chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Local swelling, Pain
Clinical narrative: No problem for the first 30 hrs. post vaccine. Then pain and itchiness began which the pharmacist explained may happen --> use of cool compresses. Bright red area 1 1/2" x 3" at site proceeded to advance to whole tricep area getting "pink" with some swelling. At 11:00 pm took a chill that lasted for 4 hours - ? fever --> had taken TYLENOL. Next day felt "washed out." Arm gradually improved over the next week.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: No problem for the first 30 hrs. post vaccine. Then pain and itchiness began which the pharmacist explained may happen --> use of cool compresses. Bright red area 1 1/2" x 3" at site proceeded to advance to whole tricep area getting "pink" with some swelling. At 11:00 pm took a chill that lasted for 4 hours - ? fever --> had taken TYLENOL. Next day felt "washed out." Arm gradually improved over the next week.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: (R) arm where vaccine was administered w/erythema and warmth about 4 cm diameter noted 12/20/13.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Myalgia
Clinical narrative: Muscle ache 3 hours after the vaccination, starting from lower extremities then moving to upper extremities. Then 3 hours later patient was shivering, but did not check if fever was present. Patient was concerned.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Pt had severe pain in injection site and body ache on the same day. She stated that she lost the range of motion and throbbing pain that lasted several wks. It has gotten better but still in pain I will go see MD.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Pruritus, Pyrexia, Rash vesicular, Varicella
Clinical narrative: Patient developed intense vesicular rash on head, neck w/ pruritus and, low grade fever, several days after ZOSTAVAX. Clinically consistent w/ Varicella as confirmed by I.D. MD's.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Carpal tunnel syndrome, Lymphadenopathy, Musculoskeletal pain, Pain in extremity
Clinical narrative: Approx 2 hours after receiving flu shot. Arm became very painful. Pain from shoulder into breast bone and scapula. Continued to hurt. On the evening of 12/8/13 lymph node for (R) armpit had tripled in size. Area was not red or warm to touch. "Felt like a huge pimple that was going to explode". Had swelling in that lymph node several years ago and lymph node has remained larger than left side. Also has carpal tunnel in (R) hand. Area still swollen and painful when she called to report on 12/10/13. She made appointment to be evaluated by physician. She returned call on 12/11/13. Physician told her she did not require any treatment. He told her she had an "active lymph node". He explained to her that once she received the flu shot, the WBC's responded to develop antibodies. Once done, the WBC's will to go the nearest lymph node and be reabsorbed. He feels the WBC's "congregated in the one lymph node". No other lymph nodes were swollen. He did not feel there was any nerve damage. He recommended she continue to receive annual flu shots, but to have administered in the left arm. He also told her she could take some ADVIL for the discomfort if needed.
Age: 1.53
Sex: M
Vaccine: HEPA
Symptoms: Chills, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, runny nose, chills couple hours after vaccine was given.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever - body aches, headache.
Sex: U
Vaccine: FLU3, HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a registered nurse, who knew it from one of her fellow nurses, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of GARDASIL and a dose of FLUZONE. On the same date the patient experienced an unspecified reaction. The outcome of unspecified reaction was unknown. The causal relationship was not provided. Additional information has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Laboratory test, Pertussis
Clinical narrative: Initial report was received from the literature on 20 December 2013. The following is verbatim from the article abstract: IMPORTANCE: Undervaccination is an increasing trend that potentially places children and their communities at an increased risk for serious infectious diseases. OBJECTIVE: To examine the association between undervaccination and pertussis in children 3 to 36 months of age. DESIGN: Matched case-control study with conditional logistic regression analysis. SETTING Eight managed care organizations of the Vaccine Safety Datalink between 2004 and 2010. PARTICIPANTS: Each laboratory-confirmed case of pertussis (72 patients) was matched to 4 randomly selected controls (for a total of 288 controls). The case patients were matched to controls by managed care organization site, sex, and age at the index date. The index date was defined as the date of pertussis diagnosis for the case patients. EXPOSURE: Undervaccination for the DTaP. Undervaccination was defined as the number of doses of DTaP that was either missing or delayed by the index date. Case patients and controls could be under vaccinated by 0, 1, 2, 3, or 4 doses of DTaP. Children undervaccinated by 0 doses were considered age-appropriately vaccinated by the index date. MAIN OUTCOME AND MEASURE: Pertussis. RESULTS Of the 72 case patients with pertussis, 12 (16.67%) were hospitalized, and 34 (47.22%) were under vaccinated for DTaP by the date of pertussis diagnosis. Of the 288 matched controls, 64 (22.22%) were under vaccinated for DTaP. Under vaccination was strongly associated with pertussis. Children under vaccinated for 3 or 4 doses of DTaP were 18.56 (95%CI, 4.92-69.95) and 28.38 (95%CI, 3.19-252.63) times more likely, respectively, to have received a diagnosis of pertussis than children who were age-appropriately vaccinated. CONCLUSIONS AND RELEVANCE: Under vaccination with DTaP increases the risk of pertussis among children 3 to 36 months of age.
