chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Lethargy, Pain in extremity, Syncope
Clinical narrative: App 15 hours after injection, patient awoke to severe pain in leg. She experienced dizziness and shortly thereafter fainted. Pt was lethargic. Also had difficulty breathing 6 hours after injection. Pain subsided but still present after 48 hours.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Respiratory tract irritation, Urticaria
Clinical narrative: 1-2 days after vaccination, had "itching in lungs", itchy hives on back of neck and shoulders and back. Took BENADRYL - 2 pills 2/day x 3 days.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, PPV
Symptoms: Injection site swelling
Clinical narrative: Flu vaccine (FLUZONE by Sanofi Pasteur) and PNEUMOVAX-23 given in (L) deltoid. (L) deltoid down to elbow swollen after 4 days. Notified office on-call Dr. on 11/24/12 - pt went to ER on 11/25/12.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Convulsion, Encephalopathy, Endotracheal intubation, Laboratory test
Clinical narrative: 9-10-12 Pain (rt) neck down shoulder (Had shingles 2 yrs ago & pt wife 1 month also) no rash. 9-28-12 ER c/o fever ? UTI 9-29-12 admit hosp fever & confusion. Diag Herpetic encephalopathy.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: 9-10-12 Pain (rt) neck down shoulder (Had shingles 2 yrs ago & pt wife 1 month also) no rash. 9-28-12 ER c/o fever ? UTI 9-29-12 admit hosp fever & confusion. Diag Herpetic encephalopathy.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness
Clinical narrative: Patient admitted through ER on 11/5/12. Patient with c/o paresthesias and increasing weakness in lower & upper extremities, also fever, chills, numbness.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Patient admitted through ER on 11/5/12. Patient with c/o paresthesias and increasing weakness in lower & upper extremities, also fever, chills, numbness.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, CSF protein increased, Cardiac arrest, Chills, Endotracheal intubation
Clinical narrative: Patient admitted through ER on 11/5/12. Patient with c/o paresthesias and increasing weakness in lower & upper extremities, also fever, chills, numbness.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care, Myalgia
Clinical narrative: Patient admitted through ER on 11/5/12. Patient with c/o paresthesias and increasing weakness in lower & upper extremities, also fever, chills, numbness.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Pneumonia, Pyrexia, Respiratory depression, White blood cell count decreased
Clinical narrative: Patient admitted through ER on 11/5/12. Patient with c/o paresthesias and increasing weakness in lower & upper extremities, also fever, chills, numbness.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness
Clinical narrative: Patient admitted to ICU on 11/5/12. Patient reports receiving flu vaccine on 10/22/12. This was the first time he had ever received this immunization. Developed symptoms of fever/chills/muscle aches/numbness/tingling on 10/27/12 in bilateral lower and upper extremities. Diagnosis of Guillain Barre Syndrome made based on clinical presentation, lack of WBC, elevated protein of 75 in CSF, and ascending weakness. Intubated due to worsening respiratory strength from 11/7/12-11/12/12 and from 11/20/12-11/26/12 and is currently intuabated as of today (11/29/12). Received 5 day course of IVIG 40mg from 11/5/12-11/9/12. Has subsequently developed pneumonia, cardiac arrest, and is in the ICU as of today (11/29/12).
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Patient admitted to ICU on 11/5/12. Patient reports receiving flu vaccine on 10/22/12. This was the first time he had ever received this immunization. Developed symptoms of fever/chills/muscle aches/numbness/tingling on 10/27/12 in bilateral lower and upper extremities. Diagnosis of Guillain Barre Syndrome made based on clinical presentation, lack of WBC, elevated protein of 75 in CSF, and ascending weakness. Intubated due to worsening respiratory strength from 11/7/12-11/12/12 and from 11/20/12-11/26/12 and is currently intuabated as of today (11/29/12). Received 5 day course of IVIG 40mg from 11/5/12-11/9/12. Has subsequently developed pneumonia, cardiac arrest, and is in the ICU as of today (11/29/12).
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, CSF protein increased, Cardiac arrest, Chills, Endotracheal intubation
Clinical narrative: Patient admitted to ICU on 11/5/12. Patient reports receiving flu vaccine on 10/22/12. This was the first time he had ever received this immunization. Developed symptoms of fever/chills/muscle aches/numbness/tingling on 10/27/12 in bilateral lower and upper extremities. Diagnosis of Guillain Barre Syndrome made based on clinical presentation, lack of WBC, elevated protein of 75 in CSF, and ascending weakness. Intubated due to worsening respiratory strength from 11/7/12-11/12/12 and from 11/20/12-11/26/12 and is currently intuabated as of today (11/29/12). Received 5 day course of IVIG 40mg from 11/5/12-11/9/12. Has subsequently developed pneumonia, cardiac arrest, and is in the ICU as of today (11/29/12).
