chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix, Treponema test
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no known drug reactions or allergies and with no pertinent medical history who on 29-DEC-2011, presented to the family practice office symptomatic (specific symptoms unspecified0 and was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (Lot # 668670/0476AA). There was no concomitant medication. "The same day" on 29-DEC-2011 after GARDASIL vaccination, the patient had a pregnancy test that showed she was pregnant. The lab diagnostics studies performed also included chlamydia test, PAP, HIV screening. On 09-JAN-2012 the patient performed "full OB screen: CBC, rubella, RPR (syphilis screen), hepatitis B, hemoglobin A1C, blood type A positive" and no lab results provided. The nurse mentioned her gestation was 26 weeks and 1 day until now. Her LMP was on 13-NOV-2011. Expected date of delivery was on 19-AUG-2012. No further information was reported. Follow up information was received from a physician who reported that the 20 year old female patient with no medical history and no concurrent medical conditions and with no previous pregnancies, was vaccinated on 03-JAN-2013 (previously reported as 29-DEC-2011) with the first dose of GARDASIL (lot number 668670/0476AA). Estimated delivery date was reported as 19-AUG-2012. It was unknown that ultrasound, amniocentesis, MSAFP were done. On 22-AUG-2012, at 37 gestation week, the patient delivered normal full term female baby with no congenital anomaly. There were no other complications or abnormalities. Apgar score was 9, 9 for the baby. The baby's birth weight was 9lbs 8oz. There were no complications during pregnancy or during labor/delivery. Follow up information was received from a physician who reported that the patient had not medical history information and that she was vaccinated on 29-DEC-2011 (previously reported as 03-JAN-2012), with the first dose of GARDASIL. The patient used miconazole 2% vaginal cream QHS on 13-MAR-2012, for yeast infection. There were no complications during pregnancy; everything went fine and Estimated conception date was reported as 21-NOV-2011. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients with unknown gender and greater than 26 years old. The physician reported that on an unknown date the patients were vaccinated with GARDASIL injection (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The physician mentioned since the approval for GARDASIL, she had been giving GARDASIL on unknown dates, to an unknown number of patients who are greater than 26 years old. No adverse effect reported. This is one of two cases from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The reporter stated that on 08-MAR-2013 an expired dose of GARDASIL (dose, indication and route of administration unknown) (lot number and expiration date 667194/1271Z; 11-DEC-2012) was given to the patient. Concomitant medications were not reported. No adverse event was reported. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash, bumps, appears to be mild chicken pox.  Worse throughout day.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Pyrexia
Clinical narrative: Fever, complaining her neck hurts.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Noticed bigger circle of redness at injection site. By Wed., Mar. 20, red circle larger than a silver dollar, arm swollen and it hurt. I went to urgent care at noon on Mar. 20.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Noticed bigger circle of redness at injection site. By Wed., Mar. 20, red circle larger than a silver dollar, arm swollen and it hurt. I went to urgent care at noon on Mar. 20.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Periarthritis
Clinical narrative: Upper arm was initially more painful than previously experienced after receiving a flu shot. Pain continued over time, especially when upper arm and shoulder are moved certain ways. Now I am experiencing symptoms of "frozen shoulder". I have limited range of movement and pain, especially when upper arm and shoulder are moved certain ways.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site vesicles, Oedema peripheral, Skin warm
Clinical narrative: Pt has swollen arm, warm to touch that spans length of her humerus, clear blister like bumps around the actual injection site, reports it being itchy and painful.  Went to primary care doctor on Friday 3/22, originally told by him to use ice and Benadryl, came in again today 3/23 Saturday for a prescription of Norco and Fluocinonide cream from same doctor stating it was not better.
Age: 18.0
Sex: M
Vaccine: HEPAB, IPV, MEN, MMR, TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Fever. Rash appeared the next day as well. Fever lasted 3 days. Rash is still present.
