chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response, Tuberculin test
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 45-year-old female subject who was vaccinated with TWINRIX administration interval too long. On September 2003 the subject received 1st dose of TWINRIX (1ml, unknown route, left deltoid). In 2013, 4 years after vaccination with 3rd dose of TWINRIX, 9 years after vaccination with 2nd dose of TWINRIX,  10 years after vaccination with 1st dose of TWINRIX, the subject experienced not responding to therapy. Relevant test results includes "serology following the 3 dose series of TWINRIX was as follows: anti-HB's less than 5 IU/L (hepatitis B surface antigen). No serology done to measure Hepatitis A response following the same 3 dose (TWINRIX) series." According to the nurse, she would consider this subject to be similar "to some who was unvaccinated." At the time of reporting this outcome of the event was unspecified.
Sex: F
Vaccine: HEPAB
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of adverse event in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of TWINRIX (unknown details). At an unspecified time after vaccination with TWINRIX, the subject experienced adverse event. The subject did not provide any details of the adverse event at the time of reporting. Attempts were unsuccessful to contact reporter. At the time of reporting the outcome of the event was unspecified.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Feeling hot, Pruritus, Underdose
Clinical narrative: This case was reported by a pharmacist and described the occurrence of erythema of cheek in a 57-year-old female subject who was vaccinated with TWINRIX. On 11 July 2013 at 18:00 the subject received 1st dose of TWINRIX (.5 ml, unknown, left arm) and experienced vaccine under dose. The subject received a 0.5 ml dose instead of the indicated 1 ml dose. On 20 July 2013, 9 days after vaccination with TWINRIX, the subject experienced erythema of cheek, heart sensation in cheek, and itchy cheek. Co-suspect medications included Omeprazole, Ondansetron and Lactulose solution. The subject developed a "reactions on one of her cheeks in the form of redness, a feeling of heat and itchiness". She had "recently" started using Omeprazole, Ondansetron and Lactulose solution and pharmacist was trying rule each of these out as the cause of the events too. At the time of reporting the outcome of the events was unspecified.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B antigen positive, Hepatitis B core antibody negative, Hepatitis B surface antigen positive, Hepatitis C antibody negative, Hepatitis C test negative
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hepatitis b antigenemia in a 35-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to azithromycin, allergy to sumatriptan, allergy to tramadol, anxiety, chronic infection and high risk sexual behavior. Concurrent medications included PAROXETINE, Cefixime, Doxycycline, Metronidazole and SKELAXIN. On 30 October 2012 the subject received 1st dose of TWINRIX (20 mcg, intramuscular, left deltoid). On 31 October 2012 to 1 November 2012, approximately 2 days after vaccination with TWINRIX, the subject experienced hepatitis b antigenemia. The reporter stated that the physician had ordered a hepatitis b surface antibody test but the hepatitis b antigen test was run. Relevant test results included hepatitis b surface antigen test on 1 November 2012 which was positive. The reporter stated that it was a "possibility of transient hepatitis B antigenemia or other chronic infection." At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 14 December 2012 via healthcare professional who reported the subject had their blood drawn again on 06 December 2012 and HBsAg was negative. HBsAg [hepatitis B antigenemia] was originally reactive on 01 November 2012 two days post vaccination. The vaccination series with TWINRIX was not delayed or discontinued. The subject did not experience any adverse events following previous vaccinations. The hepatitis B antigenemia resolved on 06 December 2012. The reporting healthcare professional considered the event probably related to vaccination with TWINRIX.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis viral test negative, Treponema test
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hepatitis b antigenemia in a 35-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to azithromycin, allergy to sumatriptan, allergy to tramadol, anxiety, chronic infection and high risk sexual behavior. Concurrent medications included PAROXETINE, Cefixime, Doxycycline, Metronidazole and SKELAXIN. On 30 October 2012 the subject received 1st dose of TWINRIX (20 mcg, intramuscular, left deltoid). On 31 October 2012 to 1 November 2012, approximately 2 days after vaccination with TWINRIX, the subject experienced hepatitis b antigenemia. The reporter stated that the physician had ordered a hepatitis b surface antibody test but the hepatitis b antigen test was run. Relevant test results included hepatitis b surface antigen test on 1 November 2012 which was positive. The reporter stated that it was a "possibility of transient hepatitis B antigenemia or other chronic infection." At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 14 December 2012 via healthcare professional who reported the subject had their blood drawn again on 06 December 2012 and HBsAg was negative. HBsAg [hepatitis B antigenemia] was originally reactive on 01 November 2012 two days post vaccination. The vaccination series with TWINRIX was not delayed or discontinued. The subject did not experience any adverse events following previous vaccinations. The hepatitis B antigenemia resolved on 06 December 2012. The reporting healthcare professional considered the event probably related to vaccination with TWINRIX.
