chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Headache
Clinical narrative: Client complained of headache and feeling of intoxication.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Client complains of headache and feeling of intoxication, along with left arm pain.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Erythema, Immediate post-injection reaction, Rash, Rash pustular
Clinical narrative: Mom reports that "immediately after shot" son developed a "sandpaper rash" on the inner aspects of both arms.  This rash went away.  Mom reports that one week later, son developed diarrhea, and "red pustules on buttocks, along with tiny bumps on abd (spotty), then sandpaper rash on chest".  "Rash will not go away".
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypoaesthesia
Clinical narrative: Child complained that forearm and hand were numb.  Numbness continued through the night and into the next morning.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Employee reported that she was running a low grade temperature on 6/11/2011 to 06/13/2010. Started having a red rash, (looked like bug bites) on her upper torso front and back, some on her neck, and a couple on her face. She decribed as being very itchy. Came to Employee Health for a nurse to ck. Some of the spots appeared to be fluid filled. Benadryl given for the itching and Calamine applied to the rash.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: In process of injecting Tdap vaccine when pt slumped in chair. She was unresponsive for 5 seconds. Laid pt down and placed cool cloths on head. BP - 112/78, Pulse - 90. Pale. Feeling "fine" in 15 min. Pt and mother wanted to continue with immunizations. Gave meningitis vaccine and HPV vaccine after 15 min.  Observed another 15 min with no symptoms of distress. Called mother 6/30/11 - patient had no other symptoms or problems after immunizations.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dizziness, Immediate post-injection reaction, Loss of consciousness, Tearfulness
Clinical narrative: Client receiving 6 vaccines today. Client appeared well, but tearful following first 3 injections in right arm. Immediately following the last injection in the left arm, client lost consciousness and began to seize. Seizure lasted approximately 30 seconds. Oxygen brought to client, however, not used due to seizure complete when oxygen arrived. Client immediately regained consciousness upon completion of seizure and was A/O x 3. When asked if still felt dizzy, client reported "just a little bit". Denied nauseousness. Client given juice and damp towels. Client remained in clinic for 20 minutes following episode for observation, and reported feeling "fine and normal" prior to leaving.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Chills, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Fever (100.4), chills, numb tingly legs and liked  Went to emergency room and she was given acetaminophen.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Blood test abnormal, Immediate post-injection reaction, Injection site reaction, Local reaction
Clinical narrative: Localized reaction at injection site immediately, then Bumpy Rash on arms and three days later streaky rash along both shin bones
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Localized reaction at injection site immediately, then Bumpy Rash on arms and three days later streaky rash along both shin bones
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: BASEBALL SIZE HIVE AT INJECTION SITE. VERY SORE, RED, SWOLLEN. SOME ITCH.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Oedema peripheral, Rash generalised, Swelling face
Clinical narrative: Hives and generalized rash from thighs to neck. Numbness and swelling of both hands, numbness in lips and swelling of the face, pt's mother described "orange peel" appearance described by ER physician.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives and generalized rash from thighs to neck. Numbness and swelling of both hands, numbness in lips and swelling of the face, pt's mother described "orange peel" appearance described by ER physician.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient complained of redness and swelling as well as pain at injection site which began and got worse.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Infection, Inflammation, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: LT with redness, warmth, hard after vaccines given 6/29/11. No warmth at site since 6/29/11 pm. Probable inflammatory process - vs - infection. Txwith: Ibuprofen & BENADRYL, outlined red area to monitor.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin tightness, Tenderness
Clinical narrative: (R) upper extremity red, tight, tender.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives w/in 48 hours of vaccine. Hives on face/arm (L) knee.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count, Stomatitis
Clinical narrative: Received vaccines, MMR, varicella & Hep A on 6/28/11. Returned to clinic 7/1/11 with bruising/petechiae & mouth sores and was admitted to hospital with ITP.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: Pain on Right arm (T-dap injection site). Pain is not getting better.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness & tenderness to (L) shoulder about 12 cm x 12 cm. No fever - decreased use in arm. Mostly resolved after 2 days of ice & MOTRIN.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Febrile convulsion, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: Fever to 103. Febrile seizure 06/30/11 about 1000 hr.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Lethargy, Pulse pressure decreased, Syncope, Vomiting
Clinical narrative: Light headed, lethargy, fainting and vomiting after ate a cracker, place cool compress on face - forehead and neck 11:14 AM. P- 40 decreased 11:15AM laying B/P 120/60 P-80 (HR+) 11:20AM P-80 weak B/P 100/60 (sitting).
