chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: DTP
Symptoms: Mycoplasma test, Oropharyngeal pain, Pertussis, Pyrexia, Rales
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 43-year-old male subject who was vaccinated with DTP (manufacturer unspecified), DTPa ((with small D + P), manufacturer unspecified). The subject was healthy. There was an outbreak of pertussis less than 20 miles away from subject's place. On unspecified dates, the subject received primary course of DTP (unknown route, injection site and batch number), booster dose of DTPa (with small D + P) (unknown route, injection site and batch number). At an unspecified time after vaccination with DTP, 1 year after vaccination with booster dose of DTPa (with small D + P), the subject presented to the emergency department with continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. He had previously been seen twice in his primary care provider's office with complaints of and an initial sore throat. After his first visit, he was thought to have a viral upper respiratory tract infection and was given supportive care. After 7 days, he was placed on prednisone and Albuterol for putative bronchospastic complications manifesting as occasional wheezing. The symptoms failed to improve requiring hospitalization for further management. The subject complained of dyspnea at rest and on exertion but denied hemoptysis or chest pain. An exam was notable for hypoxia (85% on room air) with dry rales and end-expiratory wheezing, without respiratory distress. Routine laboratory tests were unremarkable. The chest radiograph and computerized tomography scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated. The subject was diagnosed with pertussis which was considered as a vaccination failure. At the time of reporting the outcome of the events were resolved. Author's comment: despite advancements in vaccination, cases of pertussis are still seen sporadically in the adult population. In this case, despite a recent well-publicized outbreak less than 20 miles away, providers did not consider a vaccination failure due to this assumption, resulting in significant morbidity requiring hospitalization. Therefore, although rare, pertussis vaccination failure does occur, and should be considered in the workup for a coughing illness lasting more than 5 days, even without the classic whoop.
Age: 43.0
Sex: M
Vaccine: DTP
Symptoms: Vaccination failure, Viral upper respiratory tract infection, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of pertussis in a 43-year-old male subject who was vaccinated with DTP (manufacturer unspecified), DTPa ((with small D + P), manufacturer unspecified). The subject was healthy. There was an outbreak of pertussis less than 20 miles away from subject's place. On unspecified dates, the subject received primary course of DTP (unknown route, injection site and batch number), booster dose of DTPa (with small D + P) (unknown route, injection site and batch number). At an unspecified time after vaccination with DTP, 1 year after vaccination with booster dose of DTPa (with small D + P), the subject presented to the emergency department with continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. He had previously been seen twice in his primary care provider's office with complaints of and an initial sore throat. After his first visit, he was thought to have a viral upper respiratory tract infection and was given supportive care. After 7 days, he was placed on prednisone and Albuterol for putative bronchospastic complications manifesting as occasional wheezing. The symptoms failed to improve requiring hospitalization for further management. The subject complained of dyspnea at rest and on exertion but denied hemoptysis or chest pain. An exam was notable for hypoxia (85% on room air) with dry rales and end-expiratory wheezing, without respiratory distress. Routine laboratory tests were unremarkable. The chest radiograph and computerized tomography scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated. The subject was diagnosed with pertussis which was considered as a vaccination failure. At the time of reporting the outcome of the events were resolved. Author's comment: despite advancements in vaccination, cases of pertussis are still seen sporadically in the adult population. In this case, despite a recent well-publicized outbreak less than 20 miles away, providers did not consider a vaccination failure due to this assumption, resulting in significant morbidity requiring hospitalization. Therefore, although rare, pertussis vaccination failure does occur, and should be considered in the workup for a coughing illness lasting more than 5 days, even without the classic whoop.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Bronchospasm, Chest X-ray normal, Chlamydia test, Computerised tomogram normal
