chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, Anxiety, Blood pressure increased, Chest pain
Clinical narrative: She got the vaccine about 5:30 PM May 24, 2021, and initially did fine.  In the middle of the night she awoke short of breath, coughing, felt she could not breathe.  She denied any itching or hives.  Denied any swelling in throat or mouth.  Tried antihistamine.  Next day, went to work, still short of breath, and in mid day came to see us in the office.  She was wheezing and oxygen saturation was 89%.  ( 96% is normal), and hypertensive.  RR was 24-30.  BP was 160/104.   We sent her to ER for possible anaphylaxis to covid vaccine.   In ER was treated with albuterol nebs,  duonebs, prednisone, and admitted to the hospital on 8 liters oxygen.   She was in hospital 5/25/21 to 5/27/21 and sent home  off oxygen, on prednisone   DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety,  COPD exacerbation  (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Cough, Dyspnoea, Haematocrit normal, Hypertension
Clinical narrative: She got the vaccine about 5:30 PM May 24, 2021, and initially did fine.  In the middle of the night she awoke short of breath, coughing, felt she could not breathe.  She denied any itching or hives.  Denied any swelling in throat or mouth.  Tried antihistamine.  Next day, went to work, still short of breath, and in mid day came to see us in the office.  She was wheezing and oxygen saturation was 89%.  ( 96% is normal), and hypertensive.  RR was 24-30.  BP was 160/104.   We sent her to ER for possible anaphylaxis to covid vaccine.   In ER was treated with albuterol nebs,  duonebs, prednisone, and admitted to the hospital on 8 liters oxygen.   She was in hospital 5/25/21 to 5/27/21 and sent home  off oxygen, on prednisone   DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety,  COPD exacerbation  (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Lung opacity, Metabolic function test normal, Platelet count normal, SARS-CoV-2 test negative
Clinical narrative: She got the vaccine about 5:30 PM May 24, 2021, and initially did fine.  In the middle of the night she awoke short of breath, coughing, felt she could not breathe.  She denied any itching or hives.  Denied any swelling in throat or mouth.  Tried antihistamine.  Next day, went to work, still short of breath, and in mid day came to see us in the office.  She was wheezing and oxygen saturation was 89%.  ( 96% is normal), and hypertensive.  RR was 24-30.  BP was 160/104.   We sent her to ER for possible anaphylaxis to covid vaccine.   In ER was treated with albuterol nebs,  duonebs, prednisone, and admitted to the hospital on 8 liters oxygen.   She was in hospital 5/25/21 to 5/27/21 and sent home  off oxygen, on prednisone   DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety,  COPD exacerbation  (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic inflammatory response syndrome, Wheezing, White blood cell count normal
Clinical narrative: She got the vaccine about 5:30 PM May 24, 2021, and initially did fine.  In the middle of the night she awoke short of breath, coughing, felt she could not breathe.  She denied any itching or hives.  Denied any swelling in throat or mouth.  Tried antihistamine.  Next day, went to work, still short of breath, and in mid day came to see us in the office.  She was wheezing and oxygen saturation was 89%.  ( 96% is normal), and hypertensive.  RR was 24-30.  BP was 160/104.   We sent her to ER for possible anaphylaxis to covid vaccine.   In ER was treated with albuterol nebs,  duonebs, prednisone, and admitted to the hospital on 8 liters oxygen.   She was in hospital 5/25/21 to 5/27/21 and sent home  off oxygen, on prednisone   DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety,  COPD exacerbation  (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Menstruation delayed
Clinical narrative: 1. The following day I had a fever of 101, chills, headache and nausea which lasted for about 10 hours 2. Severe exhaustion for 4 or 5 days 3. Missed menstrual cycle (delayed menstrual cycle by 3 weeks) 4. Consistent diarrhea for the next month
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: 1. The following day I had a fever of 101, chills, headache and nausea which lasted for about 10 hours 2. Severe exhaustion for 4 or 5 days 3. Missed menstrual cycle (delayed menstrual cycle by 3 weeks) 4. Consistent diarrhea for the next month
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: Pt called on 06/08/2021 to inquire if she needs to take the 2nd dose since she had  Tingling of her whole arm after few minutes of the vaccine. She also recently started twitching her arms in last couple days. I referred her to consult with her doctor.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: client received 2nd dose covid vaccine Pfizer instead of Moderna. Per client to symptoms at time, observed 30 mins, gave ER precautions.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pruritus, Rash
