chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Headache, Injection site erythema, Injection site pain, Mobility decreased
Clinical narrative: 0500 AM The injection site of Anthrax was a dime size, red, and burning in pain. By 1100 AM the injection site was as big at a .50 cent peice, red, burning in pain, and arm was swelling. I showed someone in my unit and he immediately took me to see a provider. I talked to the Physican Assistant at that time because I was experiencing sharp, shooting pain through my head, neck, and back. Along with my arm swelling, burning pain in my shoulder, and the redness was spreading. The PA told me "I wasn't having an allergic reaction because I could still breathe. He said he didn't have the pamphlet in front of him to tell me what the side effects were." He circled the red spot on my arm and told me if it got even bigger to come talk to him again. I was maybe in his office for 5 minutes. I had very bad pain through out the rest of the day. I couldn't turn my neck because the pain was so bad and my back was also in so much pain. I went to the Emergency Room by 2000/ 800PM that night. They didn't know how to treat for it. They treated me for pain and gave me Benadryl to take the swelling down in my arm. To this day 11/18/2015 I still have pain in my neck and back.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Musculoskeletal pain, Neck pain, Peripheral swelling
Clinical narrative: 0500 AM The injection site of Anthrax was a dime size, red, and burning in pain. By 1100 AM the injection site was as big at a .50 cent peice, red, burning in pain, and arm was swelling. I showed someone in my unit and he immediately took me to see a provider. I talked to the Physican Assistant at that time because I was experiencing sharp, shooting pain through my head, neck, and back. Along with my arm swelling, burning pain in my shoulder, and the redness was spreading. The PA told me "I wasn't having an allergic reaction because I could still breathe. He said he didn't have the pamphlet in front of him to tell me what the side effects were." He circled the red spot on my arm and told me if it got even bigger to come talk to him again. I was maybe in his office for 5 minutes. I had very bad pain through out the rest of the day. I couldn't turn my neck because the pain was so bad and my back was also in so much pain. I went to the Emergency Room by 2000/ 800PM that night. They didn't know how to treat for it. They treated me for pain and gave me Benadryl to take the swelling down in my arm. To this day 11/18/2015 I still have pain in my neck and back.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Activities of daily living impaired, Back pain, Full blood count normal, Gait disturbance, Neck pain
Clinical narrative: 0500 AM The injection site of Anthrax was a dime size, red, and burning in pain. By 1100 AM the injection site was as big at a .50 cent peice, red, burning in pain, and arm was swelling. I showed someone in my unit and he immediately took me to see a provider. I talked to the Physican Assistant at that time because I was experiencing sharp, shooting pain through my head, neck, and back. Along with my arm swelling, burning pain in my shoulder, and the redness was spreading. The PA told me "I wasn't having an allergic reaction because I could still breathe. He said he didn't have the pamphlet in front of him to tell me what the side effects were." He circled the red spot on my arm and told me if it got even bigger to come talk to him again. I was maybe in his office for 5 minutes. I had very bad pain through out the rest of the day. I couldn't turn my neck because the pain was so bad and my back was also in so much pain. I went to the Emergency Room by 2000/ 800PM that night. They didn't know how to treat for it. They treated me for pain and gave me Benadryl to take the swelling down in my arm. To this day 11/18/2015 I still have pain in my neck and back.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Red blood cell sedimentation rate normal, Sleep disorder
Clinical narrative: 0500 AM The injection site of Anthrax was a dime size, red, and burning in pain. By 1100 AM the injection site was as big at a .50 cent peice, red, burning in pain, and arm was swelling. I showed someone in my unit and he immediately took me to see a provider. I talked to the Physican Assistant at that time because I was experiencing sharp, shooting pain through my head, neck, and back. Along with my arm swelling, burning pain in my shoulder, and the redness was spreading. The PA told me "I wasn't having an allergic reaction because I could still breathe. He said he didn't have the pamphlet in front of him to tell me what the side effects were." He circled the red spot on my arm and told me if it got even bigger to come talk to him again. I was maybe in his office for 5 minutes. I had very bad pain through out the rest of the day. I couldn't turn my neck because the pain was so bad and my back was also in so much pain. I went to the Emergency Room by 2000/ 800PM that night. They didn't know how to treat for it. They treated me for pain and gave me Benadryl to take the swelling down in my arm. To this day 11/18/2015 I still have pain in my neck and back.