Age: 0.53
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting, multiple times.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram, Syncope
Clinical narrative: Syncopal or fainting episode less than a minute after receiving Tdap and influenza shots intramuscularly. Patient slumped slowly in physician's arms & was allowed to lie on floor for 10 minutes with 2 liters of oxygen. Orthostatic vitals normal.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Lymph node pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: 6 cm x 5 cm diam red, swollen, tender area around vaccine site (L) ant thigh with 1 cm, sl. tender inguinal node.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dysphagia, Lethargy, Pharyngeal oedema, Pyrexia
Clinical narrative: Immediately felt dizzy and lightheaded. Lethargic, fever since vaccine has been between 99 and 103 even with OTC fever reducer, swollen throat - difficulty swallowing but no pain.  Currently going on fours days of symptoms with no relief.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Red area at R deltoid at site of reaction.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site papule, Injection site swelling, Rash erythematous
Clinical narrative: Patient presented to clinc for smallpox check up. He c/o red bumps on torso and arms. Pt stated he was taking of his band-aide and washing the site in the shower. Pt has alot of swelling around the site and two papules; one above and one below the smallpox site.
Age: 29.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Foetal disorder, Haemorrhage in pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for live VARIVAX (Merck), a Pregnancy Registry product, concerning a fetus his mother received VARIVAX live (Merck) and was pregnant. The mother had a positive unspecified pregnancy test and was 13 weeks into the pregnancy. Physician reported the fetus's right hand was not formed and had a malformed right forearm. Physician also reported there was bleeding from the placenta. The outcome of the events was unknown. The events were considered to be Congenital Anomaly. This report linked to case # 1303USA009381 (same source, mother case). Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Foetal disorder, Haemorrhage in pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 29 year old female patient. Physician reported that his patient received VARIVAX (Merck) and was pregnant. Patient had a positive unspecified pregnancy test and was 13 weeks into the pregnancy. Physician reported the fetus right hand was not formed and had a malformed right forearm. Physician also reported there was bleeding from the placenta. The outcome of the events was unknown. This report linked to case # 1303USA010982 (same source, baby case). Additional information has been assistant.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site inflammation, Injection site pustule, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient with allergy to sulfa drugs. In September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). In September 2012 patient had an injection site reaction: swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalized for 2 days. The vaccinated was administered by a physician and the ZOSTAVAX was given in the same arm as an unspecified flu vaccine. The patient seek medical attention by being sent to ICU and was treated with vancomycin, unspecified pain medication. The outcome of events was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Intensive care
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient with allergy to sulfa drugs. In September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). In September 2012 patient had an injection site reaction: swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalized for 2 days. The vaccinated was administered by a physician and the ZOSTAVAX was given in the same arm as an unspecified flu vaccine. The patient seek medical attention by being sent to ICU and was treated with vancomycin, unspecified pain medication. The outcome of events was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient with allergy to sulfa drugs. In September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). In September 2012 patient had an injection site reaction: swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalized for 2 days. The vaccinated was administered by a physician and the ZOSTAVAX was given in the same arm as an unspecified flu vaccine. The patient seek medical attention by being sent to ICU and was treated with vancomycin, unspecified pain medication. The outcome of events was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Intensive care, Rash pustular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 year old female patient with allergy to sulfa drugs. In September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). In September 2012 patient had an injection site reaction: swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalized for 2 days. The vaccinated was administered by a physician and the ZOSTAVAX was given in the same arm as an unspecified flu vaccine. The patient seek medical attention by being sent to ICU and was treated with vancomycin, unspecified pain medication. The outcome of events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist who reported on an unknown date an unspecified number of patients may have received PNEUMOVAX23 exposed to 78F for an unspecified period of time. The dates of administration as well as the lot/expiration date of the PNEUMOVAX23 in question were unknown. No adverse symptoms reported. The outcome of AE was not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Oedema peripheral
