chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with lot #(670978/0750AA) ZOSTAVAX on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 31-AUG-2012 the patient received expired ZOSTAVAX. No known adverse effects were reported. This case is linked to case 1210USA0002505 by same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of an unknown age, who in September 2012 (a few weeks of each other patients) was vaccinated with subcutaneously with a 0.65 ml dose of ZOSTAVAX. It was confirmed that the lot number was HO11333. No other co-suspects were reported. No concomitant medications were reported. It was reported that in September 2012, the patient experienced injection site reaction and pain. The physician suggested treat the injection site reaction by applying cold compresses and to take TYLENOL for pain. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for injection site reaction and pain was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain
Clinical narrative: This report was received from a physician reporting that the patient was a female of an unknown age, who in September 2012 (a few weeks of each other patients) was vaccinated with subcutaneously with a 0.65 ml dose of ZOSTAVAX. It was confirmed that the lot number was HO11333. No other co-suspects therapies were reported. No concomitant medications were reported. It was reported that in September 2012, the patient experienced injection site reaction and pain. The physician suggested treat the injection site reaction by applying cold compresses and to take TYLENOL for pain. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for injection site reaction and pain was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that on an unknown date, the patient developed a rash. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of rash was unknown. The relatedness for rash was not provided for VARIVAX (Merck). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a company representative who reported that a female patient (age unknown) developed shingles within one month after she received ZOSTAVAX (dates, dose not reported). No further information was provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I developed shingles then atrial fibrillation.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation, Herpes zoster
Clinical narrative: I developed shingles then atrial fibrillation.
Age: 44.0
Sex: F
Vaccine: TD, TD
Symptoms: Mobility decreased, Muscle disorder, Oedema peripheral, Pain in extremity
Clinical narrative: (L) arm pain with raising arm.
Age: 44.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain, Pain in extremity
Clinical narrative: (L) arm pain with raising arm.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a consumer regarding his 90 years old wife. Patient has an allergy to penicillin. On 14-SEP-2012, the patient was vaccinated subcutaneously with single dose of 0.65 ml ZOSTAVAX. No concomitant medications were reported. Since 14-SEP-2012, the patient had a headache for a week after receiving ZOSTAVAX and had a redness around injection site that was hard in places. Patient received treatment with TYLENOL. The outcome of redness around injection site that was hard in places and headache was reported as not recovered. The relatedness for redness around injection site that was hard in places and headache was unknown for ZOSTAVAX. Additional information is not expected.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a consumer regarding his 90 years old wife. Patient has an allergy to penicillin. On 14-SEP-2012, the patient was vaccinated subcutaneously with single dose of 0.65 ml ZOSTAVAX. No concomitant medications were reported. Since 14-SEP-2012, the patient had a headache for a week after receiving ZOSTAVAX and had a redness around injection site that was hard in places. Patient received treatment with TYLENOL. The outcome of redness around injection site that was hard in places and headache was reported as not recovered. The relatedness for redness around injection site that was hard in places and headache was unknown for ZOSTAVAX. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 74-year-old female patient. The patient's medical history included unspecified allergic reaction to a flu shot (manufacturer unspecified) at some unspecified time in the past. Current conditions included drug reactions/allergies to flu vaccine. On 08-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX vial # (0365AE) expiration date 23-MAR-2013, dose number unspecified for prophylaxis (reported as immunization). No concomitant medications were reported. On 08-SEP-2012 the patient developed injection site reactions, painful, red, hard, raised, "hot to the touch" area on her arm at the injection site after receiving ZOSTAVAX. Treatment information was unspecified by the reporter. The outcome of the event painful, red, hard, raised, "hot to the touch" area on her arm at the injection site did not resolve at the time of this report. Medical attention was sought for the event. The patient came back in to pharmacy and she called her physician. The pharmacist was requesting a lot check for ZOSTAVAX for the above mentioned lot number. No other information was available at the time of this report. This is one of several reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 74-year-old female patient. The patient's medical history included unspecified allergic