chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Infection, Nodule, Oedema peripheral, X-ray normal
Clinical narrative: Report received from a consumer on 11-OCT-2010 (received via Merck WAES: 1010USA01212). An 83 year old female patient received one dose of Influenza vaccine (brand unknown, batch number: unknown, expiry date: unknown, route of administration: not specified) in the left arm for immunisation on an unspecified date. The patient has a medical history of hypertension, mild arthritis and had a left hip replacement in September 2010. Concomitant medications included lisinopril and CELEBREX. Dose/ route of administration and indications of concomitant medication not specified. On an unspecified date, after receiving influenza vaccination with the suspect drug, the patient developed swelling and a 'knot' in her lower left leg. The patient sought medical attention. She was evaluated in the emergency room and diagnosed with an infection in her left leg. The patient was treated with ciprofloxacin (manufacturer unknown). X-rays of her left leg was negative for blood clot. The patient's outcome was recovering at the time of reporting. No other information is available at this time. The case was reported as non-serious. The reporter did not provide a causality assessment in relation to the suspect drug. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Age: 1.5
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Report received from a medical assistant on 13-OCT-2010 (received via Merck WAES: 1010USA01621). An 18 month old child (initials unknown, date of birth unknown) received a 0.5ml dose of AFLURIA (batch unknown) on an unknown date. The patient's medical history and concomitant medications were unknown. The patient did not die. The event outcome was unknown. No other information was provided. The reporter did not give a causality assessment. The case was reported as non-serious. The company considered events unassessable. Information derived from this AE report does not change the current safety profile of the product.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Report received from a pharmacist on 12-OCT-2010 (receive via Merck WAES: 1010USA01399). A 59 year-old female patient received AFLURIA (dose 0.5cc; intramuscularly; Lot# M51908) for immunization on 11-OCT-2010 10:30. The patient had no pertinent medical history or concomitant medications. On 11-OCT-2010 10:35, five minutes after AFLURIA was administered, the patient developed itching at the site of the injection. At 11:00, the patient had inflammation including redness and itching around injection site. Within 1 hour she noted bruising, redness, swelling and the area was warm to touch. The patient notified the pharmacist of the symptoms and he evaluated the injection site on 12-OCT-2010, reporting that the symptoms were still present. On 14-OCT-2010, the patient was considered to have recovered from the events. The case was reported as non-serious. The reporter considered events possible in relation to the suspect drug, AFLURIA. The company considered events non serious and possible in relation to AFLURIA. Information derived from this AE report does not change the current safety profile of the product. Follow-up (07-Dec-2010): time of injection, time to event onset, additional adverse event (inflammation around injection site), patient outcome, date of recovery.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Report received from a pharmacist on 12-OCT-2010 (receive via Merck WAES: 1010USA01399). A 59 year-old female patient received AFLURIA (dose 0.5cc; intramuscularly; Lot# M51908) for immunization on 11-OCT-2010 10:30. The patient had no pertinent medical history or concomitant medications. On 11-OCT-2010 10:35, five minutes after AFLURIA was administered, the patient developed itching at the site of the injection. At 11:00, the patient had inflammation including redness and itching around injection site. Within 1 hour she noted bruising, redness, swelling and the area was warm to touch. The patient notified the pharmacist of the symptoms and he evaluated the injection site on 12-OCT-2010, reporting that the symptoms were still present. On 14-OCT-2010, the patient was considered to have recovered from the events. The case was reported as non-serious. The reporter considered events possible in relation to the suspect drug, AFLURIA. The company considered events non serious and possible in relation to AFLURIA. Information derived from this AE report does not change the current safety profile of the product. Follow-up (07-Dec-2010): time of injection, time to event onset, additional adverse event (inflammation around injection site), patient outcome, date of recovery.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This medically confirmed spontaneous report (initial receipt 12-OCT-2010) concerns a 32-year-old female. On 11-OCT-2010 10:30, the patient received AFLURIA (Lot# M51908) at a dose of 0.5 cc intramuscularly for immunization. On 11-OCT-2010 11:00, thirty minutes after AFLURIA was administered, the patient developed inflammation around the injection site. The site was red, swollen and painful. The area was warm to the touch. On 14-OCT-2010, the patient was considered to have recovered from the events. The reporter considered events non serious. Follow up 1 (07-DEC-2010): additional adverse events, event outcome, listedness changed to unlisted, narrative added.
