chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Erythema and swelling at injection site approx. 6 cm x 2.5 cm, with induration but no fluctuation.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Full blood count, Local reaction, Metabolic function test
Clinical narrative: Serum sickness reaction with local reaction, arthralgia, pain, fatigue in multiple joints.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Red blood cell sedimentation rate, Serum sickness
Clinical narrative: Serum sickness reaction with local reaction, arthralgia, pain, fatigue in multiple joints.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling and erythema, pruritis + 10 cm diameter around injection site. No systemic side effects. Patient feels well except for localized symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as K008885, with expiration date 20-SEP-2015, dose 0.65 ml, subcutaneously, which had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Immediate post-injection reaction, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous report was received from a nurse via field employee regarding a female patient of unknown age. There was not information on pertinent medical history and drug reactions or allergies. On 23-SEP-2014, the patient was vaccinated with PNEUMOVAX23 (also reported as PNEUMOVAX VIAL) (strength, product lot #, expiry date not reported) dose reported as 1 injection, route arm (reported as subcutaneous deltoid muscle injection). There was no information on concomitant therapy. On 23-SEP-2014, immediately after being vaccinated with PNEUMOVAX23 the patient experienced stiffness, fatigue and intense pain. The patient sought medical attention "within the practice". There was no product quality complaint involved. The outcome of the events was unknown. The causality was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 65 year old female patient refers to herself. The patient stated that she had a history of shingles. Drug reaction/allergies included an unspecified reaction to an unspecified medication used to treat gout. On 10-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, strength, dose, frequency and route unspecified). Concomitant medication included blood pressure medication. Consumer stated that since vaccination, she developed shingles 3 times starting in June 2013 (reported as 6 months after vaccination) and another one in approximately 2014 (reported as "not long ago"). Upon developing shingles, consumer was prescribed ACYCLOVIR bu the consumer stated that ACYCLOVIR did not work. No lab diagnostics studies were performed. The patient sought medical attention via contacting physician. No product quality complaint (PQC) involved. The outcome of shingles was unknown. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a nurse and described the occurrence of loose stools in a 2-month-old male subject who was vaccinated with ROTARIX LYOPHILIZED FORMULATION (GlaxoSmithKline), PENTACEL and PREVENAR. On 15 August 2014, the subject received 1st dose of ROTARIX LYOPHILIZED FORMULATION (1 ml, oral), 1st dose of PENTACEL (unknown route and injection site), 1st dose of PREVENAR 13 (unknown route and injection site). On 16 August 2014, 1 day after vaccination with PENTACEL, PREVENAR 13 and ROTARIX  LYOPHILIZED FORMULATION, the subject experienced 10 loose stools per day and some irritability. He was evaluated at the clinic and had no fever, no vomiting, no sick contacts, no dehydration, no blood in his stool and his weight was good (he gained 3 ouches which is what they expected). At the time of reporting the events were unresolved. The nurse considered the events were probably related to vaccination with ROTARIX  LYOPHILIZED FORMULATION, PENTACEL and PREVENAR 13. Follow-up received on 08 October 2014: On 02 September 2014, the events were resolved. The patient had 8-10 loose stools per day for 1 week then down to 5-6 loose stools per day for 10 days. Then back to normal once a day formed stools. The patient had no fever, no vomiting, no dehydration and no viral GI illness noted.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Irritability
Clinical narrative: This case was reported by a nurse and described the occurrence of loose stools in a 2-month-old male subject who was vaccinated with ROTARIX LYOPHILIZED FORMULATION (GlaxoSmithKline), PENTACEL and PREVENAR. On 15 August 2014, the subject received 1st dose of ROTARIX LYOPHILIZED FORMULATION (1 ml, oral), 1st dose of PENTACEL (unknown route and injection site), 1st dose of PREVENAR 13 (unknown route and injection site). On 16 August 2014, 1 day after vaccination with PENTACEL, PREVENAR 13 and ROTARIX  LYOPHILIZED FORMULATION, the subject experienced 10 loose stools per day and some irritability. He was evaluated at the clinic and had no fever, no vomiting, no sick contacts, no dehydration, no blood in his stool and his weight was good (he gained 3 ouches which is what they expected). At the time of reporting the events were unresolved. The nurse considered the events were probably related to vaccination with ROTARIX  LYOPHILIZED FORMULATION, PENTACEL and PREVENAR 13. Follow-up received on 08 October 2014: On 02 September 2014, the events were resolved. The patient had 8-10 loose stools per day for 1 week then down to 5-6 loose stools per day for 10 days. Then back to normal once a day formed stools. The patient had no fever, no vomiting, no dehydration and no viral GI illness noted.
