chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: CD8 lymphocytes decreased, Diarrhoea, Electrophoresis abnormal, Fatigue, Flow cytometry
Clinical narrative: Information has been received from a published article referring to a 53 years old female patient. This patient presented with a six year lymphopenia of unknown etiology following an acute febrile illness (sore throat, polyarthralgia, fatigue, abdominal pains and diarrhea). She reported recurrent respiratory infections (pneumonia, bronchitis, sinusitis), diarrhea and extreme fatigue. Initial findings revealed a selective lymphopenia of less than 700/ul, normal serum immunoglobulin levels, normal kidney and liver functions, positive Acetylneuraminic acid (ANA) (1:160) of speckled pattern, and a mild M-spike (0.20 g/dl) on serum electrophoresis. Patient reported chronic gut disease for more than 20 years with negative Gastrointestinal examination (GI) evaluation. Further studies revealed isolated CD3+ T cell deficiency (both CD4+ and cosa) <450/ul, normal in vitro lymphocyte proliferation to Passive Hemagglutination (PHA), anti-CD3 mAb, while decreased responses to candida. Her antibody responses to PNEUMOVAX 23 as suboptimal with partial responses to 4 out of 14 antigens; antibody responses to protein antigens Thrombin Time Dilution Test (TT, DT and Hib) were normal. A profound decrease in memory and switched memory B cells on flow cytometry and increased Buff receptor expression was noted. These findings support a primary T cell defect. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulins normal, Liver function test normal, Lymphocyte count decreased, Lymphopenia, Oropharyngeal pain
Clinical narrative: Information has been received from a published article referring to a 53 years old female patient. This patient presented with a six year lymphopenia of unknown etiology following an acute febrile illness (sore throat, polyarthralgia, fatigue, abdominal pains and diarrhea). She reported recurrent respiratory infections (pneumonia, bronchitis, sinusitis), diarrhea and extreme fatigue. Initial findings revealed a selective lymphopenia of less than 700/ul, normal serum immunoglobulin levels, normal kidney and liver functions, positive Acetylneuraminic acid (ANA) (1:160) of speckled pattern, and a mild M-spike (0.20 g/dl) on serum electrophoresis. Patient reported chronic gut disease for more than 20 years with negative Gastrointestinal examination (GI) evaluation. Further studies revealed isolated CD3+ T cell deficiency (both CD4+ and cosa) <450/ul, normal in vitro lymphocyte proliferation to Passive Hemagglutination (PHA), anti-CD3 mAb, while decreased responses to candida. Her antibody responses to PNEUMOVAX 23 as suboptimal with partial responses to 4 out of 14 antigens; antibody responses to protein antigens Thrombin Time Dilution Test (TT, DT and Hib) were normal. A profound decrease in memory and switched memory B cells on flow cytometry and increased Buff receptor expression was noted. These findings support a primary T cell defect. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Pyrexia, Renal function test normal, Respiratory tract infection, Sinusitis
Clinical narrative: Information has been received from a published article referring to a 53 years old female patient. This patient presented with a six year lymphopenia of unknown etiology following an acute febrile illness (sore throat, polyarthralgia, fatigue, abdominal pains and diarrhea). She reported recurrent respiratory infections (pneumonia, bronchitis, sinusitis), diarrhea and extreme fatigue. Initial findings revealed a selective lymphopenia of less than 700/ul, normal serum immunoglobulin levels, normal kidney and liver functions, positive Acetylneuraminic acid (ANA) (1:160) of speckled pattern, and a mild M-spike (0.20 g/dl) on serum electrophoresis. Patient reported chronic gut disease for more than 20 years with negative Gastrointestinal examination (GI) evaluation. Further studies revealed isolated CD3+ T cell deficiency (both CD4+ and cosa) <450/ul, normal in vitro lymphocyte proliferation to Passive Hemagglutination (PHA), anti-CD3 mAb, while decreased responses to candida. Her antibody responses to PNEUMOVAX 23 as suboptimal with partial responses to 4 out of 14 antigens; antibody responses to protein antigens Thrombin Time Dilution Test (TT, DT and Hib) were normal. A profound decrease in memory and switched memory B cells on flow cytometry and increased Buff receptor expression was noted. These findings support a primary T cell defect. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: T-lymphocyte count decreased
Clinical narrative: Information has been received from a published article referring to a 53 years old female patient. This patient presented with a six year lymphopenia of unknown etiology following an acute febrile illness (sore throat, polyarthralgia, fatigue, abdominal pains and diarrhea). She reported recurrent respiratory infections (pneumonia, bronchitis, sinusitis), diarrhea and extreme fatigue. Initial findings revealed a selective lymphopenia of less than 700/ul, normal serum immunoglobulin levels, normal kidney and liver functions, positive Acetylneuraminic acid (ANA) (1:160) of speckled pattern, and a mild M-spike (0.20 g/dl) on serum electrophoresis. Patient reported chronic gut disease for more than 20 years with negative Gastrointestinal examination (GI) evaluation. Further studies revealed isolated CD3+ T cell deficiency (both CD4+ and cosa) <450/ul, normal in vitro lymphocyte proliferation to Passive Hemagglutination (PHA), anti-CD3 mAb, while decreased responses to candida. Her antibody responses to PNEUMOVAX 23 as suboptimal with partial responses to 4 out of 14 antigens; antibody responses to protein antigens Thrombin Time Dilution Test (TT, DT and Hib) were normal. A profound decrease in memory and switched memory B cells on flow cytometry and increased Buff receptor expression was noted. These findings support a primary T cell defect. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a certificated medical assistant concerning a 73 year old female patient. On 09-MAR-2015 the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (route and lot# not reported). On 09-MAR-2015, the patient complained of pain at injection site. The patient visited the unspecified physician's office on 12-MAR-2015 for the pain. There was no redness, swelling or warmth at the injection site. The patient was advised to taken TYLENOL and put ice packs on the site as needed. At the time of reporting, the patient stated that the site of injection was still very painful. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of GARDASIL (not GARDASIL 9) (dose, route and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Electromyogram, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Painful sore arm, redness, swelling. The swelling and redness when down but tendinitis developed and is still present six months later. Interfere with daily life. Hard to do simple tasks such as fix hair, cook, and care for my family.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Tendonitis
Clinical narrative: Painful sore arm, redness, swelling. The swelling and redness when down but tendinitis developed and is still present six months later. Interfere with daily life. Hard to do simple tasks such as fix hair, cook, and care for my family.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Tracheo-oesophageal fistula
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient with no pertinent medical history or drug reactions/allergies. On 24-FEB-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose and route not reported). The physician reported that the patient then ingested an unspecified toxin which caused a tracheoesophageal fistula to develop and the patient was hospitalized, at an unspecified facility, on 02-MAR-2015. The physician stated that this occurrence was "completely unrelated" to the VARIVAX (Merck) administration. The physician reported that part of the patient's treatment was administration of the "steroids", dexamethasone (manufacturer unknown) and methylprednisolone (manufacturer unknown) (unspecified dose and form). Following the administration of these steroids the patient developed a varicella like rash on 16-MAR-2015. The patient was being treated with acyclovir for treatment of the rash. The patient was recovering from the rash, but remained in "critical condition" due to the fistula. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Donor stated developed "Rash with itching" 3 to 4 days post immunization administration. Donor stated that he applied Calamine lotion to "rash". Denies any trouble with breathing or any other symptoms.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: Patient woke up from nap shortly after returning home from office. Mom reported crying inconsolably with redness on left leg spreading from injection site to further down the leg. No swelling, mildly warm to the touch, patient irritable when leg was touched.  Patient returned to office at 330pm after being triaged by our phone nurse. Patient was given Tylenol in office as parents had not done so and re-evaluated by Dr. who believes patient may be reacting to one of the vaccines and not the technique. Reviewed with parents signs and symptoms to watch for and advised that next set of vaccines will be broken up.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a head nurse in physician assistant office via the field representative refers to a male patient of age approximately 2 years. Concurrent conditions and medical history was not reported. In approximately 2013 (single dose given at 2, 4 and 6 months of age) the patient was vaccinated with ROTATEQ suspension 2, who received all series of doses (lot number, dose, frequency and route of administration not reported). Concomitant medications were not reported. In 2015 (reported as late February/early March) the patient experienced rotavirus infection after receiving the full series of ROTATEQ. On an unknown date approximately in 2015, the patient was taken to the emergency room and was admitted. The length of the stay in hospital was not reported and the patient was discharged on an unknown date approximately in 2015. The patient sought the medical attention. The outcome of rotavirus infection was reported as recovering. The causality assessment was not reported. No product quality complaint (PQC) was filed. It was also reported by the field representative that this event was reported through another adverse event reporting system and the Food and Drug Administration (FDA) and perhaps the Centers for Disease Control and Prevention (CDC) was reviewing this case, including checking temperature logs. No further information was provided. This is one of the 2 reports from the same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: Patient received vaccine on 2/17/15 SQ in the left arm. On 2/19/15, patient reported a burning sensation and tender to touch in the tricept region of the left arm from the armpit to the elbow. No rash, irritation, swelling, or redness was noted. Patient was still experiencing symptoms as of 3/20/15. Patient tried using aloe, Neosporin, lotion, hot pack and Aleve for the symptoms with no improvement.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, fever, chills, myalgias.
