chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Culture negative, Febrile convulsion, Pyrexia, Urine analysis normal
Clinical narrative: No signs of flu or any other infection. Urine and mucus test did not show anything. Only had very high fever which went from 100.2 to 105 F in a period of two hours even when Motrin was administered at first onset. High fever culminated in febrile seizure which lasted around 2 minutes.
Age: 54.0
Sex: F
Vaccine: FLUN4, TDAP
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Anaemia, Blood test abnormal, Erythema, Pyrexia, Sinus disorder
Clinical narrative: This is a Solicited report refers to a 45 year old female patient. The patient current condition includes non smoker, and Crohn's disease. The patient is allergic to ceclor, Asacol, Pentasa and an unknown medication and was manifested by itching and respiratory problems. The patient's medical history included sinus allergies, itching, respiratory problems and bowel resection. On 12-JAN-2014, the patient experienced sinus problems, anemic, arm was little red and low grade temperature/fever off and on. The patient reported from starting to have sinus problems on 12-JAN-2014. The patient stated she saw her physician on 13-JAN-2014 for check up. She was given a vaccine, PNEUMOVAX 23 and had blood drawn. Other suspect therapies included HUMIRA (40 mg, Solution or injection in pre-filled pen). Concomitant therapies included FLINTSONTES MULTIVITAMIN and CALCIUM (UNSPECIFIED). The patient stated that after getting the PNEUMOVAX 23 her arm was a little red and she ran a fever off and on ever since. The patient was treated with ferrous sulfate. She felt a little better but still had a low grade temperature. The patient stated sinus issues had persisted as well. The patient stated the physician called her that day to report that her blood was low. The outcome of sinus disorder was reported as not recovered/not resolved. The outcome of redness was reported as recovered/resolved. The outcome of anemic was unknown. The outcome of fever was reported as recovering/resolving. The outcome of blood low was unknown. This is linked to 1402USA012998 due to same patient link. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from registered nurse refers to 8 year old patient of unknown gender. On 14-JAN-2014, the patient was vaccinated with M-M-R II injection (strength, dose number, dose unit, lot# and route unknown) that has expired on 10-JAN-2014. No untoward effect was reported. The outcome of expired dose of M-M-R II was administered and no untoward effect was unknown. No further information provided. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a medical assistant of the physician refers to a 12 year old child of unknown gender. Medical history was reported as none. No known drug allergy was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) lot # J006732; expiry: 30-MAY-2015, dose: 0.5 ml (millilitres), subcutaneous in the right arm. Concomitant therapy was reported was none. On an unknown date the patient developed a rash at the injection site after administration of VARIVAX (Merck). The patients were evaluated in the office. No medical treatment was prescribed. The patient sought medical attention and had an office visit. The outcome of rash at the injection site was unknown. Causality assessment for the event was not provided. This case is linked to: 1402USA007622 (same reporter link). Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 11 year old child of unknown gender. Medical history was reported as none. No known drug allergy was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) lot # J006732; expiry: 30-MAY-2015, dose: 0.5 ml (millilitres), subcutaneous in the right arm. Concomitant therapy was reported was none. On an unknown date the patient developed a rash at the injection site after administration of VARIVAX (Merck). The patients were evaluated in the office. No medical treatment was prescribed. The patient sought medical attention and had an office visit. The outcome of rash at the injection site was unknown. Causality assessment for the event was not provided. This case is linked to: 1402USA013049 (same reporter link). Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. On 27-DEC-2013, the patient was vaccinated with oral ROTATEQ dose 1, oral (dosing regimen unspecified). On 25-FEB-2014 the patient was vaccinated with oral ROTATEQ dose 2, oral (dosing regimen unspecified). On 25-FEB-2014, patient received an expired (expired on 06-OCT-2013) 2nd dose of oral ROTATEQ. No adverse effects reported. The outcome of the medication error was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to a 12 month old female patient. The patient was born at 37 weeks, child was semi premature. On 25-FEB-2014, the patient was vaccinated with MMR II Lot # 1884AA (Expiry: 30-NOV-2013) dose 1. Concomitant medications included VARIVAX (Merck), PEDVAXHIB and HEPATITIS A VIRUS VACCINE (UNSPECIFIED). It was reported that the patient was vaccinated with expired MMR II. No adverse effects were reported. No further AE information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 25-FEB-2014, the patient was vaccinated with ZOSTAVAX lot # H020844 (expiry date 20-FEB-2014). On 25-FEB-2014, 1 day after