Age: 41.0
Sex: F
Vaccine: MMR, TDAP, TYP
Symptoms: Rash, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Took 1st oral Typhoid capsule 6/17/11, had rash on face that resolved. Took 2nd oral Typhoid capsule 6/19/11 resulting in rash on face, arms, legs/pruritic. Took oral BENADRYL. Stopped taking oral Typhoid. Resolved in 3 more days.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: None at time of administration or 25 minutes after. State CDC contacted.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node appeared under arm where shot was administered 2 days after.
Age: 4.0
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin reaction
Clinical narrative: Skin reaction to Dtap on (R) thigh 7x9 cm area swollen, red, non tender but itchy.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: (L) arm swollen, hot,  tender x 1 week. Seen on 6/30/11. Treatment: cool compresses, rest, Ibuprofen 600mg 3 x a day.
Age: 25.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Redness, no induration (approx. 3x5 cm) - warm compresses. F/u next week if unresolved.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus generalised, Rash
Clinical narrative: Rash, itching over whole body worse on upper legs & buttocks. Rash lasted for 2 wks. Treated with PO BENADRYL & topical hydrocortisone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right upper arm with 7 x 8 cm localized area warm with erythema. Tx: ice packs, BENADRYL 12.5mg/5mL 6mL po.
Age: 0.49
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: large area approx. 4 inches by 4 inches on the upper arm at the injection site which is red, raised and hot to the touch; is not responding to treatment with antihistimine and ice
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Begin with just a small rash on my neck the day after the shot that went away 2 days later.  Then little bug bite looking bumps started to appear on my back and stomach which was 5 days after receiving the shot.  Now 9 days after receiving the shot alot more bumps are popping and and the dry red rash is back on my neck.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Erythema, Rash macular, Sunburn
Clinical narrative: Patient returned call to clinic after leaving. Stated her face was red, she felt like her skin was slightly sunburned and she had a metallic taste in her mouth.  Patient's current location was one block from the clinic and the patient was advised to return immediately unless symptoms were severe. If severe, patient was told to call 911. Patient returned with stable vital signs, a flat circular rash to back and abdomen, and erythematous skin to face.  Patient was treated with 2 injections of 50 mg Benadryl 10 minutes apart.  After approximately 50 minutes of observation, patients skin color returned to normal. Rash was visible but diminished. Patient denied respiratory complaints and remained alert and oriented X3 throughout. Patient was discharged home. Patient later reported no further problems upon return home.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event, but inadvertently given 1st rotavirus vaccine after 15 weeks old.
Age: 1.29
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Tdap was given to the patient instead of DTap on 6-22-2011. This adverse event was reported to the State health department and to the doctor.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Vomiting
Clinical narrative: headache, sore muscles, vomiting 11AM Tylenol
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Right arm swollen and red and increasing in size
Age: 6.0
Sex: F
Vaccine: TTOX
Symptoms: Lethargy
Clinical narrative: High fever (104+), lethargy lasting for nearly a week per parents report.  Patient has not been seen since vaccination despite request.
Age: 14.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Abdominal pain upper, Dysstasia, Headache, Hypoacusis, Pain in extremity
Clinical narrative: Less than 5 minutes of receiving vaccine patient dropped to the floor fainting. Prior to fainting, trouble hearing and seeing, could not stand. Next day headache, stomach ache, arm sore.
Age: 14.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Syncope, Visual acuity reduced
Clinical narrative: Less than 5 minutes of receiving vaccine patient dropped to the floor fainting. Prior to fainting, trouble hearing and seeing, could not stand. Next day headache, stomach ache, arm sore.