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care, Myalgia
Clinical narrative: Patient admitted to ICU on 11/5/12. Patient reports receiving flu vaccine on 10/22/12. This was the first time he had ever received this immunization. Developed symptoms of fever/chills/muscle aches/numbness/tingling on 10/27/12 in bilateral lower and upper extremities. Diagnosis of Guillain Barre Syndrome made based on clinical presentation, lack of WBC, elevated protein of 75 in CSF, and ascending weakness. Intubated due to worsening respiratory strength from 11/7/12-11/12/12 and from 11/20/12-11/26/12 and is currently intuabated as of today (11/29/12). Received 5 day course of IVIG 40mg from 11/5/12-11/9/12. Has subsequently developed pneumonia, cardiac arrest, and is in the ICU as of today (11/29/12).
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Pneumonia, Pyrexia, Respiratory depression, White blood cell count decreased
Clinical narrative: Patient admitted to ICU on 11/5/12. Patient reports receiving flu vaccine on 10/22/12. This was the first time he had ever received this immunization. Developed symptoms of fever/chills/muscle aches/numbness/tingling on 10/27/12 in bilateral lower and upper extremities. Diagnosis of Guillain Barre Syndrome made based on clinical presentation, lack of WBC, elevated protein of 75 in CSF, and ascending weakness. Intubated due to worsening respiratory strength from 11/7/12-11/12/12 and from 11/20/12-11/26/12 and is currently intuabated as of today (11/29/12). Received 5 day course of IVIG 40mg from 11/5/12-11/9/12. Has subsequently developed pneumonia, cardiac arrest, and is in the ICU as of today (11/29/12).
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Influenza, Lethargy, Pyrexia, Sleep terror
Clinical narrative: High fever that lasted 5 days. Lethargic. Contracted Flu same week and doctors say fever and flu not related to vaccine. Night terrors started immediately and have not stopped. Marked change in behavior.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Throat tightness
Clinical narrative: 45-60 minutes after vaccination, clinic received phone call from Patient's co-worker who stated the Patient described the feeling of her throat closing with no other symptoms.  Ambulence was called and Patient was transferred to Health Center.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Blood culture negative, Chest X-ray normal, Full blood count normal, Headache
Clinical narrative: Fevers, myalagias, arthralgias, sweats, headache x three weeks thus far.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Metabolic function test normal, Myalgia, Pyrexia
Clinical narrative: Fevers, myalagias, arthralgias, sweats, headache x three weeks thus far.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: FEVER, VOMITING, DIARRHEA, WEAKNESS, JOINT PAIN....TREATED WITH IBUPROFEN FLUIDS REST.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Diarrhoea, Nausea, Pyrexia
Clinical narrative: NAUSEA, VOMITING, DIARRHEA, FEVER, JOINT PAIN, WEAKNESS.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: NAUSEA, VOMITING, DIARRHEA, FEVER, JOINT PAIN, WEAKNESS.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Fatigue, Pyrexia
Clinical narrative: Fever of 99 by afternoon and 100 by evening, finally ending the following day PM; fatigue for 4 days; stomach ache for entire day and next.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: NAUSEA, VOMITING, FEVER, JOINT PAIN, DIZZY, DIARRHEA, BLURRED VISION.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Vomiting
Clinical narrative: NAUSEA, VOMITING, FEVER, JOINT PAIN, DIZZY, DIARRHEA, BLURRED VISION.
Age: 67.0
Sex: F
Vaccine: TDAP, PPV, PPV, TDAP
Symptoms: Influenza like illness, Pain, Somnolence
Clinical narrative: Body aches, sleeping, feels like she has the Flu.
Age: 67.0
Sex: F
Vaccine: TDAP, PPV, PPV, TDAP
Symptoms: Abnormal behaviour, Pain, Somnolence
Clinical narrative: Body aches, sleeping, feels like she has the Flu.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Local reaction, Myalgia
Clinical narrative: Patient now painful, erythematous local reaction with myalgias.  At school on post-vaccine day 1 she developed two erythematous, slightly raised, sore lesions that felt like bruises" around the injection site.  One was 2cm x 1cm and the other 1.2cm in diameter.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Skin lesion
Clinical narrative: Patient now painful, erythematous local reaction with myalgias.  At school on post-vaccine day 1 she developed two erythematous, slightly raised, sore lesions that felt like bruises" around the injection site.  One was 2cm x 1cm and the other 1.2cm in diameter.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives all over.  Went to doctor on 11/28/12.  Claritin & Benadryl taken.