Clinical narrative: This spontaneous report as received from a consumer refers to her 80 year old mother. The patient had shingles when she was younger (date not specified). "Last Wednesday", on 13-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) at the Pharmacy (location and telephone details not specified by the reporter). A couple days later in March 2013 both hands of the patient developed blisters and became swollen. No information was provided on the patient's current condition by the reporter. The outcome was unknown. Action taken and causality were not provided at the time of report. The patient did not seek any medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Nonspecific reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age (also reported as under 50 years of age) and unknown gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date in 2013 (between 25-FEB-2013 and 19-MAR-2013), the patient experienced an unspecified reaction on the arms after being vaccinated with PNEUMOVAX23. Severity of reaction of reaction was unspecified. The outcome of the event was unknown. It was unspecified if any lab tests were performed. The relatedness for the event was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Nonspecific reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning an approximately 26 year old (also reported as under 50 years of age) male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date in 2013 (between 25-FEB-2013 and 19-MAR-2013), the patient experienced an unspecified reaction on his arms after being vaccinated with PNEUMOVAX23. It was a more severe reaction that required an antibiotic treatment. The outcome of the event was unknown. It was unspecified if any lab tests were performed. The relatedness for the event was unknown for PNEUMOVAX23. This is one of the two reports from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from an approximately 75 year old female patient regarding herself. Current condition of the patient included thyroid disorder (unspecified), high cholesterol, penicillin allergy, sulfa allergy, LIBRIUM allergy, CEPRO allergy, large doses of aspirin allergy and allergy to bone density medication (1 month, 70 milligrams, name unspecified). On an unknown date in June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapy included CRESTOR (5 milligrams, 1x) and unspecified thyroid medicine (dose unknown). On an unknown date in May 2012, the patient experienced 2nd outbreak of shingles in her head. No treatment was given. No lab tests were performed. The outcome of 2nd outbreak of shingles in her head was reported as not resolved as the patient still had the symptoms at the time of reporting. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: Whole body pain beginning Sept 1, 2012. First in neck and then going down left side of body and right hand. Emergency room, many doctors, 60 mg Prednisone. Seven months later I am still having some pain.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Redness, swelling, bruising.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Redness, swelling, bruising.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pruritus, Rash erythematous
Clinical narrative: Large red rash, itching at site.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, erythema, swelling at injection site. Benadryl oral and topical, Zyrtec, Chloraphenarimine, Zantac.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: 3/22/13 around 05:30 PM:  Tightness in chest, difficulty breathing (duration about 10 minutes), grade 1 pain in arm. 3/22/13 around 8:00 PM:  Grade 2 pain in arm.  3/24/13 around 02:00 AM: nausea & vomiting.  3/24/13 - present (it's presently 3/25/13):  nausea, swollen glands, grade 1 pain in arm.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: 3/22/13 around 05:30 PM:  Tightness in chest, difficulty breathing (duration about 10 minutes), grade 1 pain in arm. 3/22/13 around 8:00 PM:  Grade 2 pain in arm.  3/24/13 around 02:00 AM: nausea & vomiting.  3/24/13 - present (it's presently 3/25/13):  nausea, swollen glands, grade 1 pain in arm.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt. received vaccine 3-15-13, returned to Health Center 3/21/13 stating injection site remains sore to touch. States soreness has improved but persists. Injection site with mild pink color approximately 1.5 cm diameter. She worked out/exercised either the day of the vaccine or day after - she cant not remember which. No swelling or drainage of the area. She did not apply ice to the site originally, did not take pain relievers, and did not seek medical care.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Immobile, Joint range of motion decreased
Clinical narrative: Sharp pain in shoulder following removal of needle. Pain & loss of range of motion for 1st 48 hrs. 5 days later, shoulder was immobile. Returned to clinic - Rx - prednisone boost & naproxen for 6 days. Shoulder ROM & pain improved, but, when meds gone, pain returned. Saw FP 3 days later. Rx - Arthritis & topical NSAID. Pain continued.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 17 week old patient (gender unknown). On 21-MAR-2013, the patient was vaccinated with first dose, oral ROTATEQ (lot number, expiry date was not reported, route was oral). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient's medical history and concurrent conditions were not provided. On 04-MAR-2013 the patient was vaccinated with her first dose of MMR II, 0.5 ml, subcutaneous (lot #: 0190AA, expiry date: 08-FEB-2013). It was reported that the dose of MMR II was expired. No adverse effects reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Injection site infection
