chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old female patient. On 13-MAR-2013, the patient was vaccinated with a first dose of GARDASIL(lot number, expiry date, route and dose were not reported).Approximately on an unknown date in March 2013, the patient developed stomach pain. The patient sought medical attention and no treatment was provided. Laboratory test performed was none. The event stomach pain was reported as not recovered/not resolved. This is one of the report received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: On the day of vaccine he had a horrible stomach ache, dizziness and headache. The following day all the same symptoms plus fever and muscle aches. 3rd day following fever up to 104, horrible headache, muscle aches, extreme fatigue.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Pyrexia
Clinical narrative: On the day of vaccine he had a horrible stomach ache, dizziness and headache. The following day all the same symptoms plus fever and muscle aches. 3rd day following fever up to 104, horrible headache, muscle aches, extreme fatigue.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: On the day of vaccine he had a horrible stomach ache, dizziness and headache. The following day all the same symptoms plus fever and muscle aches. 3rd day following fever up to 104, horrible headache, muscle aches, extreme fatigue.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Fever for 3 days, max 104.0 oral; headache; body aches.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Pyrexia
Clinical narrative: Fever for 3 days, max 104.0 oral; headache; body aches.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever for 3 days, max 104.0 oral; headache; body aches.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Injection site became red, itchy and very sore.  Take Tylenol and warm compresses.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Vaccine administered after expiration date of 03/16/2013. No adverse events occurred as of today.
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a nurse practitioner referring to a male patient of unknown age who on an unknown date, was vaccinated with a second dose of GARDASIL (dose, route of administration and lot not reported). The nurse practitioner reported that a male patient developed a fever following the second dose of GARDASIL. The nurse practitioner reported that the male patient developed a fever of 103.5 shortly after administration of the second dose of GARDASIL (time frame development of the fever was unspecified). The fever after administration of the second dose of GARDASIL was unresponsive to Ibuprofen and TYLENOL. The fever after administration of the second dose of GARDASIL lasted for 24 hours and then resolved. Dates of administration of the first and second dose of GARDASIL were not available at the time of the call (dates unspecified). Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Abasia, Blood test, Diarrhoea, Eructation, Gait disturbance
Clinical narrative: This spontaneous report as received from a consumers mother refers to a 4 year old male patient with allergic to peanuts, molds and pollen. Patients pertinent medical history was none. On 26-FEB-2013, the patient was vaccinated with a dose of (Merck) VARIVAX (lot number, expiry date and route were not reported). 0.5 ml (reported as standard dose). Concomitantly the patient also received diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid on 26-FEB-2013. The patient had no fever, no vomiting after vaccination. On 05-MAR-2013 (reported as 7 days after vaccination), the patient has stinky egg smelling burps and similar smelling diarrhea which lasted for 12 hours. On 06-MAR-2013 (reported as the morning after diarrhea started), the patient experienced leg pain which had worsened to the point that he was not able to walk. Blood and urine testing performed on an unspecified date in March 2013, diagnosed with possible viral toxic synovitis. The patient sought medical attention and was treated with ibuprofen. On 05-MAR-2013, the events stinky egg smelling burps and similar smelling diarrhea were resolved. The reporter reported that the leg pain dissipated over 3 days moving from being unable to walk, moving through shuffling motions, regaining full mobility although rigid, and finally full recovery. Approximately on an unknown date in March 2013,the event a leg pain worsened to the point that he was not able to walk was reported as recovered/resolved. The outcome of diagnosed with possible viral toxic synovitis was unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Muscle rigidity, Pain in extremity, Urine analysis
