chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial case received 15 January 2010 from a healthcare professional. A 48 year old female patient received a right deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number U3224BB) on 14 January 2010. On 15 January 2010 the patient was seen by a nurse due to a large bump at the right deltoid (approximately the size of a golf ball). She had shoulder and axillary pain. There was swelling from the axillary area, down the arm to the wrist. She could lift her arm, but it caused pain in the shoulder. The patient had a medical history of hypertension. Concomitant medications included NORVASC and HTCZ. She had no illnesses at the time of the vaccination. At the time of the report the patient had not recovered. Follow up information was received on 12 February 2010 from a health care professional. The patient was started on methylprednisone 4 mg dose pack for 6 days on 16 January 2010. The patient recovered as a result. Based upon new information received, this case meets seriousness criteria and has been upgraded to serious. Follow-up information was received 21 April 2010 from a health care professional who provided additional contact information. No additional information was provided at the time of the report. Follow-up information was received 25 August 2010 from a health care professional who provided patient contact information. According to the reporter, they were unable to provide additional information. Documents held by sender: None.
Age: 1.6
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of administration to 19 month old was received from a registered nurse/health professional concerning a 19-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Feb-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: F
Vaccine: FLU3, MNQ, TDAP, FLU3
Symptoms: Chills, Cough, Dyspnoea, Pain, Reaction to previous exposure to any vaccine
Clinical narrative: Initial report received from a consumer on 03 October 2009. A female patient (age not reported) received FLUZONE (lot number not reported) on 28 February 2009 at 13:00 hours. Within 4-5 hours, the patient noted blurred vision as she was driving home form work. Per the patient, by the time she arrived at her house, her vision was so blurred that she was unable to safely pull her car into the garage. The patient also noted chills, aches, cough and mild shortness of breath following the vaccination, which she reported was typical for her. When she awoke the next morning, the symptoms had resolved. The patient had previously experienced the same events following vaccinations with FLUZONE, ADACEL and MENACTRA on 11 February 2009. Additional events for this same patient are recorded in case 2009-05362. Documents held by sender: None.
Sex: F
Vaccine: FLU3, MNQ, TDAP, FLU3
Symptoms: Vision blurred
Clinical narrative: Initial report received from a consumer on 03 October 2009. A female patient (age not reported) received FLUZONE (lot number not reported) on 28 February 2009 at 13:00 hours. Within 4-5 hours, the patient noted blurred vision as she was driving home form work. Per the patient, by the time she arrived at her house, her vision was so blurred that she was unable to safely pull her car into the garage. The patient also noted chills, aches, cough and mild shortness of breath following the vaccination, which she reported was typical for her. When she awoke the next morning, the symptoms had resolved. The patient had previously experienced the same events following vaccinations with FLUZONE, ADACEL and MENACTRA on 11 February 2009. Additional events for this same patient are recorded in case 2009-05362. Documents held by sender: None.
Sex: F
Vaccine: FLU3, MNQ, TDAP, FLU3
Symptoms: Chills, Cough, Dyspnoea, Pain, Vision blurred
Clinical narrative: Initial report received from a consumer on 03 October 2009. A female patient (age not reported) received FLUZONE (lot number not reported) on 28 February 2009 at 13:00 hours. Within 4-5 hours, the patient noted blurred vision as she was driving home form work. Per the patient, by the time she arrived at her house, her vision was so blurred that she was unable to safely pull her car into the garage. The patient also noted chills, aches, cough and mild shortness of breath following the vaccination, which she reported was typical for her. When she awoke the next morning, the symptoms had resolved. The patient had previously experienced the same events following vaccinations with FLUZONE, ADACEL and MENACTRA on 11 February 2009. Additional events for this same patient are recorded in case 2009-05362. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dystonia, Joint sprain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial case was received on 19 March 2010 from a physician. A 9 year old male patient received a right arm injection (route not reported) of H1N1 (lot number UP022AA) and a left arm injection (route not reported) of FLUZONE (lot number T3252BA) on 22 December 2009. According to the physician, the patient developed right leg sequential dystonia soon after a right ankle sprain which occurred 7-10 days after vaccinations. The dystonia progressed rapidly; no etiology has been found and his brain MRI was normal. The physician was ordering a cervical spine MRI to look for transverse myelitis. The patient's dystonia is severe; he is undergoing physical therapy. The reporter was not sure if the patient had previous doses of the vaccines. No adverse events occurred following prior vaccination. The patient had no illness at the time of the vaccinations, no pre-existing medical conditions, no known allergies and no concomitant medications. The outcome status of the ankle sprain was not reported. As of this report the patient had not recovered from right leg sequential dystonia. Documents held by sender: None.