Clinical narrative: This spontaneous report as received from a health professional (office manager) refers to approximately 17 year old patient of unknown gender with no drug reactions and allergies. Pertinent medical history was none. On 18-MAR-2013, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot # H014196, expiry date 19-MAR-2014, dose was not reported) intradermally in the forearm. Concomitant medications were none. Approximately on 18-MAR-2013 following vaccination, the patient experienced bacterial infection at the injection site. The next day on 19-MAR-2013, the patient returned to the physicians office with the already serious bacterial infection at the administration site and was prescribed AUGMENTIN. On 20-MAR-2013, again the patient returned to the physicians office and the infection looked even worse, hence AUGMENTIN was discontinued and the patient was prescribed with ROCEPHIN. Laboratory test performed was none. The infection had not changed and was not recovered at the time of this report. The reporter requested for the lot check since the 2 patients had received from the same lot. This is one of the reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 4 year old patient (gender unspecified). No medical history was reported. On 21-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot# an expiry not reported), 0.65 ml, subcutaneously. The nurse stated that this was related to a staff error and not due to product confusion. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site haemorrhage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 10 year old male patient. The patient had no pertinent medical history or drug reactions or allergies. On 20-MAR-2013, the patient was intravenously vaccinated with a dose of 0.5 ml VARIVAX (Merck), (lot number, expiry date was not reported) in the deltoid muscle. No Concomitant medications were reported. The physician reported that when he withdrew the needle "there was lot of blood" he was concerned that he may have given the patient VARIVAX (Merck) intravenously. No adverse effects were reported. No laboratory tests were performed. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse via company representative refers to a patient of unknown age. On an unknown date in 2010, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On 22-MAR-2013, the patient was to be vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse effect was reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No medical history was reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot#, dose, route not reported). No concomitant medications were reported. On an unknown date, the patients experienced pain at injection site after receiving GARDASIL. The outcome of pain at injection site was unknown. The relatedness of the adverse event with GARDASIL was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Incorrect route of drug administration, Injection site infection
Clinical narrative: This spontaneous report as received from a health professional (office manager) refers to approximately 78 year male old patient with no drug reactions and allergies. Pertinent medical history was none. On 18-MAR-2013, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot # H014196,expiry date 19-MAR-2014, dose was not reported) intradermally in the forearm. Concomitant medications were none. Approximately on 18-MAR-2013, following vaccination, the patient experienced bacterial infection at the injection site. On 20-MAR-2013, the patient visited the physicians office to get the results of the TB (Tuberculosis). The patient presented with a pretty bas infection at the injection site of his forearm. The patient was placed on unspecified antibiotics due to the infection. Laboratory test performed was none.The event infection was not recovered at the time of this report. The reporter requested for the lot check since the 2 patients had received from the same lot. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, 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. On an unknown date, the patient was vaccinated with a first dose of ROTATEQ (lot number and expiry date were not reported) 2 milliliter (ml) orally at 14 weeks of age, which was other-than-indicated. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age. On 18-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date in MAR-2013, the patient developed a wheal at injection site after ZOSTAVAX was administered. The outcome of the event was unknown. The patient sought medical attention. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Full blood count, No therapeutic response, Viral titre decreased
Clinical narrative: This spontaneous report was received from a physicians assistant refers to a 38 year old male patient. The patient had no pertinent medical history and drug reactions or allergies. On an unknown date in 1997, the patient was intramuscularly vaccinated with a dose of VARIVAX (Merck), (lot number expiry date was not reported). No concomitant medications were reported. On an unknown date in 2011, the patient got varicella titer done and the titer was low so he received another dose of VARIVAX (Merck). Complete blood count was performed and the result was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age(gender unspecified). On 13-JUL-2011, the patient was vaccinated with first dose of RECOMBIVAX HB, (lot number, expiry date was not reported and route intramuscular). On 16-AUG-2011, the patient was vaccinated with second dose of RECOMBIVAX HB, (lot number, expiry date was not reported and route was intramuscular). On 01-FEB-2013, the patient was vaccinated with third dose of RECOMBIVAX HB, (lot number, expiry date was not reported and route was intramuscular). Concomitant medications were not reported. The reporter stated that the patient received the third dose late. The first two doses were age appropriate, pediatric formulation RECOMBIVAX HB and the third dose was age appropriate adult formulation RECOMBIVAX HB. No adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a nurse via Evolution Marketing Research (reference # MRK30202) refers to a 12 year old healthy female patient. On an unknown ate the patient was vaccinated with a dose of GARASIL (lot# not reported) as HPV vaccination. On 08-MAR-2013 the patient experienced lightheadedness. There was none diagnostic tests carried out to diagnose the event. It was also reported that the event did not reappear after restarting suspected therapy. The outcome of lightheadedness was reported as recovered/resolved with sequelae. The relatedness of the event was unknown for GARDASIL. Additional information is not expected.
