chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Joint swelling, Malaise
Clinical narrative: Patient stepped on glass and received TD on 4/30/10. The next day (5/1/10) the injection site was hard and swollen. On 5/3/10, she was zoned out, tired, depressed, wanted to cry, obsessive with thoughts, and couldn't "get connections with her thought form", and couldn't function. On 5/4/10, patient's arms felt "like they had lead on them", her arm twitched, but that symptom has since resolved. She was very fatigued, had a horrible headache, lots of gas, and her stomach was swollen. The gas and swollen stomach symptoms have resolved as of 5/5/10. On 5/4/10, patient called clinic and was told to go to bed, drink lots of fluids, and go to the ER. Patient did not go to ER. On the evening of 5/4/10, the patient called the provider of the vaccine and again was told to go to the ER, and again, she did not. She also called her internist, and they advised her to go to the ER, and suggested she try activated charcoal powder. Patient did not go to ER, but did take some activated charcoal powder on 5/4/10. On 5/5/10, the injection site was warm, with a shooting pain when she touches the injection site. The patient has malaise, her eyes felt like there was too much pressure behind them, although they are feeling better, she feels tightness in her chest, her kidneys hurt, she feels unstable, has muscle spasms in her legs that are not severe, and are from the knee up. Despite this, she claims to be feeling better. Follow up Received 5/26/2010: The patient was contacted to see if her symptoms had resolved. The patient stated that she still has a lot of symptoms, including twitching in her arm, her fingernails went dark around the cuticle; first black, then blue. They are still blue, and the veins in her ankles are dark. The veins in her arms hurt, the nerves hurt, and her arms are very sore. She is having night sweats (she did not have them before receiving TD). Her sleeping patterns have changed, so she is really tired. She has not seen a health care provider for her symptoms, nor has she taken any medications to treat them. Follow up Received 7/7/2010: The patient stated that she was slowly getting better, but she still has some residual issues. She still has some muscle spasms at the site of injection, her kidneys are still hurting, but not every day. She has some back and joint pain, and swelling in her legs and ankles. She had a problem with her stools and a blockage, which has resolved. She is also complaining of very bad problems with her short term memory, which she attributes to the vaccine. The patient is treating her symptoms by taking one level teaspoon of charcoal powder for 5-7 days, waiting for 3-4 days, and then taking it again for 5-7 days.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Memory impairment, Muscle spasms, Muscle twitching, Nail discolouration, Neuralgia
Clinical narrative: Patient stepped on glass and received TD on 4/30/10. The next day (5/1/10) the injection site was hard and swollen. On 5/3/10, she was zoned out, tired, depressed, wanted to cry, obsessive with thoughts, and couldn't "get connections with her thought form", and couldn't function. On 5/4/10, patient's arms felt "like they had lead on them", her arm twitched, but that symptom has since resolved. She was very fatigued, had a horrible headache, lots of gas, and her stomach was swollen. The gas and swollen stomach symptoms have resolved as of 5/5/10. On 5/4/10, patient called clinic and was told to go to bed, drink lots of fluids, and go to the ER. Patient did not go to ER. On the evening of 5/4/10, the patient called the provider of the vaccine and again was told to go to the ER, and again, she did not. She also called her internist, and they advised her to go to the ER, and suggested she try activated charcoal powder. Patient did not go to ER, but did take some activated charcoal powder on 5/4/10. On 5/5/10, the injection site was warm, with a shooting pain when she touches the injection site. The patient has malaise, her eyes felt like there was too much pressure behind them, although they are feeling better, she feels tightness in her chest, her kidneys hurt, she feels unstable, has muscle spasms in her legs that are not severe, and are from the knee up. Despite this, she claims to be feeling better. Follow up Received 5/26/2010: The patient was contacted to see if her symptoms had resolved. The patient stated that she still has a lot of symptoms, including twitching in her arm, her fingernails went dark around the cuticle; first black, then blue. They are still blue, and the veins in her ankles are dark. The veins in her arms hurt, the nerves hurt, and her arms are very sore. She is having night sweats (she did not have them before receiving TD). Her sleeping patterns have changed, so she is really tired. She has not seen a health care provider for her symptoms, nor has she taken any medications to treat them. Follow up Received 7/7/2010: The patient stated that she was slowly getting better, but she still has some residual issues. She still has some muscle spasms at the site of injection, her kidneys are still hurting, but not every day. She has some back and joint pain, and swelling in her legs and ankles. She had a problem with her stools and a blockage, which has resolved. She is also complaining of very bad problems with her short term memory, which she attributes to the vaccine. The patient is treating her symptoms by taking one level teaspoon of charcoal powder for 5-7 days, waiting for 3-4 days, and then taking it again for 5-7 days.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Night sweats, Obsessive thoughts, Oedema peripheral, Pain in extremity, Renal pain
