chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Atrial fibrillation, Blood potassium decreased, Dizziness
Clinical narrative: This is a spontaneous report from the non-clinical study program from a contactable consumer (patient). A 80 year old female patient received, in the right upper arm, on an unspecified date, in Aug2015, PREVNAR 13 single dose. Relevant medical history included allergy (she is allergic to all statins, sulfa and clove oil, ongoing) and breast cancer (the patient received tamoxifen for 5 years and also radiation; breast surgery was performed). Colon surgery was performed on an unspecified date, in 2002 (18 inches of lower colon removed because of precancerous polyps), gallbladder surgery (gallstones were removed) on an unspecified date and hysterectomy on an unspecified date, in 1970. She is a cancer survivor. The patient previously took sulfur and experienced drug hypersensitivity. Concomitant medications included THYROLAR 0.115 (units unspecified) every day for thyroid disorder, ongoing, and oral Aspirin ongoing. On an unspecified date, in Aug2015, the patient experienced pain in extremity. On an unspecified date, in Sep2015, the patient experienced sleep difficult, petechiae, memory disturbance and pain aggravated. On an unspecified date, in Oct2015, the patient experienced atrial fibrillation, potassium decreased, light headedness, and nausea. She never had diagnosis of heart problems before. She was not admitted to the hospital. Activities of daily living impaired (it was difficult for her to get up and down off toilet) on an unspecified date in Nov2015. On an unspecified date, she experienced also joint pain, malaise and movement disorder and she was very tired from lack of sleep. Emergency room or doctor visit was required. Treatment was received for the event atrial fibrillation (metoprolol), and pain (ibuprofen). She saw a cardiologist. She will get monitored every 6 months. The patient recovered from the events, atrial fibrillation, and potassium decreased. She did not recover from the events, pain in extremity, sleep difficult, petechiae, memory disturbance, pain aggravated, and activities of daily living impaired; while clinical outcome of the other events was unknown. Follow-up (11Jan2016): New information reported from the same contactable consumer includes: patient details, medical history, suspect drug (changed from "PREVNAR" to "PREVNAR 13") and concomitant medications details, reaction data, case seriousness changed from "non-serious" to "serious".
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Insomnia, Malaise, Mammogram, Memory impairment
Clinical narrative: This is a spontaneous report from the non-clinical study program from a contactable consumer (patient). A 80 year old female patient received, in the right upper arm, on an unspecified date, in Aug2015, PREVNAR 13 single dose. Relevant medical history included allergy (she is allergic to all statins, sulfa and clove oil, ongoing) and breast cancer (the patient received tamoxifen for 5 years and also radiation; breast surgery was performed). Colon surgery was performed on an unspecified date, in 2002 (18 inches of lower colon removed because of precancerous polyps), gallbladder surgery (gallstones were removed) on an unspecified date and hysterectomy on an unspecified date, in 1970. She is a cancer survivor. The patient previously took sulfur and experienced drug hypersensitivity. Concomitant medications included THYROLAR 0.115 (units unspecified) every day for thyroid disorder, ongoing, and oral Aspirin ongoing. On an unspecified date, in Aug2015, the patient experienced pain in extremity. On an unspecified date, in Sep2015, the patient experienced sleep difficult, petechiae, memory disturbance and pain aggravated. On an unspecified date, in Oct2015, the patient experienced atrial fibrillation, potassium decreased, light headedness, and nausea. She never had diagnosis of heart problems before. She was not admitted to the hospital. Activities of daily living impaired (it was difficult for her to get up and down off toilet) on an unspecified date in Nov2015. On an unspecified date, she experienced also joint pain, malaise and movement disorder and she was very tired from lack of sleep. Emergency room or doctor visit was required. Treatment was received for the event atrial fibrillation (metoprolol), and pain (ibuprofen). She saw a cardiologist. She will get monitored every 6 months. The patient recovered from the events, atrial fibrillation, and potassium decreased. She did not recover from the events, pain in extremity, sleep difficult, petechiae, memory disturbance, pain aggravated, and activities of daily living impaired; while clinical outcome of the other events was unknown. Follow-up (11Jan2016): New information reported from the same contactable consumer includes: patient details, medical history, suspect drug (changed from "PREVNAR" to "PREVNAR 13") and concomitant medications details, reaction data, case seriousness changed from "non-serious" to "serious".
