chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia, Urticaria
Clinical narrative: HIVES ON TORSO AND BACK 10+ HOURS POST SECOND DOSE;  JOINT PAIN, FEVER, HEADACHES
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Full blood count normal, Metabolic function test, Pregnancy test negative, Psychogenic seizure
Clinical narrative: ED COURSE & MEDICAL DECISION MAKING Patient  is a 25-year-old female who presents as a first responder to the emergency department today.  On my initial evaluation she is awake, alert, and in no acute distress, she does appear drowsy.  She is fully oriented and able to answer questions.  She has a normal neurologic exam.  Her labs show negative pregnancy, mild anemia, no leukocytosis, unremarkable CMP, normal CK.  A CT scan of her head shows no acute abnormalities.  The evaluation she appeared back to baseline.  On chart review it appears that she has previously been diagnosed with psychogenic nonepileptiform seizure and so no medication been previously recommended by her neurologist.  It is possible that her Covid vaccine triggered a recurrence of these versus this episode represents a true seizure.  Therefore I did recommend against driving, working at heights, swimming alone, and recommended things to help avoid seizures.  I recommended she follow-up with her primary care doctor as well as her neurologist.  I do not think she requires any medication today.  She is ambulating with a stable gait in the emergency department.  She will be discharged home, she was provided with reasons return to the emergency department.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: ED COURSE & MEDICAL DECISION MAKING Patient  is a 25-year-old female who presents as a first responder to the emergency department today.  On my initial evaluation she is awake, alert, and in no acute distress, she does appear drowsy.  She is fully oriented and able to answer questions.  She has a normal neurologic exam.  Her labs show negative pregnancy, mild anemia, no leukocytosis, unremarkable CMP, normal CK.  A CT scan of her head shows no acute abnormalities.  The evaluation she appeared back to baseline.  On chart review it appears that she has previously been diagnosed with psychogenic nonepileptiform seizure and so no medication been previously recommended by her neurologist.  It is possible that her Covid vaccine triggered a recurrence of these versus this episode represents a true seizure.  Therefore I did recommend against driving, working at heights, swimming alone, and recommended things to help avoid seizures.  I recommended she follow-up with her primary care doctor as well as her neurologist.  I do not think she requires any medication today.  She is ambulating with a stable gait in the emergency department.  She will be discharged home, she was provided with reasons return to the emergency department.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: I had a fever of  103 and headache that lasted 4 days.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood potassium normal, Blood sodium normal
Clinical narrative: 1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea increased, COVID-19, Death, Dysphagia, Full blood count
Clinical narrative: 1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin decreased, Lethargy, Metabolic function test, Oxygen saturation decreased
Clinical narrative: 1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal, Polymerase chain reaction positive, Red blood cell count decreased, SARS-CoV-2 test positive, White blood cell count normal
Clinical narrative: 1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pyrexia
Clinical narrative: Fever of 101F, body aches, joint pain, headache.  Symptoms persisting beyond 48 hours post vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: ?Covid arm?. Sure is swollen, red, tender, and hot to touch
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: I believe that the covid vaccine triggered pains of rheumatoid arthritis in my right leg.  I believe I already had rheumatoid arthritis, (although I was diagnosed afterward, with tests I took prior) but I never had pain like this before.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chest pain, Electrocardiogram, Fibrin D dimer normal, Full blood count normal
Clinical narrative: I develop PVCs about 11hrs post vaccination along with other common symptoms. PVCs have continued to present.  8 days post vaccination I developed chest pain with the PVCs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Thyroid function test normal, Troponin normal, Ventricular extrasystoles
Clinical narrative: I develop PVCs about 11hrs post vaccination along with other common symptoms. PVCs have continued to present.  8 days post vaccination I developed chest pain with the PVCs.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, swelling in a square shape around injection site and tender to touch.  15 days after injection.  Still there and on day 3.  I have read they are calling this Covid arm.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching, swelling in a square shape around injection site and tender to touch.  15 days after injection.  Still there and on day 3.  I have read they are calling this Covid arm.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: INJECTION SITE ITCHING AND RASH SX STARTED 2-6-2021
