chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lethargy, Migraine, Nausea, Pain
Clinical narrative: Extreme weakness, body aches, fever, lethargy starting about 16 hours after shot.  Nausea starting about 20 hours after shot Migraine headache starting around 24 hours after shot
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme weakness, body aches, fever, lethargy starting about 16 hours after shot.  Nausea starting about 20 hours after shot Migraine headache starting around 24 hours after shot
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis, Computerised tomogram abdomen abnormal, Diarrhoea, Stool analysis
Clinical narrative: Diarrhea 1 week after 2nd vaccine, worse first week of 8/21.  CT in ED at hospital showed pancolitis
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: BK virus infection, Blood culture, Blood test, COVID-19, Chills
Clinical narrative: breakthrough covid19 infection - onset of symptoms 7/31/2021 and admitted to hospital for fever/chills, diarrhea and renal failure on 8/4/2021
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram thorax, Cytomegalovirus test, Diarrhoea, Full blood count
Clinical narrative: breakthrough covid19 infection - onset of symptoms 7/31/2021 and admitted to hospital for fever/chills, diarrhea and renal failure on 8/4/2021
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Renal failure, Urine analysis, Vaccine breakthrough infection
Clinical narrative: breakthrough covid19 infection - onset of symptoms 7/31/2021 and admitted to hospital for fever/chills, diarrhea and renal failure on 8/4/2021
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Axillary pain, Breast pain, Chills, Fatigue
Clinical narrative: -pain, swelling, redness, warmth, hard lump 1/2 inch below shot site.  Rash on arm is getting bigger by the day.  Also, there is pain on my armpit that extends to almost my left breast. - I had muscle pain.  - Headache until day 2 - Feeling tired - Fever and Shivering  -Nauseous  - Upset stomach
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: -pain, swelling, redness, warmth, hard lump 1/2 inch below shot site.  Rash on arm is getting bigger by the day.  Also, there is pain on my armpit that extends to almost my left breast. - I had muscle pain.  - Headache until day 2 - Feeling tired - Fever and Shivering  -Nauseous  - Upset stomach
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: -pain, swelling, redness, warmth, hard lump 1/2 inch below shot site.  Rash on arm is getting bigger by the day.  Also, there is pain on my armpit that extends to almost my left breast. - I had muscle pain.  - Headache until day 2 - Feeling tired - Fever and Shivering  -Nauseous  - Upset stomach
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Ear discomfort, Headache
Clinical narrative: I have been extremely dizzy and light headed. I am experiencing extreme signs of vertigo. First I have blurred vision, my ears fill full and then I see the room spinning . After a get a headache (feels like my head is full) in the back of my head.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: I have been extremely dizzy and light headed. I am experiencing extreme signs of vertigo. First I have blurred vision, my ears fill full and then I see the room spinning . After a get a headache (feels like my head is full) in the back of my head.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Night sweats
Clinical narrative: Could not move left arm, chills, and night sweats.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Woke up with a slight fever the morning after getting second dose. Fever got worse as day went on. About 24 hours after getting vaccinated, developed high fever, nausea, vomiting and a cough. All symptoms except for the cough were gone the next day. The cough and a feeling of shortness of breath and wheezing developed and has lasted for two weeks. Seems to be getting better, but still feeling the respiratory side effects  currently
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Woke up with a slight fever the morning after getting second dose. Fever got worse as day went on. About 24 hours after getting vaccinated, developed high fever, nausea, vomiting and a cough. All symptoms except for the cough were gone the next day. The cough and a feeling of shortness of breath and wheezing developed and has lasted for two weeks. Seems to be getting better, but still feeling the respiratory side effects  currently
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tremor