Age: 25.0
Sex: M
Vaccine: HEPAB
Symptoms: Biopsy skin, Rash generalised, Renal failure
Clinical narrative: Rash on hands and then spread all over the body which he is currently seeking treatment through the dermatologist.  Lesions have been biopsied and currently awaiting results.  Treatment is ointment with steroid and now on antibotics.  He also has some other issues down the road such renal/kidney failure and was hospitalized.
Age: 0.4
Sex: M
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Lethargy, Musculoskeletal stiffness, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from an other health care professional, author of a literature article. Background: Vaccines represent the most effective measures in public health by controlling and preventing the spread of infectious disease. They, like all other drugs, had the potential to cause allergic reactions. Components that may be allergenic include the infectious agent, specific antigen, preservatives, stabilizers, residual media and contaminants that are introduced during handling. Reaction characteristics such as time of onset, and localized vs. systemic involvement, could vary. Objective: The authors described a case of allergic reactions after administration of vaccines. Case Report: A current 11 year old male patient developed respiratory distress, seizure-like stiffening, and a fever after administration of Dtap, Hib conj vaccine (unspecified carrier) and Polio at his 2 month visit. He was hospitalized for 5 days with an extensive negative work up. Two months after this event, the patient received the Polio vaccine and developed lethargy, a full body macular papular rash and fever immediately after administration. Three weeks later, when he was approximately 5 months old, he was hospitalized for respiratory distress, and fever following the Hepatitis B vaccine (manufacturer unspecified). Patient had not been vaccinated since these episodes. Currently, standardized testing for ingredients in vaccines was not available. Skin testing with the vaccine and physician supervised challenges was offered. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: HEP
Symptoms: Respiratory distress, Seizure like phenomena
Clinical narrative: Information has been received from an other health care professional, author of a literature article. Background: Vaccines represent the most effective measures in public health by controlling and preventing the spread of infectious disease. They, like all other drugs, had the potential to cause allergic reactions. Components that may be allergenic include the infectious agent, specific antigen, preservatives, stabilizers, residual media and contaminants that are introduced during handling. Reaction characteristics such as time of onset, and localized vs. systemic involvement, could vary. Objective: The authors described a case of allergic reactions after administration of vaccines. Case Report: A current 11 year old male patient developed respiratory distress, seizure-like stiffening, and a fever after administration of Dtap, Hib conj vaccine (unspecified carrier) and Polio at his 2 month visit. He was hospitalized for 5 days with an extensive negative work up. Two months after this event, the patient received the Polio vaccine and developed lethargy, a full body macular papular rash and fever immediately after administration. Three weeks later, when he was approximately 5 months old, he was hospitalized for respiratory distress, and fever following the Hepatitis B vaccine (manufacturer unspecified). Patient had not been vaccinated since these episodes. Currently, standardized testing for ingredients in vaccines was not available. Skin testing with the vaccine and physician supervised challenges was offered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Guillain-Barre syndrome, Movement disorder, Oedema peripheral
Clinical narrative: This spontaneous report was received and was assigned case # 30121024484-WSC-52 refers to a female patient of unknown age. On an unspecified date in 2012, the patient was vaccinated with (lot # 671662/1160AA) ZOSTAVAX (route and dose were not reported, expiry date was 18-OCT-2012). No concomitant medications were reported. After administration of the vaccine the patient experienced swollen arm and redness (disability) on 03-OCT-2012. The patient did not want to seize and had called the pharmacist and was instructed as to what had to be done. On 14-OCT-2012, the patient was hospitalized since the patient could not move her arms or legs and the patient was diagnosed with Guillain-Barre Syndrome (disability). It was reported that at the time of the report, the patient was incapacitated and could not move her arms or legs. The patient's outcome for swollen arm and redness was unknown. This was originally reported by a consumer. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: None. Pt. had pregnancy test preformed on Nov. 9, 2012. Had FLUMIST on 10/15/2012.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Laboratory test, Musculoskeletal pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Parsonage-Turner syndrome (R) arm/shoulder pain & weakness tx with prednisone x 2-3 weeks.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Parsonage-Turner syndrome (R) arm/shoulder pain & weakness tx with prednisone x 2-3 weeks.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Insomnia, Pain, Pyrexia
Clinical narrative: Patient has a fever 102.4 degrees, c/o diffuse body aches, and arthralgia unable to sleep since last night. Advised to go to ER. Ibuprofen 600 mg q6 hours prn/ MEDROL dose pack Rx given.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Received FLUVIRIN vaccination in left deltoid. Pain with movement in left arm. Symptoms have persisted for over 8 weeks.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had redness, swelling at injection site limited to the upper arm (left).
