chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Left arm will hurts where vaccinated and can not raise it in abduction.  Received two vaccine shots (Hepatitis A and B).  Do not know which one was administered in left arm.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Paraesthesia, Tenderness
Clinical narrative: Bruise at injection site. Some tingling in injection arm down to hand.  c/o tenderness in upper arm when grasping objects.  All of the sx gradually improved over a 8-10 days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Tenderness
Clinical narrative: LEFT SIDE OF PATIENT NECK BECAME TENDER AND SORE
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chest pain, Cough, Dermatitis contact, Fatigue
Clinical narrative: Strong headache within an hour lasting 5 days, itching burning rash 10/29/10, lethargy, pain in spine to lower extremities, dry cough, chest aching, extreme tiredness.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lethargy, Pain in extremity, Rash pruritic, Skin burning sensation
Clinical narrative: Strong headache within an hour lasting 5 days, itching burning rash 10/29/10, lethargy, pain in spine to lower extremities, dry cough, chest aching, extreme tiredness.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: Pt states started itching and swelling aftrer receiving Shot on Friday. By Saturday night noticed Red swollen and warm also painful to touch to right arm.  Going to allergist next week can't take Benadryl.
Age: 69.0
Sex: F
Vaccine: DT, FLU3
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: Swelling of LUE peaking about day 9 with pain and stiffness. Also intermittent pain in the R knee.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site reaction, Muscle twitching, Pyrexia
Clinical narrative: Patient noticed twitching at injection site, lips, eyes, eyebrows and thigh. This began the night of vaccination. She also experienced minor chest pain in both sides of chest. SX lasted for 2 days then subsided on the 3rd and have completely resolved. She also had a mild fever (99.8) on the morning after vaccination.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Pain, Pain in extremity
Clinical narrative: Client called Clinic on 11/16/2010, informed me that her L arm was expectedly sore for a couple of days after injection, the ache continues without improvement.  She also c/o loss of L arm push and pull strength.  She informed me that the shot never hurt, that she thought it was a good shot, and she never had any problems with her arms before the shot.
Age: 13.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Fatigue, Headache, Influenza like illness, Pruritus, Rash maculo-papular
Clinical narrative: Started with a headache, fatigue, warm to the touch.  Flu like symptoms per mom.  Rash on the crook of her Right arm maculopapular with itching.
Age: 13.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, TDAP, VARCEL
Symptoms: Skin warm
Clinical narrative: Started with a headache, fatigue, warm to the touch.  Flu like symptoms per mom.  Rash on the crook of her Right arm maculopapular with itching.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Monoparesis, Myelitis transverse
Clinical narrative: acute transverse myelitis involving cervical spine w/ bilateral UE paresis
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine at 12:47pm 11/22/10. Came back to the pharmacy around 5pm. Injection site has swollen, red, hot and itchy. Told her to ice it and take BENADRYL 50mg q 6 H, CMC in AM.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Spoke to pt 11-22-10 6:29 P she said her arm was swollen & very painful. She went to the ER on Sat & will follow-up w/primary care MD tomorrow. She said her arm feels fine now.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic shock, Blood chloride decreased, Blood creatinine increased, Blood glucose increased, Blood potassium increased
Clinical narrative: After getting the flu shot, patient became hypotensive and bradycardic. Pt given pressors which stabilized his blood pressure. Pt had to be intubated. Symptoms resolved 2 days later and pt was extubated. Pt now awake, alert, and oriented. It was determined the pt had anaphylactic shock due to the vaccine.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Blood sodium decreased, Blood urea increased, Bradycardia, Endotracheal intubation, Extubation
Clinical narrative: After getting the flu shot, patient became hypotensive and bradycardic. Pt given pressors which stabilized his blood pressure. Pt had to be intubated. Symptoms resolved 2 days later and pt was extubated. Pt now awake, alert, and oriented. It was determined the pt had anaphylactic shock due to the vaccine.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hypotension, Red blood cell count normal, Troponin increased
Clinical narrative: After getting the flu shot, patient became hypotensive and bradycardic. Pt given pressors which stabilized his blood pressure. Pt had to be intubated. Symptoms resolved 2 days later and pt was extubated. Pt now awake, alert, and oriented. It was determined the pt had anaphylactic shock due to the vaccine.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication, White blood cell count normal
Clinical narrative: After getting the flu shot, patient became hypotensive and bradycardic. Pt given pressors which stabilized his blood pressure. Pt had to be intubated. Symptoms resolved 2 days later and pt was extubated. Pt now awake, alert, and oriented. It was determined the pt had anaphylactic shock due to the vaccine.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Pyrexia, Tremor, Vomiting
Clinical narrative: Pt got vaccine 11/17, evening 11/18 went to ER with blood pressure 210/90+, pulse 100+, violent shaking. Treated for BP & sent home. 11/19 to ER again with same symptoms & vomiting & fever - ER suspected influenza infection.