Clinical narrative: Dizziness & headache within 15 minutes   Rash within the hour going down both arms looks like pimples or bug bites. They aren?t. Constant itching sensation since. Anytime I itch I get another mark
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Breast cyst, Breast cyst drainage, Laboratory test, Lymph gland infection
Clinical narrative: Tons of cysts showed up in breast one week after second dose.  Not the breast on the side the vaccine was administered.  Also an infected  lymph node on the same side?    Maybe had something to do with vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: MY ARM WAS SORE AT THE INJECTION SITE IMMEDIATELY AFTER MEDICINE INJECTED.  MY ARM HAS CONTINUED OVER THE LAST MONTH TO GET WORSE WITH THE PAIN RADIATING DOWN THE ARM AND CAUSING MY HAND TO GO NUMB AND TINGLING AT TIMES.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Heart rate increased, Heart rate irregular, Rash, Rash pruritic
Clinical narrative: Heart started beating really fast & then would beat really slow. I felt intense anxiety & felt like I was dying with my heart going back & forth. I had covid arm for 2 weeks, on & off again rashes all over my body that would itch.  I do not go seek treatment. I am now feeling better after the 2 week period
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Heart started beating really fast & then would beat really slow. I felt intense anxiety & felt like I was dying with my heart going back & forth. I had covid arm for 2 weeks, on & off again rashes all over my body that would itch.  I do not go seek treatment. I am now feeling better after the 2 week period
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site bruising, Vaccination site pain
Clinical narrative: Currently presents a bruise with pain when touched in the area where the vaccine was placed. A little headache in the temple area.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Influenza like illness, Menstrual disorder
Clinical narrative: Initial side effects were as expected. Sore arm and feeling like I had a mild flu the next day. Very sore mid back pain, headache, chills and a fever of 101.   I am now 6 days late for my period ( neg pregnancy test). This never happens. I am like clockwork. I had not received any warning about this side effect but I came across a Reddit forum where other women were reporting menstrual problems after the vaccine also. This needs to be listed as a side effect. And it needs to be studied further in case it impacts fertility.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Initial side effects were as expected. Sore arm and feeling like I had a mild flu the next day. Very sore mid back pain, headache, chills and a fever of 101.   I am now 6 days late for my period ( neg pregnancy test). This never happens. I am like clockwork. I had not received any warning about this side effect but I came across a Reddit forum where other women were reporting menstrual problems after the vaccine also. This needs to be listed as a side effect. And it needs to be studied further in case it impacts fertility.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Dizziness, Neck pain, Pain, Swollen tongue
Clinical narrative: Client reports on 6/9/21 that 3 days after first dose she experienced seeing black dots, blurred vision, neck pain that radiated to her head , dizziness and tongue swelling that lasted 2 hours. Client reports she never had shortness of breath. No history of chronic conditions, no medications taken . Client did not follow up with pcp.   Client reports going to the emergency room and that everything was fine except her blood sugar was low.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Client reports on 6/9/21 that 3 days after first dose she experienced seeing black dots, blurred vision, neck pain that radiated to her head , dizziness and tongue swelling that lasted 2 hours. Client reports she never had shortness of breath. No history of chronic conditions, no medications taken . Client did not follow up with pcp.   Client reports going to the emergency room and that everything was fine except her blood sugar was low.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Headache, Nausea, Presyncope
Clinical narrative: Approximately 3 hours post vaccination, patient developed chills, a fever to 103F. Then felt dizzy, had a pre-syncopal event with nausea, severe headache and vision changes. No true syncope.  No vomiting.   Headache, dizziness, vision changes and lightheadedness improved with rest. Still febrile 103F about 5 hours post vaccine administration.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Visual impairment