Clinical narrative: Patient stepped on glass and received TD on 4/30/10. The next day (5/1/10) the injection site was hard and swollen. On 5/3/10, she was zoned out, tired, depressed, wanted to cry, obsessive with thoughts, and couldn't "get connections with her thought form", and couldn't function. On 5/4/10, patient's arms felt "like they had lead on them", her arm twitched, but that symptom has since resolved. She was very fatigued, had a horrible headache, lots of gas, and her stomach was swollen. The gas and swollen stomach symptoms have resolved as of 5/5/10. On 5/4/10, patient called clinic and was told to go to bed, drink lots of fluids, and go to the ER. Patient did not go to ER. On the evening of 5/4/10, the patient called the provider of the vaccine and again was told to go to the ER, and again, she did not. She also called her internist, and they advised her to go to the ER, and suggested she try activated charcoal powder. Patient did not go to ER, but did take some activated charcoal powder on 5/4/10. On 5/5/10, the injection site was warm, with a shooting pain when she touches the injection site. The patient has malaise, her eyes felt like there was too much pressure behind them, although they are feeling better, she feels tightness in her chest, her kidneys hurt, she feels unstable, has muscle spasms in her legs that are not severe, and are from the knee up. Despite this, she claims to be feeling better. Follow up Received 5/26/2010: The patient was contacted to see if her symptoms had resolved. The patient stated that she still has a lot of symptoms, including twitching in her arm, her fingernails went dark around the cuticle; first black, then blue. They are still blue, and the veins in her ankles are dark. The veins in her arms hurt, the nerves hurt, and her arms are very sore. She is having night sweats (she did not have them before receiving TD). Her sleeping patterns have changed, so she is really tired. She has not seen a health care provider for her symptoms, nor has she taken any medications to treat them. Follow up Received 7/7/2010: The patient stated that she was slowly getting better, but she still has some residual issues. She still has some muscle spasms at the site of injection, her kidneys are still hurting, but not every day. She has some back and joint pain, and swelling in her legs and ankles. She had a problem with her stools and a blockage, which has resolved. She is also complaining of very bad problems with her short term memory, which she attributes to the vaccine. The patient is treating her symptoms by taking one level teaspoon of charcoal powder for 5-7 days, waiting for 3-4 days, and then taking it again for 5-7 days.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Sleep disorder, Vein discolouration, Vein pain
Clinical narrative: Patient stepped on glass and received TD on 4/30/10. The next day (5/1/10) the injection site was hard and swollen. On 5/3/10, she was zoned out, tired, depressed, wanted to cry, obsessive with thoughts, and couldn't "get connections with her thought form", and couldn't function. On 5/4/10, patient's arms felt "like they had lead on them", her arm twitched, but that symptom has since resolved. She was very fatigued, had a horrible headache, lots of gas, and her stomach was swollen. The gas and swollen stomach symptoms have resolved as of 5/5/10. On 5/4/10, patient called clinic and was told to go to bed, drink lots of fluids, and go to the ER. Patient did not go to ER. On the evening of 5/4/10, the patient called the provider of the vaccine and again was told to go to the ER, and again, she did not. She also called her internist, and they advised her to go to the ER, and suggested she try activated charcoal powder. Patient did not go to ER, but did take some activated charcoal powder on 5/4/10. On 5/5/10, the injection site was warm, with a shooting pain when she touches the injection site. The patient has malaise, her eyes felt like there was too much pressure behind them, although they are feeling better, she feels tightness in her chest, her kidneys hurt, she feels unstable, has muscle spasms in her legs that are not severe, and are from the knee up. Despite this, she claims to be feeling better. Follow up Received 5/26/2010: The patient was contacted to see if her symptoms had resolved. The patient stated that she still has a lot of symptoms, including twitching in her arm, her fingernails went dark around the cuticle; first black, then blue. They are still blue, and the veins in her ankles are dark. The veins in her arms hurt, the nerves hurt, and her arms are very sore. She is having night sweats (she did not have them before receiving TD). Her sleeping patterns have changed, so she is really tired. She has not seen a health care provider for her symptoms, nor has she taken any medications to treat them. Follow up Received 7/7/2010: The patient stated that she was slowly getting better, but she still has some residual issues. She still has some muscle spasms at the site of injection, her kidneys are still hurting, but not every day. She has some back and joint pain, and swelling in her legs and ankles. She had a problem with her stools and a blockage, which has resolved. She is also complaining of very bad problems with her short term memory, which she attributes to the vaccine. The patient is treating her symptoms by taking one level teaspoon of charcoal powder for 5-7 days, waiting for 3-4 days, and then taking it again for 5-7 days.