Clinical narrative: Initial literature report received from a healthcare professional on 25 January 2014. A-43-year-old otherwise healthy male patient had received a dose of TDAP (route, dose number route and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date (next year of vaccination), the patient presented to the Emergency Department (ED) with complaints of continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. It was reported that patient has been seen twice in his primary care provider's office with these complaints and an initial sore throat. After his first visit, he was thought to have a viral URI (upper respiratory tract infection) and received supportive care. On day 7, he was placed on prednisone and albuterol for putative bronchospastic complications manifesting as occasional wheezing. His symptoms failed to improve requiring admission for further management. Patient had dyspnea at rest and on exertion but denied hemoptysis or chest pain. His exam was notable for hypoxia (85% on Room Air) with dry rales and end expiratory wheezing, without respiratory distress. Routine lab work was unremarkable; chest radiograph and CT scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated, indicating a vaccine failure. Patient was successfully treated with Azithromycin. On an unspecified date, the patient had recovered from the events (successfully treated). Documents held by the sender none.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Dyspnoea, Dyspnoea exertional, Hypoxia, Laboratory test normal
Clinical narrative: Initial literature report received from a healthcare professional on 25 January 2014. A-43-year-old otherwise healthy male patient had received a dose of TDAP (route, dose number route and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date (next year of vaccination), the patient presented to the Emergency Department (ED) with complaints of continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. It was reported that patient has been seen twice in his primary care provider's office with these complaints and an initial sore throat. After his first visit, he was thought to have a viral URI (upper respiratory tract infection) and received supportive care. On day 7, he was placed on prednisone and albuterol for putative bronchospastic complications manifesting as occasional wheezing. His symptoms failed to improve requiring admission for further management. Patient had dyspnea at rest and on exertion but denied hemoptysis or chest pain. His exam was notable for hypoxia (85% on Room Air) with dry rales and end expiratory wheezing, without respiratory distress. Routine lab work was unremarkable; chest radiograph and CT scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated, indicating a vaccine failure. Patient was successfully treated with Azithromycin. On an unspecified date, the patient had recovered from the events (successfully treated). Documents held by the sender none.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Mycoplasma test, Oropharyngeal pain, Pyrexia, Rales, Vaccination failure
Clinical narrative: Initial literature report received from a healthcare professional on 25 January 2014. A-43-year-old otherwise healthy male patient had received a dose of TDAP (route, dose number route and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date (next year of vaccination), the patient presented to the Emergency Department (ED) with complaints of continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. It was reported that patient has been seen twice in his primary care provider's office with these complaints and an initial sore throat. After his first visit, he was thought to have a viral URI (upper respiratory tract infection) and received supportive care. On day 7, he was placed on prednisone and albuterol for putative bronchospastic complications manifesting as occasional wheezing. His symptoms failed to improve requiring admission for further management. Patient had dyspnea at rest and on exertion but denied hemoptysis or chest pain. His exam was notable for hypoxia (85% on Room Air) with dry rales and end expiratory wheezing, without respiratory distress. Routine lab work was unremarkable; chest radiograph and CT scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated, indicating a vaccine failure. Patient was successfully treated with Azithromycin. On an unspecified date, the patient had recovered from the events (successfully treated). Documents held by the sender none.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Viral upper respiratory tract infection, Wheezing
Clinical narrative: Initial literature report received from a healthcare professional on 25 January 2014. A-43-year-old otherwise healthy male patient had received a dose of TDAP (route, dose number route and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date (next year of vaccination), the patient presented to the Emergency Department (ED) with complaints of continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. It was reported that patient has been seen twice in his primary care provider's office with these complaints and an initial sore throat. After his first visit, he was thought to have a viral URI (upper respiratory tract infection) and received supportive care. On day 7, he was placed on prednisone and albuterol for putative bronchospastic complications manifesting as occasional wheezing. His symptoms failed to improve requiring admission for further management. Patient had dyspnea at rest and on exertion but denied hemoptysis or chest pain. His exam was notable for hypoxia (85% on Room Air) with dry rales and end expiratory wheezing, without respiratory distress. Routine lab work was unremarkable; chest radiograph and CT scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated, indicating a vaccine failure. Patient was successfully treated with Azithromycin. On an unspecified date, the patient had recovered from the events (successfully treated). Documents held by the sender none.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Coordination abnormal, Paraesthesia, Vision blurred