onset of therapy the patient was administered an expired dose of ZOSTAVAX. No adverse effects reported. The outcome of was administered an expired dose of ZOSTAVAX and no adverse effects was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient has drug reactions/allergies with penicillin, cephalosporin and triptans. On 08-NOV-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 10mcg/mL, intramuscular for immunisation (lot #, expiry date not provided) with no adverse effects. On 10-DEC-2013, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot #, expiry date, route, dose and indication not reported). The pharmacist reported that the patient developed a rash on 10-FEB-2014 ("two weeks ago"). The pharmacist stated that the rash was reported to her by the patient's daughter who described it as, "hive-like, itchy and getting worse". The pharmacist stated that the patient had not yet sought treatment for the rash and had not seen a physician. No lab diagnostics studies were performed. The patient sought medical attention by call to pharmacy. At the time of reporting the outcome of the events was not recovered. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. On 10-FEB-2014, the patient was administered a dose of GARDASIL (lot#, expiry date, dose, frequency, route and indication not reported) which went through an unsupported temperature excursion. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Sensation of foreign body
Clinical narrative: This spontaneous report was received from a consumer refers to a 71 year old female patient. The patient pertinent medical history included heart disease, thyroid disease and asthma. The patient was highly allergic to egg. On 25-FEB-2014, the patient was vaccinated with the third dose of PNEUMOVAX 23 (dose, route and frequency were not reported). The patient reported that on an unknown date in 2006 (also reported as sometime in 2006) the patient received the first dose of PNEUMOVAX 23. On an unknown date in 2008 (also reported as sometime in 2008) the patient received second dose of PNEUMOVAX 23. Concomitant medications included ATORVASTATIN, METOPROLOL and ZOLPIDEM TARTRATE. The patient reported that after receiving the third dose of PNEUMOVAX 23 on 25-FEB-2014, the patient experienced chills and lump in her throat. The patient did not sought medical attention. No treatment was given to the events. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Headache since 2-24-14. Onset after receiving vaccine.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a female patient of unknown age. On 25-FEB-2014, the patient was vaccinated with the third dose of GARDASIL, 0.5 ml, intramuscular. The nurse reported that the patient vaccinated the first dose of GARDASIL on 20-SEP-2013 and second dose of GARDASIL on 17-DEC-2013. No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin induration
Clinical narrative: Left upper arm swollen, painful and itching. Induration of skin. 1.75 in red indurated and raised. Elocon 0.1% cream given to apply to affected area, hydroxyzine 10mg/5ml given for itching prn. Shot of DECADRON/DEPO MEDROL given.
Age: 82.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old female patient. The pharmacist reported that about 5 years ago, assumed in 2009, the patient was given the VARIVAX (Merck) (subcutaneous, 0.5 ml) in error. She was supposed to have gotten ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a healthcare worker for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with allergy to mushrooms and a history of irregular menses who on 01-AUG-2011 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL (lot number: 0626AA, expired date 23-JUN-2013). The patient had no known drug allergies. On 01-NOV-2011, the patient was vaccinated intramuscularly with 0.5 ml of the second of GARDASIL (lot number: 1140AA, expired date: 25-APR-2014), and the patient has been pregnant, pregnancy test was positive. The LMP was reported as 25-SEP-2011, estimated delivery date was on 01-JUL-2012. At the time of the reporting, the outcome of the pregnancy was unknown. The patient sought medical attention by office visit. Follow-up information was received from a nurse who stated that the patient was no longer a patient at the office. The patient's last appointment was on 17-NOV-2011, and was transferred to other healthcare center. On 25-FEB-2014, a phone call was placed to the new healthcare center, a nurse stated that she had no record of the patient. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient states he developed case of shinigles all over his back 1-2 weeks after receiving vaccine. Did not seek treatment. After one month was improving but had not totally cleared shingles.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt complained after her flu shot, she has pain on her arm. She thought it would go away so she didn't report to us until 2 wks later. Because she said she still has a lot of pain and can't raise her arm. I recommended her to go see MD.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain, Mobility decreased
Clinical narrative: After shot was given no pain - got home and few hours later, pt experiences pain on left shoudler, can't move thru out the night, still has pain, can't lift his arm or shoulder.