Age: 68.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Sore to touch/warm, red/raised about 2 inches.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Nausea, Pain, Vomiting
Clinical narrative: NAUSEA, VOMITING, DIZZINESS, BODY ACHES, DRY MOUTH FOR TWO DAYS.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Febrile convulsion, Generalised tonic-clonic seizure, Urine analysis
Clinical narrative: Febrile GTC seizure.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Extreme dizziness.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Monday, 11/9  the afternoon the shot was given - his arm became a little red and itchy. Tuesday, 11/10, morning  the redness and swelling was much larger and increased during the day. Wednesday, 11/11  Physician prescribed Ciprofloxacin. Thursday, 11/12  Redness and swelling continued even after two doses of Ciprofloxacin. By the end of the day the area had extended down the arm from the injection site to the elbow and encircled below the bicep; then gradually improved. Sunday, 11/15  Antibiotic stopped. Monday, 11/16  Redness and swelling gone; slight amount of itching still present.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Severe flu symptoms, called out of work. Lasted 24-36 hours. Did not seek medical help.  Slept for the most part of the day.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Weakness and tingling in my extremities and eventually paralyzing my whole body.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: Weakness and tingling in my extremities and eventually paralyzing my whole body.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: LD area - redness, swelling, induration, tenderness, pain. Treatment - KEFLEX 500 mg 1 PO QID x 10 days for cellulitis.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient c/o numb arm, upon exam by physician, arm was weak.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Significant erythema involving entire circumference of thigh.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Slight dizziness.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became red, swollen, warm 5 hrs after injection = went to ER 11/11/15 and told was having a "reaction to vaccine" - no tx given.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Eyelid rash, Herpes zoster, Rash
Clinical narrative: 1 day after flu shot developed pain in ear for 2 weeks. Then rash on face and scalp. Over eye. Developed shingles.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 2-month-old patient of unknown gender. Patient's medical history, current conditions and concomitant medications were not reported. On 13-NOV-2015, the patient received a dose of oral, ROTATEQ, (dose and lot number were not provided). On the same day, immediately after receiving the vaccine, the patient vomited. The outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as there was no consent for the follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 60 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 09-NOV-2015, the patient was vaccinated subcutaneously with an unknown ZOSTAVAX (lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date in November 2015, after receiving a dose of ZOSTAVAX, the patient experienced swelling, redness, unspecified rash and warm to the touch 2 inches around the injection site. The patient sought medical attention via see the physician on 11-NOV-2015. The patient was informed to apply hydrocortisone cream to the injection site and to take ZYRTEC and BENADRYL. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 14-SEP-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of therapy non-responder in a 57-year-old male patient who received ENGERIX B adult (batch number 995J5, expiry date 6th February 2017). This case was associated with  a product complaint. Co-suspect products included ENGERIX B adult (batch number F3BB3, expiry date 18th April 2017 and ENGERIX B adult (batch number 9937B, expiry date 2nd October 2017). On 5th January 2015, the patient received the 1st dose of ENGERIX B adult. On 11th February 2015, the patient received the 2nd dose of ENGERIX B adult. On 17th July 2015, the patient received the 3rd dose of ENGERIX B adult. On 9th September 2015, 247 days after receiving ENGERIX B adult, 210 days after receiving ENGERIX B adult and 54 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possibly related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B titers following vaccination with ENGERIX B (see cases US2015GSK136757, US2015GSK136758, US2015135763, US2015GSK136760, US2015GSK136761 and US2015GSK136762). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were same or even lower titers. All the seven patients were new hires at the company and that so the reporter was following them. This case concerned to the patient number 4. On 9th September 2015, 247 days after receiving 1st dose of ENGERIX B adult, 210 days after receiving 2nd dose of ENGERIX B adult and 54 days after receiving 3rd dose of ENGERIX B adult, the patient underwent test for Hepatitis B antibodies and it was found to be negative (quantity 0.1), causing the patient to be non-responder to the therapy.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Pneumonia bacterial