Age: 14.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Syncope
Clinical narrative: Less than 5 minutes of receiving vaccine patient dropped to the floor fainting. Prior to fainting, trouble hearing and seeing, could not stand. Next day headache, stomach ache, arm sore.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MNQ, TDAP
Symptoms: Body temperature increased, Chills, Dizziness, Dysstasia, Nausea
Clinical narrative: Temperature 101 degrees F (highest temp reached). Dizziness, chills, unable to stand up, nausea. Symptoms started on 6-27-11; PM; symptoms resolved 6-29-11; no specific treatment.
Age: 13.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Chills, Dyspnoea, Sensation of heaviness
Clinical narrative: No information on where vaccine given but patient presented to Hosp. ED 6/24/11 3 hrs after Typhoid vaccine. Complaints of weakness, chills, difficulty breathing & arm heaviness. Observed, given TYLENOL & discharged.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting for 2-3 days after vaccines received. Started at 1:30 AM on day vaccine given. Fever 100 degrees F. TYLENOL given.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash, Rash erythematous
Clinical narrative: 10:00 AM PC from mom: Injection given on 6/27/11 - on 6/28/11 child c/o sore (L) arm & redness around area on 6/28/11, mom states (L) arm was red & swollen from shoulder to elbow with redness - ice was applied. Today 6/28/11; mom states child has red raised areas on face & chest. Referred to PMD.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema in a 58-year-old male subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included LIPITOR, TOPROL, Lisinopril, Aspirin, Metformin, Glimepiride, Gingko biloba and Saw palmetto. On 27 September 2010 at 18:00 the subject received 1st dose of Flu vaccine in the left arm. On 29 September 2010, 2 days after vaccination with Flu vaccine, the subject experienced erythema, swelling and hot to touch. At the time of reporting the events were worse. Attribution of the events to flu vaccine was unknown by the reporter.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of numbness in a 35-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), H1N1 (non-gsk) and FLULAVAL. On 2 November 2009 the subject received 1st dose of FLUARIX (.5 ml, unknown route, right arm) and 1st dose of H1N1 (non-GSK) (details unknown). On 2 November 2009, 1-2 hours after vaccination with FLUARIX and H1N1 (non-GSK), the subject experienced numbness and tingling. The subject also experienced high fever 4-5 hours after vaccination. The subject was treated with TYLENOL. On 03 November 2009, the events were resolved. On 13 September 2010 the subject received 1st dose of FLULAVAL (.25 ml, unknown route, right arm). She received half the standard dose of flu vaccine due to the reaction experienced the previous year. On 13 September 2010, 1-2 hours after vaccination with FLULAVAL, the subject experienced numbness and tingling. The subject also experienced high fever (101) 4-5 hours after vaccination. The subject reported that the symptoms were not as severe as those she experienced after the 2009 flu vaccine, but they were the same events. The subject was treated with TYELENOL. On 14 September 2010, the events were resolved.
Sex: U
Vaccine: FLU3
Symptoms: Delivery, Drug exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of heart murmur in an infant subject of unspecified gender who was exposed to FLUARIX (GlaxoSmithKline) transplacentally when their mother was vaccinated. The infant was also exposed to MACROBID and Ferrous sulfate which the mother took concurrently. On 18 September 2009 at 14:26 the 16-year-old mother of the subject received a dose of FLUARIX (.5 ml, unknown route, right arm). The mother's last menstrual period was on 25 December 2008 and estimated date of delivery was on 01 October 2009. The infant was exposed to FLUARIX during the third trimester. On an unspecified date the infant was delivered by unknown method. Weight and Apgar score were unknown. On an unspecified date the infant was diagnosed with heart murmur and pulmonary complications. No further information was provided. At the time of reporting the outcome of the events was unspecified. Please see case ID A0809375A for details regarding the mother case.
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site movement impairment, Product quality issue
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site movement impairment in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site movement impairment and injection site discoloration. At the time of reporting the outcome of the events was unspecified. No further information was provided. This case was also reported as a pharmaceutical product complaint. The consumer reported a personal adverse event following FLUARIX vaccination (see case ID A0863089A). The consumer also reported that 3 other subjects at the same hospital where they received the vaccination experienced the same events. This is case 1 of 3, see case IDs A0863114A and A0863115A for the other reports. Follow-up received 18 June 2010: QA analysis revealed the complaint to be unsubstantiated.