Age: 1.28
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Polymerase chain reaction, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 221 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 20 December 2013. These 221 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Incident ID#: 1075338. Initial report received on 20 December 2013 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3633AA received on 29 July 2010, lot number C3733AA received on 01 October 2010 and lot number C3813AA received on 06 December 2010, and 1 dose of DAPTACEL; lot number C3944AA received on 08 September 2011 (routes and sites of administration not reported). Approximately 14 months after the last dose, on 17 November 2013, the subject developed a cough and on 23 November 2013 a paroxysmal cough without a whoop. The subject also experienced sleep disturbance but no apnea. Laboratory testing included positive PCR on 25 November 2013. Chest x-ray findings were negative for pneumonia. Acute encephalopathy was unknown. Corrective treatments consisted of azithromycin starting on 25 November 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 03 December 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Symptoms began two weeks after flu vaccine. Sudden onset sensory deficit with ascending weakness and numbness bilaterally from feet to knees. 2 episodes of syncope that morning as well. Admitted to Medical Center. CSF culture on 12/4 showed high protein count (micro-total protein = 67 mg/dL). On 12/5 was diagnosed with Guillain-Barre Syndrome by neurology physician at Medical Center. IVIG was started for treatment of Guillain-Barre Syndrome.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Sensory loss, Syncope
Clinical narrative: Symptoms began two weeks after flu vaccine. Sudden onset sensory deficit with ascending weakness and numbness bilaterally from feet to knees. 2 episodes of syncope that morning as well. Admitted to Medical Center. CSF culture on 12/4 showed high protein count (micro-total protein = 67 mg/dL). On 12/5 was diagnosed with Guillain-Barre Syndrome by neurology physician at Medical Center. IVIG was started for treatment of Guillain-Barre Syndrome.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 6 inch diameter swelling/erythema/warmth around the injection site. Extended further inferiorly than superiorly (dependent). Mild itching. Supportive tx (ice, Tylenol, Benadryl for itch) discussed.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Influenza virus test negative, Laboratory test normal, Nausea
Clinical narrative: Donor reported severe nausea uncontrolled by anti-nausea medications given by personal physician.  Donor then went to Emergency Room when nausea medications were noneffective. Nausea persisted for longer than 24 hours.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthropathy, Musculoskeletal pain, Rotator cuff syndrome, Tendon disorder
Clinical narrative: Rotator cuff tear, rotator tendinopathy, shoulder impingement, biceps tendinopathy (unlikely), labral tear, AC and SC joint problems, chronic tears (no other hx although has repetitive use), something caused by the hep b injections (seems chronologically related). Chronologically related to hep b injections: No further hep B injections (#3).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Received flu shot on August 28th, 2013. Came into store the week of December 15th, 2013 saying there is possible nerve damage due to receiving the vaccination.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Patient sought medical treatment on Oct 8 for a vesicular rash to right buttocks and sacral area including groin and shaft of penis. Patient stated rash started on the 5th, one day after receiving the flu vaccine in the clinic. Patient diagnosed with herpes zoster (shingles). Acyclovir 800 mg every day, gabapentin 100 mg other.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction 5 cm by 7 cm erythematous indurated area on left thigh with some darker red area at the site of the injection.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Nausea, Vertigo positional, Visual impairment, Vomiting
Clinical narrative: Sudden onset of severe vertigo as she was getting out of bed, increased with change of position or head motion, + nausea, - vomiting, - vision change, slight imbalance when walking.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt called and complained of persistent arm pain - said she went to see provider in ER and he/she said it may be nerve related.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Epstein-Barr virus test positive, Lung infection, Malaise, Pharyngitis, Sinusitis
Clinical narrative: Feeling sick.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash, Rash pustular
Clinical narrative: 1. Rash on chest with pustules 2. Headache lasting all day 12/28/2013 unrelieved by Tylenol
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Diffuse skin rash.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Scleral haemorrhage