Age: 45.0
Sex: U
Vaccine: FLUX
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swollen really bad, sore, and red. About the size of a top on a jar. Itchy.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: C/o redness, swelling & pain at inj site advised to apply ice packs. 11/22/10 - second MD visit.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Laboratory test normal, Migraine, Pain, Vertigo
Clinical narrative: Vertigo, vomiting, migraine, chills, aches.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vertigo, vomiting, migraine, chills, aches.
Age: 1.39
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pallor
Clinical narrative: Right arm 20cm x 15cm swelling red tender blanch area.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Injection site swelling, Laboratory test normal
Clinical narrative: Left shoulder pain (initially 8/10), swelling and muscle fatigue that began immediately at the injection site AVA #1 on 15 Sep 2010. These symptoms persist, but have improved. She has no numbness or tingling. She has taken MOTRIN, performed PT and was seen on 08 Oct with diagnosis of adhesive capsulitis.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Muscle fatigue, Periarthritis, X-ray normal
Clinical narrative: Left shoulder pain (initially 8/10), swelling and muscle fatigue that began immediately at the injection site AVA #1 on 15 Sep 2010. These symptoms persist, but have improved. She has no numbness or tingling. She has taken MOTRIN, performed PT and was seen on 08 Oct with diagnosis of adhesive capsulitis.
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Anti-SS-A antibody negative, Anti-SS-B antibody negative, Antinuclear antibody negative, Arthralgia, Blood test
Clinical narrative: Had immz given in right upper extremity. Had swelling of right leg 6-8 hours after received injection. Was seen in ED later that day and pt had Doppler studies done that showed no DVT. Was sent home with supportive care and pt reports that since then she has had joint pain, swelling, redness of joints. Pain was worse for about 2 mos after vaccination but sx have persisted since then chronically. Pt reports that joint pain and swelling occurred prior to this vaccine but vaccines seem to exacerbate the joint sx. Also reports that she had hives (cannot recall the timing of the onset of the hives; hives not documented in record) that lasted weeks after receiving the vaccine. Had typhoid vaccine again June 2006 without any reaction (except for worsening of her usual joint pain and swelling for months after receiving the vaccine).
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Complement factor normal, DNA antibody negative, Erythema, Haematocrit normal, Histone antibody negative
Clinical narrative: Had immz given in right upper extremity. Had swelling of right leg 6-8 hours after received injection. Was seen in ED later that day and pt had Doppler studies done that showed no DVT. Was sent home with supportive care and pt reports that since then she has had joint pain, swelling, redness of joints. Pain was worse for about 2 mos after vaccination but sx have persisted since then chronically. Pt reports that joint pain and swelling occurred prior to this vaccine but vaccines seem to exacerbate the joint sx. Also reports that she had hives (cannot recall the timing of the onset of the hives; hives not documented in record) that lasted weeks after receiving the vaccine. Had typhoid vaccine again June 2006 without any reaction (except for worsening of her usual joint pain and swelling for months after receiving the vaccine).
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Joint swelling, Oedema peripheral, Pain, Platelet count normal, Red blood cell sedimentation rate normal
Clinical narrative: Had immz given in right upper extremity. Had swelling of right leg 6-8 hours after received injection. Was seen in ED later that day and pt had Doppler studies done that showed no DVT. Was sent home with supportive care and pt reports that since then she has had joint pain, swelling, redness of joints. Pain was worse for about 2 mos after vaccination but sx have persisted since then chronically. Pt reports that joint pain and swelling occurred prior to this vaccine but vaccines seem to exacerbate the joint sx. Also reports that she had hives (cannot recall the timing of the onset of the hives; hives not documented in record) that lasted weeks after receiving the vaccine. Had typhoid vaccine again June 2006 without any reaction (except for worsening of her usual joint pain and swelling for months after receiving the vaccine).
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Rheumatoid factor negative, Ultrasound Doppler, Urticaria, White blood cell count normal
Clinical narrative: Had immz given in right upper extremity. Had swelling of right leg 6-8 hours after received injection. Was seen in ED later that day and pt had Doppler studies done that showed no DVT. Was sent home with supportive care and pt reports that since then she has had joint pain, swelling, redness of joints. Pain was worse for about 2 mos after vaccination but sx have persisted since then chronically. Pt reports that joint pain and swelling occurred prior to this vaccine but vaccines seem to exacerbate the joint sx. Also reports that she had hives (cannot recall the timing of the onset of the hives; hives not documented in record) that lasted weeks after receiving the vaccine. Had typhoid vaccine again June 2006 without any reaction (except for worsening of her usual joint pain and swelling for months after receiving the vaccine).
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: In the employees words "I got the flu shot and my left upper arm is swollen and red".