Sex: F
Vaccine: FLU3
Symptoms: Head discomfort, Nausea, Vomiting
Clinical narrative: Report received from a pharmacist on 14-OCT-2010 (via distributor 1010USA01788). A female patient (unknown age/date of birth) received a 0.5ml dose of AFLURIA (Lot#M52508, EXP: 30-JUN-2011) via intramuscular administration for immunization on 14-OCT-2010. The patient had no pertinent medical history or drug reactions/allergies. On 14-OCT-2010 (unknown time to event onset), the same day after receiving AFLURIA, the patient developed nausea and vomiting and reporting that her head felt "weird". Treatment medication was not reported. At the time of reporting the patient had not recovered from the events. No further information at this time. The case was reported as non-serious. The reporter did not provide a causality assessment in relation to the suspect drug, AFLURIA. The company considered events non-serious and possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product. Data entry correction (10-DEC-2010): country changed.
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Rash on shoulder and neck.
Sex: F
Vaccine: FLU3
Symptoms: Heart rate increased, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Report received from a nurse on 20-OCT-2010 (via License partner: 1010USA02642). An approximately 30 year old female patient (date of birth: unknown) received AFLURIA on 11-SEP-2010 for indication 'to administer for flu vaccine'. Batch number and details are unknown. It is unknown if the patient had a medical history or was taking concomitant medications. On 11-SEP-2010, the same day as vaccination with AFLURIA, the patient experienced a rapid heart rate, 101 degree fever, sweating and was really sore. The patient sought attention however treatment was unspecified. The patient outcome was reported as recovered with date unspecified. The company considered events possible to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in left deltoid.
Age: 1.28
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 18 cases received during the surveillance period from 01 January 2010 to 03 May 2011. Initial report received on 03 May 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a male subject (initials not collected), who was approximately 35 months of age, was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included one dose of DAPTACEL; lot number C3082AA received on 03 July 2009, one dose of PENTACEL, lot number C3174AA received on 08 October 2008, two dose of DAPTACEL, lot number C2956BA received on 08 August 2008 and lot number C2953AA received on 30 May 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms on an unspecified date, and on 07 March 2011, approximately 20 months after the last dose, developed a cough. On 09 March 2011, the subject developed a paroxysmal cough with no whoop and no posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 07 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 April 2011 for five days. The subject was not hospitalized. At the time of final contact on 28 April 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 52 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 18 cases received during the surveillance period from 01 January 2010 to 03 May 2011. Initial report received on 03 May 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a male subject (initials not collected), who was approximately 35 months of age, was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included one dose of DAPTACEL; lot number C3082AA received on 03 July 2009, one dose of PENTACEL, lot number C3174AA received on 08 October 2008, two dose of DAPTACEL, lot number C2956BA received on 08 August 2008 and lot number C2953AA received on 30 May 2008 (routes and sites of administration not reported). The subject developed cold-like symptoms on an unspecified date, and on 07 March 2011, approximately 20 months after the last dose, developed a cough. On 09 March 2011, the subject developed a paroxysmal cough with no whoop and no posttussive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 07 April 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 07 April 2011 for five days. The subject was not hospitalized. At the time of final contact on 28 April 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 52 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Varicella vaccine given SQ left arm 4-25-11. Went to MD 4-27-11 for c/o redness, swelling, and soreness. Assessed by Dr. and APRN. Recommended cold compresses and BENADRYL cream or hydrocortisone cream.
Age: 0.8
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given Rotarix on 5-18-11, 2nd dose, at 9 months of age.
Age: 16.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Herpes zoster, Pain, Rash vesicular, Varicella virus test positive, Viral test positive
Clinical narrative: Painful vesicular rash in a dermatomal distribution (looks like shingles). Patient had been symptomatic for one week, no treatment given.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Left deltoid red, swollen and warm to touch, "has fever in it" per mom.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound antenatal screen normal, Vaginal haemorrhage
Clinical narrative: Information has been received from a medical assistant for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient with no allergies or drug reactions and no pertinent medical history who on 01-MAR-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, subcutaneously (lot number 666121/1778Y, Exp:19-AUG-2012). Concomitant therapy included prenatal vitamins (not specified), fish oil and ZOFRAN. It was reported that the patient did not receive any concomitant vaccinations at that time. On 02-MAR-2011, the patient became pregnant her EDD (estimated delivery date) was estimated to be on 07-DEC-2011. On 11-MAY-2011, the patient experienced "spotting", the patient was assessed in the emergency room and an ultrasound confirmed a viable fetus with an audible heartbeat. The medical assistant reported that the patient came to the physician's office on 13-MAY-2011, because the patient was experiencing continued "spotting" and the patient "miscarried". The medical assistant stated that no treatment was commenced for the miscarriage. At the time of the report the patient was recovering, it was stated that the patient had recovered from the miscarriage. Upon internal review, miscarried was determined to be an other important medical event. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Blood test, Cryotherapy, Suicidal ideation
Clinical narrative: Information has been received from a 23 year old female consumer, who in January 2009, was vaccinated by injection with GARDASIL (dose and frequency was noted as unspecified and third dose). In August 2009, the patient reported she "started getting genital warts" after her third dose of GARDASIL. She also reported suicidal thoughts after these effects. The patient sought medical attention. She was not hospitalized. She reported receiving treatment by having the genital warts frozen off. She also had "blood test" performed (lab studies, dates and results not provided). Therapy with GARDASIL was not reintroduced. At the time of the report, the outcome was not recovered. Upon internal review suicidal thoughts was determined to be an other important medical event. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Vaccine induced varicella.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Local swelling & redness noted 5/14/11 better by 5/17/11 only minimal itching used BENADRYL orally & oral MOTRIN .
