chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Tenderness
Clinical narrative: Initial report was received on 31 October 2011 from a health care professional, which also involves a case of misuse. A 54 year-old female patient who had no illness at the time of vaccination had received on 31 October 2011 a 0.25 ml intradermal right forearm injection of ADACEL, lot number U4103AA (sanofi pasteur ltd lot number C3971) and an intradermal left forearm injection of TUBERSOL, lot number C3630AB and six hours later the patient reported the right forearm to be swollen and blotchy. According to the initial reporter, they administered ADACEL intradermally with a 25g 5/8 inch needle "by mistake and then they squeezed the liquid out until the site bled". No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received on 17 November 2011 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. According to the report, the TUBERSOL was administer intramuscularly in the deltoid (previously reported as intradermal in the left forearm). The patient was hospitalized for draining of a red, swollen, blistered open wound. The reporter stated that the wound was closed and healing. Treatment included IV (intravenous) antibiotics. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site haemorrhage, Injection site reaction
Clinical narrative: Initial report was received on 31 October 2011 from a health care professional, which also involves a case of misuse. A 54 year-old female patient who had no illness at the time of vaccination had received on 31 October 2011 a 0.25 ml intradermal right forearm injection of ADACEL, lot number U4103AA (sanofi pasteur ltd lot number C3971) and an intradermal left forearm injection of TUBERSOL, lot number C3630AB and six hours later the patient reported the right forearm to be swollen and blotchy. According to the initial reporter, they administered ADACEL intradermally with a 25g 5/8 inch needle "by mistake and then they squeezed the liquid out until the site bled". No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received on 17 November 2011 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. According to the report, the TUBERSOL was administer intramuscularly in the deltoid (previously reported as intradermal in the left forearm). The patient was hospitalized for draining of a red, swollen, blistered open wound. The reporter stated that the wound was closed and healing. Treatment included IV (intravenous) antibiotics. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site swelling, Injection site vesicles, Open wound, Rash macular, Wound drainage
Clinical narrative: Initial report was received on 31 October 2011 from a health care professional, which also involves a case of misuse. A 54 year-old female patient who had no illness at the time of vaccination had received on 31 October 2011 a 0.25 ml intradermal right forearm injection of ADACEL, lot number U4103AA (sanofi pasteur ltd lot number C3971) and an intradermal left forearm injection of TUBERSOL, lot number C3630AB and six hours later the patient reported the right forearm to be swollen and blotchy. According to the initial reporter, they administered ADACEL intradermally with a 25g 5/8 inch needle "by mistake and then they squeezed the liquid out until the site bled". No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received on 17 November 2011 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. According to the report, the TUBERSOL was administer intramuscularly in the deltoid (previously reported as intradermal in the left forearm). The patient was hospitalized for draining of a red, swollen, blistered open wound. The reporter stated that the wound was closed and healing. Treatment included IV (intravenous) antibiotics. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HEPA, MEN, TDAP, HEPA, MNQ, TDAP
Symptoms: Apnoea, Blood glucose, Breath sounds abnormal, Computerised tomogram head, Convulsion
Clinical narrative: Patient passed out and started jerking all over. Patient came to within about a minute. Talking and moving. Dr. evaluated patient. Patient able to walk out of office coherent and alert. Vitals stable.
Age: 11.0
Sex: F
Vaccine: HEPA, MEN, TDAP, HEPA, MNQ, TDAP
Symptoms: Laboratory test, Staring, Tremor
Clinical narrative: Patient passed out and started jerking all over. Patient came to within about a minute. Talking and moving. Dr. evaluated patient. Patient able to walk out of office coherent and alert. Vitals stable.
Age: 11.0
Sex: F
Vaccine: HEPA, MEN, TDAP, HEPA, MNQ, TDAP
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Patient passed out and started jerking all over. Patient came to within about a minute. Talking and moving. Dr. evaluated patient. Patient able to walk out of office coherent and alert. Vitals stable.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Information has been received from a medical assistant concerning a male patient who on 22-SEP-2011, was vaccinated with a dose of PNEUMOVAX 23 (lot # 669379/0453AA expiration date 08-MAR-2012 (dose and route not reported). The medical assistant reported that the patient developed arm soreness, redness and warmth to the touch at the injection site (approximately on 22-SEP-2011). The medical assistant reported that she gave 4 other patients the same lot number of the vaccine and they did not have reactions. It was unknown if the patient sought medical attention. The injection site reaction was gone by 26-SEP-2011. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot # 669379/0453AA conformed to quality release parameters and the manufacturing was typical of a lot of PNEUMOVAX 23. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information was received concerning the 64 year old male retired patient with no illness at time of vaccination who on 28-SEP-2011, was vaccinated with a first dose of PNEUMOVAX 23 on the left deltoid. On 29-SEP-2011, the patient arm swelled to a large red, hot ball. The patient became very ill for 4-5 days, it was like a tennis ball size. Patient arm swelled to a large red, hot ball, tennis ball size, and patient became very ill were considered to be disabling by the reporter. No further information is available.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101, redness, swelling and pain at injection site. Dr. prescribed antibiotics.
