chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal disorder, Pain in extremity, Pruritus
Clinical narrative: After he got the injection, he had mild itching and the next day intense itching which is continuing through today. But he called today because he is having pain in his right hand and it hurts to use it. He stated he can hardly use his hand. I suggested he see a physician right away.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Eye pain, Lymphadenopathy, Ocular hyperaemia, Rash
Clinical narrative: Received MMR vaccine (Merck lot #L007577) in left arm SQ on 11/6/15.  On 11/16/15 painful swelling of lymph nodes and sore red eyes, then on 11/18/15 rash on chest, neck and going up neck.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Generalized hives all over chest, neck and legs and scalp.
Age: 98.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Initial report received from a healthcare professional on 22 September 2014. A 98-year-old female patient had received a dose of FLUZONE HD, (batch number U5022BA, expiry date 29 April 2015, dose number, route and site of vaccination not reported) on 20 September 2014. The patient's illness at the time of vaccination was not reported. The patient had no known allergies and a medical history of hypertension and diabetes. The patient's concomitant medications were not reported. On 20 September 2014, same day after vaccination, the patient experienced hard lump at injection site and red area just below injection site. Complementary investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none. Follow-up information received from a healthcare professional on 4 May 2015. The patient's identifiers were updated and vaccine provider details were also provided also the name of the reporter was updated. It was reported that the patient had received intramuscular dose of FLUZONE HD in left deltoid. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Headache, Injection site pain, Pyrexia, Swelling
Clinical narrative: Initial report received from a Consumer (the patient) on 28 September 2014. A female patient, whose age, medical history and concomitant medication was not reported, had received a dose of INFLUENZA VACCINE (manufacturer unknown, batch number, dose in series, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patients experienced swelling, redness, fever, headache, and soreness at the injection site. Laboratory details were not reported. The patient received some treatment (unspecified). At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Based on additional information received on 24 Feb 2015 from health care professional, this case is considered as medically confirmed. Initial unsolicited report received from a healthcare professional on 29 September 2014. A 56-year-old female patient with no medical history and concomitant medications of LIPITOR and "Meinforbazole" received an intramuscular dose of FLUZONE batch number: UI199AB (dose in series not reported), in right deltoid, on 27 September 2014 at 9:30am. On 27-Sep-2014 at evening 6pm i.e. 8.5hrs after vaccination the patient experience chills, muscle aches, sore throat, headache and temperature for 101. It was reported that on 29 September 2014 the subject was feeling better. Corrective treatment and laboratory investigations were reported as unknown. At the time of this report, the outcome of the events was reported as unknown. List of documents held by sender: none. Follow-up report received from a Physician on 24 February 2015. The patient was vaccinated with FLUZONE and not with FLUZONE as previously specified. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as hypercholesterolemia and also did not receive any other vaccinations within 4 weeks prior to Influenza vaccine. Documents held by sender: None. Follow-up information received from physician on 6 April 2015. It was reported that the patient was called on form request. No treatment needed. At the time of this report, the outcome of the event was reported as recovered. List of documents held by sender: None.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (non-healthcare professional) on 30 September 2014. The case is linked with the case number 2014SA135969. A male patient (age not reported), whose medical history and concomitant medication were not reported, received an intramuscular dose of FLUZONE ID (batch number, expiration date and dose in series not reported) in to the left deltoid on an unspecified date in October 2013. The patient had experienced golf ball sized lump at injection site 4 days post injection, stated appx 1.5cm in diameter, and L arm sore to touch on an unspecified date in October 2013. The patient illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. The detail of laboratory investigations and corrective treatment were not reported. It was reported that the event was resolved after 4 days. At the time of this report, the outcome of the events was reported as recovered. List of documents held by sender: none. Follow-up information received from consumer on 18 May 2015. Patient has no concomitant medications, medical history and illness at the time of vaccination. Responsible physician details were updated. The state and country were vaccine administered was updated. It was reported that vaccine was purchased with private funds. List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Oropharyngeal pain