reaction to a flu shot (manufacturer unspecified) at some unspecified time in the past. Current conditions included drug reactions/allergies to flu vaccine. On 08-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX vial # (0365AE) expiration date 23-MAR-2013, dose number unspecified for prophylaxis (reported as immunization). No concomitant medications were reported. On 08-SEP-2012 the patient developed injection site reactions, painful, red, hard, raised, "hot to the touch" area on her arm at the injection site after receiving ZOSTAVAX. Treatment information was unspecified by the reporter. The outcome of the event painful, red, hard, raised, "hot to the touch" area on her arm at the injection site did not resolve at the time of this report. Medical attention was sought for the event. The patient came back in to pharmacy and she called her physician. The pharmacist was requesting a lot check for ZOSTAVAX for the above mentioned lot number. No other information was available at the time of this report. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Initial report was received on 28 September 2012 from a health care professional. A female patient with a history of an allergy to neomycin had received on 27 September 2012 an intramuscular injection of FLUZONE HIGH-DOSE, lot number U4496AA and one hour after vaccination, experienced a sensation of tightness of the throat and chest, and began coughing. Patient treated self with BENADRYL and symptoms began to clear up. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Throat tightness
Clinical narrative: Initial report was received on 28 September 2012 from a health care professional. A female patient with a history of an allergy to neomycin had received on 27 September 2012 an intramuscular injection of FLUZONE HIGH-DOSE, lot number U4496AA and one hour after vaccination, experienced a sensation of tightness of the throat and chest, and began coughing. Patient treated self with BENADRYL and symptoms began to clear up. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme soreness of shoulder at injection site to the point of difficulty lifting that arm.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Decreased appetite, Dehydration, Dyspnoea, Pyrexia
Clinical narrative: Trouble breathing, no appetite, fevers spiking up/down to 103. Since was dehydrated took to ER on tue 10/9, admitted to hospital.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Streptococcus test
Clinical narrative: Trouble breathing, no appetite, fevers spiking up/down to 103. Since was dehydrated took to ER on tue 10/9, admitted to hospital.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Oedema peripheral, Pain in extremity
Clinical narrative: EE received AFLURIA 2012 flu vaccine into (L) deltoid at 6:10 AM, EE went home & went to bed. EE woke up at 2pm & (L) arm was swollen, sore & (L) 3rd, 4th, 5th digits numb.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Syncope
Clinical narrative: Initial report was received on 28 September 2012 from a consumer who is also the patient. A 75 year-old female with history of hypertension, high cholesterol and allergy to sulfites had received on 08 November 2011 an intramuscular left arm injection of FLUZONE, lot number UH486AD and two hours after vaccination, experienced syncope that lasted a few minutes. The patient was transported to hospital by ambulance and was admitted overnight. The patient had a CT scan (results were not reported). The patient reported to have had previous doses of FLUZONE vaccine. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Acute pulmonary oedema
Clinical narrative: Initial report was received on 01 October 2012 from a health care professional. An unidentified patient had received FLUZONE, lot number UH731AA (route, site and date of administration not reported) and an unspecified amount of time later, developed flash pulmonary edema. The patient was hospitalized however, according to the reporter it was not known if the patient had been hospitalized "for another reason and then got the vaccination and the reaction." No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Initial report was received from a health care professional on 01 October 2012. A female patient of unknown age with no reported medical history had received FLUZONE HIGH-DOSE (lot number not reported) and after an unspecified amount of time her "right arm swelled and was red, warm and painful. On 27 September 2012, the patient was seen at the reporter's health department facility who said it looked "like an abscess and was firm to the touch but not warm." The following day, the patient was seen by a doctor who told her it was reaction to the HD vaccine. Concomitant therapy and corrective treatment were not reported. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 01 October 2012. A female patient of unknown age with no reported medical history had received FLUZONE HIGH-DOSE (lot number not reported) and after an unspecified amount of time her "right arm swelled and was red, warm and painful. On 27 September 2012, the patient was seen at the reporter's health department facility who said it looked "like an abscess and was firm to the touch but not warm." The following day, the patient was seen by a doctor who told her it was reaction to the HD vaccine. Concomitant therapy and corrective treatment were not reported. No further information was available at the time of the report. The patient outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: PER
