chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Anticoagulant therapy, Blood test normal, Computerised tomogram head normal, Deep vein thrombosis
Clinical narrative: After driving home  on June 27th, 2021 (about 1.5 hour drive), I noticed pain in my left calf muscle as I was walking out of the car. I have chronic calf pain, so I didn?t think too much of it until 5 days passed and it was still hurting. It felt like a Charlie-horse that wasn?t going away and I started to limp because the pain was so bad.  I went to urgent care center on July 2nd 2021, who then sent me to a local hospital , so I could get an ultrasound of my leg. After completing the ultrasound, I was diagnosed with a DVT in my left gastrocnemius vein. I was prescribed Eliquis 10mg BID for a week and 5mg BID for 3 months as per my hematologist.  **DISCLAIMER** There is no definitive result that my blood clot came as an adverse effect from the Moderna vaccine, but I am a healthy, active, non-overweight 31-year-old with no chronic illnesses or issues. It seems awfully strange to me that I could get a DVT in my leg when I have zero risk factors, but received the Moderna vaccine, which has links to blood clotting issues...
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Gait disturbance, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: After driving home  on June 27th, 2021 (about 1.5 hour drive), I noticed pain in my left calf muscle as I was walking out of the car. I have chronic calf pain, so I didn?t think too much of it until 5 days passed and it was still hurting. It felt like a Charlie-horse that wasn?t going away and I started to limp because the pain was so bad.  I went to urgent care center on July 2nd 2021, who then sent me to a local hospital , so I could get an ultrasound of my leg. After completing the ultrasound, I was diagnosed with a DVT in my left gastrocnemius vein. I was prescribed Eliquis 10mg BID for a week and 5mg BID for 3 months as per my hematologist.  **DISCLAIMER** There is no definitive result that my blood clot came as an adverse effect from the Moderna vaccine, but I am a healthy, active, non-overweight 31-year-old with no chronic illnesses or issues. It seems awfully strange to me that I could get a DVT in my leg when I have zero risk factors, but received the Moderna vaccine, which has links to blood clotting issues...
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: After driving home  on June 27th, 2021 (about 1.5 hour drive), I noticed pain in my left calf muscle as I was walking out of the car. I have chronic calf pain, so I didn?t think too much of it until 5 days passed and it was still hurting. It felt like a Charlie-horse that wasn?t going away and I started to limp because the pain was so bad.  I went to urgent care center on July 2nd 2021, who then sent me to a local hospital , so I could get an ultrasound of my leg. After completing the ultrasound, I was diagnosed with a DVT in my left gastrocnemius vein. I was prescribed Eliquis 10mg BID for a week and 5mg BID for 3 months as per my hematologist.  **DISCLAIMER** There is no definitive result that my blood clot came as an adverse effect from the Moderna vaccine, but I am a healthy, active, non-overweight 31-year-old with no chronic illnesses or issues. It seems awfully strange to me that I could get a DVT in my leg when I have zero risk factors, but received the Moderna vaccine, which has links to blood clotting issues...
