chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: No treatment. Pt experienced swelling, redness and warmth at injection site - still present two days after.
Sex: U
Vaccine: FLUX, FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer on 12 SEPTEMBER 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA (batch number, dose, cycle in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy to vaccine. Laboratory data and corrective treatments were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLUX, FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a Consumer (patient's wife) on 31-Aug-2015. This case involves a 77-year-old male patient had received a dose of Flu vaccine (batch number, dose, route and site of administration were not reported) on unspecified date. On unspecified date, patient had experienced allergy to vaccine. On 21-Jan-2015, physical examination included height which was reported as 5 feet 11 inches and weight which was reported as about 217 pounds. The outcome of the reported event was not reported. Documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Full blood count, Metabolic function test, Pain in extremity, Peripheral swelling
Clinical narrative: Pt received Influenza vaccine in (R) arm on 11.16.2015 at 10:14. Approx 18 hours after vaccine, (L) hand pain. During evening swelling of hands and feet. (+) itching (+) hives (+) fever (+) pruritic. Pt unable to walk.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Urine analysis, Urticaria
Clinical narrative: Pt received Influenza vaccine in (R) arm on 11.16.2015 at 10:14. Approx 18 hours after vaccine, (L) hand pain. During evening swelling of hands and feet. (+) itching (+) hives (+) fever (+) pruritic. Pt unable to walk.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a physician referring to a 24 year old female patient. No pertinent or historical conditions were reported. On 23-OCT-2015, the patient was inadvertently administered with a dose of VARIVAX (Merck) (lot # L025205, 07-JUL-2017, strength, dose and indication unknown). At the time of vaccination, the patient was pregnant (currently 9 weeks and 2 days gestation) with Last Menstrual Period (LMP) of 19-AUG-2015 and Estimated Date of Delivery (EDD) of 26-MAY-2016. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No pertinent or historical conditions were reported. On 15-OCT-2015 the patient was inadvertently administered a dose of improperly stored M-M-R II (lot # L002873, expiration date 27-JAN-2017, strength, dose and route unknown). No adverse effects were reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal X-ray, Asthenia, Dyspnoea, Eye pain, Flatulence
Clinical narrative: Lethargic, weak, vomiting, nausea, headache, eye pain and blurred vision, difficulty breathing, labored breaths, gas.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Lethargy, Nausea, Vision blurred, Vomiting
Clinical narrative: Lethargic, weak, vomiting, nausea, headache, eye pain and blurred vision, difficulty breathing, labored breaths, gas.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: ITCHING, REDNESS AND SWELLING. PATIENT TOOK AN ANTIHISTAMINE, AND USED WARM COMPRESSES.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Cough, Dyspnoea, Pain
Clinical narrative: Woke up from a nap at 5:30 pm the day of the immunization with chills, fever, shortness of breath and a cough, weakness, achy on left side of body- her arm/shoulder, her hip, the left side of her abdomen. She took some Ibuprofen and went to bed. The morning of 11/19/15 she called into Employee Health stating she had a reaction to the vaccine. She continued to feel chilled, weak, SOB. I informed her she should come into the ER to be seen. She had a temp of 101, positive reflexes and strenght in her extremities. Area of vaccination was pink and warm, with slight swelling noted- very tender to the touch. She has had the influenza vaccine for the past seven years without issues.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Woke up from a nap at 5:30 pm the day of the immunization with chills, fever, shortness of breath and a cough, weakness, achy on left side of body- her arm/shoulder, her hip, the left side of her abdomen. She took some Ibuprofen and went to bed. The morning of 11/19/15 she called into Employee Health stating she had a reaction to the vaccine. She continued to feel chilled, weak, SOB. I informed her she should come into the ER to be seen. She had a temp of 101, positive reflexes and strenght in her extremities. Area of vaccination was pink and warm, with slight swelling noted- very tender to the touch. She has had the influenza vaccine for the past seven years without issues.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: I was unable to lift my left arm. Pain was uncontrollable.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Patients right arm is swollen from deltoid down to 3/4 the biceps and it is red from the deltoid to the elbow and it's warm to the touch and puffy.  Patient states that it doesn't and there are no limitations in her mobility.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified number of patients of unknown age. Between 05-NOV-2015 and 11-NOV-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L019298, expiration date 22-JUN-2017, strength, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Ocular hyperaemia