Clinical narrative: Initial report received from a consumer on 29 September 2014. A 68-year-old male patient, who had medical history of anemia and insulin dependent diabetes and whose concomitant medications were not reported, received an intramuscular dose of FLUZONE (Lot number, Anatomical site of administration was not reported) on 11-SEP-2013. On 12-SEP-2013, within 24 hours, the patient developed a sore throat and had sore arm at injection site. The corrective treatment and laboratory details were not reported. The patient recovered from the events within 2 days. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated
Clinical narrative: Initial report received from non-healthcare professional on 30 September 2014. A female patient, whose date of birth at the time of event and concomitant medications were not reported, had received intramuscular dose of FLUZONE ID (batch number and anatomical site of administration were not reported, dose number was unknown) eight years ago on an unspecified date. The patient has asthma and no known allergies. The patient's illness at the time of vaccination was unknown. It was reported that 8 years ago on an unspecified date, after receiving FLUZONE ID vaccine, the patient experienced an exacerbation of her asthma. The patient had to be on steroid pack as a corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was recovered. Documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal disorder
Clinical narrative: Got flu shot at first only soreness at site. Progressively got worse until unable to use my right shoulder. This is the 3rd time it has happened. Alternate shoulders.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia
Clinical narrative: Case number PHEH2015US023626, is an initial spontaneous report from a nurse received on 10 Nov 2015. This report refers to a 51 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) in 2014. After vaccination the patient experienced total body alopecia which started in Oct 2014. Her hair had not re grown and she was concerned about taking this season's FLUVIRIN vaccine. Final outcome of the event was not recovered. Seriousness and causality of the event was not reported. Seriousness assessment of "total body alopecia" was upgraded based on information in the source document. Following an internal review on 19 Nov 2015 of the data received on 10 Nov 2015, it was found that the initially case was wrongly assessed as non-serious. Hence the case was upgraded.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropathy, Injected limb mobility decreased
Clinical narrative: Reduced mobility (L) arm after injection.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Swelling face
Clinical narrative: Patient called and spoke to the store manager on 10/26 and said she was just discharged from the hospital. She said her face blew up because of the flu shot. Hospital ran various tests and nothing seem wrong. She refused to speak to a pharmacist.
Age: 77.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood test normal, Electrocardiogram, Injected limb mobility decreased, Pain in extremity, X-ray
Clinical narrative: Had shot roughly around 11:00 A.M. on Oct 29, 2015. Roughly around 1:30 P.M. my left arm hurt and couldn't move it without using Rt hand to hold or move it. Being alone called 911 and got paperwork together. Being it was my left arm thought it was heart attack. EMT's came and in ambulance, they did vitals, IV and EKG. Hospital continued same blood work, using X-ray, aspirin and nitro pill. Blood work showed no attack, spent night in the hospital. Still have some pain but better.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Initial report received from Consumer on 02 October 2014. A 69-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number U5044AA, expiry date 20 May 20155 and dose number was not reported) in to the deltoid left on 30 September 2014. The patient experienced half dollar sized bruised area at the injection site, redness below the injection and warm to touch on 01 October 2014. Lab investigations were not reported and corrective treatment included ice pack applied. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects includes allergic to penicillin, macrolides, ketolides, and lidocaine. At the time of this report the outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Initial report received from the healthcare professional on 02-Oct-2014. A female patient, whose medical history and concomitant medications were not reported, had received a intramuscular dose of FLUZONE (Lot number UI187AB, Dose number not reported previous dose were reported as many) in the left deltoid, on 29 Sep 2014. On 29 Sep 2014, on the same day of vaccination, the patient's left arm injection site was red, rash area size of a silver dollar which was raised and itchy. Illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical history were unknown. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was not recovered. Documents held by sender: none. Follow-up unsolicited report received from a healthcare professional on 12 January 2015. It was reported that the patient had not experienced any adverse reaction after the previous vaccination. On an unspecified date the patient was recovered from the event. Documents held by sender: none. Addendum: 05-March-2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the product code from 271 to 450.