Clinical narrative: Bloody sclera (started 6 hours after injection, both eyes), sore throat.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abnormal behaviour, Decreased appetite, Diarrhoea, Gait disturbance, Glassy eyes
Clinical narrative: My daughter received the 5th dose of DTaP along with the 4th dose of Polio. She developed pain on her left upper thigh roughly 6 hours after the combo was given. Leg then became red and very hot to the touch. Rash developed the filling day and started progressing toward her inner thigh. Hardness surrounding the injection site about 2 fists on diameter. She had a fever of 102* I was giving Tylenol 2.5ml every 6 hours. Could not bring temp down for 4 days. She could not walk on leg. Was limping and hobbling around. Extremely lethargic with a glazed look through her eyes. Very mellow and sleepy. Not her usual self. Injection site was becoming bruised after 2 days. Green, purple and dark blue. Started to resume walking after day 3. Fever was constant at 101-102. Had to give Tylenol with Codeine for pain on her leg. Then Benadryl at night. Restless sleeping b/c of pain. Lowered appetite. Some mild diarrhea. DTaP/IPV shot administered Monday daughter finally feeling better by Saturday. Rash and fever gone by Saturday. Leg pain still lingered for 3 weeks. Called Dr they said Tylenol and cold compress and if fever got above 105. She would not tolerate cold compress. Said leg was very tender and didn't want anything touching it. Fever if 105 sounds dangerously high, I would have been to all children, not calling the Ped office.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site movement impairment, Injection site pain
Clinical narrative: My daughter received the 5th dose of DTaP along with the 4th dose of Polio. She developed pain on her left upper thigh roughly 6 hours after the combo was given. Leg then became red and very hot to the touch. Rash developed the filling day and started progressing toward her inner thigh. Hardness surrounding the injection site about 2 fists on diameter. She had a fever of 102* I was giving Tylenol 2.5ml every 6 hours. Could not bring temp down for 4 days. She could not walk on leg. Was limping and hobbling around. Extremely lethargic with a glazed look through her eyes. Very mellow and sleepy. Not her usual self. Injection site was becoming bruised after 2 days. Green, purple and dark blue. Started to resume walking after day 3. Fever was constant at 101-102. Had to give Tylenol with Codeine for pain on her leg. Then Benadryl at night. Restless sleeping b/c of pain. Lowered appetite. Some mild diarrhea. DTaP/IPV shot administered Monday daughter finally feeling better by Saturday. Rash and fever gone by Saturday. Leg pain still lingered for 3 weeks. Called Dr they said Tylenol and cold compress and if fever got above 105. She would not tolerate cold compress. Said leg was very tender and didn't want anything touching it. Fever if 105 sounds dangerously high, I would have been to all children, not calling the Ped office.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site warmth, Lethargy, Poor quality sleep, Pyrexia
Clinical narrative: My daughter received the 5th dose of DTaP along with the 4th dose of Polio. She developed pain on her left upper thigh roughly 6 hours after the combo was given. Leg then became red and very hot to the touch. Rash developed the filling day and started progressing toward her inner thigh. Hardness surrounding the injection site about 2 fists on diameter. She had a fever of 102* I was giving Tylenol 2.5ml every 6 hours. Could not bring temp down for 4 days. She could not walk on leg. Was limping and hobbling around. Extremely lethargic with a glazed look through her eyes. Very mellow and sleepy. Not her usual self. Injection site was becoming bruised after 2 days. Green, purple and dark blue. Started to resume walking after day 3. Fever was constant at 101-102. Had to give Tylenol with Codeine for pain on her leg. Then Benadryl at night. Restless sleeping b/c of pain. Lowered appetite. Some mild diarrhea. DTaP/IPV shot administered Monday daughter finally feeling better by Saturday. Rash and fever gone by Saturday. Leg pain still lingered for 3 weeks. Called Dr they said Tylenol and cold compress and if fever got above 105. She would not tolerate cold compress. Said leg was very tender and didn't want anything touching it. Fever if 105 sounds dangerously high, I would have been to all children, not calling the Ped office.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Somnolence