Age: 73.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Chills, Dizziness, Nausea, Photophobia, Tinnitus
Clinical narrative: Chills - nauseous - very dizzy - vomiting - light sensitive - ears ringing. Started 2-6-14 and worsened by 2-7-14. Was advised by Urgent Care to go to emergency at hospital.
Age: 73.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Vomiting
Clinical narrative: Chills - nauseous - very dizzy - vomiting - light sensitive - ears ringing. Started 2-6-14 and worsened by 2-7-14. Was advised by Urgent Care to go to emergency at hospital.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pruritus, Skin warm
Clinical narrative: Patient reports back 3 days after getting ZOSTAVAX with diffuse bruising, reported that the area was "hot and itchy".
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Pain, Pain in extremity
Clinical narrative: It hurts when I lift my arm up and out. I received the FLUVIRIN shot on my upper left arm. I was told there would be soreness but I am still sore, achy, my left arm hurts and is constant, I am always achy and the discomfort I feel all the time, and it won't go away.
Age: 1.32
Sex: F
Vaccine: HEP, HEPA
Symptoms: Blood chloride normal, Blood urea increased, C-reactive protein normal, Drug hypersensitivity, Injection site rash
Clinical narrative: 11/15/13 Diagnosed with pneumonia. Started AUGMENTIN. Had fever onset 11/14. Paracetamol given 11/14. 11/22/13 Rash on face, legs, thighs. Dx: urticaria. Stop AUGMENTIN. 11/23/13 Progression of rash. Admit to hospital. Given SOLU-MEDROL. Dx: Allergic to penicillin.
Age: 1.32
Sex: F
Vaccine: HEP, HEPA
Symptoms: Metabolic function test, Neutrophil count increased, Platelet count normal, Pneumonia, Pyrexia
Clinical narrative: 11/15/13 Diagnosed with pneumonia. Started AUGMENTIN. Had fever onset 11/14. Paracetamol given 11/14. 11/22/13 Rash on face, legs, thighs. Dx: urticaria. Stop AUGMENTIN. 11/23/13 Progression of rash. Admit to hospital. Given SOLU-MEDROL. Dx: Allergic to penicillin.
Age: 1.32
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash, Urticaria, White blood cell count normal
Clinical narrative: 11/15/13 Diagnosed with pneumonia. Started AUGMENTIN. Had fever onset 11/14. Paracetamol given 11/14. 11/22/13 Rash on face, legs, thighs. Dx: urticaria. Stop AUGMENTIN. 11/23/13 Progression of rash. Admit to hospital. Given SOLU-MEDROL. Dx: Allergic to penicillin.