Age: 33.0
Sex: M
Vaccine: VARZOS, TDAP
Symptoms: Expired drug administered, Wrong technique in drug usage process
Clinical narrative: Developed Guillain-Barre.
Age: 33.0
Sex: M
Vaccine: VARZOS, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Developed Guillain-Barre.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Livedo reticularis
Clinical narrative: Red, blotchy inflammation at injection site that first appeared within minutes of injection on 10-18-14. At time of OV on 10-20-14, the area of redness and inflammation measured 33 cm in length; 28 cm distal and 5 cm caudal to injection site. (R) deltoid/upper arm 4 cm > (L).
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Red, blotchy inflammation at injection site that first appeared within minutes of injection on 10-18-14. At time of OV on 10-20-14, the area of redness and inflammation measured 33 cm in length; 28 cm distal and 5 cm caudal to injection site. (R) deltoid/upper arm 4 cm > (L).
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Rash macular
Clinical narrative: Red, blotchy inflammation at injection site that first appeared within minutes of injection on 10-18-14. At time of OV on 10-20-14, the area of redness and inflammation measured 33 cm in length; 28 cm distal and 5 cm caudal to injection site. (R) deltoid/upper arm 4 cm > (L).
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Sharp pain at and around injection sight.  Experiencing trouble rotating arm and performing normal movements with arm.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Sharp pain at and around injection sight.  Experiencing trouble rotating arm and performing normal movements with arm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Intensive care
Clinical narrative: Anaphylaxis, followed by treatment in ER and ICU.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Feeling abnormal, Impaired driving ability, Influenza like illness
Clinical narrative: My eyes felt like there was a film over them, was hard to drive pulled over and washed eyes out with plenty of cold water. Did not help.  Reached where was going to felt edgy and started to get sick to my stomach. Went to girl friends house 5 miles away drove there no problem's driving.  When got to her house about 7PM felt nauseated.  Went to bed around 10PM was having trouble breathing short of breath used albuterol inhaler also have concentrator that use for borderline sleep apnea, set at 2.  Woke up about 1.5 hours later to go to the bathroom and felt like my head was going to explode felt really sick like I had the flu.  Stayed up til 1:am on the 10/12/2014 went back to bed and in the morning got up about 9;am and felt like I was hung over from a drinking binge. After a couple of hours like 4Pm in the afternoon felt fine.  Except had a rash forming on the left and right side of my nose, not on the nose but to each side. Just a slight redness and it is still with me today. Went to Urgent Care yesterday 10/21/2014 and got a Rx from the doctor there.  My girl friend is a RN and if she had not been there with me would have called emergency services as would not been able to handle the situation by myself.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Nausea, Rash, Visual impairment
Clinical narrative: My eyes felt like there was a film over them, was hard to drive pulled over and washed eyes out with plenty of cold water. Did not help.  Reached where was going to felt edgy and started to get sick to my stomach. Went to girl friends house 5 miles away drove there no problem's driving.  When got to her house about 7PM felt nauseated.  Went to bed around 10PM was having trouble breathing short of breath used albuterol inhaler also have concentrator that use for borderline sleep apnea, set at 2.  Woke up about 1.5 hours later to go to the bathroom and felt like my head was going to explode felt really sick like I had the flu.  Stayed up til 1:am on the 10/12/2014 went back to bed and in the morning got up about 9;am and felt like I was hung over from a drinking binge. After a couple of hours like 4Pm in the afternoon felt fine.  Except had a rash forming on the left and right side of my nose, not on the nose but to each side. Just a slight redness and it is still with me today. Went to Urgent Care yesterday 10/21/2014 and got a Rx from the doctor there.  My girl friend is a RN and if she had not been there with me would have called emergency services as would not been able to handle the situation by myself.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Nausea, Vaccination site pain, Vaccination site warmth
Clinical narrative: Pt had a warm red and painful area at the sight of the vaccine.  She also felt dizzy and nauseated.  The redness was about 4 cm in diameter.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Both arms started swelling due to the different vaccines given.  The area was 3-4 cm and red and warm to the touch.
Age: 82.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to the injection sights.
Age: 49.0
Sex: M
Vaccine: FLUC3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Severe arm pain. Reduced range of motion. Pain radiates down my arm. Pain in the morning is unbearable.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Body temperature increased, Chills, Headache, Hypoacusis
Clinical narrative: He did feel good. On Oct. 3rd he came down with cough with mucus, headache, chills,no fever.  Stomach and urinary tract hurt.  On Oct. 5 or 6 he had an increased hearing problem.  On the 6 or 7th he ran a temp of 102.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Urinary tract pain
Clinical narrative: He did feel good. On Oct. 3rd he came down with cough with mucus, headache, chills,no fever.  Stomach and urinary tract hurt.  On Oct. 5 or 6 he had an increased hearing problem.  On the 6 or 7th he ran a temp of 102.
