chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Joint range of motion decreased, Musculoskeletal pain, Pain, X-ray normal
Clinical narrative: Initial report was received from a health care professional on 30 March 2011. A 47 year-old female with a history of right arm bursitis from seven of more years ago had received on 25 March 2011 a first dose intramuscular right deltoid injection of ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number C3677) and unspecified amount of time later experienced muscular-skeletal pain with limited range of motion and a small nodule at the injection site. According to the reporter, the patient was unable to raise her arm above her head or bring her arm across the front of her chest without pain. Treatments were not reported. The patient had no illness at the time of vaccination and had no other vaccinations within four weeks prior to the suspect vaccine. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received 17 May 2011 from a health care professional. ADACEL had been administered with a 25 gauge 1 inch needle. The patient was seen by their primary care provider in early April. An x-ray was performed and showed negative for disease. She received corrective treatment with Methylprednisolone injection x 1 into the bursa and a course of PT (physical therapy). On 11 May 2011, the patient was fully recovered with no lasting effects. Documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Autoantibody positive, Biopsy pancreas abnormal, HLA marker study, Hyperamylasaemia, Hyperglycaemia
Clinical narrative: Initial case was retrieved from scientific literature on 16 May 2011 reported two cases however only one patient received pandemic inflenzavirus A (H1N1) vaccination (patient 1). Only patient 1 will be captured in this report and patient 2 with infection will not be captured in this report. A 52-year-old male patient, with a history of type I diabetes mellitus and pancreas transplant alone, received during the 2009-2010 flu season an injection (route and site not reported) of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported). The patient "received pancreas transplant alone (PTA) in 2001, using basiliximab induction and triple maintenance immunosuppression with tacrolimus, mycophenolate mofetil and short-course steroid." He "suddenly experienced pancreas rejection shortly after influenzavirus A (H1N1) vaccination." The patient "was a 52-year-old man (typed A*02, 08, B*18, DRB1*03; panel reactive antibody (PRA) 0%) who receive a PTA (portal-enteric drainage) in April 2001 from a 19-year-old cadaveric donor (typed A*02, 32, B*18, 35, DRB1*11, 14). Being a Jehovah witness, the recipient never received blood component transfusions. A follow-up study of serum in January 2009 by Screening Luminex assay showed no anti-HLA IgGs." "In December 2009, shortly after H1N1 vaccination (patient 1) reported hyperglycemia and hyperamylasemia, and lost insulin-independence. Blood levels of tacrolimus were within normal ranges, and pancreatic biopsies were finally performed: histologies showed septal inflammatory infiltrates and diffuse positive C4d stainings, so the recipients were finally diagnosed with acute rejection. At the time of rejection, Single-Antigen Luminex testing showed a broad sensitization against >18 different HLA class I and >13 HLA class II antigens in both patients (including donor-specific antibodies). Both patients also had a strikingly similar anti-HLA antibody pattern, suggesting a common antigen exposure, and steady autoantibody titers, excluding diabetes recurrence as the leading cause of rejection. Reactive epitopes for patient 1 were 82LR on A31 and 163LW on B35; 56PPA, 57PV and 74SV on DQB; 56RR5 and 47ERW on DQA." The outcome was not reported. Documents held by sender: None.