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dystonia, Joint sprain, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial case was received on 19 March 2010 from a physician. A 9 year old male patient received a right arm injection (route not reported) of H1N1 (lot number UP022AA) and a left arm injection (route not reported) of FLUZONE (lot number T3252BA) on 22 December 2009. According to the physician, the patient developed right leg sequential dystonia soon after a right ankle sprain which occurred 7-10 days after vaccinations. The dystonia progressed rapidly; no etiology has been found and his brain MRI was normal. The physician was ordering a cervical spine MRI to look for transverse myelitis. The patient's dystonia is severe; he is undergoing physical therapy. The reporter was not sure if the patient had previous doses of the vaccines. No adverse events occurred following prior vaccination. The patient had no illness at the time of the vaccinations, no pre-existing medical conditions, no known allergies and no concomitant medications. The outcome status of the ankle sprain was not reported. As of this report the patient had not recovered from right leg sequential dystonia. Documents held by sender: None.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired medication was received from a registered nurse/health professional concerning a seven-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product's original expiry date was 02-Apr-2010 while shortened expired date was 29-Mar-2010. On 30-Mar-2010, patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 7.0
Sex: M
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired medication was received from a registered nurse/health professional concerning a seven-year-old male child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product's original expiry date was 02-Apr-2010 while shortened expired date was 29-Mar-2010. On 30-Mar-2010, patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lumbar puncture, Paraesthesia, Paralysis, Urinary incontinence
Clinical narrative: Initial report was received on 28 April 2010 from a consumer, who is also the patient's daughter. A 72-year-old female patient (also reported as 71 year-old) who had a history of hypertension, had received an injection of FLUZONE SV 2009-2010, lot number U3378AB on 13 January 2010 and three days later, she developed tingling and a sensation of pin pricks in her lower right leg. These symptoms spread across her waist and to her right leg. According to the reporter, the patient became paralyzed from the waist down and she became incontinent of urine and feces. The patient was taken to the emergency room and was hospitalized for seven days (dates not reported). Diagnostic testing included an MRI, brain scan and lumbar puncture (results not reported). Corrective treatments were not reported; however the patient was being seen by both "ortho and neuro". The patient had been taking DIOVAN 80 mg concomitantly and she had no concurrent illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE SV 2009-2010. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Faecal incontinence, Lumbar puncture, Nuclear magnetic resonance imaging, Paraesthesia, Paralysis
Clinical narrative: Initial report was received on 28 April 2010 from a consumer, who is also the patient's daughter. A 72-year-old female patient (also reported as 71 year-old) who had a history of hypertension, had received an injection of FLUZONE SV 2009-2010, lot number U3378AB on 13 January 2010 and three days later, she developed tingling and a sensation of pin pricks in her lower right leg. These symptoms spread across her waist and to her right leg. According to the reporter, the patient became paralyzed from the waist down and she became incontinent of urine and feces. The patient was taken to the emergency room and was hospitalized for seven days (dates not reported). Diagnostic testing included an MRI, brain scan and lumbar puncture (results not reported). Corrective treatments were not reported; however the patient was being seen by both "ortho and neuro". The patient had been taking DIOVAN 80 mg concomitantly and she had no concurrent illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE SV 2009-2010. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Scan brain, Urinary incontinence
Clinical narrative: Initial report was received on 28 April 2010 from a consumer, who is also the patient's daughter. A 72-year-old female patient (also reported as 71 year-old) who had a history of hypertension, had received an injection of FLUZONE SV 2009-2010, lot number U3378AB on 13 January 2010 and three days later, she developed tingling and a sensation of pin pricks in her lower right leg. These symptoms spread across her waist and to her right leg. According to the reporter, the patient became paralyzed from the waist down and she became incontinent of urine and feces. The patient was taken to the emergency room and was hospitalized for seven days (dates not reported). Diagnostic testing included an MRI, brain scan and lumbar puncture (results not reported). Corrective treatments were not reported; however the patient was being seen by both "ortho and neuro". The patient had been taking DIOVAN 80 mg concomitantly and she had no concurrent illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE SV 2009-2010. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test normal, Dizziness, Influenza, Malaise