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Mobility decreased, Pain, Paraesthesia
Clinical narrative: In employees own words "Received a flu shot 10-8-10, when receiving flu shot felt a zing or electric type of sensation into my left shoulder and neck that is con resolved over the couple of weeks, had more pain and limited mobility esp. at week 2-3, saw MD and he thought it probably was from the injection must of hit a nerve or a tendon".
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle spasms, Myalgia
Clinical narrative: Muscle soreness for 2 days, muscle spasms becoming more frequent for next days, pain in left deltoid severe grabbing.
Age: 10.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Started on 11/15/10 day vaccine was given area was hot, swollen, red, pt had fever felt weakness. Patient had local reaction 5 x 5 cm on site of TDAP injection was given.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria, Wheezing
Clinical narrative: Urticaria, facial swelling, with wheezing within 2 hours of receiving the influenza vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain, Blood test, Electrocardiogram normal, Myalgia
Clinical narrative: (L) back pain below shoulder blade with bilateral upper thigh pain now resolved on 11/20/2010 (R) shoulder muscle pain and (L) axillary pain.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Body temperature increased, Chills, Erythema, Headache
Clinical narrative: 11/16 at 6pm - sore arm (Left) and chills. 11/17 Woke with nausea, chills, headache, feeling weak, PO temp - 100.2F. Arm is still sore & with redness & swelling. 11/18/10 seen by PMD. Temp is 100.8 degrees F. Arm sore with redness & swelling. MD gave her Cephalexin 500mg 1 PO qid x 10 days.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: 11/16 at 6pm - sore arm (Left) and chills. 11/17 Woke with nausea, chills, headache, feeling weak, PO temp - 100.2F. Arm is still sore & with redness & swelling. 11/18/10 seen by PMD. Temp is 100.8 degrees F. Arm sore with redness & swelling. MD gave her Cephalexin 500mg 1 PO qid x 10 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: "Following the flu shot I have had pain in the shoulder joint when I raise my arm up or across."
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Allergic reaction body part affected: arm - right. Where I got my flu shot on 10/8/10. The next day my right arm was hot, red, swollen and very sore. It developed a cellulitis. On 10/10/10 I went to the ER to get it looked at and obtained an order for clindamycin and prednisone.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthropathy, Musculoskeletal pain, Neck pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Location incident occurred: Upper right arm near shoulder. Received a flu shot on Friday October 8th. My shoulder and arm has been aching since shortly after I returned home. When I move my arm I get a strong pain in the front of my shoulder traveling up the rt side of my neck and sometimes down the arm. I occasionally feel a clicking or popping in the shoulder as well. I have used ADVIL, ice and BIOFREEZE to relieve the pain, but they do not seem to help. The last time I had a flu shot in the left arm I had similar symptoms that lasted for months. I told my personal physician about it when I went in for a physical. I was not sure then whether it was just from the shot or if I had strained it somehow. This time the shot was in my rt arm and I was not having any trouble with the arm before the shot.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Swelling
Clinical narrative: "Flu shot arm discomfort swelling".
Age: 68.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness & itching at injection site patient instructed to take BENADRYL. Patient was seen by physician to check site. No cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Pain
Clinical narrative: Red, warm, swollen area to (L) thigh, inguinal lymphadenopathy (L); area 4in X 8in, painful. Started 24 hours after shot, worsened. Started on KEFLEX BID & BENADRYL q 6 hours prn. On 6th day - no redness, no swelling, back to normal.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No known adverse events. Pt received the Novartis brand of influenza vaccine & Novartis vaccine is recommended for children 4 yrs of age & older.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 34-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Dizziness
Clinical narrative: Case previously recorded as MA2009-3456. Initial case report received from a registered nurse on 27 OCT 2009. 38-year-old female patient was vaccinated i.m. with S-OIV FLUVIRIN (batch no. 1008132P) on 27 OCT 2009. The patient experienced dizziness 30 minutes after vaccination and coughing 40 minutes after vaccination. The symptoms disappeared 2 hours later. Medical history: The patient was diagnosed with leukemia and received the last round of chemotherapy on 31 AUG 2009. Agency reference no.: NA09-007124.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anaphylactic reaction
Clinical narrative: Initial consumer report received on 17 Aug 2010: This polymedicated patient was vaccinated with H1N1 (manufacturer and batch number unknown) on 28 Oct 2009. After vaccination, the patient experienced life-threatening anaphylactic reaction. Final outcome of event was unknown.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Case previously recorded as MA2009-4154. Initial case received from a physician via Novartis Pharma on 11 NOV 2009. A 3-year-old female patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 1008146P) i.m., on 06 NOV 2009. Agency reference no.: NA09-007993.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case previously recorded as MA2009-4155. Initial case report received from a medical assistant via agency on 11 Nov 2009. Patient 3-year-old male was vaccinated with 0.5mL S-OIV FLUVIRIN (batch no. 1008146P) i.m on 09 NOV 2009. No adverse event was reported. Agency reference no.: NA09-007993.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Coordination abnormal, Dizziness
Clinical narrative: Case previously recorded as MA2009-4793. Initial case report received from Norvatis, on 23 NOV 2009. 48-year-old female patient was vaccinated with FLUVIRIN (batch no. 101716P1A) i.m. on 21 NOV 2009. The patient experienced dizziness, lack of balance and poor coordination on 22 NOV 2009. The patient had not recovered.
