chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt was given #6 vaccines (5 inj) on 11/9/11 - developed a fever of 103.5 degrees F. later that evening. She was given TYLENOL which helped to bring fever down. Pt woke with fever 102.3 degrees F am of 11/10/11 - seen by FNP. There was no sign of infection on clinical eval. Rx for ibu. suspension and TYLENOL liquid given for pt.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nasal congestion, Urticaria
Clinical narrative: Urticarial rash onset 24 hrs after vaccines admin. Mild nasal congestion - no airway problems. No joint pn., no vomit or diarrhea. No tongue or lip swelling.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pharyngeal oedema, Pyrexia, Sensation of foreign body, Vomiting
Clinical narrative: Pt experienced vomiting, swollen throat, feeling a lump in the throat, malaise, and fever. Pt didn't go to emergency room by informed her PCP.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Erythema, Mass, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: 11/10/11 at 820 mother called states arm received HPV et-tetanus swollen, hot, large knot felt. Denies fever or redness recommended eval per MD. After checking the record - mother wrong T-DAP given alone Rt deltoid and Lt deltoid was HPV & flu shot - mother said when she got 2 shots. Dr office reported Lt arm - quarter size red/swollen tender area. Dr instructions wait 30 min after next HPV shot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Initial case received from a pharmacist on 09 September 2011. A 67-year-old female patient received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot UH452AC) on 09 September 2011. One hour post-vaccination, the patient reported pain in her left leg, 'barely able to walk'. At the time of the report, the event was ongoing.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Computerised tomogram, Confusional state, Dizziness, Tremor
Clinical narrative: Initial report received from a health care professional on 27 October 2010. A 73-year-old female patient, with a history of hypertension, hyperlipidemia, anxiety, headache (HA) and osteoporosis, received on 25 October 2010 a right deltoid intramuscular injection of FLUZONE HIGH-DOSE, lot number U3602AA and a left deltoid injection of PNEUMOVAX, MSD lot number 0866Z. The patient's concomitant medications included lisinopril, statins, alendronate, acetaminophen, butalbital, and FIOROCET and alprazolam. The patient had "nothing acute" at the time of vaccination. On 26 October 2010, the patient experienced dizziness, confusion and shaking of the hands. She was not evaluated by a physician and received no treatment. The symptoms were resolving on 27 October 2010. Follow-up information was received from the health care professional on 23 December 2010. The patient continued to have symptoms, but they were described as "usually transient". She had followed-up with her physician, and had undergone a CT scan and other blood work; results were not available at the time of the report. Follow-up information received from a health care professional on 14 March 2011. Per the reporter, they had no further information to provide for this case. No other contact information was provided. Follow-up information received from a health care professional on 21 March 2011. Per the reporter, there are no changes since the last report. The reporter followed up with the patient on 14 March 2011. Documents held by sender: None.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Pyrexia
Clinical narrative: Initial case was received on 03 November 2010 from a healthcare professional. An 82 year old female patient received on 08 October 2010 an intramuscular right arm injection of FLUZONE HIGH DOSE (lot number U3618AA). Two days after vaccination on 10 October 2010, she experienced confusion and didn't know who she was and had a "bad" fever of 103 F for three days with general weakness. The patient had no illness at the time of the vaccination. Pre-existing medical conditions included a positive PPD test (date not reported), hyperlipidemia and blood pressure ("BP") NOS. Concomitant medications included "several" (unspecified). She was allergic to BIAXIN, PNEUMOVAX, ZETIA and statins. The patient recovered on an unspecified date. Follow-up information was received on 10 December 2010 from a health care professional. The patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with "other/unknown". No further information was provided at the time of the report. Documents held by sender: None.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Anaemia, Asthenia, Dehydration, Oedema peripheral, Pyrexia