Age: 27.0
Sex: M
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Erythema, Oropharyngeal pain, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Received vaccines 2/4/14. On 2/21/14 developed rash on face (R) UE, trunk, legs. C/O itching, erythema. No heat. Taking BENADRYL 1.25 mg, applying Cortizone cream. Taking oatmeal baths to relieve pruritis.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry eye, Eye pruritus, Localised oedema, Rash vesicular
Clinical narrative: 63 yom developed (L) eye pruritis, dryness and vesicular rash of (L) eyelid accompanied by local edema about 2 weeks after ZOSTAVAX.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Local swelling, Skin lesion
Clinical narrative: Red subcutaneous lesions (pruritic) about 1 - 3 mm in diameter occurred around both injection sites. Slightly raised areas on both cheeks (face) noted. BENADRYL ordered and the areas were gone prior to administration. Med given anyway and pt observed for 15 min prior to being released.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Injection site erythema, Protrusion tongue, Rash, Rash maculo-papular
Clinical narrative: Redness at injection side and maculopapular rash on neck and chest. Tongue swelling/thrusting, mother reported unusual affect/behavior.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Swollen tongue
Clinical narrative: Redness at injection side and maculopapular rash on neck and chest. Tongue swelling/thrusting, mother reported unusual affect/behavior.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: 2/12/14 Fever - Ibuprofen/TYLENOL. 8 am awakened with fevers 99s at office mom said it had been 103. Did have low grade fevers 2/11/14 started after shot.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Erythema, Irritability, Skin warm, Tenderness
Clinical narrative: Extreme irritability, extreme redness, hot to touch, very tender.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Pneumovax to left upper arem later developed redness swelling, warmth and soreness at injection site.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Contusion, Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Felt intense pain at injection site.  Pain rendered shoulder and arm very weak.  Severe bruising soon followed.  Loss of range of motion occurred within 1-2 days after injection.  Shooting pain and sharp pain occurred within 1-2 days of injection.  MRI was performed 3 weeks after the injection.  Revealed bursitis and inflammation of tendons.  Started physical therapy approximately 8 weeks following injection after seeing an orthopedic physician.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Tendonitis, X-ray
Clinical narrative: Felt intense pain at injection site.  Pain rendered shoulder and arm very weak.  Severe bruising soon followed.  Loss of range of motion occurred within 1-2 days after injection.  Shooting pain and sharp pain occurred within 1-2 days of injection.  MRI was performed 3 weeks after the injection.  Revealed bursitis and inflammation of tendons.  Started physical therapy approximately 8 weeks following injection after seeing an orthopedic physician.
Age: 69.0
Sex: F
Vaccine: DTAP, YF
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram head, Cough
Clinical narrative: Lightheadedness, followed by severe headache and photophobia.  Seen at Urgent Care (diagnosis migraine-like; ER 02/12 after vomiting and no relief from headache/nausea.  After spinal tap diagnosed with meningitis.  Week of 02/17 still slight headache with high blood pressure and sore throat/chest cough not yet resolved.
Age: 69.0
Sex: F
Vaccine: DTAP, YF
Symptoms: Dizziness, Headache, Hypertension, Lumbar puncture, Meningitis
Clinical narrative: Lightheadedness, followed by severe headache and photophobia.  Seen at Urgent Care (diagnosis migraine-like; ER 02/12 after vomiting and no relief from headache/nausea.  After spinal tap diagnosed with meningitis.  Week of 02/17 still slight headache with high blood pressure and sore throat/chest cough not yet resolved.
Age: 69.0
Sex: F
Vaccine: DTAP, YF
Symptoms: Migraine, Nausea, Oropharyngeal pain, Photophobia, Vomiting
Clinical narrative: Lightheadedness, followed by severe headache and photophobia.  Seen at Urgent Care (diagnosis migraine-like; ER 02/12 after vomiting and no relief from headache/nausea.  After spinal tap diagnosed with meningitis.  Week of 02/17 still slight headache with high blood pressure and sore throat/chest cough not yet resolved.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Chest discomfort, Cough, Dyspnoea, Oxygen saturation decreased
Clinical narrative: Tightness of chest the asthmatic attacks to this day (02/28/2014) @ home. Now wearing oxygen. Difficulty breathing and coughing.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Extreme pain of upper extremity, erythema 8x4 cm in size and edema extending approx 4 cm outward from arm. Treatment: ibuprofen, ice, elevation, cephalexin
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Pruritus
