chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Faintness.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia, Nausea
Clinical narrative: Pt experienced red, swollen, tenderness at injection site. Pt also reported ache at site that caused her difficulty in sleeping and nausea but no vomiting.
Age: 1.11
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC13, VARCEL
Symptoms: Cough, Insomnia, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Ran a fever all night of 102 that wouldn't go down. Up all night. Signs of sore throat. (Wouldn't take bottle or pacifier). Symptoms of a cold onset. Runny nose, cough, and sneezing. Fever finally broke around 6am. Threw up between 6am and 10am several times.
Age: 1.11
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: Ran a fever all night of 102 that wouldn't go down. Up all night. Signs of sore throat. (Wouldn't take bottle or pacifier). Symptoms of a cold onset. Runny nose, cough, and sneezing. Fever finally broke around 6am. Threw up between 6am and 10am several times.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Pt reports headache, vomiting for 3 hours, fever, chills, bodyaches.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Condition aggravated, Oedema peripheral, Sickle cell anaemia with crisis, X-ray limb abnormal
Clinical narrative: Patient received seasonal flu vaccine and Pneumovax 11/8/12 with subsequent soft tissue swelling of the arm 11/12/12; followed by hospital admission due to sickle cell crisis 11/13/12.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Injected limb mobility decreased
Clinical narrative: Left arm (injection given in left arm) increasingly sore, then sudden onset of faintness, seeing stars, nausea, arms and legs very shaky, hard time breathing, then progressed to arms and legs not able to move, left arm pain increasing to excruciating pain and feeling like large bee sting, then overall shock, chills, left arm then no longer able to move, then I laid down on sofa, daughter covered me with layers of blankets, called Walgreens, but pharmacist gone for evening, daughter then put ice pack on left arm at injection sight and I took 400 mg of ibuprofen.  After approximately 2 hours, felt slightly better, but was completely wiped out, went to bed, next morning was better, but left arm still sore.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Nausea, Pain in extremity, Shock, Tremor
Clinical narrative: Left arm (injection given in left arm) increasingly sore, then sudden onset of faintness, seeing stars, nausea, arms and legs very shaky, hard time breathing, then progressed to arms and legs not able to move, left arm pain increasing to excruciating pain and feeling like large bee sting, then overall shock, chills, left arm then no longer able to move, then I laid down on sofa, daughter covered me with layers of blankets, called Walgreens, but pharmacist gone for evening, daughter then put ice pack on left arm at injection sight and I took 400 mg of ibuprofen.  After approximately 2 hours, felt slightly better, but was completely wiped out, went to bed, next morning was better, but left arm still sore.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 27 December 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3697AA received on 08 September 2010, on 30 March 2011 (lot number not reported), and lot number C4001AB received on 19 October 2011 (routes and sites of administration not reported). The subject developed a cough on 12 November 2012, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 25 November 2012. The subject also developed cold like symptoms on 17 November 2012, and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 27 November 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 November 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 December 2012, the subject's cough was not persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. This is one out a cumulative total of 179 cases solicited from the database during the surveillance period from 01 January 2010 to 27 December 2012. These 179 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 27 December 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3697AA received on 08 September 2010, on 30 March 2011 (lot number not reported), and lot number C4001AB received on 19 October 2011 (routes and sites of administration not reported). The subject developed a cough on 12 November 2012, approximately 1 year after the last dose, and a paroxysmal cough without a whoop on 25 November 2012. The subject also developed cold like symptoms on 17 November 2012, and sleep disturbance (start date not reported). Laboratory testing included positive PCR on 27 November 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 November 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 December 2012, the subject's cough was not persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. This is one out a cumulative total of 179 cases solicited from the database during the surveillance period from 01 January 2010 to 27 December 2012. These 179 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 27 December 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 17-month-old female subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3913AB received on 18 August 2011, lot number C3923AA received on 18 October 2011, and lot number C3980AB received on 09 January 2012. The subject developed a cough on 02 December 2012, approximately 10 months after the last dose, and a paroxysmal cough without a whoop on 06 December 2012. The subject also developed cold like symptoms on 23 November 2012, posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 10 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. This is one out a cumulative total of 180 cases solicited from the database during the surveillance period from 01 January 2010 to 27 December 2012. These 180 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 27 December 2012 from the Investigator participating in a post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 17-month-old female subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3913AB received on 18 August 2011, lot number C3923AA received on 18 October 2011, and lot number C3980AB received on 09 January 2012. The subject developed a cough on 02 December 2012, approximately 10 months after the last dose, and a paroxysmal cough without a whoop on 06 December 2012. The subject also developed cold like symptoms on 23 November 2012, posttussive vomiting and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 10 December 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 December 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 18 December 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. This is one out a cumulative total of 180 cases solicited from the database during the surveillance period from 01 January 2010 to 27 December 2012. These 180 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 1.56
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Convulsion, Full blood count normal, Influenza virus test negative, Pyrexia
Clinical narrative: Generalized seizure with fever 12/8/12.