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site movement impairment, Product quality issue
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site movement impairment in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site movement impairment and injection site discoloration. At the time of reporting the outcome of the events was unspecified. No further information was provided. This case was also reported as a pharmaceutical product complaint. The consumer reported a personal adverse event following FLUARIX vaccination (see case ID A0863089A). The consumer also reported that 3 other subjects at the same hospital where they received the vaccination experienced the same events. This is case 2 of 3, see case IDs A0860108A and A0863115A for the other reports. Follow-up received 18 June 2010: QA analysis revealed the complaint to be unsubstantiated.
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site movement impairment, Product quality issue
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site movement impairment in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site movement impairment and injection site discoloration. At the time of reporting the outcome of the events was unspecified. No further information was provided. This case was also reported as a pharmaceutical product complaint. The consumer reported a personal adverse event following FLUARIX vaccination (see case ID A0863089A). The consumer also reported that 3 other subjects at the same hospital where they received the vaccination experienced the same events. This is case 3 of 3, see case IDs A0863108A and A0863114A for the other reports. Follow-up received 18 June 2010: QA analysis revealed the complaint to be unsubstantiated.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of increased blood pressure in a 78-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR 250/50 mcg. multi dose powder inhaler. There were no concurrent medications. On 20 August 2010 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) at 1 puff(s) twice per day. Approximately 7 days later, on 27 August 2010, the patient experienced increased blood pressure. Treatment with Fluticasone propionate+salmeterol xinafoate was discontinued. On 30 August 2010 the subject received unspecified dose of Flu vaccine (details unknown). On 30 August 2010, less than one day after vaccination with Flu vaccine, the subject experienced increased blood pressure of 140/60. The subject stated that her blood pressure was usually around 110/60. At the time of reporting the event was unresolved. Patient was prescribed ADVAIR by her doctor to help with her breathing. She was not specifically diagnosed with asthma or COPD. Patient stated she took the medication as prescribed for a one week and then discontinued it because she experienced an increase in her blood pressure. Today, August 30th, 3 days after discontinuing ADVAIR, patient received a flu shot, manufacturer unknown. Patient's blood pressure is usually around 110/60 and today it was slightly elevated to 140/60. Patient is not sure if the increase in her blood pressure may be due to the flu shot and/or ADVAIR. Follow-up received on 23 September 2010 from the consumer: The lot number for ADVAIR was provided as R472217; expiration date was not reported.
Age: 70.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Expired drug administered
Clinical narrative: This medically confirmed report (via distributor: 1011USA00229; initial receipt 01-NOV-2010) concerns a 70-year-old female patient. On 25-OCT-2010, the patient received an expired dose of H1N1 (Lot: 00249711A; Expiry: 30-JUN-2010) intramuscularly in the left deltoid, at a dose of 0.5 ml, for vaccination. The outcome is unknown.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Burning sensation, Swelling face, Tenderness, Urticaria, Vulvovaginal discomfort
Clinical narrative: Initial report received from a health care professional on 11 May 2011. An 11-year-old female child received on 09 May 2011 an injection (route and site not reported) of MENACTRA, sanofi pasteur lot number U3840AA and an injection (route and site not reported) of GARDASIL, Merck lot number not reported. The patient had no known allergies, no history of any medical conditions, had no other vaccines within 4 weeks, had no adverse events following prior vaccinations and took no medications. The patient received MENACTRA and GARDASIL about 9:00 AM on 09 May 2011. The mother called to report at 9:00 PM on 09 May 2011 that the patient was experiencing swelling of the face, tenderness, burning sensation, and vaginal irritation. The patient was seen by a physician on 11 May 2011 for the swelling of the lower area of the face which was mostly on the cheeks, tenderness, burning sensation, vaginal irritation and hives on the inner forearms. The patient was treated with BENADRYL. The outcome was reported as not recovered. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Flushing, Genital rash, Nasal discomfort, Pain of skin, Swelling face
Clinical narrative: Initial report received from a health care professional on 11 May 2011. An 11-year-old female child received on 09 May 2011 an injection (route and site not reported) of MENACTRA, sanofi pasteur lot number U3840AA and an injection (route and site not reported) of GARDASIL, Merck lot number not reported. The patient had no known allergies, no history of any medical conditions, had no other vaccines within 4 weeks, had no adverse events following prior vaccinations and took no medications. The patient received MENACTRA and GARDASIL about 9:00 AM on 09 May 2011. The mother called to report at 9:00 PM on 09 May 2011 that the patient was experiencing swelling of the face, tenderness, burning sensation, and vaginal irritation. The patient was seen by a physician on 11 May 2011 for the swelling of the lower area of the face which was mostly on the cheeks, tenderness, burning sensation, vaginal irritation and hives on the inner forearms. The patient was treated with BENADRYL. The outcome was reported as not recovered. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Urticaria, Vulvovaginal burning sensation, Vulvovaginal discomfort