Age: 52.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Immunosuppressant drug level, Pancreas transplant rejection, Pancreatic disorder
Clinical narrative: Initial case was retrieved from scientific literature on 16 May 2011 reported two cases however only one patient received pandemic inflenzavirus A (H1N1) vaccination (patient 1). Only patient 1 will be captured in this report and patient 2 with infection will not be captured in this report. A 52-year-old male patient, with a history of type I diabetes mellitus and pancreas transplant alone, received during the 2009-2010 flu season an injection (route and site not reported) of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported). The patient "received pancreas transplant alone (PTA) in 2001, using basiliximab induction and triple maintenance immunosuppression with tacrolimus, mycophenolate mofetil and short-course steroid." He "suddenly experienced pancreas rejection shortly after influenzavirus A (H1N1) vaccination." The patient "was a 52-year-old man (typed A*02, 08, B*18, DRB1*03; panel reactive antibody (PRA) 0%) who receive a PTA (portal-enteric drainage) in April 2001 from a 19-year-old cadaveric donor (typed A*02, 32, B*18, 35, DRB1*11, 14). Being a Jehovah witness, the recipient never received blood component transfusions. A follow-up study of serum in January 2009 by Screening Luminex assay showed no anti-HLA IgGs." "In December 2009, shortly after H1N1 vaccination (patient 1) reported hyperglycemia and hyperamylasemia, and lost insulin-independence. Blood levels of tacrolimus were within normal ranges, and pancreatic biopsies were finally performed: histologies showed septal inflammatory infiltrates and diffuse positive C4d stainings, so the recipients were finally diagnosed with acute rejection. At the time of rejection, Single-Antigen Luminex testing showed a broad sensitization against >18 different HLA class I and >13 HLA class II antigens in both patients (including donor-specific antibodies). Both patients also had a strikingly similar anti-HLA antibody pattern, suggesting a common antigen exposure, and steady autoantibody titers, excluding diabetes recurrence as the leading cause of rejection. Reactive epitopes for patient 1 were 82LR on A31 and 163LW on B35; 56PPA, 57PV and 74SV on DQB; 56RR5 and 47ERW on DQA." The outcome was not reported. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Brain oedema, Dyspnoea, Gingival swelling, Hydrocephalus, Pyrexia
Clinical narrative: Initial report was received from a consumer on 16 May 2011. A 35 year-old female patient had received ADACEL (lot number, route and site of administration not reported) on 05 or 06 May 2011 (reporter unsure) and within 24 hours experienced swelling on face and in gums, difficulty breathing, a fever of 102 F, "swelling under skull" and "water under skull". The patient went to the emergency room twice but was not admitted to the hospital. The reporter was unsure of allergies or pre-existing conditions. No further information was known by the reporter. Contact information was not provided for follow-up. The patient's outcome was not recovered. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Swelling face
Clinical narrative: Initial report was received from a consumer on 16 May 2011. A 35 year-old female patient had received ADACEL (lot number, route and site of administration not reported) on 05 or 06 May 2011 (reporter unsure) and within 24 hours experienced swelling on face and in gums, difficulty breathing, a fever of 102 F, "swelling under skull" and "water under skull". The patient went to the emergency room twice but was not admitted to the hospital. The reporter was unsure of allergies or pre-existing conditions. No further information was known by the reporter. Contact information was not provided for follow-up. The patient's outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: PPV
Symptoms: Death, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient who "quite some time ago", was vaccinated with a dose of PNEUMOVAX 23 (route and lot number not reported). On an unknown date "quite some time ago", the patient experienced cellulites like reaction around the injection site after receiving the PNEUMOVAX 23, "it got really red and swelled up". The physician reported that the patient had deceased and stated that it was unrelated to the PNEUMOVAX 23 vaccine. It was unknown if the patient sought medical attention. Outcome of cellulites like reaction around the injection site was unknown. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: TYP
Symptoms: Erythema, Joint swelling, Scab, Skin warm
Clinical narrative: Pt. had IPV & Tdap & MENOMUNE on 5/9/11 & began oral Typhoid in prep for trip 5/25. Took oral Typhoid last dose at 10PM 5/16/11. Woke up at 4 am 5/17 with swollen, sore (L) elbow, red & hot to touch with sm scab on skin. Had been gardening earlier in week. Probably not related to vaccines or Typhoid oral. Referred to MD to assess for cellulitis.