Clinical narrative: Approximately 3 hours post vaccination, patient developed chills, a fever to 103F. Then felt dizzy, had a pre-syncopal event with nausea, severe headache and vision changes. No true syncope.  No vomiting.   Headache, dizziness, vision changes and lightheadedness improved with rest. Still febrile 103F about 5 hours post vaccine administration.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain
Clinical narrative: In the weeks following my second dose, my legs and feet cramp daily. At times my feet are in a constant battle to NOT be in a cramp. The cramps move up my calves and cause extreme amounts of pain. I have been hydrating up to a gallon of water a day and that does not stop the cramps. I have started taking magnesium and all other vitamins to help but nothing has helped so far.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Flatulence, SARS-CoV-2 test negative, Somnolence
Clinical narrative: In less than 24 hours, started experience gastrointestinal issues - diarrhea and gas. It was pretty severe for the first week. And still, 3 weeks later, it has not gone away.  Other symptom was extreme fatigue, which started less than 24 hours later. And feeling exhausted after just going up a flight of stairs. And sleepy during the day. The worst of it was the first week, but still experiencing it 3 weeks later.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Feeling abnormal, Pain
Clinical narrative: The Moderna vaccine has thrown my autoimmune disorder into over drive and I am miserable had to take cortisteriods and the side effects are awful
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: Patient lost consciousness 10-20 seconds following 1st dose Pfizer vaccine. Patient awoke after 5-10 seconds and experienced nausea and vomited.  Patient was referred to urgent care as he refused EMS services.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye movement disorder, Eye pain, Fatigue, Headache
Clinical narrative: Eye pain. Right eye only.  Started day following the vaccine. Triggered by lateral and medial eye movement. No vision changes. Fatigue and headache as well. Chills initially, now resolved.  Will be seeing eye doctor tomorrow.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: After receiving 1st vaccine, I could not move my left arm or lie on that arm without crying in pain. The pain started next day at 3:00 am.  Even after second vaccine still not able to lift my arm up or lie on arm without crying in pain.   I am still having pain and discomfort to left arm.  The pain now radiates to under my arm.  It is now June 9, 2021.  I also still cannot lie on left arm.  Chills and fever only lasted one day with both vaccines but the pain and discomfort to left arm is non stop and  Interfering with work duties
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination complication, Vaccine positive rechallenge
Clinical narrative: After receiving 1st vaccine, I could not move my left arm or lie on that arm without crying in pain. The pain started next day at 3:00 am.  Even after second vaccine still not able to lift my arm up or lie on arm without crying in pain.   I am still having pain and discomfort to left arm.  The pain now radiates to under my arm.  It is now June 9, 2021.  I also still cannot lie on left arm.  Chills and fever only lasted one day with both vaccines but the pain and discomfort to left arm is non stop and  Interfering with work duties
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site urticaria, Pruritus, Swelling, Urticaria
Clinical narrative: Urticaria type reaction on upper left arm consisting of 5-10 hives with well defined borders. Hives were not itchy or irritating in behavior, but were dry and scaly in nature. Rash appeared sometime overnight follow vaccine administration and was noticed the following morning.  Wheal and flare type reaction appearing on both thighs just above the knee. Presentation was more severe on the left leg with swelling causing noticeable elevation of the area from the skin. Flare-up was itchy and reasonably bothersome.  Adverse events were regarded as relatively mild with minimal symptom management needed. Treatment consisted of only an application of Desonide to the areas on the legs which relieved the itchiness and mild burning sensation.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Hypoaesthesia, Malaise
Clinical narrative: Client sat in different chair as Mother was going to also receive vaccine. Within 10 minutes Mother alerted staff client was not feeling well. RN  PHN responded. Upon arrival client sitting upright in chair, pale, alert and oriented x4. Client stated feeling nausea. RN  gave emesis bag and water. RN began taking vitals. PHN  called 911 at 1459. At 1500 client stated feeling dizzy, nausea same. RN set anti gravity chair, per client unable to transfer by herself. Vitals at 1502: blood pressure 140/96, pulse 109. Alert and oriented x4, pale, diaphoretic. Client denied shortness of breath, chest pain. Per Mother client has allergies to olives, yellow things, and penicillin. Client does see allergist, per Mother when she gets reaction she takes client to hospital. No current medications or other medical history. At 1503 client reports new onset of blurry vision. Vitals at 1504: blood pressure 136/92, pulse 94, oxygen 99%. Client has x1 vomit episode, new onset of headache, pale, diaphoretic, alert and oriented x4. Client stated she could not feel legs. Per mother when client has reactions symptoms are headache and not being able to feel legs. Mother requesting to call 911. Mother informed PHN has been on phone with 911 dispatch. At 1507 paramedics arrived and assumed care. Client transported to medical center. Client left facility via gurney with paramedics at 1510.