Symptoms: Cough, Pertussis
Clinical narrative: This case involves a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (the mother). The other 3 patient are captured in case numbers 2012-09094, 09095, and 09096. Initial report received from a company representative who provided a link to non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient and her husband. A female consumer, who is the mother of 4 children (3boys, 1 girl), had received a PERTUSSIS VACCINE (manufacturer, date, route, site of administration not reported) and later developed whooping cough. She first noticed a cough in her 4-year-old son who was reportedly lacking one dose of PERTUSSIS vaccine because of his age and vaccine schedule. Because the patient's 2-year-old daughter was undergoing chemotherapy, the patient and her 3 sons went away for a family vacation, to avoid the risk of her daughter getting sick. The patient and her 2 older sons (ages 7 and 9) quickly came down with nagging coughs that wouldn't go away and seemed to be getting worse. After approximately 2 weeks, the 4-year-old son developed a cough where he was gasping for breath during coughs and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a pertussis test (unspecified). Her 4-year-old son was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). according to the blog posting on 14 September 2012, the patient and her 9-year-old son were reported to have a lesser, but still nasty, cough while her 7-year-old son was doing great. The patient had not received the recommended booster shot for pertussis, but her 7 and 9 year old sons were up-to-date on their vaccines. Outcome was not reported. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: 12 mo shots administered on 9/28. On 10/06 parents noticed a body covering rash while giving night time bath and called on-call provider at clinic.
Age: 9.0
Sex: M
Vaccine: PER
Symptoms: Cough, Pertussis
Clinical narrative: This case involves a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (the 9-year-old son). The other 3 patient are captured in case numbers 2012-09093, 09095, and 09096. Initial report received from a company representative who provided a link to a non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient and her husband. This case involves a 9-year-old male patient who had received a PERTUSSIS VACCINE (manufacturer, date, route, site of administration not reported) and later developed whooping cough. The patient's 4-year-old brother was the first in the family to develop a cough. Because the patient's sister was undergoing chemotherapy, the patient went away for a family vacation with his mother and 2 brothers to avoid the risk of his sister getting sick. All of them quickly came down with nagging coughs that couldn't go away and seemed to be getting worse. After approximately 2 weeks, the 4-year-old brother experienced a cough where he was gasping for breathing during coughs, and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a Pertussis test (unspecified). The 4-year-old brother was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). According to the blog posting on 14 September 2012, the patient and his mother were reported to have a lesser, but still nasty, cough while the 7-year-old brother was doing great. The patient and his 7-year-old brother were up-to-date on their vaccines; although the mother had not received the recommended booster shot for pertussis. Outcome was not recovered. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: PER
Symptoms: Cough, Pertussis
Clinical narrative: This case involved a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (7-year-old son). The other 3 patients are captured in case numbers 2012-09093, 09094, and 09096. Initial report received from a company representative who provided a link to a non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient and her husband. This case involved a 7-year-old male patient, who had received a pertussis vaccine (manufacturer, date, route, site of administration not reported) and later developed whooping cough. The patient's 4-year-old brother was the first in the family to develop a cough. Because the patient's sister was undergoing chemotherapy, the patient went away for a family vacation with his mother and 2 brothers to avoid the risk of his sister getting sick. All of them quickly came down with nagging coughs that wouldn't go away and seemed to be getting worse. After approximately 2 weeks, the 4-year-old brother experienced a cough where he was gasping for breath during coughs, and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a Pertussis test (unspecified). The 4-year-old brother was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). According to the blog posting on 14 September 2012, the patient was "doing great" while his mother and 9-year-old brother were reported to have a lesser, but still nasty, cough. The patient and his 9-year-old brother were up-to-date on their vaccines. However, the mother had not received the recommended booster shot for pertussis and his 4-year-old brother was lacking one dose of pertussis vaccine because of his age and vaccine schedule. Outcome was not reported. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: PER
Symptoms: Bordetella test positive, Cyanosis, Dyspnoea, Pertussis, Retching