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: INJECTION SITE ITCHING AND RASH SX STARTED 2-6-2021
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Large welt and swollen arm
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: pt has redness and arm swelling, but not until 10 days after receiving vaccine
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Chest X-ray, Chest pain, Dyspnoea, Systemic inflammatory response syndrome
Clinical narrative: Vaccine was administered around 5 PM on 1/14/2021. Chest pain started around 9 PM the same day and continued, also had some shortness of breath. Headed to emergency room around 4 AM on 1/15/2021. Several tests were done, found general systemic inflammation. Chest pain caused by inflammation in lungs and airways. Treated with ibuprofen and chest pain cleared in about 40 minutes. Discharged at 1/15/2021 around 7 AM.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Vaccine was administered around 5 PM on 1/14/2021. Chest pain started around 9 PM the same day and continued, also had some shortness of breath. Headed to emergency room around 4 AM on 1/15/2021. Several tests were done, found general systemic inflammation. Chest pain caused by inflammation in lungs and airways. Treated with ibuprofen and chest pain cleared in about 40 minutes. Discharged at 1/15/2021 around 7 AM.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Head injury
Clinical narrative: Patient experienced fever of 100.4, chills, diarrhea, vomiting, nausea, dizziness, and joint/body pain. Patient also passed out and suspects hit head on toilet. There is a scratch on her forehead but no bump.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient experienced fever of 100.4, chills, diarrhea, vomiting, nausea, dizziness, and joint/body pain. Patient also passed out and suspects hit head on toilet. There is a scratch on her forehead but no bump.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Patient experienced fever of 100.4, chills, diarrhea, vomiting, nausea, dizziness, and joint/body pain. Patient also passed out and suspects hit head on toilet. There is a scratch on her forehead but no bump.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Patient experienced fever of 100.4, chills, diarrhea, vomiting, nausea, dizziness, and joint/body pain. Patient also passed out and suspects hit head on toilet. There is a scratch on her forehead but no bump.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: several minutes after vaccine dose patient reported funny sensation in her tongue
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Flushing, Paraesthesia oral, Sinus rhythm
Clinical narrative: several minutes after vaccine dose patient reported funny sensation in her tongue
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: several minutes after vaccine dose patient reported funny sensation in her tongue
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Pneumovax23 giving instead of HPV, as intended
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: pt states he has altered sense of smell.  Says he has a constant smell of burnt molasses.  Pt called his physician friend and was told just to keep an eye out for any other symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue and headache on the first day, Thursday. On second day experience extreme fatigue, heaviness in body, fever up to 103; severe body aches. Lasted Friday, Sat (some relief); then on Sunday felt normal again after sleeping and taking Motrin.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: all over body itching without any rash when given the first dose.  Second dose the itching intensified
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Gait disturbance, Myalgia
Clinical narrative: 1st 2 days- Fatigue, weakness, muscle aches. 7 days later on 2/6/2021: Severe Lt hip pain, pain w/ direct pressure or walking. 9 days later on 2/8/2021: Continuous Lt hip pain as well as new onset of Rt hip pain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA Headache, nausea, no appetite, very tired.  Began when I woke the day after the injection which was a Saturday and lasted approximately 1  1/2 days.   By Sunday afternoon my appetite returned, the headache was gone, the tiredness was gone.   There was no treatment other than to sleep and put ice on my head for the headache.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Pain on site of shot. Red rash , itchy. Still have rash  12 days later . Tired
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection sight became hot and red (9th day after injection) and very itchy.  Lasted three days.  Today injection sight is not red or itchy, just slightly bruised looking..
