chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: DTAP
Symptoms: Poor quality sleep, Pyrexia, Screaming, Somnolence, Staring
Clinical narrative: Patient was administered his first vaccine on 9-6-13. Within 30 minutes he was sleeping and proceeded to sleep for 3 hours. Mother woke him for dinner. (approx 6:30 pm). Marked decreased appetite was observed. He fell asleep again approx 7:00 pm and slept for 15 hours. He had previously been a frequent night waker, nursing 2-3 times per night. The following day the vaccine injection he developed a low grade fever. Additionally, beginning this day, he would scream and scream and scream. He would double over in pain and continued to scream. This was sometimes accompanied by explosive diarrhea. When he was not screaming, mother and father attempted to engage him in play. He would stare into space. He would not smile, he would not laugh, in contrary to his usually bright and bubbly personality. He was again very sleepy this day following the vaccine and showed marked disinterest in solid food. Continued to breastfeed. At night and for the next several days and nights, he would moan and whimper in his sleep. - all night long. His sleep was restless and accompanied by much tossing and turning. Close contact was kept with the Pediatrician throughout the weekend who agreed increasing probiotics may be helpful. He was also brought to a Naturopathic Physician who prescribed 1/4 tsp probiotic 1 x daily, 5 drops Thuja 1 x daily and 5 drops of Anticromian Crudum 3 x daily. Follow up visit was done with Pediatrician on Sept 10th. The above symptoms lasted nearly a week and a half with symptoms peaking between 1-4 days following the injection and slowly beginning to taper off. He appears to be recovered as of the writing of this form.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site bruising, Platelet count decreased, Pyrexia, Thrombocytopenia
Clinical narrative: Pt came to the office with fever and thrombocytopenia. She had bruises on legs where she was held for shots - pt had never bruised before.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: day after flut shot - fingertips got warm and rutty, now moving up arm.
Age: 58.0
Sex: U
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: Pt received Tdap on 9-18-13. Pt notified RN who administered the vaccine that within 24 hours. She experienced a fever of 101 with deep muscle and joint pain requiring 800 mg Ibuprofen. She reports that the muscle and joint pain has decreased. She denies muscle wasting. No fever as of 9-24-13.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 101.5, Fatigue, Cough, Myalgia.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a medical assistant refers a female patient of unknown age. The reporter stated that the patient previously developed hives after receiving Amoxicillin. In January 1998, the patient was vaccinated with her first dose of PNEUMOVAX23 (dose, route, indication and lot number were not reported). On 26-AUG-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 lot # H022280 and expiration date 16-JUL-2014, (dose, indication and route were not reported). On 27-AUG-2013 the patient experienced fever, redness at the injection site, swelling at the injection site, warmth at the injection site and chills. On unknown date, the patient sought medical attention through call the office. Approximately, in August 2013, the patient received treatment of BENADRYL. The outcome of swelling at the injection site, redness at the injection site, warmth at the injection site, chills and fever was reported as recovering/resolving. This report is the first report of two reports from the same source. The second is 1309USA011510. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Malaise, Pain, Rash, Salivary gland enlargement
Clinical narrative: Heat, malaise, pain - glandular swelling on left side. Cervical to epitrochlear - followed by rash spreading the course of left arm. All within 24 hour time period.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Pain, Pyrexia, Sinus congestion
Clinical narrative: Symptoms of fever (not checked), aching all over, head congestion began Saturday 9-28-13 at 11:00 AM lasted for 24 hrs. Took another 12 hr to completely feel better. Was able to continue activities, but didn't really feel good enough to do so.
Age: 34.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blister, Erythema, Local reaction, Oedema, Pruritus
Clinical narrative: Pt had localized reaction(hives, edema, erythema, warm to touch) starting day of vaccination 9/11/13 which resolved 1-2 days ago. However 4 days ago developed scattered pruritic vesicles on red base consistent with mild case of varicella.