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Patient called MD office and reported area of redness around injection site. Talked to doctor's nurse on 5/19 -> f/u. Pt never called back to report any worsen of condition. Contacted pt 3 times to find detail of rash but never call back.
Age: 0.16
Sex: F
Vaccine: HIBV, PNC, RV5
Symptoms: Hyperhidrosis
Clinical narrative: Screaming for hours.
Age: 24.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Blood lead normal, Full blood count normal, Helicobacter test negative, Pain, Pruritus
Clinical narrative: 3 in region of outbreak to (L) antecubital region - some fine papular region with scabbing crusts causing "deep pain" & "itchy".
Age: 24.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Rubella antibody positive, Scab, Treponema test negative
Clinical narrative: 3 in region of outbreak to (L) antecubital region - some fine papular region with scabbing crusts causing "deep pain" & "itchy".
Age: 65.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Infectious mononucleosis
Clinical narrative: Chills, fever, arm swollen double & red from elbow to shoulder; joint ache; fatigue; light case of pneumonia - after that - 3 days later - mono.
Age: 65.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pneumonia, Pyrexia
Clinical narrative: Chills, fever, arm swollen double & red from elbow to shoulder; joint ache; fatigue; light case of pneumonia - after that - 3 days later - mono.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Blood cholesterol increased, Cough, Dermatitis
Clinical narrative: Ache: joints and muscles; balance: dizzy upon standing; balance: vertigo and dizziness; balance: vertigo; blood pressure: high; blood: high cholesterol; cough inc; cyst: kidney; dermatitis; diabetes mellitus; hearing: ringing in ears; impotence; sleep: insomnia; numbness and tingling: fingers; numbness and tingling: in arms; otitis media (middle ear infection); pain: lower back; pain: joint and muscle pain and stiffness; pain ear; pains: charlie horse; skin: itching, dry and flaky skin; skin: rashes.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Diabetes mellitus, Dizziness postural, Dry skin, Ear pain, Erectile dysfunction
Clinical narrative: Ache: joints and muscles; balance: dizzy upon standing; balance: vertigo and dizziness; balance: vertigo; blood pressure: high; blood: high cholesterol; cough inc; cyst: kidney; dermatitis; diabetes mellitus; hearing: ringing in ears; impotence; sleep: insomnia; numbness and tingling: fingers; numbness and tingling: in arms; otitis media (middle ear infection); pain: lower back; pain: joint and muscle pain and stiffness; pain ear; pains: charlie horse; skin: itching, dry and flaky skin; skin: rashes.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension, Hypoaesthesia, Insomnia, Joint stiffness, Muscle spasms
Clinical narrative: Ache: joints and muscles; balance: dizzy upon standing; balance: vertigo and dizziness; balance: vertigo; blood pressure: high; blood: high cholesterol; cough inc; cyst: kidney; dermatitis; diabetes mellitus; hearing: ringing in ears; impotence; sleep: insomnia; numbness and tingling: fingers; numbness and tingling: in arms; otitis media (middle ear infection); pain: lower back; pain: joint and muscle pain and stiffness; pain ear; pains: charlie horse; skin: itching, dry and flaky skin; skin: rashes.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Myalgia, Otitis media, Paraesthesia, Pruritus
Clinical narrative: Ache: joints and muscles; balance: dizzy upon standing; balance: vertigo and dizziness; balance: vertigo; blood pressure: high; blood: high cholesterol; cough inc; cyst: kidney; dermatitis; diabetes mellitus; hearing: ringing in ears; impotence; sleep: insomnia; numbness and tingling: fingers; numbness and tingling: in arms; otitis media (middle ear infection); pain: lower back; pain: joint and muscle pain and stiffness; pain ear; pains: charlie horse; skin: itching, dry and flaky skin; skin: rashes.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Renal cyst, Skin exfoliation, Tinnitus, Vertigo
Clinical narrative: Ache: joints and muscles; balance: dizzy upon standing; balance: vertigo and dizziness; balance: vertigo; blood pressure: high; blood: high cholesterol; cough inc; cyst: kidney; dermatitis; diabetes mellitus; hearing: ringing in ears; impotence; sleep: insomnia; numbness and tingling: fingers; numbness and tingling: in arms; otitis media (middle ear infection); pain: lower back; pain: joint and muscle pain and stiffness; pain ear; pains: charlie horse; skin: itching, dry and flaky skin; skin: rashes.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chest pain, Dizziness, Injection site erythema, Nausea