Age: 41.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Chills, Cough, Ear swelling, Fatigue, Malaise
Clinical narrative: 41 YO F, received injection on 10/15/2010. 5 hours post-injection pt C/O chills, malaise, and fatigue, cough and sore throat. 4 days S/P vaccine pt. C/O facial swelling, described as extremely puffy face/neck/ears. 3 days later when the swelling decreased, the outer layer of her skin flaked off for the next 5-6 days. Pt. sought care with family member who is a PA. Dx 'possible allergic RXN'. 9 days S/P vaccine pt. developed cough, sore throat and a fever of 103, was treated at urgent care with VALIUM, an inhaler, and cough medicine with codeine. Symptoms resolved within 10 days. Stated she took Tdap at the same time as the influenza vaccine. Pt. spoke to the CDC and found out her vaccine has formaldehyde which participant is allergic to. Pt. had a previous/similar lab reaction to formaldehyde.
Age: 41.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Oropharyngeal pain, Pyrexia, Skin exfoliation, Swelling, Swelling face
Clinical narrative: 41 YO F, received injection on 10/15/2010. 5 hours post-injection pt C/O chills, malaise, and fatigue, cough and sore throat. 4 days S/P vaccine pt. C/O facial swelling, described as extremely puffy face/neck/ears. 3 days later when the swelling decreased, the outer layer of her skin flaked off for the next 5-6 days. Pt. sought care with family member who is a PA. Dx 'possible allergic RXN'. 9 days S/P vaccine pt. developed cough, sore throat and a fever of 103, was treated at urgent care with VALIUM, an inhaler, and cough medicine with codeine. Symptoms resolved within 10 days. Stated she took Tdap at the same time as the influenza vaccine. Pt. spoke to the CDC and found out her vaccine has formaldehyde which participant is allergic to. Pt. had a previous/similar lab reaction to formaldehyde.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Skin warm
Clinical narrative: Urticarial rash.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Urticarial rash.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Acute disseminated encephalomyelitis, Childhood disintegrative disorder, Inability to crawl, Lumbar puncture, Neurological examination
Clinical narrative: lost her milestones can't sit without falling over can't crawl lost ability to feed herself swallow went back to about 4 months old
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: lost her milestones can't sit without falling over can't crawl lost ability to feed herself swallow went back to about 4 months old
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Blood test, Childhood disintegrative disorder, Fall, Inability to crawl, Lumbar puncture
Clinical narrative: lost her milestones can't sit without falling over can't crawl lost ability to feed herself swallow went back to about 4 months old
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy bone marrow, Idiopathic thrombocytopenic purpura, Platelet count decreased, Scan spleen
Clinical narrative: slight bruising, low WBC, low platelet count 3 weeks Prednisone for ITP diagnosis, Metformin, Synthroid
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Biopsy bone marrow normal, Blood count abnormal, Contusion, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: slight bruising, low WBC, low platelet count 3 weeks Prednisone for ITP diagnosis, Metformin, Synthroid
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Spleen scan normal, Thyroid function test abnormal, White blood cell count decreased
Clinical narrative: slight bruising, low WBC, low platelet count 3 weeks Prednisone for ITP diagnosis, Metformin, Synthroid
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test abnormal, Platelet count decreased
Clinical narrative: slight bruising, low WBC, low platelet count 3 weeks Prednisone for ITP diagnosis, Metformin, Synthroid
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test, Convulsion, Febrile convulsion, Pyrexia, Urine analysis
Clinical narrative: Flu vaccine given 12/2/10 pt developed fever 12/4/10 fever increased -> febrile seizure 12/5/11 seen in ER Dx febrile sz.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: Flu vaccine given 12/2/10 pt developed fever 12/4/10 fever increased -> febrile seizure 12/5/11 seen in ER Dx febrile sz.