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Lymphadenopathy, Skin warm, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen lymph nodes in neck and axillary region in a male subject aged between 20 and 29 years old who was vaccinated with TWINIX. In January 2013 the subject received 1st dose of TWINRIX (1 "dose", unknown route, unknown deltoid). In January 2013, within hours after vaccination with TWINRIX (described as "later that night"), the subject experienced swollen lymph nodes in neck and axillary region, erythema neck area, neck tenderness and warm to touch. The events of erythema neck area, neck tenderness and warm to touch described the lymph nodes in the neck and arm pit areas. Per the reporter, the arm pit was "the arm where the injection was administered." The healthcare professional stated that the subject "returned to the office so they can see it" and "no medication was given." At the time of reporting the outcome of the events were unspecified.
Age: 25.0
Sex: F
Vaccine: HEPAB
Symptoms: Product quality issue, Syringe issue, Vomiting
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of vomiting in a 25-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 1 July 2013 the subject received 2nd dose of TWINRIX (.5 ml, unknown route, left deltoid). On 1 July 2013, within minutes of vaccination with TWINRIX, the subject experienced vomiting. This case is associated with a product quality complaint. The nurse reported that the "TWINRIX prefilled syringe plunger was very difficult to depress while administering." The nurse then reported that the subject "vomited after administration." At the time of reporting the outcome of the event was unspecified.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody positive
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of hepatitis b antibody positive ina  currently 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included blood donor. The subject reported that he "traveled on business" but did not report locations. On 6 April 2007, 7 may 2007 and 8 October 2007 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (1 cc, unknown route, left arm). On 13 June 2012, 5 years after vaccination with TWINRIX, the subject experienced hepatitis b antibody positive. On 13 June 2012, the subject was "tested to see if he could donate blood. he was rejected, due to having positive antibodies of hepatitis B." The subject was "told to wait 8 weeks and return." On 30 August 2012, the subject was tested again and had "the same result" of hepatitis b antibody positive. The subject was then evaluated by his primary care physician. Relevant test results included hepatitis b antibody test positive on 13 June 2012 an d30 August 2012. After the positive Hepatitis B antibody tests, the subject reported that his primary care physician ran additional "tests and they were normal." At the time of reporting the event was unresolved. Follow up was received from physician on 30 September 2013. The physician documented that vaccinations were "distant history vaccinations" and that the subject "recently established care in our office." No further details were provided.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of TWINRIX (unknown details). At an unspecified time after vaccination with TWINRIX, the subject experienced injection site redness. The nurse described the injection site redness as "like a plum." The nurse was not able to provide any additional details. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEPAB
Symptoms: Burning sensation, Expired drug administered, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning during injection in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown) that expired on 22 June 2012. During vaccination with TWINRIX, the subject experienced burning during injection, expired vaccine used and pharmaceutical product complaint. The healthcare professional reported the subject received a dose from this TWINRIX batch and complained of burning as it went in. The reporter was planning to return this lot as she suspected the symptoms may be related to this particular lot [pharmaceutical product complaint]. At the time of reporting the outcome of the burning during injection was unspecified. The healthcare professional reported another subject who experienced adverse events with this TWINRIX lot, please see case A1018366A for this report.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of rash in a 33-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Current medical conditions included liver biopsy. On 23 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). On 18 September 2012, 26 days after vaccination with TWINRIX, the subject experienced rash, itchy bumps described as "rash and raised itchy bumps all around the arms, legs, back and chest". The subject received TWINRIX on 23 August 2012 and when he returned fro the 2nd dose at the physician's office on 26 September 2012, he complained that he had developed the events on 18 September 2012. The subject did acknowledge that he had used a new detergent and had his carpet cleaned, but no exact cause was identified. The subject was also supposed to have a liver biopsy and the 2nd dose was not administered. The liver biopsy was not scheduled as a result of the 1st dose of TWINRIX. The subject had a liver biopsy scheduled for the same date that he was to receive the 2nd dose of TWINRIX. The second dose of TWINRIX was held (immunization series delayed). At the time of reporting the outcome of the events was unspecified.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initially site of injection marked redness, tenderness, indurated lasting 3 weeks. Area remained red, tender. Dr prescribed BENADRYL, cold packs - not effective. Then prescribed Methylpred 4mg pak for 6 days - on 10-17-13. Today 11-8-13 area still pink, slight tenderness persists.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Vaccination site reaction, Varicella virus test positive
Clinical narrative: Developed shingles at site of vaccination (laboratory verified). No prior history of varicella.