Age: 1.56
Sex: M
Vaccine: DTAP
Symptoms: Streptococcus test negative
Clinical narrative: Generalized seizure with fever 12/8/12.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Oedema peripheral
Clinical narrative: Information has been received from a female consumer who was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported) on 24-OCT-2012. On 24-OCT-2012, the patient experienced an allergic reaction with left arm swelling. The patient sought medical attention and reported that she was okay. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haematoma, Injection site swelling, Pain in extremity
Clinical narrative: (L) deltoid area w/discoloration - yellow/greenish bruising noted as well as swelling on posterior of upper arm since vaccine on 10/16. Patient stated felt painful w/palpation and if he leaves his arm up/elevated for any length of time, arm becomes painful. Pt on clopidogrel, warfarin, and ASA.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Electromyogram abnormal, Injected limb mobility decreased, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Had a fever, chills and body aches the 1st 24 hrs. Saw primary to swab nose for flu. It was neg. 1 wk exactly later left arm not able to raise, or lift out to side.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Had a fever, chills and body aches the 1st 24 hrs. Saw primary to swab nose for flu. It was neg. 1 wk exactly later left arm not able to raise, or lift out to side.
Age: 1.22
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Injection site scab, Pyrexia, Rash
Clinical narrative: Pt received immunizations on 12/14. On 12/22 - fever started. Rash on chest and forehead. Lasted about 3 days. Rash on both sides of thighs. No additional fever. Mom is concerned about rash and scabbing on thighs at the injection site. Mom has been using neosporin on the rash. Rash does not bother child at all.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Myalgia
Clinical narrative: C/O muscle pain in right arm that bothers her mainly at rest. Pt is dental hygienist and pain does not bother her while working. Decribes pain as severe at times even waking her from sleep.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Eyelid oedema, Lip swelling, Oedema peripheral, Urticaria
Clinical narrative: Pt reported swelling around her eyes and eye lids as well as her lips started on 1/4/13.  Pt denied any s/s of respiratory distress or swelling of her throat. These signs resolved but pt now experiences hives on her abdomen and mild swelling on fingers.  Pt is advised to take Benadryl and schedule appt to be seen today (1/8/13).
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Chest pain, Cyanosis, Loss of consciousness, Oropharyngeal pain, Syncope
Clinical narrative: Chest pain, throat pain, fainting with eyes open, blue lips, unconscious for 10 min with a total 20 min span to being able to sit up and support body weight.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain, weakness, numbness, limited range of motion.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Activities of daily living impaired, Asthenia, Back pain, Blood test normal
Clinical narrative: Flu vaccine 12-05-12 pm; knew I was sick 12-09-12 pm; recovering 12-17-12. Started with pain across lower back & abdomen, fever 103 degrees, chills, shivering, then hot & perspiring, could not use muscles normally. Could not get out of bed, stumbled in walking; frequently could not answer the phone. 12-12-12 husband took me to Urgent Care. Diagnosis: viral infection. Weak; could not use muscles normally. Could not get out of bed most of the time. Sometimes got up after much effort, stumbled in walking. (Example: As I was trying to walk back to bed, holding on to a door facing, I went down head first into a wooden chair that had a cane seat. All my weight was on my forehead against the wood and rough cane seat. I was alone and could not use my arms or legs to get out of the painful position. Finally, I went to my knees to get the weight off my head. After much effort to get up, I stumbled to bed. I have never had this problem before. Sometimes I could not answer my cordless phone and cell phone that were on the bed with me. I had to change my gown and underwear frequently as it was wet with sweat. On Wednesday, Dec. 12, 2012 pm, my husband got me out of bed, dressed me, held me up to walk, and took me to Urgent Care, they swabbed my nosed