chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Pain, Paraesthesia, Pyrexia
Clinical narrative: Initial report received on 24 October 2006 from the patient who is also a health care professional.  A 56-year-old female patient, with a past medical history of asthma, had received an intramuscular, left deltoid injection of Fluzone SV 2006-2007, lot number U2240AA, on 05 October 2006.  Six hours later, she developed a fever of 101 degrees Fahrenheit, body aches, and malaise.  Over the next two days, her temperature was 99 degrees Fahrenheit, and she continued to have body aches.  Four days post-vaccination, she experienced severe shoulder spasms which was treated with Motrin.  On 11 October 2006, the patient had severe muscle aches, muscle weakness in her back and sacrum, and difficulty walking due to muscle aches.  She was examined by her physician and treated with Motrin, and muscle relaxers x three days.  The patient was home from work due to fatigue from 06 October 2006 to 21 October 2006.  On 21 October 2006 and 22 October 2006, her toes and fingers were tingling.  As of 24 October 2006, the patient continued to have fatigue and muscle weakness in her back.  At the time of this report, the patient had not recovered.  Follow-up information received on 09 March 2007 from the patient who is also a health care professional.  The patient had no illness at the time of vaccination.  No diagnostic testing was performed.  The patient "has returned to work".  Recovery took several weeks.  Per the reporter, she is now recovered.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Mydriasis, Ocular hyperaemia
Clinical narrative: Pupil dilated, eye red.  Initial report received on 24 October 2006 from a health care professional.  A 30 year-old female patient, with a medical history of allergies, had received an intramuscular, right deltoid injection of Fluzone SV 2006-2007, on 23 October 2006.  There was no illness at the time of vaccination, and the patient was on no other medications.  The next day, she developed a red and dilated eye.  It was not specified which eye was effected.  The patient had not yet seen a physician.  The patient had not recovered.
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Pruritus
Clinical narrative: Initial report received from a physician on 25 October 2006.  A male patient (age not reported), developed swelling of the eyes and itching of the upper extremities, 1/2 hour after he received Fluzone (lot number U2199AA) on 23 October 2006.  He went to the emergency room (he works as an EMT and was at the hospital) and was treated with Prednisone and Benadryl.  He was not on any concomitant medications.  He has had similar reactions in the past but is unclear to what.  His symptoms have resolved.  Follow-up information received ion 27 December 2006 from a health care professional.  Under the description of the adverse event, the reporter had written "seasonal allergies".  No other medically relevant information was provided.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Initial case received on 25 October 2006 from a health care professional.  A 43-year old female patient, with a history of asthma and allergy to peanuts, had received a left deltoid, intramuscular injection of Fluzone SV 2006-2007, on 18 October 2006.  At an unspecified time post-vaccination, the patient developed a three inch swollen red area.  She complained it was hot and swollen; and, once the redness subsided, she complained of pruritus.  At the time of this report, recovery status was unknown.  Follow-up information received on 29 May 2007 from the patient who is a physician.  The patient had no illnesses at the time of the vaccination on 08 October 2006.  No relevant diagnostic tests or laboratory data were performed for the adverse events.  It was reported that the patient recovered from these adverse events (date of recovery was not provided).  No further information is expected.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pyrexia, Rash, Swelling face
Clinical narrative: A 2 year old male patient had received on 23 October 2006 Fluzone (lot number U2204AA), intramuscular, into the left deltoid (dose not provided). Within 24 hours, on 24 October 2006, the patient developed swollen and reddened area of the entire upper arm. The patient was seen by a physician on 24 October 2006 and treated with oral paracetamol (Tylenol) and Diphenhydramine hydrochloride (Benadryl). At the time of this report (26 October 2006) the patient had not recovered. The patient did not received any concomitant medications. The patient experienced fever, swollen face, hands and feet post vaccination with MMR and Varicella vaccines. Denies any illness at the time of vaccination. Denies concomitant medications. Possible allergy neomycin, denies other allergies. The patient had received Fluzone vaccine last year (2005). Follow-up information received on 12 December 2006. The Fluzone vaccine administered on 23 October 2006 was a 0.5 mL dose, and it was the third dose the patient had received. The patient had not received any other vaccinations within four weeks of that vaccination. Per the reporter the patient fully recovered from these adverse events. The patient experienced rash, not fever as previously reported with MMR and Varicella vaccines. No further information is expected.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pain, Pyrexia
Clinical narrative: Initial report received on 30 October 2006 from a health care professional.  A four-year-old female child, with a concurrent upper respiratory infection, and no known allergies, had received a fourth dose, left thigh, intra-muscular injection of FLUZONE SV '2006-'2007 USP, lot number U2237AA, on 27 October 2006.  Approximately four hours post-immunization, the patient developed a fever of 103.0 degree Fahrenheit, minimal cough, and complained of bilateral eye pain.  No diagnostics were performed, and treatments received were not reported.  The patient was evaluated by the physician three days later, and her neurological exam was normal, her eye pain was gone, and her fever had gone down to 101.0 degrees Fahrenheit.  No diagnostics were performed, and treatments received were not reported.  Reportedly, the patient had experienced a previous temperature of 103.0 degrees Fahrenheit at 18 months of age (2003) after receiving a vaccine (trade name of vaccine not reported).  At the time of this report, it was unknown if the patient had fully recovered from these adverse events.  The reporter for this case is the same as for cases 2006-02858, and 2006-02860.