Age: 48.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Epistaxis, Gingival swelling, Headache, Myalgia
Clinical narrative: Initial report received from a healthcare professional on 27 Jan 2010: This patient with unknown medical history was vaccinated with SOIV FLUVIRIN (batch no 89986), IM on 07 Oct 2008. The patient experienced facial swelling, swollen gums, muscle aches, diarrhea, bleeding from the right nostril and headache on 09 Oct 2008. The outcome of events were reported resolved on unknown date.
Age: 48.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Swelling face
Clinical narrative: Initial report received from a healthcare professional on 27 Jan 2010: This patient with unknown medical history was vaccinated with SOIV FLUVIRIN (batch no 89986), IM on 07 Oct 2008. The patient experienced facial swelling, swollen gums, muscle aches, diarrhea, bleeding from the right nostril and headache on 09 Oct 2008. The outcome of events were reported resolved on unknown date.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Injection site pain, Paraesthesia, Urticaria
Clinical narrative: Case previously recorded as MA2009-4790. Received on 23 NOV 2009 from a healthcare professional the following information: A 41-year-old female patient, born on 21 DEC 1967 was vaccinated i.m. with 0.5 ml FLUVIRIN H1N1, batch no. 102041P1, on 16 NOV 2009 at 1p.m. into the left arm. The patient experienced from 16 NOV 2009 11p.m. (at night) to 17 NOV 2009 pain at injection site (heavy and sore), tingling of muscles, hives all over the body and shortness of breath which may have been anxiety-related. Agency No: NA09-008728.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, Lethargy, Wheezing
Clinical narrative: Case previously recorded as MA2009-04770. Initial case report received from a health care professional on 09 NOV 2009. A 5-year-old female patient was vaccinated i.m. for the first time with S-OIV FLUVIRIN (batch no. 100813) on 02 NOV 2009. Four days later she received another dose of H1N1 injectable vaccine (manufacturer unknown). On 07 NOV 2009, i.e. within 24 hours of vaccination with the second dose, she experienced lethargy and wheezing. The patient did not recover. Concomitant medication was not reported. Novartis Pharma reference no.: NA2009-007844.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Confusional state, Mental impairment, Muscular weakness, VIIth nerve paralysis
Clinical narrative: Initial report received from a consumer (patient's mother, who is physician) on 10 Dec 2009: This patient was received FLUVIRIN for immunization on 14 Nov 2009. She was having facial droop and right hand weakness, confusion and difficulty processing information on 15 Nov 2009. The outcome of the events was symptoms still ongoing. Attempted to get lot number unsuccessfully.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Injection site pain, Pain
Clinical narrative: Initial consumer report received on 13 Jan 2010: The patient received FLUVIRIN (batch no: unknown) in her left arm at a Pharmacy on 14 OCT 2009. The patient experienced pain in her left arm in the injection site 15 Oct 2009. The pain had grown progressively worse to the point that she can not perform everyday tasks, such as cooking, dressing, and doing household chores. The outcome of the event was reported as condition unchanged.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Case previously recorded as MA2009-4983. Received the following information via Agency from a healthcare professional on 19 NOV 2009: A 52-year-old female patient was vaccinated with S-OIV FLUVIRIN (batch number unknown) on 16 NOV 2009. Later that afternoon the patient had a rash that began at the injection site. On 17 NOV 2009 the patient awoke and noticed that the rash had spread across her whole body. The adverse event was still persisting at time of report. Ref. no.: NA09-008512
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lip swelling, Swelling face, Throat tightness, Urticaria
Clinical narrative: Case previously recorded as MA2009-4845. Initial case report from a consumer on 24 NOV 2009. A 9 year old child was vaccinated i.m. for the first time with FLUVIRIN (batch no. 102129P1) on 19 NOV 2009. Shortly after receiving the vaccine the patient experienced hives, swelling of the lips and tightening of the throat. These events were reported as hives, throat tightness and lip swelling. The patient received epinephrine, steroid injections and oral steroids. The slight swelling of her face continued at time of reporting. The patient had not recovered. Reference no.: NA09-008774. Follow up report received on 26 Apr 2010: Two requests for follow-up information were sent but no reply had been received. Hence the case was closed due to the lack of response.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Erythema, Fatigue, Hypoaesthesia, Nausea
Clinical narrative: Initial consumer report received on 15 Dec 2009: This patient with medical history of fibromyalgia, received FLUVIRIN 1 dose intramuscular on 09 Dec 2009. The patient felt tired, fatigued, and nauseated, after 6 hours and experienced redness, tingling, numbness, and pain after 36 hours after vaccination. It was reported that the tingling and pain migrated, and their movement was unpredictable. The symptoms impaired her ability to do activities of daily living (dates not provided), including caring for her child. The patient saw her primary care physician on 14 Dec 2009 and would see her rheumatologist on 16 Dec 2009. No treatment was prescribed, patient took an unspecified muscle relaxant when required for fibromyalgia symptoms. Blood tests were done on 14 Dec 2009 and results were pending. The outcome of the events was reported to be still ongoing.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain, Paraesthesia