Age: 34.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Skin warm, Urticaria, Varicella post vaccine
Clinical narrative: Pt had localized reaction(hives, edema, erythema, warm to touch) starting day of vaccination 9/11/13 which resolved 1-2 days ago. However 4 days ago developed scattered pruritic vesicles on red base consistent with mild case of varicella.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity
Clinical narrative: Arm very sore after vaccine administered, hard to lift up arm, put clothes on, etc. Has improved as of 9-30-13 but still very sore and hard to move, drive and lift up.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called on 9-29-13 and stated her right arm hurts, it's painful and unable to move. I told her to put ice on it and start ibuprofen. I called her back after 3 hrs and she stated she felt better. I called again on 9-30-13 and she stated it's much better.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tendon calcification, Tendonitis, X-ray limb abnormal
Clinical narrative: After receiving the flu shot, patient experienced pain in the shoulder lasting a few days. Patient then had an X-ray of the shoulder and her physician said she had calcification tendonitis.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient who currently at the time of the report was 17 year old with amoxicillin allergy, reporting on herself. In 2013 (exact date was not reported) the patient received a second dose of VARIVAX (Merck) injection (lot number, dose, route and site of administration were not reported). The patient was 18 weeks pregnant, when she received a vaccine. Last menstrual period was calculated as 06-MAY-2013 and EDD (estimate delivery date) would be on 10-FEB-2014. The pregnancy outcome was pending. The patient did not seek medical attention. None lab diagnostics were performed. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5.5 x 5.5 red, swollen, warm to touch area on L upper arm. Cool/warm compress. advised not to receive flu vaccine preservative or non preservative vaccine in the future.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site rash, Swelling
Clinical narrative: Vaccine administered on 9/27/2013. Patient reported swelling, redness and occurred next day (9/28/13). On 9/30/13 patient reported a rash around the injection site, but the symptoms improved. Better but not fully recovered.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Patient received FLUZONE high dose 9/29/13. Patient died 9/30/13, family believes the death is due to advanced age, not the vaccination.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: See attached documentation.
Sex: M
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a male patient of unknown age. On 23-SEP-2013, (reported as at their twelve month visit), the patient was vaccinated with PROQUAD and  M-M-R II, (lot number and expiration date unknown), dose, route and anatomical location unspecified. It was reported that there was no product confusion, just a medication error. No adverse event was reported. Additional information is not expected.
Age: 1.13
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This was a followup flu vaccine. The 1st vaccine was "Trivalent" by Sanofi, patient had no reaction whatsoever to this. This followup was a quadrivalent. Within a few hours she spiked a fever of 103.6 that lasted through the evening. Despite combinations of ibuprofen and acetaminophen, the fever was difficult to control. It persisted until about 36 hours later dropping to 102.7.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine, Malaise, Neuralgia, Pain, Pruritus
Clinical narrative: Felt ill, then palm of hand got itchy and developed nerve pain all the way down arm. Throbbing nerve pain.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Headache @ 2:00 PM for the rest of the day. Nausea & stomach ache for 36 hours after flu shot.
Age: 33.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Whelping at site of injection.  RPh detected fever at site on inspection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Circular red raised area approximately 1.5 inches in diameter at injection site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test normal, Borrelia test negative, Dizziness, Hypoaesthesia
Clinical narrative: Significant pain at injection site; onset of migraine headaches; joint pain; nerve-like pain (stabbing pain) in hands, arms, legs and face; enlarged painful lymph nodes in neck; numbness in hands, arms legs and face; dizziness; general malaise.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Malaise, Migraine
Clinical narrative: Significant pain at injection site; onset of migraine headaches; joint pain; nerve-like pain (stabbing pain) in hands, arms, legs and face; enlarged painful lymph nodes in neck; numbness in hands, arms legs and face; dizziness; general malaise.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mononucleosis heterophile test negative, Neuralgia, Pain
Clinical narrative: Significant pain at injection site; onset of migraine headaches; joint pain; nerve-like pain (stabbing pain) in hands, arms, legs and face; enlarged painful lymph nodes in neck; numbness in hands, arms legs and face; dizziness; general malaise.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Left arm redness; warmth surrounding it; tender - applying ice & taking NSAIDS.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Fever, hard shaking chills, arm pain, myalgias.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypersensitivity, Injection site swelling, Malaise, Rash
Clinical narrative: Fever, hard shaking chills, arm pain, myalgias.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Eye pain, Eye pruritus, Fatigue
Clinical narrative: Sore, red at shot site; hoarse voice; sore, itchy, red eyes; cough; headache; fatigue.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site pain, Ocular hyperaemia
Clinical narrative: Sore, red at shot site; hoarse voice; sore, itchy, red eyes; cough; headache; fatigue.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Feeling abnormal, Ocular hyperaemia, Pharyngeal oedema, Throat irritation
Clinical narrative: Started feeling bad, achy back, itchy throat and later eyes got red, throat started swelling or closing up according to patient.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Started feeling bad, achy back, itchy throat and later eyes got red, throat started swelling or closing up according to patient.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Painful injection.  Left with pain in upper arm.  Limited mobility.  Very painful during the night and in morning.  Cannot sleep without pain waking me up about every two hours.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: Itching within 30 min., first day pink at inject. Third day today pink  rash the size of a half dollar with swelling and some pain. No treatment other than daily small dose of aspirin.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Rash
Clinical narrative: Rash, pruritis, on rt arm where shot administered rash on trunk bliateral legs.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TD
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Patient was feeling weak and light headed fainted.