Clinical narrative: Initial report received from a health care professional on 11 May 2011. An 11-year-old female child received on 09 May 2011 an injection (route and site not reported) of MENACTRA, sanofi pasteur lot number U3840AA and an injection (route and site not reported) of GARDASIL, Merck lot number not reported. The patient had no known allergies, no history of any medical conditions, had no other vaccines within 4 weeks, had no adverse events following prior vaccinations and took no medications. The patient received MENACTRA and GARDASIL about 9:00 AM on 09 May 2011. The mother called to report at 9:00 PM on 09 May 2011 that the patient was experiencing swelling of the face, tenderness, burning sensation, and vaginal irritation. The patient was seen by a physician on 11 May 2011 for the swelling of the lower area of the face which was mostly on the cheeks, tenderness, burning sensation, vaginal irritation and hives on the inner forearms. The patient was treated with BENADRYL. The outcome was reported as not recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from a physician on 20 May 2011. A 17-year-old female patient had received an intramuscular right deltoid injection of MENACTRA (lot number U3556AA) on 19 May 2011 and the next morning she called the physician's office to report she had a fever, headache, nausea, and right arm and neck pain. She was being evaluated that day in the office. It was unknown if the patient had received any other vaccinations with 4 weeks prior to 19 May 2011. No relevant diagnostic tests and/or laboratory data were completed as of 20 May 2011. The patient had no concurrent illnesses or pre-existing medical conditions at time of vaccination. She was however taking birth control medication (not identified). The patient had not experienced any adverse events with prior vaccinations. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 23 May 2011 the subject received unspecified dose of KINRIX at 0.5 ml in the left arm. On 26 May 2011, 3 days after vaccination with KINRIX, the subject experienced swelling, erythema and fever. The events were indicated to be local injections site reactions. At the time of reporting the events were unresolved. In the reporter's opinion, the events were probably related to treatment with KINRIX. Follow-up information was received on 14 June 2011. It was reported that the subject experienced a local reaction at the injection site the day following administration of KINRIX, on 24 May 2011. The reaction included swelling, erythema and fever. The events resolved by 30 May 2011. In the reporter's opinion, the events were probably related to treatment with KINRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 02 May 2011 the subject received unspecified dose of KINRIX at 0.5 ml in the left arm. On 05 May 2011, 3 days after vaccination with KINRIX, the subject experienced swelling, erythema and fever The events were indicated to be local injections site reactions. At the time of reporting the events were resolved. In the reporter's opinion, the events were probably related to treatment with KINRIX. Follow-up information was received on 14 June 2011. It was reported that the subject experienced a local reaction at the injection site the day following administration of KINRIX, on 03 May 2011. The reaction included swelling, erythema and fever. The events resolved by 10 May 2011. In the reporter's opinion, the events were probably related to treatment with KINRIX.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Injection site erythema, Injection site induration, Localised infection
Clinical narrative: This case was reported by a physician and described the occurrence of edema of eyelid in a 48-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced edema of eyelid, injection area hardness, redness and localized infection. At the time of reporting the outcome of the edema of eyelid, hardness injection site, injection site redness and localized infection were unspecified.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pain in extremity, Toothache
Clinical narrative: This case was reported by a physician and described the occurrence of arm soreness in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included high blood pressure. Concurrent medications included unspecified blood pressure medication. On 26 October 2010 the subject received 1st dose of FLUARIX in the right deltoid. On 27 October 2010, 1 day after vaccination with FLUARIX, the subject experienced arm soreness (subject complained of injection site soreness) and swelling at the injection site. The subject was advised to treat with ADVIL and compression to injection site. The next day, on 28 October 2010, the subject complained of sustained tooth-achy type sensation (toothache intermittently). As of 11 November 2010, more than two weeks following onset of events, the patient continued to complain of sustained tooth-achy type of sensation; upper arm to nape of neck. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with FLUARIX. No further details were available at the time of reporting.