Clinical narrative: Tingling to (L) side face and shoulder with blurred vision and temporary decreased motor coordination (L) arm and leg. Symptoms lasted approx. 1 hour.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site rash
Clinical narrative: Child began to have erythema at injection site with rash noted by mother around 9:00PM on 2/4/2014. Mother brough child to the office at 1:00PM on 2/5/2014. Child had nodule noted under injection site on outer left deltoid. Left arm also had erythema present at the injection site and extended approximate 3 inches below the injection site.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Myalgia, Swelling
Clinical narrative: C/o redness, tenderness, inflammation at site of injection (right deltoid) hours after vaccination which worsen and spread to almost the whole right arm in 2 days. Also c/o pain the the muscle, which is getting better. Went to her MD and was told either reaction or infection from vaccine. Was prescribed Cephalexin, Benadryl, and ice. Pt reported looking swelling and redness went down substantially after 3 days on the antibiotic.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Grand mal convulsion, Hypertension, Pain in extremity, Paraesthesia
Clinical narrative: Vomiting, diarrhea 11/1/2013; bilateral fingertip and toe tingling/pain 1/16/2014; hypertension 1/26/2013, generalized tonic-clonic seizures x3 1/28/2013.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea 11/1/2013; bilateral fingertip and toe tingling/pain 1/16/2014; hypertension 1/26/2013, generalized tonic-clonic seizures x3 1/28/2013.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Record indicated that patient was due for DTP, HAV, and HPV. Dose #7 (given on 7/3/13) was listed as incorrect spacing, and another dose was due on 2/5/14. Vaccine was administered and found on 2/6/14 that record indicating incorrect spacing was wrong. Dose given on 2/5/14 for Tdap was not needed. Record took dose given on 2/5/14 as valid.
Age: 16.0
Sex: F
Vaccine: HEPAB, MMR, TDAP, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye discharge, Eye swelling, Pain
Clinical narrative: Patient reported sudden-onset of violent coughing, generalized body aches, chills, fever, runny nose, swollen eyes with greenish discharge at approximately 9 PM on 2/5/14, approx 5 hrs after flu vaccine administration.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Patient reported sudden-onset of violent coughing, generalized body aches, chills, fever, runny nose, swollen eyes with greenish discharge at approximately 9 PM on 2/5/14, approx 5 hrs after flu vaccine administration.
Age: 0.19
Sex: F
Vaccine: DTAPH, HEP, IPV, RVX
Symptoms: Erythema, Irritability, Urticaria
Clinical narrative: Hives, redness, fussiness.
Age: 6.0
Sex: M
Vaccine: DTAP, FLUN4, HEPA, MMR, VARCEL
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Warm to the touch, slightly raised and approximately 25mm redness. Continued to get worse. Pt brought back to HD where swelling and redness of Left arm was 75 X 80 mm, and itchy. Recommended Benadryl and cold compress per FNP. Advised to return if worsens.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site rash, Rash
Clinical narrative: Pt has a rash leading from small pox vaccination (left upper arm) across the front of his shoulder and up to the base of the left side neck.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Rash, Swelling
Clinical narrative: Spreading rash with swelling, heat, and severe itching.
Age: 28.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Back pain, Blood test, Chest X-ray, Chest discomfort, Computerised tomogram head
Clinical narrative: Dizziness 24/7, nausea, can't focus, neck and back pain, swollen lymph nodes, vomiting, light headed, headaches, chest pressure, heart palpitations, confusion, fatigue, severe allergic reaction on face and body.
Age: 28.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Confusional state, Disturbance in attention, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness 24/7, nausea, can't focus, neck and back pain, swollen lymph nodes, vomiting, light headed, headaches, chest pressure, heart palpitations, confusion, fatigue, severe allergic reaction on face and body.
Age: 28.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Hypersensitivity, Lymphadenopathy, Nausea, Neck pain, Palpitations
Clinical narrative: Dizziness 24/7, nausea, can't focus, neck and back pain, swollen lymph nodes, vomiting, light headed, headaches, chest pressure, heart palpitations, confusion, fatigue, severe allergic reaction on face and body.