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Based on the additional information received on 02 March 2015, this case became medically confirmed. Initial unsolicited report received from a consumer (Patient) on 2 October 2014. A 72-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number and dose number were not reported, intramuscular in right deltoid) on 29 September 2014. It was reported that, the patient has a medical history of diabetes and has no illness at the time of vaccination. It was reported that on 29 September 2014, few hours after receiving FLUZONE HD vaccine, the patient experienced nasal congestion, sore throat and her eyes became blood red with a heavy yellow drainage. The physician prescribed eye drops and nasal sprays as a corrective treatment to the patient and has no laboratory investigations. The patient required ER/doctor visit. At the time of this report, the outcome was recovered. Documents held by sender: none. Follow-up information received from a Physician on 02 March 2015: No additional information was provided. The physician requested to contact the pharmacy that gave vaccine for details. Documents held by sender: none.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 01 October 2014. A 87-year-old female patient, whose medical history and concomitant medication were not reported, received a dose of FLUZONE HD (batch number, expiration date, route, site of vaccination and dose in series not reported) on 17 September 2014. The patient had experienced pain in arm, and loss of movement at the time of vaccination on 17 September 2014. It was also reported that extreme pain in right arm was continued and had loss of movement so that she cannot feed herself or care for herself and unable to sleep. The detail of laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the events was not recovered. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: Initial unsolicited report received from a health care professional on 01 October 2014. A 75-year-old male patient, had received an intramuscular dose of FLUZONE HD vaccine (lot number: U5017BA, expiry date- 07 Apr 2015, dose number not reported) in left deltoid on 10 September 2014. The patient illness at the time of vaccination was not reported. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. On an unknown date since after vaccination patient had experienced high blood sugars. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: None. Follow up report received from a health care professional on 07-APR-2015: No new information was reported. Corrected the coding of event high blood sugars to blood sugar increased from hyperglycaemia
Sex: U
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Initial information received from a healthcare professional on 07 October 2014. A 5-patient (age and gender was not reported), whose medical history and concomitant medications were not reported had received a dose of FLUZONE QIV (batch number UI189AA, expiration date, route, site of vaccination and dose number was not reported) on 26 September 2014. The patient had experienced site reactions, itching, site reactions, warmth and site reactions, bruising, rash on an unspecified date. The patient had no laboratory investigation and corrective treatment was not reported. The patient's illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Joint stiffness, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 01 October 2014. A 69 years old female patient, whose medical history involves bronchiectasis and permanent ileostomy and concomitant medications were not reported had received intramuscular dose of FLUZONE HD (Batch number and expiry date were not reported) in the right deltoid on 30 September 2014. On 30 September 2014 on the same day after vaccination, the patient began to have pain in her right arm. She felt like they hit the bone when the vaccine was administered. The patient had symptoms of headache, malaise and stiffness in her joints. Later in the evening, it was difficult for her to raise her right arm up and down. At the time of this report she has a low grade temperature. Illness at the time of vaccination was not reported. The patient does not have any corrective treatment and laboratory data to report. At the time of this report the patient was not recovered. List of documents held by sender: none. Follow up information received from a consumer on 01 May 2015. No new additional information received. List of documents held by sender: none. Follow up information received from a non-healthcare professional on 02 June 2015. Lot number was reported as U5023BA. It was reported that, primary care physician was not vaccine administering physician to the patient. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 01 October 2014. A 69 years old female patient, whose medical history involves bronchiectasis and permanent ileostomy and concomitant medications were not reported had received intramuscular dose of FLUZONE HD (Batch number and expiry date were not reported) in the right deltoid on 30 September 2014. On 30 September 2014 on the same day after vaccination, the patient began to have pain in her right arm. She felt like they hit the bone when the vaccine was administered. The patient had symptoms of headache, malaise and stiffness in her joints. Later in the evening, it was difficult for her to raise her right arm up and down. At the time of this report she has a low grade temperature. Illness at the time of vaccination was not reported. The patient does not have any corrective treatment and laboratory data to report. At the time of this report the patient was not recovered. List of documents held by sender: none. Follow up information received from a consumer on 01 May 2015. No new additional information received. List of documents held by sender: none. Follow up information received from a non-healthcare professional on 02 June 2015. Lot number was reported as U5023BA. It was reported that, primary care physician was not vaccine administering physician to the patient. List of documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: 10/21/15 - patient received influenza injection. 10/26/15 - patient developed lower body numbness, MRI thoracic spine revealed transverse myelitis. 10/30/15 - IV SOLU-MEDROL treatment started (x 3 days), pt currently on oral taper.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia, Sinus headache