Clinical narrative: Initial report was received 12 November 2010 from a health care professional. An 85-year-old female patient received an injection of FLUZONE HIGH-DOSE, lot number U3614AA on 03 November 2010 and two days later on 05 November 2010, she experienced a high fever of 102.3, anemia and dehydration and went to the emergency room. Outcome was not reported. No additional information was provided at the time of the report. Follow-up information was received 07 December 2010 from a health care professional who reported that the patient recovered. No additional information was provided. Follow-up information received from a health care professional on 03 January 2011 reported that the patient was seen by a physician for evaluation of weakness, leg swelling and hospital follow-up. The patient had a history of neuropathy, hypertensive heart disease, lumbar disc displacement and hypothyroidism (unspecified). The patient's concomitant medications included thiamine HCl 100 milligrams (mg) one tablet (tab) once each day, potassium chloride 10 milliequivalent (mEq) one as needed, furosemide 20 mg once tab once each day, folic acid 1 mg one tab once each day, FLOMAX 0.4 mg one tab once each day, ALDACTONE 50 mg one tab twice each day, Ted hose fit to patient, LEVOXYL 30 micrograms (mcg) one tab once each day, GERITOL complete, one daily, DIOVAN HCT Aspirin EC 81 mg one tab once each day. The patient received the FLUZONE HIGH DOSE on 03 November 2010. On 05 November she reported a fever and weakness where she was triaged and advised to go to the Emergency Room (ER). The patient had no testing performed and was not hospitalized. The etiology was reported as unknown however, was reported as possible reaction to Hi Dose influenza. The outcome was reported as recovered on 05 November 2010 after the ER visit. The patient was seen in the physician's office on 09 November 2010 for follow-up from the ER. At this time, she was afebrile in the office. Follow-up information was received from a health care professional on 18 February 2011. The patient received an intramuscular right deltoid injection of FLUZONE HIGH-DOSE. No additional information available at this time. The outcome remained recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear discomfort, Flatulence, Hypoaesthesia, Increased upper airway secretion
Clinical narrative: Initial report was received from a consumer, who is also the patient on 17 January 2011. A 46 year-old female patient who had no illness at the time of vaccination, no known allergies and no reported medical conditions, had received an intramuscular left deltoid injection of Influenza vaccine (reported as FLUZONE, lot number not reported) and three to four hours later, experienced body aches and her "left lower arm went numb". She reported the next day her nose started "running like a faucet", she had gas, her ears were "plugged" and she had mucus and phlegm (spelled flem) when she coughed. Concomitant medications were none. She was not evaluated by a physician. She reported to have had a influenza vaccine "eight years ago" and had no H1N1. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 07 March 2011 reported that the patient received FLUZONE, sanofi pasteur lot number UT3563CA. The patient has not been seen since the administering of the FLUZONE, therefore, it was not known if the patient had recovered. The outcome was reported as unknown. Follow-up information was received from a health care professional on 11 April 2011 reported that the patient has not been seen since the administration of the vaccine and the outcome was unknown. The outcome remained unknown. Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rhinorrhoea
Clinical narrative: Initial report was received from a consumer, who is also the patient on 17 January 2011. A 46 year-old female patient who had no illness at the time of vaccination, no known allergies and no reported medical conditions, had received an intramuscular left deltoid injection of Influenza vaccine (reported as FLUZONE, lot number not reported) and three to four hours later, experienced body aches and her "left lower arm went numb". She reported the next day her nose started "running like a faucet", she had gas, her ears were "plugged" and she had mucus and phlegm (spelled flem) when she coughed. Concomitant medications were none. She was not evaluated by a physician. She reported to have had a influenza vaccine "eight years ago" and had no H1N1. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 07 March 2011 reported that the patient received FLUZONE, sanofi pasteur lot number UT3563CA. The patient has not been seen since the administering of the FLUZONE, therefore, it was not known if the patient had recovered. The outcome was reported as unknown. Follow-up information was received from a health care professional on 11 April 2011 reported that the patient has not been seen since the administration of the vaccine and the outcome was unknown. The outcome remained unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Body temperature increased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This is a cluster of 5 unidentified patients' who experienced similar adverse events following vaccination with FLUZONE. Initial report received from a health care professional on 09 September 2011. A group of 5 unidentified patients' received an intramuscular injection (route and sites not reported) of FLUZONE, sanofi pasteur Inc. lot number UT426AA, on unknown dates. The patients' reported symptoms after the vaccination of 2-3 inches of redness and swelling at the injection site, low grade temperature and body aches. Some of the patient's were bedridden for a few days. The outcomes were reported as recovered. Documents held by sender: None.