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache
Clinical narrative: SOB with chest pain, headache
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness around the shot area.   The Majority of the soreness went away in 2 days.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oropharyngeal pain, Pain
Clinical narrative: Moderna COVID-19 vaccine EUA I had generalized body pain within 24 hours. I developed redness below the site of injection. The site of redness is very sensitive  and warm to touch. I have also developed a sore throat within 48 hours of the vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling hot, Flushing, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Flushing, numbness left hand and fingers, quivering and burning in chest, numbness and tingling of lips with metallic taste. Blood pressure 160/100, Heart rate 125-130. O2 saturation on room air 96-98%. Patient transported to Emergency Room via private vehicle. Patient declined ambulance transport.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tremor
Clinical narrative: Flushing, numbness left hand and fingers, quivering and burning in chest, numbness and tingling of lips with metallic taste. Blood pressure 160/100, Heart rate 125-130. O2 saturation on room air 96-98%. Patient transported to Emergency Room via private vehicle. Patient declined ambulance transport.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Fatigue and weakness
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram normal, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: Patient reported left arm numbness. Went to the hospital for full stroke evaluation all tests returned negative. (CT scan, MRI, etc.). Patient was observed overnight and released from hospital with resolved symptoms and negative report of any stroke or mini-stroke. Patient has had follow-up appointments with PCP and Cardiologist. Received ok from PCP prior to second dose vaccination of COVID.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: In bed high fever nausea arm swollen to elbow extreme soreness.    Slept for 2 days
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: pt fainted post vaccination- caught by paramedic.  treated and monitored by paramedic.  BS 70, BP 99/40, HR 52.  given ginger ale and H20, assessed and monitored by  paramedic- helped to sit/stand- initially felt well then dizzy and helped to sit, HR dipped to 40s/50s after each time of sit/stand attempt-  pt was advised on benefit of further eval @ ER- he agreed and ambulance was called.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: On the Friday on the 5th, I went to coffee and on the way home it felt like my lip is swelling. I looked and noticed it swollen. It is still swollen as of today. I just sent a message to my doctor.  I have taken some allergy medication that I had and some Benadryl.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Vital signs measurement
Clinical narrative: pt verbalized tingling in hands and swelling in hands post vaccination.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go  to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself,  she fell 3 times on Feb. 3,  I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand.  Feb. 4 she had the dry heaves all morning, she slept all afternoon.  I called the doctors office @ 8:00am and again later @ 8:30am.  He said he wanted her to have a CAT scan Medical Center. He said they would call
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dyspnoea, Fall, Gait disturbance, Headache
Clinical narrative: Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go  to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself,  she fell 3 times on Feb. 3,  I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand.  Feb. 4 she had the dry heaves all morning, she slept all afternoon.  I called the doctors office @ 8:00am and again later @ 8:30am.  He said he wanted her to have a CAT scan Medical Center. He said they would call
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Retching
Clinical narrative: Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go  to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself,  she fell 3 times on Feb. 3,  I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand.  Feb. 4 she had the dry heaves all morning, she slept all afternoon.  I called the doctors office @ 8:00am and again later @ 8:30am.  He said he wanted her to have a CAT scan Medical Center. He said they would call
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry throat, Dyspnoea, Hypertension, Peripheral swelling
Clinical narrative: swollen face and hands rash on face and hands light-headed inability to walk at normal rate shortness of breath dryness in throat higher than normal blood pressure
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: swollen face and hands rash on face and hands light-headed inability to walk at normal rate shortness of breath dryness in throat higher than normal blood pressure
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Heart rate increased, Injection site pain
Clinical narrative: No reaction until 10pm.  Injection site became sore and tender,  Had chills during the night.  Following morning was running 102 degree temperature,  heart rate was 107 and blood pressure was 90/60.  Took two 650 mg  tylenol and  temperature was back to normal  within 5 or 6 hours.  Heartrate never got below 102 until late afternoon and blood pressure was still low at bedtime.  Uneventful night and all was normal the following morning.  No reaction since.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: 2/7/2021 12:00pm - diahreah 8:00 pm - headache, chills 9:00 pm - + slight fever, nausea Continued 02/08/2021
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: the first day just sore shoulder, the next day could not lift the arm in or out. had to use my other arm to lift it up. the pain is on the back side in the muscle area in my shoulder blade area . No strength in arm in the upper movement. my pain is about an 8 to 10 if i try to move it. can hold it up on my elbow on the table but if i take it off it just falls.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Numbness and tingling on set four hours after dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Diarrhoea, Headache, Injection site pain, Nausea