Clinical narrative: This case involves a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (the 4-year-old son). The other 3 patients are captured in case numbers 2012-09093, 09094, and 09095. Initial report received from a company representative who provided a link to a non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient's parents. This case involves a 4-year-old male patient who had a pertussis vaccine (manufacturer, date, route, site of administration not reported) and later developed whooping cough. When the patient's mother first noticed that he had developed a cough, she took the patient and her other 2 sons away for a family vacation, to avoid the risk of her 2-year-old daughter getting sick as her daughter was undergoing chemotherapy. The mother and the patient's older brothers (ages 7 and 9) quickly came down with nagging cough that wouldn't go away and seemed to be getting worse. After approximately 2 weeks, the patient experienced episodes where he was gasping for breath during coughs and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a Pertussis test (unspecified). The patient was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). According to the blog posting on 14 September 2012, the patient's mother and 9-year-old brother were reported to have a lesser, but still nasty, cough while his 7-year-old brother was doing great. The patient was reported to be lacking one dose of the pertussis vaccine series because of his age and the vaccine schedule. Outcome was not reported. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: PER
Symptoms: Vomiting
Clinical narrative: This case involves a cluster of 4 patients (a mother and her 3 sons). This case represents one of the 4 patients (the 4-year-old son). The other 3 patients are captured in case numbers 2012-09093, 09094, and 09095. Initial report received from a company representative who provided a link to a non-scientific news report on 26 September 2012. On the same date, another company representative provided additional information obtained from an internet source that is maintained by the patient's parents. This case involves a 4-year-old male patient who had a pertussis vaccine (manufacturer, date, route, site of administration not reported) and later developed whooping cough. When the patient's mother first noticed that he had developed a cough, she took the patient and her other 2 sons away for a family vacation, to avoid the risk of her 2-year-old daughter getting sick as her daughter was undergoing chemotherapy. The mother and the patient's older brothers (ages 7 and 9) quickly came down with nagging cough that wouldn't go away and seemed to be getting worse. After approximately 2 weeks, the patient experienced episodes where he was gasping for breath during coughs and he would turn blue, vomit, and dry heave. The next day, the family presented to the pediatrician and asked for a Pertussis test (unspecified). The patient was diagnosed with pertussis and the whole family was treated with antibiotics (unspecified). According to the blog posting on 14 September 2012, the patient's mother and 9-year-old brother were reported to have a lesser, but still nasty, cough while his 7-year-old brother was doing great. The patient was reported to be lacking one dose of the pertussis vaccine series because of his age and the vaccine schedule. Outcome was not reported. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema mouth, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Diffuse pruritic erythematous macular papular rash with perioral swelling. Emergency Room evaluation and treatment with IV + PO steroids. Discharged same day.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Bacterial infection, Balance disorder, Drug administered at inappropriate site, Erythema
Clinical narrative: Entire body aches and pains, unable to move my left arm where the injection was given for several days.  Weakness, unsteadiness, fever, itching, redness and swelling.  Had to see my family physician twice and was told by two different nurses/doctors that the pneumonia injection was given approximately 2-3 inches lower than it should have been.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Entire body aches and pains, unable to move my left arm where the injection was given for several days.  Weakness, unsteadiness, fever, itching, redness and swelling.  Had to see my family physician twice and was told by two different nurses/doctors that the pneumonia injection was given approximately 2-3 inches lower than it should have been.
Age: 39.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: Entire body aches and pains, unable to move my left arm where the injection was given for several days.  Weakness, unsteadiness, fever, itching, redness and swelling.  Had to see my family physician twice and was told by two different nurses/doctors that the pneumonia injection was given approximately 2-3 inches lower than it should have been.
Age: 5.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: At the IPV injection site, it is large (currently the size of an orange), red and swollen. The injection site is warm to the touch and my daughter is complaining that it itches and is sore to the touch.
Age: 12.0
Sex: F
Vaccine: DTP
Symptoms: Blood test, C-reactive protein increased, Hypoaesthesia, Inflammation, Oedema peripheral
Clinical narrative: Hands and feet started swelling, went numb, tingling sensation.
