chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Throat swelling, coughing, rapid heartbeat of 130/bpm.  Took max dose of liquid Benadryl with about 50% improvement.  About 9pm that same night fever of 100, chills, body ache lasting 1 day.
Age: 49.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Feeling abnormal, Hypoacusis
Clinical narrative: DONOR RECEIVED SHOT WENT TO LOBBY TO WAIT REQUIRED 15 MIN, DONOR CAME BACK TO MSA OFFICE C/O OF DIZZINESS/LIGHTHEADEDNESS AND FEELING THAT EVERYTHING WAS TUNNELING IN, AND HEARING WAS MUFFLED. DONOR WAS ASSISTED TO BED TO LIE DOWN AND GIVEN ICEPACK AND FANNED AND DONOR RECOVERED QUICKLY.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Rash
Clinical narrative: He started getting a rash on his forehad, ears and neck, spared his nose and perioral area, also rash on lower extremities.
Age: 56.0
Sex: M
Vaccine: TTOX
Symptoms: Influenza like illness
Clinical narrative: DONOR STATED THAT HE HAD FLU LIKE SYMPTOMS X2 DAYS AFTER RECEIVING TETANUS IMMUNIZATION. DONOR ONLY FELT THIS WAY FOR THE DAY AND NOW HE FEEL FINE.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site swelling, Pain in extremity
Clinical narrative: Patient reported severe pain racing up and down arm that received vaccine.  The pain caused her to not be able to mover her arm.  She also experienced swelling around sight of injection but no redness.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Headache, low grade fever, runny/stuffy nose, sore/itchy throat.
Age: 33.0
Sex: F
Vaccine: FLUN4
Symptoms: Throat irritation
Clinical narrative: Headache, low grade fever, runny/stuffy nose, sore/itchy throat.
Age: 0.11
Sex: F
Vaccine: FLU3
Symptoms: Increased upper airway secretion, Respiratory tract congestion, Wheezing, Wrong drug administered
Clinical narrative: Heavy congestion and wheezing, excessive mucus and phlegm, md inject 1 month infant with Fluzone adult vaccination (0.5 ml) instead of hep B vacination.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Eye irritation, Laboratory test
Clinical narrative: Tingling of lips and hands. Burning of eyes, throat swelling, shortness of breath, dizziness, nausea.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Tingling of lips and hands. Burning of eyes, throat swelling, shortness of breath, dizziness, nausea.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Migraine, Nausea
Clinical narrative: Migraine, nauseated, diarrhea, stomach cramps.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Blood urine present, Computerised tomogram normal, Contusion, Haematochezia, Immunoglobulin therapy
Clinical narrative: Petechiae, bruising, blood in stool & urine. To ER at 10/4 0100. Platelet count 2000. Transfusions x 3 count rose to 5000 then fell to 1000. Methylprednisolone 60mg incr to 125mg BID. Transfusion x2 w subsequent hives. IVIG 90 g begun. Count to 8000. 10/5 26000 10/6 30000.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Petechiae, Platelet count decreased, Transfusion, Urticaria
Clinical narrative: Petechiae, bruising, blood in stool & urine. To ER at 10/4 0100. Platelet count 2000. Transfusions x 3 count rose to 5000 then fell to 1000. Methylprednisolone 60mg incr to 125mg BID. Transfusion x2 w subsequent hives. IVIG 90 g begun. Count to 8000. 10/5 26000 10/6 30000.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Patient has pink rash on trunk, arms, and face (no localized reaction at injection site).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Pruritus generalised
Clinical narrative: Area of redness extending out from original area of vaccination by about 2 inches, rash initially spreading down arm from vaccination location progressing to itching over entire body and face.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Was given Quadrivalent flu vaccine, Fluarix, I.M. 1. Hives appeared on inner thighs and then appeared on the remainder of legs. Waited overnight to see if they would go away.  2. 09/16/2013 7:30 am - hives all over body - face, arms, back, neck, chest. Itching. 3. Went to Urgent Care. MD gave me an injection I.M. of prednisone (150 mg) and an RX for prednisone tablets. 4. Per instructions I was to taper off prednisone: on 9/17/13 took 60 mg prednisone; on 9/18/13 took 60 mg prednisone; on 9/19/13 took 40 mg; on 9/20/13 took 40 mg. 5. Hives were gone on 9/18/2013. 6. On 9/21/2013 my toes, feet, ankles, lower and upper thighs swelled hugely - never happened before. 7. On 9/21/2013 went to Urgent Care and MD told me to immediately stop taking prednisone. 8. My legs have been swollen ever since; keep them raised at night and try to keep them up when I sit. This is still ab problem.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Urticaria