Age: 1.95
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever and febrile seizure.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever and febrile Seizure.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Lymphadenopathy, Vaccination complication
Clinical narrative: Reaction to TDAP vaccination.  Severe swelling (size of a plum) in lymph node in arm pit on the arm where shot was administered.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Injection site erythema, Injection site macule, Myalgia, Vaccination site induration, Vaccination site pain
Clinical narrative: 6x3 oval area of raised redness, warmth tenderness and induration around the vaccine site on the right upper arm. Raised macules covering the area, + myalgias, no fever.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: 6x3 oval area of raised redness, warmth tenderness and induration around the vaccine site on the right upper arm. Raised macules covering the area, + myalgias, no fever.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Abdominal pain, Blood test normal, Colonoscopy normal, Diarrhoea, Fatigue
Clinical narrative: Missed Period, Feeling warm, diarrhea, abdominal pain, tired all the time, sore throat, headaches. Took stool sample which came back normal, Motrin and rest.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Feeling hot, Headache, Laboratory test normal, Menstruation delayed, Oesophagogastroduodenoscopy normal
Clinical narrative: Missed Period, Feeling warm, diarrhea, abdominal pain, tired all the time, sore throat, headaches. Took stool sample which came back normal, Motrin and rest.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Oophorectomy, Oropharyngeal pain, Ovarian cystectomy, Pregnancy test negative, Stool analysis normal
Clinical narrative: Missed Period, Feeling warm, diarrhea, abdominal pain, tired all the time, sore throat, headaches. Took stool sample which came back normal, Motrin and rest.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Ultrasound abdomen abnormal, Ultrasound pelvis abnormal, Urine analysis normal
Clinical narrative: Missed Period, Feeling warm, diarrhea, abdominal pain, tired all the time, sore throat, headaches. Took stool sample which came back normal, Motrin and rest.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Frequent bowel movements, Haematochezia, Occult blood positive
Clinical narrative: Patient had an increase in stooling since the administration of the Rotateq vaccine and then on 3/21/15 have small streaks of blood in a stool, and had another episode of blood in stool on 3/22/15 in the morning.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: EHR was showing birthdate incorrectly as 1/9/15 when he was seen on 2/20/15. It was beleived that he was 6 weeks old at that time, and therefore, eligible for his first set of vaccines, which were given. Mother noticed today, that the birthdate in the EHR is not correct and that he was only 4 weeks old when the first set of vaccines was given. No harm done.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients received ROTATEQ, oral, that had been improperly stored (lot #, expiration date, dose and frequency not provided). No adverse experience was reported. A telephone attempt to obtain follow-up information on 23-MAR-2015 was unsuccessful. The nurse could not supply the information regarding lot numbers, expiration dates and patient identification information at the time of the call. The reporter confirmed that there had been no reports of adverse events following administration of the vaccinations. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Chills, Malaise, Myalgia
Clinical narrative: Shivering chills, general malaise, muscle aches.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia, Vomiting
Clinical narrative: DONOR STATES SYMPTOMS BEGAN 3/23/14 MORNING WITH SWELLING AND PAIN TO LEFT ARM AT INJECTION SITE, SORENESS TO ENTIRE BODY, AND SMALL AMOUNT OF VOMITING THROUGHOUT THE DAY. AS OF 12:20 PM 3/24/15 DONOR HAS FEVER OF 102.0.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Had syncope approx. 10 minutes after receiving Hepatitis A and HPV vaccines. Patient was taken to an area where she was put supine with legs elevated. Vital signs normal, immediately regained consciousness.  Was observed for 10 minutes and was well after that.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Patient came in an insisted we report she is experiencing localized soreness.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Pyrexia
Clinical narrative: Had redness around site the day after injection. Started fever also. Next day it got really red with edema going down arm. Fever continued. He was sent into ER on 3/21/15 and started on Keflex 500mg.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Biopsy muscle, Biopsy peripheral nerve, Computerised tomogram, Hypoaesthesia, Lumbar puncture
Clinical narrative: Swelling & numbness of right foot, no treatment at that time.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Nuclear magnetic resonance imaging, Peripheral swelling, X-ray
Clinical narrative: Swelling & numbness of right foot, no treatment at that time.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash
Clinical narrative: Developed a rash on the right arm down to the wrist.  Returned next day to doctor's office and prescribed steroids etc.