Clinical narrative: Redness and inflammation at injection site 2 in. diameter as well as redness and itch on legs, arms and stomach and under breasts. Patient referred to MD for evaluation.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm - vaccination arm - radiates into arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye discharge, Pruritus, Rash
Clinical narrative: 1-2" rash areas on neck and arms, worsening over 3-4 days. Urgent care visit with Dr. prescribing prednisone for 5 days. Rashes subsided. Rashes returned on arms 4 days later, with extreme itching, blisters and oozing clear liquid. Follow up visit with Primary physician on 2/26/14. Instructed to take Benadryl orally, and prescribed steroid creme to reduce itching and rash. As of this date, 2/27/14, rash is somewhat better.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Confusional state, Depression, Diarrhoea, Malaise
Clinical narrative: She became very nervous right after the shot. Seemed confused. Had trouble getting her thoughts together. She became very depressed, started her period (which she takes medication to stop her period, having a period is very unusual), she ran a fever, loose bowel movements. Ever since the shot she has been very depressed and confused. She was doing very well prior to the shot. She has a brain injury and had been sick for sometime due to an emotional breakdown. Had been on medication to help calm her and help her to not be confused anymore. She had been doing so well we were able to wean her off of the medication. Now she is back on it cause once she got the Gardasil shot she changed right away. has even told us the shot made her sick. She has special needs and for her to make a connection to the shot and her not feeling well, that says a lot.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Mental impairment, Nervousness, Pyrexia
Clinical narrative: She became very nervous right after the shot. Seemed confused. Had trouble getting her thoughts together. She became very depressed, started her period (which she takes medication to stop her period, having a period is very unusual), she ran a fever, loose bowel movements. Ever since the shot she has been very depressed and confused. She was doing very well prior to the shot. She has a brain injury and had been sick for sometime due to an emotional breakdown. Had been on medication to help calm her and help her to not be confused anymore. She had been doing so well we were able to wean her off of the medication. Now she is back on it cause once she got the Gardasil shot she changed right away. has even told us the shot made her sick. She has special needs and for her to make a connection to the shot and her not feeling well, that says a lot.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO ADVERSE EVENT REPORTED.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Patient fell from standing position, hit head on floor, blacked out. Applied ice to back of head, had patient remain in clinic for 30 mins after this happened for observation, pt caregiver advised to take to ER if any vomiting, memory loss occured. Pt showed no symptoms prior to him getting immunization or before passing out. Parent/Guardian requesting to not continue with vaccine.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: Joint pain: Elbows, shoulders, hips, knees, ankles.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Syncope, seizure - like activity.
Age: 74.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Joint stiffness, Musculoskeletal stiffness, Neck pain, Spinal pain, Trismus
Clinical narrative: Began with stiff neck with pain.  Became severe within 2 hours.  Constant pain at top of spine, occicipital bone, right sided more affected.  Unable to turn head or move it due to pain and stiffness. Used ice with limited improvement but no medication. Symptoms included difficulty/stiffness with jaw movement.  Continued constant pain, but limited improved by morning of 2/26. Gradual improvement throughout the day. Took ketoprofen at 4:40 PM on 2/26/14 with significant improvement. Today some limited stiffness but pain not significant.  Symptoms continue worse on right side.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Oropharyngeal pain, Throat tightness
Clinical narrative: Patient c/o throat constriction w/ soreness, increased anxiety. Oxygen and oral hydration were admin w/o c/o. Patient tolerated well.
Age: 20.0
Sex: F
Vaccine: HPV2, RAB, YF
Symptoms: Erythema
Clinical narrative: Red area to L arm.
Age: 12.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4
Symptoms: Injection site urticaria
Clinical narrative: Hives at injection site of HPV, left arm, resolved with Benadryl.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: W/in 6-8 hours notices small red spot that has progressively gotten worse each day. Larger, red, warm. 2/27 is 10 1/2 cm x 7 cm. Dr visit dx as a cellulitis.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Experienced pain from shoulder down to elbow. Had to go to the ER to get pain medication. 1 month later still feeling pain throughout neck down to elbow.
Age: 24.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Erythema, Fatigue, Musculoskeletal stiffness, Nausea
Clinical narrative: Redness, soreness to arm, tired, dizzy, nausea, stiffness.
