chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: FELT LIKE SOMEONE INJECTED A LOT OF AIR INTO THE ARM; GOLF BALL SIZED MASS AT THE SITE OF INJECTION; PAIN IN THE LEFT COLLAR BONE LIKE SOMEBODY WHACKED IT; PAIN IN THE LEFT SIDE OF THE NECK / LEFT SIDE OF NECK STARTED TO FEEL LIKE PULLED MUSCLE; DIFFICULTY MOVING LEFT ARM; INTERMITTENT FEELING OF EXTREMELY SORE THROAT LIKE STEEL WOOL SCRATCHED INSIDE OF THROAT; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cholesterol issue, and other pre-existing medical conditions included: The patient did not have any change in lifestyle. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for cholesterol issue, and atorvastatin for cholesterol issue.  On 22-SEP-2021, the patient experienced felt like someone injected a lot of air into the arm. On 22-SEP-2021, the patient experienced golf ball sized mass at the site of injection. On 22-SEP-2021, the patient experienced pain in the left collar bone like somebody whacked it. On 22-SEP-2021, the patient experienced pain in the left side of the neck / left side of neck started to feel like pulled muscle. On 22-SEP-2021, the patient experienced difficulty moving left arm. On 22-SEP-2021, the patient experienced intermittent feeling of extremely sore throat like steel wool scratched inside of throat. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from golf ball sized mass at the site of injection, pain in the left collar bone like somebody whacked it, pain in the left side of the neck / left side of neck started to feel like pulled muscle, difficulty moving left arm, and intermittent feeling of extremely sore throat like steel wool scratched inside of throat, and the outcome of felt like someone injected a lot of air into the arm was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant and not breastfeeding at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant and not breastfeeding at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness, Pyrexia, Toothache, Vomiting
Clinical narrative: Real Bad toothache; He had the toothache before he took the vaccine. He has been having it like 2 years; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left (Batch/Lot Number: FD8448) (age at vaccination 21-year-old) on 15Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history included schizophrenia from an unknown date and unknown if ongoing, was diagnosed 4 months ago. The patient's concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm (unable to confirm if he was given in the muscle) on 19Aug2021 at 10:30 (lot number: EW0185) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced real bad toothache on 18Sep2021 and had the toothache before he took the vaccine, having it like 2 years on an unknown date. It was reported that, Yesterday, he got a real bad toothache and she forgot he took the shot. She later stated he has had the toothache on that same tooth for about 2 years. As a response to query, caller confirmed the patient received the COVID Vaccine second dose on 15Sep2021. The date of 15Feb2021 documented as the second dose was captured inadvertently and should have been documented as 15Sep2021. The patient dose not required to visit emergency room. The outcome of the event real bad toothache was not recovered and disease recurrence was unknown.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Toothache
Clinical narrative: Real Bad toothache; He had the toothache before he took the vaccine. He has been having it like 2 years; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left (Batch/Lot Number: FD8448) (age at vaccination 21-year-old) on 15Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history included schizophrenia from an unknown date and unknown if ongoing, was diagnosed 4 months ago. The patient's concomitant medications were not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm (unable to confirm if he was given in the muscle) on 19Aug2021 at 10:30 (lot number: EW0185) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced real bad toothache on 18Sep2021 and had the toothache before he took the vaccine, having it like 2 years on an unknown date. It was reported that, Yesterday, he got a real bad toothache and she forgot he took the shot. She later stated he has had the toothache on that same tooth for about 2 years. As a response to query, caller confirmed the patient received the COVID Vaccine second dose on 15Sep2021. The date of 15Feb2021 documented as the second dose was captured inadvertently and should have been documented as 15Sep2021. The patient dose not required to visit emergency room. The outcome of the event real bad toothache was not recovered and disease recurrence was unknown.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A,expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from administered expired vaccine. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21, expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946698.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Tremor
Clinical narrative: ongoing migranes from date of vaccine, chronic pain through entire left arm for the last 4 days, shaking that comes and goes
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neck pain, Tinnitus