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of nausea in a male subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Influenza vaccine (unknown). It was reported that the vaccine was a combination of H1N1 shot. An unspecified amount of time after vaccination with Influenza vaccine, the subject experienced nausea, diarrhea and vomiting. At the time of reporting the events were resolved. This adverse event was reported during the course of follow-up with regard to a reaction to AVODART. The subject happened to mention that he received a combination H1N1 shot with the above adverse events reported. Refer to case number A0885456A for details surrounding vents with AVODART treatment.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Condition aggravated
Clinical narrative: This case was reported by a physician and described the occurrence of arthritis in a 59-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline). Concurrent medical conditions included chronic pain, degenerative arthritis, joint pain and low back pain. Concurrent medications included PERCOCET, CIPRO, PROVIGIL, PHENERGAN, NEXIUM, MAVIK, EPIMORPH, SENNA, Vitamin D (5000 units), Vitamin B Complex, One-a-day vitamins, Baby aspirin, Iron, CITRACAL + D, DHEA and Vitamin B-12. On 15 October 2010 the subject received a dose of Flu vaccine (unknown). On 16 October 2010, 1 day after vaccination Flu vaccine (within 24 hours of receiving Flu vaccine), the subject experienced severe arthritis. The subject was treated with Prednisone taper. At the time of reporting the event was unresolved. the physician considered the event was possibly related to vaccination with Flu vaccine. It was reported that the Flu vaccine was not administered at the office reporting and the reporter did not know the contact information of the facility at which the vaccine was given. No lot number of expiration date were known. The exact vaccine that was given was not known (FLUARIX or FLULAVAL), just that it was a GlaxoSmithKline flu vaccine. The subject was referred to a rheumatologist.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Facial pain, Nuclear magnetic resonance imaging normal, Trigeminal neuralgia
Clinical narrative: This case was reported by a consumer and described the occurrence of neuralgia-trigeminal in a female patient who received VERAMYST aqueous spray for an unknown drug indication. A physician or other health care professional has not verified this report. On 2007 the patient started Fluticasone furoate (each nostril/both nostrils), unknown dosing. At an unknown time after starting Fluticasone furoate, the patient experienced neuralgia-trigeminal and facial pain. The patient was treated with NEURONTIN. At the time of reporting, the outcome of the events was unknown. The patient said she used VERAMYST since it was marketed (2007) and wondered if there could be a relation between it and the trigeminal pain she has on her cheek along the side of the nose and centers around the sinus area. She asked if there had been any reports like this with VERAMYST. Follow up information received from the patient on 03 January 2011. The patient provided the lot number for the product. The patient reported that on an unspecified date, about two to three weeks before the events occurred, she also had a flu shot (details unknown, unspecified manufacturer). The patient stated that she did not think that VERAMYST caused any problems and that she was only inquiring if there were any other reports of trigeminal neuralgia. Follow-up information was received on 27 January 2011. It was reported that the subject was a 64 year old female. Event onset was 08 November 2010. At the time of reporting, the events were improved. Attribution of events to treatment with VERAMYST and the flu shot was unknown. In the reporter's opinion, the events may have been idiopathic. Medical history included diabetes mellitus type 2, hypertension and hypothyroidism. There was no history of alcohol or tobacco use.