Age: 1.51
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: After receiving the flu shot, my son started breaking out in hives after everything he ate, after two weeks it slowed down but did not go away. It's been three weeks and he is still breaking out in hives atleast once a day when he eats.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Skin infection, Streptococcus test positive
Clinical narrative: Patient developed increased swelling and redness at site of injection. Was seen at the PMD's office the next day, where she was diagnosed with cellulitis around the area of injection. Clindamycin was prescribed for the skin infection.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Swelling
Clinical narrative: Approx 1515 noted a dry cough and trying to clear throat. Approx 2100 constantly clearing throat and then sought ER treatment. No SOB. Swelling.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large, swollen red patch at injection site. Redness lasted 1 week. Still having residual mild pain and itching 2 weeks later.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Blood test, Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Chills, achy fever of 103.8. Arm re swollen at injection sight.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: White blood cell count increased
Clinical narrative: Chills, achy fever of 103.8. Arm re swollen at injection sight.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, C-reactive protein increased, Computerised tomogram thorax normal, Musculoskeletal pain, Neck pain
Clinical narrative: Patient developed back pain, progressing to involve shoulders and neck...Eventually diagnosed with polymyalgia rheumatica with elevated ESR and CRP. Treated with IV then PO steroid with clinical response. He is following up with a rheumatologist.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Spinal X-ray normal
Clinical narrative: Patient developed back pain, progressing to involve shoulders and neck...Eventually diagnosed with polymyalgia rheumatica with elevated ESR and CRP. Treated with IV then PO steroid with clinical response. He is following up with a rheumatologist.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Joint range of motion decreased
Clinical narrative: IMMEDIATE PAIN/BLEEDING AT INJECTION SITE OCCURRED UPON RECEIVING INJECTION. BANDAIDE SOAKED THROUGH AND CONTINUED TO BLEED FOR APPROX. 5 MINUTES FOLLOWING INJECTION. PAIN LEVEL 7 (0=NONE,10=MAX) AND LIMITED RANGE OF MOTION LASTING 48HRS. APPLIED ICE COMPRESSES WITH RELIEF.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pruritus, Pyrexia
Clinical narrative: Fever 101, chills, itching, large red area 24X10cm.  Right arm.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Headache, Herpes zoster, Laboratory test abnormal, Musculoskeletal chest pain
Clinical narrative: Headache, lack of appetite, rib-pain, rash on rib cage.  Diagnosed with Shingles on 10/15/2014.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Headache, lack of appetite, rib-pain, rash on rib cage.  Diagnosed with Shingles on 10/15/2014.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Local reaction, Local swelling
Clinical narrative: Red with a sm bruise under injection site, with a raised area.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Tendonitis
Clinical narrative: Patient states that she has had pain in her arm since recieving the vaccine. Patient also said she is unable to move her arm behind her back after recieving vaccine. Patient say MD and he thinks it is tendinitis in the vaccinated arm.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Dysuria, Injection site rash, Injection site swelling
Clinical narrative: Reaction:  The evening after receiving an influenza vaccine in clinic, patient developed rash/swelling at injection site, progressive weakness, dysuria, nausea, and 10/10 back pain.  Management:  Patient evaluated in clinic 2 days after the vaccine was administered and sent to the ED for further workup. In ED neurology decided to admit the patient. In hospital, reported weakness was not demonstrated on exam (strength 5/5 at all sites) and reflexes were all intact. The patient's home dose of gabapentin was increased to 600 mg TID to help with the patient's back pain. Patient was discharged to home with physical therapy the next day.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Reaction:  The evening after receiving an influenza vaccine in clinic, patient developed rash/swelling at injection site, progressive weakness, dysuria, nausea, and 10/10 back pain.  Management:  Patient evaluated in clinic 2 days after the vaccine was administered and sent to the ED for further workup. In ED neurology decided to admit the patient. In hospital, reported weakness was not demonstrated on exam (strength 5/5 at all sites) and reflexes were all intact. The patient's home dose of gabapentin was increased to 600 mg TID to help with the patient's back pain. Patient was discharged to home with physical therapy the next day.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Dime size fluid filled blister at injection site, patient staes it itches, no other complaints.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Erythema, Injection site pain
Clinical narrative: Large area of redness, temp 100, chills, pain at injection site.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Burning sensation, Chills, Dyspnoea, Facial pain