Age: 1.39
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Crying, Incorrect dose administered, Irritability
Clinical narrative: Pt. given MMRV, Hep A, PREVNAR today which was given 2/10/11 was not in pt's electronic chart shot record was not avail to nurse at time of shot. Also given HIB & DTaP which pt was due to receive.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Oedema peripheral
Clinical narrative: Pt received vaccine on 5/19/11 at 3:30 pm. Pt developed a 2 & 1/2 inch blister. She called her MD on 5/20/11 & MD prescribed penicillin. She didn't take right away but her arm blew up on 5/22/11 & she went to ER & was prescribed penicillin. MD says might be cellulitis.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Localized reaction to injection site, approximately 2 x 4 inches in size. Painful.  Redness noted and hot to touch.
Age: 7.0
Sex: F
Vaccine: DT, HEP
Symptoms: Immunisation reaction, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Both injection sites had been completely clear, unmarked, and pain had subsided. When child woke up, she noticed pain and a bump on left deltoid. Mother saw pencil point sized small white dot in center of red swollen area which was then the size of a nickel. Administered Motrin and Benadryl every 6 hours through clinic visit at 1:30 following day, when red spot was then 2.5 in long and 2 in wide. Nurse said it was probably infected, but she did not have a code for an infected injection site so she would code it as an infected bug bite. She prescribed a cephalosporin. After the first dose, pt developed a mottled rash across chest then back, and hospital's nurse was consulted, who determined ER visit was not necessary. Ped did not return call, but another MD was consulted who suggested this was simply a reaction to shot, and advised Motrin and Benadryl until spot was gone. Ceph was thrown away.
Age: 7.0
Sex: F
Vaccine: DT, HEP
Symptoms: Livedo reticularis, Rash
Clinical narrative: Both injection sites had been completely clear, unmarked, and pain had subsided. When child woke up, she noticed pain and a bump on left deltoid. Mother saw pencil point sized small white dot in center of red swollen area which was then the size of a nickel. Administered Motrin and Benadryl every 6 hours through clinic visit at 1:30 following day, when red spot was then 2.5 in long and 2 in wide. Nurse said it was probably infected, but she did not have a code for an infected injection site so she would code it as an infected bug bite. She prescribed a cephalosporin. After the first dose, pt developed a mottled rash across chest then back, and hospital's nurse was consulted, who determined ER visit was not necessary. Ped did not return call, but another MD was consulted who suggested this was simply a reaction to shot, and advised Motrin and Benadryl until spot was gone. Ceph was thrown away.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pt had soreness in the area of injection, and redness in the general area. Pt stated the arm feels "sushy" or full of fluid. Pt also stated that she had flu like symtptoms, pain and achiness all over. The area was swollen as well. Pt was brought into the office to check site. There was redness around the injection site itself and some swelling.  Pt was told to ice the area and take ibuprofen.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Dyspnoea, Pruritus, Skin lesion
Clinical narrative: Pruritic lesions appeared over body. Some interference with breathing. Family friend advised Benadryl which helped but lesions continue to appear 96 hours later.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at site, bump at site, tenderness
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Lethargy, Vomiting
Clinical narrative: vomiting, lethargy
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Anaphylactic reaction, Dyspnoea, No reaction on previous exposure to drug, Rash maculo-papular, Rash pruritic
Clinical narrative: Probable anaphylaxis. Approximately 1/2 hour after receiving 3/3 RabAvert vaccine (pre-exposure prophylaxis) patient developed a pruritic macular papular rash and shortness of breath. She presented to the emergency room and was given Benadryl, steroids and H2 blocker. Her symptoms resolved over the next couple of hours and she was sent home. She's had no similar symptoms since that time. She did not have similar symptoms with the first 2 doses in a series.
