chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site induration
Clinical narrative: Initial report received from a Pharmacist on 10/17/05. A 74 year old female pt developed a hardened area at the injection site and bruising at the injection site which went down to the back of her arm, 24 hours after receiving the injection of Fluzone, lot number U1806AA on 10/13/05. Route and site of administration not report. The pt has a history of Alzheimer and is on medication which was not specified. She is also on Aspirin 81mg daily. Treatment was not reported. As per reporter, at the time of this report the pt had not recovered. Follow up information received from a health care provider on 1/9/06. The vaccination was administered IM in the left deltoid. The pt had received six previous doses. The pt recovered four or five days following the vaccinations.
Sex: U
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial report received from a nurse in the USA on 17-OCT-2005. A patient (gender and age not reported) complained of a metallic taste after receiving the injection of Fluzone. Route, site, lot number and date of administration not reported. Treatment and recovery status was not reported. Follow-up information received on 24-MAR-2006 from a health care provider. The event onset was OCT-2005. Per the reporter, the patient had recovered from the event, and there is no additional information available. Additional information is not expected. Same reporter in case 2005-02132.
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Pyrexia, Thermal burn, Vomiting
Clinical narrative: Initial report of a cluster involving Fluzone was received from a nurse on 10/17/2005. It was reported that pts (specific number involved, gender and age not reported) complained of nausea and vomiting, fever, diarrhea and burning at the injection site after receiving the injection of Fluzone. Route site, lot number and date of administration not reported. Treatment and recovery status was not reported. Follow up information received on 3/24/06 from a health care provider. At the time of this report, the pt had recovered from the events. The case was reviewed, and no additional information was available. Same reporter in case 2005-02131.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site rash
Clinical narrative: Initial report received from a pt (who is a nurse) on 10/18/05. A 51 year old, female pt experienced burning upon administration of 0.5ml of Fluzone given inadvertently in the left forearm Intra dermally. She also received Tubersol in the right forearm. Within 10 minutes, she developed redness and a rash covering her entire forearm. The injection site was warm to touch, swollen and itchy. At the time of the report, the rash had disappeared. The reaction site was not specified. It was not known if the other symptoms had resolved. She has not recovered.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pruritus, Thermal burn
Clinical narrative: Initial report received from a pt (who is a nurse) on 10/18/05. A 51 year old, female pt experienced burning upon administration of 0.5ml of Fluzone given inadvertently in the left forearm Intra dermally. She also received Tubersol in the right forearm. Within 10 minutes, she developed redness and a rash covering her entire forearm. The injection site was warm to touch, swollen and itchy. At the time of the report, the rash had disappeared. The reaction site was not specified. It was not known if the other symptoms had resolved. She has not recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: initial report received from a pharmacist on 10/20/05. A 53 year old female pt developed lower back pain, right side radiating to the left side two days after receiving the IM injection of Fluzone, lot number U18811AA in the left deltoid on 10/4/05. The pt is on Vicodin which was prescribed for pain 2 months ago. The type of pain was not reported. The pt had no illness at the time of vaccination. Symptoms resolve don their own. No medical treatment prescribed and the pt did not see a physician. follow up information received on 2/3/06 from a health care provider. The pt did not have a previous history of back pain and had not done anything to aggravate her lower back within seven days prior to vaccination. The duration of the lower back pain was a week. The pt had received the flu vaccine every year for 20 years. Same reporter and reporting facility in cases 2005-02155, 2005-02157.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: A 91-year-old female patient developed lower back pain on the right side, radiating to the left side over a course of 2-3 days following the intramuscular injection of FLUZONE, lot # U18811AA in the left deltoid on 04-OCT-2005. The symptoms resolved on their own. No medical treatment was sought, and no diagnostic tests performed. The patient receives the flu vaccination yearly and is on sleeping pills. As per reporter the patient recovered. Follow-up information received on 24-MAR-2006 from a health care provider. The patient had no history of back problems, and the lower back pain she experienced lasted for 7-10 days. The patient indicated the pain was quite severe for three days after vaccination and got less severe day by day after that. She had not aggravated her lower back in any way prior to vaccination. The event did not require examination by a physician. Same reporter and reporting facility in cases 2005-02155 and 2005-02156.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Pyrexia
Clinical narrative: Initial report received from a nurse in the USA on 20-OCT-2005. A 60-year-old female patient developed a severe headache, stomach pains with diarrhea and a fever of 101 degrees Fahrenheit shortly after receiving the injection of Fluzone in the left deltoid on 18-OCT-2005. Treatment received not reported. At the time of this report, which is two days post immunization, the patient "feels okay." The patient has received the influenza vaccination many times with no reactions. Follow-up information received on 27-JAN-2006 from a healthcare provider. The adverse event onset was one hour post-vaccination. The patient also experienced constipation. The patient has a history of asthma for which she takes Advair. The symptoms subsided 24-48 hours post-vaccination.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema
Clinical narrative: Initial report received from a nurse practitioner in the USA on 21-OCT-2005. A 47-year-old female developed redness of her neck and face (no rash) and joint pains of her hands and elbows three hours after receiving the injection (route not reported) of FLUZONE, lot # U1818AB, in the left deltoid on 20-OCT-2005. As per reporter symptoms resolved with no medical intervention. Follow-up information received on 13-FEB-2006. There were no other vaccinations within four weeks of the date of vaccination. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Rash
Clinical narrative: Case received from a healthcare professional in the USA on 24-OCT-2005 via the MIS/VIS under the reference number 05-0567. A 41-year-old female patient with a medical history of environmental allergy, asthma and hypothyroidism had received a dose of FLUZONE, batch number U1762AA in the left deltoid and a dose of PNEUMOVAX (batch number 0790P) in the right deltoid on 21-OCT-2005, and 24 hours post-vaccination, i.e. on 22-OCT-2005, she developed injection site cellulitis at left upper arm with raised red rash, fine rash on shoulder and back and with injection site pain. The patient did not complain of shortness of breath or chest pain. The cessation date of each symptom was not reported. The patient was receiving concomitant treatment as budesonide, Thyroid, albuterol, aciclovir (ZOVAREX) and cetirizin (ZYRTEC). The patient required a doctor visit. No relevant laboratory tests. She received intramuscular ceftriaxone (ROCEPHINE) and diphenhydramine hydrochloride (BENADRYL) per oo. Further details were requested. Follow-up information received on 03-FEB-2006 from a health care professional. Per the reporter, the patient received one dose of Rocephin for treatment of the event and then was started on Duricef by mouth. The patient had no history of food or drug allergy in the past. The patient did not return. Per the reporter, the patient recovered from these events at the time of this report.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Pyrexia, Retching
Clinical narrative: Case received from a healthcare professional in the USA on 24-OCT-2005 via MIS/VIS under the reference number 05-0568. A 64-year-old female patient with a medical history of hypercholesterolemia, diabetes mellitus and hypertension had received a dose of FLUZONE, batch number U1828AA, in the right arm and a dose of PNEUMOVAX, batch number 0055R, in the left arm on 17-OCT-2005, and 24 hours post-vaccination, i.e. on 18-OCT-2005, she developed fever at 101, which reached 103 36 hours post-vaccination, dry heaves, chills and redness at the injection site extending under her arm. She did not present with any illness at time of vaccination. Her symptoms were resolved on unspecified date except the redness which was decreased to size of 50 cent piece. The patient was receiving concomitant treatment as diuretics, LIPITOR, ZEDIC, LISINOPRIL and GLIPIZIDE. The patient required a doctor visit. Patient outcome was not recovered. Further details were requested. Follow-up information received on 03-FEB-2006 from a healthcare provider. There was no illness at the time of vaccination. Concomitant medication is corrected from ZEDIC to ZETIA. Additional information is not provided.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Lymphadenopathy, Neck pain, Pyrexia
Clinical narrative: Case received from a healthcare professional in the USA on 26-OCT-2005 via the MIS/VIS under the reference number 05-0576. A 46-year-old female with a medical history not reported had received a dose of FLUZONE, batch number U1762AA in the left deltoid on 17-OCT-2005 and 1 day later, i.e. on 18-OCT-2005, she developed a red, swollen arm, swollen lymph nodes, painful neck and low grade fever. The patient did not present with any illness at time of vaccination and received her last dose of influenza vaccine in 2003. Her symptoms were not resolved at the time of the report. The patient required a doctor visit. Further details were requested. Follow-up information received on 13-FEB-2006. Per the reporter, there is no additional information at this time. Additional information is not expected.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration, Vaccination complication
Clinical narrative: Initial report received from a health care provider on 25-OCT-2005. A cluster of approximately 270 patients experienced a "black dot" at the injection site after receiving intramuscular deltoid injections of FLUZONE from either lot number U1753AA or lot number U1746AA. Attempts to "wipe the black dot off" were not successful. Per the reporter, alcohol swabs are used to prep the vials, and they use BD Precision Glide syringe / needles and regular BD non-safety syringe needles. Approximately 300 doses were administered, now change the needle after drawing up the dose, and the black dot no longer appears at the injectino site. Per the reporter, the status of the event was unknown. Follow-up information received on 16-JUN-2006. Per the reporter, the BD PRecision Glide needles were used to administer other products at the site adn the same result of a "black dot" was observed. Because of th is, the BD Precision Glide needles were changed to another type of needle, and the site no longer saw the black dots. Per the reporter, the event of "black dot" was definitely thought to be associated with the BD Precision Glide needles and not the FLUZONE vaccine. The events of "black dot" were reported as temporary and disappeared later on.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration, Vaccination complication
Clinical narrative: Initial report received from a healthcare provider on 25-OCT-2005. A cluster of three patients experienced a "black dot" at the injection site after receiving an intramuscular deltoid injection of FLUZONE, lot number U1819AA, on an unknown date. The patients' ages, names, and dates of birth were not reported. Per the reporter, the black dot was noticed after injecting the FLUZONE. The reporter states the black dot wouldn't wipe off, and that she felt that it was an impression or outline from the diameter of the needle, not really a black mark on the skin. One inch 25 gauge needles and safety glide syringes are the devices used. This event occurred three times, and then the staff began using new needles for injection. There have been no additional occurrences since. They routinely use alcohol to prep the vial stopper. No adverse events have been reported from the three patients, and no patients have called back concerning the black dot at the injection site. The status of the patients' "black dot" was unknown. Follow-up information received on 22-FEB-2006 and 27-FEB-2006. Per reporter there is no additional information available. To the reporters' knowledge none of the patients had any adverse event except for the black dot at the site of administration. No further information expected.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration, Vaccination complication