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Nausea, Pallor, Vision blurred, Vomiting
Clinical narrative: Client sat in different chair as Mother was going to also receive vaccine. Within 10 minutes Mother alerted staff client was not feeling well. RN  PHN responded. Upon arrival client sitting upright in chair, pale, alert and oriented x4. Client stated feeling nausea. RN  gave emesis bag and water. RN began taking vitals. PHN  called 911 at 1459. At 1500 client stated feeling dizzy, nausea same. RN set anti gravity chair, per client unable to transfer by herself. Vitals at 1502: blood pressure 140/96, pulse 109. Alert and oriented x4, pale, diaphoretic. Client denied shortness of breath, chest pain. Per Mother client has allergies to olives, yellow things, and penicillin. Client does see allergist, per Mother when she gets reaction she takes client to hospital. No current medications or other medical history. At 1503 client reports new onset of blurry vision. Vitals at 1504: blood pressure 136/92, pulse 94, oxygen 99%. Client has x1 vomit episode, new onset of headache, pale, diaphoretic, alert and oriented x4. Client stated she could not feel legs. Per mother when client has reactions symptoms are headache and not being able to feel legs. Mother requesting to call 911. Mother informed PHN has been on phone with 911 dispatch. At 1507 paramedics arrived and assumed care. Client transported to medical center. Client left facility via gurney with paramedics at 1510.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102 day of vaccination Fever 101 day 2 +3 post vaccination Fever 100 day 4+5 post vaccination
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Generalized rash consistent with allergic reaction
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging head normal, Paraesthesia oral, Taste disorder
Clinical narrative: Bell's palsy; tongue tingling, "weird taste" starting May 22, developed left sided Bell's palsy May 31
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: This was a second dose, and it should have been Pfizer
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Nausea, Pallor
Clinical narrative: Client reports to EMT's that she feels nausea, dizziness and mild shortness of breath. PHN's notified and arrive to find client alert and oriented x 4.  Client reports no history of medical conditions and blood pressure is elevated: 160/78, 150/88 and 170/84.Client reports she had a similar reaction an hour after her first dose.  Client was placed in zero gravity chair but unable to be in supine position due to nausea. Patient drank water and was provided with emesis bag.  Clients dizziness improved after water but nausea never improved. Client reports she feels she cannot take a full breath so PHN called 911. Fire and paramedics arrive at 6:33 pm and assumed care. Client declined to go with paramedics and signed AMA. . Client is still pale and nauseous. Client left facility accompanied by EMT in wheelchair  to car and her son drove home.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine, COVID-19, Contusion, Electrophoresis, Full blood count
Clinical narrative: On 5/27/2021 I woke up at 4am with an horrible headache  and vomiting, lasted about 4 hrs and then went way.  On 5/28/21 I developed petechiae spots about the size of bb's on the underside of my left arm, by my armpit. they lasted 2 days and then went away.  I sent pictures to my Dr and I saw her for an in person  a visit  on 6/9/21 she is ordering blood work will be completed 6/10/2021 at 930am  for the bruising and looking into a possible blood disorder. She also diagnosed me with shingles' at this visit. The shingles are located on my ride side of my torso.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Glycosylated haemoglobin, Haemoglobin, Headache, Herpes zoster
Clinical narrative: On 5/27/2021 I woke up at 4am with an horrible headache  and vomiting, lasted about 4 hrs and then went way.  On 5/28/21 I developed petechiae spots about the size of bb's on the underside of my left arm, by my armpit. they lasted 2 days and then went away.  I sent pictures to my Dr and I saw her for an in person  a visit  on 6/9/21 she is ordering blood work will be completed 6/10/2021 at 930am  for the bruising and looking into a possible blood disorder. She also diagnosed me with shingles' at this visit. The shingles are located on my ride side of my torso.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Protein C, Rash erythematous, SARS-CoV-2 test positive, Serum ferritin
