chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-APR-2014 the patient was vaccinated with an expired unspecified dose of PNEUMOVAX 23 (route not reported, lot number: H012972 and expiration date: 09-MAR-2014). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a female patient of unknown age. In 1996 the patient was vaccinated with M-M-R II dose 1. In 1999 the patient was vaccinated with M-M-R II dose 2. The patient was seen at the local health department and had developed measles. The outcome of measles was unknown. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 years old patient. On 31-MAR-2014 the patient, was vaccinated with M-M-R II lot # 0234AE, 0.5 ml, subcutaneous. No concomitant medication or medical history was reported. The health care worker informed that on 31-MAR-2014 the patient received expired dose of M-M-R II expire date 26-JAN-2014. No adverse event effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (reported as medical assistant and healthcare worker) refers to unspecified number of patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. It was reported that from an unknown date the VARIVAX (Merck) was improperly stored for a full year and on an unknown date unspecified number of patients were vaccinated with VARIVAX (Merck) (dose strength, indication route was not reported). It was unspecified as how many doses were administered to how many patients with this improperly stored VARIVAX (Merck). It was also reported that no adverse effect was reported. The outcome of improperly stored and no adverse effect is unknown. No product quality complaint was involved. This case is linked to the case 1404USA005734. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Nurse reported that on 25-MAR-2014 the patient was inadvertently administered with an expired PNEUMOVAX 23 (lot # H010916, expiration date 15-FEB-2014) intramuscular which also had underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Asthenia, Pallor, Syncope
Clinical narrative: She fainted, and then immediately regained consciousness. She appeared pale, felt mildly weak and was teary after the event. She sat in my office and had a soda and granola bar. After about 15 minutes she regained her color felt better and went back to class. I attempted to notify parent but she was unavailable by phone, so I will continue to try. Note sent with student describing event.
Age: 1.53
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: Mom noticed left thigh redness today.  No fever.  Nontender.  Normal gait.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 53 year old patient of unknown gender. There was no pertinent medical history, drug reactions/allergies reported. On 04-APR-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously, lot h03012521 expire date 09-OCT-2013 (dose number unspecified). No concomitant medications reported. The reporter reported that the patient was administered with an expired dose of ZOSTAVAX expire date reported as 09-OCT-2013 and no adverse effects reported. The sought medical attention not reported. The product quality complaint reported as no. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching at site of injection within 1 min of injection. Gave 25mg diphenhydramine. Itching not getting worse. Mild redness about a quarter size at injection site.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Impaired work ability, Influenza
Clinical narrative: Case number PHHY2014US039847 is an initial literature report received on 01 Apr 2014. The author discussed about the effect of influenza vaccine in asthmatic patients. This report refers to a 38-year-old female patient. She was a mother to two children aged 5 and 3 years old. Her medical history included allergic rhinoconjunctivitis with sensitization to tree, grass, dust mite, cat, alternaria species and perennial mold in addition to well controlled asthma. She managed with 2 puffs of 40 mg of beclomethasone inhaled twice daily, 2 nasal squirts of 50 mg of fluticasone propionate daily and intermittent use of over-the-counter ketotifen ocular drops as needed. She used her Albuterol inhaler before exercise and intermittently (no more than once per week). It was reported that the previous few years, she averaged approximately 4 exacerbations per year and all required oral corticosteroid courses. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported, so conservatively coded as influenza vaccine INN (seasonal or pandemic)) on an unknown dates in the past 2 years. On an unknown date, the patient contracted influenza and had an asthma exacerbation causing her to miss a day of work despite receiving the vaccine. She reported past asthma flared up within a month of vaccination, which in part has motivated her decision to defer influenza vaccination for some years. She expressed that she does not want to get sick from the vaccine and that some years she felt the vaccine does not work. The author concluded that influenza vaccine itself was linked to causing any asthma flares or contraction of influenza virus but it need to be discussed that vaccination might not prevent influenza-related asthma complications. In past years, the main circulating strain of influenza B has not been in the vaccine, validating the patient's concern that vaccine efficacy might not be optimal in some years. However, vaccination is still the best recommendation to prevent her from contracting influenza and highlight that new quadrivalent vaccines are available that will hopefully provide more robust coverage against circulating influenza strains. It was reported that the patient was re-vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date and this time she was without any issue and neither had any asthma-related complications during the influenza season.