Clinical narrative: This spontaneous report as received from a consumers mother refers to a 4 year old male patient with allergic to peanuts, molds and pollen. Patients pertinent medical history was none. On 26-FEB-2013, the patient was vaccinated with a dose of (Merck) VARIVAX (lot number, expiry date and route were not reported). 0.5 ml (reported as standard dose). Concomitantly the patient also received diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid on 26-FEB-2013. The patient had no fever, no vomiting after vaccination. On 05-MAR-2013 (reported as 7 days after vaccination), the patient has stinky egg smelling burps and similar smelling diarrhea which lasted for 12 hours. On 06-MAR-2013 (reported as the morning after diarrhea started), the patient experienced leg pain which had worsened to the point that he was not able to walk. Blood and urine testing performed on an unspecified date in March 2013, diagnosed with possible viral toxic synovitis. The patient sought medical attention and was treated with ibuprofen. On 05-MAR-2013, the events stinky egg smelling burps and similar smelling diarrhea were resolved. The reporter reported that the leg pain dissipated over 3 days moving from being unable to walk, moving through shuffling motions, regaining full mobility although rigid, and finally full recovery. Approximately on an unknown date in March 2013,the event a leg pain worsened to the point that he was not able to walk was reported as recovered/resolved. The outcome of diagnosed with possible viral toxic synovitis was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Approximately on an unknown dates in 2012 (reported as about a year ago) the patient was vaccinated with the first and the second dose of GARDASIL (lot number, expiry date, route and dose were not reported). On 14-MAR-2013 the patient was in the office to get the third dose. No adverse effect reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old female patient. On 13-MAR-2013, the patient was vaccinated with a first dose of GARDASIL (lot number, expiry date, route and dose were not reported). Approximately on an unknown date in March 2013, the patient developed stomach pain. the patient sought medical attention and no treatment was provided. Laboratory test performed was none. The event stomach pain was reported as not recovered/not resolved. This is one of the report received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a line listing obtained on request by the Company from the FDA under the Freedom of Information: Refers to an 81 year old male with sciatica, constipation and edema at the time of vaccination. The pre-existing conditions included Lasix allergy, tramadol, cardiovascular disease, malignant neoplasm of prostate, spondylosis and sciatica. On 17-SEP-2007 at 14:10, the patient was vaccinated with the first dose of ZOSTAVAX (lot # 0886U; exp. date: unknown) subcutaneously in the right arm. Concomitant therapies included AMBIEN, FLOMAX (MORNIFLUMATE), LORAZEPAM, NEURONTIN, PROTONIX and ZOSTRIX. On 18-SEP-2007 at 09:15, the patient developed shingles outbreak on chest/abdomen. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm redness, swelling, hot and painful following vaccination x 2 days.
Age: 18.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus generalised, Pyrexia, Rash
Clinical narrative: Rash started next day, to face and now over body itching all over. Fever started that night after injection. Patient started treatment on 3-18-2013 MOTRIN 800mg, Hydroxyzine HCL 25mg, Hydrocortisone 1% topical ointment.
Age: 33.0
Sex: M
Vaccine: TTOX
Symptoms: Lymphadenopathy
Clinical narrative: Noted swollen lymph node to "r arm pit." The next day at "around 1:00 in afternoon." "Already getting smaller." Not doing anything for it.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, CSF glucose normal, CSF protein normal, Culture urine negative
Clinical narrative: Fever to 104.5 for 3 days.  Vomiting on day 2, seen in ER and found to have a bulging fontanelle.  Septic workup including LP was negative.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fontanelle bulging, Full blood count, Gram stain negative, Influenza virus test negative, Lumbar puncture normal
Clinical narrative: Fever to 104.5 for 3 days.  Vomiting on day 2, seen in ER and found to have a bulging fontanelle.  Septic workup including LP was negative.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil percentage increased, Pyrexia, Vomiting, White blood cell count normal
Clinical narrative: Fever to 104.5 for 3 days.  Vomiting on day 2, seen in ER and found to have a bulging fontanelle.  Septic workup including LP was negative.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Eating disorder, Headache, Nausea
Clinical narrative: I had a very bad headache that caused dizziness one day after the shot. I had to take multiple migraine medications in order to get relief. I normally never suffer from headaches or migraines. Two days after receiving the shot I suffered from weakness, paleness, and nausea which caused me to vomit multiple times and made eating difficult as I would throw up what I would try to eat. This lasted the entire day.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Vomiting