Clinical narrative: Initial report received from a health care provider on 25-OCT-2005. A cluster of approximately ten patients experienced a "dark dot" at the injection site after receiving an intramuscular deltoid injection of FLUZONE, either lot number U1819AA or U1824AA, on an unknown date. The patients' ages, names, and dates of birth were not reported. Per the reporter, the small dark dot didn't wipe off. She then noticed residual on the vial stopper after prepping the vial with an alcohol swab. The vaccine administrator felt the residue was on the needle after penetrating the vial stopper, and this is what left the dark mark at the injection site. This occurred in approximately ten patients out of 1000 patients immunized. They use Precision Glide syringes with 23 gauge one inch needles. None of the patients reported an adverse event. The status of the patients' "dark dot" was not reported.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling
Clinical narrative: Initial report received on 27 Oct 2005 from a health care professional. A 3 year old male child with no known allergies, history of asthma, failure to thrive and general abscess presented with eyes almost swollen shut few hours after the intramuscular influenza vaccine, lot no: U1838AA administration in the right thigh on 27 Oct 2005. The patient was seen by a physician, Benadryl was ordered. It was reported that the patient had a previous dose of the same vaccine last year. No other symptoms were reported. Patient's conditon got improved and he recovered at the time of the report. Follow up information received on 30/Jan/2006. Per the reporter, the patient had received an injection of Fluzone on 07/Feb/2005 and did not experience any reactions. At the time of the vaccination, the patient had Asthma, failure to thrive and a dental abscess. Patient was taking Amoxil for the dental abcess at the time of the vaccination. The patient experienced swollen eyes 30 minutes post vaccination and was treated for this with Benadryl 5mg/kg every six hours for 24 hours. No further information is expected.
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea
Clinical narrative: Initial report received on 28-OCT-2005 from a healthcare professional in USA. A 4-year-old male child patient with no reported medical history received two doses of FLUZONE on 24-SEP-2005 and 25-OCT-2005, respectively. It was reported that, however, it was not the first time the patient received the vaccine. The patient did not experience any reaction following the first dose and complained of myalgia at an unspecified time. Physician stated that the patient had normal temperature upon examination. Patient also complained of nausea at an unspecified time and he was not recovered at the time of the report.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Headache, Lymphadenopathy, Pharyngolaryngeal pain, Tenderness
Clinical narrative: Initial report received on 28 Oct 2005 from a health care professional. A 43 year old female patient a medical history on no known allergies and denies medical conditions, felt as if "her chest was expanding" 3 hours following the influenza vaccine (Fluzone SV '2005-'2006) administration on 24 Oct 2005. The next day she woke up with a head ache and sore throat. On 28 Oct 2005, headache has been resolved but the sore throat became worse. The patient was complained of lymph node tenderness and she was not recovered at the time of the report. Follow up information received on 13/Feb/2006 from a health care provider. Per the reporter, there is no additional information at this time.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Vertigo
Clinical narrative: Initial report received on 31 Oct 2005 from a health care professional. A 48 year old female patient with a medical history on no known allergies and diabetes experienced vertigo approximately 4 hours after the influenza vaccine (Fluzone SV '2005-'2006) administration on 25 Oct 2005. She was sent to an emergency room, where she was evaluated by the Emergency room physician. The glucose test was within normal limits at an unspecified time. She was concomitantly administered with insulin pump and some other unspecified medications. Outcome was not reported. Follow up information received on 20/Mar/2006 from a health care provider. The patient has a medical history of insulin dependent diabetes mellitus type 1, hypertension and hypothyroidism. Per the reporter, the patient had received a double dose of the Fluzone vaccine on 25/)ct/2005. The site of administration was in the upper left arm. The patient has not had any recurring symptoms since October 2005. It has been recommended to the patient by her treating physician not to to received the Fluzone vaccination again. No follow-up appointments have been completed.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue
Clinical narrative: An 82 year old female patient with a medical history of no known allergies developed slight dizziness and felt very much fatigued approximately 1-2 days after the influenza vaccine and Pneumovax administration on an unspecified date. The patient was not recovered at the time of the report.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Flushing, Heart rate increased, Hyperhidrosis, Injection site haemorrhage