Age: 39.0
Sex: F
Vaccine: FLUN4
Symptoms: Skin lesion
Clinical narrative: States 2 hours after receiving FLUMIST, live vaccine. she developed a 10 mm lesion on her upper (L) lip. Took BENADRYL last night, which had no effect on the lesion. Will follow up with PCP if doesn't improve.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction 5-6 inch warm, red swelling over injection site, chills overnight.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: 1 week after receiving vaccine c/o pain 5-6/10 arm injection site radiating to rt elbow tried ice packs, heat, Ibuprofen without relief. Returns several times/day lasting for a month. Refer to PCP.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Joint range of motion decreased, Nerve compression, Pain in extremity
Clinical narrative: Pain in arm lasting a week now. Patient describes as a "toothache" in arm. Saw doctor on 11-10-13. Dr thinks it is a pinched nerve or bursitis - not due to flu shot. Patient feels she has limited range of motion now.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Sharp pain during injection, slight soreness at site. That evening woke up with dull pain all down Lft arm from shoulder to hand, especially in deltoid region. 2+ months later still have range of motion issues (deltoid) better - but still there.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Joint injury, Pruritus
Clinical narrative: Night of vac - an injured ankle itched from ankle to knee all night. Next morning site of vac red size of quarter itching - leg ok - 3rd day headache off and on 3 day - never get headaches. Vac area size of half dollar - still itching 8 days.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Blood glucose, Gaze palsy, Tension, Tremor
Clinical narrative: After admin of vaccines pt became tense, eyes rolled towards back of head, began to shake. Pt was laid down on table shaking stopped. Vitals taken. MD assessed pt. Pt kept in office for 30 mins. Orthostatic b/s done. OJ given. Ice pack placed behind pt's neck. Pt d/c to home after stabilized.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness
Clinical narrative: Patient claims arm is still weak and has lost mobility on the arm.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Blood test normal, Diarrhoea, Erythema, Headache
Clinical narrative: Adverse reaction to vaccine. Headache, nausea, diarrhea, arm felt heavy and hot, red and swollen. Went to ER - BP was low, IV given and released. Ibuprofen for 3 days, give 3 every 6 hours and take it easy.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Local swelling, Nausea, Sensation of heaviness, Skin warm, Vaccination complication
Clinical narrative: Adverse reaction to vaccine. Headache, nausea, diarrhea, arm felt heavy and hot, red and swollen. Went to ER - BP was low, IV given and released. Ibuprofen for 3 days, give 3 every 6 hours and take it easy.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Dizziness, Heart rate increased, Injection site pain
Clinical narrative: Pain at injection site. Then increased heart rate, dizziness, nausea, slight upper back/chest pain. Patient vomited, had nausea. Arm started swelling within 30 min of injection and continued to swell for 24 hours. (Her right arm had swelling/none in left).
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Nausea, Vomiting
Clinical narrative: Pain at injection site. Then increased heart rate, dizziness, nausea, slight upper back/chest pain. Patient vomited, had nausea. Arm started swelling within 30 min of injection and continued to swell for 24 hours. (Her right arm had swelling/none in left).