Clinical narrative: I had a very bad headache that caused dizziness one day after the shot. I had to take multiple migraine medications in order to get relief. I normally never suffer from headaches or migraines. Two days after receiving the shot I suffered from weakness, paleness, and nausea which caused me to vomit multiple times and made eating difficult as I would throw up what I would try to eat. This lasted the entire day.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Erythema, Skin warm, Swelling
Clinical narrative: Didn't notice anything until over 24 hours after the shot. Swelling in a oval shape, at first about 2x3 inches, some redness at the center of the swelling. Swelling is hot. Treated with 50mg Benadryl every 6 hours, and ice on the swelling. (Also taking naproxen.) Continued to swell. Tender to the touch, becoming more tender. On 3/18/2013 it is about 3"x4" (it was larger on 3/17/2013). Have abdominal pain and diarrhea. Planning to start prednisone later today, waiting 12 hours after the last naproxen.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Didn't notice anything until over 24 hours after the shot. Swelling in a oval shape, at first about 2x3 inches, some redness at the center of the swelling. Swelling is hot. Treated with 50mg Benadryl every 6 hours, and ice on the swelling. (Also taking naproxen.) Continued to swell. Tender to the touch, becoming more tender. On 3/18/2013 it is about 3"x4" (it was larger on 3/17/2013). Have abdominal pain and diarrhea. Planning to start prednisone later today, waiting 12 hours after the last naproxen.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Chest X-ray normal, Influenza virus test negative, Pyrexia, Urine analysis normal
Clinical narrative: Patient woke up with a high fever of 103. After a dose of Motrin, the fever subsided, but she continued to run a fever on and off all day.  At 7:05pm she went to sleep with a fever of 101.2. She awoke at 10:15 with a fever of 104.7. She was then taken to the ER. After TWO doses of Motrin, her fever finally subsided and her fever finally broke on the evening of 3/18/2013.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site abscess sterile, Injection site cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report number A1014786A for FLUARIX. This case described the occurrence of injection site cellulitis in a 33 year old male subject who was vaccinated with a dose of PNEUMOVAX 23 (lot# H014653) and a dose of FLUARIX (lot # AFLUA716BA). Concurrent medical conditions included ankle surgery, back surgery, pneumonia and tobacco user. The subject was hospitalized on 25-FEB-2013, for pneumonia. On 26-FEB-2013, at 11:06, the subject received a dose of FLUARIX (1 unknown volume, unknown route, right deltoid), and on 26-FEB-2013 the subject received a dose of PNEUMOVAX 23 (unknown details, right deltoid) while in the hospital for pneumonia since 25-FEB-2013. On 26-FEB-2013, less than one day after vaccination with FLUARIX and PNEUMOVAX 23, the subject experienced injection site cellulitis, injection site redness, swelling injection site, and sterile abscess at injection site. The subject complained of injection site redness and injection site swelling on 26-FEB-2013. The reporter stated that "cellulitis and possibly abscess" adverse events onset on 26-FEB-2013, and the adverse events were local injection site reactions. On 27-FEB-2013, the subject was diagnosed with injection site cellulitis. At the time of reporting, the nurse stated that the subject "may have an abscess but this was not diagnosed." Per the nurse, the subject will get consults from surgery and infectious disease. The subject was hospitalised and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the outcome of the events were unspecified. This was originally reported by a nurse. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Erythema, Headache, Induration
Clinical narrative: Patient reported headache and weakness 1 day after vaccination and a large and hard red area on the back of arm the 2nd day after vaccination.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash maculo-papular, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Rash x 1 day, maculopapular rash on body, URI, clear rhinorrhea, no fever x1d.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Local 3-4 in area of red, heated, tender, swelling at injection area. Self resolving.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red disc-shaped rash (approximately 3 in diameter) appeared about 24 hours after vaccine administration. Rash was very itchy. Patient consulted with PCP and has started BENADRYL 25mg every 4-6 hours until resolved.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Red disc-shaped rash (approximately 3 in diameter) appeared about 24 hours after vaccine administration. Rash was very itchy. Patient consulted with PCP and has started BENADRYL 25mg every 4-6 hours until resolved.