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Lip swelling
Clinical narrative: Case number PHEH2014US006938 is an initial spontaneous report from the consumer received on 07 Apr 2014. This report refers to a female patient of an unknown age. She was vaccinated with FLUVIRIN (batch number: 1309401, expiry date: 30 Apr 2014) on an unknown date. On an unknown date, after vaccination she experienced lip swelling and tearing of eyes. The final outcome, seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TD
Symptoms: Expired drug administered, Wrong drug administered
Clinical narrative: Pt needed Tdap and was given expired Td by mistake.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a healthcare professional regarding an unspecified number of patients of unknown age. On an unknown date, the unspecified patient received improperly stored PEDVAXHIB (dose was not provided, Lot number reported as J011964, expiration date 19-JUN-2016). Two doses of the improperly stored PEDVAXHIB were received on 28-MAR-2014. The improperly stored PEDVAXHIB was exposed to 13C for an undetermined timeframe. Healthcare worker will provide timeframe when products are back in recommended storage range. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypersensitivity, Hypoaesthesia
Clinical narrative: Symptoms of dizziness and numbness to face after receiving 2nd GARDASIL vaccine as per patient. ER final diagnosis - allergic reaction.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. On 26-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 dose 2, 0.5 ml, intramuscular. It was reported that a patient received a dose of PNEUMOVAX 23 in 2012, "about two years ago". He stated that the patient received another dose of PNEUMOVAX 23 on 26-MAR-2014, because the patient forgot that he had previously received the dose. No adverse effects reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Body temperature increased, Laboratory test normal
Clinical narrative: Infant spike temp 102.2 8 hrs after receiving immunizations for 2 mo well child check up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a consumer refers to 5 patients of unknown age and gender. Approximately on an unknown date in 2007 (reported as 7 years ago) the patients were vaccinated with ZOSTAVAX (strength, dose number, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. On an unknown date the patients developed shingles. The physician wanted to know if there should be a booster dose of ZOSTAVAX, given to the patients after a certain period of time. The outcome of shingles was unknown. The causality of the event was not provided. This case is linked to case # 1404USA004983 via the same reporter link. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Atypical pneumonia, Blood test abnormal, Body temperature increased, Dyspnoea, Malaise
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 65 year old female patient with hypertension, arthritis, allergy to CORTIZONE and allergy to PREVACID. On 29-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 reported route "injection", 1 Dosage, reported lot # 1047955-00000712. Concomitant therapies included LEVAQUIN, prednisone and unspecified antibiotic. On 02-APR-2014, the patient experienced walking pneumonia with symptoms of 102 temperature, feeling ill and could not breathe. The patient was treated with PROAIR HFA (90), amoxicillin, promethazine and a nebulizer. Blood and urine tests were performed (results not provided). The patient sought medical attention with her physician. The patient also reported that on an unknown date, she had an unspecified allergic reaction to PREVACID. Action taken with PNEUMOVAX 23 was reported as "not reintroduced". The outcome of walking pneumonia with symptoms of 102 temperature, feeling ill and could not breathe was unknown. Causality was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 65 year old female patient with hypertension, arthritis, allergy to CORTIZONE and allergy to PREVACID. On 29-MAR-2014, the patient was vaccinated with PNEUMOVAX 23 reported route "injection", 1 Dosage, reported lot # 1047955-00000712. Concomitant therapies included LEVAQUIN, prednisone and unspecified antibiotic. On 02-APR-2014, the patient experienced walking pneumonia with symptoms of 102 temperature, feeling ill and could not breathe. The patient was treated with PROAIR HFA (90), amoxicillin, promethazine and a nebulizer. Blood and urine tests were performed (results not provided). The patient sought medical attention with her physician. The patient also reported that on an unknown date, she had an unspecified allergic reaction to PREVACID. Action taken with PNEUMOVAX 23 was reported as "not reintroduced". The outcome of walking pneumonia with symptoms of 102 temperature, feeling ill and could not breathe was unknown. Causality was not reported. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal faeces, Diarrhoea, Vomiting
Clinical narrative: Pt had 2 weeks of vomiting and diarrhea after her 4 month ROTATEQ vaccine. It started with foamy stools the day after the vaccine.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that the patient received a first dose of VAQTA on 02-JAN-2014 and a second dose of VAQTA (25/0.5 U/ml) on 31-MAR-2014. No adverse symptoms reported. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that the patient received a first dose of VAQTA on 02-JAN-2014 and a second dose of VAQTA (25/0.5 U/ml) on 31-MAR-2014. No adverse symptoms reported. No PQC involved. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth
Clinical narrative: Within short time experienced 103.4 temp. (L) thigh red and hot 4" x 2" lasating 24 hr. Redness warmth lasted 48 hours.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Diarrhoea, Inappropriate schedule of drug administration, Infantile spitting up, Irritability