Clinical narrative: Initial report received from a health care professional on 13 September 2010. An 81-year-old male patient (age reported as 82), with no illness at the time of vaccination, received on 02 September 2010 at 11:00 AM an intramuscular (IM) deltoid injection of FLUZONE HIGH-DOSE, lot number U3599AA. On the 02 September 2010 at 1:00 PM, the patient developed severe flu symptoms. The patient was very ill, weak, pale and faint. He was taken to the Emergency Room (ER) the following morning. He was advised to stay overnight but the patient declined. The patient's wife reported that his blood work was "OK". The patient's medical history was not reported but he was taking VICTOZA, LASIX and REMECON. The outcome was reported as unknown. Documents held by sender: None.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pallor
Clinical narrative: Initial report received from a health care professional on 13 September 2010. An 81-year-old male patient (age reported as 82), with no illness at the time of vaccination, received on 02 September 2010 at 11:00 AM an intramuscular (IM) deltoid injection of FLUZONE HIGH-DOSE, lot number U3599AA. On the 02 September 2010 at 1:00 PM, the patient developed severe flu symptoms. The patient was very ill, weak, pale and faint. He was taken to the Emergency Room (ER) the following morning. He was advised to stay overnight but the patient declined. The patient's wife reported that his blood work was "OK". The patient's medical history was not reported but he was taking VICTOZA, LASIX and REMECON. The outcome was reported as unknown. Documents held by sender: None.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test normal, Influenza like illness, Malaise, Pallor
Clinical narrative: Initial report received from a health care professional on 13 September 2010. An 81-year-old male patient (age reported as 82), with no illness at the time of vaccination, received on 02 September 2010 at 11:00 AM an intramuscular (IM) deltoid injection of FLUZONE HIGH-DOSE, lot number U3599AA. On the 02 September 2010 at 1:00 PM, the patient developed severe flu symptoms. The patient was very ill, weak, pale and faint. He was taken to the Emergency Room (ER) the following morning. He was advised to stay overnight but the patient declined. The patient's wife reported that his blood work was "OK". The patient's medical history was not reported but he was taking VICTOZA, LASIX and REMECON. The outcome was reported as unknown. Documents held by sender: None.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Syncope
Clinical narrative: Initial report received from a health care professional on 13 September 2010. An 81-year-old male patient (age reported as 82), with no illness at the time of vaccination, received on 02 September 2010 at 11:00 AM an intramuscular (IM) deltoid injection of FLUZONE HIGH-DOSE, lot number U3599AA. On the 02 September 2010 at 1:00 PM, the patient developed severe flu symptoms. The patient was very ill, weak, pale and faint. He was taken to the Emergency Room (ER) the following morning. He was advised to stay overnight but the patient declined. The patient's wife reported that his blood work was "OK". The patient's medical history was not reported but he was taking VICTOZA, LASIX and REMECON. The outcome was reported as unknown. Documents held by sender: None.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Oropharyngeal pain, Throat tightness
Clinical narrative: Initial report and a copy of the patient's vaccination consent release form were received 13 September 2010 from a health care professional. A 68-year-old female patient had received a first dose intramuscular deltoid injection of FLUZONE HIGH-DOSE, lot number U3600AA on 02 September 2010 at 10:00 AM and progressively over the next few hours (not immediately), she developed a very sore throat. She presented to the emergency room and was found to have throat constriction thought to be from an anaphylactic reaction. According to the vaccination consent release form, the patient had no concurrent illness and she had not experienced any adverse reactions following prior vaccinations. The patient's medical history was negative for latex sensitivity and serious allergies to medications and food. The patient had not received any vaccines within four weeks of FLUZONE HIGH-DOSE. The reporter considered the seriousness criteria for this event to be life-threatening. Outcome was recovered (date not reported). The reporter for this case is the same as for case numbers 2010-04971, -04973, -04974, -04975, -04976, -04977, -04978, -04979, -04980, -04981 and -04982. Documents held by sender: Immunization consent form.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, No reaction on previous exposure to drug, Oropharyngeal pain, Throat tightness
Clinical narrative: Initial report and a copy of the patient's vaccination consent release form were received 13 September 2010 from a health care professional. A 68-year-old female patient had received a first dose intramuscular deltoid injection of FLUZONE HIGH-DOSE, lot number U3600AA on 02 September 2010 at 10:00 AM and progressively over the next few hours (not immediately), she developed a very sore throat. She presented to the emergency room and was found to have throat constriction thought to be from an anaphylactic reaction. According to the vaccination consent release form, the patient had no concurrent illness and she had not experienced any adverse reactions following prior vaccinations. The patient's medical history was negative for latex sensitivity and serious allergies to medications and food. The patient had not received any vaccines within four weeks of FLUZONE HIGH-DOSE. The reporter considered the seriousness criteria for this event to be life-threatening. Outcome was recovered (date not reported). The reporter for this case is the same as for case numbers 2010-04971, -04973, -04974, -04975, -04976, -04977, -04978, -04979, -04980, -04981 and -04982. Documents held by sender: Immunization consent form.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Dysgeusia, Nausea