to test for flu, took blood, and a urine specimen. They said the results were good. The doctor said I had a viral infection, needed to get the fever down, drink lots of liquids, try to eat, and drink chicken soup. I was too sick to tell him what was happening to me. They gave me a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped my walking, and I could get out of bed that night after the injection. The illness lasted approximately a week - until Monday, Dec. 17, 2012. On Dec. 17, 2012, I got out of the house and drove even though I had to gain more strength after that, but I felt I was recovering. I have never had symptoms like this. I do not take Flu shots until this time (12-05-2012). I don't think I will ever take another one. I am a healthy person, do not take any prescriptions, and do not have any medical problems.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Gait disturbance, Hyperhidrosis, Influenza virus test negative
Clinical narrative: Flu vaccine 12-05-12 pm; knew I was sick 12-09-12 pm; recovering 12-17-12. Started with pain across lower back & abdomen, fever 103 degrees, chills, shivering, then hot & perspiring, could not use muscles normally. Could not get out of bed, stumbled in walking; frequently could not answer the phone. 12-12-12 husband took me to Urgent Care. Diagnosis: viral infection. Weak; could not use muscles normally. Could not get out of bed most of the time. Sometimes got up after much effort, stumbled in walking. (Example: As I was trying to walk back to bed, holding on to a door facing, I went down head first into a wooden chair that had a cane seat. All my weight was on my forehead against the wood and rough cane seat. I was alone and could not use my arms or legs to get out of the painful position. Finally, I went to my knees to get the weight off my head. After much effort to get up, I stumbled to bed. I have never had this problem before. Sometimes I could not answer my cordless phone and cell phone that were on the bed with me. I had to change my gown and underwear frequently as it was wet with sweat. On Wednesday, Dec. 12, 2012 pm, my husband got me out of bed, dressed me, held me up to walk, and took me to Urgent Care, they swabbed my nosed to test for flu, took blood, and a urine specimen. They said the results were good. The doctor said I had a viral infection, needed to get the fever down, drink lots of liquids, try to eat, and drink chicken soup. I was too sick to tell him what was happening to me. They gave me a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped my walking, and I could get out of bed that night after the injection. The illness lasted approximately a week - until Monday, Dec. 17, 2012. On Dec. 17, 2012, I got out of the house and drove even though I had to gain more strength after that, but I felt I was recovering. I have never had symptoms like this. I do not take Flu shots until this time (12-05-2012). I don't think I will ever take another one. I am a healthy person, do not take any prescriptions, and do not have any medical problems.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle disorder, Pyrexia, Urine analysis normal, Viral infection
Clinical narrative: Flu vaccine 12-05-12 pm; knew I was sick 12-09-12 pm; recovering 12-17-12. Started with pain across lower back & abdomen, fever 103 degrees, chills, shivering, then hot & perspiring, could not use muscles normally. Could not get out of bed, stumbled in walking; frequently could not answer the phone. 12-12-12 husband took me to Urgent Care. Diagnosis: viral infection. Weak; could not use muscles normally. Could not get out of bed most of the time. Sometimes got up after much effort, stumbled in walking. (Example: As I was trying to walk back to bed, holding on to a door facing, I went down head first into a wooden chair that had a cane seat. All my weight was on my forehead against the wood and rough cane seat. I was alone and could not use my arms or legs to get out of the painful position. Finally, I went to my knees to get the weight off my head. After much effort to get up, I stumbled to bed. I have never had this problem before. Sometimes I could not answer my cordless phone and cell phone that were on the bed with me. I had to change my gown and underwear frequently as it was wet with sweat. On Wednesday, Dec. 12, 2012 pm, my husband got me out of bed, dressed me, held me up to walk, and took me to Urgent Care, they swabbed