Age: 12.0
Sex: F
Vaccine: DTP
Symptoms: Paraesthesia
Clinical narrative: Hands and feet started swelling, went numb, tingling sensation.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Nausea, dizziness, chest tightness, diaphoretic, short of breath. She did not report symptoms until later though at 2:30pm and was then sent to the ER.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Facial pain, Local swelling, Neck pain, Pain in jaw, Swelling face
Clinical narrative: Left side of face, jaw and neck became puffy, swollen and painful. Vaccine was administered in Left Deltoid muscle. No Fever. No numbness or tingling.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bronchitis, Cough, Joint stiffness, Joint swelling
Clinical narrative: Stiffness, pain and swelling in all joints. Took Celebrex; Next day started coughing and that went into bronchitis. Still have a productive cough.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Productive cough
Clinical narrative: Stiffness, pain and swelling in all joints. Took Celebrex; Next day started coughing and that went into bronchitis. Still have a productive cough.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Fatigue, Vaccine positive rechallenge
Clinical narrative: (1 week 2010) I felt unbalanced, I felt like I could fall flat without being dizzy. I felt super tired, fatigued all of the time. I swore now that I knew for sure in 2011 it is the flu shot I'll never again in my life have another one if I live through it as in 2010. The same symptoms in 2011 as well, I can't remember them now. (2 weeks long 2011).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Dysphagia, Myalgia
Clinical narrative: Throat began to swell; difficulty swallowing - took allergy medicine. After few hours swallowing difficulty eased. Around 7pm uncontrollable body shaking shivers, aching muscles and feverish. - took hot tea and Tylenol. Around 8pm body temperature was 102.5. Throughout the night - felt like an elephant was on my chest. Next day- weak but functional. Reminder to self -never get FLU shot again!
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pyrexia
Clinical narrative: Throat began to swell; difficulty swallowing - took allergy medicine. After few hours swallowing difficulty eased. Around 7pm uncontrollable body shaking shivers, aching muscles and feverish. - took hot tea and Tylenol. Around 8pm body temperature was 102.5. Throughout the night - felt like an elephant was on my chest. Next day- weak but functional. Reminder to self -never get FLU shot again!
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache & fatigue, body ache.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram head, Eye oedema, Eye pain, Full blood count, Metabolic function test
Clinical narrative: Severe Left eye pain progressing over 8 day course with Left facial droop and loss of bilateral ocular motor coordination, Nausea, Photo-phobia, Vertigo, Edema to Left eye and orbit.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Oculogyric crisis, Orbital oedema, Photophobia, VIIth nerve paralysis
Clinical narrative: Severe Left eye pain progressing over 8 day course with Left facial droop and loss of bilateral ocular motor coordination, Nausea, Photo-phobia, Vertigo, Edema to Left eye and orbit.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Severe Left eye pain progressing over 8 day course with Left facial droop and loss of bilateral ocular motor coordination, Nausea, Photo-phobia, Vertigo, Edema to Left eye and orbit.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Fatigue, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Headache, followed by stiff neck, in addition on 10/6/2012 101 fever, fatigue, upset stomach lasting until 10/07.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Nasal congestion, Throat irritation
Clinical narrative: 5 hours after vaccination patient experienced minor HA, nasal congestion, "funny" throat. Next morning PT went to clinic with extreme HA, sweats, nasal congestion, "funny" throat. Clinic dispensed APAP and Benadryl. Told PT to continue these meds and rest. PT to return if symptoms persisted or worsened.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: SLIGHT FEVER 99.6.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: FEVER 100.0 TO 101.6. CHILLS AND FATIGUE.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Blood test, Cyanosis, Hepatomegaly, Joint fluid drainage
Clinical narrative: Began with slight swelling of joints in hands/joints/thumbs and started hurting. By 10/4/2012, hands & thumbs so swollen couldn't use.  Also swelling progressed to legs and feet.  By 10/5/12 toes were purple so swollen and couldn't walk.  He also stated his liver started swelling, as if onset of Hepatitis. Went to see MD/Rheumatologist.  Knee so swollen couldn't walk. Knee joint fluid drained and was put on steroids. MD also drew a large amount of blood for work-up at that time.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Joint swelling, Mobility decreased, Oedema peripheral, Pain
