chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Influenza like illness
Clinical narrative: Initial report received from a healthcare professional on 02 October 2012. A male patient of unspecified demographics, who had no illness at the time of vaccination and with unknown medical history, had received a dose of FLUZONE (Lot number, dose number and anatomical site of vaccination not reported) intramuscularly on 20 August 2012. On 21 August 2012, the patient had flu like symptoms and had chills that seemed like convulsions every 3 hours, no temperature was taken. The patient reported that he had a difficult night from exactly 12 am to 6 am on 21 August 2012. The patient did not seek medical attention from a physician; go to the hospital or ED. Laboratory details were none and corrective treatment was not reported. As of 02 October 2012, the patient had recovered from the events. Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Injection site erythema, Injection site mass, Injection site swelling, Injection site vesicles
Clinical narrative: Initial report received from a non-healthcare professional (patient) on 16 October 2012. A 64-year-old female patient, who had no illness at the time of vaccination and had concomitant medication with eye drops, had received an intramuscular dose of FLUZONE (Lot number unknown, dose number and site of vaccination not reported) on 29 September 2012. On 06 September 2012 i.e. 07 days after vaccination administration the patient's left arm started to feel sore and had flu symptoms and a high fever of 101 F. The patient had gone to the pharmacy to show them that the arm was swollen and she was told to put ice pack on it. There was a goose egg size lump at the injection site which she noticed after she put the ice on it. The next day a water blister appeared at the injection site and it was red and swollen. The patient soaked a needle in alcohol and stabbed the water blister and put Polysporin on it. Laboratory details were not reported and corrective treatment includes ibuprofen and polysporin. As of 16 October 2012, the patient had not recovered. Documents held by sender: none. Follow up information received from a healthcare professional on 31 January 2013. The patient received FLUZONE in left deltoid from lot number UH716AB. Approximate size of lump at the injection site was reported as 2 inch long, 1 inch wide and 3/4th inch high.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Initial report received from a non-healthcare professional (patient) on 16 October 2012. A 64-year-old female patient, who had no illness at the time of vaccination and had concomitant medication with eye drops, had received an intramuscular dose of FLUZONE (Lot number unknown, dose number and site of vaccination not reported) on 29 September 2012. On 06 September 2012 i.e. 07 days after vaccination administration the patient's left arm started to feel sore and had flu symptoms and a high fever of 101 F. The patient had gone to the pharmacy to show them that the arm was swollen and she was told to put ice pack on it. There was a goose egg size lump at the injection site which she noticed after she put the ice on it. The next day a water blister appeared at the injection site and it was red and swollen. The patient soaked a needle in alcohol and stabbed the water blister and put Polysporin on it. Laboratory details were not reported and corrective treatment includes ibuprofen and polysporin. As of 16 October 2012, the patient had not recovered. Documents held by sender: none. Follow up information received from a healthcare professional on 31 January 2013. The patient received FLUZONE in left deltoid from lot number UH716AB. Approximate size of lump at the injection site was reported as 2 inch long, 1 inch wide and 3/4th inch high.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Initial report received from a healthcare professional on 18 October 2012. A 61-year-old female patient, whose medical history and concomitant medications were unknown, received first dose of FLUZONE (lot number: UH745AD) intramuscularly in the left arm on 16 October 2012. On 17 October 2012, the patient's whole left arm was swollen, painful, red and itchy. Corrective medications and laboratory investigations's were not reported. As of 18 October 2012, the patient had not recovered from the events. Follow-up information received from a healthcare professional on 04 February 2013: The patient's had personal past medical history of elevated blood pressure reading without diagnosis of hypertension, (onset on an unspecified date 2012), mixed hyperlipidemia, anxiety state (unspecified, situational, resolved with counseling), allergic rhinitis, asthma (unspecified), contact dermatitis and other eczema (unspecified cause) and impaired glucose tolerance. The patient had surgical history of arthroscopy, shoulder surgical with rotator cuff repair (onset July 2008) left, for impingement and tendon sheath incision (trigger finger, onset 2001). The patient's mother had history of gout and father had history of Parkinson's diseases, asthma unspecified, and allergic rhinitis. The patient's blood pressure was 156/88 mmHg, it had generally been lower than this on previous checks. Her weight was 190.5 units not specified and temperature was 98.0 units not specified. Left arm was slightly warm as compare to red, but especially not tender even when the muscle was squeezed. There was no visible redness or puncture mark. The only visible skin lesion appears to be her old small pox vaccination scar. There was local and possible systemic reaction to influenza vaccine. No further treatment was needed. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Gastrointestinal disorder, Pain, Pyrexia
Clinical narrative: Initial report receive from a healthcare professional on 19 October 2012. A patient, whose age, gender, medical history and concomitant medications were not reported, had received FLUZONE (Lot number UH746AA, route and anatomical site of vaccination was not reported) on an unspecified date. The patient had gastrointestinal symptoms, low grade fever, body aches and dizziness following vaccination. Laboratory details and corrective treatment was not reported. The patient's outcome was unknown. List of documents held by the sender: None.