Clinical narrative: Patient felt dizzy and slightly shaking 5 minuets after receiving her 2nd dose of pfizer vaccine. She was alert and oriented. Her vs at 6pm p88, BP 178/96; Res 18 and O2 saturation 100%. She speaks a different language then reporter. Her daughter who received her second dose of vaccine did the translation. She had TIA 3 years ago. She's currently not on any medication. She denies headache or blurred vision. According to her daughter, she does get nervous from time to time. Her last physical was 1 year ago. She felt better and calm 10 minutes later. Her vital signs was repeated and was the same. She states she has appointment with her PCP in 1 week for annual check. She advised to check blood pressure daily and take BP record with her to her doctor's appointment. She also advised to seek immediate medical attention if chest pain or symptoms worsens with understanding.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: pain in arm, continuing to pain in shoulders and back, long term pain still there
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Condition aggravated, Full blood count abnormal, Magnetic resonance imaging normal, Pyrexia, Vomiting
Clinical narrative: Pt received the DTaP vaccine at 3:30PM at her annual checkup. At 7:30PM she vomited and continued vomiting 3-4 times per hour. She had a temperature of 102.1 degrees. She was perfectly fine and healthy prior to the vaccine. No one in the family was sick, nor had been around anyone who was sick. At 2:00AM, Mom took her to the emergency room at the hospital where she was given antiemesis treatment and fluids and was sent home about 7:30AM.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: White blood cell count increased
Clinical narrative: Pt received the DTaP vaccine at 3:30PM at her annual checkup. At 7:30PM she vomited and continued vomiting 3-4 times per hour. She had a temperature of 102.1 degrees. She was perfectly fine and healthy prior to the vaccine. No one in the family was sick, nor had been around anyone who was sick. At 2:00AM, Mom took her to the emergency room at the hospital where she was given antiemesis treatment and fluids and was sent home about 7:30AM.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Pyrexia
Clinical narrative: Tiredness. Chest cramps. Fever.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Blood cholesterol increased, Blood test abnormal, Dizziness
Clinical narrative: Baseball sized knot. Hard. Hot. Dizzy. Watery mouth. Migraine. Nausea. Red patch with bumps. Couldn't move arm up or out.  Swelling has now gone down. I can move my arm again. However I have been lethargic ever since & constant migraines. I feel overall weak.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hepatic enzyme abnormal, Induration, Lethargy, Migraine
Clinical narrative: Baseball sized knot. Hard. Hot. Dizzy. Watery mouth. Migraine. Nausea. Red patch with bumps. Couldn't move arm up or out.  Swelling has now gone down. I can move my arm again. However I have been lethargic ever since & constant migraines. I feel overall weak.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Rash erythematous, Salivary hypersecretion, Swelling
Clinical narrative: Baseball sized knot. Hard. Hot. Dizzy. Watery mouth. Migraine. Nausea. Red patch with bumps. Couldn't move arm up or out.  Swelling has now gone down. I can move my arm again. However I have been lethargic ever since & constant migraines. I feel overall weak.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Palpitations
Clinical narrative: 15 yr old patient stated to feel dizziness, sweating, and palpitation 10 minutes after her second dose of Pfizer COVID vaccine. She's alert and oriented. She has no medical history. She states he got headache from the 1st dose of pfizer COVID vaccine. Assisted the patient to lay on yoga mat with legs elevated . Her VS stable: P78; BP 119/86; Res 18 and O2 saturation 98%. Cool pack applied to her forehead and back. water and salt crackers provider to the patient. She felt better after about 10 minutes on yoga mat. She went back to her chair and was observed for another 10 minutes. The patient and her father were advised to follow up with her PCP and inform her PCP about her symptom after receiving 2nd dose of vaccine with understanding.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Rash, Rash pruritic
Clinical narrative: Very swollen and sore lymph nodes in armpit on the side the shot was given. Lasting for 5 days and counting. A very itchy rash with large bumps appeared on the arm where the shot was given 6 days after the shot.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Loss of consciousness, Nausea, Syncope
Clinical narrative: Nausea; dizziness; fainting; vomiting. 1:20 am I blacked-out and hit my head on floor.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; dizziness; fainting; vomiting. 1:20 am I blacked-out and hit my head on floor.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Dizziness, Head discomfort, Headache, Red blood cell count normal
Clinical narrative: Pressure in head; pain in head; vertigo; blurry vision; dizzy. Pain did not go away with medication.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vision blurred, White blood cell count normal