Clinical narrative: Was given Quadrivalent flu vaccine, Fluarix, I.M. 1. Hives appeared on inner thighs and then appeared on the remainder of legs. Waited overnight to see if they would go away.  2. 09/16/2013 7:30 am - hives all over body - face, arms, back, neck, chest. Itching. 3. Went to Urgent Care. MD gave me an injection I.M. of prednisone (150 mg) and an RX for prednisone tablets. 4. Per instructions I was to taper off prednisone: on 9/17/13 took 60 mg prednisone; on 9/18/13 took 60 mg prednisone; on 9/19/13 took 40 mg; on 9/20/13 took 40 mg. 5. Hives were gone on 9/18/2013. 6. On 9/21/2013 my toes, feet, ankles, lower and upper thighs swelled hugely - never happened before. 7. On 9/21/2013 went to Urgent Care and MD told me to immediately stop taking prednisone. 8. My legs have been swollen ever since; keep them raised at night and try to keep them up when I sit. This is still ab problem.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient received Fluzone HD vaccine and Pneumovax on 09/27 on the same arm. Patient came back to the pharmacy on  09/30 complaining of a rash and pain at the injection site. As per patient, pain started the day after immunization, but the rash only appeared in the morning of 09/29. Patient has no known allergies.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: The patient reported to the pharmacy with difficulty breathing. The patient described a heavy sensation within the chest and difficulty breathing. The patient appeared short of breath.  The patient reported experiencing these symptoms within 20 minutes of receiving the vaccine.  The patient reported to the pharmacy at a later time. The site of injection had no unusual appearance.  The patient did not appear seem to have elevated temperature.  The incident occurred over approximately 2 hours. The patient was immediately instructed to sit down, and 911 was alerted.
Age: 40.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe redness, swelling, heat in entire upper arm.  Soreness and immobility in same arm.  Headache, fever of 102 degrees lasting for 2 days.  Body aches lasting 2 days.
Age: 40.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe redness, swelling, heat in entire upper arm.  Soreness and immobility in same arm.  Headache, fever of 102 degrees lasting for 2 days.  Body aches lasting 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt states she cannot lift arm above head..believes due to flu shot. Stated burned at time of injection, but explained that is normal...no redness.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injected limb mobility decreased, Local swelling, Myosclerosis
Clinical narrative: Considerable swelling and redness below where the vaccine has been administered. Muscle hardness. Inability to lift arm even to the shoulder level.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: DULL PAIN TO MY HEART that lasted about 1 minute. Small bumps that appeared at various places on my body, itched, then disappeared. Tightness in my lungs that is still happening the next day, relieved by albuterol inhaler. Low grade fever and sweating. Soreness at site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: DULL PAIN TO MY HEART that lasted about 1 minute. Small bumps that appeared at various places on my body, itched, then disappeared. Tightness in my lungs that is still happening the next day, relieved by albuterol inhaler. Low grade fever and sweating. Soreness at site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Hypotension, Pruritus
Clinical narrative: 4 1/2 hours after receiving flu vaccine, patient called to say she had all over flushing, intense itching and that a friend had taken her BP and it was lower than normal, she had also taken 50mg BENADRYL, she was instructed to go to ER if her symptoms continued or worsened.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe erythema, pain, soreness, swelling at injection site for PNEUMOVAX23. Symptoms onset 24 hours after vaccination. Patient to follow-up with MD if needed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Local swelling, Paraesthesia
Clinical narrative: Swelling and tingling in finger tips numbness. Burning sensation in fingers. Started 3 days after immunization.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
Clinical narrative: Pt had syncope signs. She started feeling warm, dizzy, lightheaded. Helped her lay flat on the floor - felt better after 5 min's. called 911 for medical help. Called pt 2 hrs after she was doing ok.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Blister on left arm around injection site where flu shot given. Raised, red in color, pt had about 1 week and getting gradually worse.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pharyngeal oedema
Clinical narrative: Throat swelled, chills or shivering, body aches.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: Pt received quadrivalent 2013-2014 flu shot. Walked into pharmacy with parents and sister. Fell on the floor right outside pharmacy.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection was warm, itchy, red and swollen the next morning and area larger by day 2.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection was warm, itchy, red and swollen the next morning and area larger by day 2.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Local swelling, Pain, Pruritus