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Mobility decreased, Oedema peripheral, Throat irritation
Clinical narrative: Patient awoke next morning with scratchy throat, pain under arm & swelling under armpit. No visible reaction at injection site. Doctor visit after 2 days - pain decreased arm motility returned. Patient given KEFLEX 500 mg 1 QID & ZYRTEC 1 daily.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Cold sweat, Nausea, Pallor
Clinical narrative: Pt received Flu vaccine & 5 minutes afterwards c/o belly hurting, nauseated, & color change as color turned very pale, skin clammy. HR - 116/min. Pulse O2 99%. RR 24/min. Pt crying & upset prior to vaccine & upset after vaccine given.
Age: 1.26
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Red spots in random places on body starting today no other sx.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 11/2/12 Patient reported itching at injection site and a swollen red area 2.5 in x 3.5 in surrounding injection site, 24 hours after vaccine administration she used cetirizine 10mg and Diphenhydramine for 3-4 days. All itching and swelling resolved by day 5.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 11/2/12 AM, patient called to report red, swollen, itchy area below and adjacent to injection site. Hot to touch no headache, no fever, no nausea or vomiting. Referred to her MD for presumed cellulitis. MD ordered cephalexin 250 mg four times a day x 1 week, MEDROL DOSE Pk & cetirizine 10 mg daily x 1 wk.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Skin discolouration
Clinical narrative: Within 15 min of vaccine administration patient was standing to leave felt nauseous, pallor, diaphoretic. Vomited, color greyish, patient felt dizzy as if going to pass out.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Vomiting
Clinical narrative: Within 15 min of vaccine administration patient was standing to leave felt nauseous, pallor, diaphoretic. Vomited, color greyish, patient felt dizzy as if going to pass out.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain, Diarrhoea, Pain, Pyrexia
Clinical narrative: Fever, abdominal pain, severe diarrhea. Generalized pain - required IV fluids on 2 occasions. Lasted at least 48 h.
Age: 16.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain, Diarrhoea, Pyrexia, Stool analysis
Clinical narrative: Fever, abdominal pain, severe diarrhea starting 7 days after vaccine.
Age: 1.21
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR
Symptoms: Crying, Cyanosis, Febrile convulsion, Hypersensitivity, Pyrexia
Clinical narrative: Received 1st MMR, Hep A, flu shot and Hib #4 on 11/26/12. When mother took child home he developed fever of 101.2 axillary though continued playing. Suddenly pt cried, turned blue and stopped breathing. Mothers friend gave CPR, ambulance called. Today 11/27/12 child appears well per ER - febrile seizures or allergic reaction.
Age: 1.21
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR
Symptoms: Respiratory arrest
Clinical narrative: Received 1st MMR, Hep A, flu shot and Hib #4 on 11/26/12. When mother took child home he developed fever of 101.2 axillary though continued playing. Suddenly pt cried, turned blue and stopped breathing. Mothers friend gave CPR, ambulance called. Today 11/27/12 child appears well per ER - febrile seizures or allergic reaction.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: 1 week post flu shot pt c/o flu like symptoms low grade fever, headache, stuffiness, cough, some mild aches - lasted 2-3 days - now recovered - did not seek care of MD.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Redness, swelling & heat at injection site generalized aches/fever & not feeling well at all referred patient to urgent care for antibiotic treatment.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Redness, swelling & heat at injection site generalized aches/fever & not feeling well at all referred patient to urgent care for antibiotic treatment.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Asthenia, Eyelid oedema, Headache
Clinical narrative: Vertigo, muscle tightness, night sweats, tinnitus, tendon weakness [at site of pre-existing injury], loss of smell, taste [except for saltiness], headache, pressure (cranial & sinus), puffy eyes.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Night sweats, Sinus headache, Tinnitus, Vertigo
Clinical narrative: Vertigo, muscle tightness, night sweats, tinnitus, tendon weakness [at site of pre-existing injury], loss of smell, taste [except for saltiness], headache, pressure (cranial & sinus), puffy eyes.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Clostridium difficile colitis, Crying, Culture stool, Diarrhoea, Faeces discoloured
Clinical narrative: 2 days after vaccines - child started with black, mucus stools, 2-3 x q day. Then "blood" in stools - stated at day 4. Family went out of town. Loose stools increased to 8-10 x q day. Vomit 1-2 x. Cries during feed. Started losing weight. Pt. started trmt on 6/11/12. Diag: Salmonella sp. not typhi 6-11-12.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Mucous stools, Salmonellosis, Vomiting, Weight decreased
Clinical narrative: 2 days after vaccines - child started with black, mucus stools, 2-3 x q day. Then "blood" in stools - stated at day 4. Family went out of town. Loose stools increased to 8-10 x q day. Vomit 1-2 x. Cries during feed. Started losing weight. Pt. started trmt on 6/11/12. Diag: Salmonella sp. not typhi 6-11-12.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Patient developed lesions consistent with varicella.