Age: 1.6
Sex: U
Vaccine: FLU3
Symptoms: Salmonellosis
Clinical narrative: Initial case received on 05 November 2010 from a healthcare professional. An 18 month old child received on an unspecified date a 0.5 cc single dose syringe injection of FLUZONE (lot number 3620DA). The patient experienced salmonella after vaccination in an unknown time frame. The reporter had no further information since the patient was vaccinated in another facility. Outcome was unknown. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Headache, Muscular weakness
Clinical narrative: Initial information was received on 12 November 2010 from a healthcare professional. The reporter provided individual patient identifiers for each of the five previously reported unidentified patients in a cluster of five. The initial case (2010-05065) now contains information for the first of five patients. A 54 year old female received on 15 September 2010 an injection of FLUZONE (lot number U3568AA). No pre-existing medical conditions, no allergies and no concomitant medications were reported. Post vaccination on an unspecified date, the patient experienced a headache, feeling foggy and weakness in legs. No further information was provided. The patient recovered the next day on an unspecified date. Follow-up information was received 19 January 2011 from a health care professional. The patient had no illness at the time of vaccination and she had not received any vaccines within four weeks of vaccination. The reporter had no additional information to provide at the time of the report. Follow-up information was received 18 February 2011 from a health care professional. FLUZONE had been a right deltoid intramuscular injection and symptoms began on 15 September 2010, the same day as vaccination. According to the reporter, no treatment was required. The reporter for this case (2010-06445) is the same reporter for cases 2010-05065, 2010-06447 and 2010-06448. Documents held by sender. None
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site scar
Clinical narrative: Initial report was received from a health care professional on 17 November 2010. A 23 year-old female patient, had received an intramuscular left deltoid injection of INFLUENZA vaccine (invalid lot number U3572BA) on 08 October 2010. On 17 November 2010 the patient's mother reported that the patient's left injection site continued to be sore and it hurt at time with movement of the left upper arm. The reporter states it is the first time he was aware of the "injection site soreness". The patient did not have a medical evaluation and treatments were not reported. No further information was available at the time of the report. Follow-up information was received from a health care professional on 04 March 2011. The patient's mother reported on 24 February 2011 that the patient went to her regular doctor who found some scar tissue deposit at the injection site. The physician stated that it was uncommon but may happen. The patient received some tissue massaging and the pain has been well relieved. The patient has resumed her normal activity on the affected arm now. The outcome was reported as recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Laboratory test normal, Maternal exposure during pregnancy, Rash
Clinical narrative: Initial case received from a health care professional on 24 November 2010. It involves a pregnancy case, and is also a case of inappropriate schedule of vaccine administration. A 16-year-old pregnant female received an intramuscular injection of FLUZONE (lot number UH180AA) on 15 October 2010. She was later inadvertently given an intramuscular dose of FLUZONE (lot number U3775CA) on 12 November 2010. The patient did not experience any adverse reactions following either vaccination. Information regarding the patient's medical history and current pregnancy were not reported. Follow-up information was received 28 January 2011 from a health care professional. On 26 November 2010, fourteen days after receiving FLUZONE (lot number U3775CA) on 12 November 2010 and 42 days after she had received FLUZONE (lot number UH180A) on 15 October 2010, the patient developed a rash. The patient's last menstrual period occurred on 04 June 2010 and her estimated date of delivery was 12 March 2011. Gestational age calculated at 19 weeks at the time of vaccination on 15 October 2010. Current pregnancy history was negative for alcohol, tobacco, drugs and HIV. Prenatal testing was negative for MSAFP (maternal serum alpha-fetoprotein). Outcome for rash was not reported. Follow-up information was received from the health care professional on 17 February 2011. The patient was treated with BENADRYL 25-50 mg PO at bedtime. The rash recovered on an unspecified date; per the reporter, the patient was seen in the office on 08 December 2010 and the rash was not visible at that time. Follow-up information received on 25 April 2011 from a health care professional. Per the reporter, no additional information is available at this time. No information regarding the patient's pregnancy outcome was provided. Follow-up information received on 22 June 2011 from a health care professional. The patient's last menstrual period was on 04 June 2010. She had no previous pregnancies, no elective or spontaneous abortions, and no fetal deaths. She kept all prenatal appointments. Neural tube defect screening, Down Syndrome screening, Trisomy 18 testing negative for 19.0 weeks. Anatomy screen was within normal range. The patient had no pregnancy complications. Both the patient and the infant's father were reported to be healthy. On 18 February 2011, the patient delivered a single male infant via normal vaginal delivery at 40 weeks gestation. There were no complications of delivery. Apgar scores were 8 and 9 and one minutes and eight minutes respectively. The infant weighed 7 lbs (3.18 kg.) at birth. There were no congenital anomalies. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Dysgeusia, Thirst
Clinical narrative: Initial report was received on 08 March 2011 from a consumer, who is also the patient. A 24 year-old female patient with no reported past medical history, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) on 03 March 2011 at 10:30 am and three and a half hours later at 2:00 pm, experienced a strange taste in her mouth, dry mouth and "could not get enough to drink". She reported the strange taste in her mouth was like a dough or yeast taste. She reports having several flu vaccines in the past but had not received the H1N1 vaccine. Concomitant medications included birth control pill. The patient had no illness at the time of vaccination and had no reported adverse events following prior vaccinations. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received 11 April 2011 from a health care professional. The patient had received FLUZONE, lot number UT3640AA. No laboratory or diagnostic testing was performed. According to the reporter, the patient's symptoms resolved approximately two weeks after onset. The patient's outcome was recovered. No additional information was provided at the time of the report. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Photopsia