Clinical narrative: Patient got AFLURIA on 11/17 evening. 11/18 morning she woke up with swollen lips, swollen eyes and red eyes. Took BENADRYL felt little better.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Per wife - patient had fever (did not take temp) x 12 hours starting a few hours after receiving the PNEUMOVAX shot. States on 11-18-15 Rt. arm was swollen from shoulder to elbow with redness and pain. States patient was very tired also. 11-19-15 - fever gone, swelling and redness of arm persist - but improving.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unspecified patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reaction were reported> On 13-JAN-2015, the patient was vaccinated with ZOSTAVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On 28-OCT-2015, the same unspecified patient received another dose of ZOSTAVAX injection (strength, dose, route and lot number or batch number unspecified). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 9-year-old female patient who received FLUARIX. Concurrent medical conditions included allergy (unspecified allergies). On 12th November 2015, the patient received the 1st dose of Flu vaccine. On 12th November 2015, 12 hrs after receiving Flu vaccine, the patient experienced fever. The patient was treated with ADVIL and TYLENOL. On 12th November 2015, the outcome of the fever was recovered/resolved. The reporter considered the fever to be possibly related to Flu vaccine. Additional details provided were as follows: This case was reported by the patient's father. The patient had allergies on the day of her vaccination. The patient did not have a fever at the time of vaccination. On 12th November, within 12 hours after vaccination, the patient experienced fever, which then spiked to 102.2 degree F. The patient was treated with ADVIL and TYLENOL. The fever went away overnight. The patient's energy level was normal.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Blood glucose, Full blood count, Hypoglycaemia, Urine analysis
Clinical narrative: Pt had an episode of symptomatic hypoglycemia within one hr of receiving vaccines.
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Sensation of blood flow
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sensation of blood flow in a female patient who received FLUARIX QUADRIVALENT (batch number DX4SN, expiry date unknown). On 11th November 2015, the patient received FLUARIX QUADRIVALENT. On 11th November 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced sensation of blood flow and foot pain. On an unknown date, the outcome of the sensation of blood flow and foot pain were recovering/resolving. It was unknown if the reporter considered the sensation of blood flow and foot pain to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: On 11th November 2015, around noon, the patient received a dose of FLUARIX QUADRIVALENT. On 11th November 2015, in evening (several hours after) receiving FLUARIX QUADRIVALENT, the patient experienced feeling pulsating or transient pain inside of her foot (unknown foot). The patient experienced pain for the whole night on 11th November 2015 and for the whole day and night on 12th November 2015 and on 13th November 2015, by the noon the pain was subsided. The patient did not see any discoloration and the pain did not travel up her leg. The patient stated that, she did nothing that could trigger the pain in her foot. The injection site was unknown and no other information was available.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Pallor, Syncope
Clinical narrative: Fainting, pale, clammy. O2 was placed on pt.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient started to experience pain at the site of injection approximately two hours after the immunization. She said now 4 weeks later her arm hurts when she moves it up or around.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Hyperhidrosis, Lip haemorrhage, Loss of consciousness, Pallor
Clinical narrative: Apprix 2 min after seasonal flu vaccine and after watching mom get her flu vaccine. Pt had syncope episode which resulted in fall to floor loss of consciousness for a 10 secs. When pick up from fllor noted to be diaphoretic, pale and have bloody bottom lip/ BP 89/64 EMS called pt HR 106 transported to hospital on follow up 11/19 mom stated patient was observed a few hrs in ER and he is ok.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Apprix 2 min after seasonal flu vaccine and after watching mom get her flu vaccine. Pt had syncope episode which resulted in fall to floor loss of consciousness for a 10 secs. When pick up from fllor noted to be diaphoretic, pale and have bloody bottom lip/ BP 89/64 EMS called pt HR 106 transported to hospital on follow up 11/19 mom stated patient was observed a few hrs in ER and he is ok.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received FLUARIX. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a day after receiving Flu vaccine, the patient experirenced injection site erythema, injection site warmth and rash. The patient was treated with BENADRYL. On an unkonwn date, the outcome of the injection site erythema, injection site warmth and rash were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth and rash to be related to Flu vaccine. Additional details provided were as follows: This case was reported by the patient herself. Recently on an unspecified date, the patient received a dose of Flu vaccine at her workplace and experienced the adverse events. On an unknown date, within 24 hours after vaccination, the patient experienced warm and red at the injection site and rash which covered the patient's face and torso. The patient took BENADRYL and the events were resolved in 2 days. At the time of reporting, the patient was fine.