Clinical narrative: This spontaneous report as received from a nurse practitioner, who is also the mother of the patient, via a company representative refers to a 4 month old male patient. The patient's current conditions or medical history were not reported. On 24-APR-2013, the patient was vaccinated with the first dose of Oral ROTATEQ vial 1 dose (route, Lot number and expiration date were not reported) the reporter stated that the first dose was given late to the patient. On 24-APR-2014, the reporter stated that the patient had abdominal cramping. Was cringing and holding his legs and very cranky for the rest of the day but it was unknown if the symptoms still went into the next day. Also had excessive spit up multiple times and diarrhea multiple times, and both symptoms into the next day. The reporter stated that she completely breast feed her son and he had never had had any problems. The nurse decided not to continue with Oral ROTATEQ series and her son only received the first dose. Therapy with Oral ROTATEQ was discontinued and not reintroduced. After stopping therapy, all events improved. On an unspecified date, the patient recovered from the events. The patient did not sought for medical attention and did not receive treatment for the events. No lab diagnostics were performed. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: S/P 12 admin on 4/4/14 with KINRIX, MMR, VZV IN on 4/.7/14 with c/o lg reddened area to (L) thigh measuring 10x11cm. KINRIX, VZV was given in (L) thigh. Back in on 4/10/14 with improvement. Red induration improving as of 4/10/14. Pt given BENADRYL and Prednisolone.
Age: 1.31
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Full blood count normal, Injection site induration, Pallor, Pruritus
Clinical narrative: Pt has erythematous, blanching 2 cm of induration to R thigh at injection site, positive itchy. BENADRYL, hydrocortisone cream, cool compresses.
Age: 11.0
Sex: M
Vaccine: FLUN4, TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain, joint pain - arms - recurrent since Tdap.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 14 cm x 17 cm area of redness/swelling/warmth to (L) thigh around injection site. 5cm x 8cm area of redness/swelling/warmth to (R) thigh around injection site.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient experienced redness in the arm that the vaccine was administered in. Was treated for cellulitis while admitted for unrelated reason.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Apnoeic attack, Apparent life threatening event, Body temperature increased, Cardiac monitoring, Crying
Clinical narrative: Crying non-stop since approximately 1 hour post injection (approximately 5:00 PM on 12/18/13) until ALTE at 4:00 AM on 12/19/13 (received the 5-in-1 immunization as well as flu immunization and oral rotavirus vaccine) in pediatrician's office. She had began to run a temperature (approximately 102) around 7:00 PM, was administered Tylenol for this. Around 9:00 PM, she vomited. She was given more Tylenol around 10:00 PM. She vomited around 4:00 AM on 12/19/13, then about 2 minutes later, went unresponsive, cyanotic around her lips, and apneic. CPR was performed for approximately 3-4 cycles by mother (who is a nurse) and EMS was dispatched. After about 4 cycles, she began moaning and having agonal breaths, which within 30 seconds became vigorous cries. She never had any seizure-like activity. She was admitted to Hospital for 2 days observation and discharged with the diagnosis of ALTE.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Cyanosis, Dyspnoea, Full blood count, Metabolic function test, Moaning
Clinical narrative: Crying non-stop since approximately 1 hour post injection (approximately 5:00 PM on 12/18/13) until ALTE at 4:00 AM on 12/19/13 (received the 5-in-1 immunization as well as flu immunization and oral rotavirus vaccine) in pediatrician's office. She had began to run a temperature (approximately 102) around 7:00 PM, was administered Tylenol for this. Around 9:00 PM, she vomited. She was given more Tylenol around 10:00 PM. She vomited around 4:00 AM on 12/19/13, then about 2 minutes later, went unresponsive, cyanotic around her lips, and apneic. CPR was performed for approximately 3-4 cycles by mother (who is a nurse) and EMS was dispatched. After about 4 cycles, she began moaning and having agonal breaths, which within 30 seconds became vigorous cries. She never had any seizure-like activity. She was admitted to Hospital for 2 days observation and discharged with the diagnosis of ALTE.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Resuscitation, Unresponsive to stimuli, Urine analysis, Vomiting
Clinical narrative: Crying non-stop since approximately 1 hour post injection (approximately 5:00 PM on 12/18/13) until ALTE at 4:00 AM on 12/19/13 (received the 5-in-1 immunization as well as flu immunization and oral rotavirus vaccine) in pediatrician's office. She had began to run a temperature (approximately 102) around 7:00 PM, was administered Tylenol for this. Around 9:00 PM, she vomited. She was given more Tylenol around 10:00 PM. She vomited around 4:00 AM on 12/19/13, then about 2 minutes later, went unresponsive, cyanotic around her lips, and apneic. CPR was performed for approximately 3-4 cycles by mother (who is a nurse) and EMS was dispatched. After about 4 cycles, she began moaning and having agonal breaths, which within 30 seconds became vigorous cries. She never had any seizure-like activity. She was admitted to Hospital for 2 days observation and discharged with the diagnosis of ALTE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: MOTHER BROUGHT PATIENT ON MONDAY WITH BUMPS AND REDNESS TO LEFT THIGH WHERE VACCINE WHERE ADMINISTRED. MOM DENIES FEVER OR ITCHINESS.
