chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to her 68 or 69 years old grandfather with bronchitis (experienced recently), hypertension, high cholesterol and prophylaxis. The patient's medical history included angioplasty due to blocked artery in heart and back pain. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot# and route was not reported) in his arm and tetanus vaccine in opposite arm on 25-OCT-2012. No other co-suspects were reported. Concomitant medications included CRESTOR, lisinopril and ibuprofen (It was also stated there was no concomitant medications). On 26-OCT-2012, the patient developed redness, swelling, and heat at the injection site and started using BENADRYL around the clock every six hours. On 27-OCT-2012, the redness, swelling, and heat was worsened and extended past his elbow. The patient had no laboratory tests performed. As of the time of reporting, the events continued and the reporter would advise her grandfather to contact his physician. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a pharmacist regarding to a male patient of unknown age. The patient's medical history included out breaks of shingles. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, and lot number were not provided). No other co-suspects were reported. Concomitant medications included: azathioprine. The pharmacist stated that recently in giving a patient a flu shot he inquired about the option of getting a second ZOSTAVAX vaccination. He stated that when he received his first vaccination he was on azathioprine where it was noted the immune response to vaccinations might be decreased. Since his vaccination he noted he had shingles once and while it was not the most visible of his out breaks it was his most painful. Patient's outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received via a field representative from a physician refers to a 74 years old male patient. Information regarding the patient's medical history was not provided. In approximately October 2009 (reported as 'three years ago') the patient was vaccinated subcutaneously with ZOSTAVAX, 0.65 ml one shot (dose number and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. In 2009 (reported as 'he said 3 years ago') the patient experienced shingles. No treatment information was reported. The outcome of shingles is unknown. A reporter causality for shingles was not provided for ZOSTAVAX. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Contusion, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a medical assistant refers to herself, 58 years old female patient with vaccines sensitivity and a history of cellulitis developed when she received ADACEL last year, in 2011. On 18-OCT-2012, the patient was vaccinated with dose 1, 0.65 ml ZOSTAVAX (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. On 18-OCT-2012, the patient experienced immediately bruised, after being vaccinated with ZOSTAVAX. The expiration date of the ZOSTAVAX was 18-OCT-2012, the same day that the vaccine was given. On 19-OCT-2012, the patient experienced cellulitis. The patient felt that she had a general sensitivity to vaccines (product names unspecified). No other information was given. No treatment information was reported. At the time of the report, the outcome of cellulitis and immediately bruised was reported as recovering. The outcome of general sensitivity to vaccines was unknown. The relatedness for cellulitis, general sensitivity to vaccines and immediately bruised was unknown for ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old male patient. On 22-OCT-2012, the patient was vaccinated subcutaneously, back of left arm with, 0.65 ml ZOSTAVAX (lot H012521 Exp: 09-OCT-2013). No concomitant medications were reported. The pharmacist stated that on 22-OCT-2012, the patient was vaccinated with improperly stored ZOSTAVAX vaccine. No adverse effects reported. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 74 years old female patient who on 20-JAN-2008 was vaccinated with a dose of 0.65 ml ZOSTAVAX (route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient called to the office and reported lower back pain. The doctor saw that the patient had a rash on her lower back and diagnosed it as shingles. The patient was treated with valacyclovir for adverse event. The patient sought medical attention. At the time of the report, the patient's outcome for adverse event was unknown. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 65 years old female patient with a medical history of having treated for pain and depression and none drug reactions/allergies who on 06-JAN-2012 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX23 (Lot # H013581, Exp date: 03-MAR-2014). No other co-suspects were reported. Concomitant medications included FLUZONE, zolpidem tartrate and trazodone hydrochloride. The pharmacist reported that a patient developed 5-6 inches of redness and swelling at the injection site after receiving the second 0.5 ml dose IM of PNEUMOVAX23 on 18-OCT-2012. Patient's outcome was reported as recovering. Action taken with PNEUMOVAX23 was not applicable. The relatedness between PNEUMOVAX23 and the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Emergency room visit 10-20-12 and 10-21-12 shingles agony!