Clinical narrative: Arm swelling and redness at injection site, chest pain, racing heart, fever which comes and goes, and feels dizzy and weak. Symptoms: Symptoms: 3. Tachypnea, 4. Nausea Vomiting, 5. Palpitation.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Palpitations, Pyrexia, Tachypnoea, Vomiting
Clinical narrative: Arm swelling and redness at injection site, chest pain, racing heart, fever which comes and goes, and feels dizzy and weak. Symptoms: Symptoms: 3. Tachypnea, 4. Nausea Vomiting, 5. Palpitation.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Lip swelling, Pruritus generalised, Swelling face, Urticaria
Clinical narrative: Approx 2 hours from the time of vaccination, pt felt a swelling on his lips with body itching w/c developed into full body whelps progressing into more facial swelling throat tightening.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram head, Convulsion, Electroencephalogram, Full blood count, Metabolic function test
Clinical narrative: Seizure. Lasted approximately 10 sec. Entire body was shaking. Pt was transported via ambulance to the ER where w/u was performed, and pt was admitted for obs. He was released after 2 days with no further Sx.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Tremor
Clinical narrative: Seizure. Lasted approximately 10 sec. Entire body was shaking. Pt was transported via ambulance to the ER where w/u was performed, and pt was admitted for obs. He was released after 2 days with no further Sx.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: pain in arm  red face.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Blood lactic acid abnormal, Blood test normal, Convulsion, Crying, Dyspnoea
Clinical narrative: Multiple seizures, pneumonia, abnormal MRI, high blood pressure, code blue due to lack of breath, transferring to multiple facilities of medical center, on going crying, stiffness of legs.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Electroencephalogram normal, Hypertension, Lumbar puncture normal, Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Multiple seizures, pneumonia, abnormal MRI, high blood pressure, code blue due to lack of breath, transferring to multiple facilities of medical center, on going crying, stiffness of legs.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Pneumonia, Resuscitation, Urine analysis normal
Clinical narrative: Multiple seizures, pneumonia, abnormal MRI, high blood pressure, code blue due to lack of breath, transferring to multiple facilities of medical center, on going crying, stiffness of legs.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP
Symptoms: Urticaria
Clinical narrative: Broke out with the hives on stomach.  They could have appeared earlier but did not check stomach until she woke up the next morning.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hypoaesthesia, Hypopnoea, Pyrexia
Clinical narrative: Fever 102, chills, breathing became shallow, arms numb.  Received Benadryl from MD. MD thought possible panic attack with reaction.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Localised oedema, Oedema peripheral
Clinical narrative: Edema extended from elbow to neck,pain. Mom gave Benadryl and Advil with some relief.
Age: 16.0
Sex: M
Vaccine: DT, HEP
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Local reaction, Nausea
Clinical narrative: Injection site on left deltoid turned pink and was size of quarter at 12:30 pm Friday 5/20, about 3 hours after injection. Took Clairitin and Motrin. Sat am, spot was about 3 inches across, and wheezing was noted. Since pt has experience with asthma, he self administered Albuterol every 4 hours starting Sat am, and 400 mg Motrin every 6-8 hrs. Pt felt weak and nauseous all day Sat and Sunday, when parents were alerted to situation and started monitoring pt. Sunday am the spot was 4 inches diameter and very pink. Monday, the bright pink spot continued to grow to a max of 9 in long and 5 in wide, and appeared to mother to be an inch higher than other deltoid. MD office consulted, who advised continuing Claritin and adding Benadryl at night. Pt visited doc on Tues 5/24, spot had receded an inch around, and was slightly pink but still raised. Doc advised this was a severe localized reaction and to delay further Td.