Clinical narrative: Initial report received from a health care professional on 02 September 2011. A 60-year-old female patient with a history of hypertension and cataracts, received a left deltoid injection (route not reported) of FLUZONE, sanofi pasteur Inc. lot number UT443AA, on 28 August 2011. The patient had no illness at the time of vaccination. The patient's concomitant medication was reported as HTN medication. On 28 August 2011, the patient developed in the left eye a feeling like a "spider web" and light flashing. The patient reported that her doctor previously stated that she may have cataracts. The outcome was reported as unknown. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Initial report received from a health care professional on 07 September 2011. A 63-year-old female patient received an intramuscular injection (route reported as unknown) of FLUZONE, sanofi pasteur Inc. lot number UT450AA, on 06 September 2011. The patient's medical history was unknown. The patient has had previous flu vaccine doses in the past. On 06 September 2011, the patient complained of headache, fever, chills, sore throat, myalgia and wheezing which persists today. The outcome was reported as not recovered. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Initial report received from a health care professional on 07 September 2011. A 63-year-old female patient received an intramuscular injection (route reported as unknown) of FLUZONE, sanofi pasteur Inc. lot number UT450AA, on 06 September 2011. The patient's medical history was unknown. The patient has had previous flu vaccine doses in the past. On 06 September 2011, the patient complained of headache, fever, chills, sore throat, myalgia and wheezing which persists today. The outcome was reported as not recovered. Documents held by sender: None.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Malaise, Muscle spasms, Nausea, Pain
Clinical narrative: Initial report was received from a health care professional on 20 September 2010. A 72 year-old male patient with a past medical history of cardiac bypass and knee surgery, had received an intramuscular left deltoid injection of FLUZONE HIGH DOSE, lot number U3106AA (lot number invalid) on 17 September 2010 and five hours later, experienced nausea, vomiting, "cramping", chills, achy and a fever of 101.4. On 20 September 2010 the patient reported he "still did not feel well". No further information was available at the time of this report. Follow-up information was received from a health care professional on 24 November 2010. The correct lot number for FLUZONE HIGH DOSE was U3635AA. No further information was available at the time of the report. Documents held by sender: None.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial report was received from a health care professional on 20 September 2010. A 72 year-old male patient with a past medical history of cardiac bypass and knee surgery, had received an intramuscular left deltoid injection of FLUZONE HIGH DOSE, lot number U3106AA (lot number invalid) on 17 September 2010 and five hours later, experienced nausea, vomiting, "cramping", chills, achy and a fever of 101.4. On 20 September 2010 the patient reported he "still did not feel well". No further information was available at the time of this report. Follow-up information was received from a health care professional on 24 November 2010. The correct lot number for FLUZONE HIGH DOSE was U3635AA. No further information was available at the time of the report. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Wrong drug administered
Clinical narrative: Initial report was received 19 September 2010 from a health care professional which consisted of a cluster of three patients which involved  a case of misuse. This case captures one patient, and the other two patient's have been captured in case numbers 2010-05569 and 2010-05570. A 27-year-old female patient had received a 0.1 mL intradermal left forearm injection of H1N1 (lot number unknown) at 12:00 pm on 28 September 2010 and 30 minutes later, the patient developed an itchy red lump on the injection site which measured 1.5 x 1.5 inches in size. The event did not require a doctor's visit. Outcome was reported as not recovered. No additional information was provided at the time of the report. Follow-up was received from a health care professional on 12 November 2010. The patient received an intradermal injection of H1N1, sanofi pasteur lot number UP076AA. The injection was intended to be a tuberculin (TB) test. The patient's symptoms lasted about a week and did not require a doctor's visit. The patient had no illness at the time of vaccination. The patient fully recovered on 08 October 2010. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Wrong drug administered
Clinical narrative: Initial report was received 29 September 2010 from a health care professional which consisted of a cluster of three patients which involved a case of misuse. This case captures one patient, and the other two patient's have been captures in case numbers 2010-05568 and 2010-05570. A 45-year-old female patient had received a 0.1 mL intradermal left forearm injection of H1N1 (lot number unknown) at 12:00 pm on 28 September 2010 and 30 minutes later, the patient developed an itchy red lump at the injection site which measured 1.5 x 1.5 inches in size. The event did not require a doctor's visit. Outcome was reported as not recovered. Follow-up was received from a health care professional on 12 November 2010. The patient received an intradermal injection of H1N1, sanofi pasteur lot number UP076AA. The injection was intended to be a tuberculin (TB) test. The patient's symptoms of itchy red lump which was tender lasted one week and did not require a doctor's visit. The patient had no illness at the time of vaccination. The patient fully recovered on 05 October 2010. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Pain, Pruritus, Skin irritation
Clinical narrative: Itching, oval shaped inflammation, painful at the location. On 11/1/11, at 2:35 Pm, reported the irritation. She was told to see a doctor. The pharmacist reported (E-57541).
