chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antisocial behaviour, Attention deficit/hyperactivity disorder, Autism, Blindness, Bone disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL, injection, (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues," including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia." The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Developmental coordination disorder, Foetal exposure during pregnancy, Hiatus hernia, Irritable bowel syndrome, Liver disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL, injection, (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues," including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia." The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Multiple allergies, Sleep disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL, injection, (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues," including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia." The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hiatus hernia, Hypersensitivity, Irritable bowel syndrome, Liver disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL, injection, (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues," including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia." The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antisocial behaviour, Attention deficit/hyperactivity disorder, Autism, Blindness, Bone disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL injection (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues" including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia". The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Developmental coordination disorder, Foetal exposure during pregnancy, Hiatus hernia, Irritable bowel syndrome, Liver disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL injection (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues" including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia". The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Multiple allergies, Sleep disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL injection (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues" including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia". The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hiatus hernia, Hypersensitivity, Irritable bowel syndrome, Liver disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to her son. On an unknown date in October 2007 the son was received a dose of GARDASIL injection (lot #, expiration, dose and route unspecified), transplacentally. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the mother stated that she had developed many "medical issues" including "liver disease, allergies, irritable bowel syndrome and a hiatal hernia". The mother stated that her son (who was conceived when the mother received GARDASIL) had developed autism and was legally blind. No demographics were provided for the son. The reporter stated that her son had also developed "a sleep disorder, a developmental coordination disorder, attention deficit hyperactivity disorder (ADHD), an orthopedic disorder and a mixed disorder of conduct and emotions. The outcome of son's event was unknown. Upon internal review, the event of legally blind was considered as medically significant. This is one of several reports received from same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: INTENSE PAIN IN UPPER LEFT SHOULDER. DIFFICULTY IN MOVING ARM AROUND. PAIN IN DELTOID MUSCLE.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Paraesthesia, Sensation of heaviness
Clinical narrative: Paresthesia of left arm, heaviness in both legs, paresthesia of toes. Left arm numbness and limited arm movement occurred immediately, paresthesia of toes and leg heaviness began within an hour of injection and worsened over 3-4 hours.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: AREA WAS RED, HOT, SWOLLEN AND PRURITIC.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Pruritus, Urticaria
Clinical narrative: Patient noticed hives on her arms, itchy legs, itchy eyes.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis, Sneezing
Clinical narrative: Patient had sneezed and blood came out. The patient had a bloody nose that lasted for about 30 minutes.  Patient sat down at the pharmacy and tilted her head forward. She had tissues and pinched the bridge of the nose to help clotting. She also received a cup of water. She had no other reaction to the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Consciousness fluctuating, Hyperhidrosis, Hypotonia, Loss of consciousness, Pallor
Clinical narrative: Patient became unresponsive and limp while sitting in a chair two minutes after receiving a Novartis pre-filled syringe flu shot (lot: 1343 2P; Exp: 04/2014).  The patient first lost consciousness while a second immunization was being administered (Zostavax (lot:j001002)).  The patient was in and out of consciousness; conversating when awake. 911 was called and an AED was brought to the scene immediately.  The patient became pale and profusely diaphoretic while waiting for the EMT.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient became unresponsive and limp while sitting in a chair two minutes after receiving a Novartis pre-filled syringe flu shot (lot: 1343 2P; Exp: 04/2014).  The patient first lost consciousness while a second immunization was being administered (Zostavax (lot:j001002)).  The patient was in and out of consciousness; conversating when awake. 911 was called and an AED was brought to the scene immediately.  The patient became pale and profusely diaphoretic while waiting for the EMT.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthenia, Hypoaesthesia, Hypoaesthesia oral, Nasal oedema