Clinical narrative: Diarrhea, Nausea, Headache, Bodyache, and pain at the site of the injection. All symptoms are still present 4 days post injection with the exception of the pain at eh injection site.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Diarrhea, Nausea, Headache, Bodyache, and pain at the site of the injection. All symptoms are still present 4 days post injection with the exception of the pain at eh injection site.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Complaint of severe right shoulder pain that occurred almost immediately after vaccination. Shot up and down her arm. States any type of movement makes the pain worse. Denies numbness or tingling.   Reported to ED for evaluation the following day.  Prescribed: Oxycodone/APAP 5/325 prn pain; Prednisone 10mg- 6day; Robaxin 750 PRN pain;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Feeling abnormal, Lethargy
Clinical narrative: Loss of sense of smell, extreme lethargy, Brain fog
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Paraesthesia, Sleep disorder, Trigger finger
Clinical narrative: Had trigger finger in right hand lasting 3 days -resolved. Began experiencing tingling and electrical impulses down both legs (no pain). This becomes worse with walking. Comes and goes throughout the entire day and wakes me up at night at intervals. Began 4 days after vaccine and has continued since.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash (pruritic) and swelling distal and medial to the vaccination site that continued to migrate distally over the course of a week.  Treated at home with topical antihistamine cream and oral antihistamines.  Incremental resolution each day after the first two days, 95% resolved by day 6.  Adverse event did not prevent any ADLs.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Moderna COVID 19 Vaccine EUA 9 days after vaccine red rash appeared on left arm at injection site. Rash slightly itchy and painful. 3 days later rash has increased by 50%  but lighter  appearance and no longer itchy or painful
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Erythema, Feeling abnormal, Flushing, Heart rate increased
Clinical narrative: Pt received oral benadryl at 1140 due to complaint of itchiness and feeling "flushed". 2.25hours later, pt had bright red ears and did not "feel right". She came back to the medical dept, her BP was markedly elevated (180s/100), 70-90 HR, 02 saturation was WNL. Pt has normal blood pressure as her baseline. Pt c/o palpitations and racing heart beat. Pt was sent to local ED.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus
Clinical narrative: Pt received oral benadryl at 1140 due to complaint of itchiness and feeling "flushed". 2.25hours later, pt had bright red ears and did not "feel right". She came back to the medical dept, her BP was markedly elevated (180s/100), 70-90 HR, 02 saturation was WNL. Pt has normal blood pressure as her baseline. Pt c/o palpitations and racing heart beat. Pt was sent to local ED.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Anxiety, Blood pressure increased, Feeling abnormal
Clinical narrative: Classic Anxity attack with upset stomach.  Blood pressure spiked, and heart raced.  No pain, only terror feeling.  Spoke with NP and seh recommended 2 Benardyrl.  If things got worse to go to ER.   They did get better.  Next day foggy head and still upset stomach,  Yesterday was better, stomach still huts but better.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Classic Anxity attack with upset stomach.  Blood pressure spiked, and heart raced.  No pain, only terror feeling.  Spoke with NP and seh recommended 2 Benardyrl.  If things got worse to go to ER.   They did get better.  Next day foggy head and still upset stomach,  Yesterday was better, stomach still huts but better.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Decreased appetite, Discomfort, Fatigue
Clinical narrative: 6pm: body aches, feeling cold, not hungry or able to finish my dinner, drowsy. I went to bed around 7pm.  All that night, I was hot and sweating and freezing cold. I had a lot of pain in my lower back and would have to position myself in fetal position. There was no position that felt comfortable.  24 hours after the shot, still fatigue, stayed in bed for most of the day. No appetite.  48 hours: limited appetite, I was hungry, but when eating just felt bloated and not interested. Would feel stomach aches if I attempted to eat more.  The monday following the vaccine, I had eaten lunch and noticed I had a burning feeling in a lower area of my throat. My stomach felt slightly upset.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Pain, Somnolence
Clinical narrative: 6pm: body aches, feeling cold, not hungry or able to finish my dinner, drowsy. I went to bed around 7pm.  All that night, I was hot and sweating and freezing cold. I had a lot of pain in my lower back and would have to position myself in fetal position. There was no position that felt comfortable.  24 hours after the shot, still fatigue, stayed in bed for most of the day. No appetite.  48 hours: limited appetite, I was hungry, but when eating just felt bloated and not interested. Would feel stomach aches if I attempted to eat more.  The monday following the vaccine, I had eaten lunch and noticed I had a burning feeling in a lower area of my throat. My stomach felt slightly upset.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: 6pm: body aches, feeling cold, not hungry or able to finish my dinner, drowsy. I went to bed around 7pm.  All that night, I was hot and sweating and freezing cold. I had a lot of pain in my lower back and would have to position myself in fetal position. There was no position that felt comfortable.  24 hours after the shot, still fatigue, stayed in bed for most of the day. No appetite.  48 hours: limited appetite, I was hungry, but when eating just felt bloated and not interested. Would feel stomach aches if I attempted to eat more.  