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 6 November 2015. Manufacturer reference number: 2015378577 This case is linked with case number 2015SA180851 (same reporter, different patients). This case involves a female (age not reported) patient who was vaccinated with a dose of flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient had medical history of very severe form of strep that was treated with penicillin for a greatly extended period of time in order to rid body of the infection. The patient concomitantly received TRAVATAN eye drops to treat eye pressure. The patient did not mention an AE specific to TRAVATAN. On an unspecified date, four days following the vaccination, the patient developed flu. On an unspecified date, following the vaccination the patient also developed bacterial pneumonia. On 19 December 2014, the patient was hospitalized. Laboratory investigation and corrective treatment were not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Pneumonia bacterial
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) on 6 November 2015. Manufacturer reference number: 2015378589. This case is linked with case number 2015SA180840 (same reporter, different patients). This case involve a male (age not reported) patient who was vaccinated with a dose of Flu shot (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, four days following the vaccination, the patient developed Flu. On an unspecified date, following the vaccination the patient also developed bacterial pneumonia. On 18 December 2014, the patient was hospitalized. Laboratory investigation and corrective treatment were not reported. List of documents held by sender: none.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (lot #, dose and route unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patiens were vaccinated with doses of improperly stored RECOMBIVAX HB (lot #, dose and route unspecified). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Condition aggravated, Fatigue, Headache, Rash
Clinical narrative: Initial unsolicited report received from a consumer on 26 October 2015. This case involves a (37-year-old) female patient who was vaccinated with intradermally [series not reported] dose of FLUZONE ID (batch number UT5350AA, expiry date 30 June 2016) in left deltoid on 23 October 2015. Patient had received FLUZONE IM vaccine for past 11 years and never had a reaction. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergy to FLAGYL, iodine and contrast dye. Other medical history was reported as Lupus. Concomitant medications were not reported. On 23 October 2015, three hour following the vaccination patient had experienced "flare up" of her Lupus. Patient experienced rash, joint pain, fatigue, headache as her symptoms of "flare up" of Lupus. Patient required emergency room (ER)/doctor visit. Patient lab data was not reported. The patient received 40 mg prednisone as corrective treatment. The patient was not recovered at the time of report. Upon medical review, the case was considered as serious due to important medical event lupus, fatigue, rash, joint pain and headache. List of documents held by sender: none.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Systemic lupus erythematosus
Clinical narrative: Initial unsolicited report received from a consumer on 26 October 2015. This case involves a (37-year-old) female patient who was vaccinated with intradermally [series not reported] dose of FLUZONE ID (batch number UT5350AA, expiry date 30 June 2016) in left deltoid on 23 October 2015. Patient had received FLUZONE IM vaccine for past 11 years and never had a reaction. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergy to FLAGYL, iodine and contrast dye. Other medical history was reported as Lupus. Concomitant medications were not reported. On 23 October 2015, three hour following the vaccination patient had experienced "flare up" of her Lupus. Patient experienced rash, joint pain, fatigue, headache as her symptoms of "flare up" of Lupus. Patient required emergency room (ER)/doctor visit. Patient lab data was not reported. The patient received 40 mg prednisone as corrective treatment. The patient was not recovered at the time of report. Upon medical review, the case was considered as serious due to important medical event lupus, fatigue, rash, joint pain and headache. List of documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Sex: U
Vaccine: FLU3
Symptoms: Mechanical ventilation, Respiratory failure