Clinical narrative: Pressure in head; pain in head; vertigo; blurry vision; dizzy. Pain did not go away with medication.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Disturbance in attention, Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: Pressure in head; pain in head; vertigo; blurry vision; dizzy. Pain did not go away with medication.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal discomfort, SARS-CoV-2 test, Vertigo
Clinical narrative: Pressure in head; pain in head; vertigo; blurry vision; dizzy. Pain did not go away with medication.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram normal, Blood test, Chest pain, Echocardiogram, Fatigue
Clinical narrative: Patient had his first vaccination on 3/31/21 (pfeizer).  On 4/09/21  he felt tired and went to bed early at 9pm.  He  woke up at 9:45pm to major chest pains.  We called 911 and he was immediately transported to ER.  He had elevated tropinon levels (1.11) and was diagnosed as having a heart attack.  They completed an angiogram and didn't find any clogged arteries.  His organs looked good and his tests didn't show any abnormalities.  He was released 2 days later.  He was given 8 medications to take to monitor his new heart issues.  Two weeks later, on 4/23/21 he had chest pains at 6:30am in the morning and was hospitalized. He was monitored in the hospital and was later released on 4/25/21.  That evening (on 4/25) he experienced chest pains again and returned to the hospital.  He was treated for heart attack. More medication changes were made.  He has had multiple chest pains since and dr. have referred to them as "spasms".  He was admitted to the ER on 5/24 for excruciating chest pains and his medications were adjusted.  He has had "spasms" every two weeks since and his last hospitalization was on  6/25/21 for "spasms".  His current medication list incudes:  isosorbide, ranolazine, amlodipine, atorvastatin, clopidogrel, diltiazem, nitroglycerin (as needed), escitalopram.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myocardial infarction, Troponin increased
Clinical narrative: Patient had his first vaccination on 3/31/21 (pfeizer).  On 4/09/21  he felt tired and went to bed early at 9pm.  He  woke up at 9:45pm to major chest pains.  We called 911 and he was immediately transported to ER.  He had elevated tropinon levels (1.11) and was diagnosed as having a heart attack.  They completed an angiogram and didn't find any clogged arteries.  His organs looked good and his tests didn't show any abnormalities.  He was released 2 days later.  He was given 8 medications to take to monitor his new heart issues.  Two weeks later, on 4/23/21 he had chest pains at 6:30am in the morning and was hospitalized. He was monitored in the hospital and was later released on 4/25/21.  That evening (on 4/25) he experienced chest pains again and returned to the hospital.  He was treated for heart attack. More medication changes were made.  He has had multiple chest pains since and dr. have referred to them as "spasms".  He was admitted to the ER on 5/24 for excruciating chest pains and his medications were adjusted.  He has had "spasms" every two weeks since and his last hospitalization was on  6/25/21 for "spasms".  His current medication list incudes:  isosorbide, ranolazine, amlodipine, atorvastatin, clopidogrel, diltiazem, nitroglycerin (as needed), escitalopram.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cold sweat, Cough, Fatigue, Hypogeusia
Clinical narrative: cough, nasal congestion, runny nose, cold sweats, decreased taste, decreased smell, fatigue with COVID positive PCR on 08/03/2021
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hyposmia, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: cough, nasal congestion, runny nose, cold sweats, decreased taste, decreased smell, fatigue with COVID positive PCR on 08/03/2021
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Infection, SARS-CoV-2 test positive
Clinical narrative: breakthrough infection despite vaccination
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient, age 15,  received Moderna  and belongs to an unauthorized age group.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Cough, Diarrhoea, Dyspnoea
Clinical narrative: cough, wheezing, shortness of breath, nasal congestion, runny nose, fatigue, diarrhea, abdominal cramps, body aches, decreased smell with positive PCR on 08/03/2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pain, Parosmia, Rhinorrhoea
Clinical narrative: cough, wheezing, shortness of breath, nasal congestion, runny nose, fatigue, diarrhea, abdominal cramps, body aches, decreased smell with positive PCR on 08/03/2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Wheezing
Clinical narrative: cough, wheezing, shortness of breath, nasal congestion, runny nose, fatigue, diarrhea, abdominal cramps, body aches, decreased smell with positive PCR on 08/03/2021
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Oropharyngeal pain
Clinical narrative: Cough; runny nose; body aches; chills; sore throat; headache with COVID positive PCR on 08/03/2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Cough; runny nose; body aches; chills; sore throat; headache with COVID positive PCR on 08/03/2021.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Aphasia, Cerebral disorder, Coma, Eating disorder