Age: 47.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site bruising, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Fever 101.7 3-14-13, headache, muscle pain, bruise/redness on injection site.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: The day following vaccinations patient developed an urticarial rash. She was evaluated in urgent care and had a follow-up visit with me. She was treated with antihistamines and symptoms resolved. Additionally she had completed amoxicillin at 2 days prior. No infections present at time of vaccines.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Erythema, Induration, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Left deltoid at area of injection red, swollen, painful by evening on day of injection, pain in left shoulder, upper arm, down to elbow. Hard to lift shoulder. Next day injection site hard, hot, swollen. Progressed to nausea, chills, glands in neck swollen. Treated with ice & ibuprofen. At office visit 3/1/13, still had 13 x 15 cm very faint erythema, slightly warm, indurated, and mildly tender left upper arm but injection site clear.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Left deltoid at area of injection red, swollen, painful by evening on day of injection, pain in left shoulder, upper arm, down to elbow. Hard to lift shoulder. Next day injection site hard, hot, swollen. Progressed to nausea, chills, glands in neck swollen. Treated with ice & ibuprofen. At office visit 3/1/13, still had 13 x 15 cm very faint erythema, slightly warm, indurated, and mildly tender left upper arm but injection site clear.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Lymphadenopathy, Nausea, Skin warm, Tenderness
Clinical narrative: Left deltoid at area of injection red, swollen, painful by evening on day of injection, pain in left shoulder, upper arm, down to elbow. Hard to lift shoulder. Next day injection site hard, hot, swollen. Progressed to nausea, chills, glands in neck swollen. Treated with ice & ibuprofen. At office visit 3/1/13, still had 13 x 15 cm very faint erythema, slightly warm, indurated, and mildly tender left upper arm but injection site clear.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Herpes zoster, Skin exfoliation
Clinical narrative: This spontaneous report was received from an unspecified reporter concerning an approximately 66 year old female patient. Weight of the patient was reported as 150 (units unspecified). On an unknown date in September 2009, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant medications included TORADOL (reported as TOREDOL (start date unspecified) and unspecified hypertension medicine. On 29-DEC-2009, 2 months after receiving the vaccine, the patient experienced a case of the shingles, redness all over her body and her skin would start peeling. No treatment was given. The outcome of all the events was unknown. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Ear infection
Clinical narrative: This spontaneous report was received from registered nurse concerning her 15 month old grandson. Reporter stated that she learned from her daughter-in-law and son that on an unknown date, in the last few days, the patient was vaccinated with a dose of M-M-R II (lot number, expiry date, dose and route unspecified) at well baby check up. No concomitant medications were reported. On an unknown date (reported as later), the patient was diagnosed with an ear infection for which the doctor prescribed BACTRIM (manufacturer unknown). The reporter did not have the information regarding pediatrician. The patient did not seek any medical attention. No lab tests were performed. The patient was running around and fine at the time of reporting. The relatedness for ear infection was unknown for M-M-R II. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (CMA) referring to an unknown age female patient. The medical assistant reported that the patient received the first dose of GARDASIL on 31-JAN-2011 (no dose and route specified) (lot number and expiration date not provided) and the second dose of GARDASIL on 17-JAN-2012. (No third dose of GARDASIL has been administered). No adverse event reported. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a line listing obtained on request by the Company from the FDA under the Freedom of Information: Refers to a 73 years old patient with no illness noted at the time of vaccination. On 08-JUL-2008 at 10:30, the patient was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot # 0886U; exp. date: unknown). The patient went to the doctor on 15-AUG-2008 after having pain and 3-4. None of the above blisters on face for approximately 1 week and was diagnosed (dx) with Shingles. The patient was treated with Azithromycin pack and Prednisone at that time. On 04-OCT-2008, the patient had a reoccurrence of Shingles in the waistline area and was seen by the doctor on 06-JAN-2008 and was treated wit Famciclovir 500mg TID x 3 days with 1 refill. The patient still has lesions but much improved and pain was also lessened. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Nerve injury, Post herpetic neuralgia, Respiration abnormal, Speech disorder
Clinical narrative: Severe pain in my right side back. Called my pulmonary who was treating my pneumonia. Went to my primary first chance I had and she misdiagnosed the problem even though she gave me the Zoster vaccine. I was have a reaction to the vaccine PHN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Severe pain in my right side back. Called my pulmonary who was treating my pneumonia. Went to my primary first chance I had and she misdiagnosed the problem even though she gave me the Zoster vaccine. I was have a reaction to the vaccine PHN.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Neck pain, Rash
Clinical narrative: Patient given ZOSTAVAX vaccination 3/7/13 and 48 hours later developed classic Herpes Zoster rash on neck.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Culture, Herpes zoster
Clinical narrative: Patient given ZOSTAVAX vaccination 3/7/13 and 48 hours later developed classic Herpes Zoster rash on neck.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Patient given ZOSTAVAX vaccination 3/7/13 and 48 hours later developed classic Herpes Zoster rash on neck.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: The night before I was seen for the first time after the initial vaccination, I was experiencing redness and swelling at the site of injection which spread rapidly around my arm.  My arm was very sore and I was unable to move it easily.  I was diagnosed with cellulitis and given and antibiotic.  There was a lot going on in the room but did notice after the fact that the nurse was not wearing gloves and I'm not sure if I was swabbed with alcohol prior to injection.  These concerns have been addressed with the Director of Convenient Care at Clinic.