Sex: U
Vaccine: FLU4
Symptoms: Respiratory disorder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of respiratory disorder in a patient who received FLUARIX quadrivalent. In 2015, the patient received FLUARIX quadrivalent. In 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown. It was unknown if the reporter considered the respiratory disorder to be related to FLUARIX quadrivalent. Additional details were provided as follows: The healthcare professional reported that one patient experienced respiratory issues and was taken to emergency room for treatment with 24 hours after receiving the FLUARIX quadrivalent. The healthcare professional also reported that multiple patients who received the FLUARIX QIV complained of abnormal swelling and rash at the injection site within one day after receiving the vaccine (see case US2015162512). The healthcare professional initially called to inquire if there had been a change in 2015 year's formulation or if there had been an increase in reports of these type of adverse reactions with patients receiving FLUARIX QIV. The healthcare professional reported that she was not having access to further patient identifiers or product details at the time of reporting. No further information was reported regarding the event.
Sex: U
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 9 October 2014. This case is linked to the case 2014SA141512 (Same product, same lot number and same reporter). A patient, whose age, gender, medical history and concomitant medications was not reported, had received a dose of FLUZONE QIV (Batch number, dose number UI205AC and expiry date, dose number, route and site of vaccination were not reported), on 09-OCT-2014. On 09-OCT-2014, the patient became very shaky after vaccination. Illness at the time of vaccination, Pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Corrective treatment and Laboratory data were not reported. The patient required ER visit. At the time of this report the outcome was unknown. List of documents held by sender: none. Follow-up information received from a non-healthcare professional on 12 March 2015. It was stated that the event was not confirmed. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during breast feeding, Food allergy, Malaise
Clinical narrative: Initial pregnancy report received from a non-healthcare professional on 06 November 2014. It's a linked to mother case 2014SA154538. A child patient (age and gender not reported), whose medical history and concomitant medication was not reported, had received intramuscularly a dose of FLUZONE, (batch number, expiry date of vaccine, dose, cycle in series and site of vaccination not reported, on 12-Oct-2009 (One pregnancy, not her first), 26-Oct-2010 (while nursing), 13-Dec-2012 (the next pregnancy) and on 12-Sep-2013 (another while nursing). On an unspecified date, patient experienced severe allergy to eggs and peanuts, get very sick and the same time child's mother received the vaccine and was also nursing. No illness at the time of vaccination reported. Corrective treatment and lab investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial report received from consumer on 27 October 2014. A 'patient' (age and gender was not reported0, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD (lot number, and expiration date, route and site of vaccination was not reported) on an unspecified date. It was reported that the patient had experienced adverse event on an unspecified date. The details of lab investigation and corrective treatment were not reported. The outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Initial report received from a healthcare professional (Pharmacist) on 30 September 2014. An 80-year-old female patient had received an intramuscular dose of FLUZONE HD, (batch number U5062BA, expiry date and dose in series not reported) on 27 October 2014. The patient had no illness at the time of vaccination and no known allergies. On 28 October 2014, one day after vaccination, the patient experienced blurry vision. Complementary investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from the event. Documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Dyspnoea, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Initial unsolicited report received from healthcare professional on 03 Nov 2014. A 67-year-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number: U5024CA, expiry date: 12 May 2015), dose number, route of vaccination not reported) in left deltoid on 27 Oct 2014. The patient had a medical history of COPD, congestive heart failure, hyperextension, sleep