Clinical narrative: Hi, our primary told us to make a report. My husband was down (but totally functioning) due to a reduction in force (thank you COVID). However, after his second dosage...within 1-2 weeks he declined to the point he became comatose. He could NOT talk/function/eat sleep. He was hospitalized for almost 1 month. He is still not functioning and now on heavy duty meds that have not made an impact. Our doc believes the vaccine triggered something in his brain. It has been so scary to see this. He had to take a leave from his new job. I honestly cannot believe all of this happened as I have heart nothing but good things from the vaccine. We are NOT telling a lot of people because we do not want to freak anyone out. Most folks do well...but my husband is very ill. We need more help. He went from a strong CPA who worked out every day, took great care of himself...to a sick person who lost over 30lbs. He is absolutely petrified to leave the house. We are living in a nightmare and it's taken a toll on him, myself, and our daughter. If there is anyone else who can help us...please contact us. We have been going to docs...and we still cannot get to the bottom of this. I am so sorry we had to even report this. We pray no one else goes through this.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fear, General physical health deterioration, Impaired work ability, Sleep disorder
Clinical narrative: Hi, our primary told us to make a report. My husband was down (but totally functioning) due to a reduction in force (thank you COVID). However, after his second dosage...within 1-2 weeks he declined to the point he became comatose. He could NOT talk/function/eat sleep. He was hospitalized for almost 1 month. He is still not functioning and now on heavy duty meds that have not made an impact. Our doc believes the vaccine triggered something in his brain. It has been so scary to see this. He had to take a leave from his new job. I honestly cannot believe all of this happened as I have heart nothing but good things from the vaccine. We are NOT telling a lot of people because we do not want to freak anyone out. Most folks do well...but my husband is very ill. We need more help. He went from a strong CPA who worked out every day, took great care of himself...to a sick person who lost over 30lbs. He is absolutely petrified to leave the house. We are living in a nightmare and it's taken a toll on him, myself, and our daughter. If there is anyone else who can help us...please contact us. We have been going to docs...and we still cannot get to the bottom of this. I am so sorry we had to even report this. We pray no one else goes through this.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna dose 1 and 2 at age 17, which is an unauthorized age group.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine participant received Moderna dose 2, fewer than 24 days (Moderna) after  the first dose.  According to system, Moderna dose 1 received on 02/04/2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: On 7/31 I experienced painful, heavy period-like cramps and a small amount of spotting, 10 days before the predicted start date of my period. I had no symptoms until mid afternoon 8/4 and my period began one whole week early.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine participant received Moderna dose 2 fewer than 24 days (Moderna) after  the first dose. Moderna dose 1 received on 02/04/2021.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Hypogeusia, Hyposmia
Clinical narrative: nasal congestion, runny nose, tactile fever, body aches, chills, decreased taste, decreased smell, fatigue with positive PCR on 08/04/2021
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: nasal congestion, runny nose, tactile fever, body aches, chills, decreased taste, decreased smell, fatigue with positive PCR on 08/04/2021
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Symptoms of sore throat, fatigue, nasal congestion started on 08/02/21.  Tested positive for COVID on 8/3/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: A rash as itchy as poison ivy across both upper legs, under both armpits all the way to fingertips on both hands, on chest and spreading so fast I could actually SEE more forming while I took a shower. I made a mistake on the time of day that I got the 2nd shot, it was at 9:20 a.m. not 8:30. I knew it was earlier in the morning.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID on 7/31/2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: Patient was immunized with 2 doses of Moderna COVID vaccine, second shot on March 30th.  We do not have the lot numbers of her vaccines.  Her symptoms of cough, fever, body aches, headache, and sore throat started on 07/28.   she tested positive for COVID on 7/30/2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient was immunized with 2 doses of Moderna COVID vaccine, second shot on March 30th.  We do not have the lot numbers of her vaccines.  Her symptoms of cough, fever, body aches, headache, and sore throat started on 07/28.   she tested positive for COVID on 7/30/2021.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Patient was exposed to someone with COVID on 7/30/2021, he did not develop symptoms, he tested positive for COVID on 7/31/2021