Age: 0.98
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Pyrexia, Rash generalised
Clinical narrative: Fever 102F in armpit controlled with Tylenol for 3 days. Visited urgent care clinic 5/21, diagnosed with infection and given amoxicillin. On 5/23, a mild rash has developed all over his body.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: 3 days after vaccination, notice Rt upper arm at injection site become warm, swollen, burning, tender to touch with discomfort raising up arm. Consulted Dr. at employee health, prescribed with antibiotic and diagnosed with cellulitis.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash morbilliform
Clinical narrative: Pt experienced wide spread rash with discrete erythematous macules without pruritus. Rash located head to toe & appearance very similar to measles. BENADYRL & ice given for comfort. Rash onset < 12 hr from immunization & gone within 24 h.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Started 5-6 days after injection. Small bumps & itching at site of injection. Bumps have spread to both arms from wrist to shoulder & intense on both arms. Left arm from elbow to shoulder looks like sunburn. Also some redness on face.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Oedema peripheral, Skin warm
Clinical narrative: Left arm is red, swollen, warm to touch. Pt complains of pain radiating from injection site to elbow, painful to the touch.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, slight swelling, firmness & warmth & tenderness at injection site (R) upper posterior arm. W/ecchymosis radiating inferior to injection site.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Received injection on May 4, 2011. She started itching 1-2 weeks later. Today, May 23, 2011, pt noticed 3 bumps on her upper (R) arm where she received the injection. She denies pain, but says the site itches. The area is about 1 inch wide with 3 boil-appearing reddened bumps. Pt to RTC in 2 days.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Hyperventilation, Pharyngitis, Rhinitis allergic, Seasonal allergy
Clinical narrative: This 48 yo service member remembers "hyperventilating" with "a bag put over her head" following receipt of a past "influenza vaccine" in late 1990's. She denied any chest pain, hives, rashes, swelling, fevers, or anaphylactic like reactions. She does not remember anymore specifics of the event (date, time, vaccine, duration symptoms, etc). She does eat eggs and denied any reactions following any other influenza vaccine prior to this event. A review of her immunization records documented one IM influenza 11/21/1997 and one influenza vaccine on 1/11/2000. She denied receipt of documented FLUMIST vaccine on 9/30/2010. Review of medical records prior to and after these vaccine dates (1997-2000) did not identify any diagnosis of or symptoms described as hyperventilation; however she had several visit for coughing, pharyngitis, allergic rhinitis, sinus congestion, hay fever, and several GI/GU evaluations. (Records prior to 1997 were limited as SM advised they had been misplaced with records restarted.). The patient is unable to recall whether these flu vaccinations were before or after her bout of 'hyperventilation'.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Sinus congestion
Clinical narrative: This 48 yo service member remembers "hyperventilating" with "a bag put over her head" following receipt of a past "influenza vaccine" in late 1990's. She denied any chest pain, hives, rashes, swelling, fevers, or anaphylactic like reactions. She does not remember anymore specifics of the event (date, time, vaccine, duration symptoms, etc). She does eat eggs and denied any reactions following any other influenza vaccine prior to this event. A review of her immunization records documented one IM influenza 11/21/1997 and one influenza vaccine on 1/11/2000. She denied receipt of documented FLUMIST vaccine on 9/30/2010. Review of medical records prior to and after these vaccine dates (1997-2000) did not identify any diagnosis of or symptoms described as hyperventilation; however she had several visit for coughing, pharyngitis, allergic rhinitis, sinus congestion, hay fever, and several GI/GU evaluations. (Records prior to 1997 were limited as SM advised they had been misplaced with records restarted.). The patient is unable to recall whether these flu vaccinations were before or after her bout of 'hyperventilation'.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration, Injection site swelling, Pain
Clinical narrative: 4 inch zone of erythema, induration, and pain. The zone is swollen at his left lateral thigh and.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Per pt's grandfather, he noticed "a red spot the size of a 50 cent piece" on child's left thigh where Dtap #4 given IM, the day before. By the 2nd day after vac, "the red area, outer ring, was the diameter of a 20 oz soda bottle". Outer edge was red, then inside that was yellowish ring, reminding him of yellowish discoloration in bruising, then inner red area size 50 cent piece. Underneath skin felt hard & on 5/9/11 it felt hot. "Child doesn't seem bothered by it unless its touched and he has had no fever." PHN advised pt's grandfather to have his grandson seen by a medical professional which he did that day (5-09-11). The NP who saw him prescribed Erythromycin (dosage under no. 17). Per grandfather child's leg was fine by the 3rd day after starting the antibiotic - ie redness, tenderness, swelling and discoloration was essentially gone.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Rash, Rash macular
Clinical narrative: Macular facial rash with temp.