Clinical narrative: Case received from a healthcare professional in the USA on 03/Nov/2005. It is worth nothing that 4 other patient experienced similar reactions however only one report was made. A 62 year old female patient with a medical history of drug and fruit allergy and increase, had received on 27/Oct/2005 an intramuscular dose of influenza vaccine, batch number U1906AA, in the deltoid, and immediately after, she developed swelling at injection site and ecchymosis at injection site. Moreover, she became diaphoresic, red in color with increased heart rate. No "epi" was ever given. Her condition was improved but bruising and swelling at injection site persisted. The patient was allergic to peaches, PABA, sulfonamide and thiazides. She also had a history of blood pressure increased. The patient did not present with any illness at time of vaccination. She had annually received a dose of influenza vaccine for 11 years. She had concomitant treatment: baby ASA (3Xweek), enalapril (Vasotec), indapamid (Lozol), metoprolol (Toprol) and nifedipin (Procardia). Patient outcome was not recovered. Further information was requested. Follow up information was received on 15/Mar/2006 from a healthcare professional. Per the reporter, no epinephrine was given for these events, no lab was collected and it was felt that the causality of the reaction was food allergies. At the time of this report, the patient had recovered approximately one week post-vaccination around 03/Nov/2006. No further information is expected.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Case received from a healthcare professional in the USA on 03/Nov/2005. It is worth nothing that 4 other patient experienced similar reactions however only one report was made. A 62 year old female patient with a medical history of drug and fruit allergy and increase, had received on 27/Oct/2005 an intramuscular dose of influenza vaccine, batch number U1906AA, in the deltoid, and immediately after, she developed swelling at injection site and ecchymosis at injection site. Moreover, she became diaphoresic, red in color with increased heart rate. No "epi" was ever given. Her condition was improved but bruising and swelling at injection site persisted. The patient was allergic to peaches, PABA, sulfonamide and thiazides. She also had a history of blood pressure increased. The patient did not present with any illness at time of vaccination. She had annually received a dose of influenza vaccine for 11 years. She had concomitant treatment: baby ASA (3Xweek), enalapril (Vasotec), indapamid (Lozol), metoprolol (Toprol) and nifedipin (Procardia). Patient outcome was not recovered. Further information was requested. Follow up information was received on 15/Mar/2006 from a healthcare professional. Per the reporter, no epinephrine was given for these events, no lab was collected and it was felt that the causality of the reaction was food allergies. At the time of this report, the patient had recovered approximately one week post-vaccination around 03/Nov/2006. No further information is expected.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tongue black hairy, Vomiting
Clinical narrative: Case received from a healthcare professional in the USA on 03/Nov/2005. A 47 year old female patient with no known allergies , had received on 29/Oct/2005 in intramuscular dose of influenza vaccine, batch number U1811AA, in the left deltoid, and 30 minutes later, she developed white fuzzy tongue and she complained of her mouth felt slimy. Moreover, 2.5 days post-vaccination, the patient developed nausea and vomiting. She did not take any medication and did not present with any illness at time of vaccination. Patient outcome was not reported. Further information was requested. Follow up information received on 02/FEB/2006 from a healthcare provider. The patient's recovery status is unknown. Follow up information received on 17/Feb/2006 from a health care provider. The patient's recovery status is unknown.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain, Shoulder pain
Clinical narrative: A 50 year old female, with history of environmental allergy, upset stomach to eggs and asthma, had received an injection on left deltoid of influenza vaccine on 24-Oct-2005 AM. In the afternoon of the same day, she complained of shoulder pain. There was no history of injury. Then, she complained of whole arm pain, unable to raise arm laterally without pain. There was no numbness or tingling. She received corrective treatment with Tylenol, sling and ice. Patient's recovery status: not recovered. The patient has been rechecked 3 days later. Follow up information received on 03/Apr/2006. Per the reporter, the patient recovered from these events. No further information is expected.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Dry mouth, Dry skin, Rhinitis
Clinical narrative: A 48 year old female, with medical history of allergy to thimerosal in contact solution, fibromyalgia, restless leg, and irritable bowel, had received an injection of influenza vaccine FLUZONE (lot number U1811AA) in her left deltoid on 19-Oct-2005. 3 days later, she experienced extreme dry noses, eyes, skin. Also mouth, lips, teeth and sinuses were dry. She stated past history of allergy to thimerosal in contact solution. On 02-Nov-05, i.e. 11 days after beginning of symptoms, she saw a physician as symptoms were still persisting. Patient's recovery status: not recovered. Follow up received on 06/Feb/2006 from a health care provider. The patient was examined by her physician on 03/Nov/2005 and had rhinitis and dry sinuses which he attributed to medications that she is currently taking. The date of vaccination is amended to 21/Oct/2005, and the onset of the adverse events is amended to 24/Oct/2005. Per the reporter, the physician stated that the patient is recovered and that her symptoms were not a result of the vaccination.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: A 48 year old male patient, with history of enlarged prostate, depression, chronic obstructive pulmonary disease, and gastroesophageal reflux disease, reported that he experienced severe burning as flu vaccine was injected. He received FLUZONE, lot number U1839AA, intramuscularly on right deltoid on 03-Nov-2005. Patient's recovery status: not reported. Follow up information received on 06/Mar/2006 from a physician. Per the reporter, the patient only complained of injection site burning. The patient never had any other reaction or toxicity to the vaccine injection. The patient did not miss work or go to the emergency room as a result of this injection. No further information is expected. The coding of burning sensation was updated to injection site burning due to this new information. At the time of this report the patient had recovered from these events.