Clinical narrative: Initial report received from healthcare professional on 30 September 2014. A 49-year-old male patient, had medical history of hypertension and concomitant medications were not reported, had received an intramuscular dose of FLUZONE quadrivalent (Batch number UI196AA, expiry date 30 Sep 2015 and dose number was not reported) in to the deltoid right on 29 September 2014. It was also reported that the patient had numerous FLUZONE or flu vaccines- received for past 9 years. The patient had experienced minor sinus headache, chills, sweats, muscle soreness and fever 102F on 29 September 2014. Lab investigations and corrective treatments were not reported. The patient had no illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were included environmental allergies at this time of year reported. The outcome of the event was not resolved at the time of this report. List of documents held by sender: none. Follow up information received from a health care professional on 13 March 2015. It was reported that reviewed no additional information to add to the form.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Initial report received from healthcare professional on 19 September 2014. A 61-year-old female patient, whose concomitant medications were not reported, had received first dose of FLUZONE QIV (batch number UI196AC in left deltoid and route of administration was not reported) having expiry date 30 June 2015 on 18 September 2014. The patient had osteoporosis and has no known allergies. The patient has no illness at the time of vaccination and did not receive any other vaccinations within four weeks of FLUZONE QIV vaccination. It was reported that on 18 September 2014, 25 minutes after receiving FLUZONE QIV vaccine, the patient experienced large 4 by 6 inch swelling with redness which was very itchy. The patient has applied ice immediately as a corrective treatment and has no laboratory investigations. At the time of this report, the outcome was unknown. The patient required ER/doctor visit. Documents held by sender: none.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Injection site swelling, Rash macular
Clinical narrative: Initial report received from a healthcare professional on 19 September 2014. A 90-year-old female patient had received an intramuscular dose of FLUZONE HD, (batch number U5017AA, expiry date 03 April 2015, dose number not reported) in left deltoid on 19 September 2014. The patient denied illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions include lymph node removal of right arm (reason not specified) and multiple allergies but only statins listed. The patient's concomitant medications were not reported. On 19 September 2014, same day after vaccination, the patient developed swelling at the injection site. Within 30 minutes, the right side of her neck had red blotches and her face was flushed. The patient was taken to emergency room for evaluation and treatment. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Pain, Wheezing
Clinical narrative: Initial report received from a healthcare professional (Pharmacist) on 16 September 2014. A 67-year-old male patient had received an intramuscular dose of FLUZONE HD, (batch number U5016BA) in left deltoid on 15 September 2014. The reporter denied any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On 15 September 2014, same day after vaccination, the patient experienced generalized aches and pains, wheezing and temperature was 101 Fahrenheit (38.3 degree Celsius). It was unknown whether the patient received any corrective treatments or self-treated his symptoms. Laboratory tests were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129934, 2014SA129941, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were not reported. Any other vaccination within 4 week of vaccination was unknown. On 16 September 2014, one day after vaccination, the patient experienced chills, nausea, and body aches. Laboratory investigations and corrective treatment was not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Initial report received from healthcare professional on 17 September 2014. A female patient, whose age at the time of event and date of birth were unknown and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number: UI158AA, intramuscular and anatomical site of administration were not reported) on 15 September 2014. The patient's medical history and illness at the time of vaccination were unknown. It was reported that on 16 September 2014, one day after receiving FLUZONE QIV vaccine, the patient experienced headache, nausea, diarrhea and fatigue. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient received vaccine on 10-29-15 with FLUVIRIN shot calling saying red 3 inch circle around inj site. Flu site OK - went to physician told to take BENADRYL and draw bullseye around - think its just a rxn. Pt will follow up if needed. BENADRYL helped rxn gone down.