Age: 16.0
Sex: M
Vaccine: DT, HEP
Symptoms: Wheezing
Clinical narrative: Injection site on left deltoid turned pink and was size of quarter at 12:30 pm Friday 5/20, about 3 hours after injection. Took Clairitin and Motrin. Sat am, spot was about 3 inches across, and wheezing was noted. Since pt has experience with asthma, he self administered Albuterol every 4 hours starting Sat am, and 400 mg Motrin every 6-8 hrs. Pt felt weak and nauseous all day Sat and Sunday, when parents were alerted to situation and started monitoring pt. Sunday am the spot was 4 inches diameter and very pink. Monday, the bright pink spot continued to grow to a max of 9 in long and 5 in wide, and appeared to mother to be an inch higher than other deltoid. MD office consulted, who advised continuing Claritin and adding Benadryl at night. Pt visited doc on Tues 5/24, spot had receded an inch around, and was slightly pink but still raised. Doc advised this was a severe localized reaction and to delay further Td.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Oedema peripheral, Skin lesion
Clinical narrative: Leg swelled and skin leasions on body.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion
Clinical narrative: A extra lesion from the small pox shot.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Vomiting
Clinical narrative: Vomiting, fever, red bumps on trunk and face.
Age: 39.0
Sex: F
Vaccine: DTIPV, TDAP
Symptoms: Arthralgia, Chills, Headache, Injection site swelling, Muscular weakness
Clinical narrative: Swelling at injection site, fever, chills, nausea, headache, muscle weakness and joint pain.
Age: 39.0
Sex: F
Vaccine: DTIPV, TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Swelling at injection site, fever, chills, nausea, headache, muscle weakness and joint pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient received vaccination 5/19/11. Patient came into pharmacy on 5/22/11 complaining of her arm being sore, red and swollen. Also the patient complained of pain radiating down her left arm and into her left side of body.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: ZOSTAVAX was given as IM not SQ.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient experienced extreme itching on day 1 and had a few "mosquito bite" type bumps appear on back of neck and eyebrow (6-8 total).
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised, Rash
Clinical narrative: Developed rash on abdomen, generalized itching, pain, redness, swelling at injection site within 48 hrs of vaccine. KEFLEX started.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Imaging procedure, Lumbar puncture
Clinical narrative: Guillain Barre Syndrome. Acute severe.
Age: 2.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Mom called office to report patient has some swelling at injection site (L) leg and fever. Mom requesting report be filed.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood creatinine normal, Haematocrit decreased, Oedema peripheral, White blood cell count increased
Clinical narrative: Swelling in arm. Joint pain.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Within seconds after receiving vaccine, pt fainted while sitting on exam table. She was lowered to a supine position with her feet elevated. Blood pressure was taken immediately after LOC, which only lasted seconds. Pt was instructed to sit up slowly - given juice & pretzels. Blood pressure was taken again. Pt remained seated for 20 min then discharged by Dr.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed redness & swelling at the inj. site. She went to the ER on 5/18/11 due to pain in the area of inj. Pt. put on BACTRIM for suspected cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, PNC13
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: Red, itchy, swollen (L) arm from deltoid to mid forearm (crossing elbow joint). Resolved after 2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, PNC13
Symptoms: Pruritus
Clinical narrative: Red, itchy, swollen (L) arm from deltoid to mid forearm (crossing elbow joint). Resolved after 2 days.
Age: 0.66
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Crying, Decreased appetite, Dyskinesia, Irritability, Sleep disorder
Clinical narrative: Pt received PENTACEL, Hep B #1 & PREVNAR-13 on 5-16-11. Within 12 hrs pt was fussy, inconsolable crying, whining, jerky movements in sleep, interrupted sleep patterns, loss appetite, no fever.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: C/O onset pain around injection site approx. 1 hour after receiving Tdap - pain cont x 5 days - mostly with raising arm. No redness or swelling. Advised that this is a common side effect - should resolve. Advised to call back & contact PCP if worse.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: 5.5 cm in diameter, raised, red, tender area, (L) arm developed 2 days after injection.
Age: 30.0
Sex: F
Vaccine: JEV1, RAB, JEV1, JEV1
Symptoms: Convulsion, Electroencephalogram, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: This authority case was downloaded from the US VAERS Homepage on 16 May 2011. A 30 year old female received her first dose of IXIARO (batch number JEV09M39A) i.m. on 25 Feb 2011 into the right arm. Patient lost consciousness and experienced a seizure at around midnight or 1 a.m. on 26 Feb 2011 for about one minute, then regained consciousness. She did not fully recover for another hour and then fell asleep. Additional events coded without further information: chest discomfort, drug abuse, drug screen negative, dyskinesia. Concomitant medication included three pills of Calm PRT (Rhodiola rosea) for an unknown indication. Diagnostic tests: MRI and EEG - results are unknown. Patient made an appointment with a primary care provider and neurologist. Case outcome unknown. No further information available.