Sex: M
Vaccine: FLU3
Symptoms: Ear swelling, Erythema, Swelling face
Clinical narrative: Initial report received from a healthcare professional on 06 November 2012. A male patient (age and date of birth not reported), who had allergies possibly to eggs and fish, no history of medical conditions and concomitant medications were not reported, had received a dose of FLUZONE (batch number was unknown, route and site of administration were not reported) on an unspecified date about 1 week ago. The reporter stated that, on an unspecified date about 1 week ago, within 5 minutes of vaccination the patient experienced swollen, bright red ears and cheeks. The patient received corrective treatment with BENADRYL. Laboratory data was not reported. On an unspecified date, the patient had recovered. Follow-up information received from a healthcare professional on 01 July 2013: The patient address details were updated. List of documents held by sender was none.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Initial information received from a healthcare professional on 31 October 2012. A 56-year old female patient, who had no acute illness at the time of vaccination and no known allergies, had received an intramuscular dose of FLUZONE (Batch number: UH716AA) on right deltoid on 10 October 2012. The patient's concomitant medication included NEXIUM, NASONEX, Gabapentin, ADVAIR, "Alprazalem" (Alprazolam) and "Trasalone" (Trazodone). On 14 October 2012, 4 days after vaccination, the patient had quarter size bruise on right shoulder. No medical intervention. Laboratory details were none per reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: This case is from a cluster of 11 cases received from a same reporter with same vaccine lot number 2012-10136, 2012-10137, 2012-10138, 2012-10139, 2012-10092, 2012-10141, 2012-10142, 2012-10143, 2012-10144 and 2012-10145. Initial report received from healthcare professional on 18 October 2012. A patient (age, gender, date of birth were not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE, batch number: UH717AC (route and anatomical site of administration were not reported) on 11 October 2012. It was reported that on an unspecified date, after receiving FLUZONE, the patient experienced red bump and skin hot to touch. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Wheezing
Clinical narrative: Initial report received from a pharmacist on 14 November 2012. A 31 year-old female patient had received a dose of FLUZONE (lot number UH718AB) on 27 August 2012 and about 1 week later experienced cold symptoms and continues to have respiratory symptom of wheezing. The patient required doctor visit; however it was not reported whether treatment was required. The patient had no illnesses at time of vaccination. Medical history included allergies to sulfa. The patient has not recovered. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a cluster case of four patients (same reporter, same product and same batch number) and is linked with the cases 2012-11094, 2012-11095 and 2012-11083. Initial report received from a health care professional on 19 November 2012. A 50-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose FLUZONE (Lot number UH728AA, dose number and site of vaccination were not reported) intramuscularly on 10 November 2012. It was reported that, the patient was not able to raise her arm for several days after the injection. On 11 November 2012, the patient was unable to lift her arm over her head because of site soreness. The patient had been applying heat to the site as a corrective treatment. Laboratory data were reported as unknown. The outcome of the event was reported as unknown. Follow up information received from a healthcare professional on 09 April 2013. The patient concomitant medications included vitamin B12 and multiple vitamins. The patient had no illness at time of vaccination and had no adverse event after previous administration of vaccine. The patient had allergy to penicillin and LEVAQUIN. The patient had received FLUZONE in right deltoid on 10 November 2012 at 0700. The patient had recovered from the events on an unspecified date. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a cluster case of four patients (same reporter, product and product batch number) and is linked to case numbers 2012-11095, 2012-11094, 2012-11080. Initial report received from a healthcare professional on 19 November 2012. A 55-year-old female patient who had no reported medical history, concomitant medications and illness at the time of vaccination, had received a dose of FLUZONE vaccine (batch number: UH728AA) intramuscularly (dose number and site of administration not reported) on 11 October 2012. It was reported that, the patient was unable to raise her arm after the injection. On 11 November 2012, the patient was unable to life her arm over her head because of site soreness, but otherwise she was able to use the arm without incident. The patient had self-treated with TYLENOL. Lab investigations were unknown. At the time of this report, the outcome of the event was unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 08 April 2013. The patient has hypertension and was taking Lisinopril. The patient was allergic to codeine. The patient had not received any other vaccine 4 weeks prior to vaccination and had no illness at the time of vaccination. The patient had received vaccine in right deltoid on 11 October 2012 at 9.00. No laboratory investigations were done. The patient's outcome was recovered.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Erythema multiforme, Local swelling, Pruritus, Rash erythematous
