chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: Initial was received on 17 September 2014 from a company representative. A 79 year-old female patient (date of birth not reported) had received on 12 September 2014 FLUZONE High Dose (lot number not reported) and few hours later, experienced facial swelling. The patient went the emergency room and was treated for an allergic reaction and released (treatments were not reported). The patient's medical history and laboratory tests were not reported. According to the report, pharmacist followed up with the patient the next day and the patient was fine. Outcome was recovered. Follow-up information was received from the pharmacist on 29 March 2015. The patient received a left deltoid injection of FLUZONE (lot number U4997AA). Past medical history included diabetes, and the patient was taking levothyroxine, LIPITOR, LANTUS, and HUMALOG concomitantly. The event recovered the following day (also reported as 06/Sep/2014). The patient was 76 years old at the time of the event (previously reported as 79). Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Throat tightness
Clinical narrative: Initial report was received on 22 September 2014 from a health care professional, who also reported additional patients who are captured in cases 2014SA130000, 2014SA130839 and 2014SA130840. A 57 year-old female patient who had no illness at the time of vaccination had received on 16 September 2013 an intramuscular injection of FLUZONE, lot number U158AA (not a valid Sanofi Pasteur lot number, site of administration not reported) and on the same date as vaccination, experienced throat tightness. the patient did not see a doctor. No relevant diagnostic tests/laboratory tests were done. No further information was provided at the time of the report. Outcome was recovered. Follow-up information was received from a healthcare professional on 17 November 2014. The time of vaccination was reported as the AM on 16 September 2014. The FLUZONE batch number was corrected to UI158AA. The patient had no illness at the time of vaccination and recovered on 16 September 2014. No further details were reported. Follow-up information for this unsolicited case was received on 10 February 2015 from a healthcare professional. "No treatment details available and not necessary". No further medical information was reported. Follow-up information for this unsolicited case was received on 13 March 2015 from a healthcare professional. According to the reporter, the patient required no labs or medications for the alleged reaction. The patient had no visible signs and symptoms of adverse reaction and required no treatment. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Swelling face, Throat tightness
Clinical narrative: This reporter also reported two other events which are captured in cases 2014SA130836 and 2014SA130839. Initial case received on 22 September 2014 from a healthcare professional. A 51 year old female patient with no pre-existing allergies, medical conditions or illness at the time of vaccination received INFLUENZA QUADRIVAL, batch #UI158AA intramuscularly into the left deltoid on 16 September 2014. At an unspecified time on 16 September 2014, the same day as vaccination, the patient experienced facial swelling, mild throat tightness and mild shortness of breath. The patient took BENADRYL and returned to work that day. The patient recovered on an unreported date. Follow-up information was received on 17 November 2014 from a healthcare provider. The event onset occurred within minutes for 30 minutes duration total. The patient was treated with BENADRYL, 25 mg twice by the ER doctor. The patient has received the flu vaccine annually. The patient's concomitant medications, illness at time of vaccination and medical history were reported as none. The patient recovered on 17 September 2014. Follow-up information for this unsolicited event was received on 10 February 2015 from healthcare provider. The patient took BENADRYL and ibuprofen. No other treatment was required. BENADRYL was taken on 16 September 2014. Symptoms which lasted 30 minutes only were as none. The patient did not experience any events following flu vaccination in the past. Allergy testing was not performed. Documents held by sender: None.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Initial report was received on 22 September 2014 from a health care professional, who also reported additional cases captured in 2014SA130836 and 2014SA130840. A 36 year-old female with cold symptoms at the time of vaccination, had received on 17 September 2014 an intramuscular right deltoid injection of FLUZONE QIV, lot number UI158AA and an unspecified amount of time later the same day of vaccination, experienced throat tightness and shortness of breath. The patient had received yearly flu shots in the past. The patient was evaluated by a nurse practitioner who felt what the patient experienced was not an honest reaction to the flu vaccine. Treatment included ibuprofen and BENADRYL. The symptoms resolved and the patient returned to work the next day. Outcome was recovered. Follow-up information received from a healthcare professional on 17 November 2014. The patient was not ill at the time of vaccination. The patient experienced the reaction within 4 hours of vaccination. Allergy testing was not performed. The patient recovered on 17 September 2014. Documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF protein increased, Demyelinating polyneuropathy, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Initial report received from a non-healthcare professional (patient) on 17 November 2014. A 43-years-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date, site and route of vaccination not reported), on 13-SEP-2014. On 14-SEP-2014, one day after vaccination the patient had pain in his body, numbness in his face, feet, hands and legs after vaccination. The patient was hospitalized on 30 Sep 2014 and diagnosed with GBS (Guillain Barre syndrome). The patient got discharged from the hospital on 5 October 2014 and still has numbness in his face, not able to eat and not strong enough to work. The patient does not have any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were none. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. Follow-up information was received from a physician on 22 December 2014. As per neurology, an EMG on an unspecified date showed acute inflammatory demyelinating polyneuropathy, and lumbar puncture showed slightly elevated protein. The patient was discharged from the hospital on 05 October 2014. He was receiving physical therapy, and was slowly improving. The physician stated that the patient had not been seen in the office since being discharged. List of documents held by sender: none.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal, Pain
Clinical narrative: Initial report received from a non-healthcare professional (patient) on 17 November 2014. A 43-years-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Dose number, Batch number, expiry date, site and route of vaccination not reported), on 13-SEP-2014. On 14-SEP-2014, one day after vaccination the patient had pain in his body, numbness in his face, feet, hands and legs after vaccination. The patient was hospitalized on 30 Sep 2014 and diagnosed with GBS (Guillain Barre syndrome). The patient got discharged from the hospital on 5 October 2014 and still has numbness in his face, not able to eat and not strong enough to work. The patient does not have any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were none. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. Follow-up information was received from a physician on 22 December 2014. As per neurology, an EMG on an unspecified date showed acute inflammatory demyelinating polyneuropathy, and lumbar puncture showed slightly elevated protein. The patient was discharged from the hospital on 05 October 2014. He was receiving physical therapy, and was slowly improving. The physician stated that the patient had not been seen in the office since being discharged. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Initial report received from healthcare professional on 07 October 2014. A 68-year-old-female patient whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date, site of vaccination and dose number) on 05 October 2014. The patient had experienced severe limited range of motion and severe pain in arm on 06 October 2014. Lab investigation and corrective treatments were not reported. The outcome of the event was unknown at the time of this report. List of documents held by sender: none. Follow-up information received from health care professional on 29-Dec-2014. The patient had received FLUZONE HD from the lot number U5044AA and expiry date 20 May 2015.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Generalised tonic-clonic seizure
Clinical narrative: Initial report received from a health care professional (nurse practitioner) on 30 October 2014. A 14 year-old female patient, with no reported medical history, had received a dose of FLUZONE (lot number UI189AC, route of administration not reported) in the arm on an unspecified date. After the removal of the needle from the arm, the patient stated that she "felt like was going to faint" and had "full tonic clonic seizure". The patient went to the ER on 29 October 2014 (also reported as "last night") and was feeling ok on 30 October 2014 (also reported as "today"). The patient's outcome was recovered. The reporter stated that she completed a VAERS form on line on 30 October 2014 in the morning. Documents held by senders: none.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Abnormal behaviour, Arthralgia, Blood test, Confusional state, Crying
Clinical narrative: Hives at the doctors office within 10 minutes. About a half hour later, throat closed up, hands and lips turned blue, kept saying she "didn't know what world ahe was in", loss of muscle control. - took to the ER Joint pain started and since then has been treated for fibromyalgia.  Uncontrolled outbursts, crying, pain - ongoing.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Cyanosis, Dyskinesia, Fibromyalgia, Pain, Throat tightness
Clinical narrative: Hives at the doctors office within 10 minutes. About a half hour later, throat closed up, hands and lips turned blue, kept saying she "didn't know what world ahe was in", loss of muscle control. - took to the ER Joint pain started and since then has been treated for fibromyalgia.  Uncontrolled outbursts, crying, pain - ongoing.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives at the doctors office within 10 minutes. About a half hour later, throat closed up, hands and lips turned blue, kept saying she "didn't know what world ahe was in", loss of muscle control. - took to the ER Joint pain started and since then has been treated for fibromyalgia.  Uncontrolled outbursts, crying, pain - ongoing.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Acupuncture, Computerised tomogram head normal, Ear discomfort, Eyelid ptosis, Facial paresis