Clinical narrative: Initial consumer report received on 15 Dec 2009: This patient with medical history of fibromyalgia, received FLUVIRIN 1 dose intramuscular on 09 Dec 2009. The patient felt tired, fatigued, and nauseated, after 6 hours and experienced redness, tingling, numbness, and pain after 36 hours after vaccination. It was reported that the tingling and pain migrated, and their movement was unpredictable. The symptoms impaired her ability to do activities of daily living (dates not provided), including caring for her child. The patient saw her primary care physician on 14 Dec 2009 and would see her rheumatologist on 16 Dec 2009. No treatment was prescribed, patient took an unspecified muscle relaxant when required for fibromyalgia symptoms. Blood tests were done on 14 Dec 2009 and results were pending. The outcome of the events was reported to be still ongoing.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus generalised, Throat irritation, Throat tightness
Clinical narrative: Report received from a nurse via CSL MD on 14-DEC-2009. A 37 year-old female patient received Influenza A monovalent vaccine (lot# 00349611A) via intra-muscular injection in the left arm on 14-DEC-2009 at 09:30am. The patient has not received previous influenza vaccine in the past and was had no illnesses at the time of vaccination. The patient had a medical history of fibromyalgia, migraine, asthma, and hypoglycemia. The patient had allergies to cats. Concomitant medications included ALLEGRA-D, SAVELLA, PROTONIX, NEURONTIN, LASIX, MOBIC, FLEXERIL, ALAVERT, ADVAIR, albuterol, FLONASE, and TOPAMAX. On 14-DEC-2009, about 5-10 minutes following Influenza A vaccination, the patient developed tightness in her throat that lasted approximately 5 minutes. At approximately 13:00 hours, the patient experienced itching over her body and itching in her throat. She was sent for medical evaluation at her work medical clinic. It is unknown whether any diagnostic tests were done. Patient outcome was unknown. Additional information has been requested. The company considered events possible to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Batch review request received for 00394611A on 29-DEC-2009. On completion of this investigation, it has been determined that all deviations related to the manufacturer of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Myalgia, Neuralgia, Paraesthesia, Skin warm
Clinical narrative: Initial nurse report received 22 Jan 2010: This patient received FLUVIRIN, (batch number: 10127602), unknown dose, intramuscular on 11 Nov 2009. On an unspecified date within 3 days after vaccination, the patient experienced numbness and tingling in the extremities of her right side. On an unknown date, the patient experienced hot spots under her skin. The outcome of the events was reported ongoing. Follow up report received from consumer (patient) on 24 May 2010: This patient had presented with symptoms of that include muscle pain and the nerve pain that appear to be generalized but are felt more strongly in the arms and the upper part of body. The outcomes of the events were reported as condition unchanged.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Facial palsy, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Initial report received from vaccine adverse event reporting system database (376136) on 31 Aug 2010: This child patient was vaccinated with S-OIV FLUVIRIN (influenza virus vaccine monovalent H1N1, batch number unknown) on 22 Dec 2009.  Following administration with the vaccine, the patient experienced tingling and numbness at left side of the face with droop on 28 Dec 2009.  The patient also presented with cough and runny nose.  Lab tests (unspecified) were performed that showed Bell's palsy.  Final outcome of the events was not reported.  Seriousness for the events "tingling and numbness at left side of the face" and "facial droop" was reported as serious (disability).  Follow up report received on 31 Aug 2010: This case was reported as anonymously and no reporter details were available.  Hence no follow-up was possible for this case and it was considered as lost to follow up.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Cough, Hypoaesthesia facial, Laboratory test abnormal, Paraesthesia, Rhinorrhoea
Clinical narrative: Initial report received from vaccine adverse event reporting system database (376136) on 31 Aug 2010: This child patient was vaccinated with S-OIV FLUVIRIN (influenza virus vaccine monovalent H1N1, batch number unknown) on 22 Dec 2009.  Following administration with the vaccine, the patient experienced tingling and numbness at left side of the face with droop on 28 Dec 2009.  The patient also presented with cough and runny nose.  Lab tests (unspecified) were performed that showed Bell's palsy.  Final outcome of the events was not reported.  Seriousness for the events "tingling and numbness at left side of the face" and "facial droop" was reported as serious (disability).  Follow up report received on 31 Aug 2010: This case was reported as anonymously and no reporter details were available.  Hence no follow-up was possible for this case and it was considered as lost to follow up.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: VIIth nerve paralysis
Clinical narrative: Initial report received from vaccine adverse event reporting system database (376136) on 31 Aug 2010: This child patient was vaccinated with S-OIV FLUVIRIN (influenza virus vaccine monovalent H1N1, batch number unknown) on 22 Dec 2009.  Following administration with the vaccine, the patient experienced tingling and numbness at left side of the face with droop on 28 Dec 2009.  The patient also presented with cough and runny nose.  Lab tests (unspecified) were performed that showed Bell's palsy.  Final outcome of the events was not reported.  Seriousness for the events "tingling and numbness at left side of the face" and "facial droop" was reported as serious (disability).  Follow up report received on 31 Aug 2010: This case was reported as anonymously and no reporter details were available.  Hence no follow-up was possible for this case and it was considered as lost to follow up.
