chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Thrombocytopenia
Clinical narrative: Initial report received from a healthcare professional on 12 September 2012. A 29-year-old pregnant female patient had received an intramuscular (IM) first dose of ADACEL vaccine in left deltoid (lot number U4384AA) on 12 September 2012. The date of the patient Last Menstrual Period was 17 February 2012. Estimated Date of Delivery was reported as 23 November 2012. It was reported that the patient did not experienced any adverse event. The patient's obstetrical history, current medical history, and concomitant medication were not provided. The outcome was reported as unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded to serious. The patient experienced a relevant illness of thrombocytopenia during pregnancy/ongoing. Maternal history included one previous pregnancy resulting in twin births. In addition to ADACEL, medications used during pregnancy included AFLURIA and RHOGAM. The patient delivered a normal infant on 19 November 2012. Outcome for the event of thrombocytopenia was not reported. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Swelling, redness, warmth, pain to (L) arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain, Pain in extremity
Clinical narrative: Pt. received flu shot at 6 pm. The next day her arm was swollen and red (about 6" by 3" area). Took TYLENOL for pain. Pt stated no itching or troubles breathing. 9/7 -> pt went to hospital got prednisone. Pt said arm was sore and still red, slightly swollen.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Aspartate aminotransferase normal, Erythema multiforme, Haematocrit decreased, Platelet count decreased, Pyrexia
Clinical narrative: 6 days after vaccination, patient presented with macula popular rash. Fever developed day 7 and reached 103. Day 9 after vaccine rash was more involved on trunk and face. Day 10 rash was erythema multiforme with target and ursine. Fever gone Day 11. Rash resolved Day 13.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash maculo-papular, Red blood cell sedimentation rate normal, White blood cell count normal
Clinical narrative: 6 days after vaccination, patient presented with macula popular rash. Fever developed day 7 and reached 103. Day 9 after vaccine rash was more involved on trunk and face. Day 10 rash was erythema multiforme with target and ursine. Fever gone Day 11. Rash resolved Day 13.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site bruising, Injection site rash, Pyrexia
Clinical narrative: Bruising at injection site. Rash on around injection site area. Fever on and off over next few days. Dizziness on 3rd/4th/6th day of vaccine. Still dizzy today 9/7/13.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching (nothing really extraordinary).
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Amniotic cavity infection, Exposure during pregnancy, Portopulmonary hypertension
Clinical narrative: Initial pregnancy report received from a health care professional on 17 October 2012. A 31-year-old female patient, whose concomitant medications and medical history were not reported, had received an intramuscular first dose of ADACEL vaccine (lot number: U3957DA) on 17 October 2012. The patient was pregnant at the time of vaccination. The patient's last menstrual period (LMP) date was 31 March 2012 and Expected date of delivery is (EDD) 10 January 2013. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the patient's outcome was unknown. Follow-up information was received from a health care professional on 03 September 2013. Based upon new information received, this case now meets seriousness criteria and it has been upgraded to serious (chorioamnionitis). Relevant illness during pregnancy/ongoing was reported as chorioamnionitis and PP HTN. In addition to ADACEL, the patient also received AFLURIA concomitantly (lot number, route, site and date of administration not reported). Maternal history noted one previous pregnancy with a normal outcome. On 03 January 2013, the subject delivered a normal infant. Outcome for the mother was not reported. Documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 8/28/2013 Moderate Other. Patient has had increased cases of shingles since receiving vaccine (3 outbreaks in the last year). He has also had shingles lesions in 2 new locations since receiving the vaccine.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Amniotic cavity infection, Exposure during pregnancy, Loop electrosurgical excision procedure, Premature labour
Clinical narrative: Initial pregnancy report received from a healthcare professional on 17 October 2012. A 38-year-old female patient, whose medical history and concomitant medications were not reported, had received a first dose of ADACEL vaccine (Lot number: U4421AA, anatomical site of vaccination was not reported) intramuscularly on 16 October 2012. The patient was pregnant during vaccination. The patient's last menstrual period was on 10 April 2012. The patient's estimated date of delivery is 15 January 2013. As of 17 October 2012, the patient had not experienced any adverse events. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 17 October 2012, the patient's outcome was unknown. Follow-up information was received on 03 September 2013 from a health care professional. The patient's last menstrual period was reported as 20 April 2012. Relevant illness during pregnancy/ongoing included chorioamnionitis, PTL (premature labor) and LEEP (Loop electrosurgical excision procedure). Medication use during pregnancy included Tdap, Flu vaccine and terbutaline. According to the reporter, the patient had no adverse events following vaccination. The patient had 2 pregnancies. The end of pregnancy was reported as 04 January 2013 and the infant outcome was normal. List of documents held by the sender none.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Athetosis
Clinical narrative: Vaccines given on 7-26-13. Athetotic type motion in his lower extremities x 2 days. No treatment. Mother notified MD of this symptom on 9/3/13.