Clinical narrative: Initial unsolicited case received from a physician on 05-Nov-2015. This case was linked to 2015SA179107 and 2015SA179115 (same reporter and same vaccine). This case involves a patient (age and gender not reported), who was vaccinated with an intramuscular dose of FLUZONE HD (batch number, dose number and site of administration were not reported) on unspecified date in 2015. Medical history and concomitant medications were not reported. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On an unspecified date in 2015, after vaccination the patient experienced respiratory failure and was on a ventilator. On an unspecified date, patient was hospitalized. Laboratory examinations and corrective treatments were not reported. The outcome of the event was reported as unknown. Case was considered as serious due to hospitalization and life threatening event. Documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose od M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Red indurated area with itching developing in area of injection around 5-6cm in size.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 76-year-old female patient received on 04Nov2015 a single dose of PREVNAR 13; (NDC number: 0005-1971-02; Lot: M16258; Expiry date: Apr2017), and a dose of AFLURIA; (NDC number: 33332-015-01; Lot: U51209; Expiry date: 30Jun2016). The patient medical history was none. Concomitant medication included Albuterol as needed, NORVASC 5 mg daily, COREG 25 mg 2x/day, CATAPRES 0.1 mg 2x/day, PLAVIX 75 mg daily, LASIX 20 mg daily, LOMOTIL as needed, LANTUS 50 units QHF, lisinopril tablet, 20 mg 2x/day (1 tablet twice a day), loratadine 10mg as needed, GLUCOPHAGE 1000 mg 2x/day, PROTONIX 20 mg as needed, ZOCOR 40 mg as needed and tramadol 50 mg as needed. On 04Nov2015, 1 minute after receiving the immunization, the patient got dizzy. She received oxygen for 15 minutes and after that, she recovered. On an unknown date she passed out. The outcome of loss of consciousness was unknown.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Diarrhoea, Disorientation, Syncope, Vomiting
Clinical narrative: Disorientated, fainting, diarrhea, vomiting, chills, about 10 hours after injection.
Age: 60.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Asthenia, Electrocardiogram, Full blood count, Headache, Hypertension
Clinical narrative: Headaches 2 days after injections - total body weakness, had to remain in bed. 3rd day - jumpiness - nervous mood swings - (NEVER had high blood pressure). Went to pharmacy took it 161/110. Went to urgent care - followed by internist psychiatrist visits.
Age: 60.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Metabolic function test, Mood swings, Nervousness, Platelet count, Renal function test
Clinical narrative: Headaches 2 days after injections - total body weakness, had to remain in bed. 3rd day - jumpiness - nervous mood swings - (NEVER had high blood pressure). Went to pharmacy took it 161/110. Went to urgent care - followed by internist psychiatrist visits.
Age: 60.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Thyroid function test, Urine analysis
Clinical narrative: Headaches 2 days after injections - total body weakness, had to remain in bed. 3rd day - jumpiness - nervous mood swings - (NEVER had high blood pressure). Went to pharmacy took it 161/110. Went to urgent care - followed by internist psychiatrist visits.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Patient described herself of having severe flu-like symptoms for 24-48 hours immunization...recovered okay.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Coagulation test normal, Full blood count normal, Petechiae, Platelet function test abnormal
Clinical narrative: Petechiae on bilateral feet and legs that recurred over 1 month.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: Initial report was received on 17 September 2014 from a health care professional via company representative. An almost 80 year-old female patient (date of birth not reported) had received on an unspecified date FLUZONE (lot number not reported) and several hours later, experienced an allergic response. The patient's face swelled up she went to the emergency room. The patient's medical history and laboratory tests were not reported. The patient was fine the next day. Outcome was recovered. Documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Confusional state, Epistaxis, Mobility decreased, Pain in extremity
Clinical narrative: About two hours after new pneumonia vaccine, arm became painful. On a scale of 1 to 10 the pain was a ten. Never, ever had reactions to vaccines. Extreme pain lasted for 8 hrs, arm useless, mental confusion.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Injection site pruritus, Musculoskeletal pain, Skin texture abnormal
Clinical narrative: 11/7/15 c/o itching at site, change in skin texture tiredness, joint pain shoulder and elbow. 11/11/15 had wife look at injection site. Redness/swelling. Stated taking ibuprofen.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: 11/7/15 c/o itching at site, change in skin texture tiredness, joint pain shoulder and elbow. 11/11/15 had wife look at injection site. Redness/swelling. Stated taking ibuprofen.