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Cerebrovascular accident, Hypertension, Speech disorder
Clinical narrative: Stroke  in the hospital for 2 days now taking High Blood Pressure medication, Sugar  is high, and had  to  do Speech, Physical, and occupational Therapy.  Now  taking medication for blood pressure and checking blood sugar daily.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: Flu symptoms. Headache, body aches.fatigue. Covid symptoms.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Flu symptoms. Headache, body aches.fatigue. Covid symptoms.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Chest pain, Head discomfort, Headache, Heart rate increased
Clinical narrative: Numbness and loss of sensation in left side where shot was injected. Headache on left side. Uncontrollable eye twitching, fast heart beat, pain in chest, pressure in head. Throat closing and itchiness on left side of body.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Pruritus, Sensory loss, Throat tightness
Clinical narrative: Numbness and loss of sensation in left side where shot was injected. Headache on left side. Uncontrollable eye twitching, fast heart beat, pain in chest, pressure in head. Throat closing and itchiness on left side of body.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyskinesia, Loss of personal independence in daily activities, Muscle spasms, Pain
Clinical narrative: after receiving the second shot on June 17th I experienced significant debilitating pain all throughout my body that lasted for 12+ hours. a muscle on the left side of my back has been in constant spasm ever since. the intensity varies from minor annoyance to debilitating pain that interrupts whatever I may be doing. icing doesn't seem to help. I started taking magnesium a few days ago, too soon to tell if it's helping. yesterday my right thumb started spasming without pain and was moving outside of my control. it subsided after a few hours and has not repeated. today the muscles around the left side of my mouth have been spasming. as noted above, back spasms persist daily.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Haemoglobin, Intermenstrual bleeding, International normalised ratio, Pregnancy test urine negative
Clinical narrative: I have received the first (and only) dose of the Johnson and Johnson COVID-19 vaccine as of 6pm, July 7th 2021 and starting noticeably bleeding (menstruating) approximately 4 hours after I received the vaccine (10pm 7/7/2021).  It has been 23 days of continuous bleeding since I have received the vaccine (today?s date is 7/30/21).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time, Urine analysis
Clinical narrative: I have received the first (and only) dose of the Johnson and Johnson COVID-19 vaccine as of 6pm, July 7th 2021 and starting noticeably bleeding (menstruating) approximately 4 hours after I received the vaccine (10pm 7/7/2021).  It has been 23 days of continuous bleeding since I have received the vaccine (today?s date is 7/30/21).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood creatine normal, Blood iron normal, Blood test normal
Clinical narrative: Patient developed significant fatigue and migraine (vertigo, tinnitus, headaches) 3 weeks after receiving 1st dose of Moderna. Migraine and symptoms progressed to involve significant sinus pain/headaches; chronic sinusitis also diagnosed. MRI and CT scans identified chronic sinusitis with no other abnormal findings. Additional signs included insomnia and tachycardia. Patient was treated with course of levothyroxine and tapering dose of prednisone. Worse on prednisone - became fully bed-bound on highest dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Chronic sinusitis, Computerised tomogram head abnormal, Fatigue, Full blood count normal
Clinical narrative: Patient developed significant fatigue and migraine (vertigo, tinnitus, headaches) 3 weeks after receiving 1st dose of Moderna. Migraine and symptoms progressed to involve significant sinus pain/headaches; chronic sinusitis also diagnosed. MRI and CT scans identified chronic sinusitis with no other abnormal findings. Additional signs included insomnia and tachycardia. Patient was treated with course of levothyroxine and tapering dose of prednisone. Worse on prednisone - became fully bed-bound on highest dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate normal, Glycosylated haemoglobin normal, Headache, Insomnia, Iron binding capacity total normal
Clinical narrative: Patient developed significant fatigue and migraine (vertigo, tinnitus, headaches) 3 weeks after receiving 1st dose of Moderna. Migraine and symptoms progressed to involve significant sinus pain/headaches; chronic sinusitis also diagnosed. MRI and CT scans identified chronic sinusitis with no other abnormal findings. Additional signs included insomnia and tachycardia. Patient was treated with course of levothyroxine and tapering dose of prednisone. Worse on prednisone - became fully bed-bound on highest dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Migraine, Nasal septum disorder, Serum ferritin normal, Sinus pain
Clinical narrative: Patient developed significant fatigue and migraine (vertigo, tinnitus, headaches) 3 weeks after receiving 1st dose of Moderna. Migraine and symptoms progressed to involve significant sinus pain/headaches; chronic sinusitis also diagnosed. MRI and CT scans identified chronic sinusitis with no other abnormal findings. Additional signs included insomnia and tachycardia. Patient was treated with course of levothyroxine and tapering dose of prednisone. Worse on prednisone - became fully bed-bound on highest dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Tachycardia, Thyroxine normal, Tinnitus, Transferrin normal