Age: 30.0
Sex: F
Vaccine: JEV1, RAB, JEV1, JEV1
Symptoms: Chest discomfort, Convulsion, Drug abuse, Drug screen negative, Dyskinesia
Clinical narrative: This authority case was downloaded from the US VAERS Homepage on 16 May 2011. A 30 year old female received her first dose of IXIARO (batch number JEV09M39A) i.m. on 25 Feb 2011 into the right arm. Patient lost consciousness and experienced a seizure at around midnight or 1 a.m. on 26 Feb 2011 for about one minute, then regained consciousness. She did not fully recover for another hour and then fell asleep. Additional events coded without further information: chest discomfort, drug abuse, drug screen negative, dyskinesia. Concomitant medication included three pills of Calm PRT (Rhodiola rosea) for an unknown indication. Diagnostic tests: MRI and EEG - results are unknown. Patient made an appointment with a primary care provider and neurologist. Case outcome unknown. No further information available.
Age: 30.0
Sex: F
Vaccine: JEV1, RAB, JEV1, JEV1
Symptoms: Electroencephalogram, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: This authority case was downloaded from the US VAERS Homepage on 16 May 2011. A 30 year old female received her first dose of IXIARO (batch number JEV09M39A) i.m. on 25 Feb 2011 into the right arm. Patient lost consciousness and experienced a seizure at around midnight or 1 a.m. on 26 Feb 2011 for about one minute, then regained consciousness. She did not fully recover for another hour and then fell asleep. Additional events coded without further information: chest discomfort, drug abuse, drug screen negative, dyskinesia. Concomitant medication included three pills of Calm PRT (Rhodiola rosea) for an unknown indication. Diagnostic tests: MRI and EEG - results are unknown. Patient made an appointment with a primary care provider and neurologist. Case outcome unknown. No further information available.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Rash occurred a few hours after receiving MENACTRA. Widespread urticarial rash including face. Dexamethasone sodium phosphate 6mg IM administered on 5/24/11. Prednisone 10mg pack po.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling around injection site where varicella vaccine was given.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain, stiffness, heat sensation in neck the day following administration, tx seen by NP in medical center EOHW, given Tylenol 325mg 2 tablets, to return to clinic if symmptoms worsen.
Age: 9.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Dizziness, Fatigue, Loss of consciousness, Pallor
Clinical narrative: Patient recived 3 vaccines and on 3rd vaccine administration became  pale. We immediately laid the patient back on the exam table and elevated lower extremities at which time patient had passed out. He came around within 10 seconds but remained very pale and tired, dizzy for 20-30 minutes after injections. Vital signs stabilized and was sent home to rtc tomorrow for Rabies series. Pt to travel to foreign country at the end of June 2011.
Age: 24.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Activities of daily living impaired, Eye pain, Eye swelling, Facial pain, Mobility decreased
Clinical narrative: Arm was sore on Monday the 23rd (as to be expected), soreness got increasingly worse on Tuesday. Unable to really move/use my arm on Tuesday. Wednesday (5/25) morning I woke up and there is intense pain in my left shoulder blade, neck, sinuses and left eye/face is swollen and also painful.  The Health Dept. gave me the information on the shots I was given that day: TD (health Dept aware of my Pertusis allergy) - Lot#: U3421BA, Manufacturer: Sanofi Pastur, Route: Left Deltoid Muscle Hepatitus A&B - Lot#: AHABB185AA, Manufacturer: Smith Kline, Route: Right Deltoid Muscle
Age: 24.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Sinus headache, Swelling face
Clinical narrative: Arm was sore on Monday the 23rd (as to be expected), soreness got increasingly worse on Tuesday. Unable to really move/use my arm on Tuesday. Wednesday (5/25) morning I woke up and there is intense pain in my left shoulder blade, neck, sinuses and left eye/face is swollen and also painful.  The Health Dept. gave me the information on the shots I was given that day: TD (health Dept aware of my Pertusis allergy) - Lot#: U3421BA, Manufacturer: Sanofi Pastur, Route: Left Deltoid Muscle Hepatitus A&B - Lot#: AHABB185AA, Manufacturer: Smith Kline, Route: Right Deltoid Muscle
Sex: M
Vaccine: HEP
Symptoms: Constipation, Haematochezia
Clinical narrative: Child was severely constipated, bloody stool, told by ER physician and later by our pediatrician to use suppositories and Q-tip in rectum to relieve bowel movement we continued this for months. Condition worsened.