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Patient states he was immunized with Moderna vaccine, second shot in April, but he  temporarily misplaced his COVID vaccination card and we do not have the lot numbers of his immunization on file. he developed symptoms of cough, fatigue, body aches, and sore throat on 07/28.  He tested positive for COVID on 7/31/2021.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient states he was immunized with Moderna vaccine, second shot in April, but he  temporarily misplaced his COVID vaccination card and we do not have the lot numbers of his immunization on file. he developed symptoms of cough, fatigue, body aches, and sore throat on 07/28.  He tested positive for COVID on 7/31/2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nasal congestion, Pain
Clinical narrative: Patient states she was fully vaccinated with Moderna COVID vaccine, completed second shot in March.  We do not have a copy of her COVID vaccination card or know her lot numbers, she was advised to e-mail this information to her primary care provider's office.  Her symptoms of fatigue, fevers, body ache, headache, and nasal congestion started on 7/30/2021.  She tested positive for COVID on 7/31/2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient states she was fully vaccinated with Moderna COVID vaccine, completed second shot in March.  We do not have a copy of her COVID vaccination card or know her lot numbers, she was advised to e-mail this information to her primary care provider's office.  Her symptoms of fatigue, fevers, body ache, headache, and nasal congestion started on 7/30/2021.  She tested positive for COVID on 7/31/2021.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Patient develop sore throat on 7/27/2021, tested positive for COVID on 7/31/2021.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Myalgia
Clinical narrative: Patient developed cough, fatigue, muscle aches, sore throat, chills and subjective fevers on 8/2/2021. He tested positive for COVID on 8/3/2021.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Patient developed cough, fatigue, muscle aches, sore throat, chills and subjective fevers on 8/2/2021. He tested positive for COVID on 8/3/2021.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Injection site eczema, Lymphadenopathy, Peripheral swelling
Clinical narrative: The day of the injection I only had a swollen arm.  The second day was the worst, including continued swell of the arm, eczema on the site of the injection and below the armpit, and general feeling of weakness. I am writing this report on my third day and I still have a swollen arm, redness in both the arm and the armpit, and a swollen lympho gland.  I was administered one dose only since I had had covid last year, and so I was told one dose suffices.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythromelalgia, Incorrect route of product administration, Neuropathy peripheral, Postural orthostatic tachycardia syndrome
Clinical narrative: Erythromelagia, neuropathy, POtS; Erythromelagia, neuropathy, POtS; Erythromelagia, neuropathy, POtS; Inappropriate route of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Erythromelagia, neuropathy, POtS), ERYTHROMELALGIA (Erythromelagia, neuropathy, POtS) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Erythromelagia, neuropathy, POtS) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food intolerance (No food allergies but can tolerate very little foods.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 18-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (Erythromelagia, neuropathy, POtS) (seriousness criterion medically significant), ERYTHROMELALGIA (Erythromelagia, neuropathy, POtS) (seriousness criterion medically significant) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Erythromelagia, neuropathy, POtS) (seriousness criterion medically significant). On 08-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Erythromelagia, neuropathy, POtS), ERYTHROMELALGIA (Erythromelagia, neuropathy, POtS) and POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (Erythromelagia, neuropathy, POtS) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: fluctuations (abnormal) fluctuations in feet.   Concomitant medication were not provided  Treatment medication were not reported.  It was reported that, 2 weeks after vaccine patient started having hot feet and it was progress to bulging veins, tingling in face, hands and feet.  Company Comment: 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.