my nosed to test for flu, took blood, and a urine specimen. They said the results were good. The doctor said I had a viral infection, needed to get the fever down, drink lots of liquids, try to eat, and drink chicken soup. I was too sick to tell him what was happening to me. They gave me a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped my walking, and I could get out of bed that night after the injection. The illness lasted approximately a week - until Monday, Dec. 17, 2012. On Dec. 17, 2012, I got out of the house and drove even though I had to gain more strength after that, but I felt I was recovering. I have never had symptoms like this. I do not take Flu shots until this time (12-05-2012). I don't think I will ever take another one. I am a healthy person, do not take any prescriptions, and do not have any medical problems.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Dehydration, Haematocrit decreased, Hepatic function abnormal, Liver function test abnormal
Clinical narrative: Tremors and high temp 104F within 20 minutes of injection. High fever led to dehydration, kidney and liver function changes. RX with IV fluids and ABX, blood transfusion 2 units.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Renal impairment, Transfusion, Tremor
Clinical narrative: Tremors and high temp 104F within 20 minutes of injection. High fever led to dehydration, kidney and liver function changes. RX with IV fluids and ABX, blood transfusion 2 units.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Oedema, Skin warm
Clinical narrative: Erythema, hot, edematous, hard area shoulder to elbow following injection. Given prednisone taper BENADRYL & ice packs at urgent care visit on 12/24/12.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Client received zoster vaccine 11-27-12. Reports she has shingles pain on forehead into (R) ear. Denies having vesicles. Reports PP will put her on acyclovir. Denies being immunocompromised or on immunosuppression therapy. States she had chicken pox scars from childhood.
Age: 44.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized reaction - LUA. Injection site was red, swollen & warm to the touch that was painful & itchy, lasting 4-5 days. Pt applied 'Anti-itch' medication until resolution.
Age: 44.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: Localized reaction - LUA. Injection site was red, swollen & warm to the touch that was painful & itchy, lasting 4-5 days. Pt applied 'Anti-itch' medication until resolution.
Age: 0.44
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives about 10-15 min after PREVNAR 13 -> BENADRYL given & hives resolved.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient who was vaccinated with the first two dose in the GARDASIL (lot number not provided) immunization series on unspecified dates in 2008, was currently (02-JAN-2013) in the office to receive the third dose. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: TYP
Symptoms: Haematochezia, Malaise, Mucous stools
Clinical narrative: An initial report was received from a healthcare professional on 22.Nov.2012 and concerns a 43-year-old male patient who on 20.Nov.2012 received the first dose of VIVOTIF (batch no.: 3000414, expiry date: Mar.2014) as a prophylactic vaccination. The patient had no relevant medical history and concomitant medications. Following administration of VIVOTIF, the patient started passing mucus and blood (streaks) in his stool. The events had never happened before; he had no medical history of them. The patient was not on other drugs either. He did not feel 100% as well, but had no fever. The outcome of the event was not reported. The events were considered non-serious. Follow-up was received from the consumer on 20.Dec.2012. The patient reported that he had no abdominal discomfort, no fever, and was not unwell. He was advised to take no further VIVOTIF. He did not see the General Practitioner as recommended. He reported that the events resolved within 3-4 days without intervention.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Hypertension, Tachycardia, Tremor
Clinical narrative: Tachycardia, high blood pressure 186/146, weakness, shaking. I followed up with pt's husband today. Pt. is doing fine and the diagnosis was anxiety attack. Pt stated the way I administered the vaccine the technique may be to blame. I did it slowly instead of jabbing it and she thinks that was the wrong technique.