Clinical narrative: Diarrhea for 1 and 1/2 days following; Fatigued the next day; Large swollen area (3 1/2"), very sore and painful, very itchy.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection arm was hot, tender and there was swelling. Pt had been applying ice the inflammation is going down. Advise pt to continue icing and to take BENADRYL and apply Hydrocortisone 1%.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain over most of upper left arm. Onset morning after shot. Lasted 3 days total.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Patient received vaccine on 05/15/13 and traveled by car to MD. Reported sore arm and leg cramping on 05/17/13 at approx 6:45 pm.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Haematoma, Pain
Clinical narrative: Hematoma, pain.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history included asthma. On 12-MAR-2012 the patient was vaccinated with PNEUMOVAX23 (dose, route unknown) (lot# was reported as 1706AA, Exp date 03-OCT-2013). The physician reported that a patient developed an injection site reaction and developed flu-like symptoms following vaccination with PNEUMOVAX23. The injection site reaction following vaccination with PNEUMOVAX23 was described as redness and swelling at the injection site. The duration of the injection site swelling and flu-like symptoms was unspecified. The patient had contacted physician for medical attention. On an unknown date the patient had recovered from the events. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site warmth, Insomnia, Mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On "Monday" (30-SEP-2013) the patient was vaccinated with ZOSTAVAX (lot number, dose, route and indication were not reported). On an unknown date in 2013, after the patient received ZOSTAVAX the injection site was warm to the touch with a "slight" knot that was extremely painful at the time of report. The pharmacist stated the patient was having trouble moving their arm and could not sleep because of the pain. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Full blood count normal, Headache, Injection site mass, Metabolic function test normal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 18 year old female patient with no pertinent medical history. On 15-AUG-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, expiration date, dose, route not reported) in the deltoid at the proper location. Concomitant medication included oral birth control and multi vitamin. On an unspecified date in 2013, after receiving GARDASIL the patient felt achy and had a large mass at injection site. The patient visited the nurse practitioner on an unspecified date and stated that she had been experiencing headaches and joint ache in her shoulder, at the time of the visit the patient said it was currently more of "generalized body aches". There was no palpable mass at injection site during the patient's office visit and that the patient did not have any adverse effect after receiving the first dose of GARDASIL. Nurse practitioner drew lab work on an unspecified date in 2013 to verify that "nothing else was going on" with the patient, these included a Comprehensive Metabolic Panel and Complete Blood Count (CBC). The results were normal. The outcome of the joint ache in her shoulder, headaches, achy at injection site and generalized body aches was reported as not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 18 year old female patient with no pertinent medical history. On 15-AUG-2013 the patient was vaccinated with her second dose of GARDASIL (lot#, expiration date, dose, route not reported) in the deltoid at the proper location. Concomitant medication included oral birth control and multi vitamin. On an unspecified date in 2013, after receiving GARDASIL the patient felt achy and had a large mass at injection site. The patient visited the nurse practitioner on an unspecified date and stated that she had been experiencing headaches and joint ache in her shoulder, at the time of the visit the patient said it was currently more of "generalized body aches". There was no palpable mass at injection site during the patient's office visit and that the patient did not have any adverse effect after receiving the first dose of GARDASIL. Nurse practitioner drew lab work on an unspecified date in 2013 to verify that "nothing else was going on" with the patient, these included a Comprehensive Metabolic Panel and Complete Blood Count (CBC). The results were normal. The outcome of the joint ache in her shoulder, headaches, achy at injection site and generalized body aches was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Exposure during pregnancy, Eye