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot # reported as "0467AE", Exp date: 04-APR-2013) on 09-OCT-2012. There was no concomitant medication. The pharmacist reported that an unspecified caregiver of the patient's called to report that the patient developed a two inch swollen, red and itchy area at the injection site where the dose of ZOSTAVAX was administered. The patient called pharmacy for medical attention. No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot # reported as "0467AE", Exp date: 04-APR-2013) on 09-OCT-2012. There was no concomitant medication. The pharmacist reported that an unspecified caregiver of the patient's called to report that the patient developed a two inch swollen, red and itchy area at the injection site where the dose of ZOSTAVAX was administered. The patient called pharmacy for medical attention. No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder, Condition aggravated, Herpes zoster, Injection site pain, Injection site swelling
Clinical narrative: Patient reported that left arm was sore initially after flu vaccine; stated that she felt the needle "hit the bone."  She received an allergy injection in health unit on Oct. 4, 2012.  No complaints were documented at that time.  The patient returned to the health unit on Oct. 16th, 2012 to report that she had been diagnosed with shingles after experiencing weakness, numbness, tingling, in her left arm & fingers, as well as itching in her arm & upper back.  She stated that she saw her private physician for treatment the first week of October and was prescribed Valtrex for two weeks. The patient wanted the event reported in the event that the flu vaccine was related to her subsequent shingles episode.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient reported that left arm was sore initially after flu vaccine; stated that she felt the needle "hit the bone."  She received an allergy injection in health unit on Oct. 4, 2012.  No complaints were documented at that time.  The patient returned to the health unit on Oct. 16th, 2012 to report that she had been diagnosed with shingles after experiencing weakness, numbness, tingling, in her left arm & fingers, as well as itching in her arm & upper back.  She stated that she saw her private physician for treatment the first week of October and was prescribed Valtrex for two weeks. The patient wanted the event reported in the event that the flu vaccine was related to her subsequent shingles episode.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Herpes zoster, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Patient reported that left arm was sore initially after flu vaccine; stated that she felt the needle "hit the bone."  She received an allergy injection in health unit on Oct. 4, 2012.  No complaints were documented at that time.  The patient returned to the health unit on Oct. 16th, 2012 to report that she had been diagnosed with shingles after experiencing weakness, numbness, tingling, in her left arm & fingers, as well as itching in her arm & upper back.  She stated that she saw her private physician for treatment the first week of October and was prescribed Valtrex for two weeks. The patient wanted the event reported in the event that the flu vaccine was related to her subsequent shingles episode.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus
Clinical narrative: Patient reported that left arm was sore initially after flu vaccine; stated that she felt the needle "hit the bone."  She received an allergy injection in health unit on Oct. 4, 2012.  No complaints were documented at that time.  The patient returned to the health unit on Oct. 16th, 2012 to report that she had been diagnosed with shingles after experiencing weakness, numbness, tingling, in her left arm & fingers, as well as itching in her arm & upper back.  She stated that she saw her private physician for treatment the first week of October and was prescribed Valtrex for two weeks. The patient wanted the event reported in the event that the flu vaccine was related to her subsequent shingles episode.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Body temperature increased, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 57 years old female patient with diabetes, hypertension and hyperlipidemia. The patient was vaccinated intramuscularly with her primary 0.5 ml PNEUMOVAX 23 (lot # reported as H01358I, exp 03-MAR-2014) on 18-OCT-2012 for vaccination. Concomitant medications included metformin, TRICOR, enalapril maleate, hydrochlorothiazide, BYETTA and WELCHOL. On 19-OCT-2012 the patient experienced malaise and fever of 100 to 101F within 24 hours after vaccination, her enzyme measurements were within normal limits on 18-OCT-2012. The patient do some physical examination for medical attention. On 23-OCT-2012 the patient experienced liver enzymes were elevated: Aspartate aminotransferase increased 110 and Aspartate aminotransferase increased 120. No treatment information was reported. The outcome of malaise, fever and liver enzymes were elevated was reported as not recovered/not resolved. On 24-OCT-2012, the patient presented follow up examination to test for Mononucleosis and Hepatitis. The outcome of the test was unknown at the time of the report. The reporter stated that the patient was not demonstrated any type of injection site reaction. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain of skin
