chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patients of unknown demographics. Information regarding medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored M-M-R II (lot # L009214, expiry date: 17-MAR-2017). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HIBV, IPV, PPV, TD
Symptoms: Injection site pain, Injection site reaction, Skin tightness
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient of unknown age. Patient's medical history and drug allergies was not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # L002310, expiry date 08-JUL-2016. On the same day of office visit patient received other suspect therapies included TENIVAC, ACTHIB, OVERSTIM S ENERGIX and IPV (unspecified). No information on concomitant medications was provided. On an unknown date, the patient experienced tightness at the injection site as well as burning sensation after receiving PNEUMOVAX 23. On an unknown date, the patient also reported that she had an intolerable pain in the arm that she received PNEUMOVAX 23. After receiving PNEUMOVAX 23 patient had visited an unspecified emergency room on an unspecified date. It was unknown whether the patient was admitted to the hospital. It was unknown how adverse effects were treated. The outcome of the events was unknown. The relatedness of the event with the suspect therapy was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Dysphagia, Dyspnoea, Fatigue, Headache
Clinical narrative: This spontaneous report was received from a 60 year old male patient referring to himself. The patient's current conditions included degenerative joint and back disease, and arthritis. The patient's drug reactions/allergies included unspecified reaction to barium. The patient's medical history was not reported. On 25-SEP-2015, the patient was vaccinated with ZOSTAVAX injection (strength, dose, frequency, route and lot number were not reported). Concomitant therapies included influenza virus vaccine (unspecified) taken on 17-SEP-2015. After receiving ZOSTAVAX injection, on an unknown date in 2015 the patient experienced headache, nausea, difficulty breathing and swallowing, pain and redness at the injection site, exhaustion, and muscle and joint pain. Some days the adverse reactions weaken, but then they come back. On 21-OCT-2015, the patient had dental work and he had a greater sensitivity to the procedure than usual. The patient sought medical attention and visited primary care physician. The patient was given treatment with unspecified course of antibiotics. Product quality complaint (PQC) was not involved. No further information was provided. The outcome of events was unknown. The reporter did not provide the causal relationship between the events and suspect therapy. Additional information is not expected as no contact details were provided.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Nausea
Clinical narrative: This spontaneous report was received from a 60 year old male patient referring to himself. The patient's current conditions included degenerative joint and back disease, and arthritis. The patient's drug reactions/allergies included unspecified reaction to barium. The patient's medical history was not reported. On 25-SEP-2015, the patient was vaccinated with ZOSTAVAX injection (strength, dose, frequency, route and lot number were not reported). Concomitant therapies included influenza virus vaccine (unspecified) taken on 17-SEP-2015. After receiving ZOSTAVAX injection, on an unknown date in 2015 the patient experienced headache, nausea, difficulty breathing and swallowing, pain and redness at the injection site, exhaustion, and muscle and joint pain. Some days the adverse reactions weaken, but then they come back. On 21-OCT-2015, the patient had dental work and he had a greater sensitivity to the procedure than usual. The patient sought medical attention and visited primary care physician. The patient was given treatment with unspecified course of antibiotics. Product quality complaint (PQC) was not involved. No further information was provided. The outcome of events was unknown. The reporter did not provide the causal relationship between the events and suspect therapy. Additional information is not expected as no contact details were provided.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old patient of unknown gender without known drug allergies. On 13-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L026033 exp 27-MAR-2017, intramuscular. At an unspecified time post vaccination (November 2015), the patient experienced muscle pain in arm and was unable to lift their arm. At the time of this report, the outcome of paresis and myalgia was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old patient of unknown gender without known drug allergies. On 13-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # L026033 exp 27-MAR-2017, intramuscular. At an unspecified time post vaccination (November 2015), the patient experienced muscle pain in arm and was unable to lift their arm. The patient sought medical attention by contacting the pharmacy and a physician. At the time of this report, the outcome of paresis and myalgia was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the healthcare worker refers to an multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot number: 1011846 and expiry date: 16-JUN-2017) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the 4 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23, expiration date on 15-AUG-2015, (lot #, dose and route were not provided). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the healthcare worker refers to multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot number: 1022795 and 1008664: expiry date: 05-NOV-2016 and 03-NOV-2016 respectively) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of 4 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route were not reported, lot # K011077 with expiration date: 30-MAR-2017, lot # L012837 with expiration date: 11-MAR-2018). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the healthcare worker refers to an multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot number: 1010595 and expiry date: 12-NOV-2016) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the 4 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported, lot # L017404 with expiration date: 15-AUG-2017). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the healthcare worker refers to an multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (lot number: 1018499 and expiry date: 25-FEB-2017) (dose, frequency and route of administration was not reported). No concomitant medications were reported. No adverse events were experienced. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. This is one of the 4 reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of VAQTA, # L022259, expiration date: 06-APR-2017, (dosage and route were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. on 27-OCT-2015, the patient was vaccinated with a dose of an improperly stored MMR II (lot # L010488 with an expiration date on 26-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 06-JUL-2015. This case is linked to cases: 2014SA151239, 2015SA105624, 2015SA105628 and 2015SA105636 (same vaccine, same reporter and same batch number). All ten patients were vaccinated with FLUZONE ID vaccine on 30-OCT-2014. The individual identifiers were reported. A patient had received a dose of FLUZONE ID via intradermal route (batch number: UT4993BA, expiry date: 06-MAY-2015, dose in series an site of administration were not reported) on 30-OCT-2014. The pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination was reported as none. Concomitant medications were not reported. On 30-OCT-2014, the patient developed some redness and the site was sore. On an unspecified date, the patient was ill for 2 days and had fever and sever body aches. Laboratory investigations and corrective treatments were not provided. The patient required ER/doctor visit. On an unspecified date, the patient recovered from the event of illness. The outcome for the events of fever, severe body ache, sore and some redness was  not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Neck pain
Clinical narrative: Initial report received from a healthcare professional on 03 OCTOBER 2014. 5 patients (demographics not reported), had received an intramuscular dose of FLUZONE QIV, (batch  number UI205AD, expiry date 30 JUNE 2015, dose in series and site of administration was not reported) on an unspecified date of SEPTEMBER 2014. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On an unspecified date in September 2014, after vaccination, the patient developed large red, swollen and hot area where vaccine was administered, some as large as a baseball. The patient also experienced constant radiation pain up and down the arm and into the neck and bruising at injection site. Corrective treatments and laboratory tests were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none
Sex: U
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 03 OCTOBER 2014. 5 patients (demographics not reported), had received an intramuscular dose of FLUZONE QIV, (batch  number UI205AD, expiry date 30 JUNE 2015, dose in series and site of administration was not reported) on an unspecified date of SEPTEMBER 2014. The patient's illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions and concomitant medications were not reported. On an unspecified date in September 2014, after vaccination, the patient developed large red, swollen and hot area where vaccine was administered, some as large as a baseball. The patient also experienced constant radiation pain up and down the arm and into the neck and bruising at injection site. Corrective treatments and laboratory tests were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a nurse on 15 JULY 2015. A female patient has received a dose of INFLUENZA QUADRIVAL A-B (batch number U5101FA, expiry date: 30 JUNE 2015, dose, dose in series and route of administration were not reported. in left deltoid on 22 JUNE 2015 at 12:37 hours. The patient was vaccinated at private doctors office/hospital. Patient's illness at the time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical condition and other medications were denied by reporter. On an unknown date, after vaccination, the patient developed pain in left shoulder (since three months) and there was no  swelling or redness. Laboratory  investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none. Follow-up report received from a physician on 18 AUGUST 2015. The patient's date of birth was updated (born on 31 DECEMBER 1992). It was reported that patient did not state that pain in shoulder was a pre-existing condition. Other vaccination within four weeks and other medications was reported as none. Illness at the time of vaccination was none. It was also reported that patient had received dose 7 of influenza vaccine. Laboratory investigations was reported as none. Final outcome was not reported as the patient did not respond event after leaving three messages.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site pain, Ocular hyperaemia
Clinical narrative: Initial report received from a healthcare professional on 09 October 2014. A 75-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (batch number U5041BA, expiration date, and dose in series not reported) in to the deltoid left on 30 September 2014. The patient experienced bloodshot eyes, chills 100.4F, and pain at site of shot on 30 September 2014. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were reported as unknown. The patient required emergency room of doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was unknown. List of documents held by sender: none. Follow-up information received from a Pharmacist on 18 December 2014: It was reported that the expiry date of vaccine was 12 May 2015 and the patient did not receive any other medication. The reporter states that the patient had experienced chills, 100.4 degree Fahrenheit, blood shot eyes and pain at the injection site.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Pain