Clinical narrative: Initial report received from a consumer who is also the patient on 11 JANUARY 2013. A 29-year-old male patient, who had medical history of allergies to bee sting and seasonal allergies and had no other history of medical conditions, had received an intramuscular dose of FLUZONE (batch number-unknown) at right deltoid on 16 DECEMBER 2012. The patient had no illness at the time of vaccination. On 19 DECEMBER 2012 (within 72 hours of the vaccination) the patient experienced itchy palms. About 1 week later the patient experienced red spots rash on palms, spread to wrists, collar bone, and then all over body. The patient continued to have breakout of raised, swollen, itchy, red patches. On an unspecified date, own PCP diagnosed as erythema multiform. The patient required ER/Doctor visit. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient's outcome was not recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Initial report received from a consumer who is also the patient on 11 JANUARY 2013. A 29-year-old male patient, who had medical history of allergies to bee sting and seasonal allergies and had no other history of medical conditions, had received an intramuscular dose of FLUZONE (batch number-unknown) at right deltoid on 16 DECEMBER 2012. The patient had no illness at the time of vaccination. On 19 DECEMBER 2012 (within 72 hours of the vaccination) the patient experienced itchy palms. About 1 week later the patient experienced red spots rash on palms, spread to wrists, collar bone, and then all over body. The patient continued to have breakout of raised, swollen, itchy, red patches. On an unspecified date, own PCP diagnosed as erythema multiform. The patient required ER/Doctor visit. Corrective treatment and laboratory investigations were not reported. At the time of this report, the patient's outcome was not recovered. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report received form a health care professional on 19 NOVEMBER 2012. A 72-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number: UH728AA, site of vaccination was not reported) on 29 OCTOBER 2012. On 19 NOVEMBER 2012, 21 days after vaccination, the patient was not able to raise the arm over her head because of site soreness.. As per the reporter, otherwise the patient was able to use the arm without incident. The patient had self-treated with TYLENOL (acetaminophen) on unspecified dates. Laboratory data were unknown. At the time of this report, the outcome was unknown. List of documents held by sender: none. Follow-up information received from a healthcare professional on 09 APRIL 2013. The reporter details were updated. The patient had received FLUZONE in left deltoid on 19 NOVEMBER 2012 at 10:00 hours. The patient had followed up with ortho, as per his, there was no way to know if related to FLUZONE and had physical therapy. The patient had recovered on an unspecified date.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report received from a consumer (patient) on 17 JANUARY 2013. A 65-year-old female patient whose medical history and concomitant medications were not reported had received an intramuscular dose of FLUZONE (batch number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date (at the night of vaccination) the patient had bad flu symptoms. Corrective treatment and relevant laboratory data were not reported. On an unspecified date, i.e. next day the patient had recovered from the event. Document held by sender: None.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nasal congestion, Ocular hyperaemia, Pain, Sinus congestion
Clinical narrative: Initial report received from non-healthcare professional on 27 AUGUST 2013. A 48-year-old male patient had received a dose of FLUZONE (batch number was unknown and dose number, route and anatomical site of administration were not reported) on 21 AUGUST 2013. The patient is allergic to tree pollen. The patient has no medical condition as per reporter with no illness at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccination within 4 weeks of vaccination. IT was reported that on 21 AUGUST 2012, 4 hours after receiving FLUZONE, the patient experienced "throat irritation like cold coming on", sinus congestion , nasal congestion, achiness, sweating and bloodshot eyes. The patient received 3 ADVIL (ibuprofen) and 1 CLARITIN (loratadine) as a corrective treatment and laboratory investigation were not reported. On the next morning, the patient was felt 80 percent better and by later afternoon the day after vaccination all symptoms were resolved and no further symptoms noted. At the time of this report, the outcome was recovered. Documents held by sender: none.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Initial report received from non-healthcare professional on 27 AUGUST 2013. A 48-year-old male patient had received a dose of FLUZONE (batch number was unknown and dose number, route and anatomical site of administration were not reported) on 21 AUGUST 2013. The patient is allergic to tree pollen. The patient has no medical condition as per reporter with no illness at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccination within 4 weeks of vaccination. IT was reported that on 21 AUGUST 2012, 4 hours after receiving FLUZONE, the patient experienced "throat irritation like cold coming on", sinus congestion , nasal congestion, achiness, sweating and bloodshot eyes. The patient received 3 ADVIL (ibuprofen) and 1 CLARITIN (loratadine) as a corrective treatment and laboratory investigation were not reported. On the next morning, the patient was felt 80 percent better and by later afternoon the day after vaccination all symptoms were resolved and no further symptoms noted. At the time of this report, the outcome was recovered. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Faeces discoloured