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash on left shoulder and upper back. No other rash. No fever. No URI symptoms. No treatment necessary.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Rash, Throat tightness
Clinical narrative: I had an allergic reaction to the Hepatitis B Vaccine.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash, Rash
Clinical narrative: Mother reports child broke out in rash after returning home, rash located on legs, shoulders and "a couple spots" on face. Denies any shortness of breath or other s/s of adverse effects. Advised to contact pediatrician and follow up prn.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Developed shingles.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer's daughter refers to an 81 years old male patient with blood sugar issues and no drug reactions or allergies. On 12-SEP-2012, the patient was vaccinated with ZOSTAVAX (lot number not provided) one time, subcutaneously. No other co-suspects were reported. Concomitant medications included several medications not provided. In October 2012, the patient contracted shingles after receiving ZOSTAVAX vaccine. The patient sought unspecified medical attention and received unspecified treatment. At the time of the report, the outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient was vaccinated with a dose of (Merck) VARIVAX (Lot # not reported) in approximately 2003, "about 10 years ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, soon after the vaccination, the patient experienced did not seroconvert after receiving (Merck) VARIVAX. The outcome of did not seroconvert after receiving (Merck) VARIVAX was reported as not recovered/not resolved. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, Viral titre decreased
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 70 years old male patient with blood pressure, cholesterol issues, kidney disease and with no drug reactions or allergies. The patient was vaccinated with the first 1 ml dose of RECOMBIVAX HB (Lot # 1369Z, expiration date 24-AUG-2013) on 09-MAR-2011, second 1 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 08-OCT-2011 and third 1 ml dose of RECOMBIVAX HB (Lot # not reported) IM on 08-SEP-2012. No other co-suspects were reported. Concomitant medications included: calcitriol, unspecified heart medication and unspecified cholesterol medication. The pharmacist reported that "recently", the patient had serum titers drawn on an unspecified date that showed low titers for anti-HBs antibody. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning her Husband, who In "November or December 2012" had received ZOSTAVAX 0.65 ml subcutaneously. He developed a red raised area at the injection site that lasted about 5-7 days and resolved in "November or December of 2012". It was unspecified if patient received treatment. The patient did not sought medical attention. The pharmacist had also received ZOSTAVAX at the same time and experienced a similar AE (captured in Case # 1301USA002198). Additional information is not expected.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Croup infectious, Herpes zoster, Rash erythematous, Skin exfoliation
Clinical narrative: This spontaneous report was received concerning a 15 months old male patient from his mother. On 02-OCT-2012, the patient was vaccinated with a dose of VARIVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On 28-DEC-2012, the patient experienced a red rash on his left leg (described as raised bumps). The rash then spread to the patient's lower back described as a horizontal line of red, raised, scaly patches on both sides of the patients back (exact time frame of spread was unspecified). The physician saw the patient on 01-JAN-2013 and called the rash on the patient as shingles. On 31-DEC-2012, the patient also experienced croup (barky cough). The patient sought medical attention (contacted office). The patient was given one dose of steroids (exact date steroid taken, name of steroid and dose of steroid was unspecified) as a treatment for the croup. At the time of the report, the rash was reported to be getting better but the crop was continuing or worse. The relatedness for shingles and croup (barky cough) was unknown for VARIVAX. Reporter also stated that grandmother of the patient went to visit in the past summer (exact date of visit unspecified) and immediately after the visit developed shingles (Grand mother had not received ZOSTAVAX. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old male patient. The patient was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # was reported as h016230, Exp date: 30-NOV-2013) on 20-DEC-2012. Pharmacist reported that ZOSTAVAX which was stored at 46F for 30 days was administered to patient. No adverse effects reported. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 4 months old patient of unknown gender. On 29-JUL-1992 the patient was vaccinated with dose 1 RECOMBIVAX HB (lot number, expiry date, dose and route unspecified), on 22-DEC-1992 the patient was vaccinated with dose 2 RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) and on 09-FEB-1993 the patient was vaccinated with dose 3 RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effect was observed or reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Injection site scar
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient developed injection site reactions after receiving PNEUMOVAX23. The patient developed scar at the injection site. The outcome of the reported event was unknown at the time of this report. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a 46 years old non-pregnant, female nurse who refers, via company representative, to herself. The patient was vaccinated with a dose of (Merck) VARIVAX (dose, route and lot# not reported) when she was child (date and age not specified). On an unknown date the patient experienced shingles 2 times and chicken pox 13 times. The outcome of shingles 2 times and chicken pox 13 times was reported as recovered/resolved 9recovery dates were not reported). It was also reported that the patient sought unspecified medical attention. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to vaccinated person, Secondary transmission, Varicella
Clinical narrative: This spontaneous report was received from a nurse who refers, via company representative, to her mother with lupus. The nurse reported that she was vaccinated with a dose of VARIVAX (merck) (dose, route and lot# not reported) when she was child (date and age not specified). It was reported that nurse's mother had chicken pox multiple times, although reporter did not specify if it was before or after she received the vaccine or even if her mother had received VARIVAX (merck). The outcome for reported adverse event was unknown. Additional information has been requested. This is one of several reports from the same source.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Influenza like illness, Myalgia, Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: Flu like symptoms. Low grade fever, muscle ache, vomiting, diarrhea, copious drainage from sinus.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Flu like symptoms. Low grade fever, muscle ache, vomiting, diarrhea, copious drainage from sinus.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pain
Clinical narrative: Red, swollen and hot at the site.  General body ache, malaise.