Clinical narrative: Chills, shakes till 3am, body, head,face, teeth, neck, knees, wrist, back, body aches, nausea, palpitations, shortness of breath, vision wavy lines, sinus, burning mouth, face, 5am very hot, residual, headache, face pain, nausea, weakness, some chills, not feeling well.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling hot, Headache, Malaise, Nausea, Oral discomfort
Clinical narrative: Chills, shakes till 3am, body, head,face, teeth, neck, knees, wrist, back, body aches, nausea, palpitations, shortness of breath, vision wavy lines, sinus, burning mouth, face, 5am very hot, residual, headache, face pain, nausea, weakness, some chills, not feeling well.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Palpitations, Sinus disorder, Tremor, Visual impairment
Clinical narrative: Chills, shakes till 3am, body, head,face, teeth, neck, knees, wrist, back, body aches, nausea, palpitations, shortness of breath, vision wavy lines, sinus, burning mouth, face, 5am very hot, residual, headache, face pain, nausea, weakness, some chills, not feeling well.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Hypotonia, Malaise, Nausea, Skin discolouration, Unresponsive to stimuli
Clinical narrative: Patient received influenza and Gardasil IM immunization in different arms. Patient looked and acted fine. Patient put on coat and left the office. Patient was in the lobby waiting for the elevators and stated she didn't feel well, "like I'm going to throw-up". Patient sat down and coloring of face turned yellowish, then green. Mother of the patient went and got assistance from the nurse. Patient went flaccid, unable to communicate and unresponsive. Nurse asked for assistance of the medical doctor. Patient was assisted into a supine position with legs over the arm rest of the two person chair. After about 1 min or longer, patient started to make eye contact and verbally respond. Patient sat still for 15 min and ate crackers and drank sweet tea. Patient was able to walk out of the clinic.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Yellow skin
Clinical narrative: Patient received influenza and Gardasil IM immunization in different arms. Patient looked and acted fine. Patient put on coat and left the office. Patient was in the lobby waiting for the elevators and stated she didn't feel well, "like I'm going to throw-up". Patient sat down and coloring of face turned yellowish, then green. Mother of the patient went and got assistance from the nurse. Patient went flaccid, unable to communicate and unresponsive. Nurse asked for assistance of the medical doctor. Patient was assisted into a supine position with legs over the arm rest of the two person chair. After about 1 min or longer, patient started to make eye contact and verbally respond. Patient sat still for 15 min and ate crackers and drank sweet tea. Patient was able to walk out of the clinic.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, treated with prednisone.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Drug hypersensitivity, Eyelid margin crusting, Feeling abnormal, Hypoaesthesia, Oropharyngeal pain
Clinical narrative: Few hours after shot I felt funny had a low grade fever then I went to bed woke up at 6am feeling funny my eyes were sealed shut and crusty my face was swollen bad and numb then followed by a sore throat. Went to the ER was hooked up to IV then at home was to take antihistamine and pharyngitis for five days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngitis, Pyrexia, Swelling face
Clinical narrative: Few hours after shot I felt funny had a low grade fever then I went to bed woke up at 6am feeling funny my eyes were sealed shut and crusty my face was swollen bad and numb then followed by a sore throat. Went to the ER was hooked up to IV then at home was to take antihistamine and pharyngitis for five days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Body temperature increased, Disturbance in attention, Dizziness, Dry mouth
Clinical narrative: At approximately 12:30pm I developed tachycardia "felt like my heart was going to pound out of my chest", I also developed hives, reddness, and swelling on my face.  I felt like my face was sunburned, I was shaky, anxious, and I have numbness in my fingers.  I work in a surgical center, the nurse took me to the recovery room and alerted help.  After resting for 20 minutes I felt symptoms resolving- received po Benadryl 25mg, however, within approx 10 minutes symptoms returned: dizzy, elevated temp. 38.0, difficulty swallowing, dry mouth, shaking, numbness in hands, hives on face and neck, anxiety and difficulty making a decision, and nausea.  Treatment- IV epinephrine, IV Solu-Medrol, IV Benadryl 50mg, IV Zantac.  Transferred by ambulance to the ER.  Received IV Zofran and discharged after approx. 4 hours.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Erythema, Hypoaesthesia, Nausea, Skin warm
Clinical narrative: At approximately 12:30pm I developed tachycardia "felt like my heart was going to pound out of my chest", I also developed hives, reddness, and swelling on my face.  I felt like my face was sunburned, I was shaky, anxious, and I have numbness in my fingers.  I work in a surgical center, the nurse took me to the recovery room and alerted help.  After resting for 20 minutes I felt symptoms resolving- received po Benadryl 25mg, however, within approx 10 minutes symptoms returned: dizzy, elevated temp. 38.0, difficulty swallowing, dry mouth, shaking, numbness in hands, hives on face and neck, anxiety and difficulty making a decision, and nausea.  Treatment- IV epinephrine, IV Solu-Medrol, IV Benadryl 50mg, IV Zantac.  Transferred by ambulance to the ER.  Received IV Zofran and discharged after approx. 4 hours.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Tachycardia, Tremor, Urticaria