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: A 7 month old received MMR vaccine as part of accelerated vaccine schedule; none of the patients developed symptoms of vaccine related viral illness;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 7 month old male patient. The patient's concurrent concurrent conditions included critical aortic stenosis, biventricular dysfunction and ongoing partially ductal dependent systemic bloodflow. His pertinent medical history and concomitant medications was not provided by the authors.   On an unspecified date, as part of an accelerated vaccination schedule, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as part of an accelerated vaccination schedule; each dose was administered one month apart.  The second dose of the vaccine was administered 20 days prior to a scheduled orthotopic heart transplantation. The patient did not develop symptoms of vaccine related viral illness   This is one of several reports received from the same literature article.   A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2107USA002514:Original Case : 2107USA005481
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE/ PQC reported; HCP called in to reporta temperature excursion; MMR II had been administered to two patients; This spontaneous report was received from a physician, concerning a 12-month-old patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 16-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot number reported and validated as T001211 with expiration date on 12-JAN-2022) (dose, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).  The administered vaccine experienced a temperature excursion above 46 grades Fahrenheit (F) (47.5 F) during a time frame of 0 hours, 6 minutes and 0 seconds; that vaccine also had two previous temperature excursions as follows: 46 F (46.8 F) during a time frame of 0 hours, 3 minutes and 0 seconds, and, 46 F (47.8 F) during a time frame of 0 hours, 5 minutes and 0 seconds. The data logger was not involved in the call. No additional adverse events (AE).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA006983:
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: she accidently gave a patient a dose of  PNEUMOV AX 23 but the patient was ordered and supposed to receive the "Meningococcal vaccine" (unspecified); No additional adverse experiences reported by the patient; This spontaneous report as received from a medical assistant referring to a 17-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent  conditions and concomitant medications were not reported.       On an unknown date, the patient was accidentally vaccinated a dose of with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml/single dose, lot # T028093 with expiration date 24-APR-2022, for prophylaxis (strength, route of administration and anatomical location were not reported), instead of unspecified meningococcal vaccine(MENINGOCOCCAL VACCINE) (strength, dose, route of administration, anatomical location, lot #, expiration and indication were not reported). No additional adverse experiences were reported by the patient. The reporter stated that she could not verify what vaccine the patient was supposed to receive other than "meningococcal" and did not know the medical history of the patient or if the vaccine would be indicated for the patient at this age due to increased risk of pneumococcal disease. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: No patient side effects; expired vaccine administered; This spontaneous report has been received from a certified medical assistant concerning a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, and concomitant medications were not reported.  On 23-JUL-2021, the patient was vaccinated with an expired dose haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter, lot # R027322, expiration date 09-JUL-2021, administered intramuscularly x 1 dose, for prophylaxis. The caller confirmed that expired vaccine has had no temperature excursions; also, per post expiry memo, the reporter informed that expired vaccine potency was supported, and re-administration is up to the healthcare provider. No reported patient side effects. No other information was provided.
Sex: F
Vaccine: HEP, MMR
Symptoms: Antibody test negative, Extra dose administered, Hepatitis B surface antibody negative
Clinical narrative: negative antibody tests; anti-HBs antibody negative; This spontaneous report was received from a patient referring to herself, a female patient of unknown age.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and with hepatitis b vaccine (recombinant) (manufacturer unknown) for prophylaxis (dose, route of administration, frequency, lot/batch # and expiration date were not reported).   The reporter referred that she had a known condition in which she did not produce antibodies to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and with hepatitis b vaccine (recombinant) (manufacturer unknown). The patient stated she had had the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine four times (unknown dates) and still tested negative for antibodies. She also reported that she had also been vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) three times with boosters, and also still tested negative for antibodies.  It was also reported that her mother also did not make antibodies to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine (linked case # US-009507513-2108USA001036).  It was reported that the patient was vaccinated with PFIZER-BIONTECH COVID-19 VACCINE and finish her scheme of two doses in June 2021 (reported as "this year").  The outcome of antibody test negative and hepatitis b surface antibody negative was unknown.  No further clarify.   This one of two reports from the same reporter.; Sender's Comments:  US-009507513-2108USA001036:
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 7 month old male was administered Varicella vaccine and MMR vaccine as part of an accelerated vaccination schedule; none of the patients developed symptoms of vaccine related viral illness;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 7 month old male patient. The patient's concurrent conditions included biliary atresia. His pertinent medical history included failed Kasai procedure. Information regarding the patient's concomitant therapies were not provided by the authors.   On an unspecified date, as part of an accelerated vaccination schedule, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) both administered for prophylaxis (strength, dose, frequency, route of administration lot number and expiration date were not provided). The patient received these vaccine doses 21 days prior a schedule orthotopic heart transplantation. The patient did not develop symptoms of vaccine related viral illness.   This is one of several reports received from the same literature article   A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2107USA002514:
