chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/17/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/11/03. On 11/11/03, the vaccinee inadvertently received Fluvirin 0.5ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 4/27/04: A follow up report was received from a health care professional indicating that she left a message with the vaccinees parents requesting them to call if the vaccinee had experienced any adverse symptoms. The reporter did not receive a call back. No follow up pending; all information received.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: A report was received form a health care professional on 11/17/03 concerning a 27 year old female vaccinee who experienced mild itchy rash 6 hours after receiving Fluvirin on 11/10/03. On 11/10/03, the vaccinee experienced a mild itchy rash that started on the arms and progressed to the chest and back. Diphenhydramine hydrochloride and loratadine were prescribed for symptomatic relief. The vaccinee had not recovered at the time of the report. The vaccinee had no prior history of allergies and had received Influenza vaccine on an unspecified date in 2002. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/17/03 concerning a male vaccinee of unknown age who inadvertently received 1ml Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received Fluvirin 1ml IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 4/12/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. No follow up pending, no further information available.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/17/03 concerning a group of approximately 18 vaccinees who inadvertently received Fluvirin SC between 11/4/03 and 11/5/03. Between 11/4/03 and 11/5/03, approximately 18 vaccinees were administered Fluvirin SC. All vaccinees were in good health at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a consumer on 11/17/03 concerning a 48 year old female vaccinee who inadvertently received expired Fluvirin on 11/17/03. On 11/17/03, the vaccinee inadvertently received expired Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Medication error, Vomiting
Clinical narrative: A report was received from a health care professional on 11/17/03 concerning 2 vaccinees of unspecified demography who experienced vomiting and diarrhea an unspecified length of time after inadvertently receiving Fluvirin SC between 11/4/03 and 11//03. Between 11/4/03 and 11/5/03, 2 vaccinees experienced vomiting and diarrhea after receiving Fluvirin SC. The vaccinees missed work for 3 days after receiving the vaccine. The vaccinees recovered on an unspecified date. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 0.62
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a consumer on 11/18/03, concerning a 6.5 month old male vaccinee who inadvertently received Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. Follow up pending.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/18/03, concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received 0.5ml Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/13/04: A follow up report was received from a health care professional indicating that no adverse events had occurred at the time of reporting. Follow up pending.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Hypoaesthesia, Paraesthesia
Clinical narrative: A report was received from a health care professional on 11/18/03, concerning a female vaccinee in her 30s who experienced a cold sensation and numbness on the left side of her face neck and arm one hour after receiving Fluvirin on 11/18/03. On 11/18/03, the vaccinee received Fluvirin 0.5ml. One hour later the vaccinee complained of a cold sensation and numbness on the left side of her face, neck and arm. There was insufficient information to determine the reporter's causality assessment. Update 4/19/04: A follow up report was received from a health care professional indicating that the 34 year old female vaccinee experienced paraesthesia with cold sensation and numbness on the ipsilateral side of her face, neck, and arms. The vaccinee was referred to a primary care physician for examination and no neurological defect was noted. The vaccinee recovered on an unspecified date. The vaccinee had no previous exposure to Fluvirin. The reporter has assessed the relationship of the vaccinee to the events as probable. No follow up pending, all information received.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/18/03, concerning a 3 year old vaccinee of unknown gender who inadvertently received Fluvirin on 11/11/03. On 11/11/03 the vaccinee received 0.25ml Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/19/04: A follow up report was received from a health care professional indicating that the 3 year old female vaccinee received Fluvirin on 11/10/03 approximately. No follow up pending, all information received.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: A report was received from a health care professional on 11/10/03, concerning a 35 year old female vaccinee who developed erythema at the injection site on 10/10/03 after receiving Fluvirin vaccine on 10/09/03. On 10/10/03 the vaccinee developed erythema at the injection site after receiving Fluvirin on 10/9/03. The event resolved 2 days later. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat within 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, within one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sinffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that a 66 year old vaccinee received Fluvirin on 11/9/03. on 11/15/03, the patient also experienced a high temperature of 100 degrees, nasal drainage and had a productive cough. The patient recovered from these events on 11/20/03. Follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that an 88 year old vaccinee received Fluvirin on 11/10/03. On 11/12/03 the patient also experienced a productive cough and lung congestion. These events in addition to the sore throat resolved on 11/19/03. Follow up pending.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that the 78 year old vaccinee received Fluvirin on 11/3/03 and also experienced on 11/12/03 a high temperature of 99 degrees, moist cough, emesis and shortness of breath. The vaccinee recovered from these events on 11/17/03. Follow up pending.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that the 78 year old vaccinee received Fluvirin on 11/3/03 and also experienced on 11/12/03 a high temperature of 99 degrees, moist cough, emesis and shortness of breath. The vaccinee recovered from these events on 11/17/03. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report received from a health care professional on 11/19/03, concerning an unspecified number of children aged less than 4 years of age of unknown sex who inadvertently received Fluvirin on an unspecified date. On an unspecified date, an unspecified number of children aged less than 4 years of age inadvertently received Fluvirin. The reporter did not know if any of the children had experienced adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 50 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 32 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 29 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 50 year old female vaccinee who experienced a localized red wheal at the injection site which was raised, itchy and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, 4x4 inches in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Cold sweat, Coma, Dyspnoea, Eye movement disorder, Feeling cold
Clinical narrative: Seriousness Criteria: Other- Medically Significant (OMIC) From initial information received on 02/Dec/2004 from a HCP regarding an adverse event occurring, it was reported that a 41-year-old male pt received a YF-VAX vaccination, lot number UE181AA, administered subcutaneously in the upper right arm on 02/Dec/2004. At the time of vaccination the patient was also taking Tylenol or Advil. The pt had no illnesses at the time of vaccination, nor did he have any pre-existing physician diagnosed allergies, birth defects or medical conditions. His last Yellow Fever vaccination was eight years ago. Reportedly within 60 seconds of vaccination the pt became pale, cold, and clammy, his eyes rolled back and he became unresponsive with labored breathing and general body tremors which lasted approximately 45 seconds. Upon treatment at the hospital ER the pt was awake, alert and oriented. Reportedly the pt recovered from this experience.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Pallor, Tremor
Clinical narrative: Seriousness Criteria: Other- Medically Significant (OMIC) From initial information received on 02/Dec/2004 from a HCP regarding an adverse event occurring, it was reported that a 41-year-old male pt received a YF-VAX vaccination, lot number UE181AA, administered subcutaneously in the upper right arm on 02/Dec/2004. At the time of vaccination the patient was also taking Tylenol or Advil. The pt had no illnesses at the time of vaccination, nor did he have any pre-existing physician diagnosed allergies, birth defects or medical conditions. His last Yellow Fever vaccination was eight years ago. Reportedly within 60 seconds of vaccination the pt became pale, cold, and clammy, his eyes rolled back and he became unresponsive with labored breathing and general body tremors which lasted approximately 45 seconds. Upon treatment at the hospital ER the pt was awake, alert and oriented. Reportedly the pt recovered from this experience.
Age: 0.85
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Lung disorder, Otitis media, Pyrexia
Clinical narrative: Approximately 3 AM on morning following vaccine administration, pt experienced generalized tonic-clonic seizure of duration approximately 45 minutes. Transported to ED via EMS. Received Ativan x 2 dose and phenobarbital and admitted to pediatric ICU. Fever noted on presentation to ED. Discharge Summary received 1/06/2005 states inflammed tympanic membrane and rhonci.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Chest pain, Electrocardiogram abnormal, Laboratory test abnormal, Transient ischaemic attack, Vomiting