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection arm pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 17 September 2010 the subject received a dose of FLUARIX (.5 ml, unknown route, left arm). On 19 September 2010, 2 days after vaccination with FLUARIX, the subject experienced injection arm pain. She also experienced decreased range of motion in the arm where the injection was administered. The subject did not seek medical care until 2 months post vaccination. At the time of reporting the events were improved.
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Vaccination complication
Clinical narrative: This case was reported by a physician (an allergist) and described the occurrence of local reaction to flu vaccine in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (2009 vaccine). At an unspecified time after vaccination with FLUARIX, the subject experienced local reaction to flu vaccine. The physician reported that the subject received the 2009 FLUARIX vaccine and experienced a large localized reaction. At the time of reporting the outcome of the event was unspecified. The lot number was reported as AFLUAS00BA from the reporter; however based on a safety lot number review, the lot number was updated to AFLUA500BA.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pain and muscle pain/aches. The subject was told by her primary care provider that the events were a "chemical reaction from the vaccine" and that she should not receive the vaccine again. The subject was treated with Steroids. At the time of reporting, she had finished "2 packs" and was currently being treated with a 3rd pack. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 2 employees experienced adverse events including muscle pain and aches after receiving FLUARIX. See case ID A0899572A for details of the other report.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pain and muscle pain/aches. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 2 employees experienced adverse events including muscle pain and aches after receiving FLUARIX. See case ID A0899571A for details of the other report.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 71-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included SYNTHROID, Cerefolin with Nac, ZONEGRAN, WELCHOL, TRILIPIX, CRESTOR, Bisoprolol,  BONIVA, NIASPAN, Baby aspirin and CoQ-10. On 15 December 2010 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm).  On 15 December 2010, two hours after vaccination with FLUARIX, the subject experienced injection site redness and swelling injection site. The subject was administered FLUARIX by her daughter, who is also a nurse practitioner. Approximately two hours later, the subject reported redness at injection site and swelling at the injection site. The subject was treated with ice on the site. At the time of reporting the injection site redness and swelling injection site were improved in approximately five days. Follow-up information was received on 07 January 2011. It was reported that the subject experienced a site reaction with injection site redness and swelling. The events began on 15 December 2010 and resolved on 20 December 2010. The events were considered possibly related to treatment with FLUARIX. The subject had no history of drug allergies and no history of alcohol or tobacco use.
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Nonspecific reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of nonspecific reaction in a 75-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified), Herpes zoster vaccine. A physician or other health care professional has not verified this report. The subject's concurrent medical conditions included breast cancer, allergy and dermatomyositis. On an unspecified date in 2010 the subject received a dose of Influenza vaccine (unknown) and later on an unspecified date the subject received unspecified dose of Herpes zoster vaccine (unknown). In 2010, at an unspecified time after vaccination with Influenza vaccine, the subject experienced "a reaction to the flu vaccine last year" [nonspecific reaction]. Her physician wanted her to received the Shingles vaccination later; on an unspecified time after vaccination with Herpes zoster vaccine, the subject experienced "had an increased reaction the second time. It was 4.5 inches by 4.5 inches" [nonspecific reaction]. She was advised by her physician advised to discontinuing receiving all vaccines. At the time of reporting the outcome of the nonspecific reaction was unknown.
Age: 27.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Drug exposure during pregnancy, Incorrect dose administered, Injection site pain
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of injection site soreness in a 27-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified), BOOSTRIX while pregnant. On 13 December 2010 the pregnant subject received a dose of Flu vaccine (unknown) as well as a 1st dose of BOOSTRIX at 0.5 ml in the left arm. On 12 January 2011 the pregnant subject inadvertently received a 2nd dose of 0.5 ml BOOSTRIX in the left arm. This was an extra dose of BOOSTRIX. The subject experienced vaccine exposure during pregnancy. On 12 January 2011, less than one day after vaccination with BOOSTRIX, the subject experienced injection site soreness (arm). At the time of reporting the events were unresolved. The healthcare professional considered that injection site soreness was probably related to vaccination with BOOSTRIX. The subject's date of last menstrual period and estimated date of delivery were not provided. The outcome of pregnancy was not known.