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Movement disorder, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from the non-clinical study program from a contactable consumer (patient). A 80 year old female patient received, in the right upper arm, on an unspecified date, in Aug2015, PREVNAR 13 single dose. Relevant medical history included allergy (she is allergic to all statins, sulfa and clove oil, ongoing) and breast cancer (the patient received tamoxifen for 5 years and also radiation; breast surgery was performed). Colon surgery was performed on an unspecified date, in 2002 (18 inches of lower colon removed because of precancerous polyps), gallbladder surgery (gallstones were removed) on an unspecified date and hysterectomy on an unspecified date, in 1970. She is a cancer survivor. The patient previously took sulfur and experienced drug hypersensitivity. Concomitant medications included THYROLAR 0.115 (units unspecified) every day for thyroid disorder, ongoing, and oral Aspirin ongoing. On an unspecified date, in Aug2015, the patient experienced pain in extremity. On an unspecified date, in Sep2015, the patient experienced sleep difficult, petechiae, memory disturbance and pain aggravated. On an unspecified date, in Oct2015, the patient experienced atrial fibrillation, potassium decreased, light headedness, and nausea. She never had diagnosis of heart problems before. She was not admitted to the hospital. Activities of daily living impaired (it was difficult for her to get up and down off toilet) on an unspecified date in Nov2015. On an unspecified date, she experienced also joint pain, malaise and movement disorder and she was very tired from lack of sleep. Emergency room or doctor visit was required. Treatment was received for the event atrial fibrillation (metoprolol), and pain (ibuprofen). She saw a cardiologist. She will get monitored every 6 months. The patient recovered from the events, atrial fibrillation, and potassium decreased. She did not recover from the events, pain in extremity, sleep difficult, petechiae, memory disturbance, pain aggravated, and activities of daily living impaired; while clinical outcome of the other events was unknown. Follow-up (11Jan2016): New information reported from the same contactable consumer includes: patient details, medical history, suspect drug (changed from "PREVNAR" to "PREVNAR 13") and concomitant medications details, reaction data, case seriousness changed from "non-serious" to "serious".
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Petechiae
Clinical narrative: This is a spontaneous report from the non-clinical study program from a contactable consumer (patient). A 80 year old female patient received, in the right upper arm, on an unspecified date, in Aug2015, PREVNAR 13 single dose. Relevant medical history included allergy (she is allergic to all statins, sulfa and clove oil, ongoing) and breast cancer (the patient received tamoxifen for 5 years and also radiation; breast surgery was performed). Colon surgery was performed on an unspecified date, in 2002 (18 inches of lower colon removed because of precancerous polyps), gallbladder surgery (gallstones were removed) on an unspecified date and hysterectomy on an unspecified date, in 1970. She is a cancer survivor. The patient previously took sulfur and experienced drug hypersensitivity. Concomitant medications included THYROLAR 0.115 (units unspecified) every day for thyroid disorder, ongoing, and oral Aspirin ongoing. On an unspecified date, in Aug2015, the patient experienced pain in extremity. On an unspecified date, in Sep2015, the patient experienced sleep difficult, petechiae, memory disturbance and pain aggravated. On an unspecified date, in Oct2015, the patient experienced atrial fibrillation, potassium decreased, light headedness, and nausea. She never had diagnosis of heart problems before. She was not admitted to the hospital. Activities of daily living impaired (it was difficult for her to get up and down off toilet) on an unspecified date in Nov2015. On an unspecified date, she experienced also joint pain, malaise and movement disorder and she was very tired from lack of sleep. Emergency room or doctor visit was required. Treatment was received for the event atrial fibrillation (metoprolol), and pain (ibuprofen). She saw a cardiologist. She will get monitored every 6 months. The patient recovered from the events, atrial fibrillation, and potassium decreased. She did not recover from the events, pain in extremity, sleep difficult, petechiae, memory disturbance, pain aggravated, and activities of daily living impaired; while clinical outcome of the other events was unknown. Follow-up (11Jan2016): New information reported from the same contactable consumer includes: patient details, medical history, suspect drug (changed from "PREVNAR" to "PREVNAR 13") and concomitant medications details, reaction data, case seriousness changed from "non-serious" to "serious".