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 57 years old female patient with diabetes, hypertension and hyperlipidemia. The patient was vaccinated intramuscularly with her primary 0.5 ml PNEUMOVAX 23 (lot # reported as H01358I, exp 03-MAR-2014) on 18-OCT-2012 for vaccination. Concomitant medications included metformin, TRICOR, enalapril maleate, hydrochlorothiazide, BYETTA and WELCHOL. On 19-OCT-2012 the patient experienced malaise and fever of 100 to 101F within 24 hours after vaccination, her enzyme measurements were within normal limits on 18-OCT-2012. The patient do some physical examination for medical attention. On 23-OCT-2012 the patient experienced liver enzymes were elevated: Aspartate aminotransferase increased 110 and Aspartate aminotransferase increased 120. No treatment information was reported. The outcome of malaise, fever and liver enzymes were elevated was reported as not recovered/not resolved. On 24-OCT-2012, the patient presented follow up examination to test for Mononucleosis and Hepatitis. The outcome of the test was unknown at the time of the report. The reporter stated that the patient was not demonstrated any type of injection site reaction. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Hepatitis viral test, Malaise, Mononucleosis heterophile test
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 57 years old female patient with diabetes, hypertension and hyperlipidemia. The patient was vaccinated intramuscularly with her primary 0.5 ml PNEUMOVAX 23 (lot # reported as H01358I, exp 03-MAR-2014) on 18-OCT-2012 for vaccination. Concomitant medications included metformin, TRICOR, enalapril maleate, hydrochlorothiazide, BYETTA and WELCHOL. On 19-OCT-2012 the patient experienced malaise and fever of 100 to 101F within 24 hours after vaccination, her enzyme measurements were within normal limits on 18-OCT-2012. The patient do some physical examination for medical attention. On 23-OCT-2012 the patient experienced liver enzymes were elevated: Aspartate aminotransferase increased 110 and Aspartate aminotransferase increased 120. No treatment information was reported. The outcome of malaise, fever and liver enzymes were elevated was reported as not recovered/not resolved. On 24-OCT-2012, the patient presented follow up examination to test for Mononucleosis and Hepatitis. The outcome of the test was unknown at the time of the report. The reporter stated that the patient was not demonstrated any type of injection site reaction. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 57 years old female patient with diabetes, hypertension and hyperlipidemia. The patient was vaccinated intramuscularly with her primary 0.5 ml PNEUMOVAX 23 (lot # reported as H01358I, exp 03-MAR-2014) on 18-OCT-2012 for vaccination. Concomitant medications included metformin, TRICOR, enalapril maleate, hydrochlorothiazide, BYETTA and WELCHOL. On 19-OCT-2012 the patient experienced malaise and fever of 100 to 101F within 24 hours after vaccination, her enzyme measurements were within normal limits on 18-OCT-2012. The patient do some physical examination for medical attention. On 23-OCT-2012 the patient experienced liver enzymes were elevated: Aspartate aminotransferase increased 110 and Aspartate aminotransferase increased 120. No treatment information was reported. The outcome of malaise, fever and liver enzymes were elevated was reported as not recovered/not resolved. On 24-OCT-2012, the patient presented follow up examination to test for Mononucleosis and Hepatitis. The outcome of the test was unknown at the time of the report. The reporter stated that the patient was not demonstrated any type of injection site reaction. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Haemoptysis, Headache, Increased upper airway secretion, Malaise, Myalgia
Clinical narrative: Patient filled out VAERS E-65876 - this is what he described in that VAERS. "Most symptoms worse on 10/18 and 10/19. Muscle aches and pains (5 days), mild headache (2 days), mild nausea (6 days), minor wheezing (3 days). Blood in phlegm (first observed 10/19). Malaise into 10-24." Pt said on 11-2 he feels better as of 11-2-12. I was told by employer to fill out another VAERS.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Nausea, Wheezing