Age: 0.52
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 5 month old male patient. The patient had no pertinent medical history. On an unknown date, the patient was vaccinated with first dose of LIQUID PEDVAXHIB, (lot number reported as 0419AE and expiry date 17-AUG-2014, route was not reported) and had no reaction. On an unknown date, the patient was vaccinated with second dose of LIQUID PEDVAXHIB, (lot number, expiry date and route was not reported) included in PENTACEL and had no reaction. On 20-MAR-2013, the patient was vaccinated with third dose of LIQUID PEDVAXHIB, (lot number reported, expiry date and route was not reported). On 20-MAR-2013, the patient developed a 2.5 cm injection site reaction which included swelling, redness and a knot at the injection site. Treatment rendered for the events was TYLENOL. The outcome of the reported events were not recovered at the time of this report. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot# and route not reported). On an unknown date the patient experienced skin rash. It was unspecified if the patient sought medical attention. The outcome of skin rash is unknown. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to the pharmacist's 4 year old male patient. On an unknown date the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # was not reported). On an unknown date the patient experienced rash at unspecified location. It was not reported whether the patient medical attention. The outcome of rash at unspecified location was reported as recovered/resolved on an unknown date. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Mobility decreased, Musculoskeletal pain, Pain, Quality of life decreased
Clinical narrative: Extreme shoulder pain, aches, limited movement, affecting quality of life, unable to use arm for certain functions.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Full blood count normal, Influenza virus test negative, Nasal congestion, Pyrexia
Clinical narrative: Fever 102 lasted for 3 days; nasal congestion for 3 days.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chills, Erythema, Lymphadenopathy, Vaccinia virus infection
Clinical narrative: Red dots on chest/arms, swollen lymph nodes, chills.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Right arm swollen, red and tender to touch.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Heart rate increased, Nausea, Photopsia, Vomiting
Clinical narrative: Nausea; Vomiting; Flashing White Lights Within the Eyes; Rapid Heartbeat; Weakened Knees; Felt Very Weak.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Skin ulcer
Clinical narrative: Pt presented with round sores on forehead and side of face. Pt complained also of headaches claims shot gave him shingles.
Age: 39.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Swelling
Clinical narrative: Redness that extented over shoulder, swelling, secondary smallpox site.
Sex: F
Vaccine: MMR
Symptoms: Exposure to communicable disease, Measles antibody negative, Mumps antibody test negative, No therapeutic response, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female patient of unknown age. On an unknown date, in childhood, the patient was vaccinated with a dose of M-M-R II (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient had a negative titer for MMR and also recently had exposure to one of the diseases (unspecified). The outcome of the events was unknown. The relatedness for the events was unknown for M-M-R II. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Urticaria next day after injection with Dtap & Hib vaccine. Seen at urgent care per mother.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: Pt received routine 5 yr. vaccines (KINRIX and PROQUAD). Within 45 minutes of administration patient began having symptoms of anaphylaxis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Erythema, itching, raised circular area 6 cm in diameter, warm to touch.