Clinical narrative: Initial unsolicited case received from a registered nurse on 13 November 2014. A 22-years-old female patient with no reported medical history, allergies and no illness at time of vaccination, had received an intramuscular dose of FLUZONE QIV (lot number UI169AB) in the right deltoid on 07 October 2014. It was reported that she had received numerous previous doses. She did not receive other vaccinations within the 4 weeks of vaccination with FLUZONE QIV. On 23 October 2014, i.e. 16 days post vaccination, the patient experienced "odd feeling behind right ear" and visual disturbances. Then, she experienced droopy eye and droopy mouth from an unspecified date. She was diagnosed with Bell's Palsy on the right side of her face on 13 November 2014. The patient's outcome was not recovered at the time of the report. Follow-up information for this unsolicited case was received on 12 December 2014 by a healthcare professional, nurse. The patient's date of birth was corrected. The patient's age was previously reported as 22 years old and has been updated to 42 years old and reported as 43 years old by the reporter. The patient's occupation is a purchaser and has a history of being a smoker. The patient's treatments were acupuncture, massage and physical therapy was started on 05 December 2014 and is ongoing. The patient did not experience any adverse events in the past with influenza vaccine. Emergency physician records on 24 October 2014 showed the patient's chief complaint was facial droop which had started in the morning of that day. The cranial nerves in the forehead were spared. The patient did not report any recent illness and all systems were negative. The patient had new facial weakness and altered sensation on the right side, with no complaints of fever, chills, fainting or seizures. The patient had a mild headache with neck pain in the right trapezius. The neck was supple and non-tender and she was not in respiratory distress and had normal breath sounds. The skin color was normal, warm and dry and extremities were non-tender with normal range of movement and no pedal edema. The patient was alert and oriented times 3 and her mood was normal. The patient's concomitant medications were reported as none and vitamins (vits) and she had no known drug allergies. The patient has a history of an appendectomy on an unreported date and another surgery which was illegible in the report. The patient's general appearance was mild distress, but was alert with no apparent trauma. A CT scan was performed on the head and no abnormality was detected (NAD). The clinical impression was Bell's Palsy. The patient was discharged home and was stable with the condition unchanged. The patient was prescribed unspecified prescription and was counseled on the diagnosis, lab results and need for follow-up. The patient outcome is not recovered. Documents held by sender: emergency records.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Neck pain, Sensory disturbance, VIIth nerve paralysis, Visual impairment
Clinical narrative: Initial unsolicited case received from a registered nurse on 13 November 2014. A 22-years-old female patient with no reported medical history, allergies and no illness at time of vaccination, had received an intramuscular dose of FLUZONE QIV (lot number UI169AB) in the right deltoid on 07 October 2014. It was reported that she had received numerous previous doses. She did not receive other vaccinations within the 4 weeks of vaccination with FLUZONE QIV. On 23 October 2014, i.e. 16 days post vaccination, the patient experienced "odd feeling behind right ear" and visual disturbances. Then, she experienced droopy eye and droopy mouth from an unspecified date. She was diagnosed with Bell's Palsy on the right side of her face on 13 November 2014. The patient's outcome was not recovered at the time of the report. Follow-up information for this unsolicited case was received on 12 December 2014 by a healthcare professional, nurse. The patient's date of birth was corrected. The patient's age was previously reported as 22 years old and has been updated to 42 years old and reported as 43 years old by the reporter. The patient's occupation is a purchaser and has a history of being a smoker. The patient's treatments were acupuncture, massage and physical therapy was started on 05 December 2014 and is ongoing. The patient did not experience any adverse events in the past with influenza vaccine. Emergency physician records on 24 October 2014 showed the patient's chief complaint was facial droop which had started in the morning of that day. The cranial nerves in the forehead were spared. The patient did not report any recent illness and all systems were negative. The patient had new facial weakness and altered sensation on the right side, with no complaints of fever, chills, fainting or seizures. The patient had a mild headache with neck pain in the right trapezius. The neck was supple and non-tender and she was not in respiratory distress and had normal breath sounds. The skin color was normal, warm and dry and extremities were non-tender with normal range of movement and no pedal edema. The patient was alert and oriented times 3 and her mood was normal. The patient's concomitant medications were reported as none and vitamins (vits) and she had no known drug allergies. The patient has a history of an appendectomy on an unreported date and another surgery which was illegible in the report. The patient's general appearance was mild distress, but was alert with no apparent trauma. A CT scan was performed on the head and no abnormality was detected (NAD). The clinical impression was Bell's Palsy. The patient was discharged home and was stable with the condition unchanged. The patient was prescribed unspecified prescription and was counseled on the diagnosis, lab results and need for follow-up. The patient outcome is not recovered. Documents held by sender: emergency records.