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129941, 2014SA129934, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) having expiry date 30 June 2015 on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. It was unknown that the patient received any other vaccinations within 4 week of vaccination. On 15 September 2014, on the same day after vaccination, the patient experienced nausea, vomiting, diarrhea, headache and fatigue. The patient's corrective treatment and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash and itching on the first day last for 4 days.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Respiratory rate increased
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129934, 2014SA129950, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A male patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were not reported. Any other vaccination within 4 week of vaccination was unknown. On 16 September 2014, one day after vaccination, the patient experienced fatigue, headache and increased respiratory rate. Corrective treatment and laboratory investigations were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: 10 x 10 cm red hot circular blanchy lesion around injection site. Slightly tender not itchy.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129941, 2014SA129950, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were unknown. On 16 September 2014, one day after vaccination, the patient experienced headache, chills and nausea. Corrective treatment and laboratory details were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up information was received on 12-Nov-2014 from the healthcare professional. A 63-years-old patient had also experienced fatigue after vaccination on an unspecified date. The patient had not received any other vaccine within 4 week prior to influenza vaccine. The patient had received ZOLOFT, lisinopril, metoprolol and HCTZ concomitantly. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies and birth defects were unknown. It was reported that 2 to 3 days later the patient was recovered.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Heart rate increased, Pyrexia, Respiratory disorder
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129934, 2014SA129941, 2014SA129950, 2014SA129951, 2014SA129955, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were unknown. On 15 September 2014, same day after vaccination, the patient presented with elevated heart rate, low grade fever and increased respiratory rate. Corrective treatment and laboratory details were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none. Follow-up information was received on 12-Nov-2014 from the healthcare professional. It was reported that a 25-years-old patient, since vaccination, his lungs are not fully recovered that patient had more breathing issues and has more asthma attacks than usual. The patient had asthma as previous history. The patient had not received any other vaccine within 4 week prior to influenza vaccine. The patient had received multivitamin, albuterol and PZN concomitantly. The patient had no illness at the time of vaccination. It was reported that the event elevated heart rate and low grade fever was resolved.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory rate increased
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129934, 2014SA129941, 2014SA129950, 2014SA129951, 2014SA129955, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were unknown. On 15 September 2014, same day after vaccination, the patient presented with elevated heart rate, low grade fever and increased respiratory rate. Corrective treatment and laboratory details were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none. Follow-up information was received on 12-Nov-2014 from the healthcare professional. It was reported that a 25-years-old patient, since vaccination, his lungs are not fully recovered that patient had more breathing issues and has more asthma attacks than usual. The patient had asthma as previous history. The patient had not received any other vaccine within 4 week prior to influenza vaccine. The patient had received multivitamin, albuterol and PZN concomitantly. The patient had no illness at the time of vaccination. It was reported that the event elevated heart rate and low grade fever was resolved.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthritis, Feeling abnormal, Headache, Migraine
Clinical narrative: I had 3 days of severe migraine headache followed by 3 more days of headaches. at the same time entire body from head to toe aches. Joints felt inflamed and hard to use my body to perform ADL's. I felt like shit. If I had to rate my pain 1-10 I would say 40 (onset 9 hours post injection).
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: I had 3 days of severe migraine headache followed by 3 more days of headaches. at the same time entire body from head to toe aches. Joints felt inflamed and hard to use my body to perform ADL's. I felt like shit. If I had to rate my pain 1-10 I would say 40 (onset 9 hours post injection).