Age: 28.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: Dizziness 24/7, nausea, can't focus, neck and back pain, swollen lymph nodes, vomiting, light headed, headaches, chest pressure, heart palpitations, confusion, fatigue, severe allergic reaction on face and body.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chest X-ray normal, Febrile convulsion, Full blood count normal, Laboratory test normal
Clinical narrative: TC from MD @ ER. Child w/febrile seizure today for mother at home. 1 min tonic/clonic movement-child noted to be warm T-102.5. ER Dr did CXR, CBC, RSV, RIFA, QS all WNL. Child initially somnolent though improving. Given Tylenol prn and temp down to 100.4. Will observe until neurologically at baseline but will have mother continue to give antipyretics & observe. Sounds like simple febrile sz which pt has had in previously.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Respiratory syncytial virus test negative, Skin warm, Somnolence, Tonic clonic movements
Clinical narrative: TC from MD @ ER. Child w/febrile seizure today for mother at home. 1 min tonic/clonic movement-child noted to be warm T-102.5. ER Dr did CXR, CBC, RSV, RIFA, QS all WNL. Child initially somnolent though improving. Given Tylenol prn and temp down to 100.4. Will observe until neurologically at baseline but will have mother continue to give antipyretics & observe. Sounds like simple febrile sz which pt has had in previously.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Pt pulled arm away from nurse as vaccine was being given. Mother reports arm red, swollen and sore, no fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL, DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Bilateral eye swelling; difficulty breathing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL, DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Eyelid oedema, Flushing, Hyperhidrosis, Nasal congestion
Clinical narrative: Bilateral eye swelling; difficulty breathing.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Transient ischaemic attack
Clinical narrative: Patient said he had several TIAs starting the next day.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Angiogram normal, Blood test, Chest X-ray normal, Computerised tomogram normal, Convulsion
Clinical narrative: Onset Seizure. 7 seizures in 6 months .... mostly grand mal. All imaging normal. No past health history or family history.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Electrocardiogram, Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging normal, Urine analysis
Clinical narrative: Onset Seizure. 7 seizures in 6 months .... mostly grand mal. All imaging normal. No past health history or family history.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Venogram normal
Clinical narrative: Onset Seizure. 7 seizures in 6 months .... mostly grand mal. All imaging normal. No past health history or family history.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Blood culture, Body temperature increased, C-reactive protein, Chest X-ray, Erythema
Clinical narrative: Within 24 hours post vaccination patient presented to ER with elevated temp and developed redness exceeding 6 inches.  Patient hospitalized for sepsis and pneumonitis. Vaccine Coordinator and the directors of Pharmacy and Outpatient notified. Discussion with physician ensued. Data base updated.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Full blood count, Metabolic function test, Pneumonitis, Sepsis, Urine analysis
Clinical narrative: Within 24 hours post vaccination patient presented to ER with elevated temp and developed redness exceeding 6 inches.  Patient hospitalized for sepsis and pneumonitis. Vaccine Coordinator and the directors of Pharmacy and Outpatient notified. Discussion with physician ensued. Data base updated.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Blood culture, Blood magnesium, Body temperature increased, C-reactive protein, Chest X-ray
Clinical narrative: Within 24 hours post vaccination patient presented to ER with elevated temp and developed redness exceeding 6 inches.  Patient hospitalized for sepsis and pneumonitis. Vaccine Coordinator and the directors of Pharmacy and Outpatient notified. Discussion with physician ensued. Data base updated.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Full blood count, Injection site erythema, Injection site warmth, Metabolic function test, Urine analysis
Clinical narrative: Within 24 hours post vaccination patient presented to ER with elevated temp and developed redness exceeding 6 inches.  Patient hospitalized for sepsis and pneumonitis. Vaccine Coordinator and the directors of Pharmacy and Outpatient notified. Discussion with physician ensued. Data base updated.
Age: 5.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Dyspnoea, Pruritus generalised, Rash, Urticaria
Clinical narrative: Started out as a rash then turned into hives all over body, difficulty breathly and itchy all over.
Age: 5.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Dysphagia, Pruritus, Rash, Urticaria
Clinical narrative: Started out as a rash then turned into hives all over body, difficulty breathly and itchy all over.
Age: 1.06
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Hypersensitivity, Immediate post-injection reaction, Oedema, Rash vesicular
Clinical narrative: Immediate hypersensitivity reaction with erythema and edema approximately 10cm oval in shape. Urticaria, 3cm on left leg, blister-like appearance.