Clinical narrative: Feeling weak. Nose swelling. Lips face went numb. Anaphylaxis.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye movement disorder, Fatigue, Nystagmus, Oral herpes
Clinical narrative: Dizziness- Vertigo -- Tinnitus -- Nystagmus.   Was only given a half dose as each year she gets sick. She got Nystagmus 14 hours later!  Says that around 3 am that next morning she woke up with dizziness. Dizziness came in waves with rapid eye movement. Says that since then she has had a sore throat, several cold sores and is feeling very fatigued contines to have dizziness with ringing in her right ear. Has history of previous reaction to flu shots, but none as severe or long lasting as this one. She had Sanofi Pasteur Lot # UH8899AA. prefilled syringe without preservative.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Tinnitus, Underdose, Vertigo
Clinical narrative: Dizziness- Vertigo -- Tinnitus -- Nystagmus.   Was only given a half dose as each year she gets sick. She got Nystagmus 14 hours later!  Says that around 3 am that next morning she woke up with dizziness. Dizziness came in waves with rapid eye movement. Says that since then she has had a sore throat, several cold sores and is feeling very fatigued contines to have dizziness with ringing in her right ear. Has history of previous reaction to flu shots, but none as severe or long lasting as this one. She had Sanofi Pasteur Lot # UH8899AA. prefilled syringe without preservative.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: After shot given, was sore. Shot given possibly to high. It has been over a month now pain spreads to fingers. Right hand.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Local swelling, Pain in extremity, Pruritus
Clinical narrative: Pain at injection site for 3 days. Swelling, pain and itchy on rear right thigh which lasted for 6 days.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Blister, Injection site pain, Rash, Rash pruritic
Clinical narrative: Pt complaint of bumps and blisters that broke and of a patchy rash that is itchy, and with pain and occurred below injection area on the bend of the arm and elbow.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Developed skin rash post immunization. Red bumps on arm (entire upper arm).
Age: 71.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt visited local ER on 9-7-13 with s/sx of cellulitis of the left arm. Was prescribed KEFLEX and Hydrocodone.
Age: 4.0
Sex: M
Vaccine: FLU4, VARCEL
Symptoms: Abdominal distension, Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Noticed redness, swelling at injection site on L deltoid then started spreading to head, abd. legs. Treated with steroid and benadryl and referral to allergist.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Pruritus, Urticaria
Clinical narrative: Redness at the site, pain, hives and itching.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt said area below vaccine (inj site) was administered was swollen and hot to touch for almost 5 days.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Streptococcus test negative
Clinical narrative: Cellulitis, received antibiotic.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: Aches and pain in left arm, has little strength in arm, can't raise arm over head, no redness or swelling at injection site, symptoms are improving but not completely resolved.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Headache, VIIth nerve paralysis
Clinical narrative: Bells Palsy (severe) 1 week post vaccine.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Bilateral arm cellulits; redness and swelling to both arms.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash, Staphylococcal infection
Clinical narrative: Patient received a flu and pneumonia vaccine together. 2 days later, had a fever up to 102 degrees, a couple of days later, fever persisted, rash developed and went to ER. Diagnosed with a staph infection.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient received FLUZONE HD on 10/9/13 and reported a itchy rash on her legs and arms on 10/14/13. She said it started a day or 2 after she received her flu shot.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Pt sweated, turned pale, felt lightheaded shortly after the flu shot. She recovered after 10 minutes of sitting, raising her legs on chair, and drinking some water.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: The vaccine was administered on 10/10/2013 - 3:08pm. The following morning the patient woke with a horrible headache at approx. 5:00am. As the day went on he had terrible chills and sweats. He went home and laid down and felt like he could not breathe. He said his throat did not feel like it was swelling but like he could not get enough air. He fell asleep and woke in the morning feeling tired with a mild headache. He feels fine today 10/14/13.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Eye swelling
Clinical narrative: 4 hours after shot -> eyes swelled and painful (in Rt eye). 1 AM Sun.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Palpitations
Clinical narrative: c/o lightheadedness, palpitations. Reports that she went to ER later for TX with Benadryl and fluids. On 10/8/2013 - continues to report "not feeling right" since being vaccinated.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Pharyngeal oedema, Throat tightness
