaction. All tests for demyelinating diseases came back negative, so it is believed by the doctors that this was definitely caused by the Moderna vaccine. It caused a transverse myelitis reaction, which I am still dealing with. My walking is extremely slow, and the sensation issues persist, along with incontinence.  I have all of my medical records and diagnosis for record.  The hope is this will eventually correct, but for now, I am still in PT/OT twice a week.
Sex: M
Vaccine: COVID19
Symptoms: Application site discolouration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: HARD KNOT UNDERNEATH INJECTION SITE; ARM FEELS HOT TO TOUCH; WHITE SPOTS ON ARM; LEFT ARM SWELLED UP THE SIZE OF AN ORANGE; 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 covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination to the Left Arm. No concomitant medications were reported. On 31-MAR-2021, the subject experienced hard knot underneath injection site. On 31-MAR-2021, the subject experienced arm feels hot to touch. On 31-MAR-2021, the subject experienced white spots on arm. On 31-MAR-2021, the subject experienced left arm swelled up the size of an orange. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm swelled up the size of an orange, hard knot underneath injection site, arm feels hot to touch, and white spots on arm. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: First dose: -moderate arm soreness/injection site pain for 3 days ~8:00 PM 4/7/2021 (day of dose 2): -mild dizziness (30 min) ~4:00 PM 4/8/2021 -?brain fog? spaced out and very tired, trouble focusing (~30 min) -tiredness continued throughout the rest of the day ~5:00 AM 4/9/2021 -vivid bad dream -slight head ache  -mild injection site pain/arm soreness since 4/8/2021
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental impairment, Nightmare
Clinical narrative: First dose: -moderate arm soreness/injection site pain for 3 days ~8:00 PM 4/7/2021 (day of dose 2): -mild dizziness (30 min) ~4:00 PM 4/8/2021 -?brain fog? spaced out and very tired, trouble focusing (~30 min) -tiredness continued throughout the rest of the day ~5:00 AM 4/9/2021 -vivid bad dream -slight head ache  -mild injection site pain/arm soreness since 4/8/2021
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: the patient became dizzy during her 30-minute post-vaccination observation. Hypertensive state and dizziness continued for over 1-hour post-vaccination. pluse remained within normal range and the patient reported no other symptoms
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Fatigue, Headache
Clinical narrative: Fatigue muscular and body, dizziness and loss of concentration, sever headache
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: SUPER ITCHY ARM AT INJECTION SITE, ARM IS OBSESSIVELY ITCHY; REDNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced itchiness at injection site. On 02-APR-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchiness at injection site, and redness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fall, Headache, Ill-defined disorder
Clinical narrative: SHAKING ALL OVER; PROJECTILE VOMITING; FELL DOWN; ACHING; BAD SHAPE FOR ENTIRE NIGHT; WEAKNESS; SPLITTING HEADACHE; NAUSEA; SPIKE FEVER; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included osteoporosis. The patient was previously treated with teriparatide for osteoporosis, varicella zoster vaccine rge (cho), and influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 14:45 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced shaking all over. On 30-MAR-2021, the subject experienced projectile vomiting. On 30-MAR-2021, the subject experienced fell down. On 30-MAR-2021, the subject experienced aching. On 30-MAR-2021, the subject experienced bad shape for entire night. On 30-MAR-2021, the subject experienced weakness. On 30-MAR-2021, the subject experienced splitting headache. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced spike fever. Laboratory data included: Body temperature (NR: not provided) 104 (units unspecified). On 31-MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 02-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from projectile vomiting on 02-APR-2021, had not recovered from nausea, spike fever, and splitting headache, and the outcome of shaking all over, weakness, fell down, aching and bad shape for entire night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Tremor, Vomiting projectile
Clinical narrative: SHAKING ALL OVER; PROJECTILE VOMITING; FELL DOWN; ACHING; BAD SHAPE FOR ENTIRE NIGHT; WEAKNESS; SPLITTING HEADACHE; NAUSEA; SPIKE FEVER; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included osteoporosis. The patient was previously treated with teriparatide for osteoporosis, varicella zoster vaccine rge (cho), and influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 14:45 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced shaking all over. On 30-MAR-2021, the subject experienced projectile vomiting. On 30-MAR-2021, the subject experienced fell down. On 30-MAR-2021, the subject experienced aching. On 30-MAR-2021, the subject experienced bad shape for entire night. On 30-MAR-2021, the subject experienced weakness. On 30-MAR-2021, the subject experienced splitting headache. On 30-MAR-2021, the subject experienced nausea. On 30-MAR-2021, the subject experienced spike fever. Laboratory data included: Body temperature (NR: not provided) 104 (units unspecified). On 31-MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 02-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from projectile vomiting on 02-APR-2021, had not recovered from nausea, spike fever, and splitting headache, and the outcome of shaking all over, weakness, fell down, aching and bad shape for entire night was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: MUSCLE ACHE; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old female. 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: 1802072 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On an unspecified date, the subject experienced muscle ache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache and tiredness was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Skin discolouration
Clinical narrative: RED LUMP ON ARM; RED MARK ON ARM; 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 concurrent conditions included leg pain, and other pre-existing medical conditions included the patient had received flue shot in the past but past reaction was not red. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 12:30 at right deltoid for prophylactic vaccination. Concomitant medications included ibuprofen for leg pain. On 31-MAR-2021, the subject experienced red lump on arm. On 31-MAR-2021, the subject experienced red mark on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red lump on arm, and red mark on arm. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Pain
Clinical narrative: BODY ACHE; DID NOT SLEEP WELL; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 69 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on //2021 for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On //2021, the subject experienced body ache. On //2021, the subject experienced did not sleep well. On //2021, the subject experienced chills. On //2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, did not sleep well, chills, and fatigue on //2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Pain in jaw, Pyrexia
Clinical narrative: JAW PAIN; ELEVATED HEART; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned an adult female. 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, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced jaw pain, elevated heart, chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, fever, elevated heart and jaw pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING IN EAR; 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) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced ringing in ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ear. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Body temperature decreased, Tinnitus
Clinical narrative: RINGING IN EAR; 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) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced ringing in ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ear. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Constant Ringing in my head- no treatment as of yet. Lower body temperature  ranging in low 97's
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Body temperature decreased, Tinnitus
Clinical narrative: Constant Ringing in my head- no treatment as of yet. Lower body temperature  ranging in low 97's
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: HARD LUMP/BIG SWOLLEN BLOB FORMED AT INJECTION SITE; ITCHINESS AT INJECTION SITE; REDNESS AT INJECTION SITE; This spontaneous report received from an patient of an unspecified age and sex (reporting on self). 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, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 12:30 pm to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced itchiness at injection site. On 01-APR-2021, the patient experienced redness at injection site. On 01-APR-2021, the patient experienced hard lump/big swollen blob formed at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hard lump/big swollen blob formed at injection site, redness at injection site and itchiness at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: INJECTION SITE REACTION; FEVER; INJECTION SITE PAIN; INJECTION SITE SWELLING; HEADACHE; FATIGUE; MYALGIA; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced injection site reaction. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site pain. On 03-APR-2021, the subject experienced injection site swelling. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced myalgia. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site reaction, injection site pain, injection site swelling, headache, fatigue, myalgia, nausea and fever was not reported. This report was non-serious.