Sex: U
Vaccine: FLU3
Symptoms: Neuralgia, Shoulder pain
Clinical narrative: 5 patients out of 100 complained of persistent pain lasting approximately 2-3 weeks from shoulder to elbow, across the arm after they received Fluzone (lot unknown, date not reported). Follow up information received on 30/Jan/2006. Per the reporter, the orthopedic evaluation and the MRI indicated that the patient had an impinged nerve. The symptoms became noticeable at the time of the vaccination, but was not directly caused by the vaccination.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling hot, Hypoaesthesia, Injection site erythema
Clinical narrative: A female patient with no reported age and medical history complained of weakness, felt hot, dizzy and achy approximately 3 to 5 hours following the influenza vaccine administration in the right deltoid on 08-Nov-2005. The patient stated, she felt "out of commission" and she complained of left arm numbness that quickly resolved. She developed slight redness in right arm at the injection site. Outcome was not reported. Follow up information received on 27/Jan/2006. The patient recovered. Additional information is not expected.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: A female patient with no reported age and medical history complained of weakness, felt hot, dizzy and achy approximately 3 to 5 hours following the influenza vaccine administration in the right deltoid on 08-Nov-2005. The patient stated, she felt "out of commission" and she complained of left arm numbness that quickly resolved. She developed slight redness in right arm at the injection site. Outcome was not reported. Follow up information received on 27/Jan/2006. The patient recovered. Additional information is not expected.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: It was reported that about half of 11,000 doses of influenza vaccine administered have resulted in a tiny black dot "tattoo" at injection site. Outcomes were not reported. Follow up information received on 03/Feb/2006 from a health care professional. Per the reporter, about half of more of 20,000 doses of the vaccine resulted in a tiny black dot "tattoo" at the injection site, not half of 11,000 doses as previously reported. None of the recipients had problems from this injections. It was not reported if the recipients had recovered from this event at the time of this report. Follow up information received on 08/Jun/2006 from a health care professional. As per the reporter, the case has been reviewed and there is no additional information. Further information is not anticipated. Follow up information received on 16/Jun/2006. Per the reporter, it was suspected that the needles were causing the previously reported event of black dot "tattoo", but they can not rule out the possibility of a relationship with the vaccine since they have no further information.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Shoulder pain, Sleep disorder
Clinical narrative: A 48 year old male patient with a medical history of seasonal allergies developed very sore and painful clavicular and shoulder area, approximately 2-3 hours following the intramuscular influenza vaccine administration in the left deltoid on 19-Oct-2005. In the same evening, he experienced great difficulty in picking up his arm. This has improved slightly but pain wakes him at night at the time of the report. The symptoms were improving with Motrin and he has not been evaluated by a physician at the time of the reporter. Outcome was not reported. It was reported that, he was receiving the same vaccine yearly for may years. Follow up information received on 13/Mar/2006 from the patient. Per the reporter, the patient was seen by a physician on 15/Nov/2005 and it was determined that the patient was experiencing signs and symptoms of bursitis. The patient was then treated with diclofenac. His symptoms improved. In late December the patient was treated with nabumetone for a wrist injury, by the end of the second course of that NSAID, the patient had recovered from the shoulder pain. This was determined to be 09/Mar/2006. The adverse events were updated per this new information. The previous adverse events were placed as co-manifestations of the bursitis. The "arm discomfort" was changed to "Joint range of motion decreased" as this was better coding for the symptom. No further information is expected.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: The reporter provided us with the information that approximately 300 people experienced a grayish black dot at injection site, i.e. deltoid, immediately after receiving Influenza vaccine (Fluzone), batch numbers U1805AA and U1839AA, vanish point syringe/needles used. The reporter stated her arm was still having grayish black dot after her dose received on 03/Nov/2005. No reports of adverse events had been received to date and no other events were reported.