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Initial unsolicited report received from a pharmacist on 04 December 2014. A 41-year-old male patient, with no reported medical history or allergies, had receive a dose of FLUZONE (batch number UI198AD, route of administration not reported) in the left deltoid on 03 December 2014. Immediately after the vaccination, the patient became syncopal. The reporter said that they "had to get medics to the pharmacy", but by the time they arrived the patient was recovered. The patient went to the ER and received IV fluids. He was feeling well at the time of the report. There was no illness identified at the time of vaccination. The patient did not receive previous doses of FLUZONE, and he did not receive any other vaccine within 4 weeks prior vaccination with FLUZONE. Follow-up information for this unsolicited case was received from a pharmacist on 26 December 2014. The patient lost consciousness and almost immediately regained consciousness and recovered the same day after a few hours in the emergency room. According to the reporter, the patient was not admitted to the hospital. Contact information for the patient's physician was also provided. Follow-up information for this unsolicited case was received on 29 January 2015 from a physician. The patient was seen by the physician after the syncopal episode. The patient has no relevant medical history. The patient is fully recovered. Documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Based on additional information received on 7 April 2015, this case became medically confirmed. Initial report received from a consumer on 28 January 2015. This case is linked to case number 2014SA161913 (same reporter). A 72-year-old male patient had received a dose of FLUZONE TIV, (batch number was not provided, dose, dose in series and route of administration unknown) in left deltoid on 20 October 2014. Patient had not received any other vaccinations within four weeks of vaccinations and had no illness at the time of vaccination. The patient's pre-existing diagnosed allergies, birth defects, medical conditions includes codeine allergy and restless legs insomnia. On 20 October 2014, after vaccination, the patient developed pain in shoulders across back and down both arm radiating to hands and also had muscle deterioration and bone issues. Patient required ER/doctor visit. Laboratory data includes xrays and MRI but results were not reported. Corrective treatment was not reported. At the time of this report the patient was not recovered from the events. Documents held by sender: none. Follow up information received from a physician on 7 April 2015. It was reported that patient did not receive flu injection at the reported facility.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Bone disorder, Muscle disorder, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Based on additional information received on 7 April 2015, this case became medically confirmed. Initial report received from a consumer on 28 January 2015. This case is linked to case number 2014SA161913 (same reporter). A 72-year-old male patient had received a dose of FLUZONE TIV, (batch number was not provided, dose, dose in series and route of administration unknown) in left deltoid on 20 October 2014. Patient had not received any other vaccinations within four weeks of vaccinations and had no illness at the time of vaccination. The patient's pre-existing diagnosed allergies, birth defects, medical conditions includes codeine allergy and restless legs insomnia. On 20 October 2014, after vaccination, the patient developed pain in shoulders across back and down both arm radiating to hands and also had muscle deterioration and bone issues. Patient required ER/doctor visit. Laboratory data includes xrays and MRI but results were not reported. Corrective treatment was not reported. At the time of this report the patient was not recovered from the events. Documents held by sender: none. Follow up information received from a physician on 7 April 2015. It was reported that patient did not receive flu injection at the reported facility.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Based on additional information received on 7 April 2015, this case became medically confirmed. Initial report received from a consumer on 28 January 2015. This case is linked to case number 2014SA161913 (same reporter). A 72-year-old male patient had received a dose of FLUZONE TIV, (batch number was not provided, dose, dose in series and route of administration unknown) in left deltoid on 20 October 2014. Patient had not received any other vaccinations within four weeks of vaccinations and had no illness at the time of vaccination. The patient's pre-existing diagnosed allergies, birth defects, medical conditions includes codeine allergy and restless legs insomnia. On 20 October 2014, after vaccination, the patient developed pain in shoulders across back and down both arm radiating to hands and also had muscle deterioration and bone issues. Patient required ER/doctor visit. Laboratory data includes xrays and MRI but results were not reported. Corrective treatment was not reported. At the time of this report the patient was not recovered from the events. Documents held by sender: none. Follow up information received from a physician on 7 April 2015. It was reported that patient did not receive flu injection at the reported facility.
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Swelling face
Clinical narrative: Initial unsolicited case received from a pharmacist on 16 October 2014. A female patient (age and date of birth not reported), with a history of meat allergy due to tick-borne illness, received an intradermal injection of FLUZONE ID (lot number not reported) on 14 October 2014. The day after vaccination, 15 October 2014, the patient experienced widespread itching and swelling of the face. According to the reporter, the patient was stable and the event recovered on an unspecified date. Additional information will be requested. Follow-up information was received from a healthcare professional on 03 March 2015. The patient was 28 years old at the time of the event, and had recently been diagnosed with a meat allergy due to a lone star tick bite. She received FLUZONE (lot number UT4982BA) on 15 October 2014, previously reported as 14 October 2014. Documents held by sender: None. Follow-up report received from a pharmacist on 27 April 2015. It was reported that no new information was received. Documents held by sender: None.