Age: 24.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Redness, soreness to arm, tired, dizzy, nausea, stiffness.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash generalised, Urticaria
Clinical narrative: Red band around arm just below injection site. Hives and rash all over body within 24 to 30 hours which lasted 6 days. Took antihistamine and used cortisone cream to try to relieve itching.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Bone pain, Impaired driving ability, Injected limb mobility decreased, Injection site haemorrhage
Clinical narrative: PATIENT CALLED PHARMACY AT 1300 ON 2.27.14 TO REPORT THE FOLLOWING ABOUT VACCINE GIVEN ON 9.30.13: She claims that since the injection she can't drive or raise her left arm above the 3 o'clock position without pain or reach behind her or put on deodorant. She has seen Dr. 3 times, had and x-ray, MRI, and is seeing a orthopedic surgeon on March 6th 2014 due to a tear and excess fluid in tendon. Patient says that pain shot down arm and bled when shot administered and her collar bone hurt the next day. Followed protocol per physician.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Tendon rupture, X-ray
Clinical narrative: PATIENT CALLED PHARMACY AT 1300 ON 2.27.14 TO REPORT THE FOLLOWING ABOUT VACCINE GIVEN ON 9.30.13: She claims that since the injection she can't drive or raise her left arm above the 3 o'clock position without pain or reach behind her or put on deodorant. She has seen Dr. 3 times, had and x-ray, MRI, and is seeing a orthopedic surgeon on March 6th 2014 due to a tear and excess fluid in tendon. Patient says that pain shot down arm and bled when shot administered and her collar bone hurt the next day. Followed protocol per physician.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Severe diarrhea, chills, extreme pain in arm where vaccine was injected from neck to fingers. Pain raising arm over head. Tingling and numbness. Extreme pain moving arm.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Severe diarrhea, chills, extreme pain in arm where vaccine was injected from neck to fingers. Pain raising arm over head. Tingling and numbness. Extreme pain moving arm.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscle swelling, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: First 5 days after injection, I could not lift or move my arm at all. Horrible pain in shoulder and arm. Pain in should continued for 3 weeks whenever performing range of motion, pushing or lifting anything heavy. Went to a doctor, they felt my arm and felt a lump, she stated thinking my muscle was just swollen from so many antibodies. I was given a steroid prednisone 7 day pack. Pain was relieved for the 7 days. The day after the last pill pain in my shoulder returned a bit more intense then before I started steroid.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Upper extremity mass
Clinical narrative: First 5 days after injection, I could not lift or move my arm at all. Horrible pain in shoulder and arm. Pain in should continued for 3 weeks whenever performing range of motion, pushing or lifting anything heavy. Went to a doctor, they felt my arm and felt a lump, she stated thinking my muscle was just swollen from so many antibodies. I was given a steroid prednisone 7 day pack. Pain was relieved for the 7 days. The day after the last pill pain in my shoulder returned a bit more intense then before I started steroid.
Age: 0.27
Sex: M
Vaccine: 6VAX-F, IPV, PNC, RV5
Symptoms: Decreased appetite, Dry skin, Injection site dryness, Injection site erythema, Injection site pain
Clinical narrative: Fever 103.5, sore red injection site, fussiness, sleeplessness, not eating for over 6 hours, shrill screaming for over 3 hours.  All symptoms lasted for 3 days.  Also has a rough scaly dry spot on both legs where the injection was.  This has yet to disappear.
Age: 0.27
Sex: M
Vaccine: 6VAX-F, IPV, PNC, RV5
Symptoms: Injection site reaction, Insomnia, Irritability, Pyrexia, Screaming
Clinical narrative: Fever 103.5, sore red injection site, fussiness, sleeplessness, not eating for over 6 hours, shrill screaming for over 3 hours.  All symptoms lasted for 3 days.  Also has a rough scaly dry spot on both legs where the injection was.  This has yet to disappear.