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site inflammation, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Itching, oval shaped inflammation, painful at the location. On 11/1/11, at 2:35 Pm, reported the irritation. She was told to see a doctor. The pharmacist reported (E-57541).
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Mobility decreased, Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Approximately 2-3 days after vaccination, you experienced pain in both shoulders & upper arms (some pain in wrist). Pain in continuous since that day she woke up in pain. Also has lack of strength, pain in groin & back. Worst pain is at night, difficulty sleeping.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, Groin pain, Injection site pain, Insomnia
Clinical narrative: Approximately 2-3 days after vaccination, you experienced pain in both shoulders & upper arms (some pain in wrist). Pain in continuous since that day she woke up in pain. Also has lack of strength, pain in groin & back. Worst pain is at night, difficulty sleeping.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Approximately 2-3 days after vaccination, you experienced pain in both shoulders & upper arms (some pain in wrist). Pain in continuous since that day she woke up in pain. Also has lack of strength, pain in groin & back. Worst pain is at night, difficulty sleeping.
Age: 46.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Injection site reaction, Muscle spasms, Myalgia
Clinical narrative: Arm soreness for several arm, after a week intense arm pain from injection site to neck, especially at rest, intense pain while sleeping, can't sleep. Deltoid muscle spasms, injection site, shoulder sore and throbbing. Gets better with movement, intense at rest again. ER room provide pain medicines, anti-inflam, steroids not working, causing upset stomach only when taken with food. Muscle relaxers and pain meds thru Employee health on 11/10/2011. Intense pain last night waken from sleep. ER visit on 11/07/2011.
Age: 46.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Abdominal discomfort, Injection site joint pain, Injection site pain, Insomnia, Muscle spasms
Clinical narrative: Arm soreness for several arm, after a week intense arm pain from injection site to neck, especially at rest, intense pain while sleeping, can't sleep. Deltoid muscle spasms, injection site, shoulder sore and throbbing. Gets better with movement, intense at rest again. ER room provide pain medicines, anti-inflam, steroids not working, causing upset stomach only when taken with food. Muscle relaxers and pain meds thru Employee health on 11/10/2011. Intense pain last night waken from sleep. ER visit on 11/07/2011.
Age: 46.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Arm soreness for several arm, after a week intense arm pain from injection site to neck, especially at rest, intense pain while sleeping, can't sleep. Deltoid muscle spasms, injection site, shoulder sore and throbbing. Gets better with movement, intense at rest again. ER room provide pain medicines, anti-inflam, steroids not working, causing upset stomach only when taken with food. Muscle relaxers and pain meds thru Employee health on 11/10/2011. Intense pain last night waken from sleep. ER visit on 11/07/2011.
Age: 52.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Headache, Malaise, Pain
Clinical narrative: HEADACHE (NON FEBRILE), BODY ACHES, VERY LOW ENERGY, GENERAL MALAISE.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Red knot at injection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchoscopy normal, Chest X-ray abnormal, Chills, Computerised tomogram abnormal, Hypoxia
Clinical narrative: Fever, chills, and pulmonary infiltrates on chest Xray.  This worsened over time and resulted in an inpatient admission on 10/13/2011 Hospital.  She had developed high oxygen needs and required a bronchoscopy.  She did not have any infection on bronchoscopy.  She then require high dose steroids to improve her hypoxemia.  This reaction is most consistent with an organizing pneumonia (non-infectious) pattern on the chest CT and clinically.  Please contact me regarding this case if there are questions.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Lung consolidation, Lung disorder, Lung infiltration, Organising pneumonia, Pulmonary function test decreased