Clinical narrative: Initial report received from a consumer who is also the patient's parent on 12 SEPTEMBER 2013. A 2-year-old male patient, had received a second dose of FLUZONE SV 2013-2014 (lot number: unknown and site of vaccination was not reported) intramuscularly on 07 SEPTEMBER 2013. The patient had no illness at the time of vaccination and had no known allergy. The patient concomitant medications were not reported. On 10 SEPTEMBER 2013 the patient had black tarry stool early in the morning and "past 3 days" and the patient had not experienced any symptoms prior to receiving the flu shot. Laboratory details and corrective medication as not reported. The patient outcome was not recovered. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Initial information received from consumer on 17 AUGUST 2012. A 31-year-old female patient, whose medical history and concomitant medication was not reported received dose of ADACEL (batch lot number and dose not reported) intramuscularly on 27 JULY 2012. The patient stated that she was pregnant at the time of vaccination with date of last menstrual period 29 JUNE 2012 and estimated date of delivery 05 APRIL 2013. Also the patient experienced low grade fever and small lump  under the skin on upper left arm which was hot to touch for a week on unspecified date. Laboratory details and corrective treatment was not reported. Outcome of the event was unknown. Documents held by sender: none. Follow up information received from a healthcare professional on 28 JANUARY 2013. The patient had no illness at the time of vaccination. The patient had received ADACEL (lot number: C3828AA) in left deltoid on 27 JULY 2012. "The patient thought that she was not pregnant at the time of vaccination".
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Initial report received from a healthcare professional on 26 SEPTEMBER 2012. A female patient who was born on 27 NOVEMBER 1958, which unknown medical history, had received dose of FLUZONE (site, route, and lot no. unknown) on an unknown date. On an unknown date, the patient swelled up for 06 days and was seeking form medical attention and physical therapy. Lab investigations and corrective treatments were not reported. The patient's outcome was unknown. List of documents held by the sender: none.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Initial pregnancy report received from a health care professional on 31 July 2012. A 26 years old female patient, with no reported medical history and concomitant medications, had received a intramuscular dose of ADACEL on 28 July 2012. The patient experienced no adverse event. The patient's had Last Menstruation Period on 07 November 2011 and Estimated Date of Delivery was reported as 13 August 2012. Outcome of the adverse event was not reported. List of documents held by the sender: None. List of documents held by the sender: None. Pregnancy Follow-up information received on 05 October 2012: Patient had taken prenatal vitamins as other medications. Nuchal Translucency (1st trimester screen) and AFP test showed normal results and also showed normal fetal sonograms. Cesarean section was performed due to breech presentation. It was reported that mother health status was good, postpartum. It was reported that patient was recovered. On 09 August 2012, the patient gave birth to a normal female child with APGAR SCORE 9, 9 for both 1 min and 5 min. Weeks of gestation were 39 and weight of child was 3,459 kg with no congenital abnormalities.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case is lined with AER # 2013-08998 (same patient who developed injection site redness, warmth and itching after taking FLUZONE High Dose on 14 AUGUST 2013 and same reporter). Initial report received from a healthcare professional on 19 AUGUST 2013. A female patient whose age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE  SV 2012-2013 (batch number,  exact dose number, route and site of administration were not reported) on 30 JULY 2012. On an unspecified date, the patient had an unspecified adverse event. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Injection site nodule, Limb discomfort, Pain in extremity, Pruritus
Clinical narrative: Initial report received from a healthcare professional on 21 AUGUST 2013. A 25-year-old female patient had received 0.1 ml intradermal dose of FLUZONE (batch number: UH717AA) intradermally on 21 AUGUST 2013. On 21 AUGUST 2013, the patient had inadvertently received expired dose of FLUZONE instead of 0.1 ml of Tubersol. The patient had no medical history; no illness at the time of vaccination and no known allergies. On 21 AUGUST 2013, at the time of administration, the patient experienced itching and knot in forearm. After 3 hours of vaccination, the patient experienced heaviness and pain in the arm. Laboratory investigations were not reported. The patient was given ZYRTEC (Cetirizine) and ice pack to the site (forearm) as corrective treatment. The outcome of the events was unknown. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site pruritus, Injection site swelling