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Fatigue, Headache, Hypersomnia, Pain
Clinical narrative: Just over 36 hrs. after receiving flu shot -> 100 degrees temp. with generalized aches, fatigue, and headache. Extreme exhaustion -> slept 16 hrs. straight on 11/16 -> into 11/17, 5AM woke up feeling ok. Used Ibuprofen for pain and fever. (3ts x 48+ hrs.). Reported to me 11/19/13.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Convulsion, Loss of consciousness, Salivary hypersecretion, Unresponsive to stimuli
Clinical narrative: AFTER RECEIVING THE VACCINES THE PATIENT BEGAN SHOWING SIGNS OF CONVULSION, BECAME UNCONSCIOUS AND BEGAN TO SALIVATE WITHOUT VERBAL OR TACTIL RESPONSE. AFTER A SHORT PERIOD OF TIME SHE AWOKE. VITAL SIGNS WERE TAKEN: BP- 109/50, P-62, R-17, T-36.6.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Cold sweat, Myalgia
Clinical narrative: Arthralgias, myalgias, chills from 4:00 - 10:30. At this time I went to sleep. In the middle of the night I broke into a cold sweat.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Herpes Zoster right parietal, diagnosed by PCP 11/19/2013.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood creatine phosphokinase, Blood thyroid stimulating hormone, C-reactive protein, Epstein-Barr virus test
Clinical narrative: Numbness, tingling and achy feelings in her arms and legs. Myalgia, weakness and fatigue.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Full blood count, Hypoaesthesia, Metabolic function test, Myalgia
Clinical narrative: Numbness, tingling and achy feelings in her arms and legs. Myalgia, weakness and fatigue.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: Numbness, tingling and achy feelings in her arms and legs. Myalgia, weakness and fatigue.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Eye irritation, Eyelid margin crusting, Fatigue
Clinical narrative: 2:30pm - under tongue and tongue tingling. 2:45pm - mouth and tongue swelling.  300pm - slight fever - 99.5 and eyes irritated and gumming up- 4pm - mouth swelling making swallowing diffucult - eyes really gumming up - fever of 100.8.  500PM - some body temperature issues (shivering then sweating) - fever the same - breathing not an issue, swelling of tongue and mouth not getting worse, shoulder injection site slightly painful but no redness.  8PM - swelling going down, eyes not gumming up, temperature 100.5. Sweated a lot during the night.  Did not take any medicine, just drank water and had some lite food night of the 9th. Fatigue on the 10th, some shoulder swelling and pain.  night of the 10th more night sweats. all other symptoms gone during the day of the 10th.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling of body temperature change, Hyperhidrosis, Injection site pain, Joint swelling, Musculoskeletal pain
Clinical narrative: 2:30pm - under tongue and tongue tingling. 2:45pm - mouth and tongue swelling.  300pm - slight fever - 99.5 and eyes irritated and gumming up- 4pm - mouth swelling making swallowing diffucult - eyes really gumming up - fever of 100.8.  500PM - some body temperature issues (shivering then sweating) - fever the same - breathing not an issue, swelling of tongue and mouth not getting worse, shoulder injection site slightly painful but no redness.  8PM - swelling going down, eyes not gumming up, temperature 100.5. Sweated a lot during the night.  Did not take any medicine, just drank water and had some lite food night of the 9th. Fatigue on the 10th, some shoulder swelling and pain.  night of the 10th more night sweats. all other symptoms gone during the day of the 10th.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Night sweats, Oedema mouth, Paraesthesia oral, Pyrexia, Swollen tongue
Clinical narrative: 2:30pm - under tongue and tongue tingling. 2:45pm - mouth and tongue swelling.  300pm - slight fever - 99.5 and eyes irritated and gumming up- 4pm - mouth swelling making swallowing diffucult - eyes really gumming up - fever of 100.8.  500PM - some body temperature issues (shivering then sweating) - fever the same - breathing not an issue, swelling of tongue and mouth not getting worse, shoulder injection site slightly painful but no redness.  8PM - swelling going down, eyes not gumming up, temperature 100.5. Sweated a lot during the night.  Did not take any medicine, just drank water and had some lite food night of the 9th. Fatigue on the 10th, some shoulder swelling and pain.  night of the 10th more night sweats. all other symptoms gone during the day of the 10th.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Pain
Clinical narrative: Flu like symptoms, severe phyiscal pain all over. The pain still remains in my arms (not joints) and thighs.  Lately my neck is being effected also.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Barium double contrast, Intestinal perforation, Intussusception, Procedural complication, Rectal haemorrhage
Clinical narrative: Intussusception.  Patient presented with vomiting, bright red blood per rectum. Diagnosed at Medical Center via ultrasound.  Attempt made to reduce with air enema resulted in bowel perforation.  Emergency surgery performed.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Intussusception.  Patient presented with vomiting, bright red blood per rectum. Diagnosed at Medical Center via ultrasound.  Attempt made to reduce with air enema resulted in bowel perforation.  Emergency surgery performed.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, RV5
Symptoms: Crying, Emotional distress
Clinical narrative: Patient unconsolably after receiving vaccines on 4/8/13. The crying started exactly 4 hours after the time of administration.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Pain, Rash erythematous, Swelling
Clinical narrative: Swelling, burning, deep red rash, burning, pain.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Lower back pain. Started quite severe, almost debilitating. Almost fell due to pain when bending down. Didn't lift anything heavy during the day and don't recall hurting back in any other way. The pain has gotten better since date of injection and onset. However, more than 2 weeks later, lower back still hurts though not as severe as before.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Bradycardia, Respiratory distress
Clinical narrative: Respiratory distress, bradycardia, apnea.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Persistent severe left shoulder/upper arm pain.  Has not yet seen physician, but plans to.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Joint stiffness, Musculoskeletal stiffness, Pain