irrigation, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a respiratory therapist refers to a female nurse of unknown age. The respiratory therapist reported that a pregnant nurse was administering VARIVAX (Merck) to a patient on 27-SEP-2013 and the patient moved while the dose of VARIVAX (Merck) was being administered. The patient only received a partial dose of the VARIVAX (Merck) and the pregnant nurse had VARIVAX (Merck) in her eye. The pregnant nurse washed her eyes and went to her OBGYN physician (name of OBGYN physician was unspecified). No adverse event reported. The nurse's pregnancy information was not reported. The last menstrual period (LMP) and estimated due date (EDD) were not known. The pregnancy outcome was pending. The nurse sought unspecified medical attention. The patient's event was captured in 1310USA002538. Additional information is not expected.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Crying, Diarrhoea, Diet refusal, Erythema
Clinical narrative: Around 11:30 a.m ACTHIB (Sanofi) was given to left thigh, uneventfully. Around 3:15 p.m mother called that baby is crying and shaking. Was advised to come to the office (lives close by the office and mother was very scared). Baby was crying a lot, and shaking. The left thigh where the vaccine was given was red and very painful. Then the baby turn pale, with sweating. Mother wanted to give her breast, but baby did not open the mouth. His heart rate was 200/min. Cold compress to left thigh and TYLENOL supp. was given. After a few minutes, the entire face turn red and passed loose watery stool. Then slowly come back to normal. His color and the heart rate went down to 160, then 140. Rectal temp. was 99.2. Kept under observation until 4pm, then went home. Follow-up call was reassuring. Baby was fine.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Pallor, Tremor
Clinical narrative: Around 11:30 a.m ACTHIB (Sanofi) was given to left thigh, uneventfully. Around 3:15 p.m mother called that baby is crying and shaking. Was advised to come to the office (lives close by the office and mother was very scared). Baby was crying a lot, and shaking. The left thigh where the vaccine was given was red and very painful. Then the baby turn pale, with sweating. Mother wanted to give her breast, but baby did not open the mouth. His heart rate was 200/min. Cold compress to left thigh and TYLENOL supp. was given. After a few minutes, the entire face turn red and passed loose watery stool. Then slowly come back to normal. His color and the heart rate went down to 160, then 140. Rectal temp. was 99.2. Kept under observation until 4pm, then went home. Follow-up call was reassuring. Baby was fine.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Case number PHHY2013US109200 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 37-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with all 5 doses of post exposure RABAVERT (batch number: not reported) at once on an unknown date. On the same day after vaccination, she experienced myalgia, nausea and neck stiffness due to vaccine overdose. The outcome of the event was not reported. It was reported that the vaccine provider had mistaken the vaccine for HRIG (human rabies immunoglobulin). The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Wrong drug administered
Clinical narrative: Case number PHHY2013US109200 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 37-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with all 5 doses of post exposure RABAVERT (batch number: not reported) at once on an unknown date. On the same day after vaccination, she experienced myalgia, nausea and neck stiffness due to vaccine overdose. The outcome of the event was not reported. It was reported that the vaccine provider had mistaken the vaccine for HRIG (human rabies immunoglobulin). The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 0.3
Sex: U
Vaccine: DTAPIPV, HIBV, PNC, RAB
Symptoms: Choking, Cyanosis, Dysphagia, Neonatal aspiration, Pallor
Clinical narrative: Case number PHHY2013US108835 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a 3-months-old neonate patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. She also received DTaP IPV (other manufacturer, batch number: not reported, hence conservatively taken as IPV VIRELON INN), HIB (manufacturer and batch number: not reported, hence conservatively taken as VAXEMHIB INN) and PREVENAR (other manufacturer, batch number: not reported) on an unknown date. On the same date after vaccination, the neonate experienced choking and aspiration. It was reported that the patient had dysphagia, cyanosis and pallor. The outcome of the events was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases. Following an internal review of the data received on 26 Sep 2013, a significant case correction was done. The suspect vaccines DTaP and IPV VIRELON INN which were separately coded by error was recoded to combination vaccine DTaP IPV.