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 01Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the third of five reports. A 65-year-old female patient received PREVNAR 13 (lot L99262, expiration date 28Feb2017, NDC number 0005-1971-02) on 25Sep2015 at 0.5ml single dose via unspecified route. On the same date the patient received FLUARIX. On 01Oct2015 the patient experienced cellulitis. No admission to hospital was involved. The patient received treatment for the event with AUGMENTIN. The patient recovered from the event.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Diabetes mellitus, Thyroid disorder
Clinical narrative: Diabetic. Thyroid. (Currently screened possible cancer).
Age: 77.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Moderate to severe pain on both shoulders to the point that couldn't sleep on either side. Problems lasted 4 days on right shoulder, and close to 1 week and 1/2 on pneumonia side. It was very sore. Today feels ok but still feels soreness when massage or put pressure on area.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient in for vaccination visit admin at 11:30 am on 2/08/2016. At approx. midnight following, pt had fever, then had a seizure, EMS called, and pt transported to ER via ambulance. Symptoms resolved by the time they arrived at ER.
Age: 40.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: 01-23-16 fever q pm thru 01-27-16. 01-27-16 rash (circular, red, raised) on face, neck, trunk, extremities. 01-27-`6 went to MD given steroid.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Joint range of motion decreased, Laboratory test, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Excruciating pain - approx 2 weeks. Weakness - ongoing. Reduced range of motion - ongoing. Chronic pain - ongoing.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Ultrasound scan
Clinical narrative: Excruciating pain - approx 2 weeks. Weakness - ongoing. Reduced range of motion - ongoing. Chronic pain - ongoing.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: Redness/swelling at injection site. Reports feeling general malaise, body aches and fever of 102 within hours of vaccination. Fever gone 24 hrs. later. Feeling better today. Area of redness is not increasing in size.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2014US022726, is an initial spontaneous report from a pharmacist received on 10 Nov 2014. This report refers to a 28-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145304) intramuscularly on 08 Oct 2014. On an unknown date after vaccination, the patient arm was hurting and it was hard for her to put her shirt on. She also reported pain at the injection site and it was over a month now she received the vaccine. The pharmacist reported that the patient stated that vaccine was given high up (no further details provided). The outcome of the events was unknown. Seriousness and causality was not reported. The patient does not have a treating physician.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Tenderness
Clinical narrative: Case number PHEH2015US000762, is an initial spontaneous report received from a consumer on 06 Jan 2015. This report refers to a 57 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in upper left arm on 26 Dec 2014. On same day after vaccination, he experienced soreness in left arm at injection site. It was also reported that there was no redness and swelling. He also experienced tenderness which was lessened but not completely resolved. The seriousness and causality of the event was not reported.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2014US022748 is an initial spontaneous report received from a consumer on 10 Nov 2014. This report refers to a 76 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413101) intramuscularly in the left arm on 06 Nov 2014. She reported that it was just a little sore from the shot on the day of vaccine. She experienced pain in left shoulder of the arm that was injected on 08 Nov 2014 and it hurts her whole shoulder. The event outcome was unknown. The seriousness and causality were not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2014US026188, is an initial spontaneous report from a pharmacist received on 31 Dec 2014 and with a follow up information received from the pharmacist on 03 Feb 2015. This report refers to a 52-year-old female patient. Medical history and concomitant medications were not reported. Her vaccination history included vaccination with Tdap (unknown manufacturer, batch number: not reported) on unspecified date about 03 years ago. She was vaccinated with FLUVIRIN (batch number: 145403) intramuscularly in the right arm at a dose of 0.5 ml on 31 Dec 2014 at 11.00 AM. On the same day, after vaccination, the patient experienced swelling at the injection site around 1 inch in diameter. The outcome of the event was reported as complete recovery. Seriousness and causality of the event was not reported. Follow up information received from a pharmacist on 03 Feb 2015: Updated vaccination history (Tdap), site, dose and time of vaccination of FLUVIRIN and outcome of the events (complete recovery).