Clinical narrative: Fever, chills, and pulmonary infiltrates on chest Xray.  This worsened over time and resulted in an inpatient admission on 10/13/2011 Hospital.  She had developed high oxygen needs and required a bronchoscopy.  She did not have any infection on bronchoscopy.  She then require high dose steroids to improve her hypoxemia.  This reaction is most consistent with an organizing pneumonia (non-infectious) pattern on the chest CT and clinically.  Please contact me regarding this case if there are questions.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, chills, and pulmonary infiltrates on chest Xray.  This worsened over time and resulted in an inpatient admission on 10/13/2011 Hospital.  She had developed high oxygen needs and required a bronchoscopy.  She did not have any infection on bronchoscopy.  She then require high dose steroids to improve her hypoxemia.  This reaction is most consistent with an organizing pneumonia (non-infectious) pattern on the chest CT and clinically.  Please contact me regarding this case if there are questions.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: Burning pain right deltoid with radiation into arm, shoulder and neck.  Body aches. Chills. Swelling right deltoid.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Burning pain right deltoid with radiation into arm, shoulder and neck.  Body aches. Chills. Swelling right deltoid.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Increased upper airway secretion, Oropharyngeal pain, Rash, Rhinorrhoea
Clinical narrative: Sore throat & runny nose first 3 days, Headache off and on through 11/9/11, Lots of mucus production continuously until now. Small rash started to develop on face within 4 days of getting Flu Mist.  Within a week it was a severe rash on face, chest, back, fingers, neck, thighs.  Large white patches still on neck. Still has slight rough patches on back. Actually had large sore on chin. Put steroid lotion on face one application before realizing it was not the seborrheic dermatitis.  When rash got severe started oral tablets of Benadryl for 3 days. Rubbed up with aloe vera and jojoba oil, because rash started to get dry and white.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye pruritus, Eye swelling, Headache
Clinical narrative: Headache, Throat swelling, eyes itchy and swelling, nausea, vomiting, chills, cough, fever.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pharyngeal oedema, Pyrexia, Vomiting
Clinical narrative: Headache, Throat swelling, eyes itchy and swelling, nausea, vomiting, chills, cough, fever.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Began having chills around 3pm, then began running fever. Around 5pm fever was 102 degrees. Was nauseous and weak. Went to bed, took Advil, then Nyquil at bedtime. Next a.m., felt fatigued, but a lot better. By afternoon on day after, patient was fine. Had been given the enhanced vaccine (extra strength) for persons over 65. Previous years had taken regular dose and had no symptoms.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Within a few hours, patient began to have pain and numbness in elbow and last 2 fingers (pinky and ring). Patient researched common symptoms and did not think much of it. About a week and a half later, the pain in fingers was mostly gone. Currently, the pain in upper right arm, mostly in elbow, is constant and progressively getting worse. It is almost two month after the shot, and the level of pain increases with each day.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site rash, Rash
Clinical narrative: Patient woke up with a rash on the inside of left elbow as well as a rash around neck starting on the left side.  Injection was in the left arm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient called on 11/10/11 and stated that she had bruising after the vaccine was given which resolved but that her upper arm was hurting. She denied any erythema, swelling, redness, warmth, or fevers. She had not seen a physician yet and was instructed to follow up with a physician.
Age: 0.17
Sex: M
Vaccine: DTAP, PPV
Symptoms: Dysphonia, Rash
Clinical narrative: Hoarseness and localized skin rash on forehead.  At time of reporting event is ongoing.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Bone pain, Injection site pain
Clinical narrative: Left upper arm pain that has persisted for over a month.  Pain is not bruising, there is no swelling or sign of inflammation.  The pain feels like it is in the bone and can be quite severe with certain arm movements like pulling clothing over head or reaching behind.  The pain has not improved at all over time - it feels the same as day one.  Patient called this in to facility and was told to apply heat and take pain medication.  This has not helped.
Age: 1.38
Sex: F
Vaccine: HIBV
Symptoms: Abnormal behaviour, Asthenia, Crying, Fatigue, Pallor
Clinical narrative: My daughter ran a fever of 103.5 for 3 days. She experienced heaving throughout the night, fatigue and weakness and paleness, excessive crying and severe change in behavior. Required constant holding. Even her day care providers noticed a distinct difference in her daily behavior and her need to be held and contant crying.
Age: 1.38
Sex: F
Vaccine: HIBV
Symptoms: Pyrexia, Retching
Clinical narrative: My daughter ran a fever of 103.5 for 3 days. She experienced heaving throughout the night, fatigue and weakness and paleness, excessive crying and severe change in behavior. Required constant holding. Even her day care providers noticed a distinct difference in her daily behavior and her need to be held and contant crying.