apnea. The patient had reported allergies to percocet, prednisone, penicillin, Novocain. It was reported that on 28 Oct 2014, that is one day after vaccination, patient woke up with congestion, headache, fever (with temperature of 99.8 degree Fahrenheit) and had sweating. On 29 Oct 2014, the patient developed itchy rash on back and continued to have congestion with some shortness of breath and wheezing. Lab details and corrective treatments were not reported. The outcome of the event was reported as not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 02 June 2015. It was reported that after receiving a dose of FLUZONE HD, patient was in bed for a whole week and became dehydrated on an unspecified date. The symptoms lasted for 7 days. Patient had previous Flu vaccinations before and never had a problem. At the time of this report the patient had completely recovered. Documents held by sender: none.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash pruritic, Respiratory tract congestion, Wheezing
Clinical narrative: Initial unsolicited report received from healthcare professional on 03 Nov 2014. A 67-year-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number: U5024CA, expiry date: 12 May 2015), dose number, route of vaccination not reported) in left deltoid on 27 Oct 2014. The patient had a medical history of COPD, congestive heart failure, hyperextension, sleep apnea. The patient had reported allergies to percocet, prednisone, penicillin, Novocain. It was reported that on 28 Oct 2014, that is one day after vaccination, patient woke up with congestion, headache, fever (with temperature of 99.8 degree Fahrenheit) and had sweating. On 29 Oct 2014, the patient developed itchy rash on back and continued to have congestion with some shortness of breath and wheezing. Lab details and corrective treatments were not reported. The outcome of the event was reported as not recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 02 June 2015. It was reported that after receiving a dose of FLUZONE HD, patient was in bed for a whole week and became dehydrated on an unspecified date. The symptoms lasted for 7 days. Patient had previous Flu vaccinations before and never had a problem. At the time of this report the patient had completely recovered. Documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Initial report received from a non-healthcare professional (patient relative) on 03 November 2014. A male patient, whose medical history and concomitant medications was not reported, had received a dose of Flu shot (batch number, dose, dose in series, route of administration and site of administration was not reported) on 01 January 2014 at 10.15 am. On 01 January 2014, approximately 12 hr. after vaccination, the patient experienced fever 101.5 degree C. Laboratory investigations was not reported. The patient was treated with ADVIL on an unspecified date. On 02 January 2014 the patient was recovered from the event. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Cardiac flutter, Feeling abnormal, Headache, Musculoskeletal pain
Clinical narrative: Shoulder pain, headache, chest fluttering, feels 'weird'.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased
Clinical narrative: Patient complaining of limited range of movement on arm following vaccination, even after 2 & 1/2 weeks.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed localized redness to the injection site. Then developed reddened itchy bumps on trunk and left side of back. Rash gradually improved.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headache, body aches, exhaustion. No fever. No treatment.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Hypopnoea, Oropharyngeal pain, Palpitations
Clinical narrative: 11/18/15, 7:00am woke up w/ a horrible headache, runny nose, sneezing, sore throat, all day felt extreme tiredness.  During the night of 11/18/15, her heart started racing and had shallow breathing, "I thought it was the end," didn't have chills, but couldn't stop trembling, horrible headache throughout the night.  11/19/15, cough, runny nose, bad headache, extreme tiredness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sneezing, Tremor
Clinical narrative: 11/18/15, 7:00am woke up w/ a horrible headache, runny nose, sneezing, sore throat, all day felt extreme tiredness.  During the night of 11/18/15, her heart started racing and had shallow breathing, "I thought it was the end," didn't have chills, but couldn't stop trembling, horrible headache throughout the night.  11/19/15, cough, runny nose, bad headache, extreme tiredness.