Clinical narrative: Initial report received from a healthcare professional on 06 October 2014. A 80-year-old female patient, had no known allergies, medical history and concomitant medications was not reported, had received a dose of FLUZONE HD batch number- U5041BA (dose, dose in series was not reported) intramuscularly in left deltoid on 03 October 2014. On 04 October 2014 one day after vaccination the patient experienced painful, 3x4 inch red bruised area about 4 inches below injection site on her left arm. Laboratory investigation was not performed and corrective treatment was not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site warmth, Local reaction, Peripheral swelling
Clinical narrative: Initial report received from a healthcare professional on 29 SEPTEMER 2014. A 31-year-old female patient, whose concomitant medication were not reported, had received a dose of FLUZONE TIV, (batch number: UI189AC, expiry date: not reported) (dose in series, route of vaccination not reported) in left deltoid on 03-SEP-2014. On 03-SEP-2014, patient's arm became puffy, red and warm to touch/diagnosed it as a localized reaction. Corrective treatment was not reported and laboratory investigations were reported as none. Medical history was reported as Hypothyroidism, hypertension and Percutaneous Nephrolithotomy. Illness at the time of vaccination was reported as none. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none. Follow up information was received on 02 JANUARY 2015: It was reported that the patient had a 7x8 cm erythematous and warm to touch on left deltoid. The patient had received corrective treatment of cool compress and BENADRYL. Follow up information was received on 04 MAY 2015: No new information reported:, however corrected event coding and labeling of events from previous version.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Initial report received from a healthcare professional on 29 SEPTEMER 2014. A 31-year-old female patient, whose concomitant medication were not reported, had received a dose of FLUZONE TIV, (batch number: UI189AC, expiry date: not reported) (dose in series, route of vaccination not reported) in left deltoid on 03-SEP-2014. On 03-SEP-2014, patient's arm became puffy, red and warm to touch/diagnosed it as a localized reaction. Corrective treatment was not reported and laboratory investigations were reported as none. Medical history was reported as Hypothyroidism, hypertension and Percutaneous Nephrolithotomy. Illness at the time of vaccination was reported as none. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none. Follow up information was received on 02 JANUARY 2015: It was reported that the patient had a 7x8 cm erythematous and warm to touch on left deltoid. The patient had received corrective treatment of cool compress and BENADRYL. Follow up information was received on 04 MAY 2015: No new information reported:, however corrected event coding and labeling of events from previous version.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse event, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a non-healthcare professional on 03 OCTOBER 2014. This case is an invalid case as patient identifiers were not reported. This case is linked with: 2014SA138166, 2014SA138174 and 2014SA138175. Few patients (manager and few others) whose medical history and concomitant medications were not reported, received a dose of INFLUENZA vaccine (lot, route, site, expiration date not reported) on an unspecified date. On an unspecified date, post vaccination these patients developed certain adverse event (had developed reactions). Corrective treatments and laboratory details were not reported. At the time of this report, the outcome of the events was not reported. Document held by sender: None. Follow-up information received from consumer on 04 MAY 2015. A 49-year-old female patient, after vaccination experienced swelling and itching at site of injection. The patient had not received any vaccine within 4 weeks prior to vaccination. Illness at the time of vaccination and adverse event following prior vaccination, adverse event prior vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as none. At the time of this report, patient had recovered from events on an unspecified date. List of the documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Culture urine negative, Dysuria, Pollakiuria
Clinical narrative: Initial report received from healthcare professional on 06 Oct 2014. A 79-year-old male patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (lot number, dose, dose number, site of vaccination not reported), on 25 Sep 2014. The patient had a reported medical history of allergies to penicillin and sulfa drugs. It was reported that on 01 Oct 2014 (one week after vaccination), the patient developed frequency and burning on urination. The urologist advised him to increase his fluid intake and symptoms resolved. The patient diagnosed himself with possible prostatitis. The patient's urine culture reports on 03 Oct 2014 were negative. The patient required ER/doctor visit. Corrective treatments were not reported. The outcome of the event was reported as recovered. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 30 JUNE 2015. A 55-year-old female patient had received an intramuscular second dose of INFLUENZA (batch number U5101FA, expiry date 30 JUNE 2015) in left deltoid on 29 JUNE 2014 at (21:00 hours). The patient's illness at the time of vaccination, pre-existing physician-diagnosed allergies, birth defects medical condition, concomitant medications and past drug history was none. The patient was vaccinated at clinic and vaccine was purchased with private funds. The patient had previously received 1 dose of INFLUENZA on an unspecified date in past and adverse event following prior vaccination was reported as "denus" (not legible). On 29 JUNE 2015, at (22:30 hours) i.e. 1.5 hour after the vaccination the patient was not feeling well, felt weak and tired. By the midnight the patient developed fever and body hurt (date not specified). Laboratory investigations were reported as none and corrective treatments 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 nurse on 23 JULY 2015. On 03 JULY 2015, the patient recovered from the above mentioned events. Documents held by sender: none. Follow up information received from a nurse on 11 AUGUST 2015. No new information reported.