Sex: U
Vaccine: RAB
Symptoms: Road traffic accident, Syncope
Clinical narrative: Case number PHHY2013US109474 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: not reported) on an unknown date. It was reported that less than one hour after vaccination, the patient developed syncope. The patient met with a non-fatal car accident while driving. The outcome of the events was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccinations which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: U
Vaccine: RAB
Symptoms: Anaphylactic reaction, Incomplete course of vaccination
Clinical narrative: Case number PHHY2013US109272 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. It was reported that after vaccination, the patient developed anaphylaxis. The outcome of the event was not reported. The patient further received HDCV (human diploid cell vaccine, manufacture and batch number: not reported) as a fourth dose because of anaphylaxis with purified chick embryo cell vaccine (PCEC) and experienced anaphylaxis again. It was reported that the vaccination series was suspended due to the event. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: U
Vaccine: RAB
Symptoms: Anaphylactic reaction, Chest discomfort, Pruritus, Secretion discharge
Clinical narrative: Case number PHHY2013US109249 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT from 1997 to 2005. This report refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient's vaccination history included anaphylaxis after administration of a second  dose of HDCV (human diploid cell vaccine, manufacturer and batch number: not reported) on an unknown date. The patient was then vaccinated with incremental doses of RABAVERT (batch number: not reported) on an unknown date. It was reported that the patient developed mild anaphylaxis with chest tightness, increase in secretions and itching. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: U
Vaccine: RAB, TTOX, RAB, TTOX
Symptoms: Serum sickness
Clinical narrative: Case number PHHY2013US109440 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history was not reported and concomitant medications included tetanus toxoid, CLEOCIN and ciprofloxacin. The patient was vaccinated with RABAVERT (batch number: not reported) on an unknown date. The patient also received HRIG (human rabies immunoglobulin, other manufacturer, batch number: not reported) along with RABAVERT. It was reported that after vaccination, the patient developed serum sickness. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: U
Vaccine: RAB, TTOX, RAB, TTOX
Symptoms: Diarrhoea, Headache, Paraesthesia, Tremor
Clinical narrative: Case number PHHY2013US109440 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history was not reported and concomitant medications included tetanus toxoid, CLEOCIN and ciprofloxacin. The patient was vaccinated with RABAVERT (batch number: not reported) on an unknown date. The patient also received HRIG (human rabies immunoglobulin, other manufacturer, batch number: not reported) along with RABAVERT. It was reported that after vaccination, the patient developed serum sickness. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: U
Vaccine: RAB, TTOX, RAB, TTOX
Symptoms: Serum sickness
Clinical narrative: Case number PHHY2013US108975 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. The patient also received tetanus toxoid (manufacturer and batch number: not reported, hence conservatively taken as TETANOL PUR INN) and HRIG (human rabies immunoglobulin, other manufacturer, batch number: not reported) concomitantly. Six days after vaccinations, the patient experienced headache, diarrhea, paraesthesia and tremors. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: U
Vaccine: RAB, TTOX, RAB, TTOX
Symptoms: Diarrhoea, Headache, Paraesthesia, Tremor
Clinical narrative: Case number PHHY2013US108975 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with post exposure RABAVERT (batch number: not reported) on an unknown date. The patient also received tetanus toxoid (manufacturer and batch number: not reported, hence conservatively taken as TETANOL PUR INN) and HRIG (human rabies immunoglobulin, other manufacturer, batch number: not reported) concomitantly. Six days after vaccinations, the patient experienced headache, diarrhea, paraesthesia and tremors. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 51.0
Sex: M
Vaccine: RAB
Symptoms: Rhabdomyolysis
Clinical narrative: Case number PHHY2013US108735 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT from 1997 to 2005. This report refers to a 51-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: not reported) on an unknown date. He also received HRIG (human rabies immunoglobulin, other manufacturer and batch number: not reported). Two days after vaccination, he experienced possible encephalitis and rhabdomyolysis. He was hospitalized and treated for the event. On an unknown date the event improved and he was discharged. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness
Clinical narrative: My throat stated closing up inside. Went from slight close up irritation, to more pronounce. I was afraid it would close up entirely and I wouldn't be able to breathee. Took Tylenol at 6:00 PM seemed to loosen up and by 6:30 just slightly tight.