Age: 37.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash
Clinical narrative: Rash on face, chest.  Ongoing.
Age: 24.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature, Hyperhidrosis, Pain, Tenderness, Urticaria
Clinical narrative: Sweating, temp, hives on left arm, very sore and tender. Took Benadryl for pain as needed. Went to Urgent care given a Z-pac.
Age: 18.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Rash
Clinical narrative: Patient feeling lightheaded and has a rash on his back. RN stated go to ER for evaluation. Stated no other symptoms, breathing fine, no edema of face or lips. Patient took Benadryl, the rash is gone and he no longer feels lightheaded. Patient feels much better today.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Urticaria
Clinical narrative: Patient reports facial redness, and facial welts with burning sensation. Denied facial edema or respiratory distress.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Sides & back from arm pit to thighs covered with raised red bumps.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Rash
Clinical narrative: Joint swelling in hands and feet.  Rash to waist.   No treatment sought.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Sides and back from arm pit past thighs covered with raised red bumps.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: Congestion, cold symptoms then went into bronchitis. Was Hospitalized.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Convulsion, Respiratory disorder
Clinical narrative: Airway began to constrict, chest tightened, patient seized. Epinepherine given, transported to hospital by EMT's.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Red and swollen from shoulder blade down to right hand and arm. Have a lot of pain.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Flushing, Hypoaesthesia, Urticaria
Clinical narrative: Initial report received from a health care professional on 17 November 2011. A patient (age and sex not reported) received an intradermal injection of FLUZONE Intradermal, sanofi pasteur Inc. lot number not reported, on an unknown date. The patient's medical history was not reported. The patient had half inch welt with one inch circumference, flushing of the face and numbness on the left side of the face. The patient had a slight blood pressure drop 400. The patient "just did feel well". The outcome was not reported. Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 18 November 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of DAPTACEL; lot number C2870AA received on 27 February 2009, lot number C3290AA received on 30 April 2009, and lot number C3193AA received on 30 June 2009, and a dose of TRIPEDIA, lot number U3282BA received on 30 June 2010 (route and site of vaccine administration not reported). The subject developed cold-like symptoms on 11 August 2011, approximately 13 months after the last dose. On 16 August 2011, the subject developed a paroxysmal cough without a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 18 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 August 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 16 September 2011, the subject's cough had resolved. The duration of the cough was reported at that time as 30 days. Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 November 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System electronic database. The subject's vaccine history included 3 doses of DAPTACEL; lot number C2870AA received on 27 February 2009, lot number C3290AA received on 30 April 2009, and lot number C3193AA received on 30 June 2009, and a dose of TRIPEDIA, lot number U3282BA received on 30 June 2010 (route and site of vaccine administration not reported). The subject developed cold-like symptoms on 11 August 2011, approximately 13 months after the last dose. On 16 August 2011, the subject developed a paroxysmal cough without a whoop and posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 18 August 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 August 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 16 September 2011, the subject's cough had resolved. The duration of the cough was reported at that time as 30 days. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 18 November 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 8-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3758AA received on 03 March 2011, lot number C3806A received on 12 May 2011 and lot number C3852AA received on 07 July 2011 (route and site of administration not reported). The subject developed cold-like symptoms on 26 September 2011, approximately 11 weeks after the last dose. On 06 October 2011, the subject developed a paroxysmal cough without a whoop and post-tussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 06 October 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 07 October 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 24 October 2011, the subject's cough had resolved. The duration of the cough was reported at that time as 35 days. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 18 November 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in an 8-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3758AA received on 03 March 2011, lot number C3806A received on 12 May 2011 and lot number C3852AA received on 07 July 2011 (route and site of administration not reported). The subject developed cold-like symptoms on 26 September 2011, approximately 11 weeks after the last dose. On 06 October 2011, the subject developed a paroxysmal cough without a whoop and post-tussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 06 October 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 07 October 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 24 October 2011, the subject's cough had resolved. The duration of the cough was reported at that time as 35 days. Documents held by sender: None.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Aspiration joint, Joint effusion, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Osteoarthritis
Clinical narrative: Initial report was received from a health care professional on 18 November 2011. An 88 year-old female patient with an unknown past medical history had received on a Friday an intramuscular injection of FLUZONE HIGH-DOSE (lot number, site and date of administration not reported) and by that evening, complained of arm and shoulder pain. The patient was evaluated by a physician on Monday and had 60 cc of non purulent, viscous, amber colored fluid from the shoulder joint. The patient had an MRI and was found to have joint effusion and degenerative joint disease. Treatments were not reported. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 18 November 2011. An 88 year-old female patient with an unknown past medical history had received on a Friday an intramuscular injection of FLUZONE HIGH-DOSE (lot number, site and date of administration not reported) and by that evening, complained of arm and shoulder pain. The patient was evaluated by a physician on Monday and had 60 cc of non purulent, viscous, amber colored fluid from the shoulder joint. The patient had an MRI and was found to have joint effusion and degenerative joint disease. Treatments were not reported. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: 2 hours post-vaccine pt. was "unable to draw breath," had rapid heartbeat. After 1 hour of this, heart rate slowed but pt reports swollen face, tongue, lips. Had 1 episode of vomiting at 7pm. Sx resolved at bedtime on their own.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 2 hours post-vaccine pt. was "unable to draw breath," had rapid heartbeat. After 1 hour of this, heart rate slowed but pt reports swollen face, tongue, lips. Had 1 episode of vomiting at 7pm. Sx resolved at bedtime on their own.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Activities of daily living impaired, Chills, Diarrhoea, Dyspepsia
Clinical narrative: I am requesting that your office file this Vaccine Adverse Event Report. Here is my experience regarding Tdap vaccine. Prior tetanus shots (alone and with other vaccines) in the military and locally provided no adverse reactions. 10/27 9:30am. Vaccine administered. 12 noon Had lunch. 2pm Felt tightness in upper digestive tract. 5pm Could not eat supper. Upper tract still blocking digestion. 6pm Went to bed. Slept the night with poor digestion. Had chills and then fever. Did not take temperature. 10/28 Stayed in bed all day and night. Had continuing diarrhea and headache. Very tired not wanting to accomplish anything. No pains or redness at site of vaccination. 10/29 Continuing diarrhea. No headache. Tired, not wanting to accomplish anything. 10/30 Better, still some stomach discomfort. I have checked all symptoms experienced on the yellow sheet attached. This was supposed to be just a tetanus booster. I accepted that Tdap was appropriate. My concern is that this process was just part of a trial for the combined vaccine. Why would it be administered to a 76 year old? Your feedback will be appreciated and that the report was filed. 10/31/11 Call placed to pt, pt feeling better. He would like his symptoms reported.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: I am requesting that your office file this Vaccine Adverse Event Report. Here is my experience regarding Tdap vaccine. Prior tetanus shots (alone and with other vaccines) in the military and locally provided no adverse reactions. 10/27 9:30am. Vaccine administered. 12 noon Had lunch. 2pm Felt tightness in upper digestive tract. 5pm Could not eat supper. Upper tract still blocking digestion. 6pm Went to bed. Slept the night with poor digestion. Had chills and then fever. Did not take temperature. 10/28 Stayed in bed all day and night. Had continuing diarrhea and headache. Very tired not wanting to accomplish anything. No pains or redness at site of vaccination. 10/29 Continuing diarrhea. No headache. Tired, not wanting to accomplish anything. 