Sex: U
Vaccine: FLU4
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in unspecified number of patients who received FLUARIX quadrivalent. In 2015, the patients received FLUARIX quadrivalent. In 2015, less than a day after receiving FLUARIX quadrivalent, the patients experienced injection site swelling and injection site rash. On an unknown date, the outcome of the injection site swelling and injection site rash were unknown. It was unknown if the reporter considered the injection site swelling and injection site rash to be related to FLUARIX quadrivalent. Additional details were provided as follows: The healthcare professional reported the multiple patients who received the FLUARIX QIV complained of abnormal swelling and rash at the injection site within one day after receiving the vaccine. The healthcare professional reported that one patient experienced respiratory issues after vaccination with FLUARIX QIV (see case US2015GSK165000). The healthcare professional initially called to inquire if there had been a change in 2015 year's formulation or if there had been an increase in reports of these type of adverse reactions with patients receiving FLUARIX QIV. The healthcare professional reported that she was not having access to further patient identifiers or product details at the time of reporting. No further information was reported regarding the event.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site pain, Mobility decreased
Clinical narrative: Initial report received from a health care professional in on 15 October 2014. A 28-year-old female patient, had received a dose of FLUZONE QIV vaccine (lot number: UI187AA, expiry date 30 Jun 2015, route and dose number not reported) in left deltoid on 02 October 2014. The patient had no illness at the time of vaccination. The patient did not receive any other vaccinations within 4 weeks of vaccination of FLUZONE QIV. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. On 02 October 2014 i.e. same day after vaccination patient had experienced pain at the administration site since patient received the vaccine and even today patient can't move her arm. Reporter advised to seek medical attention. Corrective treatment was not reported and no laboratory details. At the time of this report, patient outcome was not recovered. Documents held by sender: None. Followup information received from a health care professional on 21 January 2015. It was reported that no new information was provided to report.
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Hypoaesthesia
Clinical narrative: Initial pregnancy report received from a healthcare professional on 13 October 2014. A female subject was pregnant. The subject had received first intramuscular dose of influenza quadrivalent vaccine (batch number, expiry date not reported) in deltoid on 13 October 2014. The subject's current pregnancy history was not available because health record was not available. The last menstrual period and estimated date of delivery was not reported. The information regarding treatment for infertility was not reported. At the time of this report, the subject had numbness in arm after vaccination. It was stated that numbness began in afternoon after vaccination. "AE filed". Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Grip strength decreased, Hypoaesthesia, Pain in extremity
Clinical narrative: Initial report received from Healthcare professional on 16 October 2014. This case is linked to case number 2014SA14350 and 2014SA143085. A 34-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (Batch number UI212AA, expiry date and dose number was not reported) in to the deltoid right on 13 October 2014. The patient had experienced arthralgia in right hand, can't grip the steering wheel, pain in right arm and hand and numbness on 13 October 2014. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination was not reported, and pre-existing diagnosed allergies and birth defects were reported as none. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Follow up information received from a health care professional on 16 March 2015. It was reported as not my patient by the physician.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Blood test normal, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Based on follow-up information received on 09 March 2015, the case became valid. Initial unsolicited report received from a non-healthcare professional on 10 November 2014. This case is invalid as the individual patient identifiers were not reported. The case is linked to 2014SA155403. A number of 5 to 6 patients (age and gender not reported), whose medical history and concomitant medication was not reported, had received a dose of FLUZONE ID (batch number, expiry date of vaccine, number of dose, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, patient experienced large knot at injection site. Illness at the time of vaccination was not reported. 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 report received from a non-healthcare professional on 09 March 2015. This is a cluster of 2 cases and is linked to case number 2014SA155403. (Same vaccine and same lot number). A 26-year-old female patient had received an intradermal dose of FLUZONE ID (batch number: UT4992AA) in right deltoid on 31 October 2014. On 01 November 2014, one day after vaccination, the patient had experienced large knot at injection site and redness, swelling, painful at injection site. The patient required emergency room visit. Laboratory investigations included allergy testing and bloodwork. Results showed the patient was not allergic to injection. On an unspecified date, the outcome of the events was recovered.