Age: 0.92
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Flu vaccine given 12/2/10 pt developed fever 12/4/10 fever increased -> febrile seizure 12/5/11 seen in ER Dx febrile sz.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Chest X-ray, Convulsion, Lumbar puncture, Pyrexia, Status epilepticus
Clinical narrative: Sudden high fever lead to status epilepticus.  Seizure event lasted 90 min.  Treatment IV Ativan x 4, Depakote x1. Rectal Tylenol.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Gaze palsy, Jaw disorder, Loss of consciousness, Muscle twitching, Opisthotonus
Clinical narrative: Patient remained sitting in chair for several minutes after injection. Patient became pale, then lost consciousness, his back arched, he started twitching, mother eased him to floor from chair. Pharmacist administering vaccine noted his jaw was clenched.  Administering pharmacist brought him a cool towel, he regained consciousness and lay on the floor for 5 minutes.  He sat up in a chair, his color turned white and his eyes rolled back in his head again.  This time no arching, or twitching.  He rested another 5 minutes, and was able to depart.  He skiied the next two days and had no complaints.  He doesn't remember anything that happened in the pharmacy.  He has fainted from previous flu shots, I thought it was fear the first time.  That is why I had him sit in the chair at the pharmacy this time to wait and see what happened.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor
Clinical narrative: Patient remained sitting in chair for several minutes after injection. Patient became pale, then lost consciousness, his back arched, he started twitching, mother eased him to floor from chair. Pharmacist administering vaccine noted his jaw was clenched.  Administering pharmacist brought him a cool towel, he regained consciousness and lay on the floor for 5 minutes.  He sat up in a chair, his color turned white and his eyes rolled back in his head again.  This time no arching, or twitching.  He rested another 5 minutes, and was able to depart.  He skiied the next two days and had no complaints.  He doesn't remember anything that happened in the pharmacy.  He has fainted from previous flu shots, I thought it was fear the first time.  That is why I had him sit in the chair at the pharmacy this time to wait and see what happened.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Tinnitus
Clinical narrative: Ringing, hissing, buzzing in both ears, horrible tinnitus.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Skeletal injury
Clinical narrative: Patient has been experiencing significant discomfort at the injection site. Patient thinks the problem occurred due to the pharmacist hitting bone with the needle.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pain, Pain in extremity
Clinical narrative: Received Flu shot 11/22/10 - 1 hr later started to hurt, chest heavy (has fibromyalgia) pain warm (L) face went onto head & shoulder & whole body hurt pain mainly upper shoulders & ears "feel like on fire, no temp, says feel like has fever no temp - says arm hurts/no redness etc. -  refused to left me see dr says hurts to talk.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture negative, Culture urine negative, Irritability, Pyrexia, White blood cell count increased
Clinical narrative: Febrile- T 100.5 (R) 1-13-11. Fussy. Elevated WBC -> 1-13-11. 1-14-11 Normal WBC & afebrile. Rechecked pt. 1-13-11 pm & 1-14-11.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Tenderness
Clinical narrative: Pt received Flu vaccine 11/4/10 at mass Flu clinic c/o pain started the next day hurt for 2 days, got better but has not stopped says couldn't move arm those 2 days & now has limited mobility - (Rt) arm site of inj. clear, no redness, no edema, cool to touch tenderness noted when touch area toward underarm.
Age: 3.0
Sex: M
Vaccine: FLUN3, HIBV, PNC13
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left Leg Sore, Swollen, Red and Hot to touch. Child refused to bear weight on leg. Crying. Parents gave Ibubrofen.
Age: 3.0
Sex: M
Vaccine: FLUN3, HIBV, PNC13
Symptoms: Weight bearing difficulty
Clinical narrative: Left Leg Sore, Swollen, Red and Hot to touch. Child refused to bear weight on leg. Crying. Parents gave Ibubrofen.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: 56 year old female with SLE received injectable. Pt experienced hives and facial swelling 1 day after vaccine. Symptoms lasted 7 days. Pt did not seek care. Resolved by 10 days post-vaccination. We have been unable to reach this patient despite repeated attempts.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Fatigue, Myalgia, Urticaria, Visual impairment
Clinical narrative: 26 y/old female received influenza vaccine injection on 10/5/2010. Patient reported that hours (specific hour not specified) post-vaccination she developed general discomfort (myalgia, fatigue). 1 day post vaccination, patient developed hives and vision problems. These symptoms still persisted on 10/7/2010. Patient did not seek medical treatment. This is the only information available, as the patient did not agree to be contacted by us.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Rash, Urticaria
Clinical narrative: 47-yr old female received injectable on 9/27. 2 hours post vaccination patient developed a rash. Patient sought medical care at occupational health; was not hospitalized or diagnosed. Was given steroids and stated the rash improved. C/o hives starting within 2 hours of vaccine and lasting 36 hours after vaccine in upper torso as well as arms and legs but not on face. 1 day later, pt. experienced chills. C/o chills starting around 4 hours after vaccine lasting about 3 hours. Both episodes lasted 2 days. Spoke with participant on the phone, stated she has never had an allergic reaction with a vaccine before.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Pruritus, Urticaria