Clinical narrative: My daughter received the 5th dose of DTaP along with the 4th dose of Polio. She developed pain on her left upper thigh roughly 6 hours after the combo was given. Leg then became red and very hot to the touch. Rash developed the filling day and started progressing toward her inner thigh. Hardness surrounding the injection site about 2 fists on diameter. She had a fever of 102* I was giving Tylenol 2.5ml every 6 hours. Could not bring temp down for 4 days. She could not walk on leg. Was limping and hobbling around. Extremely lethargic with a glazed look through her eyes. Very mellow and sleepy. Not her usual self. Injection site was becoming bruised after 2 days. Green, purple and dark blue. Started to resume walking after day 3. Fever was constant at 101-102. Had to give Tylenol with Codeine for pain on her leg. Then Benadryl at night. Restless sleeping b/c of pain. Lowered appetite. Some mild diarrhea. DTaP/IPV shot administered Monday daughter finally feeling better by Saturday. Rash and fever gone by Saturday. Leg pain still lingered for 3 weeks. Called Dr they said Tylenol and cold compress and if fever got above 105. She would not tolerate cold compress. Said leg was very tender and didn't want anything touching it. Fever if 105 sounds dangerously high, I would have been to all children, not calling the Ped office.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Hypersensitivity, Oropharyngeal pain
Clinical narrative: In this order coming to full reaction by 12/20/2013. Deep strong sneezing, tickle in sinus/upper throat area, shortness of breath, difficulty breathing even to eat, fatgue,- started nebulizer treatments 1212/21/2013, large hives on the upper torso, burning/pain in sinus/upper throat area, slight fever ranging from 100/101 degrees, out of it unable to stay away, received double shot for allergic reations, antihistimines Pepcid, updraft medication-Xopenex, cromyline solution.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sinus disorder, Sinus headache, Sneezing, Throat irritation
Clinical narrative: In this order coming to full reaction by 12/20/2013. Deep strong sneezing, tickle in sinus/upper throat area, shortness of breath, difficulty breathing even to eat, fatgue,- started nebulizer treatments 1212/21/2013, large hives on the upper torso, burning/pain in sinus/upper throat area, slight fever ranging from 100/101 degrees, out of it unable to stay away, received double shot for allergic reations, antihistimines Pepcid, updraft medication-Xopenex, cromyline solution.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: In this order coming to full reaction by 12/20/2013. Deep strong sneezing, tickle in sinus/upper throat area, shortness of breath, difficulty breathing even to eat, fatgue,- started nebulizer treatments 1212/21/2013, large hives on the upper torso, burning/pain in sinus/upper throat area, slight fever ranging from 100/101 degrees, out of it unable to stay away, received double shot for allergic reations, antihistimines Pepcid, updraft medication-Xopenex, cromyline solution.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Dizziness, Nausea, Pallor, Presyncope
Clinical narrative: Diagnosed as probable vasovagal episode, but recommend allergy testing prior to next Td.  Pt received routine Tdap immunization.  He indicates that within 5 minutes of receiving immunization, while in the waiting room, he began to feel dizzy, had blurry vision, abdominal pain, and nausea. Went to restroom and had emesis x1.  MGM reports that when he walked out, he appeared pale. Pt reports that he was blowing his nose more (mild rhinorrhea) and had mild throat tightness right before and following emesis.  Pt laid down by clinic staff and administered Epipen Jr and Benadryl.   Transported to ER via EMS where he was monitored without need for further intervention. He has not had any prior vaccine reactions.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Rhinorrhoea, Throat tightness, Vision blurred, Vomiting
Clinical narrative: Diagnosed as probable vasovagal episode, but recommend allergy testing prior to next Td.  Pt received routine Tdap immunization.  He indicates that within 5 minutes of receiving immunization, while in the waiting room, he began to feel dizzy, had blurry vision, abdominal pain, and nausea. Went to restroom and had emesis x1.  MGM reports that when he walked out, he appeared pale. Pt reports that he was blowing his nose more (mild rhinorrhea) and had mild throat tightness right before and following emesis.  Pt laid down by clinic staff and administered Epipen Jr and Benadryl.   Transported to ER via EMS where he was monitored without need for further intervention. He has not had any prior vaccine reactions.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Haemorrhage, Incorrect route of drug administration, Movement disorder, Pain in extremity
Clinical narrative: Sore arm, couldn't lift it.  Bled for 3 days, pain radiated down arm and into chest.  Continued all month.  Went to chiropractor on Dec. 23, no improvement, went to PCP on 12/26 and showed them where shot was given and told it was given too high and that she needed PT. Went to a different chiropractor on 12/27 and was somewhat better.  Pharmacy notified on 12/27.