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office staff) on 30 JUNE 2015. A female patient (age not reported) whose medical history and concomitant medication was not reported, had received intradermal 0.5 ml prefilled syringe of FLUZONE QIV, (batch number, dose of vaccine, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, approximately three days post-vaccination, patient's toes went numb, she experienced headache and the symptoms lasted about 3 weeks. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (consumer) on 19 MAY 2015. A female patient, had received a dose of INFLUENZA (batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date. Patient had previous medication of NATALIZUMAB on 01 JANUARY 2003, COPAXONE on 02 JANUARY 2000, AVONEX on 01 JANUARY 1995, aspirin for indication heart problems, JANUMET for diabetes and multiple medications for the indication hypertension and high cholesterol. It was reported that patient legs were hurt (HCP aware) and moved to south due to her intolerance to cold.  On an unspecified date, patient had experienced allergy to vaccine. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from a pharmacist on 24 June 2015. A patient, whose medical history and concomitant medications were not reported, had received a dose of Influenza vaccine and a dose of PREVENAR 13 (batch number, expiry date, dose number, route of administration and site of administration were not reported) both on unspecified date. On unspecified date, after vaccination, the patient presented allergic reaction. Patient thinks it was because of an egg component in the flu vaccine. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none. Follow up report received from a pharmacist on 28 July 2015. It was reported that patient did not have any reaction to flu vaccine at their Pharmacy. No new information reported. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Initial report received from a health care professional on 09 OCTOBER 2014. A 27-year-old female patient had received an intramuscular dose of FLUZONE QIV (lot number and expiry date not reported), in deltoid region on 18 SEPTEMBER 2014. The patient's illness at the time of vaccination and any pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. On 18 SEPTMBER 2014, i.e. same day after vaccination the patient experienced a burning sensation at the injection site. The patient did not seek medical attention or treatment. It was reported that the pharmacy has been in contact with the patient and the symptoms have resolved. The patient's laboratory investigations were not reported. The patient recovered from the event on an unspecified date. Documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Anosmia
Clinical narrative: Initial unsolicited report received from a nurse on 15 June 2015. A 75-year-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number, expiry date, dose, dose number and site of administration were not reported) intramuscularly on an unspecified date of November 2014. Illness at the time of vaccination was reported as shoulder pain. Patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions. On an unspecified date, few weeks after vaccination, patient lost his sense of smell and taste and these senses had not returned. It was also reported that, FLUZONE HD was also received in 2013 and the same symptoms occurred, but his sense of smell and taste returned after a few months. It was also reported that the patient had required a visit to emergency room. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was not recovered. Documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Eyelid ptosis
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 21 MAY 2015. A patient (age not reported) 8 years ago had received a dose of unknown INFLUENZA (dose of vaccine, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, few weeks post vaccination patient developed bilateral upper eyelid ptosis. Illness at the time of vaccination and pre-existing physician diagnosed allergies was not reported that the patient required to ER/doctor visit. Corrective treatments were not  reported and laboratory investigations reported as unknown. At the time of this report, outcome of the patient was unknown. Document's held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthenia, Chills, Dizziness, Drug administered to patient of inappropriate age