Clinical narrative: After Flu and Hep A vaccines, pt complained of chest pain, had emesis. ST - T changed on EKG and elevated troponin level suggestive of transient ischemia, required admission. Discharge Summary received on 1/13/2005 states lab test abnormal.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Severe swelling airway, SOB. Began about 24 hours after vaccine administered. To ED; treated with IV Solumedrol, IV Benadryl, PO Prednisone, PO Benadryl. Recovered completely. Follow Up: Diagnosis in ER was anaphylaxis. Patient was seen in ER 48 hourss/p vaccine receipt. Pt has history of mild egg allergy, but has received flu vaccine x 3 without AE.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Rash
Clinical narrative: About 6 hrs pt broke out rash, itching, advised, per Dr. take Benadryl as directed.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Tongue oedema
Clinical narrative: Short of breath treated in ER swollen tongue 5 days of steroids antihistimines
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Insomnia, Throat tightness
Clinical narrative: Symptoms started with a cough that after 4 hours became a restrictive cough c/o headache and fatigue. Difficulty going to sleep that night due to cough and tightness of airway used Albuterol inhaler a total of 3 times, symptoms resolving 24 hours later. Albuterol is pt's own medication.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Paraesthesia, Rash maculo-papular, Urticaria
Clinical narrative: After receiving flu vaccine, 10 min later, c/o splotchy, reddened area with soreness at site. Also c/o tingling around mouth 10 min later hives developing lower R arm. Diphenhydramine 25mg/.5cc IM given.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: 8x5cm oval red warm area, not tender, slightly indurated
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Injection site pain, Myasthenic syndrome
Clinical narrative: About 2 1/2 hours after the flu shot, I felt severe pain in my left shoulder (right shoulder too but left). My left arm was painful and useless for the next 7 days. My doctor said the needle may have scraped my muscle because there was black and blue mark 1 inch wide. The vaccine maybe fighting off something.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dysuria, Micturition urgency, Muscle spasms
Clinical narrative: Had flu shot at 10:30AM on Oct 30th 2004 at the above location. Left to go shopping at mall. At 3:00PM notice urgent need to pass urine and when I did there was burning and spasms when urination ended. I'm not a frequent UTI pt and have only had UTI 3-4 in my lifetime. Drug 412105 smz tmp 800 160 20TAB. Recovered after taking antibiotic for 10 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Tenderness
Clinical narrative: 3.0 x 3.5 cm area of erythema very hard and tender to touch.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: This is a non-serious case from a medical assistant in the USA who reports a patient experienced cough after receiving FluMist. The reporter did not assess causality between events and FluMist vaccination. This case is being submitted according to the safety surveillance accelerated reporting agreement for FluMist. Within 24 hours of receiving FluMist on 11/5/04, a 44 year old male experienced cough, headache, runny nose, fatigue, fever, and chills. The patient was treated with OTC products and has recovered.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: This is a non-serious case from a medical assistant in the USA who reports a patient experienced cough after receiving FluMist. The reporter did not assess causality between events and FluMist vaccination. This case is being submitted according to the safety surveillance accelerated reporting agreement for FluMist. Within 24 hours of receiving FluMist on 11/5/04, a 44 year old male experienced cough, headache, runny nose, fatigue, fever, and chills. The patient was treated with OTC products and has recovered.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Cough, Fatigue, Medication error, Pharyngolaryngeal pain
Clinical narrative: This is not a serious case from a nurse in the USA of involving accidental exposure. The reporter causality is not reported to FluMist. The case qualifies for accelerated reporting. This case is a case of possible accidental expoure to the FluMist vaccine. A parent called to report that she had developed sore throat, cough, weakness, and fatigue with onset beginning the same day of administration (see MEDI0002477). While reporting her own adverse event she also stated that her 14 year old daughter also experienced sore throat, cough, weakness, and fatigue beginning four days after the mother was vaccinated on 11/10/04. The child did not receive the vaccine, and was fully recovered on 11/20/04.
Age: 56.0
Sex: M
Vaccine: MMR
Symptoms: Autoimmune disorder, Laboratory test abnormal, Lethargy, Oedema
Clinical narrative: 2 wks after MMR, developed lethargy and edema. Hospitalized 10/30-11/3 with acute glomerulone periods. Kidney bx done= no sclerosis. Dx'ed by MD at hospital with autoimmune response to MMR, hospitalized again 11/15-11/19 for IV Prednisone high dose, continues on Prednisone and QOD lab tests for BUN and Creatinine.