Age: 1.06
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Immediate hypersensitivity reaction with erythema and edema approximately 10cm oval in shape. Urticaria, 3cm on left leg, blister-like appearance.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pharyngeal oedema
Clinical narrative: Pt states she had flu shot 2yrs ago with no adverse rxns, temp WNL, immunization given to Left Deltoid IM. Pt states 5 min later feeling throat is swelling and feeling flushed. Kenalog 40mg IM given at 7: 52pm and pt took Benadryl 25mg po at 1958. VSS. Pt monitored x 28min, pt states feeling better, NAD, pt assessed and exam WNL, VSS.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: Chest pain, shortness of breath, dizziness, headaches, fever, nausea, lethargic. Took to urgent care where an EKG test, mono test, flu test, strep test all completed and were negative. Headaches have been ongoing and random since the first of three injections was administered. Other symptoms happened after last and final injection took place.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Influenza virus test negative, Lethargy, Mononucleosis heterophile test negative, Nausea, Pyrexia
Clinical narrative: Chest pain, shortness of breath, dizziness, headaches, fever, nausea, lethargic. Took to urgent care where an EKG test, mono test, flu test, strep test all completed and were negative. Headaches have been ongoing and random since the first of three injections was administered. Other symptoms happened after last and final injection took place.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Streptococcus test negative
Clinical narrative: Chest pain, shortness of breath, dizziness, headaches, fever, nausea, lethargic. Took to urgent care where an EKG test, mono test, flu test, strep test all completed and were negative. Headaches have been ongoing and random since the first of three injections was administered. Other symptoms happened after last and final injection took place.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache, muscle aches, fatigue.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO ADVERSE EVENT.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Injection site urticaria
Clinical narrative: Patient developed hives all over legs, where vaccine was administered ((L) leg) but spread to both. Mild hives on face. Cried for 30 minutes. Waited in office x 45 mins. monitored, prescribed BENADRYL to take home by the time he left, hives were gone.
Age: 15.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, VARCEL
Symptoms: Presyncope, Rash erythematous, Rash pruritic
Clinical narrative: Client had vasovagal response after vaccines were given which lasted a few seconds. 5-10 minutes later developed itchy red rash on arms, legs, and torso. Given 50mg BENADRYL by mouth observed client for 45 minutes. Rash resolved, no respiratory problems.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Diagnosed with cellulitis of right leg at vaccine injection site. Treated in ER and given Rx for BACTRIM 40-200mg/5ml oral suspension. Take 2.5 ml orally every 12 hours for 10 days.
Age: 0.85
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.13
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Irritability, Pyrexia, Vomiting, Weight bearing difficulty
Clinical narrative: MMR/Varicella (PROQUAD), PREVNAR, HIB, HEP A given 2/4/14 at 1:53 PM. Patient had fever 103, emesis and irritability. No weight bearing that day. Was sent to ER. Given ZOFRAN and MOTRIN. Symptoms continued. Fever 103-104 into 206/14. Fluids advised and alternate Ibup and Acetaminophen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Unknown, info given by PDM, patient was unable to be contacted.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction Rt arm, approx 3" x 5". Taking BENADRYL and icing. Started evening of 2/5 then increased from quarter-size to present.
Age: 45.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event is known to have occurred. However, we are submitting this report b/c the patient was 45 y/o at time of vaccination, and the FDA approved age limit is 50 y/o or above. The age was missed at time of vaccination and was later brought to our attention by her primary physician. The patient is fine and to our knowledge had no AEs. She asked for the ZOSTAVAX and flu vaccines and received them the same day as her husband.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via a representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, expiry, dose and route not reported). On an unknown date, the patient experienced rash across the face area. The patient sought medical attention via office visit. The outcome of rash across the face area was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Dyspnoea, Muscular weakness, Myalgia, Palpitations
Clinical narrative: Information has been received from a third party claims administrator, concerning a male (age unknown) who on 05-JAN-2014, was vaccinated with a dose of PNEUMOVAX23 lot # J009827 expiration date 10-AUG-2014. The patient sustained an adverse/allergic reaction. It was unknown if the patient sought medical attention. At the time of this reporting, the outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV, PPV
Symptoms: Adverse reaction, Hypersensitivity