Clinical narrative: Pregnancy report received from a Health Care Professional on 24 JUNE 2012. A female patient (date of birth not reported) whose medical history and concomitant medications were not reported had received a dose of ADACEL (lot number, route and site of administration was not reported) on an unspecified date. The patient presented 9 cm swelling and itching at injection site over a week after receiving vaccines. The patient was pregnant at the time of vaccinate. Corrective treatment and laboratory investigations were not reported. The patient pregnancy history, LMP date and expected date of end of pregnancy was not reported. The outcome was not reported. Documents held by sender: none
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Swelling
Clinical narrative: Initial report received from a health care professional on 21 September 2012. A 56-years-old female patient with medical history of fibromyalgia and psych problems, whose concomitant medications were not reported, had received a dose of FLUZONE (lot number UH711AA) intramuscularly in left arm on 18 September 2012. On 20 September 2012, the patient woke up with pain and swelling in left axillary area with temperature 97 as per physician. 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 a healthcare professional on 15 November 2012. The patient received ibuprofen and ice as a corrective treatment. The laboratory investigations were none. The patient received probiotic (2 daily), clonazepam 0.5 mg table (1 tablet by oral route every day), propranolol 10 mg tablet (1 tablet by oral route every day), venlafaxine ER 150 mg 24 hour cap (1 capsule by oral route every day), niacin ER 250 mg (2 Q HS), venlafaxine ER 75 mg 24 hour tablet (1 tablet by oral route every day in the morning at the same time each day with meal), black cohosh 540 mg cap (bid), estradiol 0.05 mg/24 hour weekly transderm patch (1 patch by transdermal route every week cyclically, 3 weeks on and 1 week off), hyoscyamine sulfate 0.125 mg tablet (1 tablet by oral route 2 times every day as needed), CLIMARE 0.05 mg/24 hour transderm patch (1 patch q week), omeprazole 40 mg cap, delayed release (1 capsule by oral route every day before a meal), hydrochlorothiazide 25 mg tablet (1 tablet by oral route every other day), FLEXERIL 10 mg tablet (2 tablet by oral route every bedtime), CRESTOR 20 mg tab (1 tablet by oral route every day), ZOLOFT 100 mg tablet (1 1/2 tablets every day) as a concomitant medications. On 24 September 2012, the outcome was reported as recovered.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Initial report received from a healthcare professional on 12 September 2013. A 45-year-old female patient, had received fourth dose of FLUZONE (lot number UH899AB, route of vaccination was not reported) on 04 September 2013. The patient medical history included hypothyroid, obstructive sleep apnea, vitamin D deficiency and irritable bowel syndrome. The patient had no illness at the time of vaccination. The patient had no known allergies and concomitant medication was not reported. On 04 September 2013, the patient had soreness in the area (first 2 days). Pain down to her arm and into the chest. On 11 September 2013, in the night, the patient was unable to lift her arm and woke up due to pain. The patient had no redness, tingling, numbness or swelling. It was reported that the symptoms were getting worse and was instructed to call back if not improved. No laboratory investigations were done. On an unspecified date, ANAPROX prescribed for pain. The patient outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Papule
Clinical narrative: Initial report received from a healthcare professional who is also the patient on 15 February 2013. A male patient (age and date of birth were not reported), had received a dose of FLUZONE (batch number: UH746AC, expiry date: 06-30-2013, number in series not reported) intramuscularly in left deltoid on 29 November 2012. The patient also received a dose of BOOSTRIX (manufacturer: GlaxoSmithKline, batch number, number in series, route and site of administration were not reported) on 30 November 2012 (day after FLUZONE administration). The patient had no illness at the time of vaccination and had no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient's concomitant medications were not reported. On an unspecified date, few days after vaccination the patient developed papules in the elbow area of his right arm, and the patient believed that it was zoster. At the time of this report, the symptoms had improved, but redness to the skin in the area remained. Corrective treatment details were not reported. No laboratory investigations were performed. The patient's outcome was not recovered. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pregnancy test positive, Pregnancy test urine negative, Vaginal haemorrhage