Clinical narrative: Patient developed significant fatigue and migraine (vertigo, tinnitus, headaches) 3 weeks after receiving 1st dose of Moderna. Migraine and symptoms progressed to involve significant sinus pain/headaches; chronic sinusitis also diagnosed. MRI and CT scans identified chronic sinusitis with no other abnormal findings. Additional signs included insomnia and tachycardia. Patient was treated with course of levothyroxine and tapering dose of prednisone. Worse on prednisone - became fully bed-bound on highest dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine normal, Vertigo, Vitamin B12 normal
Clinical narrative: Patient developed significant fatigue and migraine (vertigo, tinnitus, headaches) 3 weeks after receiving 1st dose of Moderna. Migraine and symptoms progressed to involve significant sinus pain/headaches; chronic sinusitis also diagnosed. MRI and CT scans identified chronic sinusitis with no other abnormal findings. Additional signs included insomnia and tachycardia. Patient was treated with course of levothyroxine and tapering dose of prednisone. Worse on prednisone - became fully bed-bound on highest dose.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Catheterisation cardiac, Chest pain, Chills
Clinical narrative: Patient endured multiple uncontrolled symptoms, starting with (in order) 7 days of unusual headaches, nausea, vomiting, and chills, followed by multiple severe joint pains (including swelling and full body paralysis), ice cold feet that turned blue, and after all of these symptoms, there was very severe chest pain (I.e., pericarditis) that required emergency hospitalization for 3 days.   Afterwards, patient developed an autoimmune disease (I.e., Hypocomplementemia Urticarial Vasculitis) that had them urgently hospitalized for an additional 7 days.   To this day, patient has uncontrolled symptoms and is still disabled.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Disability, Electrocardiogram, Headache, Joint swelling
Clinical narrative: Patient endured multiple uncontrolled symptoms, starting with (in order) 7 days of unusual headaches, nausea, vomiting, and chills, followed by multiple severe joint pains (including swelling and full body paralysis), ice cold feet that turned blue, and after all of these symptoms, there was very severe chest pain (I.e., pericarditis) that required emergency hospitalization for 3 days.   Afterwards, patient developed an autoimmune disease (I.e., Hypocomplementemia Urticarial Vasculitis) that had them urgently hospitalized for an additional 7 days.   To this day, patient has uncontrolled symptoms and is still disabled.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paralysis, Pericarditis, Peripheral coldness, Urticarial vasculitis
Clinical narrative: Patient endured multiple uncontrolled symptoms, starting with (in order) 7 days of unusual headaches, nausea, vomiting, and chills, followed by multiple severe joint pains (including swelling and full body paralysis), ice cold feet that turned blue, and after all of these symptoms, there was very severe chest pain (I.e., pericarditis) that required emergency hospitalization for 3 days.   Afterwards, patient developed an autoimmune disease (I.e., Hypocomplementemia Urticarial Vasculitis) that had them urgently hospitalized for an additional 7 days.   To this day, patient has uncontrolled symptoms and is still disabled.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient endured multiple uncontrolled symptoms, starting with (in order) 7 days of unusual headaches, nausea, vomiting, and chills, followed by multiple severe joint pains (including swelling and full body paralysis), ice cold feet that turned blue, and after all of these symptoms, there was very severe chest pain (I.e., pericarditis) that required emergency hospitalization for 3 days.   Afterwards, patient developed an autoimmune disease (I.e., Hypocomplementemia Urticarial Vasculitis) that had them urgently hospitalized for an additional 7 days.   To this day, patient has uncontrolled symptoms and is still disabled.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Day of vaccination: Throbbing and aching muscle pain all over my body, Stabbing pain in my hand on the arm where the injection was received. Very painful injection site. Headache. Loss of appetite. Fatigue. Tylenol and Aleve were taken. Lymph node in armpit was inflamed.   Second day: On the second day I experienced the same symptoms that I did on the first day, plus chills. I was extremely cold most of the day, then at night I became extremely hot and began sweating more than usual. Developed a cough. Tylenol and Aleve were taken.   Third day:  Still have fatigue and muscle pain though not as intense as day one and two. Stabbing pain in my hand on the arm where the injection was received still occurring. Now also getting this stabbing pain in my feet. Headache. Loss of appetite. Fatigue. Lymph node in armpit still inflamed.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Day of vaccination: Throbbing and aching muscle pain all over my body, Stabbing pain in my hand on the arm where the injection was received. Very painful injection site. Headache. Loss of appetite. Fatigue. Tylenol and Aleve were taken. Lymph node in armpit was inflamed.   Second day: On the second day I experienced the same symptoms that I did on the first day, plus chills. I was extremely cold most of the day, then at night I became extremely hot and began sweating more than usual. Developed a cough. Tylenol and Aleve were taken.   Third day:  Still have fatigue and muscle pain though not as intense as day one and two. Stabbing pain in my hand on the arm where the injection was received still occurring. Now also getting this stabbing pain in my feet. Headache. Loss of appetite. Fatigue. Lymph node in armpit still inflamed.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain, Pain in extremity