Clinical narrative: Patient filled out VAERS E-65876 - this is what he described in that VAERS. "Most symptoms worse on 10/18 and 10/19. Muscle aches and pains (5 days), mild headache (2 days), mild nausea (6 days), minor wheezing (3 days). Blood in phlegm (first observed 10/19). Malaise into 10-24." Pt said on 11-2 he feels better as of 11-2-12. I was told by employer to fill out another VAERS.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Infection
Clinical narrative: This spontaneous report was received from a pharmacist who refers to a 61 years old female patient with none drug reactions and/or allergies. On 24-OCT-2012, the patient was vaccinated intramuscularly in right arm with a dose of PNEUMOVAX23 (dose not reported) lot # (1947AA), exp. 20-OCT-2013. Concomitant medications included FLUVIRIN (administered on the same day in left arm) and levothyroxine sodium. On 25-OCT-2012 the patient experienced infection "under the arm" following a vaccination. The patient sought medical attention during office visit on 25-OCT-2012. The patient received KEFLEX for adverse event treatment. At the time of the report patient's status was reported as recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Localised infection
Clinical narrative: This spontaneous report was received from a pharmacist who refers to a 61 years old female patient with none drug reactions and/or allergies. On 24-OCT-2012, the patient was vaccinated intramuscularly in right arm with a dose of PNEUMOVAX23 (dose not reported) lot # (1947AA), exp. 20-OCT-2013. Concomitant medications included FLUVIRIN (administered on the same day in left arm) and levothyroxine sodium. On 25-OCT-2012 the patient experienced infection "under the arm" following a vaccination. The patient sought medical attention during office visit on 25-OCT-2012. The patient received KEFLEX for adverse event treatment. At the time of the report patient's status was reported as recovering. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: Bilateral Joint pains in knuckles, wrist, elbows, knees, ankles, toes, jaw. Much more pain on left side. Inflamed left hand joints esp. thumb. Headache, malaise. NSAIDs from onset to present. Symptoms persist.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Arthralgia, Arthritis, C-reactive protein normal
Clinical narrative: Bilateral Joint pains in knuckles, wrist, elbows, knees, ankles, toes, jaw. Much more pain on left side. Inflamed left hand joints esp. thumb. Headache, malaise. NSAIDs from onset to present. Symptoms persist.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Full blood count normal, Headache, Laboratory test normal, Malaise, Parvovirus B19 test negative
Clinical narrative: Bilateral Joint pains in knuckles, wrist, elbows, knees, ankles, toes, jaw. Much more pain on left side. Inflamed left hand joints esp. thumb. Headache, malaise. NSAIDs from onset to present. Symptoms persist.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Red blood cell sedimentation rate increased, Thyroid function test normal, Vitamin D
Clinical narrative: Bilateral Joint pains in knuckles, wrist, elbows, knees, ankles, toes, jaw. Much more pain on left side. Inflamed left hand joints esp. thumb. Headache, malaise. NSAIDs from onset to present. Symptoms persist.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 25-Oct-2012) concerns a 56-year-old male patient, who was allergic to penicillin. Concomitant medication included an antidepressant. The patient was administered PNEUMOVAX three years ago. On 10-Oct-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided). On the same day the patient also another dose of PNEUMOVAX 23 (batch number: H010661) intramuscularly. That same evening of 10-Oct-2012 the patient was treated in an emergency room for cellulitis. The event outcome was recovered.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pronounced redness, hardness, and heat at injection site. Would scream and cry in pain if touched near the shot site or any pressure applied to the leg at all while holding him.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Screaming
Clinical narrative: Pronounced redness, hardness, and heat at injection site. Would scream and cry in pain if touched near the shot site or any pressure applied to the leg at all while holding him.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient came to Pharmacy on 11/1/2012 said he has been feeling muscle pain after his shot and still has mucle pain now. No bruising. He called his Doctor. He plans to see his Doctor.