Age: 1.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Scattered excoriated lesions trunk, varicella , vesicular lesion scalp.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Crying, Screaming
Clinical narrative: Baby had 3h of inconsolable, hyperintense totally uncharacteristic crying last Dtap vaccine. Dr advised that this is generally considered a contraindication to Pertussis.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Gait disturbance, Visual disturbance
Clinical narrative: 12/2/04 09:30 received hep B vaccine within 5-10 min became dizzy, blurred vision, general weakness all over BP 120/50 P 82. Laid pt down feet elevated. Pt in office til 12Noon. Attempted to change pt's position, not tolerated well. Given juice and food, 12 Noon, disch. to ECU, upper extremities fine, lower extremities gait unstable, legs feel heavy.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash
Clinical narrative: Rec'd Hep B #1 at approx 2:00PM, 11/2/04. Reports had rash to fever at 8:00PM same day, went to ER rec'd Benadryl, steroid shot.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hyperkinesia, Injection site erythema, Injection site oedema
Clinical narrative: Swelling/redness left arm laterally, non tender, range of motion left elbow
Age: 12.0
Sex: F
Vaccine: MMR, TD
Symptoms: Feeling hot, Injection site oedema, Skin nodule, Tenderness
Clinical narrative: Rt deltoid area became swollen (up to golf ball size), warm to touch, very tender and sensitive nodule, Ibuprofen 200 mg 2 tab periodically for 3-4 days.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: PAINFULL TO THE TOUCH SWELLING ON RIGHT ARM ABOVE ELBOW.  RED RASH.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Skin nodule, Urticaria
Clinical narrative: Child developed wheals (raised,irregular nodules) near eyes, right cheek, posterior neck, arms, and abdomen, approx. 15-20 mins. after vaccines given. Instructed mo. to take child to ED if unable to be seen stat by PMD.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: The R.N. received a flu vaccine prior to going home after night tern.  After she woke up, late afternoon, she noticed a generalized rash and itching hives.  She took a Benadryl capsule.  No fever was noted or any other symptoms.  Within a few hours, the symptoms were resolved. Symptoms resolved within 24 hrs. Rash and hives were initially noted to left arm then  later to front of the legs and stomach very sparsely.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pain
Clinical narrative: Received flu vaccine 11/15/04 and since then has had achiness in hands, elbows and legs accompanied by a warmness in hands. Physician has given her an antibiotic.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Laboratory test abnormal, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: Fever with myalgias 10/18/04 HA ,10/19/04 stiff neck, 10/25/04 rash pruritic, 10/28/04 worsening of rash, myalgias continue, 11/1/04 rash persists, neck pain, 11/8/04 getting better, 11/23/04 adverse symptoms resolved, 12/7/04 tingling of hands, stiff in back/shoulders. Follow up 12/9/04: Treatments have included Tylenol #3 PRN for headache and body ache relief. Benadryl PRN for relief of rash, Ibuprofen PRN for shoulder and neck pain. Medrol Dose pack. 10/28/04 Prednisone 60 mg x5 days, 50mg for 3 days, 40mg for 3 days, 30 mg fpr 3 days, 20 mg for 3 days, 10 mg for 3 days on 11/01/04. Symptoms resolved with use of above measures but for short periods and them to return. Follow up 12/21/04: Update on possible adverse reaction to flu vaccine; 1. Patient had a + lyme titer on 12/10/04, 2. confirmation of + lyme titer by western blot on 12/15/04, 3. patient now being trated with Doxycyline 100mg  for 1 month, 4. Patient to see rheumatologist for evaluation of symptoms on 01/03/05.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pyrexia, Rash pruritic
Clinical narrative: Fever with myalgias 10/18/04 HA ,10/19/04 stiff neck, 10/25/04 rash pruritic, 10/28/04 worsening of rash, myalgias continue, 11/1/04 rash persists, neck pain, 11/8/04 getting better, 11/23/04 adverse symptoms resolved, 12/7/04 tingling of hands, stiff in back/shoulders. Follow up 12/9/04: Treatments have included Tylenol #3 PRN for headache and body ache relief. Benadryl PRN for relief of rash, Ibuprofen PRN for shoulder and neck pain. Medrol Dose pack. 10/28/04 Prednisone 60 mg x5 days, 50mg for 3 days, 40mg for 3 days, 30 mg fpr 3 days, 20 mg for 3 days, 10 mg for 3 days on 11/01/04. Symptoms resolved with use of above measures but for short periods and them to return. Follow up 12/21/04: Update on possible adverse reaction to flu vaccine; 1. Patient had a + lyme titer on 12/10/04, 2. confirmation of + lyme titer by western blot on 12/15/04, 3. patient now being trated with Doxycyline 100mg  for 1 month, 4. Patient to see rheumatologist for evaluation of symptoms on 01/03/05.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 45 min post vaccine: hives x3 on neck interior, 1 1/2 hours post vaccine: resolution of above after elimination of Diphenhydramine 12.5/5ml 10ml PO 15 min after onset of sxs.