Clinical narrative: Initial report received from a healthcare professional on 08 JUNE 2012. A 42-year-old female patient, who denies any illness at the time of vaccination and whole medical history and concomitant medications were not reported, received a dose of ADACEL (batch number: C4169AA, site not reported) intramuscularly on 13 JUNE 2012. It was not known at the time of vaccination that the patient is pregnant, as her urine pregnancy test was negative. Later on it was confirmed by the blood test that she was pregnant. On 18 JUNE 2012, the patient started spotting and was sent to ER. Corrective medications were not reported. As of 18 JUNE 2012, the outcome of the event was unknown.  List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Gastroenteritis, Palpitations, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 28 JANUARY 2013. A 70-year-old female patient, had received first dose of FLUZONE (lot number: not available, route, and site of administration were not reported), on16 JANUARY 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. The patient's concomitant medications were not reported. On 23 JANUARY 2013, i.e. one week after vaccination, the patient developed racing heartbeat. Laboratory data and corrective treatment details were not reported. The patient had not recovered from the event at the time of this report. Follow up information received from a healthcare professional on 01 JULY 2013. The patient experienced gastroenteritis, diarrhea and vomiting on an unspecified date and it was reported that patient was sure symptoms were unrelated to vaccine. The patient had not received any vaccine within 4 weeks of 16 JANUARY 2013. On an unspecified date, the patient had recovered from the events.  Documents held by sender: none
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Cough, Dyspnoea, Hypertension
Clinical narrative: Initial report received from a healthcare professional on 25 JANUARY 2013. A 56-year-old female patient, had received a dose of FLUZONE (lot number, route and anatomical site of administration were unknown) on an unspecified date in the end of SEPTEMBER 2012 at 5:00 PM. The patient had no significant past medical history (PMH). The patient's son was diagnosed with strep throat. The patient's concomitant medication included Amoxicillin which was taken to avoid contacting strep throat from patient's son. The patient had denied any illness at the time of vaccination. On an unspecified date in SEPTEMBER 2012, the patient developed acute cough with shortness of breath and hypertension. The patient went to emergency department for evaluation and treatment. Corrective treatment details were not reported. Laboratory details included allergy tests for antibiotics (Amoxicillin) and protein based foods (Ovalbumin) were performed. All test results were negative. At the time of this report, the cause of the patient's symptoms was unknown. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: Initial information received from other company on 07 JANUARY 2013. The initial reporter was a healthcare professional. A patient, whose age, gender, medical history and concomitant medication were not reported, had received a dose of FLUZONE (batch number, dose number, route and anatomical site of vaccination were not reported) on an unspecified date a few years ago. On an unspecified date, after vaccination the patient developed an unspecified reaction. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by reported: None.
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial information received from a consumer on 05 OCTOBER 2012. A male patient, whose age, medical history and concomitant medication were not reported, received FLUZONE (lot number, dose, site of administration were not reported) on 22 SEPTEMBER 2012.  The reporter (manager) stated that, the patient (employee) took 2 days' vacation "due to the flu shot". Laboratory details and treatment were not reported. The patient's outcome was unknown. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a consumer who is also the patient on 05 October 2012. A female patient, whose age, medical history and concomitant vaccinations were not reported, had received a dose of FLUZONE (Lot number UH720AD, dose number and route of administration not reported) in left upper arm on 03 October 2012. On 03 October 2012, about 2 hours after receiving vaccination, the patient's left upper arm became bright red, hot, hard to touch, very swollen and the patient felt really sick. The patient reported that the patient cannot lift the left arm up all the way because it hurts badly to do so. The arm was still swollen and slightly red and it hurts to touch. The patient is not feeling very well and is currently just resting. The patient was taking BENADRYL twice a day and also rubbing BENADRYL lotion on the irritated injection site as corrective treatment. Laboratory details were not reported. As of 05 October 2012, the patient was not recovered from the event. Documents held by sender: None. Follow up of information received on 25 December 2012: Patient's demographic details (age and date of birth) updated. It was reported that the patient recovered from the events after one month. Reporter did not know the vaccine details including dose number and route of administration.