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial report was received 30 March 2011 via lay press report. According to the lay press article, a hospital's community health manager stated they saw "a "breakout" of people getting the flu who had been vaccinated" and the Department of Public Health had recommended health care providers submit tests again from people getting the flu who had already been vaccinated. The article did not provide the influenza vaccine name, the vaccine manufacturer's name or the vaccine lot number. The article did not specify the number of patients who experienced the event and identifiers were not provided for any of the patients. Outcomes were not reported. No additional information was provided. Follow-up information was received 17 May 2011 from a health care professional. The reporter provided patient identifying information for one female patient who contacted the reporter after she was diagnosed with influenza and questioned how she still got the flu. The patient had been vaccinated in December by another provider (vaccine manufacturer, lot number, route/site and exact date of administration was not reported). The reporter told the patient that she had heard of others in the community that had also gotten the flu after being vaccinated, but none of those people had reported the events directly to her. She stated she also explained that the vaccines cover three strains and it was possible for the strain in the community not to match what was in the vaccine and that vaccine efficacy was not 100 percent. The patient then contacted their state department of public health. The article was then published. The reporter had no contact from anyone else. Outcome was not reported. No additional information was provided. Documents held by sender: None.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blood culture negative, Bradycardia, Chills, Computerised tomogram normal, Culture urine negative
Clinical narrative: Pt developed fevers to 102-103 w/in 24 hrs of vaccine. Was given with PNEUMOVAX. Developed rigors as well. Seen in ED 24 s/p vaccines, hypotensive, tachycardic, temp 102. Admitted to ICU, on Abx (Vanco, ZOSYN). Developed cellulitis area around injection sites approximately 36 hrs s/p injections. Also noted to have bradycardia.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Hypotension, Injection site cellulitis, Intensive care, Pyrexia, Tachycardia
Clinical narrative: Pt developed fevers to 102-103 w/in 24 hrs of vaccine. Was given with PNEUMOVAX. Developed rigors as well. Seen in ED 24 s/p vaccines, hypotensive, tachycardic, temp 102. Admitted to ICU, on Abx (Vanco, ZOSYN). Developed cellulitis area around injection sites approximately 36 hrs s/p injections. Also noted to have bradycardia.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: White blood cell count
Clinical narrative: Pt developed fevers to 102-103 w/in 24 hrs of vaccine. Was given with PNEUMOVAX. Developed rigors as well. Seen in ED 24 s/p vaccines, hypotensive, tachycardic, temp 102. Admitted to ICU, on Abx (Vanco, ZOSYN). Developed cellulitis area around injection sites approximately 36 hrs s/p injections. Also noted to have bradycardia.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Wheezing
Clinical narrative: Wheezing, hoarseness. Treatment: Self Primateen Mist, BENADRYL 30 mg. Time unknown.
Age: 1.26
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever started 5/24/11.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: Ear pain, Herpes zoster oticus, Pain, Rash pruritic, Varicella post vaccine
Clinical narrative: 5/19/11 PM pt developed itchy painful rash around (L) ear & spreading up to (L) forehead & into scalp, associated with ear pain. No fever, no otitis media. I thought it looked like early varicella (Ramsay Hunt Syndrome) & sent pt to dermatology who concurred. Pt started on acyclovir & prednisolone.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Patient complaining that there is a bump (small knot) at the site of injection, bump can be felt, it is not hot, and patient states no other problems.
Age: 53.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Local reaction
Clinical narrative: Localized reaction redness & edema to upper arm. Treated with BENADRYL.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Pallor, Visual impairment
Clinical narrative: Pt. received vaccines and left exam room & became pale, lightheaded & states she saw black spots. Sat down & did not pass out.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site swelling
Clinical narrative: 5-10-11: PCV 13 administered (L) thigh. 5-11-11: Mo. called due to swelling at site & limp. 5-12-11: office visit - pt. much improved. No sx nor signs.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Nodule, Tenderness
Clinical narrative: Following varicella vaccine developed 2 knots in (L) arm about 5-11-11, on 5-12-11 area red & tender throughout, no systemic sx, red area 8 x 6 cm 2.5 x 1.5 cm and 1.5 x 1 cm indurated regions within red area, no fever.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Sm. red bumps developed on neck 2 days ago and spread today to upper arms, abdomen & back with a few on face. Afebrile - child playful. Acting as she normally does.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Drug administered to patient of inappropriate age, Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Mother stated that the child had had soreness and swelling in the left upper arm, left shoulder & left upper back. (Tdap was given by Health Dept staff to a child less than 11 y.o.).
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Mother stated that the child had had soreness and swelling in the left upper arm, left shoulder & left upper back. (Tdap was given by Health Dept staff to a child less than 11 y.o.).
Age: 25.0
Sex: F
Vaccine: HEPA, JEV1, VARCEL
Symptoms: Asthenia, Burning sensation, Disturbance in attention, Dyskinesia, Grip strength decreased
Clinical narrative: Tingling in arms & legs, difficulty concentrating, generalized weakness, slow movement, "burning sensation" in skin & muscles of legs, dropping objects more than usual. Friends described pt as a "zombie". Sx ended abruptly about 24 hours later.