Age: 13.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 34.0
Sex: F
Vaccine: FLUX, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 09/30/13: Patient reported local reaction left posterior upper arm following varicella injection on 09/27/13. Injection site red, warm, itchy, swollen measuring about 1.5' x 2'.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site erythema, induration, tenderness, swelling, pain. Grade 3 w/ peak at about 24 hrs post-vaccination. Resolved 4 days post-vaccination.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local swelling, Pain, Pruritus
Clinical narrative: Redness at injection site, localized swelling, pain, itching.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain, Tenderness
Clinical narrative: Patient states that Pneumovax 23 vaccine was given "too high up in left arm" and that she felt the serum "going in".  States she cannot lift her left arm above her shoulder.  Complains of severe pain and tenderness.  Denies redness or swelling.  No numbness or tingling reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema to right upper arm in an area 6-7 mm wide by 6-7 mm high.  Area warm to touch & slightly swollen. Erythemic area approx. 1 inch below injection site.  No itching noted.  No pain noted.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Malaise, Pruritus generalised
Clinical narrative: Severe itching all over body, extreme sweating and general feeling of illness.  Did not feel better until 9/30/2013 but still continue to sweat profusely.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Ear pain, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: BELLS PALSY.  STARTED WITH EAR HURT AND THEN WOKE UP LEFT SIDE OF FACE NUMB AND DROOPING.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Pyrexia, Renal pain
Clinical narrative: Severe diarrhea.  Tried max dosage of Imodium Advanced, no relief.  Diarrhea lasted 30 hours.  This was also accompanied by 102 fever, headache, and kidney pain.  Increased water intake and suffered through it.  This was not what I would categorize as mild and I know the difference having served overseas.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on abdomen and back.
Age: 0.35
Sex: M
Vaccine: RV5
Symptoms: Rash generalised
Clinical narrative: Within 5 minutes after receiving the rotavirus vaccine, my son broke out in a horrible full body rash.
Age: 34.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Activities of daily living impaired, Mobility decreased, Musculoskeletal pain
Clinical narrative: Pain in shoulder; difficulty with some movements, such as bending and lifting as if taking off a shirt. Pain has not subsided since vaccination.