Clinical narrative: At approximately 12:30pm I developed tachycardia "felt like my heart was going to pound out of my chest", I also developed hives, reddness, and swelling on my face.  I felt like my face was sunburned, I was shaky, anxious, and I have numbness in my fingers.  I work in a surgical center, the nurse took me to the recovery room and alerted help.  After resting for 20 minutes I felt symptoms resolving- received po Benadryl 25mg, however, within approx 10 minutes symptoms returned: dizzy, elevated temp. 38.0, difficulty swallowing, dry mouth, shaking, numbness in hands, hives on face and neck, anxiety and difficulty making a decision, and nausea.  Treatment- IV epinephrine, IV Solu-Medrol, IV Benadryl 50mg, IV Zantac.  Transferred by ambulance to the ER.  Received IV Zofran and discharged after approx. 4 hours.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Hypoaesthesia oral, Local swelling, Pruritus
Clinical narrative: Localized swelling and redness. Then numb tongue itching and redness and hives.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Localized swelling and redness. Then numb tongue itching and redness and hives.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, and heat in the injection area up to softball size per patient's daughter.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Erythema, Flushing, Skin warm
Clinical narrative: Developed redness on her face that has spread to her neck. Her skin is warm and flushed. She reports that her eyes feel warm.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Injected limb mobility decreased, Injection site pain, Insomnia, Middle insomnia
Clinical narrative: SEVERE PAIN IN UPPER RIGHT ARM NEAR SHOULDER.  INJECTION GIVEN ONLY AN INCH AND 1/2 BELOW SHOULDER.  CANNOT RAISE RIGHT ARM ABOVE 45 DEGREES AT THIS POINT.  TINGLING NERVE PAIN CONTINUES TO INCREASE AT THIS POINT.  ARM PAIN IS INTENSE AND REQUIRES PAIN MEDICATION EVERY DAY.  WOKEN FROM SLEEP WITH PAIN.  CAN NOT SLEEP ON RIGHT SIDE DUE TO PAIN.  ARE WEAKNESS IS SIGNIFICANT.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Neuralgia, Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: SEVERE PAIN IN UPPER RIGHT ARM NEAR SHOULDER.  INJECTION GIVEN ONLY AN INCH AND 1/2 BELOW SHOULDER.  CANNOT RAISE RIGHT ARM ABOVE 45 DEGREES AT THIS POINT.  TINGLING NERVE PAIN CONTINUES TO INCREASE AT THIS POINT.  ARM PAIN IS INTENSE AND REQUIRES PAIN MEDICATION EVERY DAY.  WOKEN FROM SLEEP WITH PAIN.  CAN NOT SLEEP ON RIGHT SIDE DUE TO PAIN.  ARE WEAKNESS IS SIGNIFICANT.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: SEVERE PAIN IN UPPER RIGHT ARM NEAR SHOULDER.  INJECTION GIVEN ONLY AN INCH AND 1/2 BELOW SHOULDER.  CANNOT RAISE RIGHT ARM ABOVE 45 DEGREES AT THIS POINT.  TINGLING NERVE PAIN CONTINUES TO INCREASE AT THIS POINT.  ARM PAIN IS INTENSE AND REQUIRES PAIN MEDICATION EVERY DAY.  WOKEN FROM SLEEP WITH PAIN.  CAN NOT SLEEP ON RIGHT SIDE DUE TO PAIN.  ARE WEAKNESS IS SIGNIFICANT.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arm pain in a 29-year-old female patient who received BOOSTRIX (batch number AC52B102AA, expiry date 19th March 2015). Co-suspect products included FLUARIX QUADRIVALENT (batch number 2KJ3T, expiry date 25th June 2015). Previously administered products included Flu vaccine (no reactions). Concomitant products included Birth Control Pill, levothyroxine and Muscle Relaxant. On 5th September 2014 11:30, the patient received the 1st dose of BOOSTRIX (unknown) .5 ml. On 5th September 2014, the patient received the 1st dose of FLUARIX QUADRIVALENT (unknown). On 6th September 2014, 1 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability and clinically significant/intervention required) and restricted movement in arm. The patient was treated with cortisone and ALEVE. On an unknown date, the outcome of the arm pain and restricted movement in arm were not recovered/not resolved. It was unknown if the reporter considered the arm pain and restricted movement in arm to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details: The patient had any relevant medical history and previous vaccinations went uncomplicated. The reporting physician stated the patient received the FLUARIX in the left arm, and the BOOSTRIX in the right. The patient reported the FLUARIX was given in the right, and BOOSTRIX in the left. Also, the physician has 2 practices within the same county. The AE was reported to the rep during a visit at the address listed above. It is not known at time of report which office the patient received the injections. The patient reports a Grade 2 level pain in the left arm, with restricted movement. The physician saw the patient on September 15th, and the patient was given a cortisone injection in the affected arm and told to take ALEVE twice a day. The reporter also mentioned that the patient received the injections using a 1 inch 22 gauge needle. Follow-up information received on 08 October 2014 from the physician: BOOSTRIX and FLUARIX QUADRIVALENT were given concomitantly in different arms. Less than a week after the vaccination with BOOSTRIX and FLUARIX QUADRIVALENT the patient experienced pain at injection site which prolonged to 30 days. The physician does not feel that the injection site pain was vaccine related but wanted to know of any case reports of subacromial bursitis or continued deltoid pain were received. No additional information provided.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Gait disturbance, Hyperhidrosis, Nausea