Clinical narrative: Within approx 3 1/2 hrs after getting flu vaccine pt felt her throat closing up, throat felt swollen, started coughing and had reddened sclera. Says she had no rxn w/ flu vaccine in 2012, but had cough and reddened sclera after H1N1 vaccine in 2011 and no resp s/s at that time. S/S/ improved w/ 10/11/13 vaccine after taking BENADRYL. Rec. pt f/u w/ allergist.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt reported rash at injection site (3x1/12x3", increased red in center) 10/14 that's swollen/tender. Per mfg injection site sxn's 41.3% incidence at his age, starting median 3-5 days post vac and median lasting 5 days (seems usual) wife reported 10/14 looking better already.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: When I got the vaccine I could feel it sting. A couple days after that my arm was still sore as the time passed on the pain got worse. Now if I try to lift my arm to take off clothes it really hurts. I tried pain patches, medicine, no relief at all.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Pt. experienced pain, at site, body aches, chills, red hot raised area 4" x 4" below injection site within 24-48 hours.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: 31mm slightly raised area red and warm to touch. Advised TYLENOL or IBU PRN and cold/warm compress.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Swelling and red rash at injection site for about a week. Applied hydrocortisone cream.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Breath sounds abnormal, Cough, Gaze palsy, Memory impairment, Nausea
Clinical narrative: Patient had never received a flu shot before. Gave in L arm. While pt. was waiting after, about 5 min later his wife alerted us he was having a reaction. Pt. was unresponsive, eyes rolling back, slumped in chair and raspy breathing. Unable to answer to his name or questions. Pt. started coughing and looked like he was going to vomit. 911 was called. Gave 1 0.3 mg Epi Pen in R leg. Pt. came back around, fully alert. He had no memory of the event. EMT's arrived and took pt to hospital.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient had never received a flu shot before. Gave in L arm. While pt. was waiting after, about 5 min later his wife alerted us he was having a reaction. Pt. was unresponsive, eyes rolling back, slumped in chair and raspy breathing. Unable to answer to his name or questions. Pt. started coughing and looked like he was going to vomit. 911 was called. Gave 1 0.3 mg Epi Pen in R leg. Pt. came back around, fully alert. He had no memory of the event. EMT's arrived and took pt to hospital.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: Generalized muscle stiffness, fever 103.2 started approximately 5 hrs. after receiving flu and pneumonia vaccines (pt requested both injections in left deltoid).
Age: 85.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: Very light-headed, diaphoresis, sore arm
Age: 1.02
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site pustule
Clinical narrative: Pt. has small white pustule at VARIVAX site. No temp. No itching. Pt. acting normal.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling day after flu shot. Hot to touch, sore. Swelling gone now 10/14/13. Healed bruise noticed now only.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Paraesthesia
Clinical narrative: 3"x4" area of redness, warm to touch left upper arm! Some tingling of fingers 10/11/2013. None now. Took ibuprofen with relief on 10/11/13.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Rash
Clinical narrative: Rash and swollen lips next day after having flu shot.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Tenderness
Clinical narrative: Patient describes pain going down her arm (right) the evening of the flu vaccination. She was unable to lift up her arm due to the pain. it aches during the night and she can't sleep on her rt. side. Pain has improved some but some days are worse. Now she can lift her arm straight up but not out to the side.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure to product, Eye irrigation, Eye irritation
Clinical narrative: This spontaneous report was received from a registered nurse regarding another nurse of unknown age and gender. On 07-OCT-2013, when the nurse was administering a patient with a dose of ROTATEQ, orally the patient sneezed. The nurse who was administering the vaccine felt that some of the ROTATEQ may have gotten into her eyes. The nurse flushed her eyes with water. Nurse stated that her eyes were irritated. The outcome of the events were unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 69 year old male patient. On 10-OCT-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number and expiry date were reported as 671607/1169AA and 06-MAY-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from the mother of a female patient of unknown age. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL (lot #, expiry not reported). On an unknown date, the patient received her second dose of GARDASIL (lot #, expiry not reported) 1 year after the first dose and would receive her third dose 4 months following the second dose. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site paraesthesia, Paraesthesia, Poor quality sleep