Age: 1.38
Sex: M
Vaccine: DTAP, HEP
Symptoms: Rash
Clinical narrative: Severe rash outbreak on arms and back.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Received vaccine afternoon of 1/7/2013. Patient experienced redness, swelling and pain in arm later that night. Patient called pharmacy morning of 1/8/2013 stating these symptoms and saying the pain is so bad she cannot move her arm.
Age: 1.51
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Vomiting
Clinical narrative: Daughter awoke and vomited multiple times. She did not seem like herself.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Heart rate increased, Nuclear magnetic resonance imaging, Tachycardia
Clinical narrative: Rapid heart beat; elevated blood pressure; cardiologist sent me to ER and I was later admitted and treated in hospital for 2 days.
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Seizure like phenomena
Clinical narrative: Seizure-like episode.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swelling left upper arm.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were M-M-R II, VAQTA, RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA005704, 1210USA009229 and 1210USA009231). The follow-up information was received from the medical assistant refers to a the years old patient. The patient was vaccinated with improperly stored M-M-R II on 19-SEP-2012 (Intramuscularly in right thigh, lot# was reported as 0233AE, expiry date on 26-JAN-2014). Concomitant vaccines administered on the same day included varicella virus vaccine live (manufacturer unspecified) (lot # H007702, expiration: 30-MAR-2014, subcutaneously) in the right thigh, DAPTACEL (lot # C41S4BA, expiration: 06-OCT-2014, IM) in the left thigh, and poliovirus vaccine inactivated (manufacturer unspecified) (lot # H1330, expiration: 22-JUN-2014, subcutaneously) in the left thigh. The outcome of event was unknown. This is one of several reports received from the same reporter. The other patients' information was captured in 1210USA009230 and 1301USA001266 Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Pt. passed out passed out after HPV vaccine administration. I did vitals, but before the vitals pt claimed that wanted to throw up so I grabbed pt and took her to the bathroom. Then after she threw up she passed out. Doctor came and I did vitals after we placed her in room. I monitored her for 30 minutes and after pt claimed of feeling well, she left the facility.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient called pharmacy describing a rash around his trunk and chest area with a little itching. Advised patient to take BENADRYL OTC to see if that resolved the reaction. Called patient later that evening and was told that it was not spreading but the rash was still there and he would contact his MD if it did not resolve by Monday morning.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX on 22-DEC-2012. No other co-suspects were reported. No concomitant medications were report. The pharmacist reported that a patient who received ZOSTAVAX had developed swelling at the injection site in December 2012. The patient called pharmacy on 24-DEC-2012. The outcome of swelling at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.53
Sex: U
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The reporter stated that up to 10 patients had received improperly stored vaccines during the time period of 17-SEP-2012 through 02-OCT-2012. Vaccines involved were M-M-R II, VAQTA. RECOMBIVAX HB and GARDASIL. No symptoms were reported. This is one of multiple reports from the same source (other case IDs 1210USA005704, 1210USA009229 and 1210USA009231). The follow-up information was received from the medical assistant refers to a 1 years 6 months old patient. The patient was vaccinated with improperly stored VAQTA on 18-SEP-2012 (intramuscularly in right thigh, lot # 672470/1697AA), expiry date on 22-SEP-2014). Concomitant vaccines administered on the same day included DAPTACEL(lot # C4154BA, expiration: 06-OCT-2014, IM) in the left thigh, ACTHIB (lot # 4H164AA, expiration: 16-SEP-2012, IM) in the left thigh, and PREVNAR 13 (lot # F62923, expiration: August 2013, IM) in the right thigh. The outcome of event was unknown. This is one of several reports received from the same reporter. The other patients' information was captured in 1210USA009230 and 1301USA001267. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash at the injection site spread all over the arm, redness, swelling, itching. Pt went to dermatologist and was given prednisone by doc.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, CSF protein increased, Culture throat, Dysuria, Gait disturbance