Clinical narrative: Ears are still ringing but worse my left side of my neck still hurts bad
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Foaming at mouth, Gait inability, Speech disorder, Throat tightness
Clinical narrative: Throat started to close and mouth got very foamy, hard to swallow-noticed about 5 mins after shot.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Throat started to close and mouth got very foamy, hard to swallow-noticed about 5 mins after shot.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Sensation of foreign body, Throat tightness
Clinical narrative: Throat started to close and mouth got very foamy, hard to swallow-noticed about 5 mins after shot.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy menstrual period following vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood immunoglobulin E normal, Blood immunoglobulin G normal, Blood test normal, Lichen planus
Clinical narrative: March, 2021: Developed rash on lower back, small pustules that did not itch in beginning.  Rash slowly spread from lower back, to upper back, arms, under arms, legs, torso, all over body.  Rash was extremely painful and itchy and had red raised bumps literally all over my body.   No diagnosis was found until September April: rash spread May - September - tried Clobetosal, tracolimus, oral predinsone series, multiple lotions, antibiotics, fluconozale, antihistamines, stopped all medication in fear it was drug allergy, nothing helped grand rounds considered case -- diagnosed me LPP or Graham Little  treatment: clobetosol, tracilimos, prednisone, photo therapy, dupixent, hydroxychloroquine, finisteride, antibiotics, anti fungals
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pustule, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: March, 2021: Developed rash on lower back, small pustules that did not itch in beginning.  Rash slowly spread from lower back, to upper back, arms, under arms, legs, torso, all over body.  Rash was extremely painful and itchy and had red raised bumps literally all over my body.   No diagnosis was found until September April: rash spread May - September - tried Clobetosal, tracolimus, oral predinsone series, multiple lotions, antibiotics, fluconozale, antihistamines, stopped all medication in fear it was drug allergy, nothing helped grand rounds considered case -- diagnosed me LPP or Graham Little  treatment: clobetosol, tracilimos, prednisone, photo therapy, dupixent, hydroxychloroquine, finisteride, antibiotics, anti fungals
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site discomfort, Limb discomfort, Swelling
Clinical narrative: My arm felt bruised starting the evening of the injection & I had a hard bump for several months. The hard bump has since subsided, but the area of the injection site (my left arm) still habitually feels as though I was recently punched in the arm. It feels like a bruise inside of my arm. There is no mark on the outside, it's just that it habitually feels bruised.
Age: 62.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue started a few minutes after the two vaccinations and is still swollen about 4 hours later.  I have not sought medical assistance and hope that was not a foolish decision.  Hospitals and healthcare workers are so overwhelmed right now that I'm not going to use those resources unless it becomes an absolute emergency.  I have had this happen before and it has never gone to full anaphylaxis (knock wood).  I will take Benadryl before going to sleep.  I will message my doctor through My Chart to ask if I should be more cautious when getting the second Shingrix vaccine in a couple of months.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Heart rate increased, Hyperhidrosis, Insomnia
Clinical narrative: I got the shot at 11am on 3/23/2021. I was completely fine with absolutely no symptoms for most of the day until that night. Around 8pm, after laying down on my sofa for a couple of hours, I felt intense head pressure when I tried to stand up.  When I tried to walk, I realized that my entire body was shaking. I took Tylenol (500mg) and went to bed. Throughout the night, I experienced a severe migraine, chills, fever, sweating, increased heart rate and difficulty sleeping. I took more Tylenol (500mg) around 4:30am (3/24/2021) and went back to sleep. When I woke up around 8am (3/24/2021) all symptoms had resolved and I was completely fine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia, Tremor
Clinical narrative: I got the shot at 11am on 3/23/2021. I was completely fine with absolutely no symptoms for most of the day until that night. Around 8pm, after laying down on my sofa for a couple of hours, I felt intense head pressure when I tried to stand up.  When I tried to walk, I realized that my entire body was shaking. I took Tylenol (500mg) and went to bed. Throughout the night, I experienced a severe migraine, chills, fever, sweating, increased heart rate and difficulty sleeping. I took more Tylenol (500mg) around 4:30am (3/24/2021) and went back to sleep. When I woke up around 8am (3/24/2021) all symptoms had resolved and I was completely fine.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Ear discomfort, Tinnitus