Age: 0.19
Sex: F
Vaccine: FLU3
Symptoms: Lip pain, Lip swelling
Clinical narrative: PATIENT UPPER LIP BEGAN SWELLING AND FEELING painful. She 1 tablet of Benadryl 25mg on sat 9/28 and Monday morning 9/30. She called pharmacy at 2:30 pm on 9/30 to report event. The swelling and pain are subsiding and she feels much better.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives formed on face and hands. No facial swelling, no difficulty swallowing, no difficulty breathing. Hives have lasted 3 days.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Catheterisation cardiac, Chest discomfort, Chest pain, Computerised tomogram
Clinical narrative: I woke up unable to take a deep breath. My chest felt heavy with pain, and I was not able to lay down.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram normal
Clinical narrative: I woke up unable to take a deep breath. My chest felt heavy with pain, and I was not able to lay down.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Arthritis, Bone pain, Condition aggravated, Local swelling
Clinical narrative: Sever pain in wrist bones, fingers swollen, legs swelling, ankles hurt. both shoulders and elbows hurt. On 9-30-13 Client's daughter report that Dr. told client on 9-27-13 that her condition was just her arthritis flaring up. Daughter states that the swelling seems to decreasing.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Sever pain in wrist bones, fingers swollen, legs swelling, ankles hurt. both shoulders and elbows hurt. On 9-30-13 Client's daughter report that Dr. told client on 9-27-13 that her condition was just her arthritis flaring up. Daughter states that the swelling seems to decreasing.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Paraesthesia
Clinical narrative: Patient's whole arm began to tingle and then became weak.  Soon after the patient began to experience extreme pain.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Diarrhoea, Headache
Clinical narrative: It started that evening after dinner, extreme bloating with stomach ache, threw up all night every 20 min until mid next day with continued extreme stomach pain. Also had chills and headache. After throwing up stopped, finished off day with diarrhea. Next day all symptoms gone, except headache. What I ate all day was the same as my friend, so don't think food poisoning.  Also threw up brown bile.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: It started that evening after dinner, extreme bloating with stomach ache, threw up all night every 20 min until mid next day with continued extreme stomach pain. Also had chills and headache. After throwing up stopped, finished off day with diarrhea. Next day all symptoms gone, except headache. What I ate all day was the same as my friend, so don't think food poisoning.  Also threw up brown bile.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Contact lens intolerance, Eye irritation, Eye pain, Ocular hyperaemia, Photophobia
Clinical narrative: Extreme burning and redness of eyes, unable to tolerate contacts or bright light. Was unable to even use by eye wash as everything hurt my eyes, even to wear my glasses. Lasted for 2 days, some Benadryl eye drops brought a little relief on 2nd day, but still unable to tolerate contacts, which burned like fire when I would put them in, likewise with eyewash.
Age: 21.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Vaccine given to pregnant woman before knowledge that she was pregnant. No immediate adverse event.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Feeling hot, Hypersensitivity, Injection site inflammation
Clinical narrative: Chills, high fever symptoms for 24 hours, severe inflamed site of injection, allergic reaction, very red, warm, and itchy, felt sick and needed blankets to keep warm.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pruritus, Pyrexia
Clinical narrative: Chills, high fever symptoms for 24 hours, severe inflamed site of injection, allergic reaction, very red, warm, and itchy, felt sick and needed blankets to keep warm.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Dysgeusia
Clinical narrative: Taste disturbance while eating or drinking - very bitter taste in back of the mouth.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia
Clinical narrative: Change in taste, food and drinks taste bitter.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Per Pt report: Rash to upper neck reigon, insidious onset; spreading to chest, back, and R AC.  No pain at or near injection site to R deltoid.  No treatment proivded due to delayed reporting.
Age: 1.06
Sex: M
Vaccine: HIBV, MMR
Symptoms: Attention deficit/hyperactivity disorder, Autoimmune haemolytic anaemia, Fatigue, Haemoglobin decreased, Intensive care
Clinical narrative: Autoimmune hemolytic anemia was the admission diagnosis to the PICU.  Patient needed a blood transfusion due to a hemoglobin of 5.5 in the ER which dropped to 4.5 prior to the blood transfusion and admission to intensive care unit.  He started getting "run down" a few days after his MMR vaccine.  I can't remember the name of the doctor at the time of vaccination but this can all be verified by his current pediatrician.