Clinical narrative: Initial report received from a health care professional on 13 September 2010. A 67-year-old female patient received on 02 September 2010 at 1:00 PM a deltoid intramuscular injection of FLUZONE HIGH-DOSE, lot number U3600AA. On the 02 September 2010 within a few hours after the vaccination, the patient developed life threatening symptoms of nausea, chest tightening and altered taste. She was seen in the Emergency Department and it was determined that she had an anaphylactic reaction. The outcome was reported as recovered. Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Initial reported received from a health care professional on 13 September 2010. A 75-year-old male patient, with no known drug allergies (NKDA) and no other vaccinations within 4 weeks prior, received on 02 September 2010 at 3:00 PM a left deltoid injection of FLUZONE HIGH-DOSE, lot number U3599AA. On 03 September 2010 at 2:00 AM, the patient experienced a fever, diarrhea, and vomiting. He became dehydrated and was taken to the emergency room where he was treated and released. The treatment was not specified. The patient was taking the following concomitant mediations: LIPITOR, temazepam, doxazosin, isosorbide, PLAVIX, and PROTONIX. The outcome was reported as recovered. Documents held by sender: None.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Initial report was received from a health care professional on 13 September 2010. A 73 year old female patient with no reported illness at the time of vaccination, had received an intramuscular left arm injection of FLUZONE HIGH-DOSE, lot number U3599AA on 02 September 2010 at 1143. At 1610 (approximately four hours later) she had experienced a pink, warm hand. No diagnostic tests were requested. No further information was provided at the time of this report. The patient's outcome was reported as recovered. The reporter for this case is the same for 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04976, 2010-04977, 2010-04978, 2010-04979, 2010-04980, 2010-04981 and 2010-04982. Documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Initial report was received from a health care professional on 13 September 2010. A 73 year old female patient with no reported illness at the time of vaccination, had received an intramuscular left arm injection of FLUZONE HIGH-DOSE, lot number U3599AA on 02 September 2010 at 1143. At 1610 (approximately four hours later) she had experienced a pink, warm hand. No diagnostic tests were requested. No further information was provided at the time of this report. The patient's outcome was reported as recovered. The reporter for this case is the same for 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04976, 2010-04977, 2010-04978, 2010-04979, 2010-04980, 2010-04981 and 2010-04982. Documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Hyperhidrosis, Inflammation, Pyrexia, Swelling
Clinical narrative: Initial report received on 13 September 2010 from a healthcare professional. An 80 year old female patient received an intramuscular injection of FLUZONE High-Dose (lot number U3577AA) on 07 September 2010. on 08 September 2010, she experienced a fever of "104", sweats and vaccination site inflammation, swelling and bruising. The patient was not ill at the time of the vaccination. No pre-existing medical conditions and no concomitant medications were reported. The patient recovered on an unspecified date. This case is linked by the reporter to 11 other cases: 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04975, 2010-04976, 2010-04977, 2010-04978, 2010-04980, 2010-04981, 2010-04982. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Pyrexia, Vaccination site haematoma, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Initial report received on 13 September 2010 from a healthcare professional. An 80 year old female patient received an intramuscular injection of FLUZONE High-Dose (lot number U3577AA) on 07 September 2010. on 08 September 2010, she experienced a fever of "104", sweats and vaccination site inflammation, swelling and bruising. The patient was not ill at the time of the vaccination. No pre-existing medical conditions and no concomitant medications were reported. The patient recovered on an unspecified date. This case is linked by the reporter to 11 other cases: 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04975, 2010-04976, 2010-04977, 2010-04978, 2010-04980, 2010-04981, 2010-04982. Documents held by sender: None.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Chills, Pharyngeal oedema, Sneezing
Clinical narrative: Initial report received from a health care professional on 15 September 2010. An unidentified patient (age and sex not provided) received an injection (route and site not provided) of FLUZONE, lot number not provided. The patient had an allergic reaction hours after receiving FLUZON. No specific details on type of reaction was provided at this time. The patient had to use an EPI-PEN. The outcome was not reported. Documents held by sender: None.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity
Clinical narrative: Initial report received from a health care professional on 15 September 2010. An unidentified patient (age and sex not provided) received an injection (route and site not provided) of FLUZONE, lot number not provided. The patient had an allergic reaction hours after receiving FLUZON. No specific details on type of reaction was provided at this time. The patient had to use an EPI-PEN. The outcome was not reported. Documents held by sender: None.