Age: 0.43
Sex: M
Vaccine: PNC13, RV5
Symptoms: Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: Parent states baby became extremely fussy and developed fever later in night on day of vaccine administration. Mom also noted baby to have a bulging fontanel. Baby evaluated in office and sent to ER. In office temp 100.4 O2 sat 100%.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse (also reported as a healthcare worker) refers to an unspecified patient born in 1992. The patient was vaccinated subcutaneously with first and second doses of 0.5 ml VARIVAX (Merck) (lot number, expiry date unspecified) on 11-JUN-2001 and 19-MAR-2013 respectively. The action taken of VARIVAX (Merck) and outcome were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 19-MAR-2013 the patient was vaccinated with an expired dose of 0.65 milliliters (ml) ZOSTAVAX (lot # 0364AE, expiration date 16-MAR-2013) subcutaneously. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for vaccination. Lot# was unspecified. On an unknown date the patient developed shingles after receiving a dose of ZOSTAVAX. The outcome of shingles was unknown. Causality was not reported. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
Age: 0.86
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Pt has a low grade temp and area of erythema measuring 7.5 x 10 cm around the area where immunizations were given in the (R) thigh. KEFLEX 125mg/5ml x 5 days. BENADRYL OTC.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot number, expiry date, route and dose were not reported). On an unknown date, the patient broke out in rash all over body 10 to 15 minutes after receiving a dose of GARDASIL. On an unspecified date, the event was recovered/resolved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 25 year old female patient who was allergic to CIPLACTIN and clarithromycin. The patient was not pregnant. On 16-MAR-2013 the patient was vaccinated intramuscularly with 0.5 ml GARDASIL (lot # 0420AE, expiry date 01-DEC-2014). There was no other concomitant medication. The patient fainted after being administered GARDASIL on 16-MAR-2013 in the physician's office. Ammonia capsule and cold pack were given for treatment. The outcome of fainted was reported as recovered/resolved on 16-MAR-2013. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Activities of daily living impaired, Appendicectomy, Blood test abnormal, Malaise, Pain
Clinical narrative: Initial case was received from a consumer on 15 March 2013, with follow-up information on 19 March 2013. A 17-year-old female patient received a dose of TYPHOID VACCINE, manufacturer unknown (lot number, site not reported; route unknown, reporter did not know if patient received oral or injection) on a day in March or April 2012. On follow-up, the reporter cited a voluntary recall involving TYPHIM in September 2012; however a specific batch number was not provided. According to reporter, the patient went out of the country in June 2012 for 10 days and was now diagnosed with Typhoid. On an unspecified date, the patient developed illness that went undiagnosed. In December, she "had her appendix out". The reporter stated she continues to be in extreme pain (area not specified) and unable to go to school since December. The patient's blood was tested and found Typhoid (specific test and date unspecified). The patient's outcome is not recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: TYP
Symptoms: Typhoid fever
Clinical narrative: Initial case was received from a consumer on 15 March 2013, with follow-up information on 19 March 2013. A 17-year-old female patient received a dose of TYPHOID VACCINE, manufacturer unknown (lot number, site not reported; route unknown, reporter did not know if patient received oral or injection) on a day in March or April 2012. On follow-up, the reporter cited a voluntary recall involving TYPHIM in September 2012; however a specific batch number was not provided. According to reporter, the patient went out of the country in June 2012 for 10 days and was now diagnosed with Typhoid. On an unspecified date, the patient developed illness that went undiagnosed. In December, she "had her appendix out". The reporter stated she continues to be in extreme pain (area not specified) and unable to go to school since December. The patient's blood was tested and found Typhoid (specific test and date unspecified). The patient's outcome is not recovered. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Haematoma, Laboratory test normal, Respiratory tract congestion
Clinical narrative: Wife reported events 3/18/13. About 48 hours after shot patient developed a large hematoma on the arm. Then, severe cough and chest congestion began gradually. Symptoms progressed, so pt went to pharmacy clinic. Treated with something for chest congestion. MD later prescribed Z-Pak. Persistent cough still present.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Epstein-Barr virus test negative, Full blood count normal, Metabolic function test normal
Clinical narrative: 15 year old with c/o 1 mo history mild arthralgia of knees when came in to office 3/6/13 for well care. Child and mom note worsening knee pain and milder upper back pain since vaccine. Using NAPROSYN. Rash noted at same time over knees.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: 15 year old with c/o 1 mo history mild arthralgia of knees when came in to office 3/6/13 for well care. Child and mom note worsening knee pain and milder upper back pain since vaccine. Using NAPROSYN. Rash noted at same time over knees.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin normal, Pain, Rash pruritic
Clinical narrative: Started w/itchy rash around waist area - 6 mo. Some relief w/steroid but severe reaction to them. Hospitalized 2-2008 lessened some then returned spreading other locations (areas back, arms, waist, buttock) stinging & very itchy. Hosp several times due to steroids.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy test, Burning sensation, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Started w/itchy rash around waist area - 6 mo. Some relief w/steroid but severe reaction to them. Hospitalized 2-2008 lessened some then returned spreading other locations (areas back, arms, waist, buttock) stinging & very itchy. Hosp several times due to steroids.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTaP instead ADACEL.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm redness, swelling, and pain.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Diarrhoea, Erythema, Faecal volume increased, Oxygen saturation decreased, Pruritus
Clinical narrative: Pt returned to office due to itching / hives / redness. No difficulty breathing / resp. distress. Pt O2 sat 88-91 with O2 3L blow by. Pt had large stool, loose. X2 RNs assisted father cleaning / changed pt. after pt had x1 large emesis. RN x2 assisted clean up. Pt O2 100% on room air. No diff breathing/distress. Pt dc'd home after monitoring. Gave BENADRYL 2 tsp PO upon return to office.