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Based on follow-up information received on 09 March 2015, the case became valid. Initial unsolicited report received from a non-healthcare professional on 10 November 2014. This case is invalid as the individual patient identifiers were not reported. The case is linked to 2014SA155403. A number of 5 to 6 patients (age and gender not reported), whose medical history and concomitant medication was not reported, had received a dose of FLUZONE ID (batch number, expiry date of vaccine, number of dose, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, patient experienced large knot at injection site. Illness at the time of vaccination was not reported. 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 report received from a non-healthcare professional on 09 March 2015. This is a cluster of 2 cases and is linked to case number 2014SA155403. (Same vaccine and same lot number). A 26-year-old female patient had received an intradermal dose of FLUZONE ID (batch number: UT4992AA) in right deltoid on 31 October 2014. On 01 November 2014, one day after vaccination, the patient had experienced large knot at injection site and redness, swelling, painful at injection site. The patient required emergency room visit. Laboratory investigations included allergy testing and bloodwork. Results showed the patient was not allergic to injection. On an unspecified date, the outcome of the events was recovered.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Influenza like illness, Injection site pain, Malaise, Posture abnormal
Clinical narrative: Initial report received from healthcare professional on 06 Nov 2014. A 58-year-old female patient, had received a dose of Flu shot (lot number, dose, dose number, route not reported) in the arm on 04 Nov 2014. The patient had a medical history of urinary tract infection and had a course of antibiotics (within three weeks prior vaccination). The patient had been also taking AUBAGIO for multiple sclerosis as concomitant medication. About 8 hours after vaccination, the patient developed a reaction that was not quite the flu, but flu-like, and could hardly hold her head up, did not feel well, and was in a fetal position with chills, and blankets on her. The patient also had pain and soreness in her arm in the area where the flu shot was given. There was no diarrhea or vomiting. On 06 Nov 2014, in morning, patient felt better. Lab details and corrective treatments were not reported. The outcome of the event was not recovered. Documents held by sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 24 October 2014. This case is linked to cas numbers 2014SA147665 and 2014SA150234 (same reporter). A male patient, whose age was unknown, had received a dose of FLUZONE ID, (batch number, dose number, route and site of vaccination not reported) on an unspecified date. The patient's illness at the time of vaccination, concomitant medications and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. On an unspecified date, the patient experienced severe swelling and pain at the injection site that prevented him moving his arm. Corrective treatments were not reported and laboratory details were unknown. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: Initial report received from healthcare professional on 3 November 2014. This case is linked to case 2014SA152268 (same reporter, same vaccine FLUZONE QIV). A female patient, whose date of birth, age at the time of event, medical history and concomitant medications were not reported, had received intramuscular first dose of FLUZONE QIV (batch number and anatomical site of administration were unknown) on an unspecified date of September 2014 to October 2014. It was reported that on an unspecified date of September 2014 to October 2014, after receiving FLUZONE QIV vaccine, the patient experienced fever and chills. 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. Follow up information received from healthcare professional on 13 Jan 2015. It was reported that the patient experienced fever and chills for 24 to 48 hours. The outcome of the event was resolved. Follow up information received from healthcare professional on 26 Jan 2015. A 50 year-old female patient, whose medical history included celiac disease and being prone to getting high (103 degree) fever, received a first dose of FLUZONE QIV (Batch number UI200AC, expiry date 30Jun2015) in right arm intramuscularly at 11: am on 31-Oct-2014. Corrective treatment included 1000mg TYLENOL. No diagnostic or lab tests were done. No medications routinely taken. The outcome of the event was unknown. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Depression, Disturbance in attention, Fatigue, Headache