Clinical narrative: 13 year old female with history of exercise-induced asthma received injectable 10/24/2010 in left arm. Three hours after vaccination patient experienced hives starting on lower abdomen and lower back. Pt complained of severe itching and back pain. Hives also spread to legs and arms, but were less coalesced on extremities. Mother took patient to ED, where she was treated with BENADRYL and given a 6-day Rx of steroids. The ED physician could not conclusively attribute symptoms to flu shot as hives began shortly after pt. ate a sushi dinner; however, patient had eaten the exact sushi meal over couple of months for the past few years. Symptoms have largely resolved. Pt is going to be allergy tested for sushi and eggs.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: 23 year old female with history of hypoglycemia received injectable on 10/26/2010 in left arm. First time getting flu vaccine. 10 minutes after vaccination, subject developed arm pain and 5 inch, red, local swelling at injection site. 2 hours after vaccination pt experienced malaise, myalgia, fatigue, and fever of 101.1. 4 hours after vaccination, pt. developed rash on face and began to have "crampy" upper quadrant abdominal pain with nausea. 5 hours post injection patient's arm and face started itching. 6 hours after vaccination pt. began to feel dizzy. Patient called nurse's hotline and they advised her to monitor her symptoms and take PO BENADRYL. Fever, itching, rash, and abdominal pain subsided in one day. The following day (2 days after vaccination) pt. developed cold symptoms, left arm pain persisted and began to feel stiff. 6 days after vaccination all symptoms had resolved.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Musculoskeletal stiffness, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: 23 year old female with history of hypoglycemia received injectable on 10/26/2010 in left arm. First time getting flu vaccine. 10 minutes after vaccination, subject developed arm pain and 5 inch, red, local swelling at injection site. 2 hours after vaccination pt experienced malaise, myalgia, fatigue, and fever of 101.1. 4 hours after vaccination, pt. developed rash on face and began to have "crampy" upper quadrant abdominal pain with nausea. 5 hours post injection patient's arm and face started itching. 6 hours after vaccination pt. began to feel dizzy. Patient called nurse's hotline and they advised her to monitor her symptoms and take PO BENADRYL. Fever, itching, rash, and abdominal pain subsided in one day. The following day (2 days after vaccination) pt. developed cold symptoms, left arm pain persisted and began to feel stiff. 6 days after vaccination all symptoms had resolved.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pruritus, Pyrexia, Rash
Clinical narrative: 23 year old female with history of hypoglycemia received injectable on 10/26/2010 in left arm. First time getting flu vaccine. 10 minutes after vaccination, subject developed arm pain and 5 inch, red, local swelling at injection site. 2 hours after vaccination pt experienced malaise, myalgia, fatigue, and fever of 101.1. 4 hours after vaccination, pt. developed rash on face and began to have "crampy" upper quadrant abdominal pain with nausea. 5 hours post injection patient's arm and face started itching. 6 hours after vaccination pt. began to feel dizzy. Patient called nurse's hotline and they advised her to monitor her symptoms and take PO BENADRYL. Fever, itching, rash, and abdominal pain subsided in one day. The following day (2 days after vaccination) pt. developed cold symptoms, left arm pain persisted and began to feel stiff. 6 days after vaccination all symptoms had resolved.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Hypersensitivity, Swelling face, Wheezing
Clinical narrative: 43 y/o female received her influenza vaccine injection on 10/8/2010. 3 hours post vaccination patient developed an allergic reaction, facial swelling, difficult breathing, and wheezing. Patient sought care in the emergency room where she was diagnosed with a mild allergic reaction and was discharged home same day. Patient reported that symptoms resolved within 1 day.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Caesarean section, Drug exposure during pregnancy, Face oedema, Fibrin D dimer increased
Clinical narrative: 33 year old pregnant female received injectable 9/29/2010. The two weeks prior to 10/18, she experienced intermittent edema of face, legs and abdomen, that she believed were related to pregnancy. On 10/18 at 1am she experienced sudden onset nausea, vomiting and abdominal pain. She was admitted to the labor and delivery ward and was diagnosed with pregnancy induced hypertension BP 160/80, with mild proteinuria. She was observed for 48 hours while receiving steroids for possible preeclampsia. Worsening abdominal pain, nausea, vomiting and hypertension 180/90, confirmed preeclampsia on 10/20. At that time she went into active labor and required an emergency c-section at 27.5 weeks at 3pm that day. Laboratory results confirmed HELLP syndrome. Platelets of 19 at the nadir. LFTs in the thousands (2000s). Elevated ddimer. Drop in hemoglobin. With steroids and time her condition stabilized. Baby was born at a weight of 1 pound 5 ounces. Baby is still alive but after 21 days of life still weighs less than 2 pounds; baby had intrauterine growth restriction diagnosed after a normal ultrasound was documented in late 8/2010. Pt's hypertension is returning to normal range.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Foetal growth restriction, Gestational hypertension, HELLP syndrome, Haemoglobin decreased, Liver function test abnormal