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient with high blood pressure, high cholesterol, asthma, diabetes and anxiety. On 17-SEP-2013, the day after vaccination with ZOSTAVAX the patient experienced tingling in his injection arm, radiating distally toward his hand, for an unspecified period of time. The patient continued to have tingling from his shoulder to his fingers in the arm he received ZOSTAVAX on 07-OCT-2013. The sensation was waking him up when sleeping. His sense of touch was slightly decreased, but arm strength remained normal. The patient was not experiencing rash. The patient contacted the pharmacy on 22-SEP-2013 to inquire about the symptom, and stated he has notified his physician of this experience. The patient did not receive any treatment for the events. No lab diagnostic studies were performed. At the time of the report the patient has not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a licensed registered nurse for VARIVAX, a Pregnancy Registry product, concerning an 18 year old female patient with no drug allergies or pertinent medical history who on 29-OCT-1998 was vaccinated with a dose of VARIVAX (dose, route and lot # not provided) and on 24-JUN-2013 was vaccinated with a dose of VARIVAX (lot # H018790, exp date 15-OCT-2014) (dose and route not provided). There were not concomitant medications. The patient became pregnant with LMP of 14-MAY-2013 and EDD of 18-FEB-2014. Initial exposure to VARIVAX was at 6 weeks. There was no treatment given for the event. On an unspecified date an unspecified pregnancy test and unspecified routine obstetric laboratory tests were performed (no results provided). No adverse effects were reported. The patient sought medical attention due physician's office visit. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 64 year old patient with Perdiem (reported as percadiem) allergy. No medical history was reported. On 12-SEP-2012, the patient was vaccinated with ZOSTAVAX (0468AE, expiry: 04-APR-2013), 0.65 ml, subcutaneously. Concomitant therapies included calcium (unspecified), vitamin D (unspecified). On 14-SEP-2012, the patient experienced redness and swelling at the injections site that was possibly cellulitis after receiving ZOSTAVAX. Patient received treatment with Augmentin. Patient sought medical attention: spoke with an unspecified physician. No laboratory tests were performed. The reporter verified that this adverse experience took place last year, but the physician just learned of it recently. The outcome of redness and swelling at the injections site that was possibly cellulitis was reported as recovered on an unspecified date. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 30-DEC-2008 and 26-JUN-2009 the patient was vaccinated with pediatric dose of VAQTA (route, lot # not reported) respectively. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a  doctor of pharmacy concerning an approximately 66 year old patient of unknown gender. On 10-OCT-2013, the patient was vaccinated with an expired dose of, 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as H013020 and 09-OCT-2013 respectively), subcutaneously. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Haematoma, Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 21-SEP-2013 the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route and lot# were not provided). The patient developed a large blue/purple Hematome on the Monday 23-SEP-2013. The patient consulted a physician (date unspecified) and was diagnosed as to having a reaction to the ZOSTAVAX. The outcome of event was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy, Hiatus hernia, Hypersensitivity, Irritable bowel syndrome
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to herself. On an unknown date in October 2007 the patient was vaccinated with a dose of GARDASIL, injection (lot #, expiration, dose and route unspecified) shot in the upper arm. The pregnancy outcome was live birth. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the patient stated that she had developed many "medical issues", including "liver disease,  allergies, irritable bowel syndrome and a hiatal hernia". The patient was underwent urine and blood tests with no result was provided. The patient sought medical attention via office visit on an unspecified date. No treatment was given. The outcome of hiatal hernia, allergies, and liver disease was unknown. This is one of several reports received from same source (the patient's son's experience was captured in 1310USA005273). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Liver disorder, Urine analysis
Clinical narrative: This spontaneous retrospective pregnancy report as received from a 22 year old female consumer with no Pertinent Medical History and no Drug Reactions/Allergies refers to herself. On an unknown date in October 2007 the patient was vaccinated with a dose of GARDASIL, injection (lot #, expiration, dose and route unspecified) shot in the upper arm. The pregnancy outcome was live birth. No concomitant medication was provided. Sometime in October 2007, since receiving GARDASIL, the patient stated that she had developed many "medical issues", including "liver disease,  allergies, irritable bowel syndrome and a hiatal hernia". The patient was underwent urine and blood tests with no result was provided. The patient sought medical attention via office visit on an unspecified date. No treatment was given. The outcome of hiatal hernia, allergies, and liver disease was unknown. This is one of several reports received from same source (the patient's son's experience was captured in 1310USA005273). Additional information has been requested.