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Pt returned to office due to itching / hives / redness. No difficulty breathing / resp. distress. Pt O2 sat 88-91 with O2 3L blow by. Pt had large stool, loose. X2 RNs assisted father cleaning / changed pt. after pt had x1 large emesis. RN x2 assisted clean up. Pt O2 100% on room air. No diff breathing/distress. Pt dc'd home after monitoring. Gave BENADRYL 2 tsp PO upon return to office.
Age: 64.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Pyrexia
Clinical narrative: Received YFV at 4pm. Developed high fever and profound weakness about 9 pm. Went to ER. Fully conscious in ER - went home and within 2 days was much better,fully recovered in 4 days.
Age: 42.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Client given MMR & Varicella vaccine on 3/12/13. Started with severe itching on 3/13 and got progressively worse with hives. Went to ER on Monday 3-18-13. Advised it may be allergic reaction. Rx BENADRYL.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Pain, Skin ulcer
Clinical narrative: This spontaneous report was received from a 86 year old female patient regarding herself. No medical history was reported. On an unknown date approximately in March 2003 (reported as 10 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose, route not reported). No concomitant medications were reported. On an unknown date approximately in March 2013, the patient developed shingles. The patient stated that she also developed a sore round place above her hip that has now spread around to her back. The outcome of shingles and sore round place above her hip that has now spread around to her back was unknown. The causality for the events with ZOSTAVAX was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: 2 days after receiving immunization patients arm had a rash at site of injection warm to the touch.
Age: 68.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Cellulitis on (R) arm. Measuring 21 x 24 cm. No fever. Warmth, erythema, edema & pain are present.
Age: 33.0
Sex: M
Vaccine: FLU3, HEPAB, TD
Symptoms: Local swelling, Pruritus, Rash, Urticaria
Clinical narrative: Pt was given Td, Hepatitis AB and Influenza (TIV) vaccines around 8:30 am on 3/12/13. Pt experienced hives, itching on trunk, arms & legs, swelling in neck around 7:30pm on 3/12/13. Pt's wife stated the rash came & went away several times for 6 days. Pt was not examined by a health care provider.
Age: 1.65
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Oedema peripheral, Pyrexia, Rash generalised
Clinical narrative: 2 days later swelling hands & feet, fever & rash over entire body. Treatment: oral steroids x 5 days recheck 2 days.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Swollen tongue
Clinical narrative: Thursday 3-14-13 vaccine provided. Sunday 3-17-13 arm felt hot and itchy, tongue swollen. Went to the ER, given BENADRYL (pill form). Has been taking 1 pill per day for 2 days. States the symptoms are gone.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Full blood count, Joint range of motion decreased, Liver function test, Local swelling
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Lymphadenopathy, Oedema peripheral, Rash, Rhinorrhoea
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Activities of daily living impaired, Alanine aminotransferase normal, Anion gap normal, Anti-cyclic citrullinated peptide antibody positive, Aspartate aminotransferase normal
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Basophil count normal, Basophil percentage increased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Blood calcium increased, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.
Age: 54.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal, Blood urea normal, Burning sensation
Clinical narrative: Rash to Rt side neck. Rhinorrhea right nostril, swollen lymph nodes right sublingual, right neck/clavicle, right groin for 2 weeks. Swollen right arm, hand, shoulder and right side of neck with pain in joints and decrease range of motion. Report to PCM Dr x 2. Labs done CBC & LFT's. MOTRIN 600 mg TID ordered.