Clinical narrative: Began with slight swelling of joints in hands/joints/thumbs and started hurting. By 10/4/2012, hands & thumbs so swollen couldn't use.  Also swelling progressed to legs and feet.  By 10/5/12 toes were purple so swollen and couldn't walk.  He also stated his liver started swelling, as if onset of Hepatitis. Went to see MD/Rheumatologist.  Knee so swollen couldn't walk. Knee joint fluid drained and was put on steroids. MD also drew a large amount of blood for work-up at that time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Eye swelling, Lip swelling, Pruritus generalised, Skin test negative, Urticaria
Clinical narrative: Mother was driving patient home after administration of vaccines and pt started to have swelling of her eyes and lips with hives and itching all over body. Mother brought patient back to the clinic, and pt brought back to room immediately and physician notified immediately. Physician assessed patient. Epinephrine 0.15mg (0.15mg/0.3mL) administered IM in pt's left thigh. Pt then given po Benadryl 7.5 ml (12.5mg/5ml) and Orapred 15.2 mL (15mg/5mL) in clinic. 911 called and pt transferred to Emergency Department. ED notified of pt's condition.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Dry eye, Ear discomfort, Ear pain, Headache
Clinical narrative: Approximately 11:00AM c/o slight stiffness to (L) side of neck radiating to top shoulder. Complaint pain (L)eft ear and pain left temperol region, felt ears plugged-described similar to migraine headache. 10/1/12 c/o stiffness- Oct 1, 2012 c/o (L) eye been very dry also face swollen, Left eye tearing. Consultation 10/1/12 Dr. B/P 170/90 as per client 10/4/12 pain (L) side neck radiation to shoulder. Rx Cefuroxime 500 mg BID.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Lacrimation increased, Migraine, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Approximately 11:00AM c/o slight stiffness to (L) side of neck radiating to top shoulder. Complaint pain (L)eft ear and pain left temperol region, felt ears plugged-described similar to migraine headache. 10/1/12 c/o stiffness- Oct 1, 2012 c/o (L) eye been very dry also face swollen, Left eye tearing. Consultation 10/1/12 Dr. B/P 170/90 as per client 10/4/12 pain (L) side neck radiation to shoulder. Rx Cefuroxime 500 mg BID.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Swelling face, VIIth nerve paralysis
Clinical narrative: Approximately 11:00AM c/o slight stiffness to (L) side of neck radiating to top shoulder. Complaint pain (L)eft ear and pain left temperol region, felt ears plugged-described similar to migraine headache. 10/1/12 c/o stiffness- Oct 1, 2012 c/o (L) eye been very dry also face swollen, Left eye tearing. Consultation 10/1/12 Dr. B/P 170/90 as per client 10/4/12 pain (L) side neck radiation to shoulder. Rx Cefuroxime 500 mg BID.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING OF 4-5CM AROUND SITE OF INJECTION WITH REDNESS, SWELLING, HEAT, AND INDURATION.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood test normal, Computerised tomogram normal, Hypoaesthesia, Neck pain
Clinical narrative: Pt states she woke up on Saturday morning with severe cervical and sacral pain. Then Saturday pm pt started noticing numbness on her left side started around ribs and left arm. Then progressed to left side of her body, down her left leg and to her left foot. Pt states that on Sunday that the bottom of her right foot started to feel numb. Pt states that her feet feel extremely heavy.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of heaviness, Spinal X-ray normal
Clinical narrative: Pt states she woke up on Saturday morning with severe cervical and sacral pain. Then Saturday pm pt started noticing numbness on her left side started around ribs and left arm. Then progressed to left side of her body, down her left leg and to her left foot. Pt states that on Sunday that the bottom of her right foot started to feel numb. Pt states that her feet feel extremely heavy.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Contusion, Diarrhoea, Dizziness, Gastric operation
Clinical narrative: Started sweating really bad, high fever, sick of the stomach, extremely weak, extremely dizzy, diarrhea really bad, throwing up over and over, blacked out twice, two head injuries, extremely bruised ribs, and after being admitted into hospital, had to have surgery in my stomach from throwing up so bad, my esophagus had a big hole in it, large rip. My immune system is totally destroyed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Hyperhidrosis, Immune system disorder, Loss of consciousness, Nausea