Sex: U
Vaccine: PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. No dosage information, route of administration or lot number was reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced pneumococcal meningitis (considered as medically significant per manufacturer). It is unknown if the patient received any treatment for the adverse event. The outcome of pneumococcal meningitis is unknown. The reporter did not provide a causality statement. It was added that the reporter was not sure if the patient received PNEUMOVAX23 in the past. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported). On an unknown date the patient experienced unspecified adverse reaction to ZOSTAVAX. The outcome of the event was unknown. It was unknown whether the patient sought medical attention. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 79 year old female patient. Approximately one week ago, about 28-FEB-2013 the patient was vaccinated with ZOSTAVAX (Dose, route and lot# not reported). It was reported that the patient developed a rash "approximately 2 days ago", on 05-MAR-2013. The outcome of rash was reported as recovering. The pharmacist mentioned ZOSTAVAX was not administered to this patient in her pharmacy. The patient sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a doctor of pharmacy via company representative refers to a female patient of unknown age. Approximately on 12-MAR-2013 (reported as 2-3 days ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on 12-MAR-2013 (reported as 2-3 days ago), the patient experienced "unspecified herpes rash" after receiving ZOSTAVAX. The patient was waiting for further diagnosis. The outcome of unspecified herpes rash was unknown at the time of this report. Causality was not reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with no drug reactions or allergies. On 08-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H019035, expiry date was 17-JAN-2014), 0.65 milliliter (ml), subcutaneously. Concomitant therapies included vitamins (unspecified). On 10-MAR-2013(reported as 2-3 days later) the patient developed swelling at the injection site. The patient reported that is had grown in size over the past week and was 2-3 inches across. The patient reported no pain with swelling but only slight periodic itching since an unknown date in March 2013. Laboratory test performed was none. The patient sought medical attention (visited pharmacy) and no treatment was given. The outcome of all the reported events was unknown. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician, for ZOSTAVAX, a Pregnancy Registry product, concerning a 30 year old female patient. On 11-FEB-2012 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) and a dose of influenza virus vaccine (manufacturer unknown) (dose, route and lot number not provided). The patient became pregnant about 8 weeks ago, with LMP of 17-JAN-2013 and EDD of 24-OCT-2013. Pregnancy was normal to date. The patient had sought medical attention via office visit. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Exposure during breast feeding, Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a physician, for ZOSTAVAX, a Pregnancy Registry product, concerning a 30 year old female patient. On 11-FEB-2012 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) and a dose of influenza virus vaccine (manufacturer unknown) (dose, route and lot number not provided). The patient became pregnant about 8 weeks ago, with LMP of 17-JAN-2013 and EDD of 24-OCT-2013. Pregnancy was normal to date. The patient had sought medical attention via office visit. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative refers to a 70 year old female patient. The patient's medical history included stroke several years ago. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included acyclovir. On 07-MAR-2013, the patient developed shingles. The patient had mild rash accompanied with severe pain. The outcome of the events were reported as recovering. The patient sought medical attention. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 72 year old male patient (husband). Approximately on an unknown date in March 2011 (reported as 2 years ago) the patient was vaccinated with ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date in December 2012, the patient experienced shingles rash on his right flank along with post-herpetic neuralgia. The symptoms resolved with treatments of ZOVIRAX ointment and VALTREX. The outcome of the events shingles rash on his right flank and post-herpetic neuralgia was reported as recovered/resolved. Causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was administered the first dose of GARDASIL (lot # unspecified) 0.5ml intramuscularly in February of 2007, the second dose of GARDASIL (lot # unspecified) 0.5ml intramuscularly in April of 2007 and was in the office on 14-MAR-2013 to receive a third dose of GARDASIL (lot # unspecified) 0.5ml intramuscularly. No adverse effect reported. No concomitant medication was reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Itching started 3/13 started redness 3/14. 