Clinical narrative: Based on additional information received on 31 March 2015, this case initially considered as non-serious was upgraded to serious: Important Medical Event (Guillain Barre syndrome) and was also medically confirmed. Initial unsolicited misuse report received from a consumer on 07 October 2014. A 51-year-old female patient, concomitant medications were not reported had received first intramuscular dose of FLUZONE HD batch number: U5019AA (expiry date and site of administration not reported), on 30 September 2014. Patient denied to provide medical history. On 01 Oct 2014 i.e. 1 day after vaccination the patient developed central nervous system symptoms of pins and needles of both upper and lower extremities and dizziness. The patient stated that it felt as if things were crawling all over both legs and arms. The patient was evaluated and treated with steroids, which were effective in decreasing the severity of the symptoms. The patient had plans to follow up with physician on 07 October 2014. Laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by sender: none. Follow up information received from a pharmacist on 31 March 2015 and 09 April 2015. Expiry date of FLUZONE HD was reported as 10 April 2015. It was reported the patient received FLUZONE HD at the age of 51 years old, thus was vaccinated at an inappropriate age. Post vaccination patient experienced chills, tingling of hands and feet, weakness in legs, dizziness, exhaustion, and feeling of no energy. The patient continued to have symptoms of tingling of arms and legs, weakness, dizziness, exhaustion, and had no energy. The patient was treated with 60 g of KENALOG given intramuscularly in right gluteal region. The symptoms persisted and she was referred to the neurologist for concern regarding GB syndrome. Follow up information received from a pharmacist on 8 September 2015. It was reported that on an unspecified date, fatigue has returned, she was not able to work since vaccination, sleeping 15 hours per day and taking naps. It was also reported that she had severe right epigastric pain, had 2 polyps in her gallbladder and 3 kidney stones. The patient was taking vitamins. It was reported that the patient still experiencing same symptoms as previously and she was not recovered from the events. She wanted to know how to get the toxins out of her body. The patient required emergency and physician visit.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Formication, Gallbladder polyp, Guillain-Barre syndrome, Hypersomnia
Clinical narrative: Based on additional information received on 31 March 2015, this case initially considered as non-serious was upgraded to serious: Important Medical Event (Guillain Barre syndrome) and was also medically confirmed. Initial unsolicited misuse report received from a consumer on 07 October 2014. A 51-year-old female patient, concomitant medications were not reported had received first intramuscular dose of FLUZONE HD batch number: U5019AA (expiry date and site of administration not reported), on 30 September 2014. Patient denied to provide medical history. On 01 Oct 2014 i.e. 1 day after vaccination the patient developed central nervous system symptoms of pins and needles of both upper and lower extremities and dizziness. The patient stated that it felt as if things were crawling all over both legs and arms. The patient was evaluated and treated with steroids, which were effective in decreasing the severity of the symptoms. The patient had plans to follow up with physician on 07 October 2014. Laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by sender: none. Follow up information received from a pharmacist on 31 March 2015 and 09 April 2015. Expiry date of FLUZONE HD was reported as 10 April 2015. It was reported the patient received FLUZONE HD at the age of 51 years old, thus was vaccinated at an inappropriate age. Post vaccination patient experienced chills, tingling of hands and feet, weakness in legs, dizziness, exhaustion, and feeling of no energy. The patient continued to have symptoms of tingling of arms and legs, weakness, dizziness, exhaustion, and had no energy. The patient was treated with 60 g of KENALOG given intramuscularly in right gluteal region. The symptoms persisted and she was referred to the neurologist for concern regarding GB syndrome. Follow up information received from a pharmacist on 8 September 2015. It was reported that on an unspecified date, fatigue has returned, she was not able to work since vaccination, sleeping 15 hours per day and taking naps. It was also reported that she had severe right epigastric pain, had 2 polyps in her gallbladder and 3 kidney stones. The patient was taking vitamins. It was reported that the patient still experiencing same symptoms as previously and she was not recovered from the events. She wanted to know how to get the toxins out of her body. The patient required emergency and physician visit.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Muscular weakness, Nephrolithiasis, Nervous system disorder, Paraesthesia
Clinical narrative: Based on additional information received on 31 March 2015, this case initially considered as non-serious was upgraded to serious: Important Medical Event (Guillain Barre syndrome) and was also medically confirmed. Initial unsolicited misuse report received from a consumer on 07 October 2014. A 51-year-old female patient, concomitant medications were not reported had received first intramuscular dose of FLUZONE HD batch number: U5019AA (expiry date and site of administration not reported), on 30 September 2014. Patient denied to provide medical history. On 01 Oct 2014 i.e. 1 day after vaccination the patient developed central nervous system symptoms of pins and needles of both upper and lower extremities and dizziness. The patient stated that it felt as if things were crawling all over both