Sex: U
Vaccine: RAB
Symptoms: Anaphylactic reaction, Blood immunoglobulin E increased, Food allergy, Milk allergy
Clinical narrative: Case number PHHY2013US109234 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced anaphylaxis. It was subsequently found that the patient had allergy to gelatin, milk and egg white based on increased IgE levels. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 66 year old female patient. The pertinent medical history was none. On 23-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777, expiry date 07-JUN-2014). Concomitant therapies included lisinopril, amlodipine, hydrochlorothiazide, loratadine and aspirin. Approximately on 23-SEP-2013, the patient developed shingles. On 24-SEP-2013, the patient visited the office and the unspecified physician determined the reaction to be shingles and prescribed acyclovir and ELAVIL as a treatment. The patient develops rash when taken penicillin. There was no lab tests performed. The outcome of shingles was not recovered. The patient sought medical attention. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: This spontaneous report was received from a 67 year old male patient regarding himself. The patient has gout and arthritis. The patient had no drug allergies or reactions. On 12-SEP-2013, the patient was vaccinated with ZOSTAVAX, (lot number, expiry date and route was unknown). Concomitant therapies included meloxicam. On 24-SEP-2013, the patient developed shingles. The patient was treated with prednisone and VALTREX. Blood test was performed which verified shingles. The outcome of shingles was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test abnormal, Herpes zoster
Clinical narrative: This spontaneous report was received from a 67 year old male patient regarding himself. The patient has gout and arthritis. The patient had no drug allergies or reactions. On 12-SEP-2013, the patient was vaccinated with ZOSTAVAX, (lot number, expiry date and route was unknown). Concomitant therapies included meloxicam. On 24-SEP-2013, the patient developed shingles. The patient was treated with prednisone and VALTREX. Blood test was performed which verified shingles. The outcome of shingles was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Aggression, Decreased appetite, Diet refusal, Fatigue, Hypersomnia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 year old female patient with gluten sensitivity and drug reaction to amoxicillin and cephalosporins. On 30-SEP-2013 the patient was vaccinated with VAQTA, 0.5 ml, intramuscular (lot # was not reported). On 30-SEP-2013, that a patient experienced difficulty sleeping, exhaustion, "not eating" and behavorial irritability after receiving VAQTA. No treatment was given for the AE. No lab was performed. The patient's mother called the physician's office for medical attention. The outcome of events was unknown. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Decreased appetite, Fatigue, Insomnia, Irritability
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 year old female patient with gluten sensitivity and drug reaction to amoxicillin and cephalosporins. On 30-SEP-2013 the patient was vaccinated with VAQTA, 0.5 ml, intramuscular (lot # was not reported). On 30-SEP-2013, that a patient experienced difficulty sleeping, exhaustion, "not eating" and behavorial irritability after receiving VAQTA. No treatment was given for the AE. No lab was performed. The patient's mother called the physician's office for medical attention. The outcome of events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Musculoskeletal pain, Pain
Clinical narrative: Shoulder and shoulder joint was sore and still is almost one month later. It seems to be getting worse.  It hurts to raise my arm. I am on anti-inflammatories for my hip and when I forget to take that pill, my shoulder really hurts worse. I am going to start doing rehab exercises for shoulder to see if that will help and using ice packs and heat packs.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Little red bumps appeared a day after smallpox vaccine. After a few days, it became erythematous, papule and vesicle formations.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Computerised tomogram, Herpes zoster, Musculoskeletal pain
Clinical narrative: This spontaneous report as received from a consumer refers her 64 year old husband. The patient's medical history included chemotherapy for cancerous cell in 2012 and had no known drug reactions/allergies. On 13-JAN-2010 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant medication included cholesterol medication (brand, manufacturer and dose unspecified). On 29-AUG-2013, the patient developed pain in his shoulders and back, that progressed steadily until when he was hospitalized on 03-SEP-2013 until 08-SEP-2013. The patient was diagnosed with "shingles". Prednisone, NEURONTIN, (Manufacturer and dose unspecified) were used as treatment. Cat scan, blood work and X-ray were performed (results not provided). At the time of the report, the patient was still recovering (also reported as not recovered). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray
Clinical narrative: This spontaneous report as received from a consumer refers her 64 year old husband. The patient's medical history included chemotherapy for cancerous cell in 2012 and had no known drug reactions/allergies. On 13-JAN-2010 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant medication included cholesterol medication (brand, manufacturer and dose unspecified). On 29-AUG-2013, the patient developed pain in his shoulders and back, that progressed steadily until when he was hospitalized on 03-SEP-2013 until 08-SEP-2013. The patient was diagnosed with "shingles". Prednisone, NEURONTIN, (Manufacturer and dose unspecified) were used as treatment. Cat scan, blood work and X-ray were performed (results not provided). At the time of the report, the patient was still recovering (also reported as not recovered). Additional information has been requested.