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Amnesia, Anxiety, Aphasia, Blood aluminium increased, Catatonia
Clinical narrative: Since 2009, Gradual decrease of cognitive skills, memory loss, loss of speech, symptoms of dementia, catatonia, tremors, anxiety, irritability, insomnia,  slowness of motor functions.
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Cognitive disorder, Dementia, Insomnia, Irritability, Laboratory test
Clinical narrative: Since 2009, Gradual decrease of cognitive skills, memory loss, loss of speech, symptoms of dementia, catatonia, tremors, anxiety, irritability, insomnia,  slowness of motor functions.
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Lumbar puncture, Motor dysfunction, Nuclear magnetic resonance imaging, Positron emission tomogram, Tremor
Clinical narrative: Since 2009, Gradual decrease of cognitive skills, memory loss, loss of speech, symptoms of dementia, catatonia, tremors, anxiety, irritability, insomnia,  slowness of motor functions.
Age: 13.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Activities of daily living impaired, Amnesia, Aphasia
Clinical narrative: Since 2009, Gradual decrease of cognitive skills, memory loss, loss of speech, symptoms of dementia, catatonia, tremors, anxiety, irritability, insomnia,  slowness of motor functions.
Age: 14.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Amnesia, Anxiety, Aphasia, Blood aluminium increased, Catatonia
Clinical narrative: Received message from mother today via RN USA N. Mom wanted to let us know that she is filing a complaint to the FDA related to our office's administration of the HPC vaccine to her daughter. States patient suffered memory loss, unable to speak, and homebound since 2009 (after completion of HPC vaccine). Mom stated patient is doing better with help of specialists.
Age: 14.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Cognitive disorder, Dementia, Insomnia, Irritability, Laboratory test
Clinical narrative: Received message from mother today via RN USA N. Mom wanted to let us know that she is filing a complaint to the FDA related to our office's administration of the HPC vaccine to her daughter. States patient suffered memory loss, unable to speak, and homebound since 2009 (after completion of HPC vaccine). Mom stated patient is doing better with help of specialists.
Age: 14.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Lumbar puncture, Motor dysfunction, Nuclear magnetic resonance imaging, Positron emission tomogram, Tremor
Clinical narrative: Received message from mother today via RN USA N. Mom wanted to let us know that she is filing a complaint to the FDA related to our office's administration of the HPC vaccine to her daughter. States patient suffered memory loss, unable to speak, and homebound since 2009 (after completion of HPC vaccine). Mom stated patient is doing better with help of specialists.