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2014US026182, is an initial spontaneous report from a pharmacist received on 31 Dec 2014. This report refers to a 60-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145021) intramuscularly on 30 Sep 2014. On the same day, the patient experienced soreness of arm at the injection site. The patient consulted the physician and the site appeared fine. Final outcome of the event was unknown. Seriousness and causality of the event was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2014US024684, is an initial spontaneous report from a physician via Merck National Service Center (reference: 1-12953477015) received on 09 Dec 2014. This report refers to a patient of unknown demographics. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) in Nov 2013. On an unknown date, after vaccination, the patient experienced erythema, swelling, pain and warmth at the injection site. The outcome, seriousness and causality of the events were not reported.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Case number PHEH2014US024677, is an initial spontaneous report from a consumer (patient) received on 08 Dec 2014. This report refers to a 73-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 06 Oct 2014. On 20 Oct 2014, she started experiencing diarrhea. She stated that she had experienced six or seven bouts of diarrhea since that date. She spoke to her doctor about her symptoms; doctor doesn't think it was related to vaccine. Outcome of the event was reported as condition unchanged. Seriousness and causality of the event was not reported.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus generalised
Clinical narrative: Case number PHEH2014US024617 is an initial spontaneous report received from a health care professional on 05 Dec 2014. This report refers to a 73 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015) on an unknown date. It was reported that she started itching all over the body after the hour of administration of vaccine. Over the hours, itching got worse and she had to seek medical attention. At the time of evaluation, she had red streaks on the arms and breast. The events outcome, seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Case number PHEH2014US024580 is an initial spontaneous report received from a consumer on 03 Dec 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 141301, expiry date: Jun 20150 multi-dose vial into her left deltoid muscle on 29 Oct 2014. It was reported that she contacted next day and stated that she experienced fever and pain on her arm. She required immediate medical attention and treatment. The events outcome, seriousness and causality were not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHEH2014US024083, is an initial spontaneous report received from a medical assistant on 01 Dec 2014. This report refers to a 25 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1412801) intramuscularly on 22 Oct 2014. After vaccination she experienced redness and heat at injection site. The patient fully recovered from the events on 29 Oct 2014. Seriousness and causality were not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Influenza like illness, Pain, Pyrexia, Rash
Clinical narrative: Case number PHEH2014US023845, is an initial spontaneous report from a consumer received on 25 Nov 2014. This report refers to a 64-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly on 29 Sep 2014. On 09 Oct 2014, ten days after vaccination, she experienced flu like symptoms included fever, body aches and stomach ache. Two weeks later she developed a rash. Outcome of the events was reported as not resolved. Seriousness and causality of the events was not reported.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Myalgia
Clinical narrative: Case number PHEH2014US023596, is an initial spontaneous report from a consumer (also patient) received on 24 Nov 2014. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 146305) intramuscularly 09 Oct 2014. On 12 Oct 2014, a few days after vaccination, the patient experienced myalgia and elevated temperature. The outcome of the event myalgia was not resolved and outcome of elevated temperature was unknown. Seriousness and causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2014US023267, is an initial spontaneous report from a pharmacist received on 18 Nov 2014. This report refers to a 43-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1413701) intramuscularly on 05 Nov 2014 On an unknown date, after vaccination, she experienced pain at the injection site. Outcome of the event was unknown. Seriousness and causality of the event was not reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2015US000941 is an initial spontaneous report from a consumer received on 09 Jan 2015. This report refers to a 70-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left upper arm on 18 Oct 2014. On the same date, after vaccination she experienced pain in her left upper arm near injection site. She had no redness and swelling at site. The outcome of the event reported as not recovered. The seriousness and causality of the event were not reported.