Clinical narrative: 33 year old pregnant female received injectable 9/29/2010. The two weeks prior to 10/18, she experienced intermittent edema of face, legs and abdomen, that she believed were related to pregnancy. On 10/18 at 1am she experienced sudden onset nausea, vomiting and abdominal pain. She was admitted to the labor and delivery ward and was diagnosed with pregnancy induced hypertension BP 160/80, with mild proteinuria. She was observed for 48 hours while receiving steroids for possible preeclampsia. Worsening abdominal pain, nausea, vomiting and hypertension 180/90, confirmed preeclampsia on 10/20. At that time she went into active labor and required an emergency c-section at 27.5 weeks at 3pm that day. Laboratory results confirmed HELLP syndrome. Platelets of 19 at the nadir. LFTs in the thousands (2000s). Elevated ddimer. Drop in hemoglobin. With steroids and time her condition stabilized. Baby was born at a weight of 1 pound 5 ounces. Baby is still alive but after 21 days of life still weighs less than 2 pounds; baby had intrauterine growth restriction diagnosed after a normal ultrasound was documented in late 8/2010. Pt's hypertension is returning to normal range.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Localised oedema, Nausea, Oedema peripheral, Platelet count decreased, Pre-eclampsia
Clinical narrative: 33 year old pregnant female received injectable 9/29/2010. The two weeks prior to 10/18, she experienced intermittent edema of face, legs and abdomen, that she believed were related to pregnancy. On 10/18 at 1am she experienced sudden onset nausea, vomiting and abdominal pain. She was admitted to the labor and delivery ward and was diagnosed with pregnancy induced hypertension BP 160/80, with mild proteinuria. She was observed for 48 hours while receiving steroids for possible preeclampsia. Worsening abdominal pain, nausea, vomiting and hypertension 180/90, confirmed preeclampsia on 10/20. At that time she went into active labor and required an emergency c-section at 27.5 weeks at 3pm that day. Laboratory results confirmed HELLP syndrome. Platelets of 19 at the nadir. LFTs in the thousands (2000s). Elevated ddimer. Drop in hemoglobin. With steroids and time her condition stabilized. Baby was born at a weight of 1 pound 5 ounces. Baby is still alive but after 21 days of life still weighs less than 2 pounds; baby had intrauterine growth restriction diagnosed after a normal ultrasound was documented in late 8/2010. Pt's hypertension is returning to normal range.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Premature labour, Proteinuria, Vomiting
Clinical narrative: 33 year old pregnant female received injectable 9/29/2010. The two weeks prior to 10/18, she experienced intermittent edema of face, legs and abdomen, that she believed were related to pregnancy. On 10/18 at 1am she experienced sudden onset nausea, vomiting and abdominal pain. She was admitted to the labor and delivery ward and was diagnosed with pregnancy induced hypertension BP 160/80, with mild proteinuria. She was observed for 48 hours while receiving steroids for possible preeclampsia. Worsening abdominal pain, nausea, vomiting and hypertension 180/90, confirmed preeclampsia on 10/20. At that time she went into active labor and required an emergency c-section at 27.5 weeks at 3pm that day. Laboratory results confirmed HELLP syndrome. Platelets of 19 at the nadir. LFTs in the thousands (2000s). Elevated ddimer. Drop in hemoglobin. With steroids and time her condition stabilized. Baby was born at a weight of 1 pound 5 ounces. Baby is still alive but after 21 days of life still weighs less than 2 pounds; baby had intrauterine growth restriction diagnosed after a normal ultrasound was documented in late 8/2010. Pt's hypertension is returning to normal range.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Contusion, Erythema, Fatigue, Immediate post-injection reaction
Clinical narrative: 32 year old female received injectable 10/6/2010 in left arm. Immediately after the injection pt. had bleeding at the site. Patient c/o pain, swelling, erythema, bruising, and induration 4 inches in diameter that began on the day of vaccination. 4 hours later erythema developed and 8 hours later pt. had swelling and erythema. Symptoms peaked at 48 hours and pt. began experiencing mild fever, chills, malaise, myalgia and fatigue. Patient was concerned about cellulitis but symptoms improved immensely with ibuprofen and hot compresses. The induration and erythema subsided by 4 days after the injection. As of (10/18) there still remained a bruise at the site of injection which was slowly improving. Patient is a physician herself and consulted with a few physician colleagues who all ruled out cellulitis, and diagnosed her with a local vaccine reaction.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Injection site haematoma, Injection site haemorrhage, Malaise, Myalgia