Age: 0.18
Sex: M
Vaccine: 6VAX-F, PPV, RV1
Symptoms: Cough, Dyspnoea, Pneumonia, Respiratory tract congestion
Clinical narrative: Coughing, shortness of breath, stuffiness, pneumonia.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Hypotension, Pallor, Pruritus
Clinical narrative: Patient received his immunizations given by myself at around 10:55am. DTAP LUT; ACTHIB LMT; PREVNAR 13 LTL; MMR RTU; VARIVAX RTM; Hepatitis A RTL; Mom dressed him up and went to check out at counter. Mom noticed he was itching and developed rash and she called me other there. There was diffuse erythematous rash on chest, face and abdomen with itching. He was given 5cc of BENADRYL at 11:02am, which he spit up. Then he developed urticaria rash with intense itching and difficulty breathing. His color was pale and he looked hypotensive. He was moved to exam room 3 and was given 5cc of Prednisolone at 11:05am, he immediately started vomiting continuously. He was then given EPI-PEN JR at 11:07am and 911 call was initiated. He also was given 2mg of DECADRON at 11:15am. By this time his urticaria disappeared, his color came back and was breathing much better. Then 911 team arrived and they put him on gurney and took him to ER. This was acute anaphylactic reaction to one of the vaccines.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous, Urticaria, Vomiting
Clinical narrative: Patient received his immunizations given by myself at around 10:55am. DTAP LUT; ACTHIB LMT; PREVNAR 13 LTL; MMR RTU; VARIVAX RTM; Hepatitis A RTL; Mom dressed him up and went to check out at counter. Mom noticed he was itching and developed rash and she called me other there. There was diffuse erythematous rash on chest, face and abdomen with itching. He was given 5cc of BENADRYL at 11:02am, which he spit up. Then he developed urticaria rash with intense itching and difficulty breathing. His color was pale and he looked hypotensive. He was moved to exam room 3 and was given 5cc of Prednisolone at 11:05am, he immediately started vomiting continuously. He was then given EPI-PEN JR at 11:07am and 911 call was initiated. He also was given 2mg of DECADRON at 11:15am. By this time his urticaria disappeared, his color came back and was breathing much better. Then 911 team arrived and they put him on gurney and took him to ER. This was acute anaphylactic reaction to one of the vaccines.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema with swelling approx 7 x5.5cm around injection site---LEFT DELTOID, no treatment necessary at this time other than symptomatic management.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Guillain-Barré syndrome for which he remains in the ICU.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Inflammation, Local reaction, Pyrexia
Clinical narrative: Local redness, hot, inflammation. Doctor unsure if it is cellulitis or just a local reaction. Fever and chills.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Local redness, hot, inflammation. Doctor unsure if it is cellulitis or just a local reaction. Fever and chills.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient. Pertinent medical history and drug reactions were not reported. On 17-DEC-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (concentration, dose and lot number were not reported). No concomitant therapy was reported. In December 2013, the patient experienced local irritation, redness, erythema, a little bit of swelling, pruritus and a little itchy at ZOSTAVAX injection site. On 20-DEC-2013, the patient was observed by pharmacist. No lab diagnostics studies were performed. No treatment was given for the events. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: Patient says cough developed after immunization. He still has cough.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Cough
Clinical narrative: Patient says cough developed after immunization. She still has cough.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raised erythematous and edematous area of 17 x 19 cms surrounding injection site of (L) deltoid, given SQ. Tenderness and warmth/hot to touch in area of erythema
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Pain in extremity, Paraesthesia, Poor quality sleep
Clinical narrative: Patient came to pharmacy today to report that her left arm is painful all the time with some tingling in fingers and this has been the case since her HIGH DOSE FLUZONE IM injection on 12-12-13. Arm is not red or swollen. Pain wakes her up, she can't get comfortable. I advised her to call her doctor. TYLENOL does not relieve pain.