Sex: U
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: 8 patients presented with black dots following intramuscular injection of flu vaccine (FLUZONE, lot number U1807AA). Outcomes were not reported. Follow up information received on 25/Jan/2006. Per the reporter, at the facility were the vaccines were administered, the black dots were noted by the staff nurses and medical assistants on multiple days to an unknown number of patients. During their flu shot "clinics" there is typically only one nurse giving injections. Not until later, did they realize that they were all periodically seeing the same event. The black dots were so small that none of the patients were aware of the event and there were after injection reports of pain and swelling associated with the black dots. All the patient's recovered from these events at the time of this report. No further information is expected.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Skin exfoliation
Clinical narrative: Case received from a healthcare professional in the USA on 14-NOV-2005 (MIS/VIS # 05-0660). A 10-year-old female patient had received an injection of FLUZONE with preservative (lot unknown) in OCT-2005. She developed (latency not reported) a local reaction with swelling, skin peeling and scaling. The patient had had three prior flu immunizations without any problem. Patient's recovery status not reported. Follow-up information received on 20-MAR-2006. Per the responsible physician the patient received FLUZONE, lot number U1846AA (expiry date 30-JUN-2006) on 10-OCT-2005. Patient recovered. No further information is expected.
Sex: F
Vaccine: FLU3
Symptoms: Eye disorder
Clinical narrative: Initial report received on 14/Nov/2005 from a health care professional. A female patient had received an administration (route and site not reported) of Fluzone SV (lot number not reported) on an unspecified date. At an unspecified time later the patient developed eye problems (not otherwise specified). No further information was provided. Follow up information received on 21/Apr/2006 from a health care provider. The reporter indicates that she was unable to reach the patient and that no further information is available.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Initial report received on 15 Nov 2005 from a health care professional. A 42 year old female patient with no reported medical history developed metallic taste in her mouth 2 days following the intramuscular intramuscular influenza vaccine (Fluzone SV '2005-'2006), lot no: U1773AA, administration in the left deltoid on 10 Nov 2005. She was also on nix treatment for the lice occurrence. The patient was not recovered from the adverse event at the time of the report. Follow up received on 26/Jan/2006. Per the reporter, the patient was contacted on 23/Jan/2006 and then she reported that the metallic taste resolved approximately two weeks after the initial complaint. The patient further reports having altered taste problems after each uses of Nizoral shampoo that was prescribed by her physician for a scalp issue. The patient concluded that the reported taste issues were not caused by administration of the flu shot. The patient has recovered. No further information is expected.
Sex: F
Vaccine: FLU3
Symptoms: Purpura, Skin burning sensation, Swelling
Clinical narrative: Case received from a patient, who is a healthcare professional, on 16 Nov 2005. A female patient (age unknown) had received an injection of influenza vaccine (Fluzone, lot unknown), as yearly, in left deltoid on 14 Oct 2005. On 18 Oct 2005, i.e. 4 days later, she developed a bilateral rash on legs (thigh area) of purpuric appearance, which spread to arms, forehead, face and neck. She felt swollen when warm with burning sensation. There was no itching. The symptoms resolved approximately within 3 weeks. Follow up information  received on 03/Feb/2006 from a health care provider. No treatment was received, and there was no infectious disease investigation or etiological work-up.  The lot number is provided as U1753AA. The patient had not experienced symptoms following previous vaccinations.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Flushing, Headache, Medication error
Clinical narrative: Case not medically confirmed. Case received from a patient 16 Nov 2005. A 34 year old female patient had received a 1st dose of Fluzone (lot unknown) in her left arm on 07 Nov 05. 30 minutes later, she had hot, dizzy, headache and flushed. Within 24 hours, she developed sinus and urinary tract infections (urinalysis was performed). On 07 Nov 05, after infections occurred, she visited physician. The initial symptoms lasted half hour. Patient's recovery status: not reported. Follow up information received on 07/Feb/2006 from a health care professional. Per the reporter, the lot number of the Fluzone wa U1805AA and the vaccination was given on 04/Nov/2005 not 05/Nov/2005 as previously reported. After review of this case by the reporter there was no additional information available to add at this time. Follow up information received on 13/Mar/2006. Per reporte, the injection was given with a 5/8"needle which was a medication error. The size of the patient and intramuscular route required a 1" needled. There were not cultures performed. The patient was followed up at a clinic. Reporter will be forwarding further follow up information. Follow up information received on 27 Mar 2006. Per the reporter, the case was reviewed, and there is no additional information at this time.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis, Urinary tract infection
Clinical narrative: Case not medically confirmed. Case received from a patient 16 Nov 2005. A 34 year old female patient had received a 1st dose of Fluzone (lot unknown) in her left arm on 07 Nov 05. 30 minutes later, she had hot, dizzy, headache and flushed. Within 24 hours, she developed sinus and urinary tract infections (urinalysis was performed). On 07 Nov 05, after infections occurred, she visited physician. The initial symptoms lasted half hour. Patient's recovery status: not reported. Follow up information received on 07/Feb/2006 from a health care professional. Per the reporter, the lot number of the Fluzone wa U1805AA and the vaccination was given on 04/Nov/2005 not 05/Nov/2005 as previously reported. After review of this case by the reporter there was no additional information available to add at this time. Follow up information received on 13/Mar/2006. Per reporte, the injection was given with a 5/8"needle which was a medication error. The size of the patient and intramuscular route required a 1" needled. There were not cultures performed. The patient was followed up at a clinic. Reporter will be forwarding further follow up information. Follow up information received on 27 Mar 2006. Per the reporter, the case was reviewed, and there is no additional information at this time.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling cold, Lacrimation increased, Laryngitis, Pharyngolaryngeal pain
Clinical narrative: Initial report received on 17 Nov 2005 from a health care professional. A patient with no reported age and gender experienced chills, shaking, eyes were running and sore throat almost 5 hours following the influenza vaccine (Fluzone SV '2005-'2006), lot no: U1916AA administration on 15 Nov 2005. On 17 Nov she had laryngitis. The patient was not recovered at the time of the report. Follow up information received on 26/Jan/2006. Per the reporter, the patient coincidentally contracted an upper respiratory disease at the time of the vaccination. The patient realized that the injection had no connection with her flu vaccination. No further information is expected.