Age: 1.06
Sex: M
Vaccine: HIBV, MMR
Symptoms: Transfusion
Clinical narrative: Autoimmune hemolytic anemia was the admission diagnosis to the PICU.  Patient needed a blood transfusion due to a hemoglobin of 5.5 in the ER which dropped to 4.5 prior to the blood transfusion and admission to intensive care unit.  He started getting "run down" a few days after his MMR vaccine.  I can't remember the name of the doctor at the time of vaccination but this can all be verified by his current pediatrician.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Diarrhoea, Dizziness, Pyrexia, Vertigo
Clinical narrative: Mild dizziness, slight fever, touch of diarrhea. Went to bed early. Woke up and dizziness was much worse. Also had more diarrhea. Felt like vertigo. Hard to maintain balance. Dizziness has lasted over 24 hours so far. Took 2 aspirin and am going to bed. Having been drinking water all day (over 4 liters).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal pain, Pain in extremity, Urticaria
Clinical narrative: Welt - red in middle now arm hurts to shoulder.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Pt had severe bump on shoulder raised about an inch at injection site. Bump was 3 inches long and 2 inches wide. Patient will put ice on area and take some diphenhydramine. If gets worse or doesn't go away will go to MD.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Redness and warm to the immunization site (R) thigh. Localized reaction to DTAP given on 8/27/13. Staff took the call. Pt advised to apply ice to site. RTC if s/sx changes.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Body temperature increased, Erythema, Feeling hot, Swelling
Clinical narrative: Patient noted increase swelling, redness, warmth 12 hours after vaccination. Patient complained of stomach hurting and had oral temp of 101.1F. No respiratory s/s or hives. Mother took child to urgent care and patient started steroid dose pak. RN instructed mom to use Motrin PRN and cool compresses. Spoke with mother 9/27 and patient doing much better.
Age: 1.29
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Seen 9/28/13 for positive urticaria bilat legs and diaper area. Lg. patches of irregular erythema with central hive on RT thigh. Positive erythema LT thigh superior to positive hive at site. TX: OTC Benadryl every 4-6 hours and Ibuprofen every 6-8 hours -PRN.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster rash on (C) back and chest and arm.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster rash on (C) back and chest and arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Cough, Dysphagia, Heart rate increased, Myalgia
Clinical narrative: Coughing, sore throat, couldn't swallow easily, swollen throat, fever 101-102 degrees F, muscle/bone pain, increased HR.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Coughing, sore throat, couldn't swallow easily, swollen throat, fever 101-102 degrees F, muscle/bone pain, increased HR.
Sex: U
Vaccine: FLU3, VARZOS, FLU3, TDAP, VARZOS
Symptoms: Death, Pyrexia, Surgery
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with ZOSTAVAX, injection (dose, route and lot number unknown). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (manufacturer unknown) and FLUZONE. On an unknown date in 2013 the patient experienced death, following unspecified surgery. The pharmacist stated that a physician (unspecified) called the pharmacy on 24-AUG-2013 and was inquiring about the 3(three) vaccinations that the patient had received. The physician stated that the patient had exhibited a fever. A request was made for the patient's Primary Care Physician's, name and contact information. A request was made for a copy of the patient's Death Certificate and/or Autopsy Report. The pharmacist stated that there were several physician's involved with the patient's case. The pharmacist refused to give any information and stated that the patient's information was being handled by Clinical Risk Management for Pharmacy. Relatedness between vaccination with ZOSTAVAX and death was not reported. Upon internal review surgery was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: FLU3, VARZOS, FLU3, TDAP, VARZOS
Symptoms: Death, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On 23-AUG-2013 the patient was vaccinated with ZOSTAVAX, injection (dose, route and lot number unknown). Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (manufacturer unknown) and FLUZONE. On an unknown date in 2013 the patient experienced death, following unspecified surgery. The pharmacist stated that a physician (unspecified) called the pharmacy on 24-AUG-2013 and was inquiring about the 3(three) vaccinations that the patient had received. The physician stated that the patient had exhibited a fever. A request was made for the patient's Primary Care Physician's, name and contact information. A request was made for a copy of the patient's Death Certificate and/or Autopsy Report. The pharmacist stated that there were several physician's involved with the patient's case. The pharmacist refused to give any information and stated that the patient's information was being handled by Clinical Risk Management for Pharmacy. Relatedness between vaccination with ZOSTAVAX and death was not reported. Upon internal review surgery was considered medically significant. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Injection site soreness w/ widespread red, non-blistering rash from injection site to elbow lateral and proximal upper arm. No itch, no warm, no pain, no swelling.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Within a day of getting the shot she had pain in the area. It persisted for the last 3 weeks, she has trouble lifting anything. If she tries to lift her arm too high she has "fall to the ground" pain. After talking with RPh will seek Dr visit ASAP.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Condition aggravated, Glaucoma, Intraocular pressure increased