Clinical narrative: Started sweating really bad, high fever, sick of the stomach, extremely weak, extremely dizzy, diarrhea really bad, throwing up over and over, blacked out twice, two head injuries, extremely bruised ribs, and after being admitted into hospital, had to have surgery in my stomach from throwing up so bad, my esophagus had a big hole in it, large rip. My immune system is totally destroyed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Oesophageal perforation, Pyrexia, Vomiting
Clinical narrative: Started sweating really bad, high fever, sick of the stomach, extremely weak, extremely dizzy, diarrhea really bad, throwing up over and over, blacked out twice, two head injuries, extremely bruised ribs, and after being admitted into hospital, had to have surgery in my stomach from throwing up so bad, my esophagus had a big hole in it, large rip. My immune system is totally destroyed.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea
Clinical narrative: SOB, coughing, shortness of breath.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 102.4 severe chills dropping to 100.1 over 14hrs. Continued fever of 99.8 at 20hrs post dos.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling redness right arm. Acetaminophen 650 MG QID.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: PHN used diluent with an expiration date of 7/31/12 for the MMR and varicella vaccinations.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Rash pruritic, Urticaria
Clinical narrative: Stiff neck on side of neck near arm of vaccination. This lasted 24 hours. Simultaneously, an itchy hives-rash appeared on neck and shoulders on side near arm of vaccination. The hives still remain one week later, excrutiatingly itchy. Dermatologist saw rash, suggested Zyrtec OTC.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash, itching and soreness at injection site of left deltoid.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Rash, Skin warm
Clinical narrative: Rash on belly, warm to the touch, red, painful, itchy.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Fever and Chills. Headache. Aches and pains all over my body, especially the injection site lasting until 10/8/2012. Nausea and stomach cramps lasting until 10/8/2012. Fatigue and weakness lasting until 10/8/2012. Irritability lasting until 10/8/2012.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Irritability, Nausea, Pain, Pyrexia
Clinical narrative: Fever and Chills. Headache. Aches and pains all over my body, especially the injection site lasting until 10/8/2012. Nausea and stomach cramps lasting until 10/8/2012. Fatigue and weakness lasting until 10/8/2012. Irritability lasting until 10/8/2012.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: Fever and Chills. Headache. Aches and pains all over my body, especially the injection site lasting until 10/8/2012. Nausea and stomach cramps lasting until 10/8/2012. Fatigue and weakness lasting until 10/8/2012. Irritability lasting until 10/8/2012.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Inflammation, Pain, Throat tightness
Clinical narrative: Vaccinated for influenza 10/4/12 - back to clinic with apparent redness, inflammation, warmth and pain - treated with anti-inflammatory abt. Returns 3rd time on 10/6/12 c/o throat closing.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Computerised tomogram head normal, Confusional state
Clinical narrative: Fever, confusion, rash requiring hospitalization, IV antibiotics, spinal tap, labs, CT scan of head, MRI.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Fibrin D dimer, Nuclear magnetic resonance imaging brain normal, Protein urine present, Pyrexia, Rash
Clinical narrative: Fever, confusion, rash requiring hospitalization, IV antibiotics, spinal tap, labs, CT scan of head, MRI.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Body temperature, Chills, Condition aggravated, Cough
Clinical narrative: Had temp. & check lungs before giving shot. N.P. Within 3 hours had sore arm, fever, chills, headache, muscle aches. 4th day cough, wheezing, could not breathe. Went to E.R. admitted. Low oxygen level. Pneumonia. Still cannot breathe properly - wheezing, coughing, etc.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Myalgia, Oxygen saturation decreased, Pain in extremity
Clinical narrative: Had temp. & check lungs before giving shot. N.P. Within 3 hours had sore arm, fever, chills, headache, muscle aches. 4th day cough, wheezing, could not breathe. Went to E.R. admitted. Low oxygen level. Pneumonia. Still cannot breathe properly - wheezing, coughing, etc.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia, Pyrexia, Wheezing
Clinical narrative: Had temp. & check lungs before giving shot. N.P. Within 3 hours had sore arm, fever, chills, headache, muscle aches. 4th day cough, wheezing, could not breathe. Went to E.R. admitted. Low oxygen level. Pneumonia. Still cannot breathe properly - wheezing, coughing, etc.