Age: 87.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Rash, Urticaria
Clinical narrative: Initial case was received on 13 September 2010 from a healthcare professional. An 87 year old patient (gender not reported) received an intramuscular injection of FLUZONE High-Dose (lot number U3599AA) at 5 PM on 04 September 2010. At night on 04 September 2010, the patient experienced hives and leg edema. The patient treated the rash with hydrocortisone (HC) 1% and elevated legs. No pre-existing medical conditions and no concomitant medications were reported. The outcome status of the events was unknown. This case is linked by the same reporter to the following eleven cases: 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04975, 2010-04976, 2010-04977, 2010-04978, 2010-04979, 2010-04980, 2010-04981. Documents held by sender: None.
Age: 87.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Initial case was received on 13 September 2010 from a healthcare professional. An 87 year old patient (gender not reported) received an intramuscular injection of FLUZONE High-Dose (lot number U3599AA) at 5 PM on 04 September 2010. At night on 04 September 2010, the patient experienced hives and leg edema. The patient treated the rash with hydrocortisone (HC) 1% and elevated legs. No pre-existing medical conditions and no concomitant medications were reported. The outcome status of the events was unknown. This case is linked by the same reporter to the following eleven cases: 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04975, 2010-04976, 2010-04977, 2010-04978, 2010-04979, 2010-04980, 2010-04981. Documents held by sender: None.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Back pain, Dizziness, Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 13 September 2010. A 82 year old male patient with no reported illness at the time of vaccination, had received an intramuscular left deltoid injection FLUZONE High-Dose, lot number U3600AA and an intramuscular left deltoid injection of PNEUMOVAX 23 (Merck lot number 07312) on 02 September 2010 at 1400. On 03 September 2010 the patient experienced lower backache and dizziness. On 04 September 2010 he experienced left anteriolateral arm redness and warmth with tenderness. The patient was treated with Cephalexin. No further information was provided at the time of this report. The patient's outcome was reported as recovered. The reporter for this case is the same for 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04975, 2010-04976, 2010-04977, 2010-04978, 2010-04979, 2010-04980 and 2010-04982.  Documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Initial report was received from a health care professional on 13 September 2010. A 82 year old male patient with no reported illness at the time of vaccination, had received an intramuscular left deltoid injection FLUZONE High-Dose, lot number U3600AA and an intramuscular left deltoid injection of PNEUMOVAX 23 (Merck lot number 07312) on 02 September 2010 at 1400. On 03 September 2010 the patient experienced lower backache and dizziness. On 04 September 2010 he experienced left anteriolateral arm redness and warmth with tenderness. The patient was treated with Cephalexin. No further information was provided at the time of this report. The patient's outcome was reported as recovered. The reporter for this case is the same for 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04975, 2010-04976, 2010-04977, 2010-04978, 2010-04979, 2010-04980 and 2010-04982.  Documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Back pain, Dizziness, Erythema, Skin warm, Tenderness
Clinical narrative: Initial report was received from a health care professional on 13 September 2010. A 82 year old male patient with no reported illness at the time of vaccination, had received an intramuscular left deltoid injection FLUZONE High-Dose, lot number U3600AA and an intramuscular left deltoid injection of PNEUMOVAX 23 (Merck lot number 07312) on 02 September 2010 at 1400. On 03 September 2010 the patient experienced lower backache and dizziness. On 04 September 2010 he experienced left anteriolateral arm redness and warmth with tenderness. The patient was treated with Cephalexin. No further information was provided at the time of this report. The patient's outcome was reported as recovered. The reporter for this case is the same for 2010-04971, 2010-04972, 2010-04973, 2010-04974, 2010-04975, 2010-04976, 2010-04977, 2010-04978, 2010-04979, 2010-04980 and 2010-04982.  Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Cough, Pneumonia, Rales, Wheezing
Clinical narrative: Initial case received on 10 September 2010 from a healthcare professional. A "2 and 1/2" year old (2 years 11 months per date of birth) male patient received a right thigh intramuscular injection of FLUZONE (lot number UH181AC) on 03 September 2010. The patient developed a persistent cough a few days after the vaccination. At an office visit on 09 September 2010, he was diagnosed with pneumonia with wheezing and bilateral rales. He was afebrile at that time. A chest X-ray was performed (date and results not reported). The patient had no illness at the time of the vaccination. He had no vaccinations within four weeks and no adverse events following prior vaccinations. He had no pre-existing medical conditions, allergies and no concomitant medications. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Muscular weakness