3/19/13 still red and itching.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient in his 70's, who was immunocompromised. The patient had a history of lung cancer. It was unspecified if this was known at the time of vaccination. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number not provided), 0.65 ml, subcutaneous. On an unknown date the patient experienced herpes zoster. The outcome and relatedness of herpes zoster were not reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Viral test positive
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown ages and gender. On an unknown date the patients were vaccinated with 0.5 milliliter (ml) ROTATEQ,(lot# and expiration date not reported) orally. Concomitant medications were not reported. On an unknown date the patients had diagnostic stool sample testing for rotavirus. Some of these patients has been diagnosed with ROTATEQ. The patients sought an unspecified medical attention. The outcome of rotavirus infection is unknown. Causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # H013581, expiry date 03-MAR-2014). The nurse reported that about 6 patients have experienced adverse reactions from PNEUMOVAX23 with lot# H013581, exp 03-MAR-2014 and requested lot# check for this particular lot #. The nurse did not have detailed individual patient information but she said 6 patients experienced redness and rash around injection site and a couple of patients experienced fever as well. The patient sought for medical attention via an office visit. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Rash, Rash erythematous, Rash papular, Skin lesion
Clinical narrative: Patient presented with rash, onset AM of 3/18/13. Temp 99.2 degrees. Physical exam reveals erythematous papulovesicular rash predominantly on torso, particularly back; around 25 lesions total. Suspect associated with vaccine given 10 days ago. Symptomatic treatment; routine advice. Assume will resolve.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Patient presented with rash, onset AM of 3/18/13. Temp 99.2 degrees. Physical exam reveals erythematous papulovesicular rash predominantly on torso, particularly back; around 25 lesions total. Suspect associated with vaccine given 10 days ago. Symptomatic treatment; routine advice. Assume will resolve.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Oedema, Oedema peripheral, Peripheral coldness
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 69 year old female patient. The patient's current conditions included hypertension, hypercholesterolemia, gastroesophageal reflux disease (GERD), depressive disorder, penicillin allergy, aspirin allergy, ibuprofen allergy and lisinopril allergy. On 11-MAR-2013, the patient was vaccinated with 0.5 ml (milliliter) dose of PNEUMOVAX23, (lot number reported as H018944, expiry date 01-MAR-2014, route was intramuscular). Concomitant therapies included COUMADIN. On 11-MAR-2013, the patient developed swelling along the entire arm, cool extremities, numbness, redness and edema. The Doppler test on the arm to detect deep vein thrombosis was performed which was negative. The patient was treated with prednisone 10 mg (milligram) 12 day taper, BENADRYL and ice packs to relieve pain with swelling. The patient had pneumococcal injection at an unspecified time in the past with no reaction to the first dose. The patient reported relief and symptoms were improving. The outcome of the reported events were recovering. The patient sought medical attention (seen in office). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound Doppler normal
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 69 year old female patient. The patient's current conditions included hypertension, hypercholesterolemia, gastroesophageal reflux disease (GERD), depressive disorder, penicillin allergy, aspirin allergy, ibuprofen allergy and lisinopril allergy. On 11-MAR-2013, the patient was vaccinated with 0.5 ml (milliliter) dose of PNEUMOVAX23, (lot number reported as H018944, expiry date 01-MAR-2014, route was intramuscular). Concomitant therapies included COUMADIN. On 11-MAR-2013, the patient developed swelling along the entire arm, cool extremities, numbness, redness and edema. The Doppler test on the arm to detect deep vein thrombosis was performed which was negative. The patient was treated with prednisone 10 mg (milligram) 12 day taper, BENADRYL and ice packs to relieve pain with swelling. The patient had pneumococcal injection at an unspecified time in the past with no reaction to the first dose. The patient reported relief and symptoms were improving. The outcome of the reported events were recovering. The patient sought medical attention (seen in office). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3/4" area of erythema with swelling, minimal warmth, non-tender to palpation on (R) posterior arm, inferior to shoulder.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a female patient of unknown age, who on 31-JUL-2012, was vaccinated with GARDASIL first dose (route and lot # not reported) and on 17-JAN-2013, was vaccinated with a second dose of GARDASIL (route and lot # not reported). No adverse symptoms reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Influenza like illness, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Took the pills 4 consecutive days erroneously. Flu like symptoms after 4th pill. Body aches, fever, stuffy nose, sore throat.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash 9 days after vaccines. Had MMR, Varicella on 03.08.13.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Paresthesia running down right arm started 2 days after injection.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site discharge, Injection site pustule, Local swelling, Oedema peripheral
Clinical narrative: Temp not monitored. Redness, swelling, tenderness to upper arm in deltoid area the day after vaccine. No temp. No malaise. On day 3, pustule formed on or near injection site. Swelling and tenderness continued in localized area. Pustule small, ruptured day 4 or 5 with small amount white drainage, "like a pimple" per pt. Swelling decreased steadily over about 5 day period.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Temp not monitored. Redness, swelling, tenderness to upper arm in deltoid area the day after vaccine. No temp. No malaise. On day 3, pustule formed on or near injection site. Swelling and tenderness continued in localized area. Pustule small, ruptured day 4 or 5 with small amount white drainage, "like a pimple" per pt. Swelling decreased steadily over about 5 day period.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Blood test normal, Fatigue, Full blood count normal, Laboratory test
Clinical narrative: She has had debilitating fatigue unable to go to school since vaccine administered. Patient and mom note an association in time.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate increased, Thyroid function test
Clinical narrative: She has had debilitating fatigue unable to go to school since vaccine administered. Patient and mom note an association in time.
Age: 0.18
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Irritability
Clinical narrative: Temp of 104, very fussy.
Age: 0.43
Sex: F
Vaccine: PNC13
Symptoms: Irritability, Psychomotor hyperactivity, Pyrexia
Clinical narrative: Fever and irritable x 3 days onset 2/18/12 also hyperactivity.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site rash, Pain in extremity, Rash
Clinical narrative: Rash or erythema started on Sat. evening at inj. site. It spread to below her elbow and became painful by Sun. morning. MD gave BENADRYL & steroid cream and it subsided by Tuesday.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial report was received from a consumer, under reference number 1-440511116, on 07 March 2013. A male patient received a dose of tetanus toxoid, manufacturer unknown, (lot number, route, site, side and dose in series not reported) as a small child on an unspecified date. He did not remember when (age or year), did not remember specific vaccine and had "no idea what the reaction was". The patient reported, "My mother told me I almost died". He stated he wore a bracelet that had "tetanus allergy" on it. The reporter said his mother would not be helpful in obtaining more facts. Laboratory or diagnostic testing and treatments were not reported. The patient's history as a child was not reported. The patient's outcome was recovered on unspecified date. Documents held by sender: None.
Sex: M
Vaccine: PNC13
Symptoms: Bronchiolitis
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported on behalf of his son. A male patient of an unspecified age received PREVNAR 13 0.5 ml on an unspecified date. The patient's medical history and concomitant medications were unknown. On an unknown date, the patient developed bronchiolitis. Therapeutic measures taken in response to the reported event, bronchiolitis, were unknown. As of 08Mar2013, the patient had recovered from the bronchiolitis on an unknown date.