Clinical narrative: Information has been received from a third party claims administrator, concerning a male (age unknown) who on 05-JAN-2014, was vaccinated with a dose of PNEUMOVAX23 lot # J009827 expiration date 10-AUG-2014. The patient sustained an adverse/allergic reaction. It was unknown if the patient sought medical attention. At the time of this reporting, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age referring to herself. The patient has no relevant medical history or concomitant medications. The patient was vaccinated with VARIVAX (Merck) 1 vaccine (lot# and expiry date was not reported) on an unknown date in September 2013. Her past drug history was unknown. On 20-DEC-2013, she had her menses that lasted until 23-DEC-2013. On 30-DEC-2013, she had another VARIVAX (Merck) 2 injection. On 17-JAN-2014, the patient had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks. Also on 17-JAN-2014, the patient had an ultrasound showing the tubes were clear and a small sac but too early to see anything. The patient became pregnant with last menstrual period of 20-DEC-2013 and estimated delivery date of 26-SEP-2014. The outcome of possible exposure in utero was unknown. It was unknown if patient had received any additional VARIVAX (Merck) vaccine. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age referring to herself. The patient has no relevant medical history or concomitant medications. The patient was vaccinated with VARIVAX (Merck) 1 vaccine (lot# and expiry date was not reported) on an unknown date in September 2013. Her past drug history was unknown. On 20-DEC-2013, she had her menses that lasted until 23-DEC-2013. On 30-DEC-2013, she had another VARIVAX (Merck) 2 injection. On 17-JAN-2014, the patient had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks. Also on 17-JAN-2014, the patient had an ultrasound showing the tubes were clear and a small sac but too early to see anything. The patient became pregnant with last menstrual period of 20-DEC-2013 and estimated delivery date of 26-SEP-2014. The outcome of possible exposure in utero was unknown. It was unknown if patient had received any additional VARIVAX (Merck) vaccine. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Chills, Nasopharyngitis, Odynophagia, Oropharyngeal pain, Pyrexia
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pains, headaches.
Age: 59.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Respiratory tract congestion, Sinusitis, Sneezing
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pains, headaches.
Age: 59.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Blood glucose decreased, Chills, Cough, Dehydration, Eye pruritus
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pains, headaches.
Age: 59.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Headache, Hyperhidrosis, Myalgia, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pains, headaches.
Age: 59.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Painful respiration, Pneumonia, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pains, headaches.
Age: 60.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Chills, Nasopharyngitis, Odynophagia, Oropharyngeal pain, Pyrexia
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pain, headaches.
Age: 60.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Respiratory tract congestion, Sinusitis, Sneezing
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pain, headaches.
Age: 60.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Blood glucose decreased, Chills, Cough, Dehydration, Eye pruritus
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pain, headaches.
Age: 60.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Headache, Hyperhidrosis, Myalgia, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pain, headaches.
Age: 60.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Painful respiration, Pneumonia, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Very painful breathing, coughing and severe cold, sore throat, runny nose, congested, fever, itchy eyes, pneumonia, chills and sweats, muscle aches and pain, headaches.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Asthma, Cough, Dyspnoea, Respiratory distress
Clinical narrative: This spontaneous consumer report (initial receipt 27-Jan-2014) concerns a 64-year-old female patient who had a medical history of high blood pressure, irritable bowel syndrome and was diabetic. The patient also had drug reactions/allergies to morphine and DARVOCET N-100. Her concomitant medications included SINGULAIR, fluticasone propionate, montelukast, salbutamol sulfate and mometasone/formoterol. On 10-Nov-2013, the patient received unspecified flu vaccine (manufacturer and lot number not reported) and unspecified pneumonia vaccine. The following Sunday (17-Nov-2013), the patient experienced severe cough with respiratory distress which caused her difficulty in breathing. Eventually the patient was hospitalised in an unspecified hospital over Christmas for 3 days. The patient used a nebulizer with an unspecified medication to help treat her condition while she was in hospital. She reported that her physician stated that her lungs indicated that she had a severe asthma attack. In Dec 2013, the patient commenced DULERA (inhaler, batch number: J009985, expiry date: Feb-2016) for allergies and asthma. On an unspecified date, her DULERA unit stopped spraying and therefore she missed an unspecified number of doses which caused her to have an asthma attack on 25-Jan-2014. The patient stated that she 'felt weird' and was coughing from morning until night. Outcome was not reported.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Asthma, Cough, Dyspnoea, Feeling abnormal, Respiratory distress