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: A female patient (age not reported) experienced a "metallic taste in mouth" within 24 hours after receiving Fluzone (lot number U2242AA, date, route and site of administration not reported). It was unknown if the patient recovered. This case has the same reporter as case 2006-02857.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Headache
Clinical narrative: A 66-year-old male patient, with an allergy to dyes, and Celebrex; and who has reflux disease, had received a right deltoid, intra-muscular injection of FLUZONE SV "2006-2007" USP, lot number U2187AA, on 30 October 2006. Within one hour post-immunization, the patient experienced a strong metallic taste in his mouth. The next day, the metallic taste continued and he complained of a headache. He had no other complaints. Per the reporter, a 23 gauge, 1 inch needle was used for the injection. The patient did not seek medical attention, and no diagnostic tests or laboratory work were performed. At the time of this report, the patient had not recovered. Follow-up information received on 06 December 2006 from a health care professional. The patient recovered.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Cluster of 2 patients (patient identified in case 2006-02903; patient not identified in case 2006-02904).  This case has the same reporter as case 2006-02904.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Injection site itching.  Cluster of 2 patients.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Initial report received on 02 November 2006 from a health care provider.  An unspecified number of patients had received an intramuscular injection of Fluzone SV 2006-2007, lot number U2164AA, on unspecified dates.  "Black dots" were noted as soon as the needle was removed following administration of the vaccine.  The reporter was unsure of the number of patients that had experienced this event.  The syringe used was a BD safety glide, and the needle was a 25 gauge, one inch needle.  Recovery status was unknown.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial report received on 10 October 2006 from a health care professional.  A male patient (date of birth and age were not reported) had received a left deltoid, intra-muscular injection of FLUZONE SV '2006-'2007 USP, lot number unknown; and a left deltoid, intra-muscular injection of Pneumovax, manufacturer Merck, lot number not reported, on 09 October 2006.  Approximately five hours post-immunization, the patient developed redness and swelling approximately six inches below the arm pit to the elbow.  He denied any other symptoms or local reaction to the actual injection site.  He required medical evaluation, but diagnostics and treatments received were not reported.  At the time of this report, the recovery status of the patient was unknown.  Another patient at the same facility had the same type of reaction that is reported in case 2006-02657.  Follow-up information received on 17 November 2006 from a health care professional.  As per the reporter, it was "determined that it was not the flu shot, but the Pneumovax shot".  Further information is not anticipated.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pharyngolaryngeal pain
Clinical narrative: A 55-year-old male patient, with no known allergies, had received a dose of Fluzone SV 2006-2007 on 03/Oct/2006.  The route and site of administration were not reported.  Approximately 15 to 20 minutes post-immunization, the patient developed "throat discomfort" and tingling in his hands and face.  The patient denied any shortness of breath or difficulty in breathing.  Treatment received was not reported.  The recovery status of the patient was reported as unknown.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Pregnancy induced hypertension
Clinical narrative: Initial report received on 04 April 2007, from a health care professional.  A 29 year old female patient received on 16 December 2002, 0.5 ml Fluzone (lot #U0931AA) (site, side and route of administration not reported), to protect against flu.  The patient was pregnant at that time.  No adverse event was reported for the patient.  The patient delivered a baby (unknown gender) on 25 May 2003, vacuum assisted.  The child had developmental disabilities.  The patient's medical history included: hypothyroid and sclerosis.  The patient's concomitant medication included: Synthroid.  No other information was reported.  Follow-up information received on 02 July 2007 from a health care professional.  Fluzone SV 2002-2003 had been administered as a first dose, intramuscular, deltoid injection on 10 December 2002 (previously reported a 15 December 2002).  The patient had experienced pregnancy induced hypertension while in the hospital and was administered MgSO4.  The reporter had also indicated that the patient did not experience any adverse event.  Child case number is 2007-01043.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial report received on 04 June 2007 from a health care professional.  A 50-year-old male patient, with a cardiac history which included cardiac stint placement 18 months prior to vaccination, had received a left deltoid injection of Fluzone SV 2006-2007, lot number not reported, on an unspecified date.  