Age: 41.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Headache, Malaise, Skin ulcer
Clinical narrative: Per pt 30 or more lesions, headache, no fever, just didn't feel too well. Resolved prior to pt reporting.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site mass, Injection site oedema
Clinical narrative: Left deltoid swollen and hard, no treatment needed.
Age: 2.0
Sex: U
Vaccine: DTAP, HEPA, HIBV
Symptoms: Oedema
Clinical narrative: Left deltoid swelling, no tenderness, no tx needed.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Injection site reaction
Clinical narrative: Localized reaction, no tx needed.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness
Clinical narrative: Pt felt dizzy, 10 min after receiving immunization. Rested and given juice. Recovered and left clinic. 4 hrs later symptoms returned and he was advised to go to ER. Pt did not see another MD but recovered at home.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dry skin, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Site of injection became red, sore, swollen. Swelling eventually involved entire upper arm. Skin became crusted. Client did not see doctor, she used ice packs on arm. Condition lasted 5 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Injection site erythema, Injection site mass
Clinical narrative: Erythema, induration and blistering at immunization site 24 hrs after given.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Temp 102 (highest) onset next day with mini swelling at site of injection Dtap, no other sites involved.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Mild erythema from distal deltoid to mid humerus mild tip. Not not no swelling.
Age: 1.03
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Likely breakthrough varicella , with ? 70-75 spots
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 46 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 27 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up  pending.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 51 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a healthcare professional on 11/19/03 concerning a 53 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to the touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 37 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 47 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half dollar in size, raised and warm to the touch. The vaccine had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: U
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning approximately 60 children ranging from 6 months to 3 years of age of unknown sex who inadvertently received Fluvirin between October 2003 and November 2003. Approximately 60 children under 4 years of age inadvertently received Fluvirin between October 2003 and November 2003. At the time of the report no adverse events had occurred. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a 6 month old female vaccinee who inadvertently received Fluvirin sometime during the week of 11/10/03. On an unspecified date in November 2003, a 6 month old female vaccinee inadvertently received Fluvirin. At the time of the report, no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Bone pain, Eye pain, Fatigue, Headache
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccine of unknown age who experienced total body aches, malaise, and fever after receiving Fluvirin on an unknown date. On an unknown date, the vaccinee experienced total body aches, malaise, fever, and was bedridden for 4 days after receiving Fluvirin. This was the first time the vaccinee had been exposed to the influenza vaccine. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/23/03: An update report indicated that the vaccinee was a 56 year old male who experienced severe muscle, ligament and bone pain, a temperature of 102 degrees, extreme pain in the eyes with headache which lasted for 5 days and muscle pain, fatigue, and weakness which lasted for 4 days after receiving Fluvirin on 10/10/03. No follow up pending.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning a male vaccine of unknown age who experienced total body aches, malaise, and fever after receiving Fluvirin on an unknown date. On an unknown date, the vaccinee experienced total body aches, malaise, fever, and was bedridden for 4 days after receiving Fluvirin. This was the first time the vaccinee had been exposed to the influenza vaccine. It was not reported if the vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 12/23/03: An update report indicated that the vaccinee was a 56 year old male who experienced severe muscle, ligament and bone pain, a temperature of 102 degrees, extreme pain in the eyes with headache which lasted for 5 days and muscle pain, fatigue, and weakness which lasted for 4 days after receiving Fluvirin on 10/10/03. No follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/19/03 concerning an approximately 50 year old male vaccinee who inadvertently received two doses of Fluvirin on 11/19/03. On 11/19/03 a vaccinee inadvertently received two doses of Fluvirin. The vaccinee he had not experienced any adverse events related to this incident at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 1.21