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2014US023262, is an initial spontaneous report from a pharmacist received on 18 Nov 2014. This report refers to a 15-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of FLUVIRIN (batch number: 1413701) intramuscularly on 05 Nov 2014. On an unknown date, after vaccination, she experienced pain at the injection site. Outcome of the event was unknown. Seriousness and causality of the event was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Case number PHEH2014US023204 is an initial spontaneous report from a pharmacist on 14 Nov 2014. This report refers to a 62 years old male patient. His past medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) in the past year which he experienced pain (see related case number: PHHY2014US153013). He was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly in the arm on 16 Oct 2014. It was reported that immediately after vaccination, he experienced a dull pain in the injection site of the arm. He stated that the pain from the last flu vaccines only hurt for a day or two and did not last this long. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Case number PHEH2015US019474, is an initial spontaneous report from a medical assistant received on 29 Sep 2015. This report refers to a 61-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1516201) intramuscularly at a dose of 0.5 ml on 17 Sep 2015. On the same day immediately after vaccination, the patient experienced redness and swelling in the deltoid muscle. Further the patient developed itching down the arms. Final outcome of the events was unknown. Seriousness and causality was not reported.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHEH2014US023110, is an initial spontaneous report from a consumer received on 17 Nov 2014. This report refers to a 22-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 13 Oct 2014. On the same day, after vaccination, she experienced swollen lymph nodes. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pyrexia
Clinical narrative: Case number PHEH2015US022702, is an initial and follow up spontaneous report received from a consumer on 30 Oct 2015 and 03 Nov 2015 (combined report). This report refers to an 82-year-old female patient. Medical history was not reported. Current conditions included lymphoma (battling for years). Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 1515901, expiry date: May 2016) intramuscularly on 23 Oct 2015. On the same day after vaccination, the patient experienced fever of 102 F. The patient's oncologist told to take TYLENOL and the fever went down to 99 F but it was still not normal. The patient has been experiencing severe fever consistently for 12 days and also the patient feels very weak. Final outcome of the events was not recovered. Seriousness and causality was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Case number PHEH2014US022975 is an initial spontaneous report received from a consumer on 13 Nov 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history was not reported. The patient's current condition included egg allergy and concomitant medications were not reported. The patient was administered a dose of FLUVIRIN (batch number: not reported) intramuscularly in error on 12 Nov 2014. No adverse events were reported following the maladministration.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Peripheral swelling, Pruritus
Clinical narrative: Case number PHEH2015US019477, is an initial spontaneous report from a medical assistant on 29 Sep 2015. This report refers to a 31-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1516201) intramuscularly at a dose of 0.5 ml on 17 Sep 2015. On the same day immediately after vaccination, the patient experienced redness and swelling in the deltoid muscle. Further the patient developed itching down the arms. Final outcome of the events was unknown. Seriousness and causality was not reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Case number PHEH2015US022529, is an initial spontaneous report from a nurse received on 02 Nov 2015. This report refers to a 34 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514901) intramuscularly on 28 Oct 2015. On 29 Oct 2015 the patient had a fever of 100.6 F, body aches and sore throat. Body aches and sore throat were resolved; fever was down to 99 F. The seriousness and causality of the events were not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2015US019698, is an initial spontaneous report from a pharmacist received on 01 Oct 2015. This report refers to a 24-year-old female pregnant patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 15114601) intramuscularly in Sep 2015 and later found she was pregnant. No adverse event was reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHEH2015US022483, is an initial spontaneous report received from a pharmacist on 30 Oct 2015. This report refers to a 32-year-old female patient. Medical history was not reported. Concomitant medication was not reported. It was reported that FLUVIRIN (batch number: 1515001) form multi dose vial (MDV) was administered intramuscularly to the expectant patient on 30 Oct 2015. Final outcome, seriousness and causality was not reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2015US019733, is an initial spontaneous report from a nurse received on 02 Oct 2015. This report refers to a 33-year-old female pregnant patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly on 30 Sep 2015. No adverse event was reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Case number PHEH2015US020013, is an initial spontaneous report from a health care professional received on 07 Oct 2015. This report refers to a 58 years old female patient. Concomitant medications were not reported. The patient with allergy to egg yolk was vaccinated with FLUVIRIN (batch number: 1514901) intramuscularly on 07 Oct 2015. No adverse event was reported.