On an unspecified date post-immunization, the patient experienced a metallic taste in his mouth.  There was no illness at the time of vaccination, and no further care was required.  At the time of the report, recovery status was not reported.  Follow-up information received on 16 July 2007 from a health care professional.  The patient was vaccinated on 02 November 2006, and the event was experienced on that day and the following day.  No diagnostic testing was performed.  Fluzone SV 2006-2007 lot number was U2193AA.  The duration of the event was 18 hours.  The patient recovered from the event.  The reporter in this case is the same as in cases 2006-02707 and 2007-02050.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial report received on 04 June 2007 from a health care professional.  A 53-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Fluzone SV 2006-2007, lot number not reported, on an unspecified date.  On an unspecified date post-immunization, the patient experienced a metallic taste in her mouth.  Medications included Claritin, "pseudopherine", and bio-identical hormone replacement.  No further follow-up was required after the vaccination.  At the time of this report, recovery status was not reported.  Follow-up information received on 30 July 2007 from a health care professional.  The date of vaccination was 30 October 2006, and the adverse event onset was 30 October 2006, four hours post-immunization.  The Fluzone lot number was U2193AA, and Fluzone was administered intramuscularly in the left deltoid.  Per the reporter, the duration of the event was 36-40 hours, and the patient recovered.  The reporter in this case is the same as in cases 2006-02707 and 2007-02049.
Sex: U
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: A cluster of over 100 patients out of an unspecified number of vaccinees from a hospital, who received Fluzone (lot number U2199AA) and experienced black dots at injection site.  Initial report received from a nurse at a hospital on 02-Nov-2006.  Over 100 unidentifiable patients received on an unspecified date, Fluzone (U2199AA) (multidose vial) into the deltoid (dose, side and route of administration were not reported) and experienced black dots at injection site immediately after the dose of was administered.  No corrective treatment was reported.  Patients outcome was not reported.  SafetyGlide 23g, 1", 25g 5/8 needles were used with Safety Glide syringe system (lot number for the needle used was not reported).  The alcohol brand was unknown, but the reporter said it was a generic brand, started with "M".  The black mark appeared all the way through using the vial, with no difference of the dose number.  The black spot appeared immediately after vaccination, it was unknown if it disappeared or how long it lasted.  The reporter had not ever seen this happen with any other product vial.  The black dots were noticed by all five nurses that administered the vaccines.  The reporter had not ever seen this happen in the past year.  The reporter did not track the incident, but was willing to do so if the event continued.  112 vials were purchased and 15 were used so far.  The event had been occurring routinely, but it was most noticeable on higher skinned people.  The reporter was not sure if it happened with every dose.  The reporter did not have any empty vials (all had been discarded), but stated they were doing many immunizations so they would have more empty vials by the end of the day (02 November 2006).  Concomitant vaccinations, medical history and prior exposure to Fluzone were not reported for the patients.
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pharyngolaryngeal pain
Clinical narrative: A cluster of 4 cases out of an unspecified number of vaccinees, who received Fluzone (lot number U2177AA) and experienced adverse events which reported by the same physician. Initial report received from a physician on 02 November 2006. Two unidentified patients received Fluzone (lot number U2177AA) on an unspecified date, into the deltoid (side, site and dose was not reported) and experienced sore throat, muscle and joint aches for one week. No corrective treatment was reported. The patients had recovered. The patients' medical history, concomitant vaccines and prior exposure to Fluzone were not reported. This report (for the two unidentifiable patients) has the same reporter as cases 2006-02938 and 2006-02641.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Muscular weakness, No reaction on previous exposure to drug
Clinical narrative: A 68 year old female patient received Fluzone (lot number U2243AA) on the first week of October 2006. Shortly after, the same day, she experienced upper arm discomfort and lower leg weakness. No corrective treatment was reported. The patient had recovered. No concomitant vaccines were reported. The patient had history of "RA" (probably Rheumatoid Arthritis). The patient had "many" previous doses of Fluzone with no reported symptoms. Follow-up information received on 11 December 2006. The patient was taking Plaquenil, Coumadin, Synthroid, Fosamax, Zetia, Wellbutrin, and HCTZ at the time of vaccination in October 2006. She had not received any other vaccinations within four weeks of that vaccination. No relevant diagnostic tests/laboratory data were performed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: A 34 year old, male patient (with a history of having many flu vaccine dose in the past) developed a "black ring around the needle injection site" immediately after he received an intramuscular, injection of Fluzone (lot number U2195AA) in the right deltoid on 03 November 2006. The RN who administered the vaccine reported seeing the adverse event. The patient had no pain. The nurse reported there was no sign of the "black dot" several hours later. One type of syringe, a B-D Safety Glide syringe, was used with a B-D 23 Gauge (lot number 604873) needle. Abco alcohol swipes out of "Mashbills, TW" were used. It was not known if the black marks appeared mostly at the first or second dose of the vial or more towards the end of the vial. It was not known low long the mark lasted. This has not been seen with any other product vial. There were 4 RN's vaccinating. This has not happened in the past years. Out of 50-60 doses given, she has een this 10-15 times. The patient were unaware, with no complaints. Follow-up information received on 05 February 2007. The reporter was not sure if the black mark occurred with the first or later doses. The black mark would go away after a few hours. No other known event occurred.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a nurse, on 03 November 2006.  A 53 year old female patient, received Fluzone (lot number U2164AA) into the left deltoid, on 01 November 2006.  A few hours after immunization, on 01 November 2006, the patient experienced red and swollen area, at injection site.  24 hours (post vaccination) (on 02 November 2006), the injection site was warm to touch.  48 hours (post vaccination), on 03 November 2006, the injection site was itchy and there was a 9-19 cm red area at the left deltoid, of the injection site.  No corrective treatment was reported.  At the time of the report (03 November 2006), it was unknown if the patient had recovered.  The patient's medical history included unspecified allergies.  The patient did not have any illness at the time of vaccination.  The patient's concomitant medications included Zyrtec and "Singulair".  Prior exposure to Fluzone was not reported.  Follow-up information received on 04 December 2006.  Per the reporter, the patient recovered from these adverse events as reported by a friend of the patient on 01 December 2006.  No further information is expected.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Initial report received from a health care professional, on 08 November 2006.  A 7 year old female patient, received on 31 October 2006 Fluzone (lot number U2239AA) (multidose vial), intra-muscular, into the right deltoid.  On 03 November 2006, three days later, she experienced red raised rash and itchiness at injection site.  No systemic reaction was reported.  The patient required a doctor visit.  Corrective treatment was not reported.  The patient's outcome was unknown.  No concomitant vaccinations were given.  No information on prior exposure to Fluzone was reported.  The patient had allergy to amoxicillin and no other medical conditions.  The patient's concomitant medications included "Zertec" as needed (PRN).  No illness at vaccination time were reported.  Follow-up information received on 12 March 2007 from a health care professional.  Number of previous doses of Fluzone SV 2006-2007 was none.  Concomitant medication was amended to Zyrtec (previously reported as Zertec).  At the time of this report, the patient had recovered.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pyrexia, Skin lesion, Upper respiratory tract infection
Clinical narrative: Initial report received from a health care professional on 09 November 2006.  A 46 year old, female patient developed "blister-like lesions), 24 hours after she received Fluzone (lot number U2251AA) intramuscularly in the right deltoid on 07 November 2006.  The "blister-like lesions" appeared on the opposite forearm, upper arm and trunk.  At the time of the report, it was unknown if the patient recovered.  Follow-up information received on 15 December 2006.  The patient did not have any illness at the time of vaccination.  The patient stated the lesions resolved approximately 2 weeks after the vaccine was given, but she did experience moderate URI symptoms with fever for 3 days after the vaccine which also resolved.  The patient recovered - approximately 21 November 2006.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dizziness, Erythema, Palpitations, Urticaria
Clinical narrative: Initial report received from a patient on 13 November 2006.  A 48 year old, female patient experienced hives red, burning sensation of hands, felt faint and palpitations, 2 days after she received Fluzone (lot number, site and route of administration not reported) on 02 November 2006.  She had an ear/sinus infection at the time of vaccination.  The signs and symptoms began 1/2 hour after she took Omniceph (antibiotic) for an ear infection.  The duration of the signs and symptoms was 2 hours.  As per the reporter, the patient recovered.  Follow-up information received on 11 December 2006 from a health care professional.  Fluzone SV 2006-2007, lot number U2248AA, was administered intramuscularly in the right deltoid.  The patient had an ear and sinus infection at the time of vaccination.