Clinical narrative: Stiffness in joints and muscle of arms and shoulders. Increasing pain in following days continuing to today.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site was swollen, red and itchy.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Throat tightness, Vomiting
Clinical narrative: Throat tightened, chest pain, chills, vomiting. Patient took antihistamine, went to sleep and felt better after awakening.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Body aches and sore arm the next day (R) arm became red, hot to touch (next day) pt had HA and fatigue. Saw MD and received 7 day course of cephalexin 500 mg QID on 10/22/13.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Body aches and sore arm the next day (R) arm became red, hot to touch (next day) pt had HA and fatigue. Saw MD and received 7 day course of cephalexin 500 mg QID on 10/22/13.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a physician refers to a child of unknown age and gender. No medical history was provided. On an unknown date the patient was vaccinated with ROTATEQ 9oral). No concomitant medications were provided. In 1988 ("25 years ago") the child patient developed intussusception. The physician considered this a "bad experience" with ROTATEQ and did not want his statement to become an adverse event report. The outcome of intussusception is unknown. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt. reported throbbing pain to left arm, palm of hand and ring finger - lasted about 2 wks. but has since resolved. Started after receiving FLUZONE injection to (L) deltoid.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Influenza like illness, Influenza virus test negative, Myalgia
Clinical narrative: Developed severe flu like syndrome lasting 7 days x 5 days post injection temp daily > 103 degrees myalgia chills.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator for a pharmacy concerning a male patient. ON an unspecified date the patient was vaccinated with PNEUMOVAX23 (lot # H011780 and expiration date 16FEB2014) and a flu vaccine (manufacturer not specified). On 11SEP2013 the patient experienced adverse reaction (NOS) to PNEUMOVAX23 and the flu vaccine (manufacturer not specified). Per the reporter, it was unclear which vaccine the patient had a reaction to. The outcome of the adverse reaction was unknown.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Muscular weakness, Throat irritation
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of arms feel weak in a 36-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 11 November 2013 at 16:30 the subject received 1st dose of FLULAVAL TETRA (.5 ml, unknown, unknown arm). On 11 November 2013 at 17:20, 50 minutes after vaccination with FLULAVAL TETRA, the subject experienced arm felt weak side unknown, itchy throat and strange feeling. The sales representative stated that the physician reported that the subject went to urgent care, was referred to the emergency room, was treated with BENADRYL and written prescriptions for prednisone and ZYRTEC. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with FLULAVAL TETRA.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Headache, Hypertension, Lumbar puncture normal
Clinical narrative: Nausea, dry heaves, extreme malaise.  This progressed to severe headache, vomiting, hypertension.  Had to be admitted to hospital to rule out aneurysm due to severity of headaches.  Had to have a MRI/MRA, CAT scan of brain, lumber puncture to rule out meningitis, brain bleed, etc.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Retching
Clinical narrative: Nausea, dry heaves, extreme malaise.  This progressed to severe headache, vomiting, hypertension.  Had to be admitted to hospital to rule out aneurysm due to severity of headaches.  Had to have a MRI/MRA, CAT scan of brain, lumber puncture to rule out meningitis, brain bleed, etc.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Nausea, dry heaves, extreme malaise.  This progressed to severe headache, vomiting, hypertension.  Had to be admitted to hospital to rule out aneurysm due to severity of headaches.  Had to have a MRI/MRA, CAT scan of brain, lumber puncture to rule out meningitis, brain bleed, etc.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Approximately 3 days after became red and painful at injection site. Came into pharmacy on day 5, pain had not lessened or worsened. Still red and patient described area as "hard as a rock". Advised patient to see physician on following day.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient stated that since receiving vaccine in September she has experienced pain shooting down arm and wrist, over her collarbone and up her neck.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Gaze palsy, Immediate post-injection reaction, Pallor, Seizure like phenomena
Clinical narrative: Immediately after giving the injection the patient said he felt like he was going to pass out. His head went back and his eyes rolled up in his head and it looked like he was having a seizure. It lasted for a few seconds and he looked pale. He put his head between his legs til he felt better. I called 911.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Injection site pain, Injection site swelling
Clinical narrative: Temp of 106 about 12 hours after vaccine. Resp to TYLENOL. Swelling/pain of Rt. thigh.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Patient arm was swollen and red, went to doctor and was prescribed BACTRIM.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pain
Clinical narrative: Localized redness and pain. No vesicle or fever.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-ganglioside antibody, Borrelia test negative, CSF glucose increased, CSF protein increased, CSF white blood cell count positive
Clinical narrative: Guillain Barre Syndrome - Given IVIG x 5 days. Patient will undergo rehab after discharge. Bilateral leg weakness. Admitted on 11/17/13. Weakness on legs started 11/13/13. CK on admission 361 after discontinuation of statin on 10/31. Initial CK on 10/31 - 1465.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Gram stain positive, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Red blood cells CSF positive
Clinical narrative: Guillain Barre Syndrome - Given IVIG x 5 days. Patient will undergo rehab after discharge. Bilateral leg weakness. Admitted on 11/17/13. Weakness on legs started 11/13/13. CK on admission 361 after discontinuation of statin on 10/31. Initial CK on 10/31 - 1465.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy
Clinical narrative: Subcutaneous atrophy at site of injection. Treatment = observation.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm. Treated w/ BACTRIM DS 800mg - 160mg tab.