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Case number PHEH2015US020158, is an initial spontaneous report received from a nurse on 07 Oct 2015. This report refers to a patient of an unknown age of female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514601 and expiry date: not reported) intramuscularly on 07 Oct 2015. On the same day after vaccination, she experienced ill, burning, redness and swelling around the injection site. The outcome, seriousness and causality of the events were not reported. No further details provided.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus generalised
Clinical narrative: Case number PHEH2015US20340, is an initial spontaneous report received from a pharmacist on 08 Oct 2015. This report refers to a 33 year old female patient. Historical condition and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN (batch number: 157602) intramuscularly on 06 Oct 2015. On the same day after vaccination, the patient experienced itching all over without any rash. The patient also had intermittent sharp pain. Outcome of the events were unknown. Seriousness and causality of the events were not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHEH2015US020348, is an initial spontaneous report received from a health care professional on 08 Oct 2015. This report refers to a 24 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) multi dose vial (MDV) intramuscularly on an unknown date. On 02 Oct 2015, the patient developed hives on the thighs and abdomen. The event lasted for about 5 days and was clearing up at the time of reporting The outcome of the event was condition improving. Seriousness and causality of the event was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site induration, Vaccination site nodule
Clinical narrative: Case number PHEH2015US021982, is an initial spontaneous report received from a pharmacist on 26 Oct 2015. This report refers to a 44 year old female patient. Medical history and concomitant medication were not reported. Her vaccination history included administration of FLUVIRIN (batch number: not reported) on an unknown date which was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 1514501) intramuscularly on an unknown date. On 23 Oct 2015, the patient experienced red hard knot that was itching at the vaccination site. Outcome of the events was not reported. Seriousness of the events was unknown. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2015US000949 is an initial spontaneous report from a consumer received on 09 Jan 2015. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1414101, expiry date: Jun 2015) on an unknown date. On 31 Dec 2014, after vaccination she experienced an allergic reaction (unspecified). The outcome, seriousness and causality of the event were not reported.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Case number PHEH2015US021910, is an initial spontaneous report received from a nurse on 26 Oct 2015. This report refers to a 26 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly at a dose of 0.5ml on 20 Oct 2015. On the same day, shortly after administration patient experienced rash and hive localized around the injection site. Outcome of the events was reported as unknown. Events were reported to be non-serious and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Headache, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Case number PHEH2015US001341 is an initial spontaneous report from a consumer received on 14 Jan 2015. This report refers to a female patient of an unknown age. Her vaccination history included FLUVIRIN vaccine (batch number: not reported) on an unknown date and it was well tolerated. She never experienced headache or treated for headache. The patient was vaccinated with FLUVIRIN (batch number: 1413101) on 22 Sep 2014. On 23 Sep 2014, she experienced headache which continued for 3 months. She underwent numerous tests from CT, MRI of brain and lumbar puncture (results: not provided) and had 3 trips to emergency room. The outcome of the event reported as ongoing. The seriousness of the event was not reported. Her physician stated that as the event occurred 24 hours after vaccination, it was related to the vaccine.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Sunburn, Urticaria