Clinical narrative: Day of vaccination: Throbbing and aching muscle pain all over my body, Stabbing pain in my hand on the arm where the injection was received. Very painful injection site. Headache. Loss of appetite. Fatigue. Tylenol and Aleve were taken. Lymph node in armpit was inflamed.   Second day: On the second day I experienced the same symptoms that I did on the first day, plus chills. I was extremely cold most of the day, then at night I became extremely hot and began sweating more than usual. Developed a cough. Tylenol and Aleve were taken.   Third day:  Still have fatigue and muscle pain though not as intense as day one and two. Stabbing pain in my hand on the arm where the injection was received still occurring. Now also getting this stabbing pain in my feet. Headache. Loss of appetite. Fatigue. Lymph node in armpit still inflamed.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: Fever, chill, arm pain, fatigue
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: Fever, vomiting, exhaustion, chills, stomach pain, diarrhea, brain fog, Nasty rash all down my arm, body aches/pain, joint pain
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia, Rash, Vomiting
Clinical narrative: Fever, vomiting, exhaustion, chills, stomach pain, diarrhea, brain fog, Nasty rash all down my arm, body aches/pain, joint pain
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization due to COVID-19 Reported per vaccine EUA
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Sleep disorder
Clinical narrative: I have severe pain in my left and right shoulder since the vaccine. I have difficulty lifting my arms, I have difficulty sleeping because of the pain.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in left elbow, right wrist and knuckles of right hand.  The pain is ongoing and scepter for the wrist pain.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test
Clinical narrative: Hospitalization from COVID-19 reported per vaccine
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization from COVID-19 Reported per vaccine EUA
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Magnetic resonance imaging, Occipital neuralgia
Clinical narrative: Occipital neuralgia and shingles
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization from COVID-19 Reported per vaccine EUA
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive, SARS-CoV-2 test positive
Clinical narrative: Hospitalization on COVID-19 reported per vaccine EUA
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Cardiac monitoring, Fatigue, Headache
Clinical narrative: Arm pain. Swelling of injection site. Headache. Body ache. Heartrate dropped to 56. Was placed on a heart monitor for almost a week, waiting results of tests. Cardiologist said no sports, no heavy exercise, etc. Heartrate abnormally low.  Constant headaches turned into migraines. Stomach upset 3 days. Body aches. Sleepy and tired throughout the day. Forgetful.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate decreased, Injection site swelling, Memory impairment, Migraine, Pain
Clinical narrative: Arm pain. Swelling of injection site. Headache. Body ache. Heartrate dropped to 56. Was placed on a heart monitor for almost a week, waiting results of tests. Cardiologist said no sports, no heavy exercise, etc. Heartrate abnormally low.  Constant headaches turned into migraines. Stomach upset 3 days. Body aches. Sleepy and tired throughout the day. Forgetful.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Urine analysis
Clinical narrative: Arm pain. Swelling of injection site. Headache. Body ache. Heartrate dropped to 56. Was placed on a heart monitor for almost a week, waiting results of tests. Cardiologist said no sports, no heavy exercise, etc. Heartrate abnormally low.  Constant headaches turned into migraines. Stomach upset 3 days. Body aches. Sleepy and tired throughout the day. Forgetful.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalization from COVID-19 Reported per vaccine EUA
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypotension, Incomplete course of vaccination, Palpitations
Clinical narrative: The best way I can describe it is an amped-up heartbeat.  I would put my hand on my heart and feel a strong beating. When driving I felt my heartbeat through the seatbelt pad.  It lasted for at least two weeks into the third week.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Influenza like illness, Menstruation irregular, Nausea
Clinical narrative: 1 day after receiving vaccine: Very sore arm, nausea, fatigue 2-4 days after receiving vaccine: Flu like feeling (much worse than how I felt when I actually had COVID-19 in November of 2020). These symptoms lasted approximately a week or more. Since receiving the vaccine, I have had increased menstrual cramping and 2-3 menstrual cycles per month. I have had a menstrual cycle for 20 years now and have never been "off schedule", nor should I be as I am on oral birth control and have been for over 11 years.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1 day after receiving vaccine: Very sore arm, nausea, fatigue 2-4 days after receiving vaccine: Flu like feeling (much worse than how I felt when I actually had COVID-19 in November of 2020). These symptoms lasted approximately a week or more. Since receiving the vaccine, I have had increased menstrual cramping and 2-3 menstrual cycles per month. I have had a menstrual cycle for 20 years now and have never been "off schedule", nor should I be as I am on oral birth control and have been for over 11 years.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Electrocardiogram, Eye movement disorder, Seizure like phenomena, Staring