Clinical narrative: Ear pressure, ringing and sounds in ear.  Sudden explained increased blood pressure noticed subsequently
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: A few hours later developed a headache that lasted for about 4 days. More than a month later (injection 8/18/21, today is 9/24/21) still have shooting pains in my right arm and extremely tender at injection site. Pain from the top of my arm near injection sight down to elbow. Also have a shooting pain on the whole right side of my body when taking a deep breathe, the pain is both on the front of my body as well as the back.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: First shot of Moderna, I could taste metal in the back of my throat 20 mins after shot.  My left arm was sore and I had a slight fever of 99.6 during the night.  Second shot of Moderna, I had soreness in arm, chills that came and went quickly, and then a fever of 100.8 during the night which was about 32 hours after shot.  Now 3 days after the shot I have stiffness in my neck.  The back of my head and where it meets my neck hurts when I move it left or right.  I thought I slept wrong but that usually only effects one side and not both.  This is going on 2 days now and it still hurts to turn. I can turn my head I just have to go very slow and careful.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: First shot of Moderna, I could taste metal in the back of my throat 20 mins after shot.  My left arm was sore and I had a slight fever of 99.6 during the night.  Second shot of Moderna, I had soreness in arm, chills that came and went quickly, and then a fever of 100.8 during the night which was about 32 hours after shot.  Now 3 days after the shot I have stiffness in my neck.  The back of my head and where it meets my neck hurts when I move it left or right.  I thought I slept wrong but that usually only effects one side and not both.  This is going on 2 days now and it still hurts to turn. I can turn my head I just have to go very slow and careful.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Dizziness, Influenza like illness
Clinical narrative: Flulike symptoms,  Chills for 4 hours, now hot  Aching joints Dizzy Stomachache  Muscle aches Blurred vision
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Vision blurred
Clinical narrative: Flulike symptoms,  Chills for 4 hours, now hot  Aching joints Dizzy Stomachache  Muscle aches Blurred vision
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Fever, chills, body aches, headache, mild nausea momentarily x 2, sleeplessness , severe injection site pain and mild swelling ( no redness ).
Age: 39.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache, mild nausea momentarily x 2, sleeplessness , severe injection site pain and mild swelling ( no redness ).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chest pain, Dizziness, Fatigue
Clinical narrative: Pain in arm,  under arm pain, neck lower back,  chest pain,  fatigue,  Dizzy off and on.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pain in arm,  under arm pain, neck lower back,  chest pain,  fatigue,  Dizzy off and on.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Tinnitus after 2nd dose in May starting about a week after shot. Has not stopped since then. Went to an ENT which showed no visual symptoms in outer ear. Went to an audiologist and had a hearing test. Test showed no sign of hearing loss. Was put on round of antibiotics which did not help. Was put on fluticasone propionate to take every day. I have taken it every day for 3 weeks with no relief.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral lichen planus, Stomatitis
Clinical narrative: Severe oral lichen planus new onset in which I have not had a resolution . Lesions on tongue, inner lips, uvula, and buccal areas. Fatigue
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Photopsia, Visual impairment
Clinical narrative: Visual disturbances: flashing lights (kaleidoscope vision?) in corners of eyes/peripheral of field of vision. It seems to be mostly in the left eye. It started almost immediately after receiving the injection and remained constant for approx. 5 hours. The next day it was still happening but only here and there, i.e,, sporadically, throughout the day. At the time of this writing, it is 8 days after receiving the injection, and I continue to experience the visual disturbance infrequently. I have discovered that moving my head quickly from left to right will result in the appearance of flashing lights in the peripheral of my left eye.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Persistent shingles. Starting 8/1/2021 3 rounds of anti virals abs or still won?t go away
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Coordination abnormal, Nervous system disorder, Pain in extremity, Postmenopausal haemorrhage