Sex: F
Vaccine: MMR, FLUX, MMR
Symptoms: Drug hypersensitivity
Clinical narrative: Initial unsolicited report received from physician and reported by Pfizer (other pharmaceutical company) on 20 Feb 2015. A female patient, whose medical history included known drug allergy to Nitro, PCN, CECLOR, Drug allergy to ASA, KEFLEX, NEURONTIN, ZOCOR, Anti histamine, BETHPACE and whose concomitant medications were not reported, had received a dose of MMR (batch number, route of administration, site of administration was not reported) on an unknown date and also received Flu Shot (batch number, route of administration, site of administration was not reported) on an unknown date. On an unknown date the patient had allergy to MMR vaccine and flu shot. Laboratory investigations and corrective treatments were unknown. At the time of reporting, the event outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 13 April 2015. Patient denied any reaction, when he was called on 06-Apr-15 at 3:30 pm. Documents held by sender: none.
Sex: F
Vaccine: MMR, FLUX, MMR
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from physician and reported by Pfizer (other pharmaceutical company) on 20 Feb 2015. A female patient, whose medical history included known drug allergy to Nitro, PCN, CECLOR, Drug allergy to ASA, KEFLEX, NEURONTIN, ZOCOR, Anti histamine, BETHPACE and whose concomitant medications were not reported, had received a dose of MMR (batch number, route of administration, site of administration was not reported) on an unknown date and also received Flu Shot (batch number, route of administration, site of administration was not reported) on an unknown date. On an unknown date the patient had allergy to MMR vaccine and flu shot. Laboratory investigations and corrective treatments were unknown. At the time of reporting, the event outcome was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 13 April 2015. Patient denied any reaction, when he was called on 06-Apr-15 at 3:30 pm. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Middle insomnia, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 05 April 2015. A patient (age and gender was not reported), whose medical history and concomitant medications were not reported, had received the dose of FLUZONE (Batch number, expiry date, route of vaccination and dose number was not reported) on an unspecified date in late December 2014. On an unspecified date, the patient had experienced pain emanating from that same muscle area for the three months since after the vaccination. The patient's laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a consumer on 01 June 2015. A 64-year-old female patient had received a dose of FLUZONE (batch number: UI198AE, dose and expiry date were not reported) in upper left arm on 30 December 2014. Any other vaccinations within four weeks prior to vaccination and illness at the time of vaccination reported as none. The vaccine was purchased with private funds and was vaccinated at private doctor's office/hospital. The patient's pre-existing physician-diagnosed allergies, birth defects, medical condition included allergy to penicillin. Also, adverse event prior to vaccination reported as none. On 30 December 2014 (after vaccination), the patient had pain at vaccination site (upper left arm). The patient consulted the physician and was prescribed medical massage treatment, but the pain did not alleviate and afterwards was suggested physical therapy. The pain did not subside after five months. The patient was unable to lift or rotate the arm fully and awakened at night by severe arm pain. It was reported that the "type of pain from any normal muscle pain". At the time of this report, the patient was not recovered. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Initial unsolicited report received from a consumer on 05 April 2015. A patient (age and gender was not reported), whose medical history and concomitant medications were not reported, had received the dose of FLUZONE (Batch number, expiry date, route of vaccination and dose number was not reported) on an unspecified date in late December 2014. On an unspecified date, the patient had experienced pain emanating from that same muscle area for the three months since after the vaccination. The patient's laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a consumer on 01 June 2015. A 64-year-old female patient had received a dose of FLUZONE (batch number: UI198AE, dose and expiry date were not reported) in upper left arm on 30 December 2014. Any other vaccinations within four weeks prior to vaccination and illness at the time of vaccination reported as none. The vaccine was purchased with private funds and was vaccinated at private doctor's office/hospital. The patient's pre-existing physician-diagnosed allergies, birth defects, medical condition included allergy to penicillin. Also, adverse event prior to vaccination reported as none. On 30 December 2014 (after vaccination), the patient had pain at vaccination site (upper left arm). The patient consulted the physician and was prescribed medical massage treatment, but the pain did not alleviate and afterwards was suggested physical therapy. The pain did not subside after five months. The patient was unable to lift or rotate the arm fully and awakened at night by severe arm pain. It was reported that the "type of pain from any normal muscle pain". At the time of this report, the patient was not recovered. Documents held by sender: none.