Age: 21.0
Sex: F
Vaccine: MNQ, TDAP, YF
Symptoms: Bronchitis, Dehydration, Dizziness, Headache
Clinical narrative: Quick onset sx, headaches, "extreme dehydration", dizziness, also developed bronchitis w/in 2 days sx occurred approximately 5 hours after administered vaccines.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test normal, Computerised tomogram head, Computerised tomogram normal, Grand mal convulsion, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Report received from a nurse on 18-OCt-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA, (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to recovered. The case was reported as serious due to life threatening events, hospitalisation and medical significance. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Report received from a nurse on 18-OCt-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA, (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to recovered. The case was reported as serious due to life threatening events, hospitalisation and medical significance. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test normal, Condition aggravated, Grand mal convulsion, Impaired driving ability, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Report received from a nurse on 18-OCt-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA, (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to recovered. The case was reported as serious due to life threatening events, hospitalisation and medical significance. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Vaccine positive rechallenge
Clinical narrative: Report received from a nurse on 18-OCt-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA, (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to recovered. The case was reported as serious due to life threatening events, hospitalisation and medical significance. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Grand mal convulsion, Vaccine positive rechallenge
Clinical narrative: Report received from a nurse on 18-OCt-2010 (received via Merck WAES: 1010USA02163). A 69 year old male patient received 0.5ml of AFLURIA, (batch: 11149121A, expiry: 30-JUN-2011) on 05-OCT-2010 for preventative immunization. The patient's concurrent medical conditions included hypertension and hypercholesterolaemia. The patient had no drug allergies. Concomitant medications included amlodipine, atorvastatin, olmesartan and terazosin. On 09-OCT-2010, approximately 4 days post administration with the suspect drug, the patient experienced a grand mal seizure. The patient was transported by ambulance. The patient was admitted to the hospital on a Friday and remained there over the weekend and was discharged on Monday. Tests included a CT (computed tomography) and MRI (magnetic resonance imaging) of the brain and blood tests of which all were normal. The patient said that he had the same experience last year, one month after receiving his flu shot (brand unknown). The event outcome was updated to recovered. The case was reported as serious due to life threatening events, hospitalisation and medical significance. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up 1 (29 Oct 2010): Confirmation from physician, patient date of birth, medical conditions, concomitant medications, vaccination and adverse event date, batch number, tests at hospital, details of previous adverse event to flu shot and patient outcome.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Information was received from a licensed practical nurse on 15-JUN-2010. The patient received the influenza virus immunization (manufacturer unknown) in the past. The patient subsequently experienced an allergic reaction (no details were provided). Additional information has been requested. The case was originally reported to Merck & Co., Inc. (1006USA01826). Information was received from a licensed practical nurse (via a pharmaceutical company) on 06-JUL-2010. The nurse was unable to provide the patient's date of birth. The patient had experienced an anaphylactic reaction to the flu vaccine on an unknown date. It was unknown if the patient was hospitalized. The patient recovered. The nurse was unable to identify the flu vaccine manufacturer. The patient decided not be vaccinated with GARDASIL due to the flu vaccine reaction. No further information is expected. This case was considered serious due to medical significance. The company considered event unassessable in relation to AFLURIA due to lack of information regarding time to event onset. Information derived from this AE report does not change the current safety profile of the product.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information was received from a PharmD student on 01-Sep-2010. On an unknown date, a patient (age/DOB/sex not provided) received influenza vaccine (manufacturer unspecified) and subsequently developed Guillain Barre. The patient sought medical attention. The patient's medical history and concomitant medications were unknown. The event outcome was unknown. No further information is expected. The case was originally reported to Merck & Co., Inc. (case # 1008USA04247). The case was reported as serious due to medical significance. The company considered events unassessable due to lack of information regarding time of onset. Information derived from this AE report does not change the current safety profile of the product.