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Initial report received from a consumer who is also the patient on 05 October 2012. A female patient, whose age, medical history and concomitant vaccinations were not reported, had received a dose of FLUZONE (Lot number UH720AD, dose number and route of administration not reported) in left upper arm on 03 October 2012. On 03 October 2012, about 2 hours after receiving vaccination, the patient's left upper arm became bright red, hot, hard to touch, very swollen and the patient felt really sick. The patient reported that the patient cannot lift the left arm up all the way because it hurts badly to do so. The arm was still swollen and slightly red and it hurts to touch. The patient is not feeling very well and is currently just resting. The patient was taking BENADRYL twice a day and also rubbing BENADRYL lotion on the irritated injection site as corrective treatment. Laboratory details were not reported. As of 05 October 2012, the patient was not recovered from the event. Documents held by sender: None. Follow up of information received on 25 December 2012: Patient's demographic details (age and date of birth) updated. It was reported that the patient recovered from the events after one month. Reporter did not know the vaccine details including dose number and route of administration.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: Initial information received from other company (Merck) on 21 December 2012. This information was initially reported by a healthcare professional. A female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (Batch number, dose number, route and anatomical site of vaccination were not reported) on 01 December 2012. It was reported that on an unspecified date, after vaccination, the patient had experienced an unspecified "reaction". Laboratory investigations and corrective treatment were not reported. At the time of report, the outcome of the event was not reported. Follow-up information received from the healthcare professional on 23 April 2013. The patient's age was updated as 75 years. The patient had received 0.5 ml dose of FLUZONE (batch number U45224AA, expiry date: 4/21/13) intramuscularly on the left arm. List of documents held by the reporter: None.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Rash macular
Clinical narrative: Initial report was received from a consumer on 09 OCTOBER 2012. A 62-year-old female patient, who was allergic to Advair, Flovent inhalers, Environmental, Perfume, PCN, Soy and had asthma at the time of vaccination, had received FLUZONE (batch number was unknown) intramuscularly on deltoid on 09 OCTOBER 2012. It was reported that the patient has a severe allergy to soy and premeditated with Benadryl (Diphenhydramine) and Allegra (Fexofenadine) before vaccination. On 09 OCTOBER 2012, i.e. after 30 minutes of receiving FLUZONE, the patient experienced red blotches at upper/lower extremities, trunk and under both breasts and some numbness left side of face. The laboratory investigations were not reported. As corrective measures the patient contacted her allergist who prescribed her 2 more Benadryl (Diphenhydramine) on an unspecified date. At the time of this report, the outcome was unknown. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: initial report received from a consumer who is also the patient on 19 OCTOBER 2012. A 30-year-old female patient, with no  relevant medical history, whose concomitant medications were not reported, had received FLUZONE (lot number UH4720AB, route of administration was not reported) in left arm on 15 OCTOBER 2012. On 16 OCTOBER 2012, 1 day after vaccination, the patient presented with vomiting and severe headache every evening since then. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Initial report received from a non healthcare professional (consumer) on 15 NOVEMBER 2012. A female patient born on 02 MAY 1947, whose age, medical  history and concomitant medications were not reported and was reported allergic to sulfa, received a dose of FLUZONE (lot number, route and anatomical site of vaccination was not reported) on an unspecified date, about "two weeks ago". Two hours post vaccination, patient experienced feeling of tongue swelling and throat swelling. The patient stated she d rank water and the symptoms resolved after a while with no further symptoms or reactions noted. Laboratory investigations and corrective treatments were not reported. List of documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Initial report received from a non-healthcare professional (Patient wife) on 08 January 2013 and follow-up information received on 10 January 2013. A 33-year-old male patient, who had no illness at the time of vaccination and did not receive other medications, had received an intramuscular 0.5 ml dose 1 of FLUZONE (Lot number UH729AB with expiration date 30 June 2013) in right deltoid on 07 January 2013. On 07 January 2013, immediately after vaccination, the patient had sore arm from injection site down and dizziness. "Following morning" (08 January 2013) the arm was still sore and the neck was also sore on the same side as arm (right side). Corrective treatment was not reported. Laboratory investigations were reported as not applicable. As of 09 January 2013, the patient had fully recovered from the events. Documents held by sender none.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure increased, Cold sweat, Confusional state, Crying, Dizziness