Age: 14.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Activities of daily living impaired, Amnesia, Aphasia
Clinical narrative: Received message from mother today via RN USA N. Mom wanted to let us know that she is filing a complaint to the FDA related to our office's administration of the HPC vaccine to her daughter. States patient suffered memory loss, unable to speak, and homebound since 2009 (after completion of HPC vaccine). Mom stated patient is doing better with help of specialists.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Full blood count, Myalgia, Shock
Clinical narrative: muscle aches all over body with intermittent severe shocks through body
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 10 week old female received Influenza 0.25 Trivalent vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Vaccination site warmth
Clinical narrative: Left leg is swollen, red and warm at area vaccination site. Some moderate pain expressed. No fever or other symptoms noted.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Blood test normal, Convulsion, Crying, Erythema, Foaming at mouth
Clinical narrative: A fever of 99 degrees came on around 7pm, 4/5/14.  Motrin was administered and baby was put to bed.  At 6:15 AM on 4/6/14, baby cried in crib briefly.  Mother went into babie's room, picked baby up and baby was limp and very red faced and hot.  Pajamas were removed and baby started a full body seizure in mother's arms.  Eyes were open, arms and legs were seizing and baby started to foam at mouth.  Paramedics were called.  Oxygen was administered.  Seizure lasted approximately 5-6 minutes.  Baby's temperature was 101.5 degrees when checked in the ambulance but paramedics said it was probably more like 103-104 during the seizure. In hospital, motrin and tylenol were administered. Blood was drawn to check for abnormalities and nothing was found.  Baby did not return to normal self in terms of behavior for several hours (4 hrs). Sent home from hospital after 6 hours total and continued to give motrin and tylenol for the next 24 hours. Area where the MMR shot was given on 3/27/14 (left thigh) became newly inflamed- swollen and red.  That lasted for 2 days and then returned to normal.  Baby had follow up visit with her pediatrician on 3/7/14.  It was determined by the Dr. at that time that she probably had a reaction to the MMR vaccine, which came on 10 days after it being administered.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Hypotonia, Injection site erythema, Injection site inflammation, Injection site swelling, Pyrexia
Clinical narrative: A fever of 99 degrees came on around 7pm, 4/5/14.  Motrin was administered and baby was put to bed.  At 6:15 AM on 4/6/14, baby cried in crib briefly.  Mother went into babie's room, picked baby up and baby was limp and very red faced and hot.  Pajamas were removed and baby started a full body seizure in mother's arms.  Eyes were open, arms and legs were seizing and baby started to foam at mouth.  Paramedics were called.  Oxygen was administered.  Seizure lasted approximately 5-6 minutes.  Baby's temperature was 101.5 degrees when checked in the ambulance but paramedics said it was probably more like 103-104 during the seizure. In hospital, motrin and tylenol were administered. Blood was drawn to check for abnormalities and nothing was found.  Baby did not return to normal self in terms of behavior for several hours (4 hrs). Sent home from hospital after 6 hours total and continued to give motrin and tylenol for the next 24 hours. Area where the MMR shot was given on 3/27/14 (left thigh) became newly inflamed- swollen and red.  That lasted for 2 days and then returned to normal.  Baby had follow up visit with her pediatrician on 3/7/14.  It was determined by the Dr. at that time that she probably had a reaction to the MMR vaccine, which came on 10 days after it being administered.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Vaccination complication
Clinical narrative: A fever of 99 degrees came on around 7pm, 4/5/14.  Motrin was administered and baby was put to bed.  At 6:15 AM on 4/6/14, baby cried in crib briefly.  Mother went into babie's room, picked baby up and baby was limp and very red faced and hot.  Pajamas were removed and baby started a full body seizure in mother's arms.  Eyes were open, arms and legs were seizing and baby started to foam at mouth.  Paramedics were called.  Oxygen was administered.  Seizure lasted approximately 5-6 minutes.  Baby's temperature was 101.5 degrees when checked in the ambulance but paramedics said it was probably more like 103-104 during the seizure. In hospital, motrin and tylenol were administered. Blood was drawn to check for abnormalities and nothing was found.  Baby did not return to normal self in terms of behavior for several hours (4 hrs). Sent home from hospital after 6 hours total and continued to give motrin and tylenol for the next 24 hours. Area where the MMR shot was given on 3/27/14 (left thigh) became newly inflamed- swollen and red.  That lasted for 2 days and then returned to normal.  Baby had follow up visit with her pediatrician on 3/7/14.  It was determined by the Dr. at that time that she probably had a reaction to the MMR vaccine, which came on 10 days after it being administered.
Age: 34.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Erythema, Incorrect dose administered, Local swelling, Nausea, Pain
Clinical narrative: Nausea twenty minutes after, next day large local swelling redness and pain. I just received the same vaccination 7 days prior.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hypersensitivity, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Hypersensitivity, pain in joints, 2" round red welt at point of injection.