Age: 4.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Erythema, Induration, Local swelling, Pain, Pruritus
Clinical narrative: Redness, swelling, induration from 10-20 cm locally only, with pain and pruritus.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Erythema, Headache, Hyperhidrosis
Clinical narrative: 5 or 6 hrs after vaccines - muscle pain in arm. Whole arm became swollen, and bright red (5-6 hrs after shot, continued for 1 week). Swollen like a grapefruit. Had chills and sweats, nauseous, weak, headache. Chief complaint severe swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Myalgia, Nausea, Pain in extremity, Swelling
Clinical narrative: 5 or 6 hrs after vaccines - muscle pain in arm. Whole arm became swollen, and bright red (5-6 hrs after shot, continued for 1 week). Swollen like a grapefruit. Had chills and sweats, nauseous, weak, headache. Chief complaint severe swelling.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Patient developed hive-like rash, abdomen, back, both arms both feet and legs.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a 69 year old male patient with no pertinent medical history or drug reactions/allergies. On 04-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX 23, lot # J006242, expiration date 03-AUG-2014, intramuscularly (dose not reported). Concomitant therapies included pravastatin, celecoxib, VENTOLIN, SPIRIVA (also reported as "SPRIVA"), aluminum hydroxide, magnesium hydroxide, simethicone (reported as "VAROMIL"), ranitidine, TEGRETOL, sertraline hydrochloride, FLOMAX and vitamin D (unspecified). On an unknown date in December 2013, the patient developed vomiting, dizziness, fever and chills after receiving PNEUMOVAX 23. The patient sought unspecified medical attention via office visit. ZOFRAN was given for adverse event. No lab diagnostics studies were performed. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On 11-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot #, expiration date and indication not reported). No demographics were provided for the patient involved. The pharmacist reported the patient developed an unspecified adverse reaction after vaccination. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to  a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB, 0.5 ml, intramuscular for an unknown indication. Past medical history and concomitant medications were not provided. On 29-OCT-2013 the patient was administered an expired dose of RECOMBIVAX, Lot # 0571AA. No adverse event was reported. The outcome of administered an expired dose of RECOMBIVAX is unknown. The reporter considered administered an expired dose of RECOMBIVAX to be not related to RECOMBIVAX HB. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a physician's office refers to an infant of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB via an unknown route of administration for an unknown indication. Past medical history and concomitant medications were not reported. The reporter stated that an infant received a 1.0 mL dose of hepatitis B vaccine and another 1.0 mL dose of hepatitis B vaccine two days later (dates of vaccination were not reported). She stated that she was unsure whether the vaccine was RECOMBIVAX or other hepatitis B vaccine. She stated that the patient did not have any adverse effects. The outcome of an infant received a 1.0 mL dose of hepatitis B vaccine and another 1.0 mL dose of hepatitis B vaccine two days later and no adverse event is unknown. The reporter considered an infant received a 1.0 mL dose of hepatitis B  vaccine and another 1.0 mL dose of hepatitis B vaccine two days later to be not related to RECOMBIVAX HB. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired gastric emptying
Clinical narrative: Initial report received from a healthcare professional on 23 December 2013. A female patient, whose medical history and concomitant medications were not reported, had received intramuscular dose of FLUZONE (batch number: UH756AA, Exp. Date: 30 June 2013 and site of administration was not reported) on 11 December 2012. It was reported, that the following vaccination patient has experienced numerous symptoms and developed gastroparesis on unspecified date. The patient required ER/doctor visit. Corrective treatments and laboratory details were not reported. As of 23 December 2013, the patient was not recovered from the event. Document Held by Sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Insomnia
Clinical narrative: Dizziness, Fainting, Flashing lights, Blurred Vision, Trembling, Severe Nausea, Severe Headache, Lump in throat, Chills and Fever, Diarrhea, Tremors have persisted since date of shot and can no longer sleep.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Photopsia, Pyrexia, Sensation of foreign body, Syncope
Clinical narrative: Dizziness, Fainting, Flashing lights, Blurred Vision, Trembling, Severe Nausea, Severe Headache, Lump in throat, Chills and Fever, Diarrhea, Tremors have persisted since date of shot and can no longer sleep.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vision blurred
Clinical narrative: Dizziness, Fainting, Flashing lights, Blurred Vision, Trembling, Severe Nausea, Severe Headache, Lump in throat, Chills and Fever, Diarrhea, Tremors have persisted since date of shot and can no longer sleep.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 53 year old female patient with allergy for sulfonamide medications. The patient's medical history included rashes from unspecified products. On 13-DEC-2013 the patient was vaccinated with ZOSTAVAX injection with the "standard dose". Strength and lot number were unknown. Concomitant therapies included SINGULAIR and NASONEX. On 23-DEC-2013 the patient noticed that she had developed a rash after receiving ZOSTAVAX. On that day the rash appeared all over her torso and back. The patient stated that she may have had some spots beforehand in various places that went unnoticed until 23-DEC-2013, when the reaction had become apparent to her as a rash as well as possible reaction to the vaccine. The patient did not seek medical attention. The rash was treated with an unspecified topical cream. At the time of report the rash had not resolved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Iritis, Pain, Photophobia, Tenderness