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cluster of 10 cases of injection site adverse event, out of unspecified vaccinees, who received Fluzone (lot number U2253AA).  The reporter was one of the patients.  Initial report received from a health care professional, on 13 November 2006.  A female patient received Fluzone (lot number U2253AA) (dose, site and side of administration not reported), on an unspecified date.  24-72 hours post vaccination, the patient experienced tenderness, redness and swelling at injection site, all of a size of 6 cm area.  The patient experienced a large bruise as well.  The patient recovered within approximately 24 hours.  No corrective treatment was reported.  Concomitant vaccinations, medical history and prior exposure to Fluzone were unknown.  The reporter is the same as in case 2006-03092.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein normal, Complement factor C3, Erythema nodosum, Nodule, Streptococcal identification test
Clinical narrative: Initial report received on 13 November 2006, from a physician, who contacted the company with request for medical information and to report an adverse event.  A 42 year old female patient, received Fluzone (lot number U2243AA) (multidose vial, site, side and dose not reported) on 02 November 2006, at the physician's office.  Two days later, on 04 November 2006, the patient experienced tender pretibial nodules on the right side.  On 09 November 2006, she was diagnosed with erythema nodosum.  No corrective treatment was reported.  At the time of the report (13 November 20060, the patient had not recovered.  Information on concomitant vaccines, prior exposure to Fluzone, illnesses at the time of the vaccination and medical history was not reported.  The patient took no prescription and had no over the counter medication recently.  Blood work was pending.  Follow-up information received on 15 December 2006.  The patient received 0.5cc Fluzone intramuscularly in the left deltoid.  It was unknown if the patient received Fluzone before.  She did not have any illness at the time of vaccination.  The reporter had a verbal follow-up with the patient on 07 December 2006, there was "no change".  The patient had negative blood work for C3, Compl. total, CRP, ASO.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Initial report received on 13 November 2006, from a physician, who contacted the company with request for medical information and to report an adverse event.  A 42 year old female patient, received Fluzone (lot number U2243AA) (multidose vial, site, side and dose not reported) on 02 November 2006, at the physician's office.  Two days later, on 04 November 2006, the patient experienced tender pretibial nodules on the right side.  On 09 November 2006, she was diagnosed with erythema nodosum.  No corrective treatment was reported.  At the time of the report (13 November 20060, the patient had not recovered.  Information on concomitant vaccines, prior exposure to Fluzone, illnesses at the time of the vaccination and medical history was not reported.  The patient took no prescription and had no over the counter medication recently.  Blood work was pending.  Follow-up information received on 15 December 2006.  The patient received 0.5cc Fluzone intramuscularly in the left deltoid.  It was unknown if the patient received Fluzone before.  She did not have any illness at the time of vaccination.  The reporter had a verbal follow-up with the patient on 07 December 2006, there was "no change".  The patient had negative blood work for C3, Compl. total, CRP, ASO.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Initial report received from a health care professional, on 13 November 2006.  A 21 year old female patient, received on 20 October 2006, intramuscular vaccination of Fluzone (lot number U2240AA) (multidose vial), into the left deltoid.  4 hours post vaccination, on 20 October 2006, the patient had pain in her left arm.  The patient was seen in the office, three days later, on 13 November 2006 and the pain continued.  The patient did not have swelling, redness or weakness.  The patient was prescribed Advil and heat.  No concomitant vaccines were reported.  The patient had no illnesses at the time of vaccination.  No concomitant medications were reported.  The patient received Fluzone previously.  No information on adverse events was reported.  Follow-up information received on 31 January 2007.  The patient received Fluzone previously in the fall of '05, '04 and '03.  She received 0.1ml of Tubersol (lot number C2079AA) subdermally in the left forearm on 19 September 2006.  She did not have any illness at the time of Fluzone vaccination, she was taking mirtazapine 7.5 mg daily.  On 13 November 2006, the patient complained of left arm pain.  She complained of weakness in the entire arm with an inability to lift arm completely above head.  The plan was a trial of ibuprofen 400 mg BID and heat 20 minutes two times daily.  On 14 November 2006, the patient complained the arm was numb.  On 27 November 2006, she visited a physician for the same complaints.  On 25 January 2007, the patient reported her arm was slowly getting better.  She almost has full range of motion, except for anything up high.  She still can't hold anything heavy using only that arm, and some days it will ache all day.  She still has some tenderness in the area of the shot.  She is not on any medication now or seeing a physician for her arm.  She has not had a doctors visit since November.  She did not have physical therapy.  Follow-up information received on 23 February 2007 from a health care professional.  Demographic information was received.  Per the reporter, the case was reviewed and no additional information is available at this time.