Clinical narrative: This spontaneous consumer report (initial receipt 27-Jan-2014) concerns a 64-year-old female patient who had a medical history of high blood pressure, irritable bowel syndrome and was diabetic. The patient also had drug reactions/allergies to morphine and DARVOCET N-100. Her concomitant medications included SINGULAIR, fluticasone propionate, montelukast, salbutamol sulfate and mometasone/formoterol. On 10-Nov-2013, the patient received unspecified flu vaccine (manufacturer and lot number not reported) and unspecified pneumonia vaccine. The following Sunday (17-Nov-2013), the patient experienced severe cough with respiratory distress which caused her difficulty in breathing. Eventually the patient was hospitalised in an unspecified hospital over Christmas for 3 days. The patient used a nebulizer with an unspecified medication to help treat her condition while she was in hospital. She reported that her physician stated that her lungs indicated that she had a severe asthma attack. In Dec 2013, the patient commenced DULERA (inhaler, batch number: J009985, expiry date: Feb-2016) for allergies and asthma. On an unspecified date, her DULERA unit stopped spraying and therefore she missed an unspecified number of doses which caused her to have an asthma attack on 25-Jan-2014. The patient stated that she 'felt weird' and was coughing from morning until night. Outcome was not reported.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Arthralgia, Asthenia, Asthma, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This spontaneous consumer report (initial receipt 27-Jan-2014) concerns a 64-year-old female patient who had a medical history of high blood pressure, irritable bowel syndrome and was diabetic. The patient also had drug reactions/allergies to morphine and DARVOCET N-100. Her concomitant medications included SINGULAIR, fluticasone propionate, montelukast, salbutamol sulfate and mometasone/formoterol. On 10-Nov-2013, the patient received unspecified flu vaccine (manufacturer and lot number not reported) and unspecified pneumonia vaccine. The following Sunday (17-Nov-2013), the patient experienced severe cough with respiratory distress which caused her difficulty in breathing. Eventually the patient was hospitalised in an unspecified hospital over Christmas for 3 days. The patient used a nebulizer with an unspecified medication to help treat her condition while she was in hospital. She reported that her physician stated that her lungs indicated that she had a severe asthma attack. In Dec 2013, the patient commenced DULERA (inhaler, batch number: J009985, expiry date: Feb-2016) for allergies and asthma. On an unspecified date, her DULERA unit stopped spraying and therefore she missed an unspecified number of doses which caused her to have an asthma attack on 25-Jan-2014. The patient stated that she 'felt weird' and was coughing from morning until night. Outcome was not reported.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Cough, Dermatitis contact, Dyspnoea, General physical condition abnormal, Malaise
Clinical narrative: This spontaneous consumer report (initial receipt 27-Jan-2014) concerns a 64-year-old female patient who had a medical history of high blood pressure, irritable bowel syndrome and was diabetic. The patient also had drug reactions/allergies to morphine and DARVOCET N-100. Her concomitant medications included SINGULAIR, fluticasone propionate, montelukast, salbutamol sulfate and mometasone/formoterol. On 10-Nov-2013, the patient received unspecified flu vaccine (manufacturer and lot number not reported) and unspecified pneumonia vaccine. The following Sunday (17-Nov-2013), the patient experienced severe cough with respiratory distress which caused her difficulty in breathing. Eventually the patient was hospitalised in an unspecified hospital over Christmas for 3 days. The patient used a nebulizer with an unspecified medication to help treat her condition while she was in hospital. She reported that her physician stated that her lungs indicated that she had a severe asthma attack. In Dec 2013, the patient commenced DULERA (inhaler, batch number: J009985, expiry date: Feb-2016) for allergies and asthma. On an unspecified date, her DULERA unit stopped spraying and therefore she missed an unspecified number of doses which caused her to have an asthma attack on 25-Jan-2014. The patient stated that she 'felt weird' and was coughing from morning until night. Outcome was not reported.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV, FLU3, PPV
Symptoms: Respiratory distress, Respiratory tract congestion, Type 1 diabetes mellitus
Clinical narrative: This spontaneous consumer report (initial receipt 27-Jan-2014) concerns a 64-year-old female patient who had a medical history of high blood pressure, irritable bowel syndrome and was diabetic. The patient also had drug reactions/allergies to morphine and DARVOCET N-100. Her concomitant medications included SINGULAIR, fluticasone propionate, montelukast, salbutamol sulfate and mometasone/formoterol. On 10-Nov-2013, the patient received unspecified flu vaccine (manufacturer and lot number not reported) and unspecified pneumonia vaccine. The following Sunday (17-Nov-2013), the patient experienced severe cough with respiratory distress which caused her difficulty in breathing. Eventually the patient was hospitalised in an unspecified hospital over Christmas for 3 days. The patient used a nebulizer with an unspecified medication to help treat her condition while she was in hospital. She reported that her physician stated that her lungs indicated that she had a severe asthma attack. In Dec 2013, the patient commenced DULERA (inhaler, batch number: J009985, expiry date: Feb-2016) for allergies and asthma. On an unspecified date, her DULERA unit stopped spraying and therefore she missed an unspecified number of doses which caused her to have an asthma attack on 25-Jan-2014. The patient stated that she 'felt weird' and was coughing from morning until night. Outcome was not reported.