Clinical narrative: On 5/27/2021 I woke up at 4am with an horrible headache  and vomiting, lasted about 4 hrs and then went way.  On 5/28/21 I developed petechiae spots about the size of bb's on the underside of my left arm, by my armpit. they lasted 2 days and then went away.  I sent pictures to my Dr and I saw her for an in person  a visit  on 6/9/21 she is ordering blood work will be completed 6/10/2021 at 930am  for the bruising and looking into a possible blood disorder. She also diagnosed me with shingles' at this visit. The shingles are located on my ride side of my torso.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Von Willebrand's factor antigen test
Clinical narrative: On 5/27/2021 I woke up at 4am with an horrible headache  and vomiting, lasted about 4 hrs and then went way.  On 5/28/21 I developed petechiae spots about the size of bb's on the underside of my left arm, by my armpit. they lasted 2 days and then went away.  I sent pictures to my Dr and I saw her for an in person  a visit  on 6/9/21 she is ordering blood work will be completed 6/10/2021 at 930am  for the bruising and looking into a possible blood disorder. She also diagnosed me with shingles' at this visit. The shingles are located on my ride side of my torso.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram normal, Cardiac stress test, Echocardiogram normal, Heart rate abnormal, Implantable cardiac monitor insertion
Clinical narrative: I am a healthy 43-year-old woman with no major medical problems and no history of cardiac disease of any kind. I received the COVID-19 vaccine on December 22, 2020 because I am a healthcare worker. Five days later, I felt palpitations and my fitness Watch recorded at least 30 seconds of an abnormal heart rhythm. I was admitted to the hospital where my treating cardiologists felt that the rhythm was ventricular tachycardia. I received an extensive inpatient evaluation including a CT angio, MRI, and  echocardiogram all of which were normal. I received my second dose of the vaccine on January 11 or 12th of 2021. Two weeks there after, I had a documented episode of ventricular tachycardia on a Ziopatch. I continue to be followed by a cardiologist with an implantable recorder and have  had no episodes of VT since. The etiology of my VT remains unknown but it?s timing in relation to the vaccine has prompted me to submit this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Magnetic resonance imaging normal, Palpitations, Ventricular tachycardia
Clinical narrative: I am a healthy 43-year-old woman with no major medical problems and no history of cardiac disease of any kind. I received the COVID-19 vaccine on December 22, 2020 because I am a healthcare worker. Five days later, I felt palpitations and my fitness Watch recorded at least 30 seconds of an abnormal heart rhythm. I was admitted to the hospital where my treating cardiologists felt that the rhythm was ventricular tachycardia. I received an extensive inpatient evaluation including a CT angio, MRI, and  echocardiogram all of which were normal. I received my second dose of the vaccine on January 11 or 12th of 2021. Two weeks there after, I had a documented episode of ventricular tachycardia on a Ziopatch. I continue to be followed by a cardiologist with an implantable recorder and have  had no episodes of VT since. The etiology of my VT remains unknown but it?s timing in relation to the vaccine has prompted me to submit this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Constipation, Headache, Rash, Sinus congestion
Clinical narrative: CONSTIPATION LASTING OVER A WEEK, STRONG HEADACHES FOR A WEEK, SINUS CONGESTION, RASH TYPE SKIN ERUPTIONS ON FACE, REMARKABLY SIZED AND A TYPICAL BOIL TYPE CANKER SORES INSIDE MOUTH.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Hemiparesis
Clinical narrative: Blood clot in left side of brain resulting in stroke and reduced functionality of the right side of my body.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Periorbital oedema, Swelling face
Clinical narrative: 2nd dose of Pfizer COVID vaccine in the am on 6/9/21. Facial edema to the lips and periorbital region  starting at 1400. No evidence of anaphylaxis on arrival to the ER at 2000. Pt given Benadryl 50mg and Dexamethasone 10mg with mild improvement of edema. Pt discharged home with Benadryl and epipen.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Pain, Vomiting
Clinical narrative: J&J vaccine today @0930, Nausea/Vomiting denies diarrhea, and has generalized weakness. PT does not feel any other symptoms at the moment.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Injection site erythema, Malaise, Pyrexia