Age: 25.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Cough, Injection site pain, Malaise, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Initial report received from a patient on 15 November 2006.  A 25 year old, female patient developed a sore throat, runny nose, cough and malaise for 5 days, approximately 24 hours after she received Fluzone (lot number unknown and route of administration not reported) in the left deltoid on 07 November 2006.  She also received a tetanus booster (Tradename, manufacturer, lot number and route of administration not reported) at the right deltoid.  She also complained of soreness at the sites of both injections.  It was reported that the adverse events had resolved.  Follow-up information received on 18 December 2006.  The patient received Fluzone, lot number U2285AA, intramuscularly and Td toxoids, manufacturer Massachusetts Public Health Biologic Laboratories, lot number Td-165, intramuscularly.  The patient previously received Fluzone on 16 September 2004 and no symptoms were observed.  Her medical history was hay fever, hernia, hemorrhoids. The patient did not report any treatment or therapy for the symptoms.
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received on 16 November 2006, from a health car professional.  A female patient received on 14 November 2006, Fluzone (U2187AA), into the left deltoid (route and dose not reported).  On 15 November 2006, a day post vaccination, the patient experienced injection site redness, induration and itching at the left deltoid, 5 cm diameter, well circumscribed.  No other signs (corrected) and symptoms were reported.  No corrective treatment was reported.  At the time of the report (16 November 2006), the patient had not recovered.  The patient's medical history, other medications, illnesses at the time of vaccination and concomitant vaccinations were unknown.  Follow-up information received on 20 December 2006.  The patient received Fluzone at approximately 3PM.  The next morning, she had discomfort in the left deltoid and on 16 November 2006, she noted a 5 x 5 cm oval shaped area of erythema and swelling at the injection site - described as itchy.  No significant discomfort.  She has had previous flu shots before with no adverse problems. The patient did not have any other vaccinations within 4 weeks of receiving Fluzone, did not have any illness at the time of vaccination and did not have any medical history.  It was reported the patient recovered.
Age: 17.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Delivery, Drug exposure during pregnancy, Serology normal, Ultrasound scan normal
Clinical narrative: Initial report received from a health care professional, on 27 November 2006.  A 17 year old female patient, with no previous pregnancies, received on 07 August 2006, intra-muscular, 0.5 ml booster of Adacel (lot number C2492BA), while she was 13 weeks pregnant (Last Menstrual Period was on 04 May 2006, Estimated Due Date: 07 February 200)).  The patient did not receive any concomitant vaccines.  The patient had ultrasound on 08 August 2006 and 06 October 2006, the results were normal.  At the time of this report, 27 November 2006, the patient did not experience any adverse reactions.  The patient was taking Prenatal as concomitant medication.  The patient had no known allergies, medical conditions or illnesses.  No information about prior exposures to Adacel was provided.  Follow-up information received on 19 March 2007.  The patient also received Engerix B (GSK, lot number AHBVB194AA) - dose 1, intramuscularly in the right deltoid on 07 August 2006.  She received dose 2 of Engerix B (GSK, lot number AHBVB194AA) intramuscularly (site not reported) on 02 September 2006 and Fluzone (lot number U2189AA) intramuscularly in the left deltoid on 01 November 2006.  Her maternal drug exposure was the following: Prenatal vitamins - 1 daily, po, starting 05 July 2006; Chromagen Forte, for anemia - 1 bid, po, starting 09 August 2006; Rhogam, Rh negative - 1 dose - intramuscularly on 20 November 2006 and Nasonex, for allergies - 2 sprays nasally daily, intranasally beginning 03 January 2007.  She did not experience any adverse event.  Her current pregnant history had "no risks and was a normal pregnancy".  She had serologies performed on 07 August 2006 with normal results.  The patient gave birth vaginally on 31 January 2007, at 39 gestational weeks, to one (1) female, live child (with no congenital anomaly).  The child weighed 7 lbs, 1 oz.  Her Apgar scores were "8" at 1 minute and "9" at 5 minutes.  Follow-up information received on 16 April 2007.  The patient recovered from the anemia.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Flushing, Headache, Hypoaesthesia, Nausea
Clinical narrative: Initial report received on 01 December 2006 from a health care professional.  Five patients, with unknown medical history, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2308AA, on an unknown date.  The routes and site of administration were not reported.  Twenty-four to 48 hours post-immunization, all five patients experienced severe headache, nausea, and flushing.  Three of those patients had additional symptoms of chest discomfort, numbness, and tingling.  Per the reporter, none of the patients received relief from the severe headache after taking "pain relievers".  None of the patients were identified as to who had what.  Reportedly, none of the patients were medically evaluated.  At the time of this report, the recovery status of the patients was unknown.  Follow-up information was received on 15 January 2007.  The reporter indicated that the obtained the original information for this case from a service person and they are prohibited by privacy laws to divulge any identifying information about the person who reported the events to them.  The reporter does no have access to the medical records that would provide additional information about this case.  This reporter is unable to provide any further information regarding this case.  The reporter for this case is the same as for case 2006-03338.