Clinical narrative: Initial report received from a Consumer (Patient) on 10 November 2014. A 65-year-old female patient, had received an intramuscular first dose of FLUZONE HD vaccine (lot number: unknown, site of administration was not reported) on 25 October 2014. The patient illness at the time of vaccination was not reported. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as "patient have a lot of things wrong with her and take a lot of meds" for lung disease and takes prednisone. On 26 October 2014 i.e. one day after vaccination patient had experienced malaise due to fatigue from lack of sleep, headache, sinus trouble, lack of concentration and depression for the 2 weeks following vaccination. It was reported that patient developed a burning sensation and pain outside the lungs around the rib cage much like pleurisy. She took prednisone 15mg-10mg-5mg regimen for 3 days and a 20mg-15mg-10mg-5mg regimen for 4 days. Patient stated she takes this for a lung condition (unspecified). Patient had received antihistamines for the sinus trouble as a corrective treatment. Laboratory investigations were not reported. At the time of this report, patient outcome was resolving she is feeling much better at this time. Documents held by sender: None. Follow up information received from a consumer on 26 March 2015. It was reported that batch no of FLUZONE HD was U5063BA. Prednisolone therapy start date was reported as 25 October 2014.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Malaise, Musculoskeletal chest pain, Pleurisy, Sinus disorder
Clinical narrative: Initial report received from a Consumer (Patient) on 10 November 2014. A 65-year-old female patient, had received an intramuscular first dose of FLUZONE HD vaccine (lot number: unknown, site of administration was not reported) on 25 October 2014. The patient illness at the time of vaccination was not reported. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as "patient have a lot of things wrong with her and take a lot of meds" for lung disease and takes prednisone. On 26 October 2014 i.e. one day after vaccination patient had experienced malaise due to fatigue from lack of sleep, headache, sinus trouble, lack of concentration and depression for the 2 weeks following vaccination. It was reported that patient developed a burning sensation and pain outside the lungs around the rib cage much like pleurisy. She took prednisone 15mg-10mg-5mg regimen for 3 days and a 20mg-15mg-10mg-5mg regimen for 4 days. Patient stated she takes this for a lung condition (unspecified). Patient had received antihistamines for the sinus trouble as a corrective treatment. Laboratory investigations were not reported. At the time of this report, patient outcome was resolving she is feeling much better at this time. Documents held by sender: None. Follow up information received from a consumer on 26 March 2015. It was reported that batch no of FLUZONE HD was U5063BA. Prednisolone therapy start date was reported as 25 October 2014.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site induration
Clinical narrative: Initial misuse report received from a healthcare professional on 07 November 2014 and follow-up information received on 10 November 2014. A 61-year-old female patient had received first dose of FLUZONE HD, (batch number 45063BA, intramuscularly in left deltoid) on 06 November 2014. The reporter denied any illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions include autism, hypothyroidism, lupus, RA (rheumatoid arthritis) and allergy to bee stings. The patient's concomitant medications were not reported. The patient received vaccine at an inappropriate age. On 07 November 2014, one day after vaccination, the patient presented with site reaction of 14 cm erythema, redness and 7cm induration. The patient was sent to emergency room for evaluation. Laboratory investigations were not reported. The patient was prescribed KEFLEX as corrective treatment. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow up information received from a healthcare professional on 20 February 2015. It was confirmed that the lot number of the suspect product was 45063BA. The patient had no laboratory investigations. As corrective treatment the patient received BENADRYL. It was reported that the patient recovered within 24 hours of onset of the event.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Initial report received from healthcare professional on 20 October 2014. A 50-year-old male patient, had medical history of diabetes, hypertension, hypercholesterolemia, sleep apnea and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI159AA, expiry date 30 Jun 2015 and dose number was not reported) in to the deltoid right on 13 October 2014. The patient had experienced joint pain and fever to 101.6 F on 15 October 2014. Lab investigations were not reported and corrective treatments included ADVIL. It was reported that the pain and joint pain resolved on an unspecified date. The patient had no illness at the time of vaccination, pre-existing diagnosed allergies prednisone and sulfa drugs and birth defects were reported. At the time of this report outcome of pain was resolved and fever was unknown. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Initial report received from a consumer on 21 October 2014. A patient, whose gender, age at the time of event and concomitant medications were not reported, had received a dose of influenza vaccine (batch number, dose number, route and anatomical site of administration were not reported) of unknown manufacturer on an unspecified date. It was reported that, the patient had migraine headache in the past and didn't have for the past 7 or 8 years. It was reported that on an unspecified date, immediately after receiving Influenza vaccine, the patient experienced severe headache. It was reported that, headache continued for two days. Headache was severe and after taking ADVIL also as a corrective treatment it was coming back within few hours which were continued in the night also. As per reporter, influenza vaccination triggered migraine as it was as severe as patient's migraine headache. The patient's laboratory investigations were not reported. At the time of this reporter, the outcome was not recovered. Documents held by sender: none. Follow-up information received from a consumer on 24 December 2014. On 01-Oct-2014, a female patient was vaccinated with influenza vaccine and patient details were updated. List of documents held by sender: None. Follow up information received from a consumer on 27-Mar-2015. The patent demographics (age and date of birth were provided). A 63 year old patient had received first dose of influenza vaccine. On 01-Oct-2014 the vaccine was administered to all employees. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions included "heart bypass" and history of migraines in childhood. There was no illness at the time of vaccination. Concomitant medications included LIPITOR, metoprolol and aspirin (81 mg). There was no other vaccine administered 4 weeks prior to the vaccination date. There was no adverse event prior to the vaccination. It was reported that the patient was doing well and there were no other problems after few days. There were no laboratory investigations performed. At the time of this report, the patient had recovered from the event of severe headache on an unspecified date. Follow-up information received from a Nurse on 11 May 2015. Reporter stated that she could not confirm the case based on the information provided. It was possible that the above - named individual was a temporary contact at the site, but they were not current or past employee. List of the documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Limb discomfort, Myalgia
Clinical narrative: Initial report received from healthcare professional on 21 OCTOBER 2014. A 65-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (batch number U5023BA, expiry date 27 APR 2015, route, size of vaccination and dose number were not reported) on 06 OCTOBER 2014. The patient had experienced muscle pain in the arm, her arm feels heavy, and pain at injection site on an unspecified date after vaccination. Lab investigation and corrective treatments were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were not 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 healthcare professional on 03 NOVEMBER 2014. It was reported that patient still has heaviness in her left arm where vaccination was given. List of documents held by sender: none. Follow-up information received from healthcare professional on 10 NOVEMBER 2014. Th patient stated that she was offered the FLUZONE HD as a choice but, it was recommended by her physician because she has asthma. The patient had claims that she was still having symptoms 5 weeks later. The patient stated the heaviness persists in her right arm. The patient stated that she decided not to be evaluated and treated with symptomatically by her physician. The patient was self-treated with Ibuprofen for muscle aches and joint pain. At the time of this report the patient was not resolved from the event. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Initial report received from healthcare professional on 21 October 2014. A 74-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number U5022BA, expiry date 29 Apr 2015 and dose number was not reported) in to the deltoid left on 20 October 2014. The patient had experienced an area of redness 2 inches below the injection site on 21 October 2014. Lab investigations were not reported and corrective treatments included ice therapy. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were not reported. The outcome of the event was unknown at the time of this report. List of documents held by sender: none.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: Initial report received from Healthcare professional on 24 October 2014. This case is linked to case 2014SA147665 and 2014SA150234. A two patient over 65 year, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Batch number, expiry date, route, site of vaccination and dose number was not reported) on an unspecified date. The diabetic patients with elevated glucose 3 hours post administration on an unspecified date. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects was not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Rash generalised, Vomiting
Clinical narrative: Nausea and vomiting with a fever on tuesday am (11.17) on Wednesday (11.18) also had a rash all over.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site macule, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: Upon focused PE finding 11/19/15 there is a 5cm circumferential light erythematous macule around the injection site of left deltoid which then leads to a 5cm circumferential hive-appearing lesion with very mild edema and mild tenderness on the left medial bicep. Mild pruritis. No warmth.  Afebrile.  Denies throat itching, dyspnea, SOB, wheezing, CP.  Able to tolerate food well.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Upon focused PE finding 11/19/15 there is a 5cm circumferential light erythematous macule around the injection site of left deltoid which then leads to a 5cm circumferential hive-appearing lesion with very mild edema and mild tenderness on the left medial bicep. Mild pruritis. No warmth.  Afebrile.  Denies throat itching, dyspnea, SOB, wheezing, CP.  Able to tolerate food well.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Red spot on arm where shot was administered.