Clinical narrative: Stared, eyes wiggled, shook, unresponsive ( looked like a seizure) ER dr seemed to think it was syncope. However, she didn?t faint. No bloodwork was done. Daughter seemed to have been dehydrated.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli, Urine analysis
Clinical narrative: Stared, eyes wiggled, shook, unresponsive ( looked like a seizure) ER dr seemed to think it was syncope. However, she didn?t faint. No bloodwork was done. Daughter seemed to have been dehydrated.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Pain
Clinical narrative: moderate body aches, headache, chills, possible low-grade fever. soreness and swelling at the site.   No rash that I can see.  I will definitely live, but thought it best to document.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: Sores in mouth
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Feeling abnormal, Heavy menstrual bleeding, Menstrual disorder, Perineal pain
Clinical narrative: Menstrual cycle changes:  Atypical heavy flow, perineum pain/feeling of fullness.  Atypical breast tenderness.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 39 year old 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: 1816022 expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUL-2021, the subject experienced body aches. On 29-JUL-2021, the subject experienced fatigue. On 29-JUL-2021, the subject experienced fever. On 29-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, fever, headache and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a non-contactable consumer (patient).   A 69-year-old non-pregnant female patient received of first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot Number: EW0181) via an unspecified route of administration, administered in Arm Left on 01Jul2021 09:00 as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no Covid prior vaccination. The patient did not receive any other vaccine in four weeks and not received other medications in two weeks. On 07Jul2021 the patient experienced blood clot. The adverse event was resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested COVID-19 post vaccination. The outcome of the event was unknown.   No follow up attempts are possible. No further information is expected.
Age: 0.17
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Dermatitis allergic, Pyrexia, Rash
Clinical narrative: the allergic reaction started with a rash behind the legs that had spread across the body; low grade fever / High fever; This spontaneous report has been received from a consumer, who was also the patient's mother, referring to her 12-month-old daughter. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not reported. The patient had food allergies.   On 03-JUL-2007, the patient was vaccinated with the first dose of Haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB) (dose, route of administration, anatomical site of vaccination, lot number, vaccine scheme and expiration date were not provided) as prophylaxis.  On 01-MAY-2008, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (ml) once, administered subcutaneously (dose number, anatomical site of vaccination, vaccine scheme, lot number and expiration date were not provided) as prophylaxis.  The reporter did not know if it was varicella virus vaccine live (Oka/Merck) (VARIVAX) or not. On the same date, after the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) she developed low grade fever (pyrexia) and a rash that started on her leg and moved over her body. The patient sought unspecified medical attention; no lab diagnostics studies performed.  On 27-AUG-2008, the patient was vaccinated with the second dose of Haemophilus b conjugate vaccine (meningococcal protein conjugate) (PEDVAXHIB).   The causality assessment between the events and the suspect vaccines was not reported. The outcome of the events was not provided.   Follow-up information has been received from a consumer on 19-JUL-2021. On 01-MAY-2008, the patient experienced an allergic reaction that started with a rash behind the legs that had spread across the body (dermatitis allergic). Also, she experienced a high fever (pyrexia) during 4 consecutive nights. It was reported that treatment with ibuprofen (ADVIL) and paracetamol (TYLENOL) was provided for the events.   The reporter stated that the patient did not receive the recommended booster vaccine due to the allergic reaction, and reported that the patient had a titer test done and the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was still significant.  On approximately 06-MAY-2008 (reported as "by day 5 or 6") the patient recovered from the events.   The causality assessment between the event of dermatitis allergic and varicella virus vaccine live (Oka/Merck) (VARIVAX) was related.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received his first dose of V ARlV AX at 15 months second at 10 years old.; No additional AE reported; This spontaneous report was received from a registered nurse, referring to her son, a 24 years-old at the reporting time, male patient. The patient's concurrent conditions, pertinent medical history, concomitant medication, drug and allergy reaction were not provided.  On an unspecified date (approximately between 1198 and 1999 and reported as "at 15-months old"),  the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX). Also, it was reported that On an unspecified date (approximately between 2006 and 2007 and reported as "at 10-years old"), the patient received the second dose on varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration).  No additional adverse event reported.