Age: 52.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Abasia, Balance disorder, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Severe numbness and tingling in hands and feet. Symptoms ascended up legs to thighs, resulting in imbalance and inability to walk. Diagnosed as Guillain-Barre syndrome.
Age: 52.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Lumbar puncture, Nerve conduction studies, Paraesthesia
Clinical narrative: Severe numbness and tingling in hands and feet. Symptoms ascended up legs to thighs, resulting in imbalance and inability to walk. Diagnosed as Guillain-Barre syndrome.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe shoulder pain and pain in arm, hand, fingers. Left side. Tingling in fingers. Difficulty raising arm, pain is constant throb took ALEVE and MOTRIN helps slightly. Pain in shoulder and arm have continued for 5 weeks. Seeing doctor on 11/9/15.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Injection site pain, Sleep disorder
Clinical narrative: Shoulder pain radiating down the arm from injection site. My arm does not work like it should. I can't sleep because of the pain. I have tried Ibuprofen 800 mg and tried sulindac 200 mg. Does very little.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Shot administered at 10:00 am. Pt contacted Rph at 3:30 PM to inform tha lips began to swell. Referred pt immediately to E.R. and Rph informed PCP. Pt saw PCP - swelling resolved without tx.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Rash, Skin warm
Clinical narrative: Pain in arm instantly - rash on arm w/heat. Applied ice and received BENADRYL.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Cold sweat, Feeling cold, Headache, Pain
Clinical narrative: Arm soreness, headache, severe body aches, severe joint pain, tremors, fever 103.1 F, body felt cold, cold sweats.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Arm soreness, headache, severe body aches, severe joint pain, tremors, fever 103.1 F, body felt cold, cold sweats.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Flu-like symptoms the day after vaccines administered (approx 10-12 hrs), low-grade headache, nausea, chills, slight fever, weakness throughout body. All symptoms gone the following day.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms the day after vaccines administered (approx 10-12 hrs), low-grade headache, nausea, chills, slight fever, weakness throughout body. All symptoms gone the following day.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was mistakenly given FLUARIX instead of BOOSTRIX. No other adverse events were reported.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Claustrophobia, Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient stated she gets nervous when receiving shots and sometimes faints but want to proceed with flu immunization. She was feeling claustrophobic in immunization room and walked out to waiting room, sat down in chair and fainted. 911 was called and paramedics arrived shortly after. Patient was unconscious for about 20 seconds and bumped head on wall when passing out.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient erroneously was given FLUARIX instead of BOOSTRIX. No additional adverse events were reported.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Mom noticed redness on left leg 11-10, redness was larger and leg swollen on 11-11. She noticed water filled blisters in center of redness on 11-12. Redness measures 10 cm x 10 cm, hot to touch. Rx'd SEPTRA susp. 7 mL.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swollen tongue, Tongue pruritus
Clinical narrative: Tongue became itchy and swollen, fine rash on face, inner arms, anterior thighs and head. IV BENADRYL , SOLU-MEDROL and PEPCID was given in the E.D.