10/30 Better, still some stomach discomfort. I have checked all symptoms experienced on the yellow sheet attached. This was supposed to be just a tetanus booster. I accepted that Tdap was appropriate. My concern is that this process was just part of a trial for the combined vaccine. Why would it be administered to a 76 year old? Your feedback will be appreciated and that the report was filed. 10/31/11 Call placed to pt, pt feeling better. He would like his symptoms reported.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Itchy red rash in blotches on lower back and legs. Lasted off & on for 3 days. BENADRYL given.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Baseball size red & warmth at injection site - ZYRTEC, BENADRYL, ice & KEFLEX.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Pt developed small blisters at site of injection (varicella SQ). Advise parent to give BENADRYL and MOTRIN or TYLENOL as needed & to apply cool compress on & off. To also seek medical tx at dr or ER if s/s worsen.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pharyngitis, Pyrexia, Skin ulcer
Clinical narrative: Fever, chills, open sores, pharyngitis.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Pt had 0.05 ml of INFLUENZA vaccine at 2:00 pm. At 2:03 pm she had seizure. Has hx of uncontrolled seizures taking KEPPRA, ADVIL, amitriptyline, levetiracetam.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Persistent sharp pain at injection site 2 wks after vaccination on 11/9/11.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Infection, Oedema peripheral, Urticaria
Clinical narrative: Patient showed signs of erythema, hives, and other allergy signs down length of upper arm. Very swollen. Patient required visit to MD and was informed of allergic reaction & infection. Called patient on 11/21/11 who informed me she is ok.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Injection site erythema, Pain, Pyrexia
Clinical narrative: 11/12/11 - Fever, pain, redness at injection site. 11/16/11 - Went to the doctor, was given an injection of antibiotic & oral AUGMENTIN & oral prednisone for infection.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Pyrexia, Tremor
Clinical narrative: Fever, shaking, aching, sore all over, weak.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site bigger than quarter size. Feels warm at injection site. Feels hard at injection site. No rash / no trouble breathing.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests abnormal, Chest discomfort, Deafness unilateral, Dysphonia, Ear disorder
Clinical narrative: Within 24 hours pt developed chest, head symptoms and hoarseness. 2 weeks later still have aforementioned symptoms and woke up with ear problems. Pt states sounds like "running fridge". Pt's PCP said not caused by congestion so sent to ENT who gave prednisone which did not help. ENT sent to hearing specialist who reported severe irreversible hearing loss in left ear
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Head discomfort, Tinnitus
Clinical narrative: Within 24 hours pt developed chest, head symptoms and hoarseness. 2 weeks later still have aforementioned symptoms and woke up with ear problems. Pt states sounds like "running fridge". Pt's PCP said not caused by congestion so sent to ENT who gave prednisone which did not help. ENT sent to hearing specialist who reported severe irreversible hearing loss in left ear
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Eye discharge, Rash erythematous, Thirst
Clinical narrative: PNEUMOVAX 23 (R) arm. Patient reported being very thirsty after administration through the night hours. He awoke having discharge from eyes. On day two he had developed a red rash around arm near injection site & extended down his torso. On day three he reported to Rph with red rash only around arm near injection site. Rph recommended BENADRYL; advise to call MD if persists or gets worse.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Received vaccination 11/18 woke up 11/19 at 0300 with fever, body aches. Continued with fever of 102, redness, swelling, tenderness to Rt deltoid, symptoms continued through 11/24/11.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Drug administered at inappropriate site, Influenza like illness, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous consumer report (initial receipt 08-Nov-2011) concerns a 42-year old female patient who was highly reactive to medicine. On 23-Sep-2011 the patient received a flu shot injection. She also received PNEUMOVAX 23 injection in the same at the same time for vaccination. On 23-Sep-2011 the patient stated that the nurse 'missed the deltoid by injecting too low. That evening the patient developed pain, swelling and cellulitis at the site, with a possible infection. She also had flu like symptoms. She went to a local emergency room and was started on cephalexin. She was not admitted to hospital. The symptoms lasted for two weeks.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Patient woke up temperature 103 with chills and shaking all over. Aches and pains that lasted all night. Fever all day Sunday. No rash or swelling at injection site. Only sore arm. Fever gone by Monday.