Age: 1.11
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bradycardia, CSF glucose normal, CSF protein increased, Cardiac pacemaker insertion, Cytomegalovirus test negative
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diplopia, Dysphagia, Fibrin D dimer, Guillain-Barre syndrome, HIV test negative
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hepatitis B test negative, Hepatitis C test negative, Mechanical ventilation, Muscular weakness, Pneumonia aspiration
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tracheostomy
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Cardiac pacemaker insertion, Catheter placement, Computerised tomogram head, Gastrointestinal tube insertion
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Intensive care, Life support, Lumbar puncture, Mechanical ventilation
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Paralysis, Tracheostomy, Vena cava filter insertion
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Developed Guillain-Barre Syndrome - progressive muscle weakness, lower extremities and upper extremities, bulbar area with failure to swallow, diplopia, aspiration pneumonia, BP 180/95. Now on ventilator, trached, bradycardia requiring pacemaker insertion. Hospitalized from 10/16/12 to current 11/2/12.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Neuralgia
Clinical narrative: This spontaneous report as received from a 68 years old male consumer with high blood pressure and no drug reactions/allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot # not reported) on approximately 26-SEP-2012, "about 30 days ago" in the left arm. Other suspect therapies given on the same date, included a dose of Influenza Virus Vaccine (manufacturer unknown) (dose and lot # not reported) given subcutaneously in the left arm. Concomitant medications included lisinopril (manufacturer unspecified). On an unspecified date, the patient experienced an injection site reaction consisting of swelling and redness, which went away after a few days. About one week ago, on approximately 19-OCT-2012, the patient started to experience nerve pain on his left side, which traveled from his thigh down to his calf. He was seen by his doctor for the nerve pain. His doctor administered an unspecified steroid shot (unspecified manufacturer) and prescribed hydrocodone/acetaminophen 10 mg/650 mg for the pain. There were no labs/diagnostic studies performed. The patient continued to take the hydrocodone/acetaminophen and stated that the steroid shot did alleviate the pain greatly. However, he described his present status as still recovering because the steroid shot seems to have "worn off," and the nerve pain had returned. The patient stated "Even with the pain medication, I still have some pain." The relatedness for nerve pain on his left side, injection site redness and injection site swelling was unknown for ZOSTAVAX  and Influenza Virus Vaccine (manufacturer unspecified). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: This spontaneous medically confirmed report (initial receipt 23-Oct-2012) concerns a 63 year old male patient with a medical history of diabetes and hypercholesterolaemia. Concomitant medications include pioglitazone, glimiperide, Calcium with vitamin D, desloratadine, metformin and simvastatin. There were no allergies. On 09-Oct-2012, the patient received an unspecified flu vaccine (manufacturer and batch number unknown). The patient also received a second dose of co-suspect drug 'Sylatron Kit 296/1.25' (peginterferon alpha 2B) on 12-Oct-2012 for melanoma. A dose of SYLATRON was administered subcutaneously with a dose (296 mcg) taken once weekly. The patient started SYLATRON on 05-Oct-2012 (5 days prior to receiving the flu vaccine). On 14-Oct-2012, 6 days after receiving the flu vaccine, the patient developed a diffuse, red, raised rash. On this day the patient presented to the emergency room with a diffuse rash on his trunk and arms. He was prescribed a tapering dose of oral prednisone and completed the course on 19-Oct-2012. On 19-Oct-2012, the patient advised to use topical hydrocortisone cream and promethazine. On 22-Oct-2012 (14 days following flu vaccination), the patient's rash was worse. He had a fever of 103.5 Fahrenheit, a heart rate of 120 and the rash had progressed to cover his neck, lower extremities and back. He was admitted to hospital with a diagnosis of possible shingles. The patient outcome is not yet recovered at the time of reporting.
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: Initial case was received from a consumer on 23 October 2012. This reporter also reported another adverse event which was captured in case number 2012-09995. A female patient had received an injection of INFLUENZA (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a rash and her arm was so sore she couldn't lift it for two days. The patient saw a physician and was treated with steroids. The patient never had issues before. Outcome was not reported. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness, Sensory disturbance