Clinical narrative: Case number PHEH2015US001769, is an initial spontaneous report from a consumer received on 21 Jan 2015. This report refers to a 63 years old male patient. Concurrent condition included allergy to latex. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 02 Nov 2014. On 04 Nov 2014, 48 hours after vaccination, he experienced severe hives over most of his body with major involvement of the trunk, armpits and groin and sunburn looking rash. Outcome of the events was reported as not resolved at the time of this report. Seriousness and causality of the events was not reported.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Case number PHEH2015US021907, is an initial spontaneous report received from a nurse on 26 Oct 2015. This report refers to a 53 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly at a dose of 0.5 ml on 16 Oct 2015. On the same day, shortly after administration patient experienced rash and hive localized around the injection site. Outcome of the events was reported as unknown. Evens were reported to be non-serious and causality of the events was not reported.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHEH2015US021597, is an initial spontaneous report received from health care professional on 22 Oct 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514901) intramuscularly on an unknown date. On 19 Oct 2015 the patient experienced numbness in her left arm that radiates down her arm towards her hand. This was the same arm where she received vaccination. The patient was planning to consult primary doctor on 23 Oct 2015. The outcome, seriousness and causality of the event were not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea
Clinical narrative: Case number PHEH2015US021491, is an initial spontaneous report from a consumer received on 20 Oct 2015. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly on 17 Oct 2015. On the same day after vaccination the patient experienced headache, chills and nausea. It was reported that chills were intermittent that progressed in the past couple of days and the constant nausea and the only time nausea leaves was when the patient was eating. The patient had appetite, eats fine and had no vomiting. The headache was intermittent and dull; sometimes a little worse than other times and was better today. The patient had no body aches. The patient states she went to the MD office and had her blood pressure checked. The patient blood pressure was fine. The patient asked the nurse about the symptom experienced by her but did not report to the physician. The nurse said that if the patient still has the symptoms a week after the shot she should call the physician then and it wakes me up in the middle of the night. Final outcome of the events was unknown. Seriousness and causality was not reported.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2015US003394, is an initial spontaneous report from a pharmacist on 17 Feb 2015. This report refers to an 84 year old male patient. He was vaccinated with FLUVIRIN (batch number: 1411001) intramuscular on 10 Sep 2014. On the same day post vaccination he continued to experience intermittent pain in arm at the injection site. Outcome of the event was unknown. Seriousness and causality assessment was not reported. No further information was available.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Case number PHEH2015US020113, is an initial spontaneous report from a health care professional received on 07 Oct 2015. This report refers to a 44-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157004) intramuscularly on 07 Oct 2015. On the same day after vaccination the patient experienced itching at the injection site. Final outcome, seriousness and causality were not reported
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site hypersensitivity, Pain, Urticaria
Clinical narrative: Case number PHEH2015US003518, is an initial spontaneous report from a consumer (patient) on 17 Feb 2015. This report refers to a female patient of unknown age. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: unknown) on 10 Oct 2014. On 11 Oct 2014, she developed an allergic reaction at the injection site, full body pain, hives and headache. Outcome of the event, seriousness and causality assessment was not reported. No further information was available.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Case number PHEH2015US021458 is an initial spontaneous report received from a pharmacist on 20 Oct 2015. This report refers to a 54 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly on 20 Oct 2015. On the same day, patient experienced immediate injection site reaction. It was reported that the site was a little red, hard and swollen. The outcome of the events was reported as complete recovery. Seriousness and causality of the events were not reported