Age: 44.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, TYP
Symptoms: Swelling face
Clinical narrative: Received med at approx 12:20p, returned 25 minutes later with (R) cheek swelling near the ear, 50 mg Diphenhydramine, ice. Repeated med and ice later in day. No further problems. Swelling the size of large orange. No difficulty breathing or swallowing. US WNL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Cellulitis, Vaccination complication
Clinical narrative: Seen in emergency room 11/15/15 for vaccine reaction. Diagnosed with cellulitis and started BACTRIM. Seen for follow up in office on 11/17/15, cellulitis improving. Patient to complete antibiotic and follow up if symptoms do not fully resolve.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram normal, Enzyme activity normal, Heart rate increased
Clinical narrative: Initial case received from a consumer on 30 September 2014. A 70-year-old female patient, with a medical history of breast cancer with radiation treatment in 2001, received an intramuscular injection of FLUZONE HD (lot number not reported) on 25 September 2014. Within 30 minutes of vaccination, she experienced a difficulty breathing and increased heart rate. She was evaluated by a physician, and reported that vital signs, "blood enzymes", and EKG were all within normal limits. She was treated with CLARITIN and PEPCID. According to the consumer, she continued to have episodes of shortness of breathing lasting a few minutes. Outcome was not reported. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Headache, Nuclear magnetic resonance imaging normal, Tension headache
Clinical narrative: Initial report was received on 24 September 2014 from a health care professional , who is also the patient. A 51 year-old female with a history of allergies to erythromycin (anaphylaxis) and DILANTIN (rash) had on an unspecified date in 2010 an intramuscular injection of FLUZONE (lot number and site of administration not reported) and five days later, experienced a headache. The patient described it as a tension headache but slightly worse. The headaches progressed to occur almost daily. In December 2010, the patient was hospitalized. The patient had a CT scan, MRI and EEG all was negative. She was evaluated by a neurologist. According to the patient, the headaches lasted six months and then resolved in 2011. The patient continued to receive the flu shot each year with the same result but less than 2010. According to the reporter, she thinks that this happens no matter who the manufacturer happens to be. The patient's outcome was recovered. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Abscess, Abscess drainage, Pain, Pyrexia, Staphylococcus test positive
Clinical narrative: Initial report received on 16 September 2014 and follow up information received on 19 September 2014 from an investigator participating in a study. A 25-month-old male subject was diagnosed with left submandibular abscess on 07 September 2014 i.e. 18 days after receiving first intramuscular 0.25ml dose of the study vaccine FLUZONE quadrivalent in right thigh on 20 August 2014 (batch number: U4978AB). The event appeared after visit 01. No medical history was reported. The subject had no concomitant therapies. The subject had symptom fever from 07 September 2014. Subject presented to the emergency department on 07 September 2014 with left mandibular abscess and fever. He was admitted to the hospital on the same day and was given one dose of Morphine, IV Ceftriaxone and Clindamycin. The abscess was drained. Culture grew MSSA and subject was changed to Cefazolin. Pain well controlled with TYLENOL or MOTRIN. Subject was transitioned to PO AUGMENTIN and was discharged. Subject was afebrile for more than 24 hours prior to discharge. The lab data was not reported. The subject had corrective treatment with Morphine - 1 dose on 7 September 2014, IV Ceftriaxone from 07 September 2014 to 10 September 2014, IV Clindamycin from 07 September 2014 to 10 September 2014, IV Cefazolin from 10 September 2014 to 13 September 2014, PO AUGMENTIN 13 September 2014 to 18 September 2014, TYLENOL from 07 September 2014 to 13 September 2014 and MOTRIN from 7 September 2014 to 13 September 2014. The symptom of fever was resolved on 16 September 2014. The subject was discharged from the hospital on 13 September 2014. The event of left submandibular abscess was ongoing at the time of the report. According to the investigator, the event was not related to the study vaccine or trial procedures. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 30 October 2014: It was updated that the subject presented to the emergency department on 07 September 2014 with left submandibular (previously reported as left mandibular) abscess and fever. Follow up information received on 10 December 2014: It was reported that the subject had no ongoing illnesses, medical history or risk factors. There were no complimentary investigations. At the time of reporting the event was still ongoing.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chills, Erythema of eyelid, Eyelids pruritus, Limb discomfort