Clinical narrative: I am a RN working at a hospital where we are required to receive a flu shot. Every year I develop iritis 2 weeks after receiving the vaccination. At first I have tenderness and some light sensitivity. The pain increases rapidly if untreated. I begin PRED-FORTE eye drops ASAP. The first time I had a flu shot the pain and photophobia was so severe the eye doctor dilated my pupils and injected a steroid into the eye chamber. At 1st it was in left eye each year - this year it was both.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a office coordinator refers to a 60 year old female patient. No pertinent medical history and drug reactions/allergies reported. The patient's concomitant therapies included albuterol (manufacturer unknown) and estradiol. The reported stated that after a patient received ZOSTAVAX (lot # J008432, 0.65 ml, once, subcutaneous site of administration was not reported), on 16-DEC-2013, she developed a red, raised area at the injection site that was sore to the touch. The reporter stated there was no blisters, pustules or rash present. The patient called into the office today on 18-DEC-2013 and reported adverse reaction. The patient stated the reaction onset date was 17-DEC-2013 (reported as "a day after" receiving the ZOSTAVAX. No laboratory test were performed. The patient sought unspecified medical attention. The physician, instructed the patient to take BENADRYL for the reaction. The reported stated this was the second adverse event associated with Lot # J008432. The reporter requested a lot check for this received ZOSTAVAX on behalf of physician. The outcome of red raised area at the injection site and injection site that was sore to the touch was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Musculoskeletal pain, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to approximately 60 year old female patient with pain, unspecified back pain and no drug reactions and allergies. Concomitant medications: unspecified pain medications. On 14-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # J007856, expiration date: 28-SEP-2014, dose 0.65 ml) subcutaneously. On an unknown date in 2013, (reported as a few days after the patient was administered ZOSTAVAX, the patient developed intense itching on unspecified locations on her body and slight shoulder pain. The pharmacist reproted that there was no rash and nothing visible on the patient's skin. The patient was reporting the feeling of itching not only at the ZOSTAVAX injection site. The patient went to the routine appointment with an unspecified physician on 16-DEC-2013 and was prescribed an unspecified topical steroid (manufacturer unknown) and betamethasone (manufacturer unknown). The patient sought medical attention via contacting pharmacist. The outcome of events was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported. No laboratory diagnostic studies were performed. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: After administering the shot, an immediate wheal reaction developed. It grew to about an inch and a half in diameter, red surrounding area. Administered 50 mg BENADRYL and iced the area for approximately 10 minutes. Area stabilized and no further reaction occurred.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date, the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. Concomitant medications were not reported. No adverse effect reported. The outcome was unknown and causality was assessed as not related. Product quality complaint was not involved. No other information provided. Additional information is not expected.
Age: 1.27
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from another health professional refers to a 3 year old female. On 25-NOV-2013 the patient was vaccinated with second dose of RECOMBIVAX HB, intramuscular. Previously on 27-DEC-2011, the patient was vaccinated with first dose of RECOMBIVAX HB, intramuscular. Concomitant medications were/reported as none. Medical history and drug allergies were also reported as  none. On approximately 09-DEc-2013 (reported as approximately two weeks after that second dose of RECOMBIVAX), the patient experienced hives and skin rash which comes and goes. The mother has give BENADRYL to the child. The patient currently has the hives now. The outcome of hives was reported as not recovered. The outcome of skin rash was unknown. Causality assessment was not provided by the reporter. The patient present4ed to the office today, but no additional doses of RECOMBIVAX HB were administered. No patient contact details provided. No further information provided. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: Shoulder Lt. arm - back of upper arm redness - edema with itchiing.