legs and arms. The patient was evaluated and treated with steroids, which were effective in decreasing the severity of the symptoms. The patient had plans to follow up with physician on 07 October 2014. Laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by sender: none. Follow up information received from a pharmacist on 31 March 2015 and 09 April 2015. Expiry date of FLUZONE HD was reported as 10 April 2015. It was reported the patient received FLUZONE HD at the age of 51 years old, thus was vaccinated at an inappropriate age. Post vaccination patient experienced chills, tingling of hands and feet, weakness in legs, dizziness, exhaustion, and feeling of no energy. The patient continued to have symptoms of tingling of arms and legs, weakness, dizziness, exhaustion, and had no energy. The patient was treated with 60 g of KENALOG given intramuscularly in right gluteal region. The symptoms persisted and she was referred to the neurologist for concern regarding GB syndrome. Follow up information received from a pharmacist on 8 September 2015. It was reported that on an unspecified date, fatigue has returned, she was not able to work since vaccination, sleeping 15 hours per day and taking naps. It was also reported that she had severe right epigastric pain, had 2 polyps in her gallbladder and 3 kidney stones. The patient was taking vitamins. It was reported that the patient still experiencing same symptoms as previously and she was not recovered from the events. She wanted to know how to get the toxins out of her body. The patient required emergency and physician visit.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Immediate post-injection reaction
Clinical narrative: Initial report received from a healthcare professional (nurse) on 09 October 2014. A female patient (age not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, expiration date, route, site of vaccination and dose in series not reported) on 09 October 2014. The patient had experienced chest tightness immediately after vaccination on 09 October 2014. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were unknown. The patient required emergency room or doctor visit. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was unknown. List of documents held by sender: none. Follow-up information received from the healthcare professional (nurse) on 11 May 2015. FLUZONE vaccine lot number reported as UI188AB. List of the documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Adenoidal hypertrophy, Dysphonia, Middle ear effusion, Pharyngeal oedema, Throat irritation
Clinical narrative: Initial unsolicited report received from a nurse on 14 November 2014. A 54-year-old female patient had received a intramuscular dose of FLUZONE QIV (batch number UI159AB) in the left deltoid on 12 November 2014. There was no illness identified at time of vaccination. The reporter denied any medical conditions. The patient is allergic to nuts and "many other things". She is currently on an inhaler (no further details provided). On 12 November 2014, one hour after vaccination, the patient felt like her throat was swelling up, began to feel like there was smoke in her throat and she could not clear it, tightness in throat. Her voice became raspy. She took two BENADRYL and noticed some improvement. She went to the ER, was examined and released. Prednisone was administered. On examination, it was noted that the patient had swollen tonsils and adenoids as well as fluid behind left ear. Patient's outcome was reported as not recovered. Documents held by sender: none. Follow up information received from a health care professional on 15-DEC-2014: It was reported that the patient was not seen or treated by the doctor; the immunization was done in employee health. The patient was treated in Emergency room (ER).
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Throat tightness, Tonsillar hypertrophy
Clinical narrative: Initial unsolicited report received from a nurse on 14 November 2014. A 54-year-old female patient had received a intramuscular dose of FLUZONE QIV (batch number UI159AB) in the left deltoid on 12 November 2014. There was no illness identified at time of vaccination. The reporter denied any medical conditions. The patient is allergic to nuts and "many other things". She is currently on an inhaler (no further details provided). On 12 November 2014, one hour after vaccination, the patient felt like her throat was swelling up, began to feel like there was smoke in her throat and she could not clear it, tightness in throat. Her voice became raspy. She took two BENADRYL and noticed some improvement. She went to the ER, was examined and released. Prednisone was administered. On examination, it was noted that the patient had swollen tonsils and adenoids as well as fluid behind left ear. Patient's outcome was reported as not recovered. Documents held by sender: none. Follow up information received from a health care professional on 15-DEC-2014: It was reported that the patient was not seen or treated by the doctor; the immunization was done in employee health. The patient was treated in Emergency room (ER).