Clinical narrative: 45 yo f c/o increased redness/pain to covid19 vaccination site on L upper arm/shoulder (deltoid region) from vaccine given at center approx 72hrs pta, states uncomplicated administration of dose (1st in shot series) but had increasing fevers/chills and general malaise over next 24-36hrs, then felt improving, but returned 24hrs pta; came to ED yesterday but did not want to check in, had nursing staff mark arm w/skin marker, and redness has spread outside the borders; Pt reports taking motrin/tylenol w/o sig improvement in sx's; Pt denies any distal numbness/tingling/weakness, prior hx of vaccine adverse events
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 45 yo f c/o increased redness/pain to covid19 vaccination site on L upper arm/shoulder (deltoid region) from vaccine given at center approx 72hrs pta, states uncomplicated administration of dose (1st in shot series) but had increasing fevers/chills and general malaise over next 24-36hrs, then felt improving, but returned 24hrs pta; came to ED yesterday but did not want to check in, had nursing staff mark arm w/skin marker, and redness has spread outside the borders; Pt reports taking motrin/tylenol w/o sig improvement in sx's; Pt denies any distal numbness/tingling/weakness, prior hx of vaccine adverse events
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Headache, Lip swelling
Clinical narrative: Pt got J&J vaccine yesterday around 0900. and woke up w/ swelling of lower lip. No issues with breathing, chest pain. Denies pain but discomfort. c/o slight headache
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: got J&J vaccine yesterday around 0800. c/o nausea, chills, headache and bodyache per pt. Denies blurry vision or dizziness. Eating and drinking normally per pt. Last dose of Tylenol was 0800.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache
Clinical narrative: Adolescent son (recently turned 15 years old): 6/7 - casually mentioned that it was a little difficult to breathe before going to bed about 10:00 pm 6/8 - still experiencing some breathing difficulty and mild headache during the morning/afternoon but by evening complaining of severe headache, chest pain and shortness of breath; began an Acetaminophen + Ibuprofen regimen starting about 10:00 pm in the evening 6/9 - woke up with mild chest pain, but no headache, which subsided by early afternoon; seemed to be ok by late afternoon/early evening; last dose of Ibruprofen was about 6:00 am that morning
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site rash, Photophobia, Pyrexia
Clinical narrative: Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the arm where injection was given
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Fever over 103°, chills, severe headache with light sensitivity, rash halfway down my arm on the arm where injection was given
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Lethargy, Myalgia, Neck pain, Pyrexia
Clinical narrative: Bad rash all over torso and both arms (not head or legs). Mild fever. Lethargy. Muscle pain -- especially neck and left ear. Rash was red bumps like Chicken Pox/Shingles -- about a hundred of them, not particularly itchy. Patient has had full course of all recommended childhood vaccines, but none recently. Symptoms started to subside on third day. Ibuprofen reduced aches. After fourth day, bumps are still visible but fading and causing no more discomfort.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Bad rash all over torso and both arms (not head or legs). Mild fever. Lethargy. Muscle pain -- especially neck and left ear. Rash was red bumps like Chicken Pox/Shingles -- about a hundred of them, not particularly itchy. Patient has had full course of all recommended childhood vaccines, but none recently. Symptoms started to subside on third day. Ibuprofen reduced aches. After fourth day, bumps are still visible but fading and causing no more discomfort.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Heavy menstrual bleeding, Menstruation irregular, Metabolic function test, Ultrasound pelvis
Clinical narrative: post-vaccination menstrual irregularities, including vaginal haemorrhages. experiencing heavy bleeding since the vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: post-vaccination menstrual irregularities, including vaginal haemorrhages. experiencing heavy bleeding since the vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Heart rate, Palpitations
Clinical narrative: Racing heart and anxiety attack at 0400. Woke up in the middle of the night with BP of 150/90 and heart rate of 180. Ambulance was called and diagnosed with heart palpitations from the vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Dyspnoea, Sleep disorder
Clinical narrative: Chest discomfort. Difficulty breathing. Still have dyspnea. Went to Urgent Care clinic and had neg. chest X-Ray. Wake up frequently at night due to shortness of breath.