Age: 1.1
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Child has fever 102 or more for about a week with each set of shots per mom.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Injection site urticaria
Clinical narrative: Hives on both thighs.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Amnesia, Blood test, Depression, Influenza like illness, Injection site erythema
Clinical narrative: This spontaneous consumer report (initial receipt 18-Nov-2011) concerns a 41-year old male patient, who had a medical history of back surgery. Concomitant medications included sertraline, dicycloverine hydrochloride, ramipril, metoprolol, cPAX Aneurysm Treatment System as a Humanitarian Use Device ('Neurovask'), multivitamins and hydrocodone; paracetamol combination. On 23-Oct-2011 the patient received a single 0.5 mL of AFLURIA (batch number: N57107) injection as routine flu shot. After receiving the vaccine the patient's eyes were glazed. He said getting the vaccine burned like alcohol. The injection site area looked as if it was sun burnt. The patient developed flu like symptoms within 3 days following vaccination. He did not usually get sick. The patient was down with flu like symptoms for about a week. When it seemed that he was 'coming back' from these symptoms, he has now suffered from memory loss, suicidal ideations and increasing depression. He was not himself. The patient sought medical attention and unspecified blood work was performed. The event outcome was not recovered.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Staring, Suicidal ideation
Clinical narrative: This spontaneous consumer report (initial receipt 18-Nov-2011) concerns a 41-year old male patient, who had a medical history of back surgery. Concomitant medications included sertraline, dicycloverine hydrochloride, ramipril, metoprolol, cPAX Aneurysm Treatment System as a Humanitarian Use Device ('Neurovask'), multivitamins and hydrocodone; paracetamol combination. On 23-Oct-2011 the patient received a single 0.5 mL of AFLURIA (batch number: N57107) injection as routine flu shot. After receiving the vaccine the patient's eyes were glazed. He said getting the vaccine burned like alcohol. The injection site area looked as if it was sun burnt. The patient developed flu like symptoms within 3 days following vaccination. He did not usually get sick. The patient was down with flu like symptoms for about a week. When it seemed that he was 'coming back' from these symptoms, he has now suffered from memory loss, suicidal ideations and increasing depression. He was not himself. The patient sought medical attention and unspecified blood work was performed. The event outcome was not recovered.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Nov-2011) concerns a 85-year old female patient, who had a medical history of hypertension. Concomitant medications included blood pressure and bladder medications. On 13-Sep-2011 the patient received AFLURIA and PNEUMOVAX 23. On 13-Oct-2011 the patient received a single dose of 0.65 mL ZOSTAVAX subcutaneous injection. On 24-Oct-2011 the patient was diagnosed with an episode of shingles by the physician. The patient presented to the physician's office with a 'zoster-like rash in the upper right quadrant'. She was prescribed acyclovir ointment for the rash. The event outcome was recovering.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 6 x 9 inch swelling to injection site with erythema.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anxiety, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This medically confirmed spontaneous report (initial receipt 27-Sep-2011) concerns a 64-year old female patient, who had a medical history of diabetes, hypertension, diverticulosis, hemorrhoid, colon polyps and stroke. She had drug reactions/allergies to sulfa drugs and penicillin. Concomitant medications included glimepiride, alprazolam, atorvastatin, amlodipine, lisinopril, sitagliptin; metformin combination and dipyridamole. On 19-Sep-2011 the patient received AFLURIA in left arm. On the same day she also received PNEUMOVAX 23 (batch number: 1157Z) subcutaneous injection on back of the right arm for indication 'to be vaccinated'. After one day the patient started to swell and it (injected arm) was red and hot. Each day it kept getting bigger and then covered entire back side of her arm from elbow to shoulder. The healthcare profession told her to take diphenhydramine and put ice on it. The physician said it was the dorsal surface of upper right arm, 10 cm red, warm 'succular' and processing from injection site. There were no lab diagnostics studies performed. The event outcome was recovering, but it increased her anxiety. The reporter considered events to be serious as it required intervention to prevent serious criteria.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Malaise, Muscular weakness
Clinical narrative: Numbness in arm & joint above the shoulder area. Extreme weakness in legs when standing. Feeling of being ill.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 24 hours after vaccine (L) bicep developed whelps, then stomach and leg. Several hours later whelps developed on (R) bicep. Patient used hydrocortisone cream and symptoms improved.
Age: 4.0
Sex: M
Vaccine: FLUN3, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site vesicles
Clinical narrative: C/o left leg pain & rash on evening after vaccine. Received 2 vaccines in same leg. Rash increasing in size and became blister like - 2 x 2 cm erythematous & blistering with mild weeping. BENADRYL 10 mg given in office. KEFLEX 250 mg/5ml  x 10 days. May apply cool compress.