Clinical narrative: Guillain Barre syndrome. Complete paralysis. IV immunoglobulin treatment - 5 doses.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre syndrome. Complete paralysis. IV immunoglobulin treatment - 5 doses.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test, Cardiac stress test, Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain Barre syndrome. Complete paralysis. IV immunoglobulin treatment - 5 doses.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Guillain Barre syndrome. Complete paralysis. IV immunoglobulin treatment - 5 doses.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Burning sensation, Dyspnoea, Erythema, Mobility decreased, Oedema peripheral
Clinical narrative: Information has been received from a registered pharmacist and a 69 year old female consumer with no pertinent medical history, no drug reactions/allergies, who on 30-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. Concomitant therapy included influenza virus vaccine (manufacturer unknown). On 30-OCT-2010 the patient experienced injection site reaction after receiving PNEUMOVAX 23. She experienced immediate swelling and burning sensation after the vaccination. She then experienced, difficulty in breathing and the one inch swelling area moved to the lower part of the arm. She could not sleep for 2 days and the site turned very painful, red, and purple. The patient reported that her left arm where she received PNEUMOVAX 23 (Lot # 665904/0866Z) had been swollen with fluid. The swollen area was about "24 inches in length" and "4 inches in height". There were no lab diagnostic studies performed. She was prescribed KEFLEX and a steroid. Injection site reaction, immediate swelling and burning sensation, difficulty in breathing, one inch swelling area moved to the lower part of the arm/left arm swollen with fluid, could not sleep for 2 days and the site turned very painful, red, and purple were considered to be disabling by the reporter because the patient could not move her arm. The patient saw the pharmacist. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Skin discolouration, Skin warm
Clinical narrative: Information has been received from a registered pharmacist and a 69 year old female consumer with no pertinent medical history, no drug reactions/allergies, who on 30-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. Concomitant therapy included influenza virus vaccine (manufacturer unknown). On 30-OCT-2010 the patient experienced injection site reaction after receiving PNEUMOVAX 23. She experienced immediate swelling and burning sensation after the vaccination. She then experienced, difficulty in breathing and the one inch swelling area moved to the lower part of the arm. She could not sleep for 2 days and the site turned very painful, red, and purple. The patient reported that her left arm where she received PNEUMOVAX 23 (Lot # 665904/0866Z) had been swollen with fluid. The swollen area was about "24 inches in length" and "4 inches in height". There were no lab diagnostic studies performed. She was prescribed KEFLEX and a steroid. Injection site reaction, immediate swelling and burning sensation, difficulty in breathing, one inch swelling area moved to the lower part of the arm/left arm swollen with fluid, could not sleep for 2 days and the site turned very painful, red, and purple were considered to be disabling by the reporter because the patient could not move her arm. The patient saw the pharmacist. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Fluid retention, Immediate post-injection reaction, Injected limb mobility decreased, Injection site discolouration
Clinical narrative: Information has been received from a registered pharmacist and a 69 year old female consumer with no pertinent medical history, no drug reactions/allergies, who on 30-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. Concomitant therapy included influenza virus vaccine (manufacturer unknown). On 30-OCT-2010 the patient experienced injection site reaction after receiving PNEUMOVAX 23. She experienced immediate swelling and burning sensation after the vaccination. She then experienced, difficulty in breathing and the one inch swelling area moved to the lower part of the arm. She could not sleep for 2 days and the site turned very painful, red, and purple. The patient reported that her left arm where she received PNEUMOVAX 23 (Lot # 665904/0866Z) had been swollen with fluid. The swollen area was about "24 inches in length" and "4 inches in height". There were no lab diagnostic studies performed. She was prescribed KEFLEX and a steroid. Injection site reaction, immediate swelling and burning sensation, difficulty in breathing, one inch swelling area moved to the lower part of the arm/left arm swollen with fluid, could not sleep for 2 days and the site turned very painful, red, and purple were considered to be disabling by the reporter because the patient could not move her arm. The patient saw the pharmacist. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Information has been received from a registered pharmacist and a 69 year old female consumer with no pertinent medical history, no drug reactions/allergies, who on 30-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. Concomitant therapy included influenza virus vaccine (manufacturer unknown). On 30-OCT-2010 the patient experienced injection site reaction after receiving PNEUMOVAX 23. She experienced immediate swelling and burning sensation after the vaccination. She then experienced, difficulty in breathing and the one inch swelling area moved to the lower part of the arm. She could not sleep for 2 days and the site turned very painful, red, and purple. The patient reported that her left arm where she received PNEUMOVAX 23 (Lot # 665904/0866Z) had been swollen with fluid. The swollen area was about "24 inches in length" and "4 inches in height". There were no lab diagnostic studies performed. She was prescribed KEFLEX and a steroid. Injection site reaction, immediate swelling and burning sensation, difficulty in breathing, one inch swelling area moved to the lower part of the arm/left arm swollen with fluid, could not sleep for 2 days and the site turned very painful, red, and purple were considered to be disabling by the reporter because the patient could not move her arm. The patient saw the pharmacist. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered pharmacist and a 69 year old female consumer with no pertinent medical history, no drug reactions/allergies, who on 30-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. Concomitant therapy included influenza virus vaccine (manufacturer unknown). On 30-OCT-2010 the patient experienced injection site reaction after receiving PNEUMOVAX 23. She experienced immediate swelling and burning sensation after the vaccination. She then experienced, difficulty in breathing and the one inch swelling area moved to the lower part of the arm. She could not sleep for 2 days and the site turned very painful, red, and purple. The patient reported that her left arm where she received PNEUMOVAX 23 (Lot # 665904/0866Z) had been swollen with fluid. The swollen area was about "24 inches in length" and "4 inches in height". There were no lab diagnostic studies performed. She was prescribed KEFLEX and a steroid. Injection site reaction, immediate swelling and burning sensation, difficulty in breathing, one inch swelling area moved to the lower part of the arm/left arm swollen with fluid, could not sleep for 2 days and the site turned very painful, red, and purple were considered to be disabling by the reporter because the patient could not move her arm. The patient saw the pharmacist. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Chills, Depressed level of consciousness, Dizziness
Clinical narrative: Initial report received from a consumer on 05 November 2010. A 65-year-old patient received on 22 October 2010 a left deltoid intramuscular (IM) injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number unknown. The patient had a history of diabetes, thyroid disorder, nerve pain in the feet and allergy to penicillin. Her concomitant medications included metformin, LEVOTHROID and gabapentin. She had no illness at the time of vaccination. The patient has had seasonal flu in the past 28 years but did not have either H1N1 or flu last year. One hour after vaccine the patient was dizzy with chills and then shaking. She then had repeated vomiting, extreme cold feeling and severe weakness. She could not get up to move to get the phone. The patient was found the next day "out of it on the couch covered with vomit". She could not turn her head to prevent herself from choking on the vomit due to her neck stiffness. The patient stated in one week she was "back to normal". The outcome was reported as recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling cold, Mobility decreased, Nausea, Tremor, Vomiting
Clinical narrative: Initial report received from a consumer on 05 November 2010. A 65-year-old patient received on 22 October 2010 a left deltoid intramuscular (IM) injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number unknown. The patient had a history of diabetes, thyroid disorder, nerve pain in the feet and allergy to penicillin. Her concomitant medications included metformin, LEVOTHROID and gabapentin. She had no illness at the time of vaccination. The patient has had seasonal flu in the past 28 years but did not have either H1N1 or flu last year. One hour after vaccine the patient was dizzy with chills and then shaking. She then had repeated vomiting, extreme cold feeling and severe weakness. She could not get up to move to get the phone. The patient was found the next day "out of it on the couch covered with vomit". She could not turn her head to prevent herself from choking on the vomit due to her neck stiffness. The patient stated in one week she was "back to normal". The outcome was reported as recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chills, Choking, Depressed level of consciousness
Clinical narrative: Initial report received from a consumer on 05 November 2010. A 65-year-old patient received on 22 October 2010 a left deltoid intramuscular (IM) injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number unknown. The patient had a history of diabetes, thyroid disorder, nerve pain in the feet and allergy to penicillin. Her concomitant medications included metformin, LEVOTHROID and gabapentin. She had no illness at the time of vaccination. The patient has had seasonal flu in the past 28 years but did not have either H1N1 or flu last year. One hour after vaccine the patient was dizzy with chills and then shaking. She then had repeated vomiting, extreme cold feeling and severe weakness. She could not get up to move to get the phone. The patient was found the next day "out of it on the couch covered with vomit". She could not turn her head to prevent herself from choking on the vomit due to her neck