Clinical narrative: Case number PHEH2014US020449, is an initial spontaneous report from a consumer (patient) received on 10 Oct 2014. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly on 07 Oct 2014. On 08 Oct 2014, she developed perspiration, nausea, dizziness and trouble walking. The outcome of the events was unknown. Seriousness and causality was not reported.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Blood test, Computerised tomogram, Dizziness
Clinical narrative: Case number PHEH2014US020449, is an initial spontaneous report from a consumer (patient) received on 10 Oct 2014. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly on 07 Oct 2014. On 08 Oct 2014, she developed perspiration, nausea, dizziness and trouble walking. The outcome of the events was unknown. Seriousness and causality was not reported.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Urine analysis, Walking aid user
Clinical narrative: Case number PHEH2014US020449, is an initial spontaneous report from a consumer (patient) received on 10 Oct 2014. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly on 07 Oct 2014. On 08 Oct 2014, she developed perspiration, nausea, dizziness and trouble walking. The outcome of the events was unknown. Seriousness and causality was not reported.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Gait disturbance, Hyperhidrosis, Nausea
Clinical narrative: Dizzy, weak, unable to walk without assistance, nausea, symptoms began 8 hours after injection.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Blood test, Computerised tomogram, Dizziness
Clinical narrative: Dizzy, weak, unable to walk without assistance, nausea, symptoms began 8 hours after injection.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Urine analysis, Walking aid user
Clinical narrative: Dizzy, weak, unable to walk without assistance, nausea, symptoms began 8 hours after injection.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: This spontaneous child prospective pregnancy report was received from a 32 years old pregnant licensed practical nurse reporting on her second female fetus. On 27-MAR-2014 the patient's mother was vaccinated with one dose of GARDASIL through injection (unspecified dose once), lot number and expiration date were not reported. The patient's mother got pregnant with estimated date of conception 07-APR-2014 (reported as she conceived a few days before or after 07-APR-2014) and Last Menstrual Date LMP estimated as of 24-MAR-2014. Pregnancy outcome was pending. On approximately 28-JUL-2014 (reported as "ultrasound was done at 18 weeks of pregnancy") the ultrasound revealed that the fetus had middle bone missing from her pinky finger. Despite GARDASIL the fetus was also exposed to mother's other concomitant medications via transplacental route of administration (progesterone, FLAGYL, clindamycin vaginal cream and terconazole vaginal cream, probiotic, vitamin D and prenatal vitamins). The outcomes of missing middle bone from her pinky finger(s) was unknown. The relatedness between GARDASIL and the events was not reported. The event of missing middle bone on her pinky finger was considered as congenital anomaly. This report is linked to MARRS# 1410USA010188 (Parent-Child Link) and MARRS# 1410USA101329 (sibling). Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal malformation
Clinical narrative: This spontaneous child prospective pregnancy report was received from a 32 years old pregnant licensed practical nurse reporting on her second female fetus. On 27-MAR-2014 the patient's mother was vaccinated with one dose of GARDASIL through injection (unspecified dose once), lot number and expiration date were not reported. The patient's mother got pregnant with estimated date of conception 07-APR-2014 (reported as she conceived a few days before or after 07-APR-2014) and Last Menstrual Date LMP estimated as of 24-MAR-2014. Pregnancy outcome was pending. On approximately 28-JUL-2014 (reported as "ultrasound was done at 18 weeks of pregnancy") the ultrasound revealed that the fetus had middle bone missing from her pinky finger. Despite GARDASIL the fetus was also exposed to mother's other concomitant medications via transplacental route of administration (progesterone, FLAGYL, clindamycin vaginal cream and terconazole vaginal cream, probiotic, vitamin D and prenatal vitamins). The outcomes of missing middle bone from her pinky finger(s) was unknown. The relatedness between GARDASIL and the events was not reported. The event of missing middle bone on her pinky finger was considered as congenital anomaly. This report is linked to MARRS# 1410USA010188 (Parent-Child Link) and MARRS# 1410USA101329 (sibling). Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Progesterone decreased, Vaginitis bacterial