Age: 1.13
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Constipation, Pyrexia
Clinical narrative: Initial report received from another manufacturer, report number WAES0511USA00146, on 09-NOV-2005. A nine-month-old female patient received in the left thigh an injection of FLUZONE, lot number 01754AA, on 11-OCT-2005. The patient has a history of facial rash and eye discharge, and her mother was vaccinated with varicella virus vaccine while pregnant. The patient also has a history of febrile seizure and urinary tract infection on 28-SEP-2005. On the day of vaccination the patient had been constipated for one day, was afebrile and had completed cephalexin that was being taken for a urinary tract infection. Eighteen days post-vaccination, on 29-OCT-2005, the patient complained of constipation and fever for four days. The patient's vaccination history includes, on 29-OCT-2004, a first dose of IPOL, lot number X1006, given in the right thigh; a first dose of DAPTACEL, lot number C1996AA, given in the left thigh; a first dose of PREVNAR, lot number 495-721, given in the left thigh, and a first dose of COMVAX, given in the right thigh; a second dose of ACTHIB (dose one was a different product), lot number UE335AC, given in the left thigh; and a second dose of PREVNAR, lot number A7400E, given in the right thigh. Vaccinations received on 28-JAN-2005 include a third dose of DAPTACEL, lot number C2131AA, in the left thigh; a second dose of IPOL, lot number X1189, given in the left thigh; a second dose of COMVAX, lot number 6481423/0128P, given in the right thigh; and a third dose of PREVNAR, lot number A57562B, given in the right thigh. Vaccinations received on 29-MAR-2005 include a third dose of Hepatitis B virus vaccine (doses one and two were COMVAX, lot number 647593/0465P, given in the left thigh; and a first dose of FLUZONE, lot number U1381AA, given in the right thigh. Vaccinations received on 29-APR-2005 include a second dose of FLUZONE, lot number U1381AA, administered in the left thigh. The patient has a history of a previous adverse event recorded in case 2005-02398. At the time of this report, the patient's recovery status was unknown.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Reiter's syndrome, Urticaria
Clinical narrative: Initial report received on 21-Nov-2005 from a health care professional in USA. A 51 year old male patient, who is a physician with a medical history of no known allergies and discoid lupus erythematosus developed urticaria on abdomen, arms, occipital scalp and sacrum approximately 2 days following the influenza vaccine (Fluzone SV 2005-2006) lot no:U1817AA in the right deltoid on 09-Nov-2005. He was also complained of digital swelling of toes and heels and also heel pain. He self diagnosed with "Reiters syndrome:, self medicated since an unspecified time with zithromax, cipro and doxycycline but no steroids. The CBC, CMP, sedimentation rate, C-reactive protein and HIV negative at an unspecified time. he had not seen any of note that he was receiving Fluzone annually and concomitantly taking plaquenil since an unspecified time.
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: A male patient of unspecified age with a medical history of emphysema and asthma experienced cramping and diarrhea 10-15 minutes following eating, duration 4 days, the day he received influenza vaccine (Fluzone SV 2005-2006) lot no:U1871BA in an unspecified arm on 17-Nov-2005. The event began in the evening at 06.00 PM of the vaccination. Signs and symptoms still persisted at the time of the report in relation to eating. Follow up information received on 212/Mar/2006. The initial reporter advises that the patient did not received the flu vaccine at their facility. However, he has no additional information about the case and no contact information for the patient or his physician. Additional information is not expected in this case.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Case received from a healthcare professional in the USA on 22/Nov/2005 via the MIS/VIS under the reference number 05-0699. This case is included in a cluster of 5 cases and is linked with an 08 year old male patient with no medical history noted had received on 05/Nov/2005 an intramuscular dose of influenza vaccine (Fluzone), batch number U1819AA in the deltoid and 2 days later, i.e. on 07/Nov/2005 he experienced redness and swelling from deltoid to back beyond shoulder and down to elbow with injection site warmth to touch per he mummy. The patient was recovered on unspecified date.