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2015US021306, is an initial spontaneous report received from a consumer (patient) on 19 Oct 2015. This report refers to a 33 year old female patient. Medical history and concomitant medication was not reported. The patient reported that she could be pregnant and received FLUVIRIN (batch number: 1515801) intramuscular on 19 Oct 2015. No adverse event was reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2015US008569, is an initial spontaneous report from a pharmacist received on 30 Apr 2015. This report refers to a 64-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413701) on 17 Oct 2014. On an unknown date after the vaccination she had muscle pain at injection site. The final outcome of the event was unknown. The event was reported as non-serious. Causality was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2015US021106, is an initial spontaneous report from a nurse received on 16 Oct 2015. This report refers to a 32 years old female pregnant patient. Medical history and concomitant medications were not reported. Her last menstrual period (LMP) was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) 0.5 ml intramuscular on 01 Oct 2015 The case was assessed as non-serious. No adverse event was reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHEH2015US021031, is an initial spontaneous report from a consumer received on 16 Oct 2015. This report refers to a 56 years old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly on 14 Oct 2015. On the same day after vaccination the patient developed swollen lymph node on the left side, which was the same side as injection. Outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Case number PHEH2015US017902, is an initial spontaneous report from a pharmacist received on 09 Sep 2015. This report refers to a 33-year-old female patient. The patient received prefilled FLUVIRIN (batch number: 157102) intramuscularly on 09 Sep 2015. After vaccination, the patient stated that she was allergic to latex. No adverse event was reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Case number PHEH2015US018940 is a combined initial and follow-up spontaneous report from a pharmacist received on 18 Sep 2015. This report refers to a 63 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) in 2014. On 10 Oct 2014 the patient experienced rash on the arm of the injection site. The pharmacist inquired whether the patient be vaccinated again following an adverse event from her vaccination last year. The outcome, seriousness and causality of the event were not reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dyspnoea, Gait disturbance, Nausea
Clinical narrative: Difficulty breathing, difficulty walking, dizzy, nausea. Called clinic to report and the nurse said it was "normal".
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Swelling face, Urticaria
Clinical narrative: Urticaria and Facial Swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth, Pain in extremity, Sleep disorder
Clinical narrative: Left arm was sore; hot at the injection site; arm red on inner part of arm to elbow; These specific side effects subsided after one week.  On-going effects is loss of range of motion in left arm;  unable to put weight or sleep on left side at night due to on-going pain in upper part of arm.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: My arm was sore immediately after the shot and remained sore for several weeks. Then my arm was sore if moved in certain positions. It remains sore in certain positions to this day. I am now attending exercise classes at a local gym. The exercise has helped a small amount.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: My arm was sore immediately after the shot and remained sore for several weeks. Then my arm was sore if moved in certain positions. It remains sore in certain positions to this day. I am now attending exercise classes at a local gym. The exercise has helped a small amount.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: AREA AROUND INJECTION SITE SWOLLEN AND RED.  PATIENT REPORTS SIMILIAR REACTION TO FLU SHOTS IN THE PAST.
Age: 26.0
Sex: F
Vaccine: HEPA, HPV9, MMR, TDAP
Symptoms: Erythema, Pain
Clinical narrative: 25 x 30 mm redness noted to area. Client complains of pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dizziness, Feeling abnormal, Hypoaesthesia
Clinical narrative: Nausea, dizziness, foggy feeling, chills, elevated temp and significant large local redness, pain, itching and pinching at site of injection on left arm, numbness and tingling in fingers.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: Nausea, dizziness, foggy feeling, chills, elevated temp and significant large local redness, pain, itching and pinching at site of injection on left arm, numbness and tingling in fingers.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Nausea, dizziness, foggy feeling, chills, elevated temp and significant large local redness, pain, itching and pinching at site of injection on left arm, numbness and tingling in fingers.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Sore injection site right arm, right arm muscle weakness, hard to move right arm, redness at injection site. This continued on for over three weeks after the shot and still on an off to this day I still have muscle weakness and arm pain.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature decreased, Cough, Fatigue, Herpes zoster, Lymphadenopathy
Clinical narrative: Chest congestion began, following next morning by acute sore throat & swollen gland in throat, coughing & coughing.  After 2 wk had strep culture (negative) & developed Shingles. Low temp. at & below 97 most of time, continues 3 wk later. Improving very slowly, too tired to do anything except rest.