Clinical narrative: 32 year old female received injectable 10/6/2010 in left arm. Immediately after the injection pt. had bleeding at the site. Patient c/o pain, swelling, erythema, bruising, and induration 4 inches in diameter that began on the day of vaccination. 4 hours later erythema developed and 8 hours later pt. had swelling and erythema. Symptoms peaked at 48 hours and pt. began experiencing mild fever, chills, malaise, myalgia and fatigue. Patient was concerned about cellulitis but symptoms improved immensely with ibuprofen and hot compresses. The induration and erythema subsided by 4 days after the injection. As of (10/18) there still remained a bruise at the site of injection which was slowly improving. Patient is a physician herself and consulted with a few physician colleagues who all ruled out cellulitis, and diagnosed her with a local vaccine reaction.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Swelling, Vaccination site reaction
Clinical narrative: 32 year old female received injectable 10/6/2010 in left arm. Immediately after the injection pt. had bleeding at the site. Patient c/o pain, swelling, erythema, bruising, and induration 4 inches in diameter that began on the day of vaccination. 4 hours later erythema developed and 8 hours later pt. had swelling and erythema. Symptoms peaked at 48 hours and pt. began experiencing mild fever, chills, malaise, myalgia and fatigue. Patient was concerned about cellulitis but symptoms improved immensely with ibuprofen and hot compresses. The induration and erythema subsided by 4 days after the injection. As of (10/18) there still remained a bruise at the site of injection which was slowly improving. Patient is a physician herself and consulted with a few physician colleagues who all ruled out cellulitis, and diagnosed her with a local vaccine reaction.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Hypersensitivity, Nasal congestion, Swelling face
Clinical narrative: 22 y/o female received influenza vaccine injection on 10/05/2010. 5 days post vaccination patient developed wheezing, cough, and nasal congestion, which persisted for two days. Additionally, five days post vaccination patient developed hives, rash, facial swelling, trouble breathing, and wheezing. Patient was seen in the Emergency Room and was diagnosed with an allergic reaction.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria, Wheezing
Clinical narrative: 22 y/o female received influenza vaccine injection on 10/05/2010. 5 days post vaccination patient developed wheezing, cough, and nasal congestion, which persisted for two days. Additionally, five days post vaccination patient developed hives, rash, facial swelling, trouble breathing, and wheezing. Patient was seen in the Emergency Room and was diagnosed with an allergic reaction.
Age: 0.83
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Irritability, Otitis media acute, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Got very fussy immediately post flu vaccine then URI signs/symptoms 3 days later and now worse last couple days.  Clear nasal discharge, no documented fever.  Acute Otitis Media diagnosed 1/25/2011.
Age: 1.51
Sex: M
Vaccine: DTAP, MMR
Symptoms: Eye movement disorder
Clinical narrative: Eye twitching.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Headache, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: This healthy 8 year old boy came for he second PRIORIX MMR immunization for school registration. He received the PRIORIX on left deltoid. A few hours after the injection his mother called to report that he had developed a fever and swelling on the injection site. He was complaining of headaches and multiple joint pains. I saw this boy the next day to confirm the swelling on the injection site. The swelling was severe and the boy was lethargic and still complaining of joint pains.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Epstein-Barr virus infection, Epstein-Barr virus test positive, Erythema, Fatigue
Clinical narrative: In June, 2009, I received a shingles vaccination. My arm swelled up enormously, and was red as if I have a boil from elbow to shoulder. I became sick and had some spots on my legs. I immediately started feeling exhausted and my body ached. One and a half years later, I still have fibromyalgia and chronic fatigue. I have not had one day without extreme fatigue and deep muscle aching in my legs. My life is entirely changed. I am extremely damaged and impaired as a result of this vaccination. I reported to my doctors and to Merck at the time of this reaction. I have lost my ability to work in my profession without many medications, but at this time, I am going to have to stop the minimal work that I do because of the fatigue and mental confusion and pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fibromyalgia, Immediate post-injection reaction, Impaired work ability, Malaise, Myalgia
Clinical narrative: In June, 2009, I received a shingles vaccination. My arm swelled up enormously, and was red as if I have a boil from elbow to shoulder. I became sick and had some spots on my legs. I immediately started feeling exhausted and my body ached. One and a half years later, I still have fibromyalgia and chronic fatigue. I have not had one day without extreme fatigue and deep muscle aching in my legs. My life is entirely changed. I am extremely damaged and impaired as a result of this vaccination. I reported to my doctors and to Merck at the time of this reaction. I have lost my ability to work in my profession without many medications, but at this time, I am going to have to stop the minimal work that I do because of the fatigue and mental confusion and pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain, Rash