Age: 4.0
Sex: M
Vaccine: FLUN3, PNC13, VARCEL
Symptoms: Wound secretion
Clinical narrative: C/o left leg pain & rash on evening after vaccine. Received 2 vaccines in same leg. Rash increasing in size and became blister like - 2 x 2 cm erythematous & blistering with mild weeping. BENADRYL 10 mg given in office. KEFLEX 250 mg/5ml  x 10 days. May apply cool compress.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Cough, Malaise, Pain, Pain in extremity
Clinical narrative: 11/9/11 - Vaccine administered without incident. On 11/10/11 client began to not feel well in school with c/o "legs" hurting, fever -102.6. Client instructed to call pediatrician. Client reports on 11/15/11 that child's temp increased to 103 degrees & then child started saying that he could not walk because of the pain. On Friday clients leg pain resolved on MOTRIN in alternating with TYLENOL. Fever until 11/12/11 & coughing & aching for 1 week past vaccine. All symptoms resolved.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 11/9/11 - Vaccine administered without incident. On 11/10/11 client began to not feel well in school with c/o "legs" hurting, fever -102.6. Client instructed to call pediatrician. Client reports on 11/15/11 that child's temp increased to 103 degrees & then child started saying that he could not walk because of the pain. On Friday clients leg pain resolved on MOTRIN in alternating with TYLENOL. Fever until 11/12/11 & coughing & aching for 1 week past vaccine. All symptoms resolved.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt given flu shot 10/19/11. Pt pain started 10/21/11. Pt complained of radiating pain from (L) arm up to shoulder which lasted 7 days. Pt was told to take oral analgesic and f/u with PCP.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort
Clinical narrative: Patient stated experiencing discomfort on left arm (inject site) for extended period of the time. Initial doctor visit was made and the follow up is required according to the patient.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Right arm red and swollen. Went to ER. Dx: Cellulitis. Antibiotics then oral antibiotics cephalexin 500mg.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discomfort
Clinical narrative: Patient stated experiencing discomfort on left arm (injection site) for extended period of time. Initial doctor visit was made and the follow us required according to the patient.
Age: 15.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT STATES LEFT ARM WAS RED, SWOLLEN, HOT TO TOUCH, AND PAINFUL AT AND AROUND SITE OF INJECTION. AREA MEASURED APPROXIMATELY 50MM.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain in extremity, Rash
Clinical narrative: Rash on left arm extending to neck and uper back. Soreness at site extending to lower left arm.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hyperhidrosis, Musculoskeletal stiffness, Nasal congestion, Oropharyngeal pain
Clinical narrative: I started to feel really drowsy, sore throat, stuffy nose, red blotches on my chest, bright red, hot cheeks, sweaty and around 5:00 PM I started to gradually get a stiff neck.  More than 24 hours later, I am still feeling these symptoms and my neck hurts to turn side to side, up and down.  I have been taking Motrin 800 to relieve the pain, and haven't had success.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash macular, Skin warm, Somnolence
Clinical narrative: I started to feel really drowsy, sore throat, stuffy nose, red blotches on my chest, bright red, hot cheeks, sweaty and around 5:00 PM I started to gradually get a stiff neck.  More than 24 hours later, I am still feeling these symptoms and my neck hurts to turn side to side, up and down.  I have been taking Motrin 800 to relieve the pain, and haven't had success.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Malaise, Pain
Clinical narrative: Weakness, Difficulty breathing, Malaise, Body Aches.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Activities of daily living impaired, Body temperature increased, Crying, Headache, Nasal congestion
Clinical narrative: Child c/o mild HA at 4 pm 11/29 when home from school, refused meds at that time. At 9:30 pm same night, woke up in tears c/o severe headache, body aches, nasal congestion & low grade temp (mom did not measure with thermometer). Gave ibuprofen & went back to bed.  Mom called in to report event at 11:30 am 11/30/2011 on her way to child's school to pick her up d/t child in tears with HA again.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain
Clinical narrative: Child c/o mild HA at 4 pm 11/29 when home from school, refused meds at that time. At 9:30 pm same night, woke up in tears c/o severe headache, body aches, nasal congestion & low grade temp (mom did not measure with thermometer). Gave ibuprofen & went back to bed.  Mom called in to report event at 11:30 am 11/30/2011 on her way to child's school to pick her up d/t child in tears with HA again.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Red, swollen, pain and a node the size of her palm. Went to Dr. and he prescribed medication and treated her for cellulitis.