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 23-MAY-2013 the patient was vaccinated with the first dose if GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular for the prevention of the HPV virus. On 27-SEP-2013 the patient was vaccinated with the second dose of   GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular for the prevention of the HPV virus. On 17-DEC-2013 the patient was vaccinated with the third dose of GARDASIL (dose 0.5, lot number and expiration date not reported) intramuscular for the prevention of the HPV virus. The nurse reported that the patient received the third dose of GARDASIL "3 days earlier of the 12 week interval within the provisional dosing schedule. No adverse effects reported. It was reported that the patient did not seek for medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL and VARIVAX. Information regarding dose, route and lot number was not provided. Concomitant therapies included MENACTRA and TDAP (manufacturer unknown). The nurse reported that the patient was very anxious when she was informed that she would be receiving four vaccines in a clinic visit on an unspecified date. When the patient received dose of GARDASIL, VARIVAX, MENACTRA, and TDAP, the patient became "dizzy and passed out." The patient recovered fully, and the nurse attributed the patient's adverse experience to her own state-of-mind at the time of receipt of the four vaccine doses. The nurse stated that "her reaction wasn't unusual." "Patient became dizzy and passed out" was determined medically significant upon internal review. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of GARDASIL and VARIVAX (merck). Information regarding dose, route and lot number was not provided. Concomitant therapies included MENACTRA and Tdap (manufacturer unknown). The nurse reported that the patient was very anxious when she was informed that she would be receiving four vaccines in a clinic visit on an unspecified date. When the patient received doses of GARDASIL, VARIVAX (merck), MENACTRA, and "Tdap" (manufacturer unknown), the patient became "dizzy and passed out". The patient recovered fully, and the nurse attributed the patient's adverse experience to her own state-of-mind at the time of the receipt of the four vaccine doses. The nurse stated that "her reaction wasn't unusual." "Patient became dizzy and passed out" was determined medically significant upon internal review. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient reports systemic reaction of whole body rash the day after receiving FLUVIRIN on 10/11/13.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Rash, Skin warm
Clinical narrative: Patient has slight redness at injection site and itchy, warm rash on arm on below injection.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: 12/3-skin red, sore slight swelling lt. upper arm. 12/4-red area increased eventually to 3" x 5" area, w/more swelling. 12/7-more swelling, hot to touch, pain. 12/10-area finally reduced to normal.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Urticaria
Clinical narrative: Pt noticed soreness in arm 12/14, noticed some redness 12/14, 12/15, pt had welt on arm roughly 4" in diameter sore to the touch, no other symptoms observed/reported.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Crying, Face injury, Fall, Haemoglobin normal, Headache
Clinical narrative: Pt. received vaccines and was fine as nurse left the room with pt in mom's care. I entered room after loud bang heard and pt on the floor. Mom stated she passed our and fell face first into the floor. Pt with syncope and lying face up with cut on forehead crying saying teeth felt funny and head and nose hurt. Forehead with cut and gaping nasal bridge swollen and lower central incisor with chips to see dentist and nasal films. Kept in office x 1 hour til able to walk out. VSS.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Laceration, Loss of consciousness, Rhinalgia, Sensory disturbance, Swelling
Clinical narrative: Pt. received vaccines and was fine as nurse left the room with pt in mom's care. I entered room after loud bang heard and pt on the floor. Mom stated she passed our and fell face first into the floor. Pt with syncope and lying face up with cut on forehead crying saying teeth felt funny and head and nose hurt. Forehead with cut and gaping nasal bridge swollen and lower central incisor with chips to see dentist and nasal films. Kept in office x 1 hour til able to walk out. VSS.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Syncope, Tooth fracture
Clinical narrative: Pt. received vaccines and was fine as nurse left the room with pt in mom's care. I entered room after loud bang heard and pt on the floor. Mom stated she passed our and fell face first into the floor. Pt with syncope and lying face up with cut on forehead crying saying teeth felt funny and head and nose hurt. Forehead with cut and gaping nasal bridge swollen and lower central incisor with chips to see dentist and nasal films. Kept in office x 1 hour til able to walk out. VSS.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Dysstasia
Clinical narrative: Heart pounding. First ER visit 11:00 AM - 3:50pm dizzy, SOB, unable to stand, systolic B/P > 200, rapid irregular pulse, diaphoretic. Felt like passing out several times. Transported by EMT over to ER. Rx with IV. MD said it was a severe white count reaction. Second ER visit: 7pm - 11:30pm. Nausea, severe diarrhea that started at 6 pm. Unable to stand, weak, SOB, diaphoretic, felt like passing out several times. Husband called ambulance. Rx with IV, BENADRYL, prednisone. This MD said it was a reaction to the flu shot and never to have another one. Times are approximate.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Heart rate irregular, Hyperhidrosis, Laboratory test, Lacrimation increased
Clinical narrative: Heart pounding. First ER visit 11:00 AM - 3:50pm dizzy, SOB, unable to stand, systolic B/P > 200, rapid irregular pulse, diaphoretic. Felt like passing out several times. Transported by EMT over to ER. Rx with IV. MD said it was a severe white count reaction. Second ER visit: 7pm - 11:30pm. Nausea, severe diarrhea that started at 6 pm. Unable to stand, weak, SOB, diaphoretic, felt like passing out several times. Husband called ambulance. Rx with IV, BENADRYL, prednisone. This MD said it was a reaction to the flu shot and never to have another one. Times are approximate.