Clinical narrative: I was informed by the patients daughter that pt BP shot up about 3-4 hours after flu shot administered. Patient has glaucoma and she said his eye pressure also increased. Verified next day by eye doctor. Per daughter she could not give me values.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema
Clinical narrative: Pt received FLUZONE at 12pm on 9/28/13. At 1045pm started have pitting edema bilateral both calf. 9/30/13 edema decreased to 1 (+) pitting.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Vaccination site bruising, Vaccination site swelling
Clinical narrative: After vaccine administered, patient bled stream down arm but stopped after cotton swab applied. Mild bruising and swelling around vaccine site. Pt calm.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Skin lesion
Clinical narrative: Pt. presented with lesion on nose, neck and back for 2 days.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Erythema, Pain
Clinical narrative: Arm redness, chills, and body aches.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cold sweat, Local swelling, Pain
Clinical narrative: Swollen arm associated with pain, cold sweats. Advised to ice arm and take APAP or ibuprofen. Unknown if advice was taken or if felt bad enough go to ER. Hadn't gone with follow-up call 9/29/13.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at an unspecified trimester. At an unspecified time after vaccination with H1N1 and prior to 20 week's gestation, the subject experienced spontaneous abortion. This case was assessed as medically serious by GSK. This case is linked to 27 other cases (related by publication). The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remains less than optimal. . Surveys have demonstrated that mothers' concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 pandemic season, when lack of safety data about the pandemic H1N1 (pH1N1) monovalent vaccine was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on pH1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. To assess risks and relative safety of the pH1N1-containing vaccines, the author conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 20009 and August 2012. There were 1032 subjects available for analysis; 841 were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Within a day of getting shot area felt sore, went away after a few days, then returned. 3 weeks after shot arm is sore and hurts to lift too high. After talking with RPh will seek Dr visit ASAP.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Local swelling, possible hematoma bruising.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at an unspecified trimester. At an unspecified time after vaccination with H1N1 and prior to 20 week's gestation, the subject experienced spontaneous abortion. This case was assessed as medically serious by GSK. This case is linked to 27 other cases (related by publication). Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mother's concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 season, when lack of safety data about the H1N1 was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on H1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the H1N1. To assess risks and relative safety of the H1N1-containing vaccines, the author conducted a prospective cohort study of H1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a H1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Chest X-ray, Lobar pneumonia, Pneumonia bacterial
Clinical narrative: Flu vaccine given while patient had mild URI (runny nose). 4 days later had significant RLL pneumonia (suspected bacteria). Improving on azithromycin. Had remote (2-3 yrs ago) hx asthma.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Flushing, Vomiting, Wheezing
Clinical narrative: Wheezing, difficulty breathing, flushing, vomiting.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Raised bump at injection site.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Flu shot received 9-25-13. Later that evening she felt area between nose and throat was swollen. She has celiac disease and has this problem when she eats wheat but she did not have any wheat that day to her knowledge. The injection site was warm to touch, swollen, and very red. The next day all of her joints hurt. She could barely walk or use her hands.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Nasal congestion, Pharyngeal oedema
Clinical narrative: Flu shot received 9-25-13. Later that evening she felt area between nose and throat was swollen. She has celiac disease and has this problem when she eats wheat but she did not have any wheat that day to her knowledge. The injection site was warm to touch, swollen, and very red. The next day all of her joints hurt. She could barely walk or use her hands.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Exposure during pregnancy, Stillbirth
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of stillbirth in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during the first trimester. At an unspecified time after vaccination with H1N1 and after an unspecified number of weeks of gestation, the subject experienced stillbirth. This case was assessed as medically serious by GSK. This case is linked to 27 other cases (related by publication). Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mother's concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 season, when lack of safety data about the H1N1 was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on H1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the H1N1. To assess risks and relative safety of the H1N1-containing vaccines, the author conducted a prospective cohort study of H1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a H1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Warmth at injection site, local redness, edema, joint pain body aches, hip pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Radiculitis, Rash erythematous, Rash macular, Rash maculo-papular