Clinical narrative: This spontaneous child prospective pregnancy report was received from a 32 years old pregnant licensed practical nurse reporting on her second female fetus. On 27-MAR-2014 the patient's mother was vaccinated with one dose of GARDASIL through injection (unspecified dose once), lot number and expiration date were not reported. The patient's mother got pregnant with estimated date of conception 07-APR-2014 (reported as she conceived a few days before or after 07-APR-2014) and Last Menstrual Date LMP estimated as of 24-MAR-2014. Pregnancy outcome was pending. On approximately 28-JUL-2014 (reported as "ultrasound was done at 18 weeks of pregnancy") the ultrasound revealed that the fetus had middle bone missing from her pinky finger. Despite GARDASIL the fetus was also exposed to mother's other concomitant medications via transplacental route of administration (progesterone, FLAGYL, clindamycin vaginal cream and terconazole vaginal cream, probiotic, vitamin D and prenatal vitamins). The outcomes of missing middle bone from her pinky finger(s) was unknown. The relatedness between GARDASIL and the events was not reported. The event of missing middle bone on her pinky finger was considered as congenital anomaly. This report is linked to MARRS# 1410USA010188 (Parent-Child Link) and MARRS# 1410USA101329 (sibling). Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Premature delivery, Twin pregnancy, Urinary tract infection, Vaginitis bacterial
Clinical narrative: This spontaneous child prospective pregnancy report was received from a 32 years old pregnant licensed practical nurse reporting on her second female fetus. On 27-MAR-2014 the patient's mother was vaccinated with one dose of GARDASIL through injection (unspecified dose once), lot number and expiration date were not reported. The patient's mother got pregnant with estimated date of conception 07-APR-2014 (reported as she conceived a few days before or after 07-APR-2014) and Last Menstrual Date LMP estimated as of 24-MAR-2014. Pregnancy outcome was pending. On approximately 28-JUL-2014 (reported as "ultrasound was done at 18 weeks of pregnancy") the ultrasound revealed that the fetus had middle bone missing from her pinky finger. Despite GARDASIL the fetus was also exposed to mother's other concomitant medications via transplacental route of administration (progesterone, FLAGYL, clindamycin vaginal cream and terconazole vaginal cream, probiotic, vitamin D and prenatal vitamins). The outcomes of missing middle bone from her pinky finger(s) was unknown. The relatedness between GARDASIL and the events was not reported. The event of missing middle bone on her pinky finger was considered as congenital anomaly. This report is linked to MARRS# 1410USA010188 (Parent-Child Link) and MARRS# 1410USA101329 (sibling). Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a Licensed Practical Nurse who is also the mother of the female patient (32 years old) who on 27-MAR-2014 experienced exposure in utero to GARDASIL (Lot number and expiration date unknown). Relevant medical history for the mom included: exposure to GARDASIL during pregnancy (MARRS 1410USA010188). In 2014 an ultrasound was done to the mother at 18 weeks of pregnancy which revealed that the fetus had excess fluid on her brain and had a middle bone missing from her pinky finger(s). As of 17OCT-2014, the outcome of exposure in utero, the excess fluid on her brain and the missing middle bone on her pinky finger(s) was unknown. Relationship between excess fluid on her brain, middle bone missing from her pinky finger(s) and vaccination with GARDASIL was not reported. The reporter considered excess fluid on her brain and middle bone missing from her pinky finger(s) to be serious due to congenital anomaly. This report is linked to MARRS 1410USA010207 (sibling). Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Foetal disorder, Foetal malformation
Clinical narrative: Information has been received from a Licensed Practical Nurse who is also the mother of the female patient (32 years old) who on 27-MAR-2014 experienced exposure in utero to GARDASIL (Lot number and expiration date unknown). Relevant medical history for the mom included: exposure to GARDASIL during pregnancy (MARRS 1410USA010188). In 2014 an ultrasound was done to the mother at 18 weeks of pregnancy which revealed that the fetus had excess fluid on her brain and had a middle bone missing from her pinky finger(s). As of 17OCT-2014, the outcome of exposure in utero, the excess fluid on her brain and the missing middle bone on her pinky finger(s) was unknown. Relationship between excess fluid on her brain, middle bone missing from her pinky finger(s) and vaccination with GARDASIL was not reported. The reporter considered excess fluid on her brain and middle bone missing from her pinky finger(s) to be serious due to congenital anomaly. This report is linked to MARRS 1410USA010207 (sibling). Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Progesterone decreased, Vaginitis bacterial