Age: 53.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Report received from a VAERS database search on 29-Jun-2010 (VAERS case 376392). A 53 year-old male received one dose of H1N1 vaccine (lot 00449611A) via intramuscular injection on 23-Nov-2009. Within 28 days (21-Dec-2009), the patient was admitted to the hospital with electromyogram abnormal, Guillain-Barre syndrome, and lumbar puncture abnormal. The clinical exam, LP, and EMG were also consistent with Guillain-Barre. The patient remained in the hospital for 4 days (25-Dec-2009) and has recovered (date not specified). No further information is expected. This case was considered serious due to hospitalisation. The company considered events possibly related to the suspect drug, PANVAX H1N1, due to delayed time to onset of 28 days. Information derived from this AE report does not change the current safety profile of the product.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Food allergy
Clinical narrative: Initial HCP report received on 19 Jan 2010: The patient was vaccinated with FLUVIRIN (batch: 9721504) in Dec 2009 (date unknown) On an unspecified date, the reporter stated that, every time they eat seafood, they get a rash on their arm. The outcome of the event was reported as ongoing. No other information was provided at the time of this report. Follow-up report received from a health care professional on 28 Mar 2010: It was reported that after receiving FLUVIRIN, whenever the patient eats seafood, he experiences the event. The patient had never experienced the event prior to receiving the vaccination. No further information was provided.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU(H1N1)
Symptoms: Rash
Clinical narrative: Initial HCP report received on 19 Jan 2010: The patient was vaccinated with FLUVIRIN (batch: 9721504) in Dec 2009 (date unknown) On an unspecified date, the reporter stated that, every time they eat seafood, they get a rash on their arm. The outcome of the event was reported as ongoing. No other information was provided at the time of this report. Follow-up report received from a health care professional on 28 Mar 2010: It was reported that after receiving FLUVIRIN, whenever the patient eats seafood, he experiences the event. The patient had never experienced the event prior to receiving the vaccination. No further information was provided.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Heart rate increased, Pharyngeal oedema
Clinical narrative: Case previously recorded as MA2009-4082. Initial case report received from a consumer on 13 NOV 2009. A 46 year-old female patient was vaccinated with 0.5 mL FLUVIRIN 2009/2010 (batch no. 102046P1) i.m on 12 NOV 2009. Shortly after receiving the vaccine, the patient experienced shortness of breath followed by the appearance of a rash on her chest, arms and face, hoarseness and itchiness. The patient rushed to hospital on 12 NOV 2009. Treatment included epinephrine and diphenhydramine. The patient did not recover. Reference no.: NA09-008160. Initial case report received from a consumer on 13 NOV 2009. A 46 year-old female patient was vaccinated with 0.5 mL FLUVIRIN 2009/2010 (batch no. 102046P1) i.m on 12 NOV 2009. Shortly after receiving the vaccine, the patient experienced shortness of breath followed by the appearance of a rash on her chest, arms and face, hoarseness and itchiness. The patient was rushed to hospital on 12 NOV 2009. Treatment included epinephrine and diphenhydramine. The patient did not recover. Reference no.: NA09-008160. Follow up report received on 26 Apr 2010: Two requests for follow-up information were sent but no reply had been received. Hence the case was closed due to the lack of response.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pruritus, Swelling face, Swollen tongue
Clinical narrative: Case previously recorded as MA2009-4082. Initial case report received from a consumer on 13 NOV 2009. A 46 year-old female patient was vaccinated with 0.5 mL FLUVIRIN 2009/2010 (batch no. 102046P1) i.m on 12 NOV 2009. Shortly after receiving the vaccine, the patient experienced shortness of breath followed by the appearance of a rash on her chest, arms and face, hoarseness and itchiness. The patient rushed to hospital on 12 NOV 2009. Treatment included epinephrine and diphenhydramine. The patient did not recover. Reference no.: NA09-008160. Initial case report received from a consumer on 13 NOV 2009. A 46 year-old female patient was vaccinated with 0.5 mL FLUVIRIN 2009/2010 (batch no. 102046P1) i.m on 12 NOV 2009. Shortly after receiving the vaccine, the patient experienced shortness of breath followed by the appearance of a rash on her chest, arms and face, hoarseness and itchiness. The patient was rushed to hospital on 12 NOV 2009. Treatment included epinephrine and diphenhydramine. The patient did not recover. Reference no.: NA09-008160. Follow up report received on 26 Apr 2010: Two requests for follow-up information were sent but no reply had been received. Hence the case was closed due to the lack of response.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Dysphonia, Dyspnoea, Pruritus, Rash