Age: 51.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Cough, Ear congestion, Influenza like illness, Lacrimation increased, Myalgia
Clinical narrative: Steady degradation into flu-like symptoms, very noticeable starting around April 4th.  Intermittent fever feeling, muscle pain (chest, neck...) congestion in ears and nose, runny nose, tearing eyes, coughing, sneezing... somewhat similar to reaction following last immunization round in June 2013.  No formal treatment to date, but strongly considering a visit to an urgent care clinic.
Age: 51.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Nasal congestion, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Steady degradation into flu-like symptoms, very noticeable starting around April 4th.  Intermittent fever feeling, muscle pain (chest, neck...) congestion in ears and nose, runny nose, tearing eyes, coughing, sneezing... somewhat similar to reaction following last immunization round in June 2013.  No formal treatment to date, but strongly considering a visit to an urgent care clinic.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Fatigue, Headache, Joint swelling, Local swelling
Clinical narrative: Fatigue, swollen glands, swollen joints, swollen fingers, headache, dizziness, light headidness
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Fatigue, swollen glands, swollen joints, swollen fingers, headache, dizziness, light headidness
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Dyspnoea, Erythema, Erythema of eyelid, Eyelid oedema
Clinical narrative: The area around left eye became red about 9AM and redder through the day, but not severe. 3/20/14 5:00AM: Patient was thrashing her arms and head about and appeared desperate as if struggling to breath. I moved patient to an elevated position and burped her to see if this would help her breath. She was virtually unresponsive and acted lethargic. She appeared frightened and made no noise, but gurgling as if not breathing well. The skin was very red and swollen around both eyes and onto the forehead. She appeared very ill. Normally, 5AM is a time when patient is very alert, babbling and playful. I took patient to the ER. They administered Benadryl. The swelling and redness began to diminish about 20 minutes later.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Increased upper airway secretion, Lethargy, Unresponsive to stimuli
Clinical narrative: The area around left eye became red about 9AM and redder through the day, but not severe. 3/20/14 5:00AM: Patient was thrashing her arms and head about and appeared desperate as if struggling to breath. I moved patient to an elevated position and burped her to see if this would help her breath. She was virtually unresponsive and acted lethargic. She appeared frightened and made no noise, but gurgling as if not breathing well. The skin was very red and swollen around both eyes and onto the forehead. She appeared very ill. Normally, 5AM is a time when patient is very alert, babbling and playful. I took patient to the ER. They administered Benadryl. The swelling and redness began to diminish about 20 minutes later.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Expired drug administered
Clinical narrative: EXPIRED PEDIATRIC DOSE OF HAVRIX ADMINISTERED TO ADULT.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Redness, hard swelling, was improving by 4/4/14.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Autoimmune haemolytic anaemia, Blood immunoglobulin A increased, Blood immunoglobulin G normal, Complement factor C3, Complement factor normal
Clinical narrative: Case reference number B0984326A was reported in a literature article and refers to a 4-month-old male subject who developed autoimmune haemolytic anaemia shortly after receiving his four-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the subject's medical, family history or concurrent medication. A 4-month-old male subject was taken to a community hospital with a 2-day history of irritability, vomiting and dark stools shortly after receiving his 4-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the clinical examination performed on the subject. Blood analysis revealed initial haemoglobin of 2.7 g/dL so he was transferred to an academic centre. Once there he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Diagnosis was autoimmune vaccine-related haemolytic anaemia based on these results. Treatment consisted of oral corticosteroids. Outcome is improvement in his haemoglobin levels after treatment. The 6-month immunisations were given using a staggered approach that included serial full blood counts following each individual vaccine to monitor for evidence of haemolysis. Both IPOL and DTPa vaccines were given without incident; but his haemoglobin dropped to 7.0 g/dL and haemolysis was noted after the administration of the Hib vaccine. According to the authors this suggests that this vaccine was responsible for the initial episode so they plan to give him further Hib vaccine doses with steroid pre-treatment in the future. Author's conclusion: "We believe this case illustrates a novel method for not only confirming immunization associated AIHA but also isolating the causative vaccination".