Clinical narrative: In June, 2009, I received a shingles vaccination. My arm swelled up enormously, and was red as if I have a boil from elbow to shoulder. I became sick and had some spots on my legs. I immediately started feeling exhausted and my body ached. One and a half years later, I still have fibromyalgia and chronic fatigue. I have not had one day without extreme fatigue and deep muscle aching in my legs. My life is entirely changed. I am extremely damaged and impaired as a result of this vaccination. I reported to my doctors and to Merck at the time of this reaction. I have lost my ability to work in my profession without many medications, but at this time, I am going to have to stop the minimal work that I do because of the fatigue and mental confusion and pain.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 9 month old, female subject was identified by the investigator based on review of data from the Agency. The subject's vaccine history included 3 doses of PENTACEL: lot number C3496AA received on 25 January 2010, lot number C3555AA received on 01 April 2010, and lot number C3608A received on 07 June 2010 (route and site of administration not reported). Approximately 3 months after the last dose, on 03 September 2010, the subject developed a cough. Two days later, the subject developed a paroxysmal cough. The subject also experienced posttussive vomiting, cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 09 September 2010. Corrective treatment consisted of AZITHROMYCIN for 5 days starting on 10 September 2010. At the time of final contact on 04 November 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 35 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. Documents held by sender: None
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 9 month old, female subject was identified by the investigator based on review of data from the Agency. The subject's vaccine history included 3 doses of PENTACEL: lot number C3496AA received on 25 January 2010, lot number C3555AA received on 01 April 2010, and lot number C3608A received on 07 June 2010 (route and site of administration not reported). Approximately 3 months after the last dose, on 03 September 2010, the subject developed a cough. Two days later, the subject developed a paroxysmal cough. The subject also experienced posttussive vomiting, cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 09 September 2010. Corrective treatment consisted of AZITHROMYCIN for 5 days starting on 10 September 2010. At the time of final contact on 04 November 2010, the subject's cough had resolved. The duration of the cough was reported at that time as 35 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. Documents held by sender: None
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one in a series of 11 cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 8 month old, male subject (initials not collected) was identified by the investigator based on review of data from Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL: lot number C3545AA received on 10 December 2009, lot number C3451AA received on 12 March 2010, and lot number C3588AA received on 26 April 2010 (route and site of administration not reported). Approximately 2 months after the last dose, the subject developed a cough on 26 June 2010. Four days later, the subject developed a paroxysmal cough with whoop and posttussive vomiting. The subject also experienced symptoms of cold-like illness and sleep disturbance (dates not reported). Laboratory testing included positive PCR on 30 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of a single dose of azithromycin on 30 June 2010. The subject was not hospitalized. At the time of final contact on 05 August 2010, the subject's cough had resolved. The duration of the cough was reported at the time as 20 days. Investigator causality assessment is not required as per protocol.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one in a series of 11 cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 8 month old, male subject (initials not collected) was identified by the investigator based on review of data from Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL: lot number C3545AA received on 10 December 2009, lot number C3451AA received on 12 March 2010, and lot number C3588AA received on 26 April 2010 (route and site of administration not reported). Approximately 2 months after the last dose, the subject developed a cough on 26 June 2010. Four days later, the subject developed a paroxysmal cough with whoop and posttussive vomiting. The subject also experienced symptoms of cold-like illness and sleep disturbance (dates not reported). Laboratory testing included positive PCR on 30 June 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of a single dose of azithromycin on 30 June 2010. The subject was not hospitalized. At the time of final contact on 05 August 2010, the subject's cough had resolved. The duration of the cough was reported at the time as 20 days. Investigator causality assessment is not required as per protocol.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 11 January 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in an 11 month old, male subject was identified by the investigator based on review of data from the Agency. The subject's vaccine history included 3 doses of PENTACEL received on 12 August 2009, 22 October 2009, and 23 December 2009 (route, site of administration, and lot numbers were not reported). Approximately 6 months after the last dose, on 15 June 2010, he developed a paroxysmal cough. He also experienced symptoms of cold-like illness, posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 17 June 2010. Chest X-ray findings were negative for pneumonia. Corrective treatment consisted of AZITHROMYCIN for 5 days starting on 17 June 2010. The subject was not hospitalized. At the time of final contact on 04 July 2010, the subject's cough had been resolved. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. Documents held by sender: None.