Sex: U
Vaccine: TDAP
Symptoms: Convulsion, Immobile
Clinical narrative: Initial report was received from a company representative on 28 September 2012. An unidentified patient with an unknown past medical history had received ADACEL (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced seizures and loss of mobility. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Neurological symptom
Clinical narrative: Case number PHHY2012HR086860, is an initial spontaneous report received from agency press report on 03 Oct 2012. This report refers to an unspecified patient (age and gender). His medical history and concomitant medications were not reported. The patient was vaccinated with FLUIMUN (batch number: unknown) in Dec 2011. The patient experienced neurological symptoms (description of reported side effect, according to available data, does not fit the definition of GBS) from an unknown date. Connection between reported symptoms and applied vaccine was evaluated possible, but other possible causes, such as infections, and medications used in that time period, cannot be excluded. Official follow up information from agency should follow. Event outcome, seriousness and causality assessment were not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal pain, Neck pain, Oedema peripheral, Swelling face
Clinical narrative: Patient reports swelling of hands, feet, and face evening of injection, also extreme pain in head, neck, and shoulder, she took BENADRYL.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Feeling hot, Nausea, Pain
Clinical narrative: On 10/07 in morning, red, hot, swollen, and sore and nausea. Pt took BENADRYL Sunday. Temp 101.6 F on Sat, no temp now.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: On 10/07 in morning, red, hot, swollen, and sore and nausea. Pt took BENADRYL Sunday. Temp 101.6 F on Sat, no temp now.
Sex: M
Vaccine: FLU3
Symptoms: Differential white blood cell count, Erythema, Full blood count, Oedema peripheral, Pain in extremity
Clinical narrative: (Rt) arm red, pain, swelling.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Patient developed enlarged (L) axillary lymph node about 5-6 cm in size in same area that vaccine was given within 24 hrs of vaccine administration.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, HEPAB, MNQ, TDAP
Symptoms: Asthenia, Back pain, Balance disorder, Barium swallow abnormal, Basophil count decreased
Clinical narrative: The pt arrived on 8/7/12. He received multiple vaccinations on 8/8/12 at which time he was in his normal state of good health. He reported that he had no local reactions (erythema, pain, swelling or tenderness). Additionally he denied any systemic reactions (headache, body aches, fever, chills, N, V, diarrhea). The pt noted a "pins and needles" sensation in his toes and fingers on 8/17/12 which progressed to his hands and feet the same day. He reported to medical on 8/20/12. At that time he was afebrile and his neurological exam was normal. The pt was started on Prednisone 60mg/day for inflammation. On 8/21/12 the pt noted "chest tightness" which he described as "difficulty taking an adequate breath" and no change in the tingling in his hands and feet--his neuro exam was normal and the pt was placed on 48 hours SIQ. On 8/23/12 the pt complained of left shoulder pain (6/10) with numbness and tingling in his arms and legs and difficulty walking due to "weakness". On PE grip weakness (L>R), left shoulder weakness, an abnormal wide gait and decreased reflexes of L4 were noted. The pt was referred to Neurology and was subsequently admitted to Hospital with the diagnosis of Guillain-Barre Syndrome. On admission to the hospital the pt reported new onset of: difficulty swallowing; pain in his left deltoid, mid back and neck; and a mild cough and nasal congestion. He was noted to have decreased BUE/BLE reflexes and motor strength, bilateral weak grip strength and impaired coordination on exam. A NCS and Swallow test were performed (both were abnormal: see results below); the pt was admitted to ICU and started on IVIG 500mg/kg/day for 4 days. He denied incontinence (bowel or bladder) but he did state that he was no longer experiencing morning or night time erections. The pt also reports that his cough worsened and from 8/24-8/26 his cough was productive with thick yellow secretions. He denied rhinorrhea, sneezing, fever, chills, N, V, diarrhea. The pt was NPO and self suctioned to manage his secretions (he was able to move his right forearm). When the pt was transferred to the acute rehab center on 8/28/12 he was able to move all four extremities although with difficulty. His strength was 4/5 in all four extremities and he was areflexic. A repeat swallow test showed improvement. Intensive speech, physical and occupational therapy were initiated. A review of medical records of 9/26/12 indicate that the pt is able to ambulate without assistance; his strength and endurance continue to improve although the pt requires rest breaks during therapy secondary to fatigue; the pt performed lower than expected on standard balance testing. The pt remains at the acute rehab center.