Clinical narrative: Based on additional information received on 24 November 2014, this case became medically confirmed. Initial report received from a consumer, who is also the patient, on 10 October 2014. A 71-year-old female patient, with a history of allergies to cedar, ragweed, and poison ivy, received in intramuscular left deltoid injection of FLUZONE HD (lot number not reported) on 27 September 2014. She reported no illness at the time of vaccination. Two days post-vaccination, on 29 September 2014, the patient began experiencing chills, and complained of her left arm feeling "heavy". Six days post-vaccination, the patient developed a red, raised, itchy rash of varying size, widespread over her body. Her eyelids also became red and itchy. She stated it "feels like she is on fire inside". She also stated that she had been feeling a little bit of muscle weakness, and felt as if she had some swelling in her throat. She was seen by her primary care physician and was advised to use BENADRYL every six hours and use cortisone cream; a few days later she was given a shot of cortisone. She reported that she had not seen significant improvement, and an additional unspecified prescription treatment had been ordered by her physician. At the time of the report, the events had not yet recovered. Follow-up information was received on 24 November 2014 from a healthcare professional. The lot number was reported as U5022AA. The report was reviewed and the reporter had no additional information to provide. Documents held by sender: None.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pharyngeal oedema, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Based on additional information received on 24 November 2014, this case became medically confirmed. Initial report received from a consumer, who is also the patient, on 10 October 2014. A 71-year-old female patient, with a history of allergies to cedar, ragweed, and poison ivy, received in intramuscular left deltoid injection of FLUZONE HD (lot number not reported) on 27 September 2014. She reported no illness at the time of vaccination. Two days post-vaccination, on 29 September 2014, the patient began experiencing chills, and complained of her left arm feeling "heavy". Six days post-vaccination, the patient developed a red, raised, itchy rash of varying size, widespread over her body. Her eyelids also became red and itchy. She stated it "feels like she is on fire inside". She also stated that she had been feeling a little bit of muscle weakness, and felt as if she had some swelling in her throat. She was seen by her primary care physician and was advised to use BENADRYL every six hours and use cortisone cream; a few days later she was given a shot of cortisone. She reported that she had not seen significant improvement, and an additional unspecified prescription treatment had been ordered by her physician. At the time of the report, the events had not yet recovered. Follow-up information was received on 24 November 2014 from a healthcare professional. The lot number was reported as U5022AA. The report was reviewed and the reporter had no additional information to provide. Documents held by sender: None.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial case received from a healthcare professional (the patient's responsible physician) on 01-Oct-2014. A 43-year-old male patient, with no reported medical history and no illness at the time of vaccination, had received her intramuscular dose of FLUZONE QIV, (batch number UI172AA) in the left deltoid on 15-Sept-2014. On 20-Sept-2014, 5 days post-vaccination, the patient had a possible Guillain-Barre syndrome diagnosed. The patient was admitted to the hospital on 30 September 2014. No other symptoms were reported. The responsible physician was notified by an infectious disease doctor. The outcome was unknown. No further details were provided. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial information received from a healthcare professional on 30 September 2014. An unidentified female patient (date of birth not reported) with a history of egg and gelatin allergy and asthma was vaccinated on an unspecified date with FLUZONE Trivalent, batch, and route of administration were not reported. At an unspecified time in 2012, the patient experienced anaphylaxis which required an EPIPEN treatment. The patient's concomitant medications were not reported. The patient was being desensitized at an allergist office, but no other information was given. The patient outcome was recovered. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Angioedema, Blood pressure decreased, Hypotension, Pruritus