Age: 1.2
Sex: F
Vaccine: FLU3, MMRV, VARCEL, FLUX, MMRV, PNC, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Based on the additional information received on 5 June 2015, this case became medical confirmed. Initial unsolicited report received from a non-health care professional on 23-Apr-2015. A 16 months old female patient had received a second dose of INFLUENZA vaccine via intramuscular route in the left thigh (Manufacturer: unknown, batch number: L44983P4 and expiry date not reported), first dose of VARIVAX via subcutaneous route in left leg (Manufacturer: Merck, batch number: LJ008358 and expiry date not reported), first dose of PROQUAD via subcutaneous route in right leg (Manufacturer: Merck, batch number: LK005644 and expiry date not reported) and a dose of PREVNAR via intramuscular route in right thigh (Manufacturer: Pfizer, batch number: LJ16883 and expiry date not reported) on 27-Jan-2015. The patient illness at the time of vaccination (specify) was unknown. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. On an unspecified date after vaccination, the patient experienced adverse event NOS. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow up information received from a physician on 5 June 2015. The patient received Influenza vaccine lot number- L44983FA, VARIVAX on right thigh, PROQUAD lot number LK005644 into left thigh and PREVNAR lot number on LJ16883 into right thigh. It was reported that nurse mistakenly gave Varicella virus vaccine, live and PROQUAD to the patient on the same day. Documents held by sender: none.
Age: 1.2
Sex: F
Vaccine: FLU3, MMRV, VARCEL, FLUX, MMRV, PNC, VARCEL
Symptoms: Adverse event, Medication error
Clinical narrative: Based on the additional information received on 5 June 2015, this case became medical confirmed. Initial unsolicited report received from a non-health care professional on 23-Apr-2015. A 16 months old female patient had received a second dose of INFLUENZA vaccine via intramuscular route in the left thigh (Manufacturer: unknown, batch number: L44983P4 and expiry date not reported), first dose of VARIVAX via subcutaneous route in left leg (Manufacturer: Merck, batch number: LJ008358 and expiry date not reported), first dose of PROQUAD via subcutaneous route in right leg (Manufacturer: Merck, batch number: LK005644 and expiry date not reported) and a dose of PREVNAR via intramuscular route in right thigh (Manufacturer: Pfizer, batch number: LJ16883 and expiry date not reported) on 27-Jan-2015. The patient illness at the time of vaccination (specify) was unknown. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. On an unspecified date after vaccination, the patient experienced adverse event NOS. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow up information received from a physician on 5 June 2015. The patient received Influenza vaccine lot number- L44983FA, VARIVAX on right thigh, PROQUAD lot number LK005644 into left thigh and PREVNAR lot number on LJ16883 into right thigh. It was reported that nurse mistakenly gave Varicella virus vaccine, live and PROQUAD to the patient on the same day. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Allergy test negative, Anaphylactic reaction, Blood test, Eye swelling, Rash
Clinical narrative: Initial unsolicited report received from a consumer on 29 June 2015. A 54-year-old female patient had received a dose of ADACEL (batch number U5030AA, expiry date: 001 May 2014, dose, dose in series and site of administration were not reported) via intramuscular route and dose of FLUZONE NP (batch number: UI214AB, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) via intramuscular route both on 03 March 2015. Patient denies illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to cats, hypothyroidism, synthroid. Concomitant medications were not reported. On an unknown date, four hours after vaccination, the patient broke out in hives. On 04 March 2015, the patient developed right facial, lip and eye swelling. The symptoms keep reoccurring since March. Patient required ER/doctor visit. The patient was hospitalized in May/June with episodes of hives, throat closings. Relevant diagnostic test/laboratory data included skin biopsies, blood work, antibody testing. Corrective treatments included steroids, Singulair, Zantac, Zyrtec and Medrol packs. The patient was prescribed with Epi Pens. The patient also self-treated with Benadryl. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 29 June 2015. A 54-year-old female patient had received a dose of ADACEL (batch number U5030AA, expiry date: 001 May 2014, dose, dose in series and site of administration were not reported) via intramuscular route and dose of FLUZONE NP (batch number: UI214AB, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) via intramuscular route both on 03 March 2015. Patient denies illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to cats, hypothyroidism, synthroid. Concomitant medications were not reported. On an unknown date, four hours after vaccination, the patient broke out in hives. On 04 March 2015, the patient developed right facial, lip and eye swelling. The symptoms keep reoccurring since March. Patient required ER/doctor visit. The patient was hospitalized in May/June with episodes of hives, throat closings. Relevant diagnostic test/laboratory data included skin biopsies, blood work, antibody testing. Corrective treatments included steroids, Singulair, Zantac, Zyrtec and Medrol packs. The patient was prescribed with Epi Pens. The patient also self-treated with Benadryl. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Antibody test, Biopsy skin, Blood test, Eye swelling, Lip swelling