Clinical narrative: This medically confirmed spontaneous report concerns a 52 year old female patient. The reporter is the patient who is also a pharmacist. Medical history included a drug reaction to doxycycline (rash). Concomitant medications included multivitamins daily. The patient has had influenza vaccine once last year which was not AFLURIA. On 02-Oct-2012, the patient received AFLURIA (batch no. unspecified) via intramuscular route in the left arm. About one week to 10 days post vaccination, the patient developed sensory issues. She had numbness, tingling of the buttocks, genitals, that moved down one side of her leg. It was almost like a hypersensitivity reaction. The patient stated that subsided somewhat, but now has mostly tingling, numbness, coldness in her legs and feet. Even when lying down in bed the tingling occurs where her body is in contact with the bed. The patient states she thinks this is an immune mediated response to AFLURIA. The event outcome was not recovered.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Breath holding, Loss of consciousness
Clinical narrative: Initial case received from a consumer on 23 October 2012. A male patient age 15 months received a dose of DAPTACEL Lot # C4186AA, intramuscularly into the left thigh, a dose of FLUZONE Lot # U4531BA, intramuscularly into the left thigh and a dose of PREVNAR, Lot # G10784 manufactured by Wyeth, intramuscularly into the right thigh on 23 October 2012. The patient had a history of eczema, facial rash with egg whites, but tolerates egg yolks. Concomitant medications and lab results were not reported. On an unspecified time after administration of vaccines, the patient held his breath for 10 seconds and then passed out for 1 to 2 seconds. The patient was described to be easily awakened by the nurse practitioner. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain in extremity, Tendonitis
Clinical narrative: Initial case was received from a healthcare professional, who was also the patient, on 23 October 2012. A 37-year-old female patient received a right deltoid intramuscular injection of FLUZONE SV, sanofi pasteur Inc., lot number unknown, on 04 October 2012 at 9:00AM. By 3:00pm, on 04 October 2012, the patient had arm pain, for which she stated "had to use my other arm to lift the right one", and arm pain persisted. On 23 October 2012, she was diagnosed with tendonitis "tenoditis". Laboratory or diagnostic testing were not reported. Treatment included Naproxen 500 milligram (mg) twice a day (BID) for 72 hours and to be seen for follow-up on 05 November 2012. The patient stated the "shot is very high in my arm, right on my shoulder", but she also reported site as right deltoid. The patient had no past medical history or allergies and denied illness at time of vaccination. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Culture, Injection site erythema, Injection site pustule, Injection site rash, Injection site swelling
Clinical narrative: Initial report was received from a health care professional on 23 October 2012. An 11-year-old female patient had received an injection of MENACTRA, lot number U4267AB (route, site and date of administration not reported) and an unspecified amount of time later experienced a rash at the site of injection that formed a blister and small bumps with pus in them. The physician did a culture of the bumps but has not received results yet. The injection site was also swollen and red. No further information was provided. The patient's outcome was not reported. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site vesicles
Clinical narrative: Initial report was received from a health care professional on 23 October 2012. An 11-year-old female patient had received an injection of MENACTRA, lot number U4267AB (route, site and date of administration not reported) and an unspecified amount of time later experienced a rash at the site of injection that formed a blister and small bumps with pus in them. The physician did a culture of the bumps but has not received results yet. The injection site was also swollen and red. No further information was provided. The patient's outcome was not reported. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Abasia, Abdominal pain upper, Crying, Haematemesis, Headache
Clinical narrative: Dr. gave 1st HPV 9-2-10. Within a few days, pt. passed out, in 2 weeks passed out again. Spit up blood, bad headaches, stomach ache, hives. Dr. gave her HPV shot; recommended booster in 1 month. She passed out a week later, had panic attack, bad headaches, stomach and pelvic pain, legs cramping up at night. Waking crying, couldn't walk at first.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Loss of consciousness, Muscle spasms, Panic attack, Pelvic pain, Urticaria
Clinical narrative: Dr. gave 1st HPV 9-2-10. Within a few days, pt. passed out, in 2 weeks passed out again. Spit up blood, bad headaches, stomach ache, hives. Dr. gave her HPV shot; recommended booster in 1 month. She passed out a week later, had panic attack, bad headaches, stomach and pelvic pain, legs cramping up at night. Waking crying, couldn't walk at first.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Red raised bump size of silver dollar. Hot to the touch. Firm to the touch x 7 days.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Diplopia, Hypoaesthesia, Hypoaesthesia oral, Nerve degeneration, VIIth nerve paralysis
Clinical narrative: A report has been received from a physician concerning a 32 years old male patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 10-Oct-2012, the patient received nasal FLUMIST. On 11-Oct-2012, the patient developed right sided Bells Palsy with left sided nerve deficiency and bilateral double vision. Patient was getting progressively worse. The symptoms began with tongue numbness, then face numbness and progressed to facial drooping. The patient was hospitalized on 18-Oct-2012. At the time of reporting, the events of Bells Palsy, left sided nerve deficiency and bilateral double vision were ongoing. The reporting considered the events to be serious due to hospitalization.