Age: 18.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Patient received Tdap vaccination at student clinic required for attendance.  Took Acetaminophen, reported that he felt OK. Came back to clinic at 11:55PM the next day and stated that he had a headache, soreness in his left arm (received immununization in left deltoid), some intermittent nausea.  He was seen by a nurse practitioner.  He was given Ibuprofen for the soreness and advised to return to student health services.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Pt states that arm where the injection was given became red and swollen a few hours following vaccine adminstration.  Pt reports that he is unable to move his arm and was unable to sleep as any the night before.  Pt states the arm where vaccination was given is swollen up twice as big as his other arm.  I instructed the patient to go to the emergency or his physician but he stated that he did not have time to go to this doctor or the money to go to his doctor.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Feeling abnormal, Tongue disorder
Clinical narrative: Stated felt a "drugged" feeling. Thick tongue and slurred speech.  Seen by PMD in the clinic office.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Malaise, Pain in extremity, Pruritus
Clinical narrative: Patient reported a warm, painful rash on the back and inside of the arm that grew to extend from armpit to elbow (approximately 8 inches) and 4-5 inches wide. It was first reported on 11/8/11 and worsened to a peak on 11/10/11 in the AM. Rash was accompanied by feeling "under the weather" and mild headache, which has persisted until 11/11/11. On 11/8/11, patient was advised to take Tylenol for pain and Benadryl for the reaction. On 11/11, patient reports having taken 50mg Benadryl x2 nights and Advil several times without any notable relief. This morning, the reaction appears to be resolving. It is cool to the touch, itchy, and a lighter pink color. However, around the injection site, a darker red 2x3in patch remains. Patient reports feeling better.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Patient reported a warm, painful rash on the back and inside of the arm that grew to extend from armpit to elbow (approximately 8 inches) and 4-5 inches wide. It was first reported on 11/8/11 and worsened to a peak on 11/10/11 in the AM. Rash was accompanied by feeling "under the weather" and mild headache, which has persisted until 11/11/11. On 11/8/11, patient was advised to take Tylenol for pain and Benadryl for the reaction. On 11/11, patient reports having taken 50mg Benadryl x2 nights and Advil several times without any notable relief. This morning, the reaction appears to be resolving. It is cool to the touch, itchy, and a lighter pink color. However, around the injection site, a darker red 2x3in patch remains. Patient reports feeling better.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Aphonia, Odynophagia, Oropharyngeal pain, Pain in jaw
Clinical narrative: Jaw pain, pain in throat, pain with swallowing, felt like "a punch to the throat", lost voice at one point. Resolved completely by morning.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Lacrimation increased, Paranasal sinus hypersecretion
Clinical narrative: Shortness of breath, sinus drainage, coughing, tight chest, teary eyes.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Right arm muscle in which vaccine was injected became increasingly sore throughout the day after receiving in the morning of that same day.  Very painful that night and had difficulty sleeping although I took ibuprofen.  Next 2 days (2nd and 3rd days), could not lift arm up.  On 4th day, could only lift arm with much pain to take off shirt, undergarments, or pour water from a tea kettle, etc.  On 5th day, still very sore but noticed slight improvement.  By 6th day, could perform all normal activity but still feel slight soreness when doing so.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Feeling drunk, Nausea, Vertigo
Clinical narrative: Approximately 3 hours after patient received the flu shot, experienced severe dizziness and nausea with vomiting. The dizziness was so bad that felt as if patient were drunk and had vertigo. The "world was spinning" whether patient was standing, sitting or laying down. Had very severe nausea for several hour accompanied by vomiting. The effects were not as severe the following day. Was just very exhausted and woozy feeling for 2 days. Patient has never had a reaction to a flu shot previously.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Approximately 3 hours after patient received the flu shot, experienced severe dizziness and nausea with vomiting. The dizziness was so bad that felt as if patient were drunk and had vertigo. The "world was spinning" whether patient was standing, sitting or laying down. Had very severe nausea for several hour accompanied by vomiting. The effects were not as severe the following day. Was just very exhausted and woozy feeling for 2 days. Patient has never had a reaction to a flu shot previously.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal pain, Myalgia
Clinical narrative: Pain in deltoid & triceps muscle and upper shoulder.  Weakness noted in attempting to lift heavy objects.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dyspnoea, Hot flush, Pyrexia
Clinical narrative: Labored breathing.  Tightness in throat/lungs.  This became chills for 2hrs and hot flashes.  A fever of 101.5 was present for 1.5 days.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Labored breathing.  Tightness in throat/lungs.  This became chills for 2hrs and hot flashes.  A fever of 101.5 was present for 1.5 days.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Headache, Heart rate increased, Injection site pain