Age: 31.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 31 year old patient. On 03-OCT-2013, the patient was vaccinated with an expired dose of 0.5ml M-M-R II, (lot number 1759AA, expired on 12-JUL-2013), subcutaneous. No adverse effects were reported. The patient did not seek medical attention. The pharmacist enquired regarding revaccination recommendation post administration of expired M-M-R II. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist heard from other unspecified pharmacists refers to unspecified number of unspecified patients. On an unknown date the unspecified pharmacists had drawn up less than 0.65 ml of reconstituted ZOSTAVAX (lot#, expiration, dose and route unspecified) and had administered this dose to unspecified number of unspecified patients. PQC filed. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an unknown number of patients of unknown age. Approximately in 2012 (about one and half years ago) the unknown number of patients were vaccinated with ZOSTAVAX (lot# and dose not reported), subcutaneous, in the "tricep" area of the arms of these patients. The pharmacist reported that the unknown number of patients developed welts on their arms at the injection site after receiving ZOSTAVAX. The outcome of the event was unknown. The patients sought medical attention by unknown method. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VAQTA (lot and batch # J002347, expiring on 09-APR-2015, that was exposed 12 degrees C for 99 hours. No adverse symptoms were reported. This is one of several reports received from same source. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VAQTA lot and batch # J002347, expiring date 09-APR-15 that was exposed to 12 degrees C for 172.5 hours. No adverse symptoms were reported. This is one of several reports received from same source. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Induration, Injection site vesicles, Skin warm, Swelling
Clinical narrative: Redness, swelling within 24 hours. Single blister formation at injection site. As of 10/14/13 25 x 24 cm area of redness/warmth/induration lt arm 2 cm blister.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: vaccines received 10/9/13 - MENVEO and HPV. 10/8/13 3 1/2" x 3" nontender, firm, blanchable area of erythema. 10/9/13 6" x 8" nontender, firm, blanchable erythematous area at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an about 61 year old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date not reported, 0.65 ml, route not reported, once). On an unknown date, an unspecified time after the vaccination, the patient developed rash on the injection arm. On an unknown date the patient recovered from rash on the injection arm. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling
Clinical narrative: Patient developed swelling 4 x 3 cm in (R) arm.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Dizziness, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her husband, a male patient of unknown age. Eight years ago, in approximately October 2005, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported) injection. Concomitant medications were not reported. On an unknown date (reported as a couple of months ago), the patient had a severe case of dizziness, he got shingles and a little blister by his ear. The outcome of shingles and dizziness was not reported. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 year old female patient. On 30-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose was not reported) (Lot number reported as J005848, expiration date 17-AUG-2014), subcutaneous. Concomitant medications were not reported. On 01-OCT-2013, patient developed a 2 inch round warm bull's eye rash at the injection site after vaccination with ZOSTAVAX. The outcome of round warm bull's eye rash at the injection site was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Patient contacted the pharmacist. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Diagnosed with shingles in eye 10/14/13 by dr.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Abd flat red rash onset 10/13/13 AM spreading to entire lower torso chest down, face around eyes and mouth and neck, no lessening with OTC BENADRYL.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 70 year old male patient with hypertension, hyperlipidemia, sleep apnea, gout, Benign prostatic hyperplasia (BPH), restless leg syndrome and degenerative joint disease. The patient's medical history included bypass surgery in 2005. The patient had no drug reactions/allergies. On 26-SEP-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant therapies included FLONASE, metoprolol, lisinopril (manufacturer unknown), simvastatin (manufacturer unknown), nitroglycerin, indomethacin, baclofen, allopurinol and baby aspirin. Physician reported that the patient developed a rash on 28-SEP-2013. Physician reported that patient was seen the day of the report, on 02-OCT-2013, in the office. Physician reported that patient had a dermatome distribution of severe shingles in the lower thoracic region - front to back. Physician reported that this was the worst case of shingles he had ever seen, the patient had over 1,000 vesicles. Physician reported that he treated with VALTREX and drew unspecified blood labs, all of which were normal. The outcome of shingles was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site hypersensitivity, Injection site vesicles
Clinical narrative: Allergic reaction around injection site w/extensive blistering. Pt. given loratadine by MD to control reaction. She is to report back if reaction doesn't resolve.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gastrooesophageal reflux disease, Hypertension, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Allergic reaction around injection site w/extensive blistering. Pt. given loratadine by MD to control reaction. She is to report back if reaction doesn't resolve.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash erythematous