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Initial report received on 01 December 2006 from a health care professional.  Five patients, with unknown medical history, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2308AA, on an unknown date.  The routes and site of administration were not reported.  Twenty-four to 48 hours post-immunization, all five patients experienced severe headache, nausea, and flushing.  Three of those patients had additional symptoms of chest discomfort, numbness, and tingling.  Per the reporter, none of the patients received relief from the severe headache after taking "pain relievers".  None of the patients were identified as to who had what.  Reportedly, none of the patients were medically evaluated.  At the time of this report, the recovery status of the patients was unknown.  Follow-up information was received on 15 January 2007.  The reporter indicated that the obtained the original information for this case from a service person and they are prohibited by privacy laws to divulge any identifying information about the person who reported the events to them.  The reporter does no have access to the medical records that would provide additional information about this case.  This reporter is unable to provide any further information regarding this case.  The reporter for this case is the same as for case 2006-03338.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Flushing, Injection site erythema, Pruritus generalised
Clinical narrative: Initial report received from a patient (with a history of allergies to latex, SMZ-TMP, Nubain, Darvocet and asthma) developed mild itching on the back, trunk and arms at 0900 after she received an injection of Fluzone (lot number u2195aa) intramuscularly in the right deltoid on 26 October 2006 at 0745.  She had generalized itching by 1100, felt flushed at 1200 and noted her face, neck and ears were very red. The injection site was red and had chills, her neck,face and ears were red and she had generalized rash. From 1600-1900 hours, she was sleeping. At 1900 she had itching and took Benadryl 50 mg. At 2045, she had a low grade fever and at 2300, she had chills and took Benadryl 50 mg and Advair puffs. On 27 October 2006, her rash was gone and itching was gone, however her neck and ears remained red and hot. She did not have any illness at the time of vaccination. It was reported the patient.  Follow-up information received on 23 January 2007 from the patient. A diagnosis was not determined, and no diagnostic testing was performed. There was no illness at the time of vaccination.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Initial report received from a patient (with a history of allergies to latex, SMZ-TMP, Nubain, Darvocet and asthma) developed mild itching on the back, trunk and arms at 0900 after she received an injection of Fluzone (lot number u2195aa) intramuscularly in the right deltoid on 26 October 2006 at 0745.  She had generalized itching by 1100, felt flushed at 1200 and noted her face, neck and ears were very red. The injection site was red and had chills, her neck,face and ears were red and she had generalized rash. From 1600-1900 hours, she was sleeping. At 1900 she had itching and took Benadryl 50 mg. At 2045, she had a low grade fever and at 2300, she had chills and took Benadryl 50 mg and Advair puffs. On 27 October 2006, her rash was gone and itching was gone, however her neck and ears remained red and hot. She did not have any illness at the time of vaccination. It was reported the patient.  Follow-up information received on 23 January 2007 from the patient. A diagnosis was not determined, and no diagnostic testing was performed. There was no illness at the time of vaccination.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: A 40-year-old female patient had received an intramuscular, left deltoid injection of Fluzone SV 2006-2007, lot number U2195AA, on 04 October 2006. Immediately following administration, she noticed a black dot at the injection site. After several hours, it still had not resolved. The patient provided pictures of the site which demonstrate a small, dark, discoloration on the skin surface. The needle used was a BD Safety Glide, 23 gauge, one inch needle, lot number 611520 CAV03. The reporter indicated that there were 12 other patients (out of 46 administrations) that also experienced a black dot following vaccination. The black dot was present on some of the patients up to a week later. Per the reporter, "all kinds of needles" were used including BD Safety Glide and BO Integra as well as two other types for which she was not sure of the names. The reporter stated that they, "tested drawing up the vaccine and then wiping the needle on an alcohol pad, and the black residue was visible." "We ran three of the same needles through the alcohol pad right out of their packages and there was no residue." At the time of this report, recovery status was unknown. Follow-up information received on 03 November 2006 from the patient. Per the reporter, the dot does not resolve until either the skin is removed or over time as the skin is shed. The patient removed the dot by removing the affected skin. The patient recovered from the event.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: A female patient (date of birth and age not reported) had received a left deltoid, intra-muscular injection of FLUZONE SV "2006-2007" USP, lot number unknown; and a left deltoid, intra-muscular injection of Pneumovax, manufacturer Merck, lot number not reported, on 09 October 2006. Approximately five hours post-immunisation, the patient developed redness and swelling approximately six inches below the arm pit to the elbow. She denied any other symptoms or any local reaction to the actual injection site. The patient required medical evaluation, but the diagnostics and treatments received were not reported. At the time of this report, it was unknown if the patient had recovered from these adverse events. Another patient had the same type of reaction at the same facility that is reported in case 2006-02658. Follow-up information received on 17 November 2006 from a health care professional. As per the reporter, it was "determined that it was not the flu shot, but the Pneumovax shot". Further information is not anticipated.