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure to product, Eye irritation, Eye pruritus
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 40 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 23-JAN-2014 the patient's child was vaccinated with a dose of M-M-R II (lot# unspecified) (dose, location unspecified). The nurse reported that the mother of the child was inadvertently splashed in the right eye with M-M-R II on 23-JAN-2014. The child who vaccinated struggled during the attempted administration of M-M-R II and the needle disengaged from the syringe. The mother's eye was immediately flushed with water. The mother had experienced burning, irritation and itching of the right eye and she was scheduled to be evaluated by an unspecified optometrist on 05-FEB-2014. No concomitant medication was reported. The patient had sought medical attention in office. No treatment was given for the burning, irritation and itching of the right eye. No lab diagnostics studies performed. At the time of the event, the outcome of the events was not recovered. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irritation, Eye pruritus
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 40 years old female patient. The patient had no pertinent medical history and drug reactions/allergies. On 23-JAN-2014 the patient's child was vaccinated with a dose of M-M-R II (lot# unspecified) (dose, location unspecified). The nurse reported that the mother of the child was inadvertently splashed in the right eye with M-M-R II on 23-JAN-2014. The child who vaccinated struggled during the attempted administration of M-M-R II and the needle disengaged from the syringe. The mother's eye was immediately flushed with water. The mother had experienced burning, irritation and itching of the right eye and she was scheduled to be evaluated by an unspecified optometrist on 05-FEB-2014. No concomitant medication was reported. The patient had sought medical attention in office. No treatment was given for the burning, irritation and itching of the right eye. No lab diagnostics studies performed. At the time of the event, the outcome of the events was not recovered. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL, DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Puffy eye lids, nasal congestion, flushed face, sweaty.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL, DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Eyelid oedema, Flushing, Hyperhidrosis, Nasal congestion
Clinical narrative: Puffy eye lids, nasal congestion, flushed face, sweaty.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Swelling, induration, itching and skin rash in the entire deltoid muscle.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Limb discomfort, Local reaction, Skin warm
Clinical narrative: MOC stated child c/o LA discomfort since the night of vaccination. She states that upper LA has two areas (one golf ball size, the other tennis ball size) that are red and warm to the touch. She states that this local reaction has progressively become more pronounced. Vaccines may have been given in opposite arms to what is noted below per MOC comment.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 87 year old female patient. On 12-JAN-2014 the patient was vaccinated with a dose of ZOSTAVAX, lot # J008432, expiry date 11-OCT-2014, 0.65 ml, subcutaneous. No concomitant medication, pertinent medical history, drug reactions or allergies were reported. On an unknown date in 2014, the patient developed a varicella like rash on her face. The rash was on one side of her face and continued up onto her scalp. She stated that the rash was vesicular, but did not report that it was painful. She told the pharmacist that the lesions had crusted over, and was beginning to heal. He stated that the patient had not seen a physician concerning this rash. No treatment was given for adverse event. The patient called the pharmacist to seek medical attention. No lab diagnostics studies were performed. The action taken of the therapy also reported as continued. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. A patient received ZOSTAVAX on an unspecified date approximately one week ago (approximately 16-JAN-2014) (strength, dose, frequency, route, lot # and indication were not provided) and now needed to take a tapering dose prednisone starting from 60mg for 16 days. The outcome of the event was unknown. Additional information has been requested.