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional adverse event or product quality concern; She reports that a vial of PNEUMOVAX 23 (0.5ml) was drawn up in a syringe along with 0.7ml of STERILE DILUENT and administered.; This spontaneous report has been received from a medical assistant, referring to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, drug reaction or allergies, and concomitant medication were not reported.  On 30-JUN-2021 the vaccine Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vial 0.5 milliliter (lot number T028446 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), with expiration date 15-JUL-2022) (vaccination scheme, route of administration and anatomical location were not reported) was drawn up in a syringe along with sterile diluent 0.7 milliliter (lot number and expiration date unknown as it was discarded) and were administered as prophylaxis (product preparation issue). No adverse events were reported.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; Patient who was previously administered with VARlV AX was inadvertently administered PROQUAD; Healthcare Professional had Just saw MMR' lettering from PROQUAD; This spontaneous report has been received from a physician, referring to a 12 months-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug and allergy reactions was unknown by the reporter.  On an unknown date (reported as: previously administered), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). On 02-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strengths, formulations, doses, route of  administration, anatomical location of administrations, lot numbers and expiration dates were not provided for both suspect vaccines) both of them administered as prophylaxis. Consequently on the same day, the healthcare professional had "just saw MMR lettering" from the suspect vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product label confusion); therefore, the vaccine was inadvertently administered to the patient (wrong product administered). No additional adverse event were reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008727: US-009507513-2107USA008728: US-009507513-2107USA008733: US-009507513-2107USA008729: US-009507513-2107USA008732: US-009507513-2107USA008731: US-009507513-3107USA008730:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC reported; ROTATEQ administered after temperature excursion; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 12-JUL-2021, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1741377, expiration date 07-MAR-2022) underwent a temperature excursion prior to being administered. On the same day, the patient was administered with the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, 2ml) for prophylaxis (product storage error).   The storage temperature of the vaccine was 9.6 degree Celsius for a time frame of 11 minutes. There was no previous temperature excursion. The call was because of a data logger. No additional adverse events or product quality complaint was reported.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; a 14 year old patient received a dose of PROQUAD inadvertently on 8-JUL-2021; Information has been received from a physician referring to a 14 years old patient of unknown gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 08-JUL-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (a dose; albumin status, route, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events or product quality complaint (PQC) were reported.
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered
Clinical narrative: No other issues or concerns noted; a patient was given expired PNU23 that was expired; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information concernig the patient's concurrent conditions, pertinent medical history and concomitant medications was not provided.     On 14-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Lot # S034299, expiration date 01-JUL-2121) dose, route of administration and anatomical location were not provided, for prophylaxis. No other issues or concerns were noted by the Nurse.  This is one of two cases received from the same reporter (2107USA005417). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA005417:
Age: 16.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs were reported; saw meningococcal on the box and thought that was the correct vaccine; PEDVAX HIB was administered instead of Menactra; This spontaneous report was received from a registered nurse referring to a 16-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 19-JUL-2021, the patient was vaccinated with 0.5 ml of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S023646, expiration date 31-MAR-2022) for prophylaxis instead of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA). The nurse confirmed that there was no confusion between the two products. The person that administered the vaccine reported to the nurse that she saw meningococcal on the box and thought that was the correct vaccine to administer. The patient previously received 1 dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and this was going to be her second dose. No additional adverse event reported.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; patient was given a dose of V AQTA that expired in October 2020; This spontaneous report has been received from a physician and refers to a 18-year-old patient of unknown gender. No information regarding the patient's concomitant therapies, medical history and drug reactions or allergies was provided.  On 22-JUL-2021, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) that expired on an unknown date in October 2020 (dose, route of administration and lot # were not provided), for prophylaxis. No previous temperature excursion occurred. No adverse events were reported.