Age: 1.43
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Bilateral swelling of legs, induration and mild erythema See by Dr, instructed to apply ice to area. Referral to Allergist.
Age: 71.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Large red circle around injection site. Pain down right arm where injection was administered. NOTE:  Red circle has lessened each day but still remains (much smaller) on 3/24/15.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Dysphonia, Malaise, Pharyngeal oedema
Clinical narrative: Swelling of the throat, change in voice. General malaise. Tx: Zyzol, Prednisone.
Age: 43.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Chills, Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 44-year-old female patient who received TWINRIX adult (batch number 797K7, expiry date 29th April 2017). Co-suspect products included ADACEL (batch number U5081AA, expiry date 25th June 2017). Concurrent medical conditions included drug allergy (to codeine). Concomitant products included TYPHOID. On 16th March 2015, the patient received the 1st dose of TWINRIX adult (intramuscular) 1 ml and ADACEL (intramuscular) .5 ml. on 16th March 2015, less than a day after receiving TWINRIX adult, the patient experienced injection site pain (serious criteria disability), injection site wheal (serious criteria disability), injection site warmth (serious criteria disability), chills (serious criteria disability), numbness of upper extremities (serious criteria disability), injection site induration (serious criteria disability), injection site erythema (serious criteria disability) and stiff neck (serious criteria disability). On an unknown date, the outcome of the injection site pain, injection site wheal, injection site warmth, chills, numbness of upper extremities, injection site induration, injection site erythema and stiff neck were unknown. The reporter considered the injection site pain, injection site wheal, injection site warmth, chills, numbness of upper extremities, injection site induration, injection site erythema and stiff neck to be possibly related to TWINRIX adult. Additional information was provided as follow: The medical assistant reported that the patient had two vaccines in her left arm (TWINRIX and ADACEL) and experienced the above side effects.
Age: 43.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Injection site urticaria, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 44-year-old female patient who received TWINRIX adult (batch number 797K7, expiry date 29th April 2017). Co-suspect products included ADACEL (batch number U5081AA, expiry date 25th June 2017). Concurrent medical conditions included drug allergy (to codeine). Concomitant products included TYPHOID. On 16th March 2015, the patient received the 1st dose of TWINRIX adult (intramuscular) 1 ml and ADACEL (intramuscular) .5 ml. on 16th March 2015, less than a day after receiving TWINRIX adult, the patient experienced injection site pain (serious criteria disability), injection site wheal (serious criteria disability), injection site warmth (serious criteria disability), chills (serious criteria disability), numbness of upper extremities (serious criteria disability), injection site induration (serious criteria disability), injection site erythema (serious criteria disability) and stiff neck (serious criteria disability). On an unknown date, the outcome of the injection site pain, injection site wheal, injection site warmth, chills, numbness of upper extremities, injection site induration, injection site erythema and stiff neck were unknown. The reporter considered the injection site pain, injection site wheal, injection site warmth, chills, numbness of upper extremities, injection site induration, injection site erythema and stiff neck to be possibly related to TWINRIX adult. Additional information was provided as follow: The medical assistant reported that the patient had two vaccines in her left arm (TWINRIX and ADACEL) and experienced the above side effects.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Face injury, Fall, Feeling abnormal, Head injury
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. the patient's concurrent conditions, medical history and concomitant medications were none. The patient completed, the series with GARDASIL (date unspecified). On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, expiration date: 24-FEB-2017, intramuscular (dose was not reported), while sitting in the pharmacy chair. Within a few minutes (about 1-2) after receiving the GARDASIL 9, the patient began walking and reported feeling dizzy. the patient passed out and fell from a standing position onto the floor, where he hit his head, bit his lip and had now marks on his nose. During this time, the patient's muscles were rigid. The patient woke up after about 2-3 minutes and stated that he felt like he had a dream. The patient was then escorted to a local hospital. The patient sought medical attention. The patient's present status was unspecified by the reporter. The outcome of the event was not reported, at the time of the report. The relatedness between the events and the vaccine was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Lip injury, Loss of consciousness, Muscle rigidity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. the patient's concurrent conditions, medical history and concomitant medications were none. The patient completed, the series with GARDASIL (date unspecified). On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, expiration date: 24-FEB-2017, intramuscular (dose was not reported), while sitting in the pharmacy chair. Within a few minutes (about 1-2) after receiving the GARDASIL 9, the patient began walking and reported feeling dizzy. the patient passed out and fell from a standing position onto the floor, where he hit his head, bit his lip and had now marks on his nose. During this time, the patient's muscles were rigid. The patient woke up after about 2-3 minutes and stated that he felt like he had a dream. The patient was then escorted to a local hospital. The patient sought medical attention. The patient's present status was unspecified by the reporter. The outcome of the event was not reported, at the time of the report. The relatedness between the events and the vaccine was not provided. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 16 year old male patient. the patient's concurrent conditions, medical history and concomitant medications were none. The patient completed, the series with GARDASIL (date unspecified). On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, expiration date: 24-FEB-2017, intramuscular (dose was not reported), while sitting in the pharmacy chair. Within a few minutes (about 1-2) after receiving the GARDASIL 9, the patient began walking and reported feeling dizzy. the patient passed out and fell from a standing position onto the floor, where he hit his head, bit his lip and had now marks on his nose. During this time, the patient's muscles were rigid. The patient woke up after about 2-3 minutes and stated that he felt like he had a dream. The patient was then escorted to a local hospital. The patient sought medical attention. The patient's present status was unspecified by the reporter. The outcome of the event was not reported, at the time of the report. The relatedness between the events and the vaccine was not provided. Additional information has been requested.
Age: 1.09
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-month-old female patient who received BOOSTRIX (batch number 33AG5, expiry date 18th September 2015). Concomitant products included Hepatitis A, MMR, PCV13 and Varicella vaccine. On 6th January 2015, the patient received the 4th dose of BOOSTRIX (intramuscular) .5 ml. On 6th January 2015, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information received: a nurse reported that a one year old child was administered the BOOSTRIX vaccine by mistake which lead to an inappropriate age at vaccination and incorrect vaccine administered.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a 25-year-old female patient who received FLULAVAL (batch number AFLLA285AA, expiry date unknown). On 4th October 2009, the patient received FLULAVAL. On 4th October 2009, immediately after receiving FLULAVAL, the patient experienced hives. On an unknown date, the patient experienced sickness. On an unknown date, the outcome of the hives and sickness were recovered/resolved. It was unknown if the reporter considered the hives and sickness to be related to FLULAVAL. Additional information was provided: The patient was sick a lot in the winter following vaccination. Since then, she had not received any additional doses of flu vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored ROTATEQ (dose and lot# were not reported) orally. No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of arm discomfort in a female patient who received FLUARIX (batch number X9HM3, expiry date 15th June 2015). In October 2014, the patient received FLUARIX. On an unknown date, unknown after receiving FLUARIX, the patient experienced arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown. It was unknown if the reporter considered the arm discomfort to be related to FLUARIX. Additional information received: Patient received a FLUARIX QIV in October 2014 and is still having some arm soreness. No further info relayed.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to unspecified number of patient of unknown demographics. These unspecified patients were administered an unspecified number of doses of improperly stored ROTATEQ (lot # and expiry date unspecified) on an unspecified date since 02-FEB-2015. No adverse effects were reported. Outcome of the event was unknown. The reporter considered the event to be related to ROTATEQ. This is one of several reports from the same reporter (MARRS # 1503USA006661). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients of an unspecified date received improperly stored ROTATEQ (lot No, dose and route of administration not provided). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a 14 week and 5 days old patient of unknown gender. There was no information about patient's concurrent condition and historical condition. On 23-FEB-2015, the patient was vaccinated with ROTATEQ dose 1, 2 ml, oral at the age of 14 week and 5 days. No adverse event was reported. No concomitant medication was reported. No product quality complaint was involved. The outcome of the event was unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Insomnia, Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Substantially decreased mobility, cannot lift arm to side/front/across body sometimes cannot elevated arm inches. Constant pain in shoulder, arm, forearm, fingers, back/scapula, neck pain level so high, unable to sleep.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Substantially decreased mobility, cannot lift arm to side/front/across body sometimes cannot elevated arm inches. Constant pain in shoulder, arm, forearm, fingers, back/scapula, neck pain level so high, unable to sleep.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Abnormal faeces, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Diarrhea, foul odor, fatigue, not sleeping well, runny nose, congestion, decreased appetite, abdominal pain. Positive for Rotavirus after full series of vaccine.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Poor quality sleep, Respiratory tract congestion, Rhinorrhoea, Rotavirus test positive