Sex: F
Vaccine: PNC13
Symptoms: Atrial fibrillation, Cellulitis, Condition aggravated
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer vaccine sales representative. The physician reported a female patient in her 50s received PREVNAR-13 single dose on an unknown date. The patient's relevant medical history included ongoing atrial fibrillation since an unknown date. Relevant concomitant medications were unknown. On an unknown date, two days after receiving the vaccination, the patient developed cellulitis in her arms and her atrial fibrillation worsened for which she was taken to the emergency room and had seen a cardiologist. Relevant lab tests were unknown. Therapeutic measures taken for the reported events, cellulitis and worsened atrial fibrillation, were unknown. The clinical outcome of the reported events, cellulitis and worsened atrial fibrillation was reported as unknown.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap administered 3/12/13. Present to office 3/14/13 with c/o swollen arm at site. Red, warm to touch at site. Temp 99.4 (TY).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Skin warm, Urticaria, Vaccination complication
Clinical narrative: I took the Shingle Vaccine on 3/8/13 at approximately 3:30 p.m. I felt a little sore that night. On Saturday 3/9/13 about 12:00 noon, my arm was very sore and warm. I looked in the mirror my rt arm was swollen 15 cm with a big lump. Very painful with severe huge hives. I notified the pharmacist on 3/11/13. It was a reaction to the shingle vaccine. I took BENADRYL/anti-itch cream/TYLENOL until I saw the Dr. Went to Dr. on 3/12/13. Shingle vaccine reaction prescribed Hydroxyz HCL 25mg.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Goitre, Incorrect dose administered, Incorrect drug dosage form administered, Local swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of blister of throat in a 24-year-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline), hepatitis B vaccine. On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B vaccine (unknown). At an unspecified time after completing the vaccination series with hepatitis B vaccine, the subject experienced decreased therapeutic response. On 12 March 2013 the subject received 4th dose in the form of two injections with ENGERIX B pediatric (unknown, unknown deltoid) and experienced inappropriate formulation of vaccine administered and extra dose administered. On 12 March 2013, within 12 hours of vaccination with ENGERIX B pediatric, the subject experienced throat swelling, blister/ patches in the throat. On 13 March 2013, one day after vaccination with ENGERIX B pediatric, the subject experienced neck swelling and enlarged thyroid. A healthcare professional at an employee health clinic reported, the subject, who is also an employee, received two pediatric doses of ENGERIX B to make up one dose that was counted as the 4th dose. The subject completed the three dose series previously; details regarding when and which brand of hepatitis B vaccine were unknown, but it was "completed at least more than a year ago". The subject needed an additional dose as his titers came back low. On the evening of 12 March 2013, within 12 hours, he felt throat swelling and had patches/blisters in the throat. On the morning of 13 March 2013, the subject's neck was swollen and thought his thyroid was enlarged. The subject was recommended to see his primary care physician. This case was assessed as medically serious by GSK. At the time of reporting the throat swelling, blister of throat, throat lesion, neck swelling and enlarged thyroid were unresolved.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Oropharyngeal blistering, Pharyngeal oedema, Therapeutic response decreased, Throat lesion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of blister of throat in a 24-year-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline), hepatitis B vaccine. On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B vaccine (unknown). At an unspecified time after completing the vaccination series with hepatitis B vaccine, the subject experienced decreased therapeutic response. On 12 March 2013 the subject received 4th dose in the form of two injections with ENGERIX B pediatric (unknown, unknown deltoid) and experienced inappropriate formulation of vaccine administered and extra dose administered. On 12 March 2013, within 12 hours of vaccination with ENGERIX B pediatric, the subject experienced throat swelling, blister/ patches in the throat. On 13 March 2013, one day after vaccination with ENGERIX B pediatric, the subject experienced neck swelling and enlarged thyroid. A healthcare professional at an employee health clinic reported, the subject, who is also an employee, received two pediatric doses of ENGERIX B to make up one dose that was counted as the 4th dose. The subject completed the three dose series previously; details regarding when and which brand of hepatitis B vaccine were unknown, but it was "completed at least more than a year ago". The subject needed an additional dose as his titers came back low. On the evening of 12 March 2013, within 12 hours, he felt throat swelling and had patches/blisters in the throat. On the morning of 13 March 2013, the subject's neck was swollen and thought his thyroid was enlarged. The subject was recommended to see his primary care physician. This case was assessed as medically serious by GSK. At the time of reporting the throat swelling, blister of throat, throat lesion, neck swelling and enlarged thyroid were unresolved.