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Report received from a pharmacist on 28-SEP-2010 (received via Merck WAES: 1009USA05341). A male patient (initials: unknown, date of birth: unknown) received one dose of unknown seasonal flu vaccine (unknown brand/manufacturer, batch number and expiry not provided, route of administration: not specified) for unspecified indication on an unknown date. The patient's medical history and concomitant medications were not specified. On an unknown date, after receiving the suspect drug, the patient had an anaphylactic reaction with breathing difficulties and went to the Emergency Department. The patient's outcome was not provided at the time of reporting. The reporter did not provide a causality assessment in relation to the suspect drug. The company considered events serious due to medical significance. The company considered events unassessable due to lack of information regarding time to onset. Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a consumer on 09-Jun-2010. A female (initials and DOB unknown) received influenza virus vaccine polyvalent (manufacturer unknown) and experienced an unspecified reaction. The reporter felt the reaction was due to the vaccine containing eggs. Additional information is not expected. This case was originally report to Merck & Co., Inc. (manufacturer case # 1006USA01073). The company considered the event unassessable due to insufficient information. Information derived from this AE report does not change the current safety profile of the product.
Sex: U
Vaccine: FLUX
Symptoms: Injection site reaction
Clinical narrative: Information was received from a pharmacist on 14-JUL-2010. An adult patient (initials, gender, and DOB unknown) received the flu vaccine injection in 2008 (manufacturer unspecified). The patient had a history of egg allergy and injection site reaction to tetanus and diphtheria toxoids absorbed vaccine (manufacturer unspecified) at age "44 years" prior to 1997 (resolved). The patient experienced an injection site reaction with the flu vaccine injection in 2008. The case was originally reported to Merck & Co., Inc. (case# 1007USA01350). Additional information is expected. The company considered event as non serious. The company considered event unassessable in relation to FLUVAX given the brand name is unknown and vaccination date is unknown. Information derived from this AE report does not change the current safety profile of the product.
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer on 02-AUG-2010. The female's grandson (initials and DOB unknown) received the flu vaccine (manufacturer unspecified) in the past and developed high fever. Medical history included high fever from the polio vaccine in the past. This case was originally reported to Merck & Co., Inc. (case number: 1007USA04068). Additional information has been requested. The company considers the event as unassessable due to insufficient information. Information derived from this AE report does not change the current safety profile of the product.
Sex: M
Vaccine: FLUX
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information was received from a consumer on 26-Aug-2010. The male (initials and DOB unknown) was administered two doses of unspecified influenza vaccine (manufacturer unknown). Dates of administration are unknown. No adverse symptoms were reported. No further information is expected. Information was originally received to Merck & Co., Inc. (case# 1008USA03684). The company considered the event unassessable to the suspect drug influenza vaccine. Information derived from this AE report does not change the current safety profile of the product.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Rash macular, Urticaria
Clinical narrative: Information has been received from a registered nurse on 03-SEP-2010. The 43 year-old male was vaccinated with a pre-filled syringe of AFLURIA 0.5 ml IM on 02-SEP-2009 (lot number 05649111A, expiration date: 10-JUN-2010). There was no pertinent medical history or history of drug reactions/allergies. Concomitant medication was unspecified by reporter. On about 28-SEP-2009 (the last week of Sep-2009), he experienced hives with big splotches from his shoulders to knees. His hives continued and did not completely clear. His hives would subside then continue "again". Many allergies were ruled out by the allergist. The patient received the H1N1 vaccine 20-JAN-2010 with no adverse symptoms noted. There was no change in his hives. The event outcome was not yet recovered. Additional information has been requested. The case was originally reported to Merck & Co., Inc. (case#: 1009USA00266). The case was not considered to be serious. 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.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever 104F, 09/08/2010 to 09/10/2010 for a duration of 2 days.  Outcome is recovered/resolved.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Heart rate increased