Clinical narrative: Post-menopausal (4+ years) bleeding. Nerve problems on left side. Severe abdominal cramping. Pain in legs. Loss of coordination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: The morning following vaccination, I had shortness of breath, chest pressure, nausea and fatigue. I called Walgreens pharmacy where I received my vaccination thinking this was not a normal reaction. They told me to head to the urgent care. Once at the urgent care, they ran an ekg, which showed a possible incomplete right bundle branch block. They rushed me in an ambulance over to the nearest ER. Ran a full  blood and metabolic panel, another ekg, and chest x-ray. All came back normal. Over the next few hours symptoms dissipated. Doc mentions the possibility of myocarditis. Tells me to come back to the ER if symptoms return. Symptoms come and go over the week but then come back strong. Check in to the same ER, they run the same tests in addition to an ultrasound on my heart. Tests return back normal. Doc recommends checking in with my primary care doc in a week and mentions that my body is most likely creating some kind of inflammatory response to the vaccine and that if this continues we may have to run more tests. A week later I see my primary care doc, still experiencing shortness of breath but not as severe throughout the week. Doc prescribes an albuterol inhaler and mentions if things don't clear up we may want to try prednisone. The doctor thinks I may have a mild case of myocarditis. Symptoms flared up again, I then startee prednisone. The shortness of breath seems combated, chest pressure/pain continues on and off. Doctor referred me out to a pulmonary specialist.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Inflammation, Inhalation therapy, Myocarditis
Clinical narrative: The morning following vaccination, I had shortness of breath, chest pressure, nausea and fatigue. I called Walgreens pharmacy where I received my vaccination thinking this was not a normal reaction. They told me to head to the urgent care. Once at the urgent care, they ran an ekg, which showed a possible incomplete right bundle branch block. They rushed me in an ambulance over to the nearest ER. Ran a full  blood and metabolic panel, another ekg, and chest x-ray. All came back normal. Over the next few hours symptoms dissipated. Doc mentions the possibility of myocarditis. Tells me to come back to the ER if symptoms return. Symptoms come and go over the week but then come back strong. Check in to the same ER, they run the same tests in addition to an ultrasound on my heart. Tests return back normal. Doc recommends checking in with my primary care doc in a week and mentions that my body is most likely creating some kind of inflammatory response to the vaccine and that if this continues we may have to run more tests. A week later I see my primary care doc, still experiencing shortness of breath but not as severe throughout the week. Doc prescribes an albuterol inhaler and mentions if things don't clear up we may want to try prednisone. The doctor thinks I may have a mild case of myocarditis. Symptoms flared up again, I then startee prednisone. The shortness of breath seems combated, chest pressure/pain continues on and off. Doctor referred me out to a pulmonary specialist.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: The morning following vaccination, I had shortness of breath, chest pressure, nausea and fatigue. I called Walgreens pharmacy where I received my vaccination thinking this was not a normal reaction. They told me to head to the urgent care. Once at the urgent care, they ran an ekg, which showed a possible incomplete right bundle branch block. They rushed me in an ambulance over to the nearest ER. Ran a full  blood and metabolic panel, another ekg, and chest x-ray. All came back normal. Over the next few hours symptoms dissipated. Doc mentions the possibility of myocarditis. Tells me to come back to the ER if symptoms return. Symptoms come and go over the week but then come back strong. Check in to the same ER, they run the same tests in addition to an ultrasound on my heart. Tests return back normal. Doc recommends checking in with my primary care doc in a week and mentions that my body is most likely creating some kind of inflammatory response to the vaccine and that if this continues we may have to run more tests. A week later I see my primary care doc, still experiencing shortness of breath but not as severe throughout the week. Doc prescribes an albuterol inhaler and mentions if things don't clear up we may want to try prednisone. The doctor thinks I may have a mild case of myocarditis. Symptoms flared up again, I then startee prednisone. The shortness of breath seems combated, chest pressure/pain continues on and off. Doctor referred me out to a pulmonary specialist.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Keratomileusis, Retinal haemorrhage, Retinal tear, Ultrasound eye
Clinical narrative: Severe headache for 2 days then spontaneous retinal tear with hemorrhage
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Spinal pain
Clinical narrative: Severe headache that lasted 8 days, then it  went away for 2-3 days and came back very strong headache and spinal pain that lasted for about one more week, i went to the doctor and dr prescribed pain medicine and anti-inflamatory meds for 7 days.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Anal sphincter atony, Diarrhoea, Dysaesthesia, Dyspnoea