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Pain, Pyrexia
Clinical narrative: Upon internal review, a significant correction was performed on 08 December 2014 to change the coding of the event congestion from 'unevaluable event' to 'nasal congestion'. Initial report received from a healthcare professional on 17 Sep 2014. A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (lot number: UI158AA, dose, dose number, site of vaccination not reported) on 15 Sep 2014. It was reported that, on 16 Sep 2014, the patient felt achy, had congestion and experienced slight fever. Lab investigation details and corrective treatment were not reported. The outcome of the event was reported as unknown. Documents held by sender: None. Follow-up information received from healthcare professional on 12 November 2014. It was reported that the patient was no longer employed by the company. And it was unable to provide answers for the question. Hence end of follow-up. List of documents held by sender: none. Addendum on 08 December 2014: Upon internal review, a significant correction was performed to change the coding of the event congestion from 'unevaluable event' to 'nasal congestion'.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nasal congestion, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. A female patient, whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE QIV, (batch number: UI158AA, expiry date: not reported), in unspecified site on 15-Sep-2014. On 16-Sep-2014, patient experienced congestion, felt achy and slight fever. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from healthcare professional on 12 November 2014. Age of the female is reported as 30-year-old. It was reported that patient had fever for 24 hours with the chills. She had congestion in her nose and body ache for a couple of day. Other medication, Illness at the time of vaccination and pre-existing diagnosed allergies and medical condition was reported as No. At the time of this report, the outcome of the event was reported as recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: My arm is swelling very big. Very painful and itching.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Based on the additional information received on 25 June 2015, this case became medically confirmed. Initial unsolicited report received from a Non-healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129934, 2014SA129941, 2014SA129950, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were not reported. Any other vaccination within 4 week of vaccination was unknown. On 16 September 2014, one day after vaccination, the patient experienced achy, congested and had a slight fever. Laboratory investigations and corrective treatment was not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 25 June 2015. It was reported that the patient had received the vaccine in Left deltoid and this was the first dose for the year. The patient had recovered 3 to 4 days later on an unspecified date. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. A female patient (age not reported) whose medical history and concomitant medication were not reported, received intramuscularly a dose of FLUZONE QIV batch number: UI158AA (site and dose in series not reported) on 15-Sep-2014. On 16-Sep-2014, patient had congestion, felt achy and had slight fever. Corrective treatment and laboratory investigations were reported as unknown. At the time of this report, the outcome of the events were reported as unknown. List of documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Received vax 10/20/15 by 10/22 noted pain/stiffness abductor muscles of hips - continued with hip pain, then around Nov 12 moved to shoulder - joint "shoulder girdle" weakness from pain, stiffness, moving slower alt stiffness/pin. weakness in shoulders improve some in day, increased very noticeable in morning - difficult to get out of bed weakness.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Rash erythematous, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Call from client's neighbor/ interpreter stating client had "big red, itchy, blister like rash" all over the body and scalp, "low grade" temperature. Temp resolved after a few hrs, per caller.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Peripheral swelling, Upper respiratory tract congestion
Clinical narrative: Initial report received from a healthcare professional on 17 September 2014. A 69-year-old female patient, whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD, (manufacturer: Sanofi Pasteur Inc) (batch number: U5015BA, expiry date: not reported), in her left deltoid on 03-Sep-2014 and a dose of pneumococcal vaccine, (manufacturer: other) (batch number: K007773, expiry date: not reported), in her right deltoid on 03-Sep-2014. On 05-Sep-2014, patient experienced bilateral upper extremity swelling, upper respiratory congestion and difficulty breathing. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Blood test normal, Blood thyroid stimulating hormone increased, Cough
Clinical narrative: Approx 7 to 10 days after shot - felt very "weird" malaise - headache - nausea - weak - tired - runny nose - slight cough - terrible digestive issues - abdominal pain - nausea continuous without vomit or diarrhea - no appetite last 1 month.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Gastrointestinal disorder, Headache
Clinical narrative: Approx 7 to 10 days after shot - felt very "weird" malaise - headache - nausea - weak - tired - runny nose - slight cough - terrible digestive issues - abdominal pain - nausea continuous without vomit or diarrhea - no appetite last 1 month.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Rhinorrhoea
Clinical narrative: Approx 7 to 10 days after shot - felt very "weird" malaise - headache - nausea - weak - tired - runny nose - slight cough - terrible digestive issues - abdominal pain - nausea continuous without vomit or diarrhea - no appetite last 1 month.