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 month old male was administered Varicella vaccine and MMR vaccine; none of the patients developed symptoms of vaccine related viral illness;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 7 month old male patient. The patient's concurrent conditions included biliary atresia. His pertinent medical history included failed Kasai procedure. Information regarding the patient's concomitant therapies were not provided by the authors.   On an unspecified date, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and a dose of varicella virus vaccine live (oka/merck) (manufacturer unknown) both administered for prophylaxis (strength, dose, frequency, route of administration lot number and expiration date were not provided). The patient received these vaccine doses 11 and 12 days prior a schedule orthotopic liver transplant and a small bowel obstruction surgical porcedure. The patient did not develop symptoms of vaccine related viral illness.   This is one of several reports received from the same literature article   A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2107USA002514:Original Case : 2107USA005481
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE; Nurse inadvertenly administered PROQUAD instead of MMRII; Nurse inadvertently administered PROQUAD on 07/27/2021 to a Patient who was, at same time, administered VARIVAX; This spontaneous report was received from a nurse referring to a 52-week-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 27-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous  lot number T035268, expiration date 15-OCT-2022 (dosage regimen was not reported) for prophylaxis and inadvertently the nurse administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD) lot number T030480, expiration date 07-MAR-2022 (dosage regimen and route of administration) (extra dose administered and wrong product administered) instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). No adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; experienced the temperature excursion was administered to a patient,; This spontaneous report was received from an office manager (also reported as healthcare business professional (HBP)) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 20-JUL-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter; lot # T035379 with expiration date 31-MAY-2022 (route of administration, anatomical location and dose number were not provided) for prophylaxis. The temperature excursion was 46.8 degrees Fahrenheit (F) for 9 hours. The digital data logger was involved. No adverse effects were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-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
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; Medical Assistant reports the administration of PROQUAD to 16 year old patient; This spontaneous report was received from a medical assitant referring to a 16-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 14-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T036562, expiration date 26-APR-2022 (route of administration was not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse events were reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs,; via the intramuscular (IM) route instead of the subcutaneous (SQ) route; was administered VARIVAX and MMR II via the intramuscular (IM) route instead of the subcutaneous (SQ) route at another facility on 29-JUL-2021; This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.       On 29-JUL-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) reported as 1 time dose (dose, frequency, lot # and expiration date were not reported) via intramuscular (IM) route instead of subcutaneous (SQ) route.  No additional adverse event reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: 3 patients received PROQUAD and 1 patient received VARIVAX vaccine which experienced a temp excursion; No additional AE details reported; This spontaneous report was received from an officer manager referring to four patients of unknown age and gender. The patients' concurrent conditions, medical history, and concomitant medications were not reported.   On an unknown date, 3 patients were vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T034823 with an expiration date on 11-APR-2022), and 1 patient was vaccinated with included varicella virus vaccine live (oka/merck)(VARIVAX) (lot# 1010311 with an expiration date on 24-MAR-2022). Both vaccines were exposed to a temperature excursion of 25.6°F degrees Fahrenheit (°F) for 3 hours before administration (product storage error). The data logger was not involved.  Strength, dose, anatomical location, and route of administration were not reported for all vaccines.     No additional adverse events were reported.  There was no previous temperature excursion reported.  Lot Number 1010311 was not valid for varicella virus vaccine live (oka/merck)(VARIVAX).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Reporting a temperature excursion and stated that doses have been administered; Spontaneous information has been received from a Medical Assistance referring to patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not provided.   On 16-JUN-2021, the patient was vaccinated with improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter (route, site and indication were not reported; lot # T030479, expiration date 07-MAR-2022, were found valid). The administered dose of the vaccine experienced a temperature of -7.2° Celsius for 2 hour and 21 minutes.  The vaccines had had previous temperature excursions of -5.9° C for 2 hour and 31 minutes.  Information was called because of data logger. No product quality complaint was involved.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: overdose; no adverse event; Spontaneous information has been received from the patient's aunt, referring to male patient of unknown age (reported as 1). The patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not provided.   On an unknown date, the patient received 2 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route, site, indication, lot # and expiration date were not provided) at the same time instead of getting one dose at the doctor's visit and the coming back for the second dose. The patient's aunt was concerned that this was an overdose, and after finishing the call, the patient's aunt mentioned that the company was going to get sued. No additional adverse event information was reported or product quality complaint reported.
Age: 12.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; temperature excursion / temperature: 11.1 C, 8.8 C; This spontaneous report was received from a nurse and refers to a 12-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, lot # T024831, expiration date 18-NOV-2022 (route of administration and anatomical location were not provided). The administered vaccine was stored in a temperature of 11.1 degree Celsius (C) for 1 hour 17 minutes and 8.8.C for 1 hour 17 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was 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; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-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