Age: 42.0
Sex: U
Vaccine: FLUN4
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Received FLUMIST on 11/13/13. Started to developed hives on 11/15/13. Took BENADRYL 25mg po PRN. 11/19/13 - rash spread - referred to Dr. received DEPO-MEDROL.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea
Clinical narrative: It was noticed that the member was coughing across the room. Member was assessed and was having difficulty breathing. Patient had used her inhaler a few times on her own. Patient was given o2 via a NR at 156pm. On call provider was notified and patient was helped to administer her own Epi-pen and EMS was activated.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Contusion, Erythema
Clinical narrative: 1 3/4 inch width by 1 1/2inch length round systemic reaction. Slight redness with minimal bruising. No induration. Mother reports she noticed it a day later. Examined patient on 11/20/2013 @ 13:15 PM. No signs of distress, recommended to keep an eye on it and call us any other signs or symptoms occur. No medications given at office visit.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: REDNESS, PAIN AND ITCHING AT INJECTION SITE.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Body temperature increased, Injection site pain, Nausea, Pain
Clinical narrative: Sore arm near injection site, body aches, nausea.  11/18/2013: elevated blood glucose, elevated blood pressure, elevated temperature,  severe body shaking, repeated vomiting, HEARTRATE 120/MIN lasting about 16 hours.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, Vomiting
Clinical narrative: Sore arm near injection site, body aches, nausea.  11/18/2013: elevated blood glucose, elevated blood pressure, elevated temperature,  severe body shaking, repeated vomiting, HEARTRATE 120/MIN lasting about 16 hours.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Malaise, Pyrexia
Clinical narrative: Fever, joint pain, malaise. Symptoms resolved approx 10 hours after onset without treatment.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: Patient received her Pneumovax and Fluvirin in separate arms.  She said that around 4 hours after receiving her vaccines, her right arm in which she received her Pneumovax hurt so bad that she could no lift it and she was nauseous and dizzy.  She said that after getting her vaccines she did some yard work and thought that could have been the cause of some of her arm pain. She said her left arm where she got the Fluvirin did not hurt.
Age: 0.51
Sex: F
Vaccine: 6VAX-F, FLU3, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Rotavirus expired, immunization out-dated, no treatment indicated or adverse symptoms reported.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Skin warm
Clinical narrative: Flu shot given on 11/11/13 - that night felt warm rash noted 11/12/13 on trunk, arms to elbows, legs to upper thighs - saw Dr who gave him a Prednisone prescription for 7 days and cortisone cream and BENADRYL 50 mg 2 PM.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Bundle branch block right, Electrocardiogram abnormal, Fibrin D dimer increased, Flushing, Renal failure acute
Clinical narrative: Within 8 hours after vaccine administration had sinus tachycardia, acute on chronic renal fail; elevated D Dimer, flushing, new (R) bundle branch blk on EKG.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Sinus tachycardia
Clinical narrative: Within 8 hours after vaccine administration had sinus tachycardia, acute on chronic renal fail; elevated D Dimer, flushing, new (R) bundle branch blk on EKG.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Balance disorder, Dizziness, Headache, Immediate post-injection reaction, Laboratory test
Clinical narrative: Headache immediately after immunizations, dizzy, balance issues. Patient subsequently seen in ER for further eval.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Headache immediately after immunizations, dizzy, balance issues. Patient subsequently seen in ER for further eval.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Chills, Computerised tomogram, Dyspnoea, Pulmonary embolism
Clinical narrative: Chills, could not get a full breath. Next day went to emergency ... I had pulmonary embolism in each lung.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Chills, could not get a full breath. Next day went to emergency ... I had pulmonary embolism in each lung.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Administered the High-dose Fluzone to a pregnant woman. No adverse events have yet resulted from this error.