Age: 25.0
Sex: F
Vaccine: HEPA, JEV1, VARCEL
Symptoms: Paraesthesia, Skin burning sensation
Clinical narrative: Tingling in arms & legs, difficulty concentrating, generalized weakness, slow movement, "burning sensation" in skin & muscles of legs, dropping objects more than usual. Friends described pt as a "zombie". Sx ended abruptly about 24 hours later.
Age: 1.29
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site reaction, Injection site urticaria
Clinical narrative: Pt is a 15 months 19 days old female who presents for injection site reaction on her (L) thigh after a DTAP injection Weds. She also felt feverish. 3 d after shot some hive type lesions developed on her (L) LE but did not involve other parts of body. She had previous DTAP shots without any noted reactions. Reck of rash. This seemed to start since her dtap and she has had some urticarial sxs also. Mom brings in pictures on her phone. No fever. Eating ok and active but fussy. They have been using some BENADRYL. Follow up if problem worsens or does not resolve completely.
Age: 1.29
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Rash erythematous, Rash macular, Skin lesion, Skin warm
Clinical narrative: Pt is a 15 months 19 days old female who presents for injection site reaction on her (L) thigh after a DTAP injection Weds. She also felt feverish. 3 d after shot some hive type lesions developed on her (L) LE but did not involve other parts of body. She had previous DTAP shots without any noted reactions. Reck of rash. This seemed to start since her dtap and she has had some urticarial sxs also. Mom brings in pictures on her phone. No fever. Eating ok and active but fussy. They have been using some BENADRYL. Follow up if problem worsens or does not resolve completely.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5-12-11 Received vaccine; arm pain x 5 days, on 6th day arm redness and swelling filled upper arm area and was warm and painful to touch, nausea, lightheaded, short of breath-tightness in throat.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Nausea, Pain in extremity, Throat tightness, Ultrasound Doppler
Clinical narrative: 5-12-11 Received vaccine; arm pain x 5 days, on 6th day arm redness and swelling filled upper arm area and was warm and painful to touch, nausea, lightheaded, short of breath-tightness in throat.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Temp 100 degrees on 4/17. (L) deltoid area redness, warmth and induration at site of injection - approx 10 x 10 cm2.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 1 week after shot - red raised rash - itches on arm below injection site was given betamethasone dipropionate 0.05% cream.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: Approx 32 hours after injection mother noted inflammation around site; MD noted 48 hours - induration 12cm x 9cm, 14 cm x 11 cm inflammation.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Tues, woke up next day red, swollen size of egg, itchy at site of injection. Weds - size of tennis ball; yesterday size of baseball. Red, warm, swollen, painful, itchy, aches.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Tues, woke up next day red, swollen size of egg, itchy at site of injection. Weds - size of tennis ball; yesterday size of baseball. Red, warm, swollen, painful, itchy, aches.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Chest discomfort, Headache, Lip swelling, Pain
Clinical narrative: Pt. c/o weakness, chest tightness, bottom lip swollen, HA, body aches - mom feels it is related to MENACTRA vaccine given day before.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Mom told Dr. at 6 mo. well check that child had a fever of 102 the night of his last shots and had x 2 febrile seizures. Was seen at Emergency room that night. Not reported by ER.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Local reaction, Pain, Swelling
Clinical narrative: Developed significant local reaction 24 hrs after injection. Pain/redness/warmth/swelling.
Age: 36.0
Sex: M
Vaccine: FLU3, IPV, MMR
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Oedema peripheral, Paraesthesia
Clinical narrative: Last night (L) arm went numb, tingling, & swollen. Difficulty lifting arm.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Developed apparent cellulitis over (L) upper arm injection site. Treated with Z-PACK & Prednisone tabs.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site nodule, Injection site pain, Muscle spasms
Clinical narrative: Pain in injection site, large knot at injection site, & numbness in (L) arm & (L) hand & cramping of (L) hand.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Large red erythematous area of 4 inch by 4 inch, very hot to touch, Cellulitis.
Age: 1.28
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: FEVER TO 104F, axillary. RASH OF SMALL RED BUMPS, INITIALLY ON TRUNK, SPREADING TO FACE. SX LASTED A FEW DAYS.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Positive for large (15cm) in diameter redness, with some swelling & tenderness in the middle (3 cm diameter) on left anterior thigh with needle puncture spot in center. Treatment - Ibuprofen prn, cool compresses, BENADRYL 25-50mg every 4-6 hour prn - observation.