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Hypersensitivity, Skin test positive
Clinical narrative: Initial report received from a physician on 23 October 2014. A 3-year-old female patient, with no reported medical history, received a dose of FLUZONE, (lot number not reported) "last year", i.e. 2013. Within one hour of vaccination, she experienced a significant allergic reaction, consisting of angioedema. The patient was seen by a physician, and the event subsequently recovered on an unspecified date. The reporter was concerned that the patient might have an issue with gelatin. No additional information was reported. Documents held by sender: None. Follow-up information received on 17-NOV-2014 by a health care professional. The patient had received Flu vaccine in the past. She had an allergic reaction following administration of MMRV, Dtap and IPV vaccine. Her Allergy skin prick test was positive to MMRV vaccine, gelatin or NEOMYCIN.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Pain in extremity, Swelling
Clinical narrative: Initial information received on 30 October 2014 from a healthcare provider. A 63 year old male patient with a previous history of hypertension and hyperlipidemia was vaccinated intramuscularly into the right deltoid with FLUZONE batch number UT491AB on 08 December 2014 and 12 days later on 20 December 2011, he experienced foot pain, some associated swelling and dizziness and pain in his hands after vaccination. The patient was not ill at the time of vaccination. The patient received three doses of FLUZONE in the past. Concomitant medications were not reported. The patient was seen by a neurologist on 01 Feb 2012 who continued to follow his labs. Laboratory test results and treatments were not reported. The patient states that he cannot get Flu vaccine due to GBS. The patient outcome is unknown. Documents held by sender: None.
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Anaemia, Colonoscopy normal, Computerised tomogram abdomen normal, Computerised tomogram normal, Computerised tomogram pelvis
Clinical narrative: Initial reported received on 31 October 2014 and follow up information received on 06 November 2014 and 08 November 2014 from an investigator participating in a trial. An 83-year-old male subject was diagnosed with Hematochezia on 30 October 2014 i.e. 20 days after the subject had received first dose of FLUZONE QUADRIVALENT (lot number, route and site of administration not reported), 10 October 2014. The event appeared after visit 1. The subject's medical history was not reported. The subject had no concomitant medications. The subject had associated symptom of severe anemia from 30 October 2014. The subject was hospitalized on 30 October 2014. The subject's wife reported that the subject experienced a possible TIA (Transient Ischemic Attack) and was seen at the emergency room . The subject's labs were done and severe anemia was diagnosed. The subject was sent to the hospital in ICU where he received 2 units of blood as a corrective measure. The subject's further diagnostic tests would be done. The subject's complementary investigations were not reported. The subject recovered from the event of Hematochezia on 04 November 2014. According to the investigator, the event was not related to the study vaccine, trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow-up information received on 13 November 2014: The subject had medical history of coronary heart disease, cardio vascular attacks, atrial fibrillation, hypertension, arthritis, enlarged prostate, alzheimer, dyslipidemia and prostate cancer. Concomitant medications were Finasteride, Pravastatin, Furosemide, NAMENDA, ARICEPT, Losartan, Famotidine, XARELTO. Carvedilol and Aspirin. Subject's wife reported a possible ischemic attack (previously reported as TIA) and was seen at the ER. Labs done, severe anemia was diagnosed and sent to the hospital, in intensive care receiving 4 units of blood (previously reported as 2 units of blood). Complementary investigations were colonoscopy which was unremarkable, CBC showed hematocrit and hemoglobin improved, echocardiogram showed ejection fraction of 30%, carotid duplex scan showed no evidence of carotid artery disease and CT scan abdomen and pelvis was unremarkable. It was reported that the subject was discontinued with XARELTO. The subject had received 4 units of blood (previously reported as 2 units of blood). The associated symptom of severe anemia was resolved on 04 November 2014 and the subject was discharged from the hospital on the same day i.e. 04 November 2014. According to the investigator, the event was not related to the concomitant medications. Follow up information received on 04 December 2014 and 09 December 2014. The subject had received first dose of FLUZONE QUADRIVALENT intramuscularly in left deltoid region (batch number UI158AA) on 10 October 2014.