Clinical narrative: Initial report received from a physician on 03 October 2014. A 9-year-old male patient, with a history of hay fever and asthma, received an intramuscular injection of FLUZONE QIV (lot number UI191AB) at 4:30 pm on 01 October 2014. The patient had previously received six doses of influenza vaccine with no reported adverse events. At approximately 6:30 pm, the patient's mother called the physician to report that the patient was experiencing hives and facial swelling, and was "very itchy". She was instructed to take the patient to the emergency room. In the hour and one-half that they were waiting, the patient developed shortness of breath and his blood pressure dropped to 73/46. He was diagnosed with anaphylaxis and treated with fluids, intravenous steroids, and intravenous BENADRYL. The patient recovered and was discharged home. He was being referred to an allergist/immunologist. Follow-up information received from a physician on 06 November 2014. At the time of flu vaccination, the patient was taking concomitant medications with multivitamins daily and acetaminophen (at 5pm). The patient had not experienced adverse events following prior vaccinations. He has no siblings. There was no illness noted at the time of vaccination. The patient started to experience adverse events at 6:30 pm on 01 October 2014. He had decreased blood pressure of 73/46 on 01 October 2014. Shortness of breath was removed from the symptoms experienced by patient. Follow-up information for this unsolicited case was received from a physician (an allergist), on 01 December 2014. The patient's past medical history included allergic rhinoconjunctivitis (spring and fall), and asthma, primarily infectious. The event was clarified as anaphylaxis with angioedema, urticaria, and hypotension. Based upon the historical information, it was the reporter's conclusion that the anaphylaxis was induced either by the acetaminophen administered one hour prior to vaccination, or the influenza vaccine. The patient had no history of egg allergy and ingested eggs regularly without adverse reaction. Pulmonary function testing on 24 October 2014 demonstrated mild reversible small airway obstruction. The patient was provided a written anaphylaxis plan, and was instructed to use AUVI-Q as needed until the source of his anaphylaxis had been identified. The patient had been referred to another facility for additional allergy testing; the appointment was scheduled for 08 January 2015. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Pulmonary function test abnormal, Reversible airways obstruction, Swelling face, Urticaria
Clinical narrative: Initial report received from a physician on 03 October 2014. A 9-year-old male patient, with a history of hay fever and asthma, received an intramuscular injection of FLUZONE QIV (lot number UI191AB) at 4:30 pm on 01 October 2014. The patient had previously received six doses of influenza vaccine with no reported adverse events. At approximately 6:30 pm, the patient's mother called the physician to report that the patient was experiencing hives and facial swelling, and was "very itchy". She was instructed to take the patient to the emergency room. In the hour and one-half that they were waiting, the patient developed shortness of breath and his blood pressure dropped to 73/46. He was diagnosed with anaphylaxis and treated with fluids, intravenous steroids, and intravenous BENADRYL. The patient recovered and was discharged home. He was being referred to an allergist/immunologist. Follow-up information received from a physician on 06 November 2014. At the time of flu vaccination, the patient was taking concomitant medications with multivitamins daily and acetaminophen (at 5pm). The patient had not experienced adverse events following prior vaccinations. He has no siblings. There was no illness noted at the time of vaccination. The patient started to experience adverse events at 6:30 pm on 01 October 2014. He had decreased blood pressure of 73/46 on 01 October 2014. Shortness of breath was removed from the symptoms experienced by patient. Follow-up information for this unsolicited case was received from a physician (an allergist), on 01 December 2014. The patient's past medical history included allergic rhinoconjunctivitis (spring and fall), and asthma, primarily infectious. The event was clarified as anaphylaxis with angioedema, urticaria, and hypotension. Based upon the historical information, it was the reporter's conclusion that the anaphylaxis was induced either by the acetaminophen administered one hour prior to vaccination, or the influenza vaccine. The patient had no history of egg allergy and ingested eggs regularly without adverse reaction. Pulmonary function testing on 24 October 2014 demonstrated mild reversible small airway obstruction. The patient was provided a written anaphylaxis plan, and was instructed to use AUVI-Q as needed until the source of his anaphylaxis had been identified. The patient had been referred to another facility for additional allergy testing; the appointment was scheduled for 08 January 2015. Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received from a pharmacist, via Merck, on 08 October 2014. A patient (age, gender, and medical history not reported) received FLUZONE (lot number and administration details not reported) and later experienced Guillain-Barre syndrome. No additional information was reported, and no contact information was provided. Documents held by sender: None.