Clinical narrative: Soreness at injection site, dry cough, hoarseness, headache, itching. Fast heart beat past midnight.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Soreness at injection site, dry cough, hoarseness, headache, itching. Fast heart beat past midnight.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Developed cellulitis at injection site and radiating down entire forearm. Saw MD and recieved antibiotic therapy.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient describes injection site to be red, hard, occasionally itchy and sort of has a bumpy feeling.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site pain, Pain, Skin warm
Clinical narrative: Redness and warmth under site of vaccines on left deltoid, which became larger, more red and painful 11/09/11 with pain at injection site noted as well on 11/09/11.  Mother gave Benadryl, which did not help.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea
Clinical narrative: Out of breath, a little bit trouble of breath.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Single, raised, quarter sized hive and red, itchy rash immediatedly below injection site.  Took two Tylenol PM, rash/hive did not spread. Itching stopped. Some shortness of breath when climbing stairs. Light head ache. Rash and hive were gone by 11/08/2011. Other symptoms did not reappear after taking Tylenol PM.  No other treatment.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Muscle tightness, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Upper left arm swollen, tender to touch, slightly itchy and red circle approximately 4.5 inches in diameter. No action taken at that time. Late Friday night became more painful and red, muscle tight in bicep area.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Upper left arm swollen, tender to touch, slightly itchy and red circle approximately 4.5 inches in diameter. No action taken at that time. Late Friday night became more painful and red, muscle tight in bicep area.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Aphasia, Cognitive disorder, Malaise, Rash
Clinical narrative: Case number PHEH2011US08486 is an initial spontaneous report received from a physician on 28 Oct 2011: This report refers to an adult female patient. She was bitten by a vampire bat on an undetermined date. Subsequently she was vaccinated with RABAVERT vaccine (batch number: unknown) intramuscularly and was also given immunoglobulin human anti-rabies (manufacturer and batch number: unknown) on 28 Oct 2011. After vaccination, she developed bilateral rash, malaise and receptive aphasia. She was admitted in to the hospital for monitoring and was having difficulty with higher cognitive focus. Outcome of the events was reported as unknown.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Apnoeic attack, Convulsion, Hypopnoea, Hypotonia, Pallor
Clinical narrative: See attached visit note. Stimulated lasted 20 min. Pt presents with apneic spells. Initial eval or follow-up. The patient presents for new evaluation of a possible seizure disorder. Witnessed seizure activity is described as unresponsive staring. The duration of the last (most recent) seizure was approximately 10 to 15 minutes. This occurred at 9 pm last night. She became very limp and pale and her breathing was very shallow. She was unresponsive and lips became cyanotic.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Seizure like phenomena, Staring, Unresponsive to stimuli
Clinical narrative: See attached visit note. Stimulated lasted 20 min. Pt presents with apneic spells. Initial eval or follow-up. The patient presents for new evaluation of a possible seizure disorder. Witnessed seizure activity is described as unresponsive staring. The duration of the last (most recent) seizure was approximately 10 to 15 minutes. This occurred at 9 pm last night. She became very limp and pale and her breathing was very shallow. She was unresponsive and lips became cyanotic.
Age: 29.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Ear itching, red around injection site, not warm or swollen. Told pt to take BENADRYL and contact MD. Also it could be side effect.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ataxia, CSF protein increased, Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Ataxic gait 1 wk after immunization. Progressed to (L) hip flexor weakness and (R) leg paresthesias. Admitted for eval. Imaging negative. LP (+) protein; consistent with Guillain Barre.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Ataxic gait 1 wk after immunization. Progressed to (L) hip flexor weakness and (R) leg paresthesias. Admitted for eval. Imaging negative. LP (+) protein; consistent with Guillain Barre.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site reaction, Injection site urticaria, Skin lesion
Clinical narrative: Case number PHEH2011US05600 is an initial spontaneous report received from a health care professional on 29 Sep 2011 and a follow up information received from a physician on 12 Oct 2011: This report refers to a 10 years old female patient. She was given only MenCYW 135 liquid conjugate component of MENVEO vaccine (batch number: M10062) intramuscularly into her right arm on 26 Sep 2011. On 28 Sep 2011 she developed circular raised erythematous lesion and raised urticarial periphery at the injection site which was 3cm in diameter and non-tender. She was given warm compression at the injection site, thrice daily for two days and oral BENADRYL was administered. The lesion disappeared in two days without treatment. Follow up information received from the physician on 12 Oct 2011: Updated vaccination date, event, treatment and outcome of the events.
Age: 12.0
Sex: F
Vaccine: FLUN3, PPV
Symptoms: Dyspnoea, Erythema, Feeling jittery, Flushing
Clinical narrative: Reddened, flushed face, SOB, jitteriness.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red slightly edematous (L) thigh 9 cm in diameter, hours after receiving Hep A #1.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Swollen tongue
Clinical narrative: Pt. developed swollen glands and tongue within 20-30 mins of admin. Pt taken to ER - received BENADRYL & cortisone.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on arm after shot administered. Recommended antihistamines.