Age: 11.0
Sex: M
Vaccine: HEP, IPV, MMR, MNQ, TDAP
Symptoms: Local swelling, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Recieved call from school nurse reporting left arm swollen and sore. Child was sent home with fever and vomiting also.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Pt. received Prevnar (4th dose), MMR (1st dose), and Hepatitis A (1st dose).  About 6 hrs after vaccinations were given, patient developed hives to entire body and a fever.  Mother took her to ER where they medicated her with Benadryl and sent her home.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling abnormal, Nausea, Vomiting
Clinical narrative: 11/01/2013 @ 1100-1200 feeling poorly with nausea; went home early. 11/02-03/2013: vomiting and frequent runs (liquid stools). 11/04/2013: stayed home from work. 1105/2013: returned to work - felt okay.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Within a few minutes of receiving the vaccine, the patient reported feeling dizzy.  She sat down and started to go unconscious.  The pharmacist called for help.  The store manager called 911, and a physician, who happened to be in the store shopping, came over offering to help.  The physician checked the patient's pulse and respiratory rate.  An Epi-pen was available for administration, but the physician felt the patient was not going into anaphylatic shock and the Epipen was not needed.  The patient was unconscious for several minutes.  The EMS arrived, and the patient started to regain consciousness.  The EMS remained with the patient and monitored her vital signs.  The patient left a short time later under her own power.  A follow-up call was made to the patient on 11/18, and she reported that she was doing well, with no further adverse events.  She also would be following up with her physician on 11/19/2013.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: I receive flu shot to my left arm. The area where the shot was given to turned red, swollen and felt hot to touch for about 4 days.
Age: 42.0
Sex: M
Vaccine: JEV1
Symptoms: Cardiac arrest, Sudden death
Clinical narrative: Sudden death, cardiac arrest of unknown cause at this time.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Nausea, Rhinorrhoea, Tremor
Clinical narrative: Clear dripping nose, nausea, severe chills, rigors with body shaking, teeth popping, and headache all lasting for 3 or 4 hours.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site with big red swelling or bump - hard and hot to touch.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site with big, red swelling or bump - hot to touch and hard.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cough, Dizziness, Fatigue, Hypoaesthesia
Clinical narrative: DIZZINESS, FATIGUE, NUMBNESS IN TONGUE, WEAKNESS, COUGH, NUMBNESS IN LEFT ARM, TACHYCARDIA, NAUSEA, MUSCLE ACHES AND PAINS, MILD FEVER, FEELINGS OF A HEAD COLD.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia oral, Myalgia, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: DIZZINESS, FATIGUE, NUMBNESS IN TONGUE, WEAKNESS, COUGH, NUMBNESS IN LEFT ARM, TACHYCARDIA, NAUSEA, MUSCLE ACHES AND PAINS, MILD FEVER, FEELINGS OF A HEAD COLD.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Tachycardia
Clinical narrative: DIZZINESS, FATIGUE, NUMBNESS IN TONGUE, WEAKNESS, COUGH, NUMBNESS IN LEFT ARM, TACHYCARDIA, NAUSEA, MUSCLE ACHES AND PAINS, MILD FEVER, FEELINGS OF A HEAD COLD.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Blood culture, Decreased appetite, Headache, Joint swelling
Clinical narrative: Patient came into the pharmacy tonight extremely upset wanting to report an adverse reaction to a vaccine. She received both Fluvirin and Pneumovax 23 on 11/15. She reports feeling loss of appetite, muscle weakness, headache, fever, muscle and joint pain in the back of her legs and in her arms, and swollen glands. She saw a doctor in regards to a rash and swollen elbow joint below the injection site. Both injections were given in her left deltoid approximately one inch apart. The doctor prescribed ibuprofen, and the patient reports that the doctor is doing a blood test to determine the need for antibiotics.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy, Muscular weakness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Patient came into the pharmacy tonight extremely upset wanting to report an adverse reaction to a vaccine. She received both Fluvirin and Pneumovax 23 on 11/15. She reports feeling loss of appetite, muscle weakness, headache, fever, muscle and joint pain in the back of her legs and in her arms, and swollen glands. She saw a doctor in regards to a rash and swollen elbow joint below the injection site. Both injections were given in her left deltoid approximately one inch apart. The doctor prescribed ibuprofen, and the patient reports that the doctor is doing a blood test to determine the need for antibiotics.