Age: 21.0
Sex: U
Vaccine: UNK
Symptoms: Erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Pain from under arm all the way to wrist swelling from where shot was taken to elbow. Redness & fever.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient stating that she had skin breakout after 1-2 weeks of vaccination. She describe it as itching and it spreads all over her body. It has been ongoing and she been seen her MD/ER.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient stating that she had skin breakout after 1-2 weeks of vaccination. She describe it as itching and it spreads all over her body. It has been ongoing and she been seen her MD/ER.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus, Swelling
Clinical narrative: Pt received ZOSTAVAX Lot # H011427 in her (R) upper arm 10/26. She was seen for a different issue 11/28 and mentioned she had a reaction which lasted 2 1/2 wks including redness, itching, blisters & swelling.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Date of injection, became redness/warmth & swelling at injection site. During sleep developed chills with temp of 102 degrees F (not < 101 x 2 days) & body aches, dizziness. 11/28 pm began developing redness/warmth of hairs, axilla, popliteal anticubital. Present Temp 99.4. Seen by dr 11/29/12 & DX serum sickness with steroids & antihistamines.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Serum sickness
Clinical narrative: Date of injection, became redness/warmth & swelling at injection site. During sleep developed chills with temp of 102 degrees F (not < 101 x 2 days) & body aches, dizziness. 11/28 pm began developing redness/warmth of hairs, axilla, popliteal anticubital. Present Temp 99.4. Seen by dr 11/29/12 & DX serum sickness with steroids & antihistamines.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Pt. received ZOSTAVAX injection on Friday 8/3 in right abdomen and noticed a red rash on his lower right abdomen that was growing in size from Saturday 8/4 until it was reported on 8/6. He was given diphenhydramine and ranitidine x5 days.
Age: 16.0
Sex: F
Vaccine: IPV, TD
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Today 11/29/12 - mother reported that client had a severe rxn 2 days after Td & polio shots - Rxn was hives & she required a steroid.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Allergy test, Differential white blood cell count, Full blood count, Lip swelling, Rash
Clinical narrative: Received vaccines at 1 PM - Mother noticed a rash on face, abdomen, back, face, swelling of lips, rhinorrhea - No SOB about 12 hours later; Tx with one dose of BENADRYL - sx resolved.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Received vaccines at 1 PM - Mother noticed a rash on face, abdomen, back, face, swelling of lips, rhinorrhea - No SOB about 12 hours later; Tx with one dose of BENADRYL - sx resolved.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 30-OCT-2012 09:57, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 01-NOV-2012 at 12:30, the patient was vaccinated with RECOMVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 01-NOV-2012 06:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a doctor or pharmacy refers to a 58 years old female patient with drug reactions or allergies to "Sulfa" antibiotics and none pertinent medical history. On 23-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (lot number reported as H016230, expiration date unspecified) and levothyroxine sodium. On 25-NOV-2012, the patient developed an injection site reaction that with-in a day spread to the back of her arm with a rash. The injection site reaction was described by the patient to the pharmacist as a red, swollen, hot to the touch area with some discomfort at the injection site. The injection site reaction that spread to the back of the patients arm was described as red, with a rash. The pharmacist could not describe the rash. No treatment was given for adverse events. No laboratory tests were performed. At the time of the report the patient's outcome was reported as not recovered. The relatedness for adverse events was not reported for ZOSTAVAX. The patient sought medical attention, contacted pharmacist (the pharmacist only spoke with the patient on the phone). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse concerning one of twins patients (gender and age unknown). On unknown date, the patient was vaccinated with VARIVAX (Merck) (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that their county was experienced an outbreak of chickenpox. Also, the twins developed chickenpox. The nurse stated that this county had a very high rate of parents who opt-out of vaccines. At the time of the report, the outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for VARIVAX (Merck). Additional information has been requested. This is one of the several reports of the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse concerning a one of the twins (gender and age unknown). On unknown date, the twins were vaccinated with VARIVAX (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. It was reported that their county was experienced an out break of chickenpox. Also, the patient developed chickenpox. The nurse stated that this county had a very high rate of parents who opt-out of vaccines. At the time of the report, the outcome of chickenpox was unknown. The relatedness for chickenpox was unknown for VARIVAX (Merck). Additional information has been requested. This is one of the several reports of the same source. The experience of the other one of the twins was captured in MARRS# 1211USA005227. The experience of the other one of the twins was captured in MARRS# 1211USA005227.