Clinical narrative: Initial information received from another manufacturer (service request number 1-5587971112) on 02 October 2012. The information was originally provided to the other manufacturer from a health care professional." A patient, whose age, gender, medical history and concomitant medications were not reported, received a dose of intramuscular (IM) FLUZONE injection (lot number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patient had "a severe reaction to FLUZONE". Corrective medications and laboratory investigations were not reported. The patient's outcome was not reported. Follow-up information was received from a healthcare professional on 02 January 2013. Based upon the new information provided, this case has been upgraded to serious due to hospitalization and was life threatening illness with prolonged hospitalization. A five-year-old male patient received dose three, right arm intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number U4483AA on 10 October 2012 at 2:58. The patient had an upper respiratory infection (URI) one to two weeks before adverse event started. Nineteen days post vaccination on 29 October 2012 (also reported as "on about 29 October 2012") the patient complained of leg pain, left leg initially. The patient was seen in the emergency room (E.R.) on 04 November 2012 with leg pain and limping. X-rays were normal, and the child was given MOTRIN and discharged home. The child was seen in the office on 05 November 2012 for complaint of child unable to walk at school. X-rays and throat culture were obtained. On 09 November 2012, the patient was seen at another E.R. for inability to move muscles without pain and was discharged to home. On 12 November 2012, 33 days post vaccination, the child was seen in the office for incontinence (unspecified) related to pain with sitting and urinating. The adverse event was previously reported as "a severe reaction to FLUZONE" with MedDRA coding adverse event NOS. On an unspecified date the child was hospitalized and was still in the hospital at time of the report. Other laboratory tests performed on unspecified dates were: elevated erythrocyte sedimentation rate (sed rate), spinal tap revealed huge amount of protein, and magnetic resonance imaging (MRI) with coronal lighting up. Concomitant medications were reported as none. The child has one brother. The patient had two previous doses of influenza vaccine H1N1 on unspecified dates in 2009 and 2011. At the time of report, the patient's outcome was reported as unknown as he was still in the hospital. List of documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Incontinence, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Initial information received from another manufacturer (service request number 1-5587971112) on 02 October 2012. The information was originally provided to the other manufacturer from a health care professional." A patient, whose age, gender, medical history and concomitant medications were not reported, received a dose of intramuscular (IM) FLUZONE injection (lot number, route and site of vaccination not reported) on an unspecified date. On an unspecified date, the patient had "a severe reaction to FLUZONE". Corrective medications and laboratory investigations were not reported. The patient's outcome was not reported. Follow-up information was received from a healthcare professional on 02 January 2013. Based upon the new information provided, this case has been upgraded to serious due to hospitalization and was life threatening illness with prolonged hospitalization. A five-year-old male patient received dose three, right arm intramuscular injection of FLUZONE, sanofi pasteur Inc., lot number U4483AA on 10 October 2012 at 2:58. The patient had an upper respiratory infection (URI) one to two weeks before adverse event started. Nineteen days post vaccination on 29 October 2012 (also reported as "on about 29 October 2012") the patient complained of leg pain, left leg initially. The patient was seen in the emergency room (E.R.) on 04 November 2012 with leg pain and limping. X-rays were normal, and the child was given MOTRIN and discharged home. The child was seen in the office on 05 November 2012 for complaint of child unable to walk at school. X-rays and throat culture were obtained. On 09 November 2012, the patient was seen at another E.R. for inability to move muscles without pain and was discharged to home. On 12 November 2012, 33 days post vaccination, the child was seen in the office for incontinence (unspecified) related to pain with sitting and urinating. The adverse event was previously reported as "a severe reaction to FLUZONE" with MedDRA coding adverse event NOS. On an unspecified date the child was hospitalized and was still in the hospital at time of the report. Other laboratory tests performed on unspecified dates were: elevated erythrocyte sedimentation rate (sed rate), spinal tap revealed huge amount of protein, and magnetic resonance imaging (MRI) with coronal lighting up. Concomitant medications were reported as none. The child has one brother. The patient had two previous doses of influenza vaccine H1N1 on unspecified dates in 2009 and 2011. At the time of report, the patient's outcome was reported as unknown as he was still in the hospital. List of documents held by sender: None.