Clinical narrative: 10 cm erythemic raised rash with pain of "8" on a 0 - 10 scale. Suspect vaccine reaction and possible infection.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Evening of 10/10/2013 - Had shoulder pain and site soreness. Still having shoulder pian 10/12/13 - explain can take Tylenol and referred pt to MD.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Patient had some mild shakiness to both hands. Monitoring for 20 min - mom states this happened as well with HPV #1, and it lasted for about 2 hours then it went away.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: ZOSTAVAX vaccine was given in error - pt. was to receive MMR. Parent of patient aware and symptoms to watch for.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthenia, Fatigue, Pruritus, Rash, Rash erythematous
Clinical narrative: Rash started 10/8/13 cont to spread over entire body - feels tired and weak today 10/14/13 - Rash red with itching. Received varicella vaccine 9/30/13 flu vaccine 10/9/13.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash started 10/8/13 cont to spread over entire body - feels tired and weak today 10/14/13 - Rash red with itching. Received varicella vaccine 9/30/13 flu vaccine 10/9/13.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Aspect (R) upper extremities swelling, redness warm and pain started after receiving pneumo vaccine. The covering MD order ibuprofen 600 mg PRN TID for pain. If symptoms don't get better told to go urgent care.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 10-APR-2013 the patient was vaccinated early with VAQTA dose 2. Therapy with VAQTA was started on 10-DEC-2012. Dosage and route were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with VARIVAX (Merck) (subcutaneous, 0.5 ml; dose number unknown; lot # G007461 exp 02-AUG-2013). The patient was administered an expired dose of VARIVAX (Merck). No adverse effect was reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nasopharyngitis, Pain, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a pharmacist refers to himself, a male patient of unknown age. On 23-SEP-2013 the patient was vaccinated with ZOSTAVAX (route and dosage unknown; lot # J001005 exp 24-APR-2014) for immunization. After the dose of ZOSTAVAX the patient experienced cold or flu like symptoms including chills, aches, and runny nose for about 36 hours post vaccination. The patient did not sought medical attention nor received treatment. The outcome of patient experienced cold or flu like symptoms was reported as recovered approximately on 24-SEP-2013 (reported as: for about 36 hours). Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site mass, Mass
Clinical narrative: Left upper lateral arm lesion the patient believes it showed up after a flu shot 9/12/12. On 5/8/13 surgical procedure: removal of left arm lipoma.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Lipoma excision, Skin lesion
Clinical narrative: Left upper lateral arm lesion the patient believes it showed up after a flu shot 9/12/12. On 5/8/13 surgical procedure: removal of left arm lipoma.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fall, Haemorrhage, Swelling
Clinical narrative: Initial report was received on 01 October 2013 from a nonhealth care professional. An 80 year-old female with an unknown past medical history had received on 15 August 2013 an influenza vaccine reported as FLUZONE (lot number, route and site of administration was not known) and 10 minutes after vaccination felt dizzy. The patient then fainted was transported to the hospital and was found to have a brain hemorrhage. The patient then went to a nursing home for rehabilitation and was discharged on 30 September 2013. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cerebral haemorrhage, Dizziness, Syncope
Clinical narrative: Initial report was received on 01 October 2013 from a nonhealth care professional. An 80 year-old female with an unknown past medical history had received on 15 August 2013 an influenza vaccine reported as FLUZONE (lot number, route and site of administration was not known) and 10 minutes after vaccination felt dizzy. The patient then fainted was transported to the hospital and was found to have a brain hemorrhage. The patient then went to a nursing home for rehabilitation and was discharged on 30 September 2013. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Condition aggravated, Dizziness, Dysphonia, Sleep disorder
Clinical narrative: Temp. 99 degrees F, Headache, dizziness, was seen on 10/3/13.
Age: 54.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Dizziness, Full blood count, Headache, Metabolic function test
Clinical narrative: Temp. 99 degrees F, Headache, dizziness, was seen on 10/3/13.
Age: 7.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 7 year old female patient with asthma and drug reactions/allergies to morphine (manufacturer and dose/frequency unknown). The patient's medical history included previous case of pneumonia. On 04-OCT-2013, the patient was vaccinated with PNEUMOVAX23 lot # H015780 exp date 11-JUN-2014, in the right arm (dose and route not reported). On 04-OCT-2013, concomitantly was vaccinated with FLUZONE 0.5 ml, in the right arm, with different injection sites. On 04-OCT-2013, the patient mother called the physician and stated that her daughter's arm was swollen. The physician advised to ice the arm and take MOTRIN (unspecified dose and frequency). On 06-OCT-2013, the patient visited an unspecified emergency room and was treated for potential cellulitis and low grade fever with SEPTRA (unspecified dose and frequency). It is unknown whether the patient was admitted to the hospital. At the time of the report the outcome of the events was not reported. Additional information has been requested.