Clinical narrative: Case previously recorded as MA2009-4082. Initial case report received from a consumer on 13 NOV 2009. A 46 year-old female patient was vaccinated with 0.5 mL FLUVIRIN 2009/2010 (batch no. 102046P1) i.m on 12 NOV 2009. Shortly after receiving the vaccine, the patient experienced shortness of breath followed by the appearance of a rash on her chest, arms and face, hoarseness and itchiness. The patient rushed to hospital on 12 NOV 2009. Treatment included epinephrine and diphenhydramine. The patient did not recover. Reference no.: NA09-008160. Initial case report received from a consumer on 13 NOV 2009. A 46 year-old female patient was vaccinated with 0.5 mL FLUVIRIN 2009/2010 (batch no. 102046P1) i.m on 12 NOV 2009. Shortly after receiving the vaccine, the patient experienced shortness of breath followed by the appearance of a rash on her chest, arms and face, hoarseness and itchiness. The patient was rushed to hospital on 12 NOV 2009. Treatment included epinephrine and diphenhydramine. The patient did not recover. Reference no.: NA09-008160. Follow up report received on 26 Apr 2010: Two requests for follow-up information were sent but no reply had been received. Hence the case was closed due to the lack of response.
Age: 0.8
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a pharmacist on 15 Jan 2010: The patient (10 month old) was vaccinated with FLUVIRIN (batch no: 1013294P) 0.5 ml intramuscular on 10 Dec 2009. No adverse event was reported.
Age: 0.8
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial report received from a pharmacist on 15 Jan 2010: The patient (10 month old) was vaccinated with FLUVIRIN (batch no: 1013294P) 0.5 ml intramuscular on 10 Dec 2009. No adverse event was reported.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Injection site pain
Clinical narrative: Initial pharmacist report received on 22 Jan 2010: This patient received FLUVIRIN (batch number: 97848P1C), 0.5ml, intramuscular on right arm, on 07 Oct 2009. On 09 Oct 2009, the patient experienced soreness and lump beneath the skin at the injection site. The outcome of the event was reported ongoing.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU(H1N1)
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Initial pharmacist report received on 22 Jan 2010: This patient received FLUVIRIN (batch number: 97848P1C), 0.5ml, intramuscular on right arm, on 07 Oct 2009. On 09 Oct 2009, the patient experienced soreness and lump beneath the skin at the injection site. The outcome of the event was reported ongoing.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Blood creatine phosphokinase increased, Chest discomfort, Discomfort, Dizziness, Fatigue
Clinical narrative: Report received from a consumer on 18-JAN-2010. A 34 year old male received H1N1 (lot# 01049611A) 0.5 ml injection on 30-DEC-2009. He reported exercising 4-5 times per week. The patient noted that he has been jogging and has been playing tennis. He had a medical history of low back pain. He experienced a slight increase in temperature and heavy breathing within 24 hours of the injection. These symptoms dissipated within 2-3 days. He also reported initially experiencing chest tightness (duration unknown). The patient took a trip to another country from 01-Jan-2010 to 09-Jan-2010 and did not require any immunizations. At the time of reporting, he was experiencing muscular aches, "omnipresent" lower back pain, fatigue and heavy legs "2-3" weeks after immunization. He was unsure if his symptoms were related to the H1N1 vaccine. Additional information has been requested. Assessment: The company considered events possible to PANVAX administration. Information derived from this AE report does not change the current safety profile of the product.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Malaise, Pain, Red blood cell sedimentation rate normal, Skin warm, Tremor
Clinical narrative: Report received from a consumer on 18-JAN-2010. A 34 year old male received H1N1 (lot# 01049611A) 0.5 ml injection on 30-DEC-2009. He reported exercising 4-5 times per week. The patient noted that he has been jogging and has been playing tennis. He had a medical history of low back pain. He experienced a slight increase in temperature and heavy breathing within 24 hours of the injection. These symptoms dissipated within 2-3 days. He also reported initially experiencing chest tightness (duration unknown). The patient took a trip to another country from 01-Jan-2010 to 09-Jan-2010 and did not require any immunizations. At the time of reporting, he was experiencing muscular aches, "omnipresent" lower back pain, fatigue and heavy legs "2-3" weeks after immunization. He was unsure if his symptoms were related to the H1N1 vaccine. Additional information has been requested. Assessment: The company considered events possible to PANVAX administration. Information derived from this AE report does not change the current safety profile of the product.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: White blood cell count normal