Clinical narrative: Initial unsolicited report received from a consumer on 29 June 2015. A 54-year-old female patient had received a dose of ADACEL (batch number U5030AA, expiry date: 001 May 2014, dose, dose in series and site of administration were not reported) via intramuscular route and dose of FLUZONE NP (batch number: UI214AB, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) via intramuscular route both on 03 March 2015. Patient denies illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to cats, hypothyroidism, synthroid. Concomitant medications were not reported. On an unknown date, four hours after vaccination, the patient broke out in hives. On 04 March 2015, the patient developed right facial, lip and eye swelling. The symptoms keep reoccurring since March. Patient required ER/doctor visit. The patient was hospitalized in May/June with episodes of hives, throat closings. Relevant diagnostic test/laboratory data included skin biopsies, blood work, antibody testing. Corrective treatments included steroids, Singulair, Zantac, Zyrtec and Medrol packs. The patient was prescribed with Epi Pens. The patient also self-treated with Benadryl. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP, UNK, FLU3, TDAP
Symptoms: Swelling face, Throat tightness, Urticaria
Clinical narrative: Initial unsolicited report received from a consumer on 29 June 2015. A 54-year-old female patient had received a dose of ADACEL (batch number U5030AA, expiry date: 001 May 2014, dose, dose in series and site of administration were not reported) via intramuscular route and dose of FLUZONE NP (batch number: UI214AB, expiry date: 30 June 2015, dose, dose in series and site of administration were not reported) via intramuscular route both on 03 March 2015. Patient denies illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included allergy to cats, hypothyroidism, synthroid. Concomitant medications were not reported. On an unknown date, four hours after vaccination, the patient broke out in hives. On 04 March 2015, the patient developed right facial, lip and eye swelling. The symptoms keep reoccurring since March. Patient required ER/doctor visit. The patient was hospitalized in May/June with episodes of hives, throat closings. Relevant diagnostic test/laboratory data included skin biopsies, blood work, antibody testing. Corrective treatments included steroids, Singulair, Zantac, Zyrtec and Medrol packs. The patient was prescribed with Epi Pens. The patient also self-treated with Benadryl. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Severe pain and lump at injection area. Five inch diameter patient bruise immediately after vaccine. Today, seven days later patient still has bruising.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Severe pain and lump at injection area. Five inch diameter patient bruise immediately after vaccine. Today, seven days later patient still has bruising.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Immediate post-injection reaction, Injection site mass, Injection site pain
Clinical narrative: Severe pain and lump at injection area. Five inch diameter patient bruise immediately after vaccine. Today, seven days later patient still has bruising.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Thought normal ache for shot, but after 5 weeks in great pain still. Man did too high in muscle - didn't feel injection. Now no relief, constant ache to sharp pains while moved certain directions. Can't sleep or do job tasks to chores, errands. Reading nothing can do for it, lasting months, years or permanetly like bursitis set in.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Adverse drug reaction, Insomnia, Pain, Swelling
Clinical narrative: Thought normal ache for shot, but after 5 weeks in great pain still. Man did too high in muscle - didn't feel injection. Now no relief, constant ache to sharp pains while moved certain directions. Can't sleep or do job tasks to chores, errands. Reading nothing can do for it, lasting months, years or permanetly like bursitis set in.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Thought normal ache for shot, but after 5 weeks in great pain still. Man did too high in muscle - didn't feel injection. Now no relief, constant ache to sharp pains while moved certain directions. Can't sleep or do job tasks to chores, errands. Reading nothing can do for it, lasting months, years or permanetly like bursitis set in.
Age: 54.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Seizure, Throat irritation
Clinical narrative: Case number PHEH2015US022734 is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 55-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 157925) intramuscularly from a pre-filled syringe on 30 Oct 2015. Ten minutes after vaccination, the patient experienced itchy throat, itching all over the body, tightness of throat and had a seizure. The patient recovered from the events on the same date. The seriousness and causality of the events were not reported. Seriousness assessment of the event seizure upgraded based on the NVx key event list.