Clinical narrative: Initial report was received from a non-healthcare professional on 12 November 2013. A female patient (no details provided), with no reported personal and family medical history, and no reported concomitant therapy, had received her dose of MENACTRA (lot number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced lightheadedness, seizure-like symptoms, confusion and rash. No further information was provided. The outcome was unknown. Documents held by sender: None. Follow-up information was received from a healthcare professional on 15 December 2013. The 15-year-old female patient had received first dose of MENACTRA batch number- U4657AA, intramuscularly in left arm on an unspecified date. The patient had no medical history, no illness at the time of vaccination, no other vaccination within 4 week of vaccination, no other medication and no other adverse event following prior vaccination. On an unspecified date, 3 minutes after vaccination the patient was not feeling quite well. Patient had increased in blood pressure was lightheaded, dizzy, and as thing progressed become clammy, noted to be tachycardic and hypertensive. The patient also developed rash on anterior chest, on forehead around the ear and on back. And patient complain of stiff leg and had difficulty in walking. She was crying and also had hyperreflexia, tingle sensation on hands, hyperreflexia of lower extremities, jerking/tremors of hands, arms, legs and allergic reaction. Patient's corrective treatment include 50 mg of BENADRYL, 125 mg of SOLU-MEDROL and 20 mg of PEPCID. Laboratory test include blood pressure 143/77, repeated 130/73, pulse was 122, temperature was 98.3, respiration was 16. On an unspecified date the patient had recovered from the event. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Gait disturbance, Hyperreflexia, Hypersensitivity, Hypertension
Clinical narrative: Initial report was received from a non-healthcare professional on 12 November 2013. A female patient (no details provided), with no reported personal and family medical history, and no reported concomitant therapy, had received her dose of MENACTRA (lot number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced lightheadedness, seizure-like symptoms, confusion and rash. No further information was provided. The outcome was unknown. Documents held by sender: None. Follow-up information was received from a healthcare professional on 15 December 2013. The 15-year-old female patient had received first dose of MENACTRA batch number- U4657AA, intramuscularly in left arm on an unspecified date. The patient had no medical history, no illness at the time of vaccination, no other vaccination within 4 week of vaccination, no other medication and no other adverse event following prior vaccination. On an unspecified date, 3 minutes after vaccination the patient was not feeling quite well. Patient had increased in blood pressure was lightheaded, dizzy, and as thing progressed become clammy, noted to be tachycardic and hypertensive. The patient also developed rash on anterior chest, on forehead around the ear and on back. And patient complain of stiff leg and had difficulty in walking. She was crying and also had hyperreflexia, tingle sensation on hands, hyperreflexia of lower extremities, jerking/tremors of hands, arms, legs and allergic reaction. Patient's corrective treatment include 50 mg of BENADRYL, 125 mg of SOLU-MEDROL and 20 mg of PEPCID. Laboratory test include blood pressure 143/77, repeated 130/73, pulse was 122, temperature was 98.3, respiration was 16. On an unspecified date the patient had recovered from the event. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Malaise, Musculoskeletal stiffness, Paraesthesia, Rash, Seizure like phenomena
Clinical narrative: Initial report was received from a non-healthcare professional on 12 November 2013. A female patient (no details provided), with no reported personal and family medical history, and no reported concomitant therapy, had received her dose of MENACTRA (lot number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced lightheadedness, seizure-like symptoms, confusion and rash. No further information was provided. The outcome was unknown. Documents held by sender: None. Follow-up information was received from a healthcare professional on 15 December 2013. The 15-year-old female patient had received first dose of MENACTRA batch number- U4657AA, intramuscularly in left arm on an unspecified date. The patient had no medical history, no illness at the time of vaccination, no other vaccination within 4 week of vaccination, no other medication and no other adverse event following prior vaccination. On an unspecified date, 3 minutes after vaccination the patient was not feeling quite well. Patient had increased in blood pressure was lightheaded, dizzy, and as thing progressed become clammy, noted to be tachycardic and hypertensive. The patient also developed rash on anterior chest, on forehead around the ear and on back. And patient complain of stiff leg and had difficulty in walking. She was crying and also had hyperreflexia, tingle sensation on hands, hyperreflexia of lower extremities, jerking/tremors of hands, arms, legs and allergic reaction. Patient's corrective treatment include 50 mg of BENADRYL, 125 mg of SOLU-MEDROL and 20 mg of PEPCID. Laboratory test include blood pressure 143/77, repeated 130/73, pulse was 122, temperature was 98.3, respiration was 16. On an unspecified date the patient had recovered from the event. Documents held by sender: None.