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Coombs direct test positive, Faeces discoloured, Haemoglobin decreased, Haemolysis, Irritability
Clinical narrative: Case reference number B0984326A was reported in a literature article and refers to a 4-month-old male subject who developed autoimmune haemolytic anaemia shortly after receiving his four-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the subject's medical, family history or concurrent medication. A 4-month-old male subject was taken to a community hospital with a 2-day history of irritability, vomiting and dark stools shortly after receiving his 4-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the clinical examination performed on the subject. Blood analysis revealed initial haemoglobin of 2.7 g/dL so he was transferred to an academic centre. Once there he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Diagnosis was autoimmune vaccine-related haemolytic anaemia based on these results. Treatment consisted of oral corticosteroids. Outcome is improvement in his haemoglobin levels after treatment. The 6-month immunisations were given using a staggered approach that included serial full blood counts following each individual vaccine to monitor for evidence of haemolysis. Both IPOL and DTPa vaccines were given without incident; but his haemoglobin dropped to 7.0 g/dL and haemolysis was noted after the administration of the Hib vaccine. According to the authors this suggests that this vaccine was responsible for the initial episode so they plan to give him further Hib vaccine doses with steroid pre-treatment in the future. Author's conclusion: "We believe this case illustrates a novel method for not only confirming immunization associated AIHA but also isolating the causative vaccination".
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Vomiting
Clinical narrative: Case reference number B0984326A was reported in a literature article and refers to a 4-month-old male subject who developed autoimmune haemolytic anaemia shortly after receiving his four-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the subject's medical, family history or concurrent medication. A 4-month-old male subject was taken to a community hospital with a 2-day history of irritability, vomiting and dark stools shortly after receiving his 4-month immunisations including DTPa, Hib, rotavirus, pneumococcal conjugate and IPOL on an unspecified date (manufacturers, batch numbers, doses and injection sites unknown). No information has been provided on the clinical examination performed on the subject. Blood analysis revealed initial haemoglobin of 2.7 g/dL so he was transferred to an academic centre. Once there he had a weakly positive direct antiglobulin test with negative complement component 3 and immunoglobulin G. Further testing revealed immunoglobulin A mediated autoantibodies. Diagnosis was autoimmune vaccine-related haemolytic anaemia based on these results. Treatment consisted of oral corticosteroids. Outcome is improvement in his haemoglobin levels after treatment. The 6-month immunisations were given using a staggered approach that included serial full blood counts following each individual vaccine to monitor for evidence of haemolysis. Both IPOL and DTPa vaccines were given without incident; but his haemoglobin dropped to 7.0 g/dL and haemolysis was noted after the administration of the Hib vaccine. According to the authors this suggests that this vaccine was responsible for the initial episode so they plan to give him further Hib vaccine doses with steroid pre-treatment in the future. Author's conclusion: "We believe this case illustrates a novel method for not only confirming immunization associated AIHA but also isolating the causative vaccination".
Age: 4.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old, child patient. The patient's medical history and past drug history were unknown. On 08-APR-2014 the patient was accidentally vaccinated once with ZOSTAVAX, (lot # J012658, expiration date 10-JAN-2015), subcutaneously in the left arm instead of PROQUAD (Merck) as prescribed. The child will not receive another dose of ZOSTAVAX. Concomitant medications were not unknown. The outcome of receiving ZOSTAVAX instead of PROQUAD (Merck) was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a physician who is also the grandfather of the patient, regarding a 13 year old female patient with no pertinent medical history reported. Approximately in April 2009 (reported as about 5 years ago), the patient was vaccinated with the third dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). The dates of the first two doses were not specified. On an unknown date the patient experienced persistent headaches for a couple of weeks after receiving the third dose of GARDASIL. The patient recovered on an unspecified date. No treatment information was reported. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh with redness, itching, warm to touch, swelling at inj site. Size is 14 cm x 17 cm.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to an about 4 years old male patient who on an unknown date, at one year of age in 2011 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). At 2 years of age, on an unknown date in 2012, the patient developed shingles and then a second case of shingles was experienced at 3 years of age on an unknown date in 2013 (unspecified dates, but the patient was reported to be 4 years of age). At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for shingles and VARIVAX (Merck) was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were provided. On 27-MAR-2014, the patient was vaccinated with M-M-R II inj (dose, route and lot number not provided). No co-suspect or concomitant therapies were provided. On 27-MAR-2014, the patient was administered a dose of M-M-R II that was improperly stored. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Epistaxis, Nasal discharge discolouration, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a male consumer of unknown age. On 24-MAR-2013 (reported as a year ago) the patient was vaccinated with PNEUMOVAX 23 (Lot # not reported) (dose, route and frequency not reported). No other co suspects were reported. Concomitant therapies included PREVNAR 13. On an unknown date the patient experienced a green/yellow nasal discharge and bloody discharge from his nose. The outcome of he has green/yellow nasal discharge and bloody discharge from his nose was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Diarrhoea, Injection site rash, Rash vesicular, Viral rash
Clinical narrative: Initial information has been received from a physician via company representative refers to a 12 month old male patient with no drug reactions or allergies and no pertinent medical history. On 19-MAR-2014 the patient was vaccinated with dose of PROQUAD (thimerosal free) lot # J014235 expiration date 07-MAY-2015 dose and therapy route was not reported. There was no concomitant medication reported. On 29-MAR-2014 (ten days after vaccination) the patient had an adverse reaction to PROQUAD (Merck). The patient experienced diarrhea and viral like rash on the abdomen area. On approximately 01-APR-2014 (on day's 13 and 14 after vaccination) a zoster-like rash that was about the size of a half dollar appeared in the injection site.  The patient sought medical attention, saw the physician and none lab diagnostic studies was performed. The outcome of viral like rash on the abdomen area and the child had diarrhea was reported as recovered on approximately 01-APR-2014. The outcome of zoster like rash that was about the size of half dollar, was unknown. Unspecified antibiotic treatment for the adverse events was given. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of left upper arm, warm to touch, rash, redness.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Developed redness, itching in the afternoon vaccine given in a.m. Hard, warm to touch, redness to upper arm shot was given. Spreading at Urgent Care. Given ROCEPHIN for possible cellulitis at Urgent Care. Given BENADRYL, prednisone.
Age: 1.06
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site plaque, Injection site rash, Pyrexia, Somnolence
Clinical narrative: 12-mo imm. Given 03-26-14; Developed fever 102.6 on 4/05/14; Reported increased sleep 5 hours during day. Rash to (rt) arm began 04-09-14. Seen 4-09-14 at office -> 30 mm x 17 mm raised erythematous plaque around injection site on (rt) tx: APAP/MOTRIN PRN (Recommend giving MMR and varicella at 4-5 yr vac, - separately.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site macule, Injection site warmth
Clinical narrative: Rec'd KD imm on04-07-14. Seen for s/s in office on 04/10/14. 2" x 2 1/2" mild erythema with slight warmth and T.T.P macule on (lt) upper arm - afebrile. Tx with APAP/MOTRIN PRN and cool pack to site prn.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: On examination of right thigh: (+) swelling, no erythema, (+) slight tenderness. Subsequently left thigh: no swelling or tenderness noted. Gave diphenhydramine in office and ibuprofen at home.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain, Swelling
Clinical narrative: At 1:45 PM pt came in stating that since she got the Tdap vaccine per pt. it was swollen and hurting a lot. After swelling went down in x3 day then site of injection became itching/red burning like chile per pt. Pt was seen by Dr. and she was given antibiotic clindamycin HCl capsule 300 mg. four time a day 28 cap.
Age: 23.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Confusional state, Diarrhoea
Clinical narrative: Confusion, diarrhea.
Age: 0.43
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Flushing, Injection site bruising, Urticaria
Clinical narrative: Onset of hives about 4 hours after IZ's. Mom reports hives on head, body (Front and back) and under arm pits, but not on extremities. Advised by MD to given BENADRYL when triaged, but mom opted not give and says hives resolved on own. Little "Flushed" on 4/9, but no fever or other concerns. F/U phone call 4/10/14 all WNL, except little "bruise" at injection site.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Blindness, Confusional state, Diarrhoea, Dyspepsia
Clinical narrative: 3 hrs. after administration pt. experienced heartburn, vision loss, convulsions, stomach pain, diarrhea. Was taken by ambulance to hospital and received treatment to stop the reaction. Currently experiencing facial swelling, redness, fever and confusion.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pyrexia, Swelling face
Clinical narrative: 3 hrs. after administration pt. experienced heartburn, vision loss, convulsions, stomach pain, diarrhea. Was taken by ambulance to hospital and received treatment to stop the reaction. Currently experiencing facial swelling, redness, fever and confusion.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Pt. arrived today for an appt. Pt. explained that her (R) deltoid (upper extremity) had a reaction from vaccine. Area noted to be 50mm x 50mm (round and circular). Pt. denies pain. No fever/chills. Area noted to be pink, no evidence of cellulitis.