The monday following the vaccine, I had eaten lunch and noticed I had a burning feeling in a lower area of my throat. My stomach felt slightly upset.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site reaction, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: The patient called stating that she had Pneumococcal -23 on Tuesday and her right arm is swollen and she has red blotches from the injection site to her elbow.  She states the first night after the immunization her arm ached even under her armpit. She denies itching. She denies fever. She denies difficulty swallowing or swelling of her lips or tongue. Per protocol, the patient was asked to go to ER for evaluation. She states that she works at the cancer center and will have the nurse supervisor look at it.  She was again advised to seek medical care. Unsure if she will go.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Axillary pain, Epigastric discomfort, Headache, Injection site erythema
Clinical narrative: Swollen, red,  hot,  painful arm, armpit, and trap muscle ipsilateral of injection site. Accompanied by headache, epigastric and RUQ abdominal pain and nausea. This happened the day after the injection and has continued to today (3rd day following 2nd Moderna vaccine shot). I had no reactions after the 1st shot.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: Swollen, red,  hot,  painful arm, armpit, and trap muscle ipsilateral of injection site. Accompanied by headache, epigastric and RUQ abdominal pain and nausea. This happened the day after the injection and has continued to today (3rd day following 2nd Moderna vaccine shot). I had no reactions after the 1st shot.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Lymphadenopathy, Pain, Swelling
Clinical narrative: very bad reaction/ she was swollen, hot, lymph nodes enlarged, and she hurt; hurt; she was swollen; she was hot/ doctor put cold packs on it; very bad reaction; she didn't mix the vaccine and feels like it wasn't mixed correctly; 0.5 ml; This spontaneous report was received from a currently 71-year-old nurse who is also a female patient and she refers to herself. There was no information about the patient's concurrent conditions or medical history provided. Her concomitant therapies included possibly blood pressure medication. She had drug hypersensitivity to doxycycline and penicillin, she had rubber (latex) sensitivity, and she was allergic to bee stings. On an unknown date, approximately in 2011 (reported as 10 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection in dose 0.5 (units not reported) for shingles (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, approximately in 2011 (reported as 10 years ago), the patient had a very bad reaction when she was vaccinated. She stated, she was swollen, hot, lymph nodes were enlarged, and she was hurt. It got worse 48 hours later. The patient did see the doctor and put cold packs on it as she was taking anti-inflammatories. Caller stated that she didn't mix the vaccine and it felt like it wasn't mixed correctly. She had never had a reaction like that before and it seemed uncommon. The patient recovered from all the events on an unknown date. The causality assessment between all the events and zoster vaccine live (ZOSTAVAX) was not provided.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; a temperature excursion involving PNEUMOVAX23; This spontaneous report as received from a "HBP" refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-DEC-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T007790, expiration date: 03-DEC-2021 (anatomical location and route of administration were not reported), for prophylaxis.  Administered dose of vaccine underwent the temperature excursion of 31.2 degrees Fahrenheit for 30 minutes. Digital data logger was involved. There were no previous excursions reported. No adverse event was reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA010281: US-009507513-2101USA010448:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion for VARIVAX/administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 07-DEC-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038698, expiration date 01-DEC-2021, 0.5 ml, administered subcutaneously (SQ), 1 dose prophylaxis. The temperature was 32.4 degrees Fahrenheit (F) for 4 hours. There was no previous temperature excursion. Data logger was involved. The outcome was unknown.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA010446: US-009507513-2101USA009977: US-009507513-2101USA010358: US-009507513-2101USA010369:
Age: 64.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; a dose of VAQTA was inadvertently administered after its labeled expiry date; This spontaneous report as received from a registered nurse referring to a 64-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 21-JAN-2021, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated(VAQTA) 50U/1.0 ml (lot # S036494, expiration date not reported, upon internal validation established as 09-JAN-2021, 1 dosage form) after its labeled expiry date for prophylaxis (expired product administered). There were no known temperature excursions on the involved vaccine. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered
Clinical narrative: No additional AEs or PQCs reported in this case; This is an adverse event for use outside of the recommended dosing intervals in the prescribing information; This spontaneous report as received from a health care professional (also reported as administrator) to a patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 25-SEP-2020 and 05-NOV-2020,  the patient was vaccinated with a first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9),dose :0 .5 milliliter for prophylaxis (routes of administration, lot numbers and expiration date were not reported).  It was reported that the patient received a third dose of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9),dose :0 .5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported), on 26-JAN-2021, used outside of the recommended dosing intervals in the prescribing information. No additional AEs or PQCs reported in this case, and no further information was provided.