Clinical narrative: High fever,headache,diarrhea,shortness of breath started on May 30th 2021,treated and cured on June 14th,2021. Sphincter weakness of urine and feces,lower limbs weakness numbness and zonesthesia,abdomen and lumbar numbness and zonesthesia gradually started from June 4th,which still has not been cured till now with over 3 months past. Based on the symptoms above,doctors think it might be acute myelitis caused by Vaccine. And I was given treatment of acute myelitis but I still can not get recovered. I am looking forward to your help.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Muscular weakness, Pyrexia, Urinary incontinence
Clinical narrative: High fever,headache,diarrhea,shortness of breath started on May 30th 2021,treated and cured on June 14th,2021. Sphincter weakness of urine and feces,lower limbs weakness numbness and zonesthesia,abdomen and lumbar numbness and zonesthesia gradually started from June 4th,which still has not been cured till now with over 3 months past. Based on the symptoms above,doctors think it might be acute myelitis caused by Vaccine. And I was given treatment of acute myelitis but I still can not get recovered. I am looking forward to your help.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Burning sensation, Pain, SARS-CoV-2 test negative
Clinical narrative: Extreme burning sensation starting over a week after second dose and has continued throughout the entire body and has increased in intensity. It feels like a sunburn under the skin or as if I had shingles all over my body. Pain level 8/9.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eating disorder, Fatigue, Injection site induration, Injection site pain
Clinical narrative: The injection site is fevered, swollen and hard about 6 inches long and 3 inches wide. The second day after the vaccine the actual puncture mark swelled and you can tell exactly where the needle was stuck.  It is hot to the touch. I've been experiencing Very super severe fatigue. I mean tiredness I've never felt nor ever been (and I do have 3 children.) The day after ( on the 21st)  I was very very queasy and anything I ate made my stomach hurt and I couldn't eat much. Thankfully that passed as of the 22nd but the swelling, heat and pain is still present as of this report as well as the fatigue.  I have a fever tonight and the symptoms (besides the stomach ) have worsened progressively!
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: The injection site is fevered, swollen and hard about 6 inches long and 3 inches wide. The second day after the vaccine the actual puncture mark swelled and you can tell exactly where the needle was stuck.  It is hot to the touch. I've been experiencing Very super severe fatigue. I mean tiredness I've never felt nor ever been (and I do have 3 children.) The day after ( on the 21st)  I was very very queasy and anything I ate made my stomach hurt and I couldn't eat much. Thankfully that passed as of the 22nd but the swelling, heat and pain is still present as of this report as well as the fatigue.  I have a fever tonight and the symptoms (besides the stomach ) have worsened progressively!
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dysmenorrhoea, Hot flush
Clinical narrative: I am 56 and ive beem in menopause for several years, I?d say this past month My hot flashes are hitting me hard. For the past month,  I?m experiencing hot flashes constantly.  Worse than ever. Every day all day and night off and on. And I feel a bit of cramping but no blood or discharge. I stay onto of annual OB appointments. I was officially on memopause several years ago.  No problems with bleeding for years. Not even break through bleeding. This past month Im  getting hot flashes constantly. All day no latter the weather.  Now, Im experiencing cramps. Not severe. Just an ache such as when you are menstrating. Thats something new this past week.  Again, its not severe at all. Its mild, but its unusual because Its been years since my last menstruation. My concern other than comstantly having hot flashes is going back to menstruating.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Fatigue, Muscle twitching, Pain
Clinical narrative: As of this past Monday I started to experience severe fatigue and body ache. Symptoms have only increased. Today muscle twitch and electrical sensation began, mostly in my upper arms.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Syncope
Clinical narrative: Syncope; Vasovagal reflex; This case was received via a company (Reference number: 2021TJP092479) on 10-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This case, initially reported to a regulatory authority by a physician, was received via another regulatory authority (Ref, v21126402).  Syncope was assessed as a serious.  On an unknown date, body temperature before examination: 36.5 degrees Celsius.  On 09-Sep-2021, the patient received the 1st dose of this vaccination in the afternoon.  The patient had a sick feeling during follow-up observation after vaccination.  Around 14:30, vasovagal reflex developed, which led to syncope.  The patient recovered with the leg elevation.  The symptoms remitted.  The outcome of vasovagal reflex and syncope was reported as recovered.  Follow-up investigation will be made.  Company Comment:  The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter's Comments: Vasovagal reflex accompanied by syncope.; Sender's Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable as the event occurred after the first dose. The event was considered unrelated to the vaccine per the reporter's assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Atrial fibrillation, Condition aggravated, Electrocardiogram, Pyrexia