Clinical narrative: Diarrhea, foul odor, fatigue, not sleeping well, runny nose, congestion, decreased appetite, abdominal pain. Positive for Rotavirus after full series of vaccine.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10 x 10 cm erythema (R) deltoid area (around Tdap injection) with swelling and tenderness.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPAB, MNQ, PPV, TDAP, FLU3, HEPAB, MNQ, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Patient had cellulitis 24 hrs after vaccine administra. About 6 cm distal to the injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Blood pressure immeasurable, Hyperhidrosis, Pulse absent, Skin discolouration
Clinical narrative: After receiving Tdap and MENACTRA child fainted. BP 100/70. Drank juice 8 oz. Then became grey, sweaty. BP not audible, radial pulse not palpable. 911 called. Given another 8oz of juice, granola bar. BP came up to 110/70, blood sugar 79. Went to ER for evaluation. No problems breathing. Alert and oriented throughout.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Left arm numbness.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: (L) arm cellulitis.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain, F/C - resolved.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: No reaction during office visit on 3/19/15 - was notified on 3/23/15 - when I returned to work. Dr notified - returned call to mother no answer on Monday 3/23/15 left message to return call mother returned call on Tuesday 3/24/15 - taken to ER night of 3/19/15. Allergic reaction - hives.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, Exposure via direct contact, Ocular hyperaemia
Clinical narrative: Information of this prospective pregnancy report has been received from a 33 year old female pharmacist referring to herself. The patient had an anaphylactic reaction to cephalosporins. The patient became pregnant with Last Menstrual Period of approximately 04-DEC-2014. On 12-MAR-2015, at the patient's 14 weeks gestation while she was injecting the diluent in the syringe into the vial of ZOSTAVAX, lot # K023624, exp. date 19-FEB-2016, the diluent splashed into her eye and her face. There was no concomitant medication. The pharmacist stated that her eyeball was "red" on 12-MAR-2015. She used "eye wash" as a treatment for the event. The Estimated Date of Delivery was approximately 10-SEP-2015. The pregnancy outcome was pending. There was no lab diagnostics studies performed. The outcome of event "red" eyeball was unknown. The patient did not seek any medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unknown number of patients. Since an unspecified date in February 2015, the patients had been administered subcutaneously PROQUAD (Merck) injection which was not stored properly, (lot number, expiry date and dose were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients received dose of (Oka/Merck) VARIVAX that had been improperly stored (lot #, expiration date, route, dose and frequency not provided). No adverse experience was reported. A telephone attempt to obtain follow-up information on 23-MAR-2015 was unsuccessful. The nurse could not supply the information regarding lot numbers, expiration dates and patient identification information at the time of the call. The reporter confirmed that there had been no reports of adverse events following administration of the vaccinations. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old female patient. Patient's current conditions included asthma, hypertension and allergy to penicillin. On 27-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K016320, Expiry: 24-DEC-2015) (0.65 ml, subcutaneous, left deltoid region). Concomitant medications included unspecified asthma and blood pressure medication. On 28-FEB-2015, the patient developed inflammation and redness at her injection site that lasted "7 to 10 days" and reproted that the patient consulted her physician, who noted that her lymph nodes in her left axilla were swollen. Patient received treatment with Ibuprofen. Patient sought medical attention, consulted physician. No product quality complaint was involved. The outcome of the events inflammation and redness at her injection site and lymph nodes in her left axilla were swollen was reported as recovering. The reproter causality was not provided. No additional information was provided. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Erythema, Immediate post-injection reaction, Pallor, Skin discolouration
Clinical narrative: Infant cried immediately after the vaccine injections and turned red. Mom states seconds later his face turned pale / "almost blue". I checked him and his pulse was 140, pulse ox 94, BP 82/42 and his color was pink. He was observed for 30 min and was normal. 4 hrs later infant is fine.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student regarding two adult patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. Yesterday, on 19-MAR-2015, the patients were vaccinated with PNEUMOVAX 23, .5 milliliter (ml), intramuscularly (site unspecified) (product lot# not available) which expired on 08-MAR-2015. There was no information on concomitant medications. No adverse events were reported. There was no product quality complaint involved. The outcome of the events were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. No medical history and current conditions were reported. On an unknown date in March 2015 (reported as within the past week) the patient was vaccinated with ZOSTAVAX (dose, lot number was unknown) for prevention of shingles. No concomitant medications were reported. On an unknown date in March 2015 (reported as within hours after receiving ZOSTAVAX) the patient experienced a rash, redness and swelling around the injection site. The patient received topical hydrocortisone as a treatment. Patient sought medical attention, saw pharmacist. No product quality complaint was involved. The outcome of the events rash, redness and swelling around the injection site was unknown. The reporter causality was not provided. No further information was provided. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 39 year old female patient. No medical history and current conditions were reported. On 11-MAR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J014152, Expiry: 07-NOV-2015) (0.5 ml, subcutaneous). No concomitant medications were reported. On 12-MAR-2015 (reported as within 24 hours) the patient experienced injection site reactions, 4-inch oblong area with significant swelling, redness, inflammation, itching and the injectio site was warm to touch after receiving (Oka/Merck) VARIVAX. Nurse reported she used the sterile diluent provided, but had not recorded the lot number. Patient received treatment with ice compress. The outcome of the events was reported as recovering. The reporter causality was not provided. No further information was provided. This case is linked to MARRS# 1503USA010703 with the same reporter link. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to a 39 year old female patient. No medical history and current conditions were reported. On 11-MAR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # J014152, Expiry: 07-NOV-2015) (0.5 ml, subcutaneous). No concomitant medications were reported. On 12-MAR-2015 (reported as within 24 hours) the patient experienced injection site reactions, 4-inch oblong area with significant swelling, redness, inflammation, itching and the injectio site was warm to touch after receiving (Oka/Merck) VARIVAX. Nurse reported she used the sterile diluent provided, but had not recorded the lot number. Patient received treatment with ice compress. The outcome of the events was reported as recovering. The reporter causality was not provided. No further information was provided. This case is linked to MARRS# 1503USA010703 with the same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about the patient's relevant medical history and concomitant medication was not reported. On 12-MAR-2015 the patient was vaccinated with one dose of (Oka/Merck) VARIVAX (route, lot# and expiration date were not reported), which had been exposed to temperature outside of the recommended range. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. Information about the patients' relevant medical history and concomitant medications was not reported. On unkonwn dates, the patients were vaccinated subcutaneously with doses of VARIVAX (Merck) (0.5 ml, lot# and expiration date were not reported) that underwent a supported temperature excursion. No adverse experiences were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to herself: a 62 year old female patient. Her medical history included unspecified reaction to FLAGYL. On 17-MAY-2012, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number, expiration date not provided). Concomitant therapy included unspecified antihistamine drugs. On 17-MAY-2012, the patient experienced a small, rectangular shaped rash at the injection site which was about 1.5x3 cm. There were no lab diagnostic studies performed, and no treatment was given for the adverse event. On an unknown date, the patient recovered from the injection site rash. The patient did not seek medical attention. The relatedness between adverse event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Hives within one hour of administration. Improved with BENADRYL at home and PEPCID AC.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were inadvertently vaccinated with the doses of PNEUMOVAX 23 that were improperly stored (route of administration, lot number, expiry date was not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients received dose of PNEUMOVAX 23, that had been improperly stored (lot #, expiration date, route, dose and frequency not provided). No adverse experience was reported. A telephone attempt to obtain follow-up information on 23-MAR-2015 was unsuccessful. The nurse could not supply the information regarding lot numbers, expiration dates and patient identification information at the time of the call. The reporter confirmed that there had been no reports of adverse events following administration of the vaccinations. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date in July 2012, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot# and expiration date not reported). On 10-MAR-2015 the patient was in the physician's office to be vaccinated with the second dose of GARDASIL, which would be late. There were no symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the patients received dose of RECOMBIVAX HB, that had been improperly stored (lot #, expiration date, route, dose and frequency not provided). No adverse experience was reported. A telephone attempt to obtain follow-up information on 23-MAR-2015 was unsuccessful. The nurse could not supply the information regarding lot numbers, expiration dates and patient identification information at the time of the call. The reporter confirmed that there had been no reports of adverse events following administration of the vaccinations. This is one of several reports received from the same reporter. Additional information has been requested.