Clinical narrative: Information has been received from a Licensed Practical Nurse who is also the mother of the female patient (32 years old) who on 27-MAR-2014 experienced exposure in utero to GARDASIL (Lot number and expiration date unknown). Relevant medical history for the mom included: exposure to GARDASIL during pregnancy (MARRS 1410USA010188). In 2014 an ultrasound was done to the mother at 18 weeks of pregnancy which revealed that the fetus had excess fluid on her brain and had a middle bone missing from her pinky finger(s). As of 17OCT-2014, the outcome of exposure in utero, the excess fluid on her brain and the missing middle bone on her pinky finger(s) was unknown. Relationship between excess fluid on her brain, middle bone missing from her pinky finger(s) and vaccination with GARDASIL was not reported. The reporter considered excess fluid on her brain and middle bone missing from her pinky finger(s) to be serious due to congenital anomaly. This report is linked to MARRS 1410USA010207 (sibling). Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Exposure during pregnancy, Premature delivery, Twin pregnancy, Urinary tract infection, Vaginitis bacterial
Clinical narrative: Information has been received from a Licensed Practical Nurse who is also the mother of the female patient (32 years old) who on 27-MAR-2014 experienced exposure in utero to GARDASIL (Lot number and expiration date unknown). Relevant medical history for the mom included: exposure to GARDASIL during pregnancy (MARRS 1410USA010188). In 2014 an ultrasound was done to the mother at 18 weeks of pregnancy which revealed that the fetus had excess fluid on her brain and had a middle bone missing from her pinky finger(s). As of 17OCT-2014, the outcome of exposure in utero, the excess fluid on her brain and the missing middle bone on her pinky finger(s) was unknown. Relationship between excess fluid on her brain, middle bone missing from her pinky finger(s) and vaccination with GARDASIL was not reported. The reporter considered excess fluid on her brain and middle bone missing from her pinky finger(s) to be serious due to congenital anomaly. This report is linked to MARRS 1410USA010207 (sibling). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Confusional state, Encephalitis, Hypoaesthesia, Intervertebral disc protrusion
Clinical narrative: This spontaneous report as received from a currently 69 years old female consumer with seizures. The patient's medical history included shingles and 6 thoracic operations. On 14-DEC-2005, the patient was vaccinated with ZOSTAVAX (Lot # not reported), 0.65 ml, single injection, subcutaneous. Concomitant therapies included oxycodone and morphine. The patient reported that after receiving ZOSTAVAX, initially did not have any adverse events, but on an unspecified date, after getting back surgery at an unspecified time and location, the patient experienced numbness throughout her entire body for an unspecified time, "unexplained" extreme pain along the left side of her body, encephalitis, terrible memory loss, confusion and the patient stated she was paraplegic with a slipped disc in her back. The patient did not recall when the adverse events first started. There was no treatment given for the events. The patient sought medical attention by a physician visit. No further adverse events reported. At the time of the report, the patient's outcome for back surgery, numbness throughout her entire body, "unexplained" extreme pain along the left side of her body, encephalitis, terrible memory loss, confusion and paraplegic with a slipped disc in her back was not recovered. Upon internal review encephalitis and back surgery were considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraplegia, Surgery
Clinical narrative: This spontaneous report as received from a currently 69 years old female consumer with seizures. The patient's medical history included shingles and 6 thoracic operations. On 14-DEC-2005, the patient was vaccinated with ZOSTAVAX (Lot # not reported), 0.65 ml, single injection, subcutaneous. Concomitant therapies included oxycodone and morphine. The patient reported that after receiving ZOSTAVAX, initially did not have any adverse events, but on an unspecified date, after getting back surgery at an unspecified time and location, the patient experienced numbness throughout her entire body for an unspecified time, "unexplained" extreme pain along the left side of her body, encephalitis, terrible memory loss, confusion and the patient stated she was paraplegic with a slipped disc in her back. The patient did not recall when the adverse events first started. There was no treatment given for the events. The patient sought medical attention by a physician visit. No further adverse events reported. At the time of the report, the patient's outcome for back surgery, numbness throughout her entire body, "unexplained" extreme pain along the left side of her body, encephalitis, terrible memory loss, confusion and paraplegic with a slipped disc in her back was not recovered. Upon internal review encephalitis and back surgery were considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not provided. On 21-OCT-2009, the patient was vaccinated with her first dose of PNEUMOVAX 23 intramuscular (dose, lot number and expiration date were not reported). No adverse effects were reported after the 1st dose. On an unknown date, the patient received her 2nd dose of PNEUMOVAX 23 (lot # J009833, expiration date: 25-JAN-2015) intramuscular, 1 single shot (exact dose was not reported). On an unknown date, the patient experienced cellulitis at the injection site after receiving the 2nd dose of PNEUMOVAX 23 and was admitted to hospital on an unspecified date. The patient sought medical attention. The patient received unspecified IV antibiotics as a treatment for the event. The outcome of cellulitis at the injection site was unknown. The relatedness between the event and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.