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a licensed practical nurse via a company representative regarding a adolescent patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot#, expiry, route and dose not reported). No concomitant medications were reported. On an unknown date, the patient contracted physician documented shingles. The company representative noted a second dose of VARIVAX had not been administered. No treatment information was reported. The outcome of shingles was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to a 71 years old female patient. The patient was vaccinated (route not reported) with ZOSTAVAX (lot number and expiry date not reported) on July 2012. No other co-suspects were reported. Concomitant medications included: vitamin B complex). On 14-NOV-2012 the patient developed shingles on her tailbone. The clustered bumps itched and hurt so bad that she had to cover them to avoid irritation. No treatment information was reported. The outcome of shingles on tailbone was unknown. The relatedness for shingles on tailbone was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex, Herpes simplex serology positive
Clinical narrative: This spontaneous report as received from a company representative refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced positive serologic test for herpes simplex 1 and Herpes Simplex 2. No treatment information was reported. The outcome of herpes simplex is unknown. The relatedness for herpes simplex is unknown for ZOSTAVAX. 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 pharmacist refers to a patient of unknown age. The pharmacist noted that the patient was inadvertently vaccinated subcutaneously with an expired dose of VARIVAX (Merck) (1188Z exp 09-OCT-2012) on 19-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The pharmacist did not known if this was the first or second dose of VARIVAX (Merck) that this patient had received. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. The patient was vaccinated with, .65 ml ZOSTAVAX "about a month ago". No other co-suspects were reported. No concomitant medications were reported. The physician reported the patient "broke out in a rash in the shoulder blade area the day after getting" ZOSTAVAX. The patient admitted to having pain in that area prior to getting the injection and the doctor believes the patient had shingles prior to receiving ZOSTAVAX. Treatment information was unspecified. The outcome of shingles is recovered/resolved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 01-NOV-2012 at 10:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 16-OCT-2012 17:39, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 01-NOV-2012 08:19, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 16-OCT-2012 16:47, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2013; and 0385AE, expiry date on 08-nov-2014. it was unspecified which lot # the patient was administered. the outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 16-OCT-2012 18:01, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old male patient. The patient was vaccinated (route unknown) with ZOSTAVAX (lotnumber and expiry date not provided) on 19-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-NOV-2012 the patient experienced "a lump the size of a tennis ball" at the injection site, 3 days after onset of therapy, warmth at injection site and redness at the injection site. The pharmacist advised the patient to take ibuprofen. The patient called back on 26-NOV-2012, stating the lump had decreased in size to a "golf ball" however the injection site was now warmer than it had been the prior week. The outcome of "a lump the size of a tennis ball" at the injection site was reported as recovering/resolving. The outcome of redness at the injection site is unknown. The outcome of warmth at injection site was reported as not recovered/not resolved. The relatedness for "a lump the size of a tennis all" at the injection site, warmth at injection site and redness at the injection site is unknown for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-OCT-2012 14:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-nov-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-OCT-2012 11:05, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 11:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 01-NOV-2012 at 10:28, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hours time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 14:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During the 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 19:59, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 15-OCT-2012 11:37, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report was received from a physician refers to a 4 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a second dose of PNEUMOVAX 23, (lot number, expiration date and route not reported). On an unknown date, the patient was administered only half a dose was administered as the syringe came apart during administration and no adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 27-OCT-2012 11:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 13:14, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. I was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.