Sex: F
Vaccine: HPV4
Symptoms: Monoplegia
Clinical narrative: This spontaneous report was received from a registered nurse, via a company representative, referring to a female patient of unknown age. The adverse event was reported to the nurse by a physician because it was one of the physician's patients. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (Lot number, expiration date, dose and route of administration were not reported) at a hospital. Concomitant medication was not reported. On an unknown date, the patient experienced left lower extremity paralysis problems. the outcome of monoplegia was reported as recovered (on an unknown date) in a 6 month timeframe. The causality of monoplegia was unknown. Upon internal review, monoplegia was considered medically significant. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial information received from a healthcare worker provider on 16 September 2014. A 66 year old female patient was vaccinated intramuscularly on 08 September 2014 with FLUZONE High Dose, batch number U5019AA, site of administration not reported. At an unspecified time on the same day, she experienced a metallic taste in her mouth for 1.5 days after vaccination. The symptoms subsided on an unsepcified dat eand the patient recovered. The patient has a history of high cholesterol and hyperlipidemia. The patient was not ill at the time of vaccination. Concomitant medicaitons and laboratory tests were not reported. The patient outocme was recovered. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Lip swelling, Nausea, Pyrexia, Skin fissures
Clinical narrative: Mom states child c/o of sore arm evening of vaccination. She went to bed earlier than normal. She woke up at approx. 0600 with nausea/vomiting/fever of 101. Mom states her cheeks looked swollen and chapped. Her lips were also slightly swollen. We instructed client to go to PCP. Client saw APRN who states it was a reaction to Flu vaccine. Mom denies client has any allergies to food or meds.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Vaccination complication, Vomiting
Clinical narrative: Mom states child c/o of sore arm evening of vaccination. She went to bed earlier than normal. She woke up at approx. 0600 with nausea/vomiting/fever of 101. Mom states her cheeks looked swollen and chapped. Her lips were also slightly swollen. We instructed client to go to PCP. Client saw APRN who states it was a reaction to Flu vaccine. Mom denies client has any allergies to food or meds.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Cardiac monitoring, Dehydration, Extra dose administered, Fall
Clinical narrative: This spontaneous report was received from a 75 year old male patient, regarding himself. Patient's concurrent conditions included hypertension, syncope, dislocation, delusion, acute edema of feet, and gastric reflux. He reported that on an unspecified date, he was vaccinated with ZOSTAVAX eight times in a row (overdose). He explained that each of the 8 injections were consecutive and delivered on the top of his foot by an unknown physician at an unknown hospital. Concomitant therapies included PROZAC, XANAX, potassium sodium hydrogen citrate (Manufacturer unknown) and ADDERALL tablets. Patient reported that he also received a ninth dose of ZOSTAVAX on his shoulder on an unspecified date. On 01-JUL-2015 the patient blacked out on the floor for a period of 30 hours and woke up with terrible pain. He was taken to an unknown hospital for an unspecified amount of time. On an unknown date in 2015, during his hospital stay, it was determined that he was severely dehydrated and had unspecified kidney issues. Patient stated that he felt like he was poisoned and the vaccine was intentionally given to him in the manner to harm him. The patient went on to explain that he felt his mental state was messed. The patient further explained that he then went under an unspecified invasive procedure to test for any heart irregularities. On 06-SEP-2015, he dislocated his shoulder due to a second episode where he blacked out and fell. He was taken back to the same hospital facility for an unknown amount of time, where an unknown medical professional implanted a chip in his chest to monitor his heart on an unknown date in 2015. Furthermore, patient developed hypotension which later turned into hypertension (documented as reported by the patient) and was diagnosed with an autoimmune marker. Patient mentioned that he was in the process of starting a legal case with this unknown hospital. Outcome of the events were unknown. Causality assessment was not provided. Upon internal review, the patient blacked out to be medically significant and considered serious due to hospitalization. The event dislocated shoulder was considered serious due to hospitalization. Additional information is not expected, no contact details were provided.