Sex: F
Vaccine: FLUN3
Symptoms: Hypoaesthesia
Clinical narrative: A report has been received from a Pharmacist concerning a female patient of unknown age. Medical history and concomitant drugs of the patient were not reported. The patient had been receiving Nasal FLUMIST, started during the year 2011 for an unknown indication. The pharmacist reported in the year 2011, that the patient experienced numbness of the face four weeks after receiving FLUMIST. Action taken with the suspect vaccine was unknown. The patient recovered from the event of numbness of face 4 weeks after receiving FLUMIST on an unknown date. The reporting pharmacist assessed the event of numbness of face 4 weeks after receiving FLUMIST to be serious with the seriousness criteria of important medical event. The neurologist considered that there was a causal relation between the event numbness of face 4 weeks after receiving FLUMIST and the suspect drug FLUMIST.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Drug administered at inappropriate site, Injection site pain, Insomnia
Clinical narrative: Vaccine administered very high on left shoulder.  Significant resistance on injection.  Localized soreness and left arm pain (from neck to forearm) within 2 hours.  Pain unrelieved by OTC NSAIDs, interfering with sleep for 2 nights.  Gradual improvement in symptoms since. At the time of report, lingering symptoms including joint tenderness, weakness and decreased shoulder range of motion.  No redness, bruising or significant swelling at any point.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Vaccine administered very high on left shoulder.  Significant resistance on injection.  Localized soreness and left arm pain (from neck to forearm) within 2 hours.  Pain unrelieved by OTC NSAIDs, interfering with sleep for 2 nights.  Gradual improvement in symptoms since. At the time of report, lingering symptoms including joint tenderness, weakness and decreased shoulder range of motion.  No redness, bruising or significant swelling at any point.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Pyrexia, Tremor
Clinical narrative: Shaking continuously, fever, difficult breathing, hives, weakness and fast heart beat.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Shaking continuously, fever, difficult breathing, hives, weakness and fast heart beat.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness and edema from upper thigh to knee, warmth at touch two hours post vaccination until now.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Eye discharge, Fatigue, Pain, Pyrexia, Vision blurred
Clinical narrative: Eyes became gooey and hazy.  Fever. Aches in left side of body.  Overall Fatigue.
Age: 1.55
Sex: F
Vaccine: HIBV, UNK
Symptoms: Injection site rash, Rash
Clinical narrative: Rash developed around the injection site, which was on her left thigh, and then spread to the rest of her left leg.  Within days it spread to her left side of abdomen, left arm and slowly spread to her right side as well, although less pronounced on her right side. So far, it has not spread to feet, hands, or face.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Throat tightness
Clinical narrative: Eyes became swollen, lips swelled, throat closed.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Body temperature increased, Injected limb mobility decreased, Myalgia
Clinical narrative: 96.5 kg 54 yo F with NKDA was administered Tdap, influenza and pneumococcal vaccines on 10/31. Flu 0.5ml to left deltoid manufacturer SKB lot AFLUA715AA; Pneumovax 23 0.5ml right deltoid manufacturer MSD lot H013581; TDap left deltoid 0.5ml manufacturer SKB lot AC52B094CA. On 11/1/12, pt reported being unable to raise her arm due to muscle pain. Area not erythematous or warm to touch. Pt had temp of 99.4 oral.  Unreported but this appears to be first vaccination with Pneumovax.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Pain in right jaw joint.  No treatment.  Pain continues into next day.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: The nurse administering the shot gave the shot at the top of my shoulder and it was painful when she put the needle in and then when she pushed the meds in also.  Never have I had a shot given in that location before and never did I have pain like this during a flu shot.  My arm was sore all day and thought it was going to go away in time.  I has been getting worse and not better. This is keeping me up at night and I have loss of function and mobility along with pain. I reported this to my HR manager and found out that there were others with the same issue.  Was contacted by a nurse who asked me to explain what happened that day.  She suggested we see our PCP, which was my next move, and then gave us contact info and fax number where we can send any and all receipts for treatment related to the pain of this shot. I have an appointment with my PCP 11/7/12.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Developed shingles.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dyspnoea
Clinical narrative: Dyspnea, oxygen saturation 100% in room air dropped to 77% during albuterol RX-sent via Ambulance to ER -received IV-Solu-Medrol 90mg and Duoneb neb, plus Benadryl and Pepcid.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Abdominal discomfort, Crying, Erythema, Grunting, Irritability