Sex: M
Vaccine: FLUX
Symptoms: Sleep apnoea syndrome
Clinical narrative: This case was reported by a consumer and described the occurrence of sleep apnea in an adult male subject who was vaccinated with Flu vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after vaccination with Flu vaccine, the subject experienced sleep apnea. The subject, who is in the military, "received H1N1 and developed sleep apnea round that time". The reporter refused to provide any information and she was not sure which manufacturer's flu vaccine the subject received in the military. At the time of reporting the outcome of the sleep apnea was unspecified.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling injection site in a 58-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). On 28 March 2011 at 12:00 the subject received unspecified dose of Flu vaccine (.5 cc, unknown route, right arm). On 29 March 2011, 1 day after vaccination with Flu vaccine, the subject experienced swelling injection site and injection site tenderness. At the time of reporting the events were unresolved. The physician was asking for recommendations to treat the site of the vaccine and provided no further information.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Syncope event after receiving Tdap. Client had momentary fainting spell. No obvious injury to head or body. Pt denies hitting head. Able to speak and move right after incident. C/o lightheadedness. Was assisted to clinic room for further eval. Neuro check & VS monitored. Clts BP remained low, so given liquids & rest until stable.
Age: 42.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Muscle tightness, Pain in jaw
Clinical narrative: Initial report was received on 25 February 2011 from a health care professional. A 42 year-old male patient with no reported past medical history, had received on 10 February 2011 at 6:30 PM an intramuscular upper right deltoid injection of ADACEL, lot number U3553CA (sanofi pasteur Ltd. lot number C3677) and an intramuscular lower right deltoid injection of FLUZONE, lot number U3796AA and at 12:00 midnight on 11 February 2011, developed an acute onset of left jaw pain and tightness. No further information was available at the time of the report. The patient's outcome was reported as recovered on 13 February 2011 at 6:30 PM. Follow-up information received on 25 March 2011 from a health care professional. No diagnosis was given for the symptoms experienced by the patient. The etiology is not known. No relevant diagnostic testing was completed, and there were no results of medical evaluation or impressions. The patient recovered without treatment or intervention. Documents held by sender: none.
Age: 82.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Burning sensation, Feeling hot, Hyperaesthesia
Clinical narrative: Burning & hot, sensitive to touch. Tx Doxycycline x 10d.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Condition aggravated, Rash, Urticaria
Clinical narrative: Mom states that pt started with a rash that she describes as hives on bilateral upper extremities, back and torso.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Pt rec'd varicella vaccine in the left arm on 6/29 and pt states that  Thursday morning 6/30 that she noticed that it was sore, itching and getting swollen. Pt states that for 2 days it became progressively worse and warm to touch.
Age: 1.23
Sex: F
Vaccine: MMR
Symptoms: Ear infection, Injection site rash, Irritability, Rash
Clinical narrative: Very fussy, slight fever, then rash starting on her trunk and spreading out to limbs and later face and head.  Also was diagnosed with an ear infection in both ears.
Age: 1.12
Sex: M
Vaccine: PNC13, TDAP, VARCEL
Symptoms: Convulsion, Cyanosis, Drooling, Dyspnoea, Febrile convulsion
Clinical narrative: My baby was drooling excessively, he was lethargic and lifeless. He was seizing and he could barely breathe and his lips were turning blue. The doctors said that it was more than likely a febrile seizure brought on by the chicken pox vaccine that he received 5 days earlier. This was by far the scariest day of my life and I will be discouraging this vaccine to everyone I know.
Age: 1.12
Sex: M
Vaccine: PNC13, TDAP, VARCEL
Symptoms: Feeling abnormal, Lethargy
Clinical narrative: My baby was drooling excessively, he was lethargic and lifeless. He was seizing and he could barely breathe and his lips were turning blue. The doctors said that it was more than likely a febrile seizure brought on by the chicken pox vaccine that he received 5 days earlier. This was by far the scariest day of my life and I will be discouraging this vaccine to everyone I know.