Clinical narrative: Report received from a health professional on 14-SEP-2010. This case was original reported to Merck (WAES number: 1009USA03335). A 64 year old male patient received 0.5ml of AFLURIA (batch 09949121B, expiry 15-JUN-2011) via intramuscular route in the left deltoid on 11-SEP-2010 for the prevention of flu. The patient's medical conditions included atrial fibrillation and diabetes. Concomitant medications were unknown. The patient has an allergy to morphine. On 11-SEP-2010, the day of receiving the suspect drug, the patient went home and felt funny and then had increased heart rate. The patient has had unspecified flu shots in the past and was ok. The patient sought medical attention from the pharmacist and the physician. The event outcome was unknown. The company considered this case to be not serious. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased
Clinical narrative: Report received from a field employee on 15-SEP-2010 (received via Merck WAES: 1009USA03458). A 5 year old female patient (initials unknown, date of birth unknown) received AFLURIA vial Wet MD 45Y (product lot number: M51908) 45mg once via intramuscular route on 10-SEP-2010 for influenza virus treatment. The patient's medical history and concomitant medications were unknown. On 10-SEP-2010, the day of vaccination with the suspect drug, the patient experienced a temperature of 104 degrees Fahrenheit for two and a half days. The temperature then dropped and returned to normal. The patient sought medical attention. The event outcome was recovered. The reporter did not assess event causality. The company considered this case to be non serious. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site pain
Clinical narrative: Report received from a pharmacist on 17-SEP-2010 (received via Merck WAES: 1009USA03785). A female patient in her 70s (initials unknown, date of birth unknown) received AFLURIA (lot number M50907, expiry 30-JUN-2011) on 16-SEP-2010 for vaccination. The patient had no pertinent medical history and had no concomitant medications. On 16-SEP-2010, the day of vaccination with the suspect drug, the patient complained of 'stings' when she received cold AFLURIA vaccines that were just taken out of the refrigerator. The patient sought medical attention. (This case was initially reported as two sisters who complained of stings. The sibling case is WAVES number 2010026496). The event outcome was not recovered. The reporter did not give a causality assessment. This case was reported as not serious. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Report received from a pharmacist on 17-SEP-2010 (received via Merck WAES: 1009USA03785). A female patient in her 70s (initials unknown, date of birth unknown) received AFLURIA (lot number M50907, expiry 30-JUN-2011) on 16-SEP-2010 for vaccination. The patient had no pertinent medical history and had no concomitant medications. On 16-SEP-2010, the day of vaccination with the suspect drug, the patient complained of 'stings' when she received the cold AFLURIA vaccine that was just taken out of the refrigerator. The patient sought medical attention. (This case was initially reported as two sisters who both complained of stings. The sibling case is WAVES number 2010026495). The event outcome was not recovered. The reporter did not give a causality assessment. This case was reported as not serious. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Report received from a pharmacist on 20-SEP-2010 (received via Merck, WAES: 1009USA04048). A 56 year old female patient received 0.5ml of AFLURIA (batch M50907, expiry 30-JUN-2011) for vaccination on 10-SEP-2010. The patient had a medical history of cancer. The patient had no concomitant medications. On 9-SEP-2010, the same day as vaccination, the patient developed severe pain, warmth and swelling at the injection site. The patient even complained of severe pain during the administration. The patient could not move her arm for 3 days. The patient sought medical attention. The event outcome was recovered on 16-SEP-2010. The reporter did not give an assessment of seriousness or causality. The company considered the case to be not serious. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow-up received 16-NOV-2010. Lot number was changed to 09949121B (EXPIRY 15-JUL-2011) and date of recovery changed to 14-SEP-2010 as per new source data from reporter. Time of AFLURIA administration (15:00) also added.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Malaise, Myalgia
Clinical narrative: Severe headache. Chills. Malaise/struggling. Muscle aches.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Malaise, Myalgia
Clinical narrative: Severe headache. Chills. Malaise/struggling. Muscle aches.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pollakiuria, Pyrexia
Clinical narrative: Report received from a consumer on 28-SEP-2010 (received via Merck WAES: 1009USA05339). A male patient (date of birth: unknown) received a dose of AFLURIA (batch number: M52108, expiry date: 30-JUN-2011) via intramuscular injection for influenza virus vaccination on 23-SEP-2010. The patient's medical history and concomitant medication was not specified. On 24-SEP-2010, the day after receiving the suspect drug AFLURIA, the patient developed a fever, chills and frequent urination. The patient had not sought medical attention. The patient's outcome was not specified at the time of reporting. No further information was provided. The case was reported as non-serious. The reporter did not provide a causality assessment in relation to the suspect drug, AFLURIA. The company considered events possible in relation to the suspect drug, AFLURIA. Information derived from this AE report does not change the current safety profile of the product.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Hypoaesthesia, Injection site pain, Throat tightness
Clinical narrative: Report received from a pharmacist on 29-SEP-2010 (received via Merck - WAES: 1009USA05566). A 52 year old female patient (date of birth unknown) received AFLURIA (batch M50907, expiry 30-JUN-2011) for vaccination on 24-SEP-2010. The patient had no pertinent medical history or allergies. Concomitant medications were unknown. On 24-SEP-2010, the day of vaccination with the suspect drug, the patient experienced site pain, she had a bitter taste and within 15 minutes, she felt numbness and her throat closing. Paramedics were summoned. No medication was administered and the patient was released within 1 hour without further symptoms. The patient sought medical attention from the pharmacist. The event outcome was recovered on 24-SEP-2010. The reporter did not give a causality assessment. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Hyperhidrosis, Nausea, Tremor
Clinical narrative: Report received from a healthcare student on 30-SEP-2010 (received via Merck WAES: 1010USA00052). A 59 year old female patient (date of birth unknown) received AFLURIA (batch M52308, expiry 30-JUN-2011) for vaccination on 29-SEP-2010. The patient had no pertinent medical history or allergies. The patient was on hormone therapy. On 29-SEP-2010, the day of vaccination with the suspect drug, the patient developed shaking, sweating, felt cold, nausea and headache. By 30-SEP-2010, all symptoms resolved except for the headache. The adverse events improved, the patient was on therapy unspecified. The patient sought medical attention by calling the pharmacy. The event outcome was recovering at the time of reporting. The reporter did not provide a causality assessment. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Report received via a healthcare student on 04-OCT-2010 (received via Merck WAES: 1010USA00210). An 82 year old female patient received 0.5ml dose of AFLURIA (batch 0644911A, expiry 24-JUN-2010) via intramuscular route on 01-OCT-2010. The patient's medical history and concomitant medications were not reported. On 01-OCT-2010, the patient received an expired dose of AFLURIA. No adverse effects were known. The event outcome was unknown. No additional information available. The reporter did no give a causality assessment. The company considered events unassessable. Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick.
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Injection site itches.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test, Borrelia test, Hypoaesthesia facial
Clinical narrative: Report received from a microbiologist on 08-OCT-2010. (Via distributor Merck case# 1010USA01081). A female patient (DOB: unknown) received AFLURIA (batch unknown) on 06-OCT-2010 for a flu-shot. The patient's medical history and concomitant medications were unknown. On the 07-OCT-2010, 24 hours after receiving the suspect drug, the patient experienced numbness on the left-side of her face. The microbiologist said the patient was given prednisone and a Lyme disease titer-test was performed on the patient. The patient did not seek medical attention. The adverse event did not improve and the patient had not recovered on reporting. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product. Follow up information received on 22-NOV-2010. Original report was from a pharmacist (medically confirmed).