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Hypersensitivity, Injection site pain, Joint range of motion decreased, Peripheral swelling
Clinical narrative: side effects and an allergic reaction to this pneumonia vaccine; allergic reaction to this pneumonia vaccine; not being able to bend her arm; disoriented; whole arm swelled up; fever; sharp pain at the injection site; administered two shots together on the same day; This spontaneous report was received from a 68 years old female patient, who was referring to herself. The patient's current conditions included thyroid issues, asthma and 22 unspecified allergies. The patient had a history of epistaxis while on therapy with montelukast sodium (SINGULAIR) (case # 2101USA013273). Concomitant therapies included sucralfate and levothyroxine sodium.  On 13-NOV-2020, the patient was vaccinated with 2 shots of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (reported as "pneumonia vaccine" but lot # confirmed it was Company product) injection, prefilled syringe, intramuscularly, lot # T016159, expiration date was not reported but upon internal validation process, it was established as 28-FEB-2022 (dose and anatomical location were not reported) for prophylaxis (overdose).  On the same date, the patient started experiencing side effects and an allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Her whole arm swelled up and it affected her arm muscles "intermittently". She was having a fever and was feeling disoriented and she was not able to bend her arm. At the reporting time, she was still feeling sharp pain at the injection site. She sought medical attention, but she did not receive any treatment for the event. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered.  The reporter considered side effects and an allergic reaction related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the rest of the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA013273:
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: side effects and an allergic reaction to this pneumonia vaccine; allergic reaction to this pneumonia vaccine; not being able to bend her arm; disoriented; whole arm swelled up; fever; sharp pain at the injection site; administered two shots together on the same day; This spontaneous report was received from a 68 years old female patient, who was referring to herself. The patient's current conditions included thyroid issues, asthma and 22 unspecified allergies. The patient had a history of epistaxis while on therapy with montelukast sodium (SINGULAIR) (case # 2101USA013273). Concomitant therapies included sucralfate and levothyroxine sodium.  On 13-NOV-2020, the patient was vaccinated with 2 shots of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (reported as "pneumonia vaccine" but lot # confirmed it was Company product) injection, prefilled syringe, intramuscularly, lot # T016159, expiration date was not reported but upon internal validation process, it was established as 28-FEB-2022 (dose and anatomical location were not reported) for prophylaxis (overdose).  On the same date, the patient started experiencing side effects and an allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Her whole arm swelled up and it affected her arm muscles "intermittently". She was having a fever and was feeling disoriented and she was not able to bend her arm. At the reporting time, she was still feeling sharp pain at the injection site. She sought medical attention, but she did not receive any treatment for the event. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered.  The reporter considered side effects and an allergic reaction related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the rest of the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA013273:
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 19-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as after received zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered peripheral neuropathy. As a result of these symptoms, the patient was saw and treated by medical provider and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient symptoms have resulted in physical limitations not presented prior to used zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulted physical limitations and seriousness of patient condition. As a resulted of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of conduct, the patient had suffered and incurred damaged, included medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of peripheral neuropathy was not recovered. The reporter considered peripheral neuropathy to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: He was meant to receive step 1 of VARlVAX but instead got PROQUAD; This spontaneous report was received from a physician assistant and refers to a male adult patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 01-FEB-2021, the patient was meant to be vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (formulation, strength, dose, route of administration, frequency, lot # and expiration date were not reported) for prophylaxis but instead he received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, dose, route of administration, frequency, lot # and expiration date were not reported) for prophylaxis (wrong vaccine administered).
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Headache; arm pain; mild nausea; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, pain in arm and nausea. On an unknown date, the outcome of the headache, pain in arm and nausea were unknown.   It was unknown if the reporter considered the headache, pain in arm and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had headache, pain in arm and nausea. The reporter asked could take Motrin to treat side effects of shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash on back; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2020, the patient received Shingrix. On 18th December 2020, 2 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were procided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. Then reporter stated that, received dose of Shingrix on wednesday and by friday night had rash on back and shingles. The reporter stated that, rash was not listed as side effect but no doubt, had shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pharyngeal swelling
Clinical narrative: swollen throat; headache; felt tired; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received Shingrix. On 27th December 2020, 1 days after receiving Shingrix, the patient experienced headache and fatigue. On 28th December 2020, the patient experienced throat swelling. On an unknown date, the outcome of the headache, fatigue and throat swelling were not recovered/not resolved.   It was unknown if the reporter considered the headache, fatigue and throat swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The reporter stated that, the symptoms were on left side. The patient was looking for more advice.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: COVID; This case was reported by a pharmacist and described the occurrence of coronavirus infection in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced coronavirus infection. The patient was treated with monoclonal antibody (nos) (Monoclonal Antibody). On an unknown date, the outcome of the coronavirus infection was recovered/resolved.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed COVID. The patient received monoclonal antibody treatment and the COVID infection has resolved. The reporter consented to follow up. The HCP did not had the exact date of the COVID diagnosis and did not had the lot and expiry.