Clinical narrative: fever, afrib with rvr and NSTEMI
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: fever, afrib with rvr and NSTEMI
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache, Pain
Clinical narrative: Heart racing, fever, headache, body aches, chest tightness, coughing shortness of breath.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Heart racing, fever, headache, body aches, chest tightness, coughing shortness of breath.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, C-reactive protein normal, Chest X-ray normal, Computerised tomogram head normal, Computerised tomogram spine
Clinical narrative: fever, syncopoe, ataxia with ambulation and LE weakness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Drug screen negative, Full blood count normal, Metabolic function test normal, Muscular weakness, Pyrexia
Clinical narrative: fever, syncopoe, ataxia with ambulation and LE weakness
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Troponin normal, Urine analysis normal
Clinical narrative: fever, syncopoe, ataxia with ambulation and LE weakness
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Mouth swelling, Rash, Swelling, Swelling face
Clinical narrative: allergic reaction/rash/hives Pt. reports had johnson and johnson shot wed. 9/17/21. Now has hives and swelling to mouth, face and all over his body. Large hives/welts on buttocks.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: allergic reaction/rash/hives Pt. reports had johnson and johnson shot wed. 9/17/21. Now has hives and swelling to mouth, face and all over his body. Large hives/welts on buttocks.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in both arms
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Muscular weakness
Clinical narrative: chest tightness, SOB, bilat arms and leg weakness. Still ongoing
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Cor pulmonale acute, Pulmonary embolism
Clinical narrative: acute saddle pulmonary embolism w acute cor pulmonale
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood test, Extrasystoles, Fatigue
Clinical narrative: Pt. states feels fatigued x2weeks and heart heart beat skips occasionally over last month. Pt pcp ordered blood work which showed low potassium level.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination complication
Clinical narrative: report side effects; insomnia for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia for 3 weeks) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy, Asthma and Allergy to antibiotic.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced INSOMNIA (insomnia for 3 weeks) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION COMPLICATION (report side effects). At the time of the report, INSOMNIA (insomnia for 3 weeks) had not resolved and VACCINATION COMPLICATION (report side effects) outcome was unknown.            No concomitant medication were reported.  MD had prescribed medication but did not worked. So she had taken self medication with over the counter medications to help him asleep.  Company comment- This case concerns a 37-year-old, female patient with previous relevant medical history of Food allergy, Asthma and Allergy to antibiotic, who experienced the unexpected events of Insomnia and Vaccination complication. The event Insomnia occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable since the events occurred after the first dose. The reporter assessed the events as possible.  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow Up information was received on 16-Sep-2021 and contains new event added.; Sender's Comments: This case concerns a 37-year-old, female patient with previous relevant medical history of Food allergy, Asthma and Allergy to antibiotic, who experienced the unexpected events of Insomnia and Vaccination complication. The event Insomnia occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable since the events occurred after the first dose. The reporter assessed the events as possible.  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness, Malaise
Clinical narrative: 3rd dose on 10th sep/ second dose on 10-Feb-2021; slight headache, flu like symptoms, very tired and feeling out of sorts; slight headache, flu like symptoms, very tired and feeling out of sorts; slight headache, flu like symptoms, very tired and feeling out of sorts; slight headache, flu like symptoms, very tired and feeling out of sorts; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (slight headache, flu like symptoms, very tired and feeling out of sorts), INFLUENZA LIKE ILLNESS (slight headache, flu like symptoms, very tired and feeling out of sorts), FATIGUE (slight headache, flu like symptoms, very tired and feeling out of sorts), HEADACHE (slight headache, flu like symptoms, very tired and feeling out of sorts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose on 10th sep/ second dose on 10-Feb-2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced MALAISE (slight headache, flu like symptoms, very tired and feeling out of sorts), INFLUENZA LIKE ILLNESS (slight headache, flu like symptoms, very tired and feeling out of sorts), FATIGUE (slight headache, flu like symptoms, very tired and feeling out of sorts) and HEADACHE (slight headache, flu like symptoms, very tired and feeling out of sorts). On 10-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose on 10th sep/ second dose on 10-Feb-2021). On 16-Sep-2021, MALAISE (slight headache, flu like symptoms, very tired and feeling out of sorts), INFLUENZA LIKE ILLNESS (slight headache, flu like symptoms, very tired and feeling out of sorts), FATIGUE (slight headache, flu like symptoms, very tired and feeling out of sorts) and HEADACHE (slight headache, flu like symptoms, very tired and feeling out of sorts) was resolving. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose on 10th sep/ second dose on 10-Feb-2021) outcome was unknown. Not Provided          Patient History contained no known allergies.  No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: No additional AEs or PQC reported; patient received PROQUAD and VARlVAX vaccines at same time; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 14-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) (lot # T034612, expiration date 10-APR-2022, 0.5 milliliter, subcutaneous) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T040418, expiration date 01-DEC-2022, 0.5 milliliter, subcutaneous) at same time for prophylaxis (overdose). No adverse event was reported.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events reported.; patient received one dose of HPV vaccine at the age of 18 and did not receive any additional doses or follow-up appropriately until today; This spontaneous report as received from a pharmacist refers to a 24-year-old patient, gender unknown. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  In 2015, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown), unidentified Merck hpv vaccine administered (name and lot number not provided) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The pharmacist was unable to be confirmed which valent the patient received.  It was reported that the patient did not receive any additional doses or follow-up appropriately until today, on 15-SEP-2021. The patient was vaccinated with a dose  of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) prefilled syringe, lot #: S028738, expiration date: 03-APR-2022 for prophylaxis (dose, and  route of administration, were not reported) (inappropriate schedule of product administration). No further information provided. No additional adverse events reported. No product quality complaints. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred.; product was administered to a patient on 9/14/2021 after a temperature excursion; This spontaneous report was received from a consumer, and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 14-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose for prophylaxis (lot number U008183 was verified to be valid, expiration date reported and established as 07-FEB-2023); (exact dose, route and site of administration were not provided).   The administered dose of vaccine experienced a temperature excursion of 12.9 Fahrenheit degrees (F) for 3 hours and 45 minutes; 11 F for 5 hours and 5 minutes; 13.2 F for 7 hours; and 14.9 F for 15 minutes. The administered dose of vaccine experienced also previous temperature excursion of 6 F to 14 F (7.5 F) for 1 hour and 10 minutes. The patient did not experience any additional adverse event.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AEs; PNEUMOVAX 23 was administered after expiration date; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, intramuscularly, lot # T010293 (has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) formulation vial), expiration date: 30-AUG-2021 (dose number and anatomical location were not reported) for prophylaxis after expiration date (expired product administered). No other adverse event was reported (no adverse event). The outcome was unknown.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: First case of shingles after ZOSTAVAX; reporter had cases of shingles twice / she had a mild case of shingles; This spontaneous report was received from a consumer referring on herself a female patient of unknown age. The patient's medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection, as prophylaxis (dose, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  On an unspecified date (also reported as after zoster vaccine live (ZOSTAVAX)), the patient experienced her first case of shingles (herpes zoster).   In approximately 2017, the patient was vaccinated with varicella zoster vaccine RGE (CHO) (SHINGRIX) solution for injection (dose, route of administration, anatomical site of injection, indication, lot number, and expiration date were not reported). The patient completed the series. Then, she had a mild second case of shingles (herpes zoster reactivation).   At the time of reporting, the patient recovered from herpes zoster. The outcome of herpes zoster reactivation was not reported. The causal relationship between the aforementioned events, zoster vaccine live (ZOSTAVAX) and varicella zoster vaccine RGE (CHO) (SHINGRIX), was not provided.