Clinical narrative: Report received from a consumer on 18-JAN-2010. A 34 year old male received H1N1 (lot# 01049611A) 0.5 ml injection on 30-DEC-2009. He reported exercising 4-5 times per week. The patient noted that he has been jogging and has been playing tennis. He had a medical history of low back pain. He experienced a slight increase in temperature and heavy breathing within 24 hours of the injection. These symptoms dissipated within 2-3 days. He also reported initially experiencing chest tightness (duration unknown). The patient took a trip to another country from 01-Jan-2010 to 09-Jan-2010 and did not require any immunizations. At the time of reporting, he was experiencing muscular aches, "omnipresent" lower back pain, fatigue and heavy legs "2-3" weeks after immunization. He was unsure if his symptoms were related to the H1N1 vaccine. Additional information has been requested. Assessment: The company considered events possible to PANVAX administration. Information derived from this AE report does not change the current safety profile of the product.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Back pain, Body temperature increased, Chest discomfort, Condition aggravated, Dyspnoea
Clinical narrative: Report received from a consumer on 18-JAN-2010. A 34 year old male received H1N1 (lot# 01049611A) 0.5 ml injection on 30-DEC-2009. He reported exercising 4-5 times per week. The patient noted that he has been jogging and has been playing tennis. He had a medical history of low back pain. He experienced a slight increase in temperature and heavy breathing within 24 hours of the injection. These symptoms dissipated within 2-3 days. He also reported initially experiencing chest tightness (duration unknown). The patient took a trip to another country from 01-Jan-2010 to 09-Jan-2010 and did not require any immunizations. At the time of reporting, he was experiencing muscular aches, "omnipresent" lower back pain, fatigue and heavy legs "2-3" weeks after immunization. He was unsure if his symptoms were related to the H1N1 vaccine. Additional information has been requested. Assessment: The company considered events possible to PANVAX administration. Information derived from this AE report does not change the current safety profile of the product.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Fatigue, Myalgia, Sensation of heaviness
Clinical narrative: Report received from a consumer on 18-JAN-2010. A 34 year old male received H1N1 (lot# 01049611A) 0.5 ml injection on 30-DEC-2009. He reported exercising 4-5 times per week. The patient noted that he has been jogging and has been playing tennis. He had a medical history of low back pain. He experienced a slight increase in temperature and heavy breathing within 24 hours of the injection. These symptoms dissipated within 2-3 days. He also reported initially experiencing chest tightness (duration unknown). The patient took a trip to another country from 01-Jan-2010 to 09-Jan-2010 and did not require any immunizations. At the time of reporting, he was experiencing muscular aches, "omnipresent" lower back pain, fatigue and heavy legs "2-3" weeks after immunization. He was unsure if his symptoms were related to the H1N1 vaccine. Additional information has been requested. Assessment: The company considered events possible to PANVAX administration. Information derived from this AE report does not change the current safety profile of the product.
Age: 44.0
Sex: U
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Incorrect drug dosage form administered
Clinical narrative: A 44 year-old patient received H1N1 vaccine lot 3031 on 19-Jan-2010. The patient had a medical history of allergies to Vancomycin, LOTREL, HCTZ, and doxycycline. The reporter indicated accidental maladministration of the vaccine (intranasally) to the patient. The reporter stated the incident just occurred (19-Jan-2010) and so far no adverse reaction has occurred. Awaiting further information. The company considered event causality as unassessable to PANVAX administration. Information derived from this AE does not change the current safety profile of the product.
Age: 44.0
Sex: U
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Drug administration error, No adverse event
Clinical narrative: A 44 year-old patient received H1N1 vaccine lot 3031 on 19-Jan-2010. The patient had a medical history of allergies to Vancomycin, LOTREL, HCTZ, and doxycycline. The reporter indicated accidental maladministration of the vaccine (intranasally) to the patient. The reporter stated the incident just occurred (19-Jan-2010) and so far no adverse reaction has occurred. Awaiting further information. The company considered event causality as unassessable to PANVAX administration. Information derived from this AE does not change the current safety profile of the product.