Age: 1.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased
Clinical narrative: Case received from a healthcare professional in the USA on 22/Nov/2005 via the MIS/VIS under the reference number 05-0700. This case is included in a cluster of 5 cases and is linked with 2005-02542,2005-02543,2005-02545 and 2005-02546 cases. A 1 year old female patient with no medical history noted had received on 05/Nov/2005 his first intramuscular dose of influenza vaccine (Fluzone), batch number U1819AA and 2 days later, i.e. on 07/Nov/2005 she experienced temperature at 100-100 degrees F, "slight red" and mild cold symptoms. It is worthy noting that the patient received her third intramuscular injection of Hepatitis B vaccine (other MFR), batch number 0336R in the left leg and her first subcutaneous injection of Varivax (other MFG), batch number 0427R in the left thigh on 26/)ct/2005. The patient did not present with any illness at time of vaccination. The patient was recovered on unspecified date. Follow up information received on 15/Feb/2006 from a health care professional. Per the reporter the patient had the injection in the left thigh. No relevant diagnostic tests/laboratory data were collected.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Case received from a healthcare professional in the USA on 22/Nov/2005 via the MIS/VIS under the reference number 05-0700. This case is included in a cluster of 5 cases and is linked with 2005-02542,2005-02543, and 2005-02546 cases. A 4 year old female patient with no medical history noted had received on 05/Nov/2005 an intramuscular dose of influenza (Fluzone), batch number U1819AA and 1 day later, i.e. on 06/Nov/2005 she experienced fever at 102 degrees F, sore throat and increased body aches. She was on amoxicllin time 6 days per Mom. The patient was recovered on unspecified date. Follow up information received on 17/Mar/2006 from a health care worker. The site of administration of the vaccine was unknown. Per the reporter, the case was reviewed and there is no additional information at this time. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report received on 30-Nov-2005 from a health care professional in USA. A 62 year old female patient with ongoing knee and joint pain complained of severe leg pain on 29-Nov2005 i.e. the day after the influenza vaccine (Fluzone SV 2005-2006)), lot no:U1815AA administration in the right gluteal site. Consulting physician evaluated on 30-Nov-2005. Outcome was unknown at the time of the report.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Initial report received on 07-DEC-2005 from a health care professional in USA. A 33 year old female patient with knee problem felt pain and burning immediately upon the intramuscular influenza vaccine (Fluzone SV 2005-2006), lot no:U1763AA administration in the left deltoid on 03-Nov-2005. The events persisted for 1 month 2 weeks, soreness arm appeared normal, 3 weeks injection site OK, pain with movement especially lifting since an unspecified time. The patient was taking altran and feldene. Outcome was not reported. Follow up information received on 30/Jan/20006. Per the reporter, the patient continued to experience occasional left deltoid pain. The patient had not fully recovered from these events at the time of this report. Follow up information received on 13/Feb/2006. There were no relevant diagnostic tests. At the time of this report, the patient had recovered.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Initial report received on 07-Dec-2005 from a health care professional in USA. A 30 year old female patient with a medical history of no known allergies experienced nausea and dizziness at the beginning of the day of immunization with influenza vaccine (Fluzone SV 2005-2006), lot no:U1811AA in the month of Oct-2005. The symptoms gradually worsened and patient was not recovered at the time of the report.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Breast pain, Chest pain, Injection site pain
Clinical narrative: Initial report received from a physician in the USA on 09/Dec/2005. An 18 year old female patient complained of pain at the injection site with numbness in the arm, pain in left upper chest and right breast with radiation into the back around the dermatome after receiving the injection (route not reported) of Fluzone, lot number U1869AA in the left deltoid on 08/Dec/2005. The patient was seen by the physician and treated with Benadryl and anti-inflammatories. The patient had no illness at the time of immunization. As per reporter, at the time of this report the patient had not recovered.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Injection site pain, Paraesthesia
Clinical narrative: Initial report received from a pharmacist in the USA on 09/Dec/2005. A 59 year old male patient developed pain at the injection site three days after receiving the intramuscular injection of Fluzone, lot number U1803AA in the left arm on 02/Nov/2005. Two weeks later the patient visited his Primary care physician and complained on tingling fingers and pain in the entire left arm. The patient had no illness at the time of vaccination and has received the flu vaccine previously. As per reporter the patient had not recovered at the time of this report. Follow up information received on 30/Jan/2006. The case was reviewed and no additional medical information is provided.