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphemia
Clinical narrative: My daughter started stuttering soon after receiving her flu vaccine. Prior to the vaccine she was above average with her vocabulary and speech.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chills, Convulsion, Musculoskeletal stiffness, Pyrexia, Tremor
Clinical narrative: Patient was sleeping and woke up around 8:30 pm and vomited. Her fever immediately increased to 101.7 (temporal).  Vomited again around 10:30 PM.  Was in the shower with mom immediately after to clean up emesis.  In the shower, she continued to having chill-like shivering, but then her entire body started shaking violently, her body went stiff, and she was not responsive.  At this time, she was still in the shower with mom.  After she stopped convulsing, she slept.  Emesis occurred again at 2:30 am at the hospital (temp 102.7 rectal).  Later that morning, she returned to her previous self, playful and happy with no subsequent emesis.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: Patient was sleeping and woke up around 8:30 pm and vomited. Her fever immediately increased to 101.7 (temporal).  Vomited again around 10:30 PM.  Was in the shower with mom immediately after to clean up emesis.  In the shower, she continued to having chill-like shivering, but then her entire body started shaking violently, her body went stiff, and she was not responsive.  At this time, she was still in the shower with mom.  After she stopped convulsing, she slept.  Emesis occurred again at 2:30 am at the hospital (temp 102.7 rectal).  Later that morning, she returned to her previous self, playful and happy with no subsequent emesis.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Prolonged painful right arm, especially when twisting.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth, Oedema peripheral
Clinical narrative: Noticed pain, swelling and tightness in right arm. Site red, hot to touch with raised wheal measuring approx. 6-8 inches. Itching noted around edges of wheal.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Skin tightness
Clinical narrative: Noticed pain, swelling and tightness in right arm. Site red, hot to touch with raised wheal measuring approx. 6-8 inches. Itching noted around edges of wheal.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Axillary pain, Bacterial infection, Injection site infection, Lymph gland infection
Clinical narrative: FLUZONE HD given 11/14/11. The next evening, she found a "sore, itchy lump in left arm pit. She saw the doctor on 11/16/11 and told us he said it was an "infected lymph gland due to bacteria that migrated from the site of the flu shot." Patient was given BACTRIM DS to take twice daily for 3 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: FLUZONE HD given 11/14/11. The next evening, she found a "sore, itchy lump in left arm pit. She saw the doctor on 11/16/11 and told us he said it was an "infected lymph gland due to bacteria that migrated from the site of the flu shot." Patient was given BACTRIM DS to take twice daily for 3 days.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: - Pt reported chills, headache and fever.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: About 10-15 min after injection pt stated heaviness in chest & was a little hard to breath. Pt stated she's going to see her doctor. Spoke to doctor after and he stated he didn't find anything wrong with her lung function and she was fine when he saw her. Patient stated she had preservative free prev. with no problem.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Inflammation, Pain
Clinical narrative: 7-19-2011 picked up ZOSTAVAX vial at pharmacy. Went to MD office. LPN gave injection (L) deltoid. On 8/12/2011 shingles posterior rt leg, upper thigh. Had ZOVIRAX 5% ointment from previous shingles. Applied to sterile dsg. taped on area (R) leg. MD contacted 8/17/2011 script for famciclovir. Taken per MD order. 8/23/2011 shingles scabbed. No dsg. 11-7-2011 (flu vaccine MDV) given by LPN. 8/12/2011 Blisters, inflammation, pain, red , swelling.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Scab, Swelling
Clinical narrative: 7-19-2011 picked up ZOSTAVAX vial at pharmacy. Went to MD office. LPN gave injection (L) deltoid. On 8/12/2011 shingles posterior rt leg, upper thigh. Had ZOVIRAX 5% ointment from previous shingles. Applied to sterile dsg. taped on area (R) leg. MD contacted 8/17/2011 script for famciclovir. Taken per MD order. 8/23/2011 shingles scabbed. No dsg. 11-7-2011 (flu vaccine MDV) given by LPN. 8/12/2011 Blisters, inflammation, pain, red , swelling.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Pt states after receiving flu and TDAP injection that she felt tingling sensation in mouth and then as time progressed she felt her throat "tighten" but did not keep her from breathing did not seek any medical attention. First time getting flu vaccine 11-15-11 3:00 pm visit.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Asthma, Decreased appetite, Injection site erythema, Injection site pain
Clinical narrative: 14 hrs after 2 vaccines in Rt arm I developed elevated fever, asthma, trembling, nausea & excessive urination. Felt weak - had ice pack on arm - 5" below injection a rash developed with itching, erythema & pain. No food in 2 days. Called another pharmacist in PM 11/20/11. Recommended MD on 11/21/11. Now I have 1" band red 5 " below inj. Sat 11AM unable to see MD yet.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site rash, Nausea, Pyrexia, Tremor
Clinical narrative: 14 hrs after 2 vaccines in Rt arm I developed elevated fever, asthma, trembling, nausea & excessive urination. Felt weak - had ice pack on arm - 5" below injection a rash developed with itching, erythema & pain. No food in 2 days. Called another pharmacist in PM 11/20/11. Recommended MD on 11/21/11. Now I have 1" band red 5 " below inj. Sat 11AM unable to see MD yet.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urine output increased
Clinical narrative: 14 hrs after 2 vaccines in Rt arm I developed elevated fever, asthma, trembling, nausea & excessive urination. Felt weak - had ice pack on arm - 5" below injection a rash developed with itching, erythema & pain. No food in 2 days. Called another pharmacist in PM 11/20/11. Recommended MD on 11/21/11. Now I have 1" band red 5 " below inj. Sat 11AM unable to see MD yet.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Soreness in left arm, then on day four, noticed lg. red patch on arm and felt warm and itchy. Not at spots, injection. As of 11/20/11 everything is all better.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Mass, Pain
Clinical narrative: Growth/ lump on left shoulder. Growing larger each year 3 yrs pain of shooting needles when movement in arm. Muscle relaxants, physical therapy.