Sex: U
Vaccine: HPV4
Symptoms: Foetal exposure during pregnancy, Ill-defined disorder
Clinical narrative: The nurse described her child as being "wild" but other than that her child is healthy.; feotal exposure during pregnancy; This spontaneous report was received from a registered nurse referring to her child, a patient of unknown age and gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The reporter was pregnant about 7 years before the reporting time. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The reporter's concomitant medications included cromolyn sodium (NASALCROM), loratadine and budesonide. The reporter had no pertinent medical history or drug reactions or allergies. On 07-MAR-2014, the reporter was inadvertently administered a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (intramuscular; strength, dose, lot # and expiration date were not provided) for prophylaxis, instead of the intended "diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (tdap)" vaccine, no adverse effect was reported (Wrong product administered; Exposure during pregnancy, No adverse effect; captured into 1403USA004380) (Foetal exposure during pregnancy; captured into 2105USA002713). It was also reported that the company representative could not confirm if the patient had received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The pregnancy outcome was live birth. The fetal outcome was normal. The reporter described the patient was being "wild" (ill-defined disorder) but other than that the patient was healthy. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown.  The outcome of the event ill-defined disorder was unknown. The causality between the event ill-defined disorder and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.; Sender's Comments:  US-009507513-1403USA004380:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product dose omission issue, Product quality issue
Clinical narrative: No additional AEs.; Since the patient did not receive the varicella portion of what would have been PROQU AD received, a missed dose AE is being filed; a different color than normal. It was off in color and reported to be slightly tannish.; Product foaming; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.           The reporter received 20 vials of new measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) and on 12-MAY-2021, when a nurse reconstituted a vial she noticed a different color than normal. It was off in color and slightly tannish. The lyophilized powder appeared as it normally did and the sterile diluent (indication: prophylaxis, dose, strength, route were not reported, lot# T008475, expiration date 19-NOV-2022) was the same as usual. The reporter also reported that there was foam in the vial. The patient did not receive measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0.5 ml (lot# U002540, expiration date 24-JUL-2022, dose, route and anatomical location were not reported) for prophylaxis on that day (missed dose) as the reporter did not want to use any of the 20 vials. The patient instead received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter did not have a varicella vaccine on site to give the patient as a complete replacement for the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD). No additional adverse events were reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Per caller all patients, asymptomatic/ No additional AE's/PQC's reported.; Caller reported a temperature excursion for frozen products. Caller notes PROQUAD administered to (3) patients; This spontaneous report was received from a nurse (vaccine provider), referring to a 5 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant therapy were not provided.  On 12-APR-2021, the patient was vaccinated with improperly stored (frozen) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # T010288 has been verified to be a valid lot number, expiration date reported as 20-SEP-2021) (strength and route were not reported) at a dose of 1 (unit not provided) for prophylaxis, administered by the reporter (incorrect product storage). The vaccine was stored under - 6.8 degree Celsius for 3 hours and 54 minutes. It was reported that there was no previous temperature excursion. The patient was asymptomatic, and there's no adverse reaction. No additional adverse event (AE) or product quality complaints (PQC) were reported.   This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody, Measles antibody negative
Clinical narrative: The measles part of the MMR titre showed it was low; This spontaneous report was received from a consumer via Pfizer referring to a 63-year-old patient of unknown gender. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported).       It was reported, on an unspecified date in 2009, the patient last titer test done showed to be positive. However, on an unknown date (reported as 3 weeks after first shot of Pfizer covid vaccine), her measles part of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) titer showed it was low (measles antibody negative).      The outcome of measles antibody negative and the causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the aforementioned event was not reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; was administered after a temperature excursion; This spontaneous report was received from a office manager and refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml, lot # S024363 has been verified to be a valid lot number, expiration date was reported as 06-AUG-2021 (formulation, strength, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (-10) to (8) (-4.2C) degrees Celsius for 17 hours and 30 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported; VARIVAX and PROQUAD were inadvertently administered to the same patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 12-MAY-2021, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T031381 with an expiration date on 15-SEP-2022) and measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# T037958 with an expiration date on 09-MAY-2022) at the same time for prophylaxis (accidental overdose).    Strength, dose, anatomical location, and route of administration were not reported for both vaccines.       No additional adverse event was reported.