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/20/03 concerning a female vaccinee aged between 15 and 18 months who inadvertently received Fluvirin on 10/31/03. On 10/31/03 a vaccinee under 4 years of age inadvertently received Fluvirin. No adverse symptoms were experienced at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1/13/04: A follow up report was received from a health care profession indicating that the vaccinee was 14 months old at the time of vaccination. No adverse events had occurred at the time of reporting. No follow up pending, all information received.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/20/03 concerning a female vaccinee aged 2 years who inadvertently received Fluvirin on 11/5/03. On 11/5 a vaccinee under 4 years of age inadvertently received Fluvirin. No adverse symptoms were experienced at the time of the report. There was insufficient information to determine the reporter's causality assessment. A follow up report was received from a health care professional indicating that no adverse events had occurred at the time of reporting. No follow up pending, all information.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Medication error
Clinical narrative: A report was received from a health care professional on 11/20/03 concerning a male vaccinee in his 20's who experienced a red, swollen and warm to touch injection site immediately after inadvertently receiving Fluvirin via a needleless injector on 11/13/03. On 11/13/03 the vaccinee experienced a red, swollen and warm to touch injection site after inadvertently receiving Fluvirin via a needleless injector. The outcome of the events was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Medication error
Clinical narrative: A report was received from a health care professional on 11/20/03 concerning a male vaccinee in his 50's who experienced a redness at the site of injection 2 days after inadvertently receiving Fluvirin via a needleless injector on 10/20/03. On 10/22/03 the vaccinee experienced redness at the site of injection after inadvertently receiving Fluvirin via a needleless injector. The redness lasted a few days and had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Medication error
Clinical narrative: A report was received from a health care professional on 11/20/03 concerning a female vaccinee in her 50's who experienced a redness at the site of injection 2 days after inadvertently receiving Fluvirin via a needleless injector on 10/20/03. On 10/22/03 the vaccinee experienced redness at the site of injection after inadvertently receiving Fluvirin via a needleless injector. The redness lasted a few days and had resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Difficulty in walking, Hypotonia, Labyrinthitis
Clinical narrative: A report was received from a health care professional on 11/21/03 concerning a 48 year old female vaccinee who experienced labyrinthitis after she received Fluvirin on 11/17/03. On 11/17/03 the vaccinee received Fluvirin. One hour after vaccination the vaccinee felt limp and weak in her extremities and head but not dizzy. The vaccinee could not walk and went to the emergency room and was diagnosed with labyrinthitis. On 11/18/03 the vaccinee experienced the same symptoms again. On 11/19/03 the vaccinee did not have any symptoms when her physician advised her not to take her other medications. On 11/20/03 the vaccinee experienced 2 episodes of the same symptoms and also had difficulty in holding up her head. On 11/21/03 the vaccinee experienced 1 episode of the same symptoms with less difficulty in holding up her head. On 11/25/03 the vaccinee 's condition had greatly improved. There was insufficient information to determine the reporter's causality assessment. Update 2/2/04: A follow up report was received from a health care professional indicating that the vaccinees symptoms had resolved 8 days after onset, when the schedule of the vaccinees medications was changed. The medications are Valproic Acid, Venlafaxine HCl and Amitriptyline. No follow up pending, all information received.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/21/03 concerning a 53 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin intradermally on 11/21/03. On 11/21/03 the vaccinee inadvertently received 0.1ml Fluvirin intradermally instead of PPD vaccination. At the time of reporting the vaccinee did not exhibit any adverse events. There was insufficient information to determine the reporter's causality assessment. Update 3/8/04: Further information was received from a health care professional indicating that the vaccinee experienced a local reaction which resolved in 3 days without any lasting effects. The reporter has assessed the relationship of the vaccine to the event as probable. No follow up pending, all information received.
Age: 0.77
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: A report was received from a health care professional on 11/20/03 concerning an 8 month old male vaccinee who inadvertently received Fluvirin on 11/20/03. On 11/20/03, the vaccinee inadvertently received Fluvirin. The vaccinee had previously received a dose of Fluzone. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/19/04: A follow up report was received from a health care professional indicating that a second dose of Fluvirin was administered on 11/20/04. The vaccinee then returned in one week for 0.25ml of Fluzone. No further medical follow up was ordered by the physician. No adverse experiences were reported that the time of reporting. Update 2/24/04: A follow up report was received from a health care professional indicating that the vaccinee received Fluzone initially, followed by Fluvirin and finally a second dose of Fluzone was given 1 week after the inadvertent administration of Fluvirin. No adverse event had occurred at the time of reporting. No follow up pending, all information received.