Age: 9.0
Sex: M
Vaccine: FLU3, HIBV, PPV, VARCEL
Symptoms: C-reactive protein increased, Injection site erythema, Injection site induration, Pyrexia, White blood cell count increased
Clinical narrative: Pt. developed fever evening after immunizations & continued for next 3 days. Developed significant area of erythema & induration of (R) upper arm. Seen in ER - WBC - 30,000 and CRP of 144 (about 14).
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dysgeusia, Headache, Nausea, Pruritus
Clinical narrative: Quick onset of nausea, abdominal cramping, headache, metallic taste, and itching. Resolved with VISTARIL.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Complained that arm "hurt" after a couple hours after injection given (specified it was the PNEUMOVAX vaccine which was given in the right arm). Pt applied warm compresses was not seen in clinic for follow up, just called to complain.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Chills, Cough, Dysphonia, Lacrimation increased
Clinical narrative: Watery eyes, chest tightness, hoarseness, runny nose, coughing, eyes became very bloodshot, chills.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Watery eyes, chest tightness, hoarseness, runny nose, coughing, eyes became very bloodshot, chills.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Cardiomyopathy, Death, Fatigue, General physical health deterioration, Hepatorenal failure
Clinical narrative: ER VISIT C/O VOMITING NAUSEA ALSO REPORTING SIMILAR SYMPTOMS INTERMITTENTLY OVER PAST THREE DAYS-DISCHARGED HOME AFTER UNEVENTFUL ER WORK UP. RETURNED TO CLINIC FOR FOLLOW UP 11/14 AND REPORT OF INCREASING FATIGUE AND SIMILAR SYMPTOMS OVER PREVIOUS THREE WEEKS. ADMITTED TO HOSPITAL. RAPID DETERIORATION AND EMERGENCY XFER BY LIFE FLIGHT TO HIGHER LEVEL OF CARE> MULTIPLE ORGAN FAILURE > LIFE SUPPORT > SUBSEQUENT DEMISE 11/29 AT OTHER HOSP.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Laboratory test abnormal, Life support, Multi-organ failure, Nausea, Vomiting
Clinical narrative: ER VISIT C/O VOMITING NAUSEA ALSO REPORTING SIMILAR SYMPTOMS INTERMITTENTLY OVER PAST THREE DAYS-DISCHARGED HOME AFTER UNEVENTFUL ER WORK UP. RETURNED TO CLINIC FOR FOLLOW UP 11/14 AND REPORT OF INCREASING FATIGUE AND SIMILAR SYMPTOMS OVER PREVIOUS THREE WEEKS. ADMITTED TO HOSPITAL. RAPID DETERIORATION AND EMERGENCY XFER BY LIFE FLIGHT TO HIGHER LEVEL OF CARE> MULTIPLE ORGAN FAILURE > LIFE SUPPORT > SUBSEQUENT DEMISE 11/29 AT OTHER HOSP.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Throat irritation
Clinical narrative: Began having itchy eyes and scratchy throat -- no aches, rash, no difficulty with breathing.
Age: 0.17
Sex: F
Vaccine: RVX
Symptoms: Bowel movement irregularity, Diarrhoea, Flatulence
Clinical narrative: Excessive gas and diarrhea lasting longer than 2 1/2 weeks. Change in BM pattern and consistency.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness
Clinical narrative: Very dizzy, for approximatly 4 hours.  Have had a few other dizzy episodes.  1st dizzy time was off and on for approx. 3 hours on day 22 (1st shot of 3= day 1).
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: Body cold, violent chills, ache joints, sharp pains in head, dizzy, nauseated, weak, pain in arm.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain in extremity, Peripheral coldness
Clinical narrative: Body cold, violent chills, ache joints, sharp pains in head, dizzy, nauseated, weak, pain in arm.