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: warts on hands; This spontaneous report was received from a physician, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, frequency, route, lot# and expiration date were unknown) for prophylaxis (also reported as vaccination).  On an unknown date, the patient developed warts on hands. The outcome of warts on hands was unknown.  The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Herpes zoster, Ill-defined disorder
Clinical narrative: Congestive heart failure; shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt.) of unknown age and gender. There was no information provided about the pt's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history. On or around 01-OCT-2013, the pt. was inoculated by a healthcare provider (HCP) with zoster vaccine live (ZOSTAVAX) injection (strength, dosage, route of administration, anatomical site of vaccination, lot number, and expiration date were not reported) at a clinic for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequently to the vaccine inoculation, the pt. was treated by a physician in a hospital for shingles (herpes zoster), congestive heart failure (cardiac failure congestive) and other zoster-related conditions (ill-defined disorder). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not reported. The reporter considered the events to be related to vaccination with zoster vaccine live (ZOSTAVAX).  Upon internal review, event cardiac failure congestive was determined to be medically significant.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Hypersensitivity, Irritability
Clinical narrative: blood within the stool/ 2 occasions, blood in the stool,; severe diarrhea with mucous; the patient may have had a hypersensitivity reaction; extremely fussy; This spontaneous report was received from a physician referring to a 4 month male patient at the reporting time of unknown age. The patient's concurrent conditions and medical history medications were not reported. His concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13). No known drug allergies were reported.   On 13-MAY-2021 at the age of 2 months old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliters by oral route (lot# 1707408 with an expiration date on 07-JAN-2022) for rotavirus prophylaxis (strength was not reported).     On an unknown date within the first week after the vaccination on an unknown date in May 2021, the patient was extremely fussy (irritability), experienced 8 days of severe diarrea with mucous and on 2 occasions blood in the stool (haematochezia).  The second dose of the vaccine was not administered after this visit.  On 14-JUL-2021, the patient received the second dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13), but the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was held by the physician as she suspected the patient may have had an hypersensitivity reaction.  It was reported that no treatment was given.  The outcome of irritability was unknown. The other events were resolved without intervention on an unknown date in 2021.  The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.    Upon internal review, haematochezia was considered a medically significant event.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Improperly stored vaccines administered; This spontaneous has been received from a medical assistant, concerning a 14- year-old patient of unknown gender.       The patient's concurrent conditions, medical history and concomitant medication were not reported.  On 28-JUL-2021, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (lot # 1687291 has been verified to be valid, expiration date reported as 11-SEP-2022) for prophylaxis.   Addittionally, the temperature of excursion was 80.6 farenheit (F), with time frame: 14 hours and 51 minutes, with previous temperature excursion: 73.2F for 9 hours and 25 minutes, 73.4F for 8 hours and 48 minutes. The error was identified by digital logger.   This is one of the several cases reported by the same source.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008728: US-009507513-2107USA008733: US-009507513-2107USA008729: US-009507513-2107USA008732: US-009507513-2107USA008731: US-009507513-2107USA008730: US-009507513-2107USA001853:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008730: US-009507513-2107USA008731: US-009507513-2107USA008732: US-009507513-2107USA008729: US-009507513-2107USA008733: US-009507513-2107USA008727:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008730: US-009507513-2107USA008731: US-009507513-2107USA008732: US-009507513-2107USA008733: US-009507513-2107USA008728: US-009507513-2107USA008727:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008731: US-009507513-2107USA008732: US-009507513-2107USA008729: US-009507513-2107USA008733: US-009507513-2107USA008728: US-009507513-2107USA008727: