chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Nausea, Pain in extremity
Clinical narrative: After vaccination patient had arm pain that was constant and achy in nature starting around 7PM the night of the vaccination. She also reports flu-like symptoms: muscle pain, nausea, chills, fever, etc. These flu-like symptoms persisted for 2 days. She was able to resolve the arm pain and fever by taking acetaminophen.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: After vaccination patient had arm pain that was constant and achy in nature starting around 7PM the night of the vaccination. She also reports flu-like symptoms: muscle pain, nausea, chills, fever, etc. These flu-like symptoms persisted for 2 days. She was able to resolve the arm pain and fever by taking acetaminophen.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test, Renal impairment, Tremor
Clinical narrative: Severe shaking and tremors - it started with the hands then went through the whole body. After seeing my MD, I was given 2 steroid shots and prescribed Prednisone (20mg) and Hydroxyzine (25mg). The shaking and tremors continue to this day.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary mass, Chest pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient reported on 6/15/18 "pain through the arm, shoulder and that side of chest, It feels like it did when I had the Shingles on the other side. Also a hard lump in the armpit of arm that he got the vaccine in." Follow up call 7/9/18 still some aching on that side but lump is gone and feeling improved. Still a "little achy on that side".
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid with redness, swelling, warmth, 8x6cm, instructed to apply warm compress 3-4 times daily and to call for appointment if fever or worsening symptoms occur within 24 hours.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Exposure during pregnancy, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, warmth, tenderness, swelling present. Appointment for evaluation scheduled 07/10/2018. 1st pregnancy, 30w4d along (as of 7/9/18).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Rash
Clinical narrative: During the evening after the shot (7/2/2018) the patient reported feeling exhausted - The next morning (7/3/2018) the patient stated they had a rash and shingles on the injection side.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Gastrointestinal pain, Headache, Influenza like illness
Clinical narrative: Entire body had flu-like soreness, both muscles and joints. Throbbing headache. Severe intestinal pain & diarrhea unlike anything she had ever experienced from her Crohn's. Started the evening of the shot, lasted about 3 days.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Entire body had flu-like soreness, both muscles and joints. Throbbing headache. Severe intestinal pain & diarrhea unlike anything she had ever experienced from her Crohn's. Started the evening of the shot, lasted about 3 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Pain, Pyrexia
Clinical narrative: Patient's wife said he had a fever, felt like someone beat him over his entire body (sore) and that caused him to stay home from work.
Age: 16.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Client's parent called. Client reports headache, tired and nauseous for the last 3-4 hours. Approximately 2.5 hours since initial injection. Client had no immediate reaction at the time of injection. Client also has pain and tenderness in right deltoid at the site of the Men B #2 (BEXSERO).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye operation, Ocular hyperaemia, Visual impairment
Clinical narrative: Red eye that started on May 10 and on May 15 went to my primary doctor then several eye doctors and then to a specialist. I have lost half of my eyesight on my right eye I had surgery still can't see.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Around 10:45am on July 6, 2018  I started noticing red bumps appearing on my skin. As the day went on there were more and more bumps and they started to look worse. At 3:30pm I called my doctors office where they put me on hold for 15 minutes then was told by the front office to take a Benadryl. I told them I didn't know if I could take Benadryl because I have asthma so they directed me to urgent care. I had to leave work to go to urgent care where they confirmed I could take benadyrl and they also gave me a shot of dexamethasone and another shot for the itching. Urgent care also informed me that I was supposed to have gotten a paper with information about the shot and possible side effects and how to report it if something goes wrong and the doctors office never gave me this paper. Urgent care then said if it gets worse to go to the emergency room. Saturday July 7, 2018 my rash was much worse so I went into urgent care where I was evaluated and told to keep taking Benadryl and was also prescribed a 5 day course of Prednisone and  famotidine. Sunday July 8, 2018 my rash started to look better but it is still present as of 2:30pm on Monday July 9, 2018
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Fatigue, Hypersomnia, Injection site pruritus, Injection site swelling
Clinical narrative: Itchy at the injection site right after the HPV. She had felt lightheaded and faint after the injection. Since she has had swelling to the injection site. Treated with BENADRYL. She has been overly fatigued since that injection. Sleeping excessively.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Tenderness
Clinical narrative: The patient reported pain in left arm starting the evening of the injection, July 6. This got worse over the next two days and additional sx included hot skin and erythema in the form of a red stripe on his skin, approx 3-4" wide and 8" long, from the injection site to his elbow. He described the pain as severe soreness and tenderness, not tingling. No rash, no swelling, no trouble breathing. He had no ADE when he received the first dose of SHINGRIX on 4/17/18. He has been treating with ice and EXCEDRIN, and the pain and redness decreased slightly from 7/8 to 7/9. He will continue to treat with ice and monitor closely. I advised him to see a doctor if sx remain or get worse, or if he has any signs of a severe allergic reaction.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Heart rate decreased, Oxygen saturation decreased, Syncope, Unresponsive to stimuli
Clinical narrative: Patient had a syncope episode and was unresponsive. Patient had decreased oxygen saturation and pulse with blood pressure remaining stable. EMT called and patient transferred to medical center.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Oxygen saturation decreased
Clinical narrative: Patient had a syncope episode and was unresponsive. Patient had decreased oxygen saturation and pulse with blood pressure remaining stable. EMT called and patient transferred to medical center.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: Patient was getting her 2nd dose of the SHINGRIX vaccine (1st dose was 4/19/2018). Later the same day, she had chills and flu-like symptoms. She started to feel better the next day but was still "achy."
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient's arm became really sore later in the day after receiving vaccine then overnight became very swollen according to the patient's wife.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm
Clinical narrative: Patient received the vaccine on 6/21/18 and presented back to the pharmacy on 6/27 reporting of a really red, warm-to-the-touch area. She was in no pain. However, there was a small amount of itching. She was told it was a injection site reaction. She went to the walk-in providers to be seen. They also confirmed it was a injection site reaction.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Malaise, Pain
Clinical narrative: Pt experienced pain, malaise, extreme redness and heat, headache. Pt applied ice and took BENADRYL and it was slowly getting better.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Muscle spasms
Clinical narrative: FEVER 102, MUSCLE ACHE, LEG CRAMPS HARD TO WALK, HEADACHE, CHILLS, TIRED.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: FEVER 102, MUSCLE ACHE, LEG CRAMPS HARD TO WALK, HEADACHE, CHILLS, TIRED.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Loss of consciousness, Tremor
Clinical narrative: HPV vaccine given patient passed out about 5 min after vaccination administration. She also mention she was having lots of headaches, shakiness and was feeling dizzy.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, swelling and soreness in right arm. Patient allowed rxn to takes its course and resolve itself.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Cough, Decreased appetite, Dyspnoea, Injected limb mobility decreased
Clinical narrative: Pain in left upper arm, did not move arm, throat seized, difficulty breathing, nausea, loss of appetite, sleeplessness, congestion, chest and nasal congestion, coughing, feeling ill, malaise, felt like having pneumonia, chills.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Insomnia, Malaise, Nasal congestion, Nausea
Clinical narrative: Pain in left upper arm, did not move arm, throat seized, difficulty breathing, nausea, loss of appetite, sleeplessness, congestion, chest and nasal congestion, coughing, feeling ill, malaise, felt like having pneumonia, chills.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Respiratory tract congestion, Throat tightness
Clinical narrative: Pain in left upper arm, did not move arm, throat seized, difficulty breathing, nausea, loss of appetite, sleeplessness, congestion, chest and nasal congestion, coughing, feeling ill, malaise, felt like having pneumonia, chills.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging, Sleep disorder
Clinical narrative: I had pain in my upper arm, shoulder area after the shot to the point that I could not lift my arm or sleep on my left side. The pain was immediate and never subsided. I am currently attending physical therapy.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Vaccines were both given in right arm in deltoid muscle at least 1 inch apart. Pt says she experiences a rash from about 40 minutes after vaccination. It was on her arm looking the most prominent around SHINGRIX site (which was lower on arm than PREVNAR). Pt said rash went up her neck. No swelling of lips or trouble breathing. Pt is taking BENADRYL and will go to the ER if gets worse or starts having swelling of lips or trouble breathing. Pt will call doctor tomorrow as well. I attempted to call doctor today but they are closed and no way to leave msg. Will call and inform Dr. in the morning on 7/10. Pt will let us know if anything changes.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Palpitations
Clinical narrative: Vaccination given at approximately 2 pm. Patient stated racing heart and dizziness at 3:37 pm. Pulse was 72 and respirations 14. Patient was taken to nearby hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue, Hypotension, Joint range of motion decreased
Clinical narrative: Beginning the evening of the shot, my arm /shoulder began to hurt and I became fatigued. By the following day it worsened and that night required sleeping with hot compresses on shoulder. Hot compresses were need the third day. By this time severe fatigue and low blood pressure set in, to the point of getting lightheaded and nauseous with normal activities, and had occasional loose stools. Range of motion on the shoulder became extremely limited (slightest lifting of arm caused pain) and this continued for about 10 days, curtailing normal activities. During this time, the fatigue, lightheadedness and low BP persisted. Avg. BP was 90/61 and at times was 87/50 (note my normal BP is about 101/68). After that the pain started subsiding and by about day 16, the arm pain was resolved and I could resume normal activities. The extreme fatigue also improved. BP is still low for unknown reason.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Nausea, Pain, Pain in extremity
Clinical narrative: Beginning the evening of the shot, my arm /shoulder began to hurt and I became fatigued. By the following day it worsened and that night required sleeping with hot compresses on shoulder. Hot compresses were need the third day. By this time severe fatigue and low blood pressure set in, to the point of getting lightheaded and nauseous with normal activities, and had occasional loose stools. Range of motion on the shoulder became extremely limited (slightest lifting of arm caused pain) and this continued for about 10 days, curtailing normal activities. During this time, the fatigue, lightheadedness and low BP persisted. Avg. BP was 90/61 and at times was 87/50 (note my normal BP is about 101/68). After that the pain started subsiding and by about day 16, the arm pain was resolved and I could resume normal activities. The extreme fatigue also improved. BP is still low for unknown reason.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: Fever (101F temperature per pt), Nausea, Malaise.
Age: 71.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt received vaccines on 7/3, on R deltoid received pneumococcal vaccine. Presents to clinic today with CC of 'rash' with redness and pain at injection site of R deltoid. Pt was concerned so was seeking advice. Denies fever, chills, SOB, chest pain. Plan: Ice area 20 min on and 20 min off. Take Benadryl PRN. Advised if redness, warmth or pain extends from the marked circumference to RTC ASAP for re-evaluation. Advised pt that is fever, chills, SOB, chest pain or any new symptoms develop to come into clinic ASAP. Pt advised she can walk in at any time. Reported understanding and declined further questions or concerns.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Approximately 2 days after the vaccine, patient reports having a fever, rash, burning, and swelling on arm. Four days post-vaccination symptoms seem to be improving.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Redness at site. Flu like symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Patient received vaccine around 1300, patient called pharmacy at 1900 reporting "nerve-like pain in legs/feet". Patient has decided to monitor reaction and take OTC pain medication if necessary the day after. I documented conversation with patient in her profile and asked her to follow-up next day.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: After 24 hours: Muscle aches, chills, headache, fatigue, stomach upset, soreness in injected area. After 48 hours: large (4? x 2?) area of redness around injection area.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: After 24 hours: Muscle aches, chills, headache, fatigue, stomach upset, soreness in injected area. After 48 hours: large (4? x 2?) area of redness around injection area.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Chills, nausea, headache, diarrhea (lasted 2 1/2 days).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm, Tenderness
Clinical narrative: Induration and erythema, largest size 2 3/4 inches x 4 inches. Hot and hard tender to touch. Started increasing in size at about 24 hours post injection and stopped at about 40 hours post injection. At 4 days post remains 2 3/4 x 4 in. indurated, hard and painful.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Induration and erythema, largest size 2 3/4 inches x 4 inches. Hot and hard tender to touch. Started increasing in size at about 24 hours post injection and stopped at about 40 hours post injection. At 4 days post remains 2 3/4 x 4 in. indurated, hard and painful.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blood glucose normal, Febrile convulsion
Clinical narrative: MMR/VARIVAX/PREVNAR given 6/19/18, 6/27 went to ED with febrile seizure resolved without medications.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Patient presented with 4 inch diameter red, hard all around, raised area that she said was starting to become itchy she also said the area was warm to the touch told patient to take BENADRYL and ice the area.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received the second dose of SHINGRIX on 6/15/18. Patient developed rash from her torso down. Patient receiving medical treatment currently due to the rash.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Herpes zoster, Pain, Paraesthesia
Clinical narrative: Second SHINGRIX immunization w/in 6 months - first was 2/13/18, last one was 6/28/18. I'd noticed weird tingling in my back, across my ribs horizontally and actually had a dermatologist mention it looked like I had a shingles outbreak in a visit some months after the first shot. This last injection seemed fine at first, but later that day, I became achey with chills. The following day, I had a terrible headache, fever, chills and threw up repeatedly...I was in a bed a full 36 hours and a bit shakey after being able to eat, the Saturday following the Thursday immunization. I have heard other people say they have had a rough time following this injection, as well, the tingling continues and it's not painful but weirdly bothersome, to say the least.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Second SHINGRIX immunization w/in 6 months - first was 2/13/18, last one was 6/28/18. I'd noticed weird tingling in my back, across my ribs horizontally and actually had a dermatologist mention it looked like I had a shingles outbreak in a visit some months after the first shot. This last injection seemed fine at first, but later that day, I became achey with chills. The following day, I had a terrible headache, fever, chills and threw up repeatedly...I was in a bed a full 36 hours and a bit shakey after being able to eat, the Saturday following the Thursday immunization. I have heard other people say they have had a rough time following this injection, as well, the tingling continues and it's not painful but weirdly bothersome, to say the least.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: Second SHINGRIX immunization w/in 6 months - first was 2/13/18, last one was 6/28/18. I'd noticed weird tingling in my back, across my ribs horizontally and actually had a dermatologist mention it looked like I had a shingles outbreak in a visit some months after the first shot. This last injection seemed fine at first, but later that day, I became achey with chills. The following day, I had a terrible headache, fever, chills and threw up repeatedly...I was in a bed a full 36 hours and a bit shakey after being able to eat, the Saturday following the Thursday immunization. I have heard other people say they have had a rough time following this injection, as well, the tingling continues and it's not painful but weirdly bothersome, to say the least.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: Second SHINGRIX immunization w/in 6 months - first was 2/13/18, last one was 6/28/18. I'd noticed weird tingling in my back, across my ribs horizontally and actually had a dermatologist mention it looked like I had a shingles outbreak in a visit some months after the first shot. This last injection seemed fine at first, but later that day, I became achey with chills. The following day, I had a terrible headache, fever, chills and threw up repeatedly...I was in a bed a full 36 hours and a bit shakey after being able to eat, the Saturday following the Thursday immunization. I have heard other people say they have had a rough time following this injection, as well, the tingling continues and it's not painful but weirdly bothersome, to say the least.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia, Scratch, Vomiting
Clinical narrative: Second SHINGRIX immunization w/in 6 months - first was 2/13/18, last one was 6/28/18. I'd noticed weird tingling in my back, across my ribs horizontally and actually had a dermatologist mention it looked like I had a shingles outbreak in a visit some months after the first shot. This last injection seemed fine at first, but later that day, I became achey with chills. The following day, I had a terrible headache, fever, chills and threw up repeatedly...I was in a bed a full 36 hours and a bit shakey after being able to eat, the Saturday following the Thursday immunization. I have heard other people say they have had a rough time following this injection, as well, the tingling continues and it's not painful but weirdly bothersome, to say the least.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Adverse drug reaction, Arthralgia, Joint injury, Joint swelling, Orthosis user
Clinical narrative: Took 1 shot of Cortozione on the 3-19-13, then started me on Synvisc One, 5 shots given, Legs swelled up so big with the last 2 shots, had to walk on a walker for 2 weeks, knees swelled as big as cantalopes, I hurt in both legs all the time, both knees stay very, very cold, have to wear knee warmers all the time, to get them to warm up, constantly stay cold and in pain, have suffered every day since having these injections, something that was supposed to help my knees, but ended up me having to wear braces on both knees because of these shots, wearing braces for support for the knees, the shots didnt help me at all only damaged my knees further.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral coldness, Peripheral swelling, Walking aid user, X-ray
Clinical narrative: Took 1 shot of Cortozione on the 3-19-13, then started me on Synvisc One, 5 shots given, Legs swelled up so big with the last 2 shots, had to walk on a walker for 2 weeks, knees swelled as big as cantalopes, I hurt in both legs all the time, both knees stay very, very cold, have to wear knee warmers all the time, to get them to warm up, constantly stay cold and in pain, have suffered every day since having these injections, something that was supposed to help my knees, but ended up me having to wear braces on both knees because of these shots, wearing braces for support for the knees, the shots didnt help me at all only damaged my knees further.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to currently 4 year old patient of unknown gender. The concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, frequency and route were not reported) (lot # N029878, expiry date: 22-APR-2019) in the left arm for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) vaccines were reconstituted with properly stored vials of sterile diluent. No adverse events were reported. No product quality complaint was involved.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) underwent temperature excursion (stored at 15 degree Fahrenheit (°F) to 46°F) for 49 minutes. Digital data logger was involved. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Blood creatine phosphokinase, C-reactive protein, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Myocarditis. Symptoms: Chest pain, unspecified.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Pericarditis, Troponin
Clinical narrative: Myocarditis. Symptoms: Chest pain, unspecified.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Chest pain, Electrocardiogram change, Myocarditis, Troponin increased
Clinical narrative: Myocarditis. Symptoms: Chest pain, unspecified.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Chest pain, Coxsackie virus test positive, Electrocardiogram change, Myocarditis, Parvovirus B19 test positive
Clinical narrative: Myocarditis. Symptoms: Chest pain, unspecified.
Age: 27.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: Myocarditis. Symptoms: Chest pain, unspecified.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Blood pressure increased, Blood test, Chest discomfort, Chest pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 57-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. Concomitant products included Liothyronine. On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th June 2018, 1 days after receiving SHINGRIX, the patient experienced chest tightness (serious criteria life threatening and other: As per reporter), blood pressure high (serious criteria life threatening and other), aphasia (serious criteria life threatening and other: As per reporter), shortness of breath (serious criteria life threatening and other: As per reporter) and chest pain (serious criteria life threatening and other: As per reporter). On an unknown date, the outcome of the chest tightness, aphasia, shortness of breath and chest pain were not recovered/not resolved and the outcome of the blood pressure high was recovered/resolved. It was unknown if the reporter considered the chest tightness, blood pressure high, aphasia, shortness of breath and chest pain to be related to SHINGRIX. Additional details were provided as follows: At 11:00 hours, the patient received SHINGRIX on left arm. The following day, the patient experienced chest tightness, chest pain, had a shortness of breath and the patient could not talk. On 1st July 2018, Sunday, the patient went to the emergency room (ER) because their blood pressure was 203/150. The patient was in the hospital for 4 hours and they were given Nitro and cardiac tests were performed (x-ray, electrocardiography) and any cardiac episodes were ruled out. On the reporting date, the patient's blood pressure was back down but they were still experiencing symptoms (chest pain, chest tightness). The patient felt this was due to the SHINGRIX but the healthcare professional (HCP) was unsure. Clarification was raised to confirm the seriousness criteria Hospitalization', as no reply received the hospitalization criteria was removed as the patient was in the hospital for 4 hours only.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Electrocardiogram normal, Myalgia, X-ray
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 57-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. Concomitant products included Liothyronine. On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th June 2018, 1 days after receiving SHINGRIX, the patient experienced chest tightness (serious criteria life threatening and other: As per reporter), blood pressure high (serious criteria life threatening and other), aphasia (serious criteria life threatening and other: As per reporter), shortness of breath (serious criteria life threatening and other: As per reporter) and chest pain (serious criteria life threatening and other: As per reporter). On an unknown date, the outcome of the chest tightness, aphasia, shortness of breath and chest pain were not recovered/not resolved and the outcome of the blood pressure high was recovered/resolved. It was unknown if the reporter considered the chest tightness, blood pressure high, aphasia, shortness of breath and chest pain to be related to SHINGRIX. Additional details were provided as follows: At 11:00 hours, the patient received SHINGRIX on left arm. The following day, the patient experienced chest tightness, chest pain, had a shortness of breath and the patient could not talk. On 1st July 2018, Sunday, the patient went to the emergency room (ER) because their blood pressure was 203/150. The patient was in the hospital for 4 hours and they were given Nitro and cardiac tests were performed (x-ray, electrocardiography) and any cardiac episodes were ruled out. On the reporting date, the patient's blood pressure was back down but they were still experiencing symptoms (chest pain, chest tightness). The patient felt this was due to the SHINGRIX but the healthcare professional (HCP) was unsure. Clarification was raised to confirm the seriousness criteria Hospitalization', as no reply received the hospitalization criteria was removed as the patient was in the hospital for 4 hours only.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Aphasia, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 57-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. Concomitant products included Liothyronine. On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th June 2018, 1 days after receiving SHINGRIX, the patient experienced chest tightness (serious criteria life threatening and other: As per reporter), blood pressure high (serious criteria life threatening and other), aphasia (serious criteria life threatening and other: As per reporter), shortness of breath (serious criteria life threatening and other: As per reporter) and chest pain (serious criteria life threatening and other: As per reporter). On an unknown date, the outcome of the chest tightness, aphasia, shortness of breath and chest pain were not recovered/not resolved and the outcome of the blood pressure high was recovered/resolved. It was unknown if the reporter considered the chest tightness, blood pressure high, aphasia, shortness of breath and chest pain to be related to SHINGRIX. Additional details were provided as follows: At 11:00 hours, the patient received SHINGRIX on left arm. The following day, the patient experienced chest tightness, chest pain, had a shortness of breath and the patient could not talk. On 1st July 2018, Sunday, the patient went to the emergency room (ER) because their blood pressure was 203/150. The patient was in the hospital for 4 hours and they were given Nitro and cardiac tests were performed (x-ray, electrocardiography) and any cardiac episodes were ruled out. On the reporting date, the patient's blood pressure was back down but they were still experiencing symptoms (chest pain, chest tightness). The patient felt this was due to the SHINGRIX but the healthcare professional (HCP) was unsure. Clarification was raised to confirm the seriousness criteria Hospitalization', as no reply received the hospitalization criteria was removed as the patient was in the hospital for 4 hours only.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Hypertension
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 57-year-old female patient who received SHINGRIX (batch number 5737X, expiry date 23rd January 2021) for prophylaxis. Concomitant products included Liothyronine. On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th June 2018, 1 days after receiving SHINGRIX, the patient experienced chest tightness (serious criteria life threatening and other: As per reporter), blood pressure high (serious criteria life threatening and other), aphasia (serious criteria life threatening and other: As per reporter), shortness of breath (serious criteria life threatening and other: As per reporter) and chest pain (serious criteria life threatening and other: As per reporter). On an unknown date, the outcome of the chest tightness, aphasia, shortness of breath and chest pain were not recovered/not resolved and the outcome of the blood pressure high was recovered/resolved. It was unknown if the reporter considered the chest tightness, blood pressure high, aphasia, shortness of breath and chest pain to be related to SHINGRIX. Additional details were provided as follows: At 11:00 hours, the patient received SHINGRIX on left arm. The following day, the patient experienced chest tightness, chest pain, had a shortness of breath and the patient could not talk. On 1st July 2018, Sunday, the patient went to the emergency room (ER) because their blood pressure was 203/150. The patient was in the hospital for 4 hours and they were given Nitro and cardiac tests were performed (x-ray, electrocardiography) and any cardiac episodes were ruled out. On the reporting date, the patient's blood pressure was back down but they were still experiencing symptoms (chest pain, chest tightness). The patient felt this was due to the SHINGRIX but the healthcare professional (HCP) was unsure. Clarification was raised to confirm the seriousness criteria Hospitalization', as no reply received the hospitalization criteria was removed as the patient was in the hospital for 4 hours only.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Headache, fever, severe body aches, and hot, swollen and red injection site with tenderness from 24 hours after the vaccination until approx. 36 hours later. Injection site remained red and sensitive for two more days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Headache, fever, severe body aches, and hot, swollen and red injection site with tenderness from 24 hours after the vaccination until approx. 36 hours later. Injection site remained red and sensitive for two more days.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Crying, Discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Marked swelling, redness, and pain at injection site. Fever of 103 degrees Fahrenheit measured with a standard thermometer under the patient's arm. Discomfort, crying, and general fussiness from patient.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Pyrexia
Clinical narrative: Marked swelling, redness, and pain at injection site. Fever of 103 degrees Fahrenheit measured with a standard thermometer under the patient's arm. Discomfort, crying, and general fussiness from patient.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Blood culture negative, C-reactive protein normal, CSF culture negative, Culture urine negative, Echocardiogram normal
Clinical narrative: NOTE: PATIENT IS 2 MONTHS OLD (the website would not allow me to correct the age). He was born at 34 week gestational age; Baby was seen here in well baby clinic, a day before symptoms, was given primary series (PENTACEL, Hep B, ROTARIX and PREVNAR 13). Mother reports fever of 101.5F at 5AM next day for which she gave no medication and presented at ER. Temperature in ED was normal; Fever was attributed to the vaccines, mother reassured and discharged home; Another fever was noted at 1pm, 100.7F which resolved after TYLENOL was given(2 ml). Mother describes 2 episodes of stiffening and discoloration. 1st episode was about 8hrs after the fever, 9pm when she was bathing the baby, she noted stiffening of the limbs, baby also appeared flushed and like he was not breathing, episode lasted few seconds and afterwards he let out a loud scream and was back to his baseline tone, color, breathing, responsiveness. 2nd episode was this morning while the baby was in the crib (on the back), also had stiffening, cessation of breathing and facial blushing with associated eye deviation, also few seconds; Baby was admitted for full sepsis workup and other investigation including, EKG, Echo, EEG and Observation; All test results were benign.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Electrocardiogram normal, Electroencephalogram, Enterovirus test negative, Eye movement disorder, Flushing
Clinical narrative: NOTE: PATIENT IS 2 MONTHS OLD (the website would not allow me to correct the age). He was born at 34 week gestational age; Baby was seen here in well baby clinic, a day before symptoms, was given primary series (PENTACEL, Hep B, ROTARIX and PREVNAR 13). Mother reports fever of 101.5F at 5AM next day for which she gave no medication and presented at ER. Temperature in ED was normal; Fever was attributed to the vaccines, mother reassured and discharged home; Another fever was noted at 1pm, 100.7F which resolved after TYLENOL was given(2 ml). Mother describes 2 episodes of stiffening and discoloration. 1st episode was about 8hrs after the fever, 9pm when she was bathing the baby, she noted stiffening of the limbs, baby also appeared flushed and like he was not breathing, episode lasted few seconds and afterwards he let out a loud scream and was back to his baseline tone, color, breathing, responsiveness. 2nd episode was this morning while the baby was in the crib (on the back), also had stiffening, cessation of breathing and facial blushing with associated eye deviation, also few seconds; Baby was admitted for full sepsis workup and other investigation including, EKG, Echo, EEG and Observation; All test results were benign.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Full blood count normal, Herpes simplex test negative, Laboratory test normal, Liver function test normal, Musculoskeletal stiffness
Clinical narrative: NOTE: PATIENT IS 2 MONTHS OLD (the website would not allow me to correct the age). He was born at 34 week gestational age; Baby was seen here in well baby clinic, a day before symptoms, was given primary series (PENTACEL, Hep B, ROTARIX and PREVNAR 13). Mother reports fever of 101.5F at 5AM next day for which she gave no medication and presented at ER. Temperature in ED was normal; Fever was attributed to the vaccines, mother reassured and discharged home; Another fever was noted at 1pm, 100.7F which resolved after TYLENOL was given(2 ml). Mother describes 2 episodes of stiffening and discoloration. 1st episode was about 8hrs after the fever, 9pm when she was bathing the baby, she noted stiffening of the limbs, baby also appeared flushed and like he was not breathing, episode lasted few seconds and afterwards he let out a loud scream and was back to his baseline tone, color, breathing, responsiveness. 2nd episode was this morning while the baby was in the crib (on the back), also had stiffening, cessation of breathing and facial blushing with associated eye deviation, also few seconds; Baby was admitted for full sepsis workup and other investigation including, EKG, Echo, EEG and Observation; All test results were benign.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Polymerase chain reaction, Pyrexia, Respiratory arrest, Screaming, Skin discolouration
Clinical narrative: NOTE: PATIENT IS 2 MONTHS OLD (the website would not allow me to correct the age). He was born at 34 week gestational age; Baby was seen here in well baby clinic, a day before symptoms, was given primary series (PENTACEL, Hep B, ROTARIX and PREVNAR 13). Mother reports fever of 101.5F at 5AM next day for which she gave no medication and presented at ER. Temperature in ED was normal; Fever was attributed to the vaccines, mother reassured and discharged home; Another fever was noted at 1pm, 100.7F which resolved after TYLENOL was given(2 ml). Mother describes 2 episodes of stiffening and discoloration. 1st episode was about 8hrs after the fever, 9pm when she was bathing the baby, she noted stiffening of the limbs, baby also appeared flushed and like he was not breathing, episode lasted few seconds and afterwards he let out a loud scream and was back to his baseline tone, color, breathing, responsiveness. 2nd episode was this morning while the baby was in the crib (on the back), also had stiffening, cessation of breathing and facial blushing with associated eye deviation, also few seconds; Baby was admitted for full sepsis workup and other investigation including, EKG, Echo, EEG and Observation; All test results were benign.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Urine analysis normal, Vaccination complication
Clinical narrative: NOTE: PATIENT IS 2 MONTHS OLD (the website would not allow me to correct the age). He was born at 34 week gestational age; Baby was seen here in well baby clinic, a day before symptoms, was given primary series (PENTACEL, Hep B, ROTARIX and PREVNAR 13). Mother reports fever of 101.5F at 5AM next day for which she gave no medication and presented at ER. Temperature in ED was normal; Fever was attributed to the vaccines, mother reassured and discharged home; Another fever was noted at 1pm, 100.7F which resolved after TYLENOL was given(2 ml). Mother describes 2 episodes of stiffening and discoloration. 1st episode was about 8hrs after the fever, 9pm when she was bathing the baby, she noted stiffening of the limbs, baby also appeared flushed and like he was not breathing, episode lasted few seconds and afterwards he let out a loud scream and was back to his baseline tone, color, breathing, responsiveness. 2nd episode was this morning while the baby was in the crib (on the back), also had stiffening, cessation of breathing and facial blushing with associated eye deviation, also few seconds; Baby was admitted for full sepsis workup and other investigation including, EKG, Echo, EEG and Observation; All test results were benign.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Discomfort, Pruritus, Rash, Rash vesicular, Skin lesion
Clinical narrative: On 04 July dev rash, some lesions vesicular, some are flat. Lesions on his hands, arms, elbows, knuckles and knees. He has one lesion on his lip. No evidence of EM. SPV site normal. Pt is not ill, c/o itching and some discomfort. Symptoms: RASH&OTH NONSPEC SKIN ERUPTION(R21), PRURITUS, UNSPECIFIED(L299).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, Inflammation, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old female patient. The patient's concurrent conditions, concomitant medications and medical history were not reported. On 04-JUN-2018, the patient was vaccinated with an unspecified, expired dose of PROQUAD, recombinant human albumin (rHA), lot number M038229, expiration date 06-MAR-2018 (dose, route of administration and injection site were not reported), reconstituted with sterile diluent (lot and expiration date not provided). No adverse effect was reported. No treatment was given and no lab diagnostics/studies were performed. On an unspecified date in approximately June 2018, the patient was vaccinated with an unspecified dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid (reported as DTaP Polio) (dose, route of administration, lot number and expiration date not reported) in the left leg. On an unknown date in approximately June 2018, the patient developed a mild inflammatory reaction to diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid vaccine. The reporter also stated that the patient's left leg was hard at the injection site and she began to experience redness, pain and swelling at the injection site of diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid. The outcome of reported symptoms was reported as improving on 08-JUN-2018, when the patient was seen in the clinic. The reporter considered mild inflammation and injection site induration, redness, pain and swelling to be related to diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid. The relatedness between the events and PROQUAD was not reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4-year-old female patient. The patient's concurrent conditions, concomitant medications and medical history were not reported. On 04-JUN-2018, the patient was vaccinated with an unspecified, expired dose of PROQUAD, recombinant human albumin (rHA), lot number M038229, expiration date 06-MAR-2018 (dose, route of administration and injection site were not reported), reconstituted with sterile diluent (lot and expiration date not provided). No adverse effect was reported. No treatment was given and no lab diagnostics/studies were performed. On an unspecified date in approximately June 2018, the patient was vaccinated with an unspecified dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid (reported as DTaP Polio) (dose, route of administration, lot number and expiration date not reported) in the left leg. On an unknown date in approximately June 2018, the patient developed a mild inflammatory reaction to diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid vaccine. The reporter also stated that the patient's left leg was hard at the injection site and she began to experience redness, pain and swelling at the injection site of diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid. The outcome of reported symptoms was reported as improving on 08-JUN-2018, when the patient was seen in the clinic. The reporter considered mild inflammation and injection site induration, redness, pain and swelling to be related to diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid. The relatedness between the events and PROQUAD was not reported.