Sex: U
Vaccine: RAB
Symptoms: Face oedema, Hypersensitivity, Type III immune complex mediated reaction, Urticaria
Clinical narrative: Case number PHHY2013US109495 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: not reported) on an unknown date. Two days after vaccination, the patient developed systemic arthus type allergic reaction with facial edema and urticaria. The outcome of the events was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Sex: U
Vaccine: RAB
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: Case number PHHY2013US109526 is an initial literature report received on 26 Sep 2013. The authors presented an analysis of post-licensure safety reports after RABAVERT anti-rabies vaccine from 1997 to 2005. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with RABAVERT (batch number: not reported) intradermally on an unknown date. On an unspecified date the patient experienced injection site reaction (unspecified) following the erroneous intradermal administration. The event was reported as medically important. The outcome of the event was not reported. The author stated that the ongoing evaluation of VAERS reports did not suggest a high frequency or unusual pattern of serious and other medically important adverse events. The author concluded the article stating that rabies vaccination which was the only prevention against fatal rabies was generally well tolerated and providers should follow the package insert and ACIP recommendations for using pre-exposure or post exposure prophylaxis and should consult with local public health authorities for complex cases.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Odynophagia, Pharyngeal erythema
Clinical narrative: This medically confirmed spontaneous report (initial receipt 24-Sep-2013) concerns a 55-year-old female patient with no allergies. Concomitant medication included levothyroxine. On 23-Sep-2013, the patient was administered intramuscular AFLURIA (batch number R54307) at a dose of 0.5ml. On 23-Sep-2013, within 8-12 hours post-vaccination, the patient developed severe redness of the eyes, throat and uvula along with discomfort swallowing. There was no evidence of swelling. That evening, on the 23-Sep-2013, the patient attended an emergency room and was treated with an unspecified injectable steroid and an unspecified non-narcotic analgesic. As of the 24-Sep-2013, the redness in the eyes was greatly diminished, some of the redness in the throat had diminished and the patient still had some difficulty swallowing. Outcome was reported as recovering.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Dizzy; light headed; fever; chills; diarrhea; nausea.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Hypoaesthesia, Immediate post-injection reaction, Laboratory test, Paraesthesia
Clinical narrative: Right after administration of Flu shot to left arm, left arm was numb feeling and left hand was tingling.  Wednesday 0900, right arm numb and right hand tingling.  Next day, Thursday around 1200PM both feet had tingling sensation, slight numbness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Neuropathy peripheral, Paraesthesia
Clinical narrative: Reported feeling "a rush of fluid through the arm" and some tingling; felt like the neuropathy in her feet.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Skin warm, Urticaria
Clinical narrative: Parent picked up student at dismissal from school and noted bilateral upper arm raised welts/hives.  Skin surrounding hives, warm to touch.  Took child to clinic, however upon arrival hives disappeared.  Hives reappeared later that evening and the next day 10/5/13 to other areas of the body.  Benadryl given through the weekend.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Erythema, Urticaria
Clinical narrative: Parent picked up student at dismissal from school and noted bilateral upper arm raised welts/hives.  Skin surrounding hives, warm to touch.  Took child to clinic, however upon arrival hives disappeared.  Hives reappeared later that evening and the next day 10/5/13 to other areas of the body.  Benadryl given through the weekend.