Clinical narrative: Irritability, crying, appearance of intestinal distress - intense grunting with fists clenched, face getting red.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states: Sore arm, bruised, red area around injection site, swollen, pain that travels to upper shoulder.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Axillary mass, Rash erythematous
Clinical narrative: On 2 Nov 12 member came in to clinic presenting concern with raised red round bump underneath left arm. Member denies chest pain, fever, but states underarm swollen and feels like a bruise. Seen by Dr.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Lymphadenopathy, Malaise, Musculoskeletal pain, Pyrexia
Clinical narrative: Client received Tdap vaccine on October 18th. Friday during the day, client states he was fine. Friday night shoulder felt sore so took some Tylenol PM. Saturday October 19th, client states he felt like he had a fever and didn't feel well. He took some regular Tylenol.  On Sunday October 20th, client state there was swelling in the shoulder and armpit area. The lymph nodes of the armpit swelled to the size of a baseball. He said the left side of upper chest was throbbing, sore, and swollen. He placed ice on it and took more Tylenol. On Monday October 21st, he went to work and iced his shoulder and armpit during breaks. On Monday, shot area was still sore and lymph nodes were still swollen. On Wednesday October 23rd, lymph nodes starting to go down. By Saturday October 26th, everything seemed back to normal. Client stated he took ibuprofen all week twice a day. He stated that he thought the medicine helped.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Client received Tdap vaccine on October 18th. Friday during the day, client states he was fine. Friday night shoulder felt sore so took some Tylenol PM. Saturday October 19th, client states he felt like he had a fever and didn't feel well. He took some regular Tylenol.  On Sunday October 20th, client state there was swelling in the shoulder and armpit area. The lymph nodes of the armpit swelled to the size of a baseball. He said the left side of upper chest was throbbing, sore, and swollen. He placed ice on it and took more Tylenol. On Monday October 21st, he went to work and iced his shoulder and armpit during breaks. On Monday, shot area was still sore and lymph nodes were still swollen. On Wednesday October 23rd, lymph nodes starting to go down. By Saturday October 26th, everything seemed back to normal. Client stated he took ibuprofen all week twice a day. He stated that he thought the medicine helped.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Aphasia, Asthenia, Bradycardia, Dyspnoea, Erythema
Clinical narrative: Allergy, redness, couldn't breath, low pressure, yesterday morning that is 1/11/2012 my father fainted twice, couldn't breath or talk, his pressure was 80/60 he was extremely weak.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Hypotension, Syncope
Clinical narrative: Allergy, redness, couldn't breath, low pressure, yesterday morning that is 1/11/2012 my father fainted twice, couldn't breath or talk, his pressure was 80/60 he was extremely weak.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Sore muscle and joint in left arm.  Has ranged from limited mobility in shoulder joint to numbness to elbow.  As of 10/31/2012, there is pain in the left elbow joint.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Note: I do not know the exact time of onset of her pain.  Patient has experienced intermittent left shoulder pain that has not improved since she received her shot.  She has had PT, injections and is now scheduled for arthroscopy 11/13/2012.
Age: 0.25
Sex: M
Vaccine: MEN, MM
Symptoms: Arnold-Chiari malformation, Autism, Convulsion, Developmental delay, Scan brain
Clinical narrative: Seizure. Stopped talking and walking. Started high pitched screaming within hours of immunization.  He was later diagnosed with severe autism and chianti malformation when a brain scan previously did not show chiari. He tested at 24 months the day of vaccination, he was 15 months old at the time.
Age: 0.25
Sex: M
Vaccine: MEN, MM
Symptoms: Screaming, Surgery
Clinical narrative: Seizure. Stopped talking and walking. Started high pitched screaming within hours of immunization.  He was later diagnosed with severe autism and chianti malformation when a brain scan previously did not show chiari. He tested at 24 months the day of vaccination, he was 15 months old at the time.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chest discomfort, Chills, Decreased appetite, Pulmonary congestion
Clinical narrative: Report from patient "Within two hours of the injection I contracted a fever, chills, chest heaviness congested, achy joints and did not feel like eating or drinking anything.  Felt this way until about 8pm then all symptoms slowly subsided except the aching joints.  Aching joints slowly went away the next day."
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Report from patient "Within two hours of the injection I contracted a fever, chills, chest heaviness congested, achy joints and did not feel like eating or drinking anything.  Felt this way until about 8pm then all symptoms slowly subsided except the aching joints.  Aching joints slowly went away the next day."