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Haematology test normal, Injection site discharge, Pilonidal cyst, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with acne who in June 2007, was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant therapy included BENZACLIN. In June 2007, the patient experienced a yellow milky discharge soon after the vaccination on the injection site. She also developed some very itchy rash on legs two to three weeks later. The patient eventually recovered from these symptoms on an unspecified date. on 10-SEP-2007, the patient was vaccinated with the second dose of Gardasil (lot# 658560/1062U). On approximately 24-SEP-2007 "two weeks after the second dose", the patient developed an itchy rash which started on both of her arms and spread to her legs. The patient also had some pilonidal cysts or skin infections on her body. Unspecified medical attention was sought. On an unspecified date, a complete blood count and serum ICG were performed which the results were normal. The patient's itchy rash arms and legs and pilonidal cysts or skin infections on her body persisted. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Skin infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female with acne who in June 2007, was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant therapy included BENZACLIN. In June 2007, the patient experienced a yellow milky discharge soon after the vaccination on the injection site. She also developed some very itchy rash on legs two to three weeks later. The patient eventually recovered from these symptoms on an unspecified date. on 10-SEP-2007, the patient was vaccinated with the second dose of Gardasil (lot# 658560/1062U). On approximately 24-SEP-2007 "two weeks after the second dose", the patient developed an itchy rash which started on both of her arms and spread to her legs. The patient also had some pilonidal cysts or skin infections on her body. Unspecified medical attention was sought. On an unspecified date, a complete blood count and serum ICG were performed which the results were normal. The patient's itchy rash arms and legs and pilonidal cysts or skin infections on her body persisted. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chills, Eyelid oedema, Headache, Pain
Clinical narrative: Information has been  received from a physician concerning a 23 year old female student with an allergy to CEFZIL who on 30-AUG-2007 was vaccinated IM with a first dose of GARDASIL at 08:30 am. Concomitant therapy included PROZAC and KARIVA. There was no known illness at the time of vaccination.  On 31-AUG-2007 at 7:00 pm the patient developed swollen eye lids, chills, body aches, temperature of 102.5 a low wbc and a headache. She was seen in the emergency room and subsequently, she was feeling better and the patient recovered on 20-SEP-2007.  It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0711usa01667). Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count decreased
Clinical narrative: Information has been  received from a physician concerning a 23 year old female student with an allergy to CEFZIL who on 30-AUG-2007 was vaccinated IM with a first dose of GARDASIL at 08:30 am. Concomitant therapy included PROZAC and KARIVA. There was no known illness at the time of vaccination.  On 31-AUG-2007 at 7:00 pm the patient developed swollen eye lids, chills, body aches, temperature of 102.5 a low wbc and a headache. She was seen in the emergency room and subsequently, she was feeling better and the patient recovered on 20-SEP-2007.  It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0711usa01667). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning her friend's 17 year old daughter, on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced pain and redness at the injection site. It was reported that "she had a raised area at the injection site." The patient did not seek medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Skin disorder
Clinical narrative: Information has been received from a physician concerning his 21 year old daughter, who in MAY-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed "dark discoloration" or "bruising" to her ankles and the bottom of her feet. The discoloration was most prominent during June and July 2007. On an unspecified date, the patient received her second dose of Gardasil. The patient was evaluated by her family physician. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Sensation of heaviness
Clinical narrative: Information has been received from a physician concerning her 13 year old daughter, who, on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently, the patient experienced a headache, and "heavy limbs" whereby it "hurt to move legs." The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a non-sexually active female who on 06-APR-2007 was vaccinated with a third dose of Gardasil. On 13-APR-2007 the patient had her first sexual experience. On approximately 26-SEP-2007 the patient underwent a routine Papanicolaou test. On 03-OCT-2007 the results revealed positive for a high-grade squamous intraepithelial lesion. The patient received unspecified follow-up monitoring. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a female who was vaccinated with a second dose of Gardasil. Subsequently the patient fainted in the office. Subsequently, the patient recovered. Additional information is not expected.