Age: 54.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Seizure, Throat irritation, Throat tightness
Clinical narrative: Case number PHEH2015US022734 is an initial spontaneous report from a health care professional received on 04 Nov 2015. This report refers to a 55-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 157925) intramuscularly from a pre-filled syringe on 30 Oct 2015. Ten minutes after vaccination, the patient experienced itchy throat, itching all over the body, tightness of throat and had a seizure. The patient recovered from the events on the same date. The seriousness and causality of the events were not reported. Seriousness assessment of the event seizure upgraded based on the NVx key event list.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Unevaluable event
Clinical narrative: Myalgia in right upper arm and right shoulder, lasting more than 2 weeks after injection. No erythema or edema at the injection site. Given ibuprofen for symptom ache relief. Discontinued simvastatin 40 mg. 1 week after injection, perioral dermatitis was present, around mouth only.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood creatine phosphokinase normal, Dermatitis, Full blood count normal, Injection site pain, Metabolic function test normal
Clinical narrative: Myalgia in right upper arm and right shoulder, lasting more than 2 weeks after injection. No erythema or edema at the injection site. Given ibuprofen for symptom ache relief. Discontinued simvastatin 40 mg. 1 week after injection, perioral dermatitis was present, around mouth only.
Age: 57.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Myalgia in right upper arm and right shoulder, lasting more than 2 weeks after injection. No erythema or edema at the injection site. Given ibuprofen for symptom ache relief. Discontinued simvastatin 40 mg. 1 week after injection, perioral dermatitis was present, around mouth only.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, X-ray
Clinical narrative: SORENESS AND PAIN IN LEFT SHOULDER, LIMITED LEFT ARM-SHOULDER USE, MOVEMENT ASSOCIATED WITH PAIN. INITIALLY RECEIVED A STEROID INJECTION FROM PRIMARY DOCTOR, FOLLOW UP WITH ORTHOPEDIC DR, PRESCRIBED METHYLPREDNISOLONE AND PHYSICAL THERAPY.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Hands, feet and face swollen to aprox 3 times their original size. Took Benadryl but did not help.
Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Laboratory test, Pneumonia
Clinical narrative: Double pneumonia for 19 weeks.
Age: 81.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Atrial fibrillation, Condition aggravated, Fatigue, Pneumonia, Thrombosis
Clinical narrative: Double pneumonia for 19 weeks.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Cough, Pyrexia, Restlessness, Rhinorrhoea, Sleep disorder
Clinical narrative: FEVER OF 101.0F AS WELL AS RUNNY NOSE, SNIFFLING, SNEEZING. PROGRESSED TO COUGHING AS NIGHT WENT ON, RESTLESS, CAN NOT SLEEP DUE TO COUGH AND FEVER.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Sneezing
Clinical narrative: FEVER OF 101.0F AS WELL AS RUNNY NOSE, SNIFFLING, SNEEZING. PROGRESSED TO COUGHING AS NIGHT WENT ON, RESTLESS, CAN NOT SLEEP DUE TO COUGH AND FEVER.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site haemorrhage, Pain in extremity
Clinical narrative: Blood was gushing out when shot was given. Immediately after arm was aching. Months later I still have excruciating pain on my left arm. Especially at night I cannot move my arms without having to support it with my other arm. Went back to the doctor to tell her what happened. She said sorry for what happened and gave me muscle relaxer and blood thinners which I have been taking but has not worked. Please tell me what I need to do to fix this pain.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Erythema, Urticaria, Vomiting
Clinical narrative: My daughter after flu shot has shown hives (red mapping raised skin) all over her body around 5:30 PM, 6 hours after her flu shot. Then the following day about 5:30 AM, and after being given children's Benadryl chewable tablets (2x) she woke up with tummy pain and threw up a clear but yellowish discharge.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest X-ray abnormal, Chest pain, Electrocardiogram normal, Painful respiration, Pleural effusion
Clinical narrative: 12 Oct 15: Patient complained of left side chest pain, 7/10, which had been gradually increasing since 08 Oct 15.  Pain was worse with deep breaths. Treating physician wrote, "small left-sided pleural effusion with otherwise clear lungs." Diagnosis: Acute pleural effusion. Treated with NSAIDS by mouth for pain. 21 Oct 15: Symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Awoke with mild fever 2 days after vaccines given.  Awoke on 11/2 with rash on cheeks and trunk. To pediatrician who did not prescribe any treatment, only rest.