Age: 11.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; Improperly Stored dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 11-year-old patient. No information regarding the patients' pertinent medical history, drug reactions, allergies, or concomitant therapies was provided.  On 25-MAY-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 ml, lot # 1687292, expiration date 25-MAY-2021 (route of administration was not provided) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of above 47 Fahrenheit degrees (F) (also reported as 46.9F) for 84 hours and 30 minutes. The digital data logger was not involved in recording the temperature excursion details. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-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: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No other AE; a dose of MMRII was administered to a patient after the expiration date; This spontaneous report was received from a customer 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 25-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 dose, lot # s015092, expiration date 15-MAY-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis. No other adverse event (AE) reported.  The customer also stated that on 15-APR-2021, the vaccine underwent a temperature excursion (TE) of 7.28 degrees Fahrenheit for 45 minutes. However, that temperature was within the recommended storage range for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and no TE occurred.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; patient was administered MMRlI that expired; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. Concomitant therapies included sterile diluent  On 07-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Recombinant Human Albumin (rHA) (lot number S015284, expiration date 19-MAY-2021) 0.5 milliliter for prophylaxis  (strength and route were not reported).    The vaccine had not had a temperature excursion. No additional adverse events reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE/PQC at time of call; VAQTA was dosed to a patient past the labeled expiry; This spontaneous report as received from a medical assistant concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 07-JUN-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) prefilled syringe reported as "past the labeled expiry" ,  dose: 1 milliter, lot # T008698,expiration date: 04-JUN-2021  for prophylaxis  (dose number, and route of administration were not reported).  The reporter stated that it was not known temperature excursions, no additional adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-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
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Chest X-ray, Chills, Headache, Oxygen saturation
Clinical narrative: Cellulitis; Pain; oxygen saturation decreased; Headache; Chills; Pyrexia; This case was received on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bypass surgery in July 2020. Concurrent medical conditions included Type 2 diabetes mellitus, High cholesterol and Hypertension. Concomitant products included METFORMIN, ERTUGLIFLOZIN PIDOLATE (STEGLATRO), LOSARTAN, METOPROLOL, VITAMIN D NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia). 10-Feb-2021, the patient experienced OXYGEN SATURATION DECREASED (oxygen saturation decreased). At the time of the report, CELLULITIS (Cellulitis), PAIN (Pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved and OXYGEN SATURATION DECREASED (oxygen saturation decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Chest X-ray: clear (Inconclusive) Clear. On 10-Feb-2021, Oxygen saturation: 92% (Low) 92%. On 10-Feb-2021, Pyrexia: 102 degrees (High) 102 degrees. On 10-Feb-2021, SARS-CoV-2 test: no results (Inconclusive) no results and inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was injected on 08-Feb-2021. He began getting headache the afternoon of the 10-Feb-2021 and developed sever night chills by 11.30 pm the night of the 10-Feb-2021, along with fever of 102 degrees, body aches and pain.  He experienced low O2 saturation at 92%. Though possibly unrelated the patient developed cellulitis at incision on left knee which was being treated with unspecified antibiotics. The patient was directed to and seen by urgent care facility. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.