Clinical narrative: (L) abdominal red maculopapular rash, very itchy and several red flat macular spots on forearm 3 weeks after ZOSTAVAX. No fevers. Is on prednisone for radiculitis.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age who was immunocompromised. On an unspecified date several years ago, the patient was vaccinated with an initial dose of PNEUMOVAX23 (dose, route and lot # not provided), then received a second dose of PNEUMOVAX23 on an unspecified date 2 to 3 years later. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date and route not reported) off schedule. No adverse symptoms were reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a consumer, who is also an office manager, refers to her son, a 13 years old male patient. The patient had no pertinent medical history or drug reactions/allergies. On 21-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and indication were not reported). On 12-SEP-2013, the patient received the second dose of GARDASIL (lot # J006879, expiration date 04-DEC-2013) (dose and route were not reported) injection. Concomitant medications were not reported. On 12-SEP-2013, reporter noted leaking from the syringe, while the patient was receiving the second dose of GARDASIL from medical assistant. Reporter also stated that her son experienced injection site pain because the dose was given "a little high". No treatment was given for the injection site pain. No lab diagnostics were performed. Patient did not seek medical attention. The outcome of injection site pain was reported as recovered/resolved, on an unspecified date. The relationship between GARDASIL and the injection site pain was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ vial, lot # H17671, expiration date 25-MAR-2014 (dose and route were not reported) that was exposed to 12C for 173.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. No concomitant medications were reported. This is one of several reports received from same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling. Epinephrine one units once IM, prednisone 10 mg BID PO, diphenhydramine mg 50 once IM.
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Headache, Nasopharyngitis
Clinical narrative: Cold, blurred vision, headache (feels like swelling pressure of brain), cough, labored breathing (heavy chest), nausea. Was feeling better on Wednesday 09/25/13.
Age: 63.0
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Sensation of pressure, Vision blurred
Clinical narrative: Cold, blurred vision, headache (feels like swelling pressure of brain), cough, labored breathing (heavy chest), nausea. Was feeling better on Wednesday 09/25/13.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Computerised tomogram, Confusional state, Delirium, Echocardiogram
Clinical narrative: About 6 hours later Pt began getting tired, fatigued that escalated into vomiting and unresponsive, non-verbal, confused, delirious, 103 degrees fever, 911 was called pt admitted to ICU.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Electroencephalogram, Fatigue, Intensive care, Lumbar puncture
Clinical narrative: About 6 hours later Pt began getting tired, fatigued that escalated into vomiting and unresponsive, non-verbal, confused, delirious, 103 degrees fever, 911 was called pt admitted to ICU.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Ultrasound scan, Unresponsive to stimuli, Vomiting
Clinical narrative: About 6 hours later Pt began getting tired, fatigued that escalated into vomiting and unresponsive, non-verbal, confused, delirious, 103 degrees fever, 911 was called pt admitted to ICU.
Age: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Lower back pain and no treatment given.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Blood test, Eye swelling, Fatigue, Ocular hyperaemia
Clinical narrative: This spontaneous report was received from an 41 year old female consumer reporting on herself. Consumer reported she usually experiences diarrhea after taking penicillin (unspecified). The patient had no pertinent medical history. On 15-AUG-2013 the patient was vaccinated with RECOMBIVAX HB (dose, route and lot number were not reported). Concomitant therapies included SYNTHROID and an unspecified treatment for birth control. About two days later of RECOMBIVAX HB vaccination, on approximately 17-AUG-2013, patient experienced "inflammation diagnosed as sclera", severe joint pain in one of her hands, extreme fatigue and swollen and red eyes. The vaccine was recommended by a Nurse Practitioner. Based on her experience after the RECOMBIVAX HB first dose, consumer stated she planned to return to the physician's office to discuss whether she should receive the second dose of RECOMBIVAX HB and might decide to discontinue RECOMBIVAX HB therapy. It was reported that the patient did not received treatment for the adverse events. Steroid (not specified) was prescribed for the eye. Patient performed a not specified type of blood test. Patient was seen in the office. The outcome of inflammation diagnosed as sclera, red eyes, swollen eyes, extreme fatigue and joint pain in one of her hands was reported as not recovered/not resolved. The relationship between RECOMBIVAX HB and the events was not reported. Additional information has been requested.