stiffness. The patient stated in one week she was "back to normal". The outcome was reported as recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Feeling cold, Malaise, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Initial report received from a consumer on 05 November 2010. A 65-year-old patient received on 22 October 2010 a left deltoid intramuscular (IM) injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number unknown. The patient had a history of diabetes, thyroid disorder, nerve pain in the feet and allergy to penicillin. Her concomitant medications included metformin, LEVOTHROID and gabapentin. She had no illness at the time of vaccination. The patient has had seasonal flu in the past 28 years but did not have either H1N1 or flu last year. One hour after vaccine the patient was dizzy with chills and then shaking. She then had repeated vomiting, extreme cold feeling and severe weakness. She could not get up to move to get the phone. The patient was found the next day "out of it on the couch covered with vomit". She could not turn her head to prevent herself from choking on the vomit due to her neck stiffness. The patient stated in one week she was "back to normal". The outcome was reported as recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Initial report received from a consumer on 05 November 2010. A 65-year-old patient received on 22 October 2010 a left deltoid intramuscular (IM) injection of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number unknown. The patient had a history of diabetes, thyroid disorder, nerve pain in the feet and allergy to penicillin. Her concomitant medications included metformin, LEVOTHROID and gabapentin. She had no illness at the time of vaccination. The patient has had seasonal flu in the past 28 years but did not have either H1N1 or flu last year. One hour after vaccine the patient was dizzy with chills and then shaking. She then had repeated vomiting, extreme cold feeling and severe weakness. She could not get up to move to get the phone. The patient was found the next day "out of it on the couch covered with vomit". She could not turn her head to prevent herself from choking on the vomit due to her neck stiffness. The patient stated in one week she was "back to normal". The outcome was reported as recovered. Documents held by sender: None.
Age: 0.21
Sex: M
Vaccine: PNC, UNK
Symptoms: Body temperature increased, Lymphadenopathy, Pyrexia
Clinical narrative: Pt has had reactions to all of the vaccines given to him starting 3-16-2009; our office did not give these. They were given at the County Health Department. Therefore I can not provide the manufacturer, lot number or site given. We did provide 2 of his vaccines - the Influenza 2009/2010, manufactured by Sanofi Pasteur, Lot# U3262JA, given IM in his left vastus lateralis on 11-16-2009, no previous doses given. Approximately 10min after vaccine given a flat rash was noted by the nurse, advice and instructions were given for BENADRYL usage, when to seek other assistance for worsening symptoms. We also gave the MMR - manufactured by Merck, Lot#1290Y, given sub q in his left upper lateral thigh, no previous dose given. There was no reaction noted directly after dosage administration. A rash and fever were noted up to 7 days after vaccine administration. I also can not give you his reactions to the majority of his vaccines due to the fact that he was not seen here after the vaccines were administered. He has recently been seen by doctor. He is an allergist/pulmonologist took a verbal history from pt's mother that gave his reactions and treatments.
Age: 0.21
Sex: M
Vaccine: PNC, UNK
Symptoms: Pyrexia, Rash, Vaccine positive rechallenge
Clinical narrative: Pt has had reactions to all of the vaccines given to him starting 3-16-2009; our office did not give these. They were given at the County Health Department. Therefore I can not provide the manufacturer, lot number or site given. We did provide 2 of his vaccines - the Influenza 2009/2010, manufactured by Sanofi Pasteur, Lot# U3262JA, given IM in his left vastus lateralis on 11-16-2009, no previous doses given. Approximately 10min after vaccine given a flat rash was noted by the nurse, advice and instructions were given for BENADRYL usage, when to seek other assistance for worsening symptoms. We also gave the MMR - manufactured by Merck, Lot#1290Y, given sub q in his left upper lateral thigh, no previous dose given. There was no reaction noted directly after dosage administration. A rash and fever were noted up to 7 days after vaccine administration. I also can not give you his reactions to the majority of his vaccines due to the fact that he was not seen here after the vaccines were administered. He has recently been seen by doctor. He is an allergist/pulmonologist took a verbal history from pt's mother that gave his reactions and treatments.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dysphagia, Tongue disorder
Clinical narrative: Pt is a 43 y.o. female admitted to the hospital, on 10/4/10, for alcohol and heroin withdrawal. She was vaccinated with PNEUMOVAX 23 and influenza vaccine prior to discharge on 10/7/10. Shortly after vaccination, the patient reported to nurse that she was having difficulty swallowing and her tongue felt thick. The hospitalist was called and ordered epinephrine 0.3 mg IM x 1, diphenhydramine 25 mg po x 1 and albuterol nebulizer treatment x 1. The patient recovered quickly and was discharged on 10/7/10.