Age: 0.27
Sex: M
Vaccine: 6VAX-F, IPV, PNC, RV5
Symptoms: Skin exfoliation
Clinical narrative: Fever 103.5, sore red injection site, fussiness, sleeplessness, not eating for over 6 hours, shrill screaming for over 3 hours.  All symptoms lasted for 3 days.  Also has a rough scaly dry spot on both legs where the injection was.  This has yet to disappear.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Lymph node palpable, Pain in extremity, Ultrasound scan abnormal, Vaccination site inflammation
Clinical narrative: Influenza Vaccine. Right arm pain/swelling. U/S  Mild swelling/inflammatory changes within the lateral aspect of upper arm in the region of recent vaccination. Multiple mildly prominent lymph nodes within the left axilla in the region of palpable abnormality. RX lortab, augmentin.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site swelling
Clinical narrative: Influenza Vaccine. Right arm pain/swelling. U/S  Mild swelling/inflammatory changes within the lateral aspect of upper arm in the region of recent vaccination. Multiple mildly prominent lymph nodes within the left axilla in the region of palpable abnormality. RX lortab, augmentin.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Dizziness, Hyporesponsive to stimuli
Clinical narrative: About 5-8 minutes after vaccine given became lightheaded, less verbally responsive. Placed in supine position, eyes closed not verbally responsive for 1-2 minutes. Gradually felt better, verbally responsive all sx resolved within 15 minutes.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: On 10/4/13 - was screened and had (L) shoulder pain with ROM. Pain worsened on next day 3-4 out 10 with extend shoulder (L) ROM. Returns 2/27/14 for shoulder pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site erythema, Swelling
Clinical narrative: Per chart note, pt developed redness at injection site, swelling and soreness in armpit. No chest palpitations or shortness of breath. Symptoms did improve some but provider recommended patient try heat to area and monitor for worsening symptoms. On 2/24/14 pt states symptoms calmed down but still has a red mark to the area where vaccine was given.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Rash generalised, Urticaria
Clinical narrative: Patient describes rash/hives all over body, this occurred 3 hours after vaccine administration. Pt. reported this today.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site inflammation
Clinical narrative: The left upper arm is inflamed. The physician treating it diagnosed it as cellulitis. According to the patient it started in the evening after the vaccine was administered, it got worse the next morning. The patient has been started on MEDROL dose pack and BACTRIM DS.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse practitioner for GARDASIL, Pregnancy Registry product, concerning a 22 year old female patient with no drug reactions or allergies and no pertinent medical history who on 10-OCT-2011, was intramuscularly vaccinated with a first, 0.5 mL dose of GARDASIL (lot # was not reported) in the left deltoid and on 15-DEC-2011, the patient was vaccinated with the second dose of GARDASIL lot# and dose were not reported), in the left deltoid. There was no concomitant medication. The nurse practitioner reported that the patient was vaccinated with 2 doses of GARDASIL and was pregnant (last menstrual period 27-NOV-2011, estimated delivery date: 02-SEP-2012, also reported as 09-SEP-2012). The patient was not experiencing any adverse effects or problems. Follow-up information has been received from a registered nurse. The nurse stated that the did not have any information regarding the patient. The patient transferred practices during her pregnancy and the physician's office did not administer GARDASIL vaccination. No forwarding physician information was available at this time. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Rash macular
Clinical narrative: This literature marketed report as received from a other health professional refers to a 5 month old female patient. On an unknown date the patient was vaccinated with PEDVAXHIB. Concomitant therapies were not reported. On an unknown date the patient experienced blotchy skin rash. There was no associated shortness of breath or wheeze. The reporter opted not to perform skin testing due to the mild nature of the reaction and the desire to avoid excessive skin tests in this very young patient. The patient was administered the vaccine antigens individually, each at the next recommended dosing interval, in challenge doses. The reporter selected alternative preparations to administer based on subsequent reactions and components of the individual vaccines, using the CDC's Vaccine Excipient and Media Summary which lists all components of commercially available vaccines. Haemophilus b antigen was determined to be the causative agent. Conclusions: Identifying the causative agent in a patient with a vaccine reaction is critical to minimize the change of reaction recurrence which, if IgE-mediated, could be life-threatening upon reexposure. Concurrently, the necessity of immunization cannot be overstated. Many reactions are often attributed to vaccine excipients. In this case, careful evaluation demonstrated that the rash was in response to the hemophilus b antigen itself. The outcome of blotchy skin rash was reported as recovered after 20 minutes without treatment. The reporter considered blotchy skin rash to be related to PEDVAXHIB. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered at inappropriate site, Erythema multiforme, Laboratory test, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Drug administered at inappropriate site, Erythema multiforme
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Blood potassium increased, Blood sodium normal, Blood urea normal, C-reactive protein increased
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture, Dermatitis allergic, Dermatitis contact, Drug administered at inappropriate site, Erythema
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Haematocrit decreased, Haemoglobin decreased, Lumbar puncture abnormal, Neutrophil count increased
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.