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Patient came into the pharmacy tonight extremely upset wanting to report an adverse reaction to a vaccine. She received both Fluvirin and Pneumovax 23 on 11/15. She reports feeling loss of appetite, muscle weakness, headache, fever, muscle and joint pain in the back of her legs and in her arms, and swollen glands. She saw a doctor in regards to a rash and swollen elbow joint below the injection site. Both injections were given in her left deltoid approximately one inch apart. The doctor prescribed ibuprofen, and the patient reports that the doctor is doing a blood test to determine the need for antibiotics.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood thyroid stimulating hormone, Fatigue, Full blood count, Hyperhidrosis
Clinical narrative: I started to itch over my entire body around 11:00 AM on the same day I got the vaccine. Later on in the afternoon I noticed a lack of energy. When I woke up around 7:00 AM the next day (11/19/2013), the itching had got worse, in some areas I had small little bumps that came up and itched, and was feeling very fatigued. By mid day, I started sweating & felt like I was running a fever, along with the constant itching over my entire body.  I ended up taking 2, sometimes 3, Benadryl every 4 hours. when I got home from work, I soaked in an oatmeal bath. Around 7:00 PM, I took my temperature and it was 99.7 (my normal temperature averages 97.6). I was very tired, felt weak, still itching over my entire body, and still had small little bumps coming up. When I woke up around 7:00 AM on Wednesday (11/2/2013), I was still itching and still had a few bumps. You can tell where all the bumps came up because they are scabbed over some (I scratched the skin off). I have continued to feel fatigued and feel like I am still running a fever. However, I am no longer sweating or feel like I am burning up. I still may have to return to the doctor's office if the symptoms continue for another day or two.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Metabolic function test, Pruritus generalised, Pyrexia, Rash pruritic, Scab
Clinical narrative: I started to itch over my entire body around 11:00 AM on the same day I got the vaccine. Later on in the afternoon I noticed a lack of energy. When I woke up around 7:00 AM the next day (11/19/2013), the itching had got worse, in some areas I had small little bumps that came up and itched, and was feeling very fatigued. By mid day, I started sweating & felt like I was running a fever, along with the constant itching over my entire body.  I ended up taking 2, sometimes 3, Benadryl every 4 hours. when I got home from work, I soaked in an oatmeal bath. Around 7:00 PM, I took my temperature and it was 99.7 (my normal temperature averages 97.6). I was very tired, felt weak, still itching over my entire body, and still had small little bumps coming up. When I woke up around 7:00 AM on Wednesday (11/2/2013), I was still itching and still had a few bumps. You can tell where all the bumps came up because they are scabbed over some (I scratched the skin off). I have continued to feel fatigued and feel like I am still running a fever. However, I am no longer sweating or feel like I am burning up. I still may have to return to the doctor's office if the symptoms continue for another day or two.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: Sore neck, head hurting, fever chills.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness/warmth/swelling at vaccine site.
Age: 39.0
Sex: F
Vaccine: FLUX, HEP, TDAP
Symptoms: Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in shoulder, down arm to hand. Numbness and tingling in arm, shoulder and hand.
Age: 31.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: Complained of severe pain injection circa arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient felt tender and warm at the injection site first then rash developed and spread to the elbow and even under arm in 1 - 2 days. Doctor. Dx: cellulitis and prescribed KEFLEX. Pt. felt better after 1 week.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Hypoaesthesia, Local swelling, Pain in extremity, Palpitations
Clinical narrative: At 14 hr - (L) arm extremely painful and some numbness of arm and hand. Fever (did not measure). Fatigue. 11/16 and 17 palpation. Today - 11/18 - cont of (L) arm and swollen arm.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: At 14 hr - (L) arm extremely painful and some numbness of arm and hand. Fever (did not measure). Fatigue. 11/16 and 17 palpation. Today - 11/18 - cont of (L) arm and swollen arm.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: As per mom noticed child's left arm red, swollen, hot and hard. Hurt to touch. Aprox 11.5 x 6 cm. Mom noticed on 11/19/2013 at around 7:00pm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Red rash, itch, progressive at site of injection. Rash progressed for 3 days, then resolved.