Age: 1.04
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Vaccination complication, Weight bearing difficulty
Clinical narrative: Patient started having fevers within 3 hours of receiving the vaccination. Even with 3 mg MOTRIN and TYLENOL intermittently he was still having fever highest of which was measured the next morning at 104. She was told to bring him to the ER for evaluation. They concurred adverse reaction to to vaccine and to continue MOTRIN and TYLENOL fevers continued for 4 days after and no weight bearing for 2 days after immunization.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Gestational diabetes, Macrosomia
Clinical narrative: Initial pregnancy report received from a healthcare professional on 19 November 2012. A female patient had received an intramuscular first dose of ADACEL in left deltoid (lot number U4421AA) on an unspecified date. The patient was pregnant. The last menstrual period date was 01 May 2012 and the estimated date of delivery was reported as 05 February 2013. As per reporter, the patient did not experience any adverse event. The patient's health during pregnancy and risk factors, medical history and concomitant medication were not reported. Follow-up information was received from a healthcare professional on 03 September 2013. Based on the new information, this case has been upgraded to serious. The patient was 31-years-old. The patient also received a dose of RHOGAM (manufacturer, lot number, route, site and date not reported). Her last menstrual period was 01 May 2012 and she had a history of 2 previous pregnancies. The patient experienced gestational diabetes mellitus (GDM) and macrosomia (dates not reported). End of pregnancy date was 05 February 2013. Birth outcome was a normal infant. Documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt contracted cellulitis 2 days after receiving ZOSTAVAX immunization. Received a course of cephalexin from MD to treat cellulitis infection.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right shoulder with approx 8 cm area of induration, swelling superficial area of swelling and redness, heat, tenderness. Ultram 50 mg 1 tablet PRN for severe pain. L injection site-no abnormality.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Right shoulder with approx 8 cm area of induration, swelling superficial area of swelling and redness, heat, tenderness. Ultram 50 mg 1 tablet PRN for severe pain. L injection site-no abnormality.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pain, Rash, Swelling
Clinical narrative: Rash, swelling, sore/pain, nausea, light headedness. Rash had spread from shoulder to elbow. Patient said Dr at Urgent Care told him to take BENADRYL and MOTRIN.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Disorientation, Dizziness, Influenza like illness, Nausea
Clinical narrative: No reaction at site but flu like symptoms no energy dizziness, fever, nausea, disorientation.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: No reaction at site but flu like symptoms no energy dizziness, fever, nausea, disorientation.
Age: 1.02
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: 2 days after vaccination fever 99.4 degrees F. Generalized macular rash. No anaphylaxis noted. Went to ER and was given oral TYLENOL and BENADRYL.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen and warm at site.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Bladder catheterisation, Hydronephrosis, Irritability, Ultrasound abdomen abnormal, Urine analysis normal
Clinical narrative: The patient had an abdominal ultrasound, which showed no evidence of intussusception but they did note that there was some hydronephrosis of her left kidney. The child has not had a previous history of UTI, but with discussion with mom she believes that this was noted in utero as well. We did send a urine. We had to wait some time for a bag urine had leaked, so she was actually catheterized., the urine was negative. Since her arrive to the emergency room, the patient was able to tolerate some P.O. and was resting comfortably. She had no further episodes of irritability. Is for the mom to go home with the infant and have her follow up on Tuesday with her primary doctor. She is to return sooner if there is any increasing abdominal pain, changes in the child's stool or not taking P.O. We did discuss that workup of the left hydronephrosis will need to be done as an outpatient. The etiology of this child's presentation is likely a viral syndrome, which I explained to the patients. But the plan is that they will follow up with her outpatient provider or sooner to the emergency room if there is changes in her clinical status.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: The patient had an abdominal ultrasound, which showed no evidence of intussusception but they did note that there was some hydronephrosis of her left kidney. The child has not had a previous history of UTI, but with discussion with mom she believes that this was noted in utero as well. We did send a urine. We had to wait some time for a bag urine had leaked, so she was actually catheterized., the urine was negative. Since her arrive to the emergency room, the patient was able to tolerate some P.O. and was resting comfortably. She had no further episodes of irritability. Is for the mom to go home with the infant and have her follow up on Tuesday with her primary doctor. She is to return sooner if there is any increasing abdominal pain, changes in the child's stool or not taking P.O. We did discuss that workup of the left hydronephrosis will need to be done as an outpatient. The etiology of this child's presentation is likely a viral syndrome, which I explained to the patients. But the plan is that they will follow up with her outpatient provider or sooner to the emergency room if there is changes in her clinical status.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin papilloma, Swelling
Clinical narrative: Red, swollen and very warm. We recommended Ice and BENADRYL. Follow up with Family Physician.
Age: 17.0
Sex: M
Vaccine: HPV4, MMR, MNQ, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pallor
Clinical narrative: Pt received MMR, varicella, MCV and finally HPV. When HPV was administered pt became pale, sweaty and light headed immediately. Pt was reclined w/ feet up and recovered within minutes. Pt kept in clinic 30 minutes then left w/ father.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called on 9/12/13 complaining of "sore arm" and inability to raise arm. Vaccine was given on 9/3/13. Patient said issue started morning of 9/4/13. Recommended patient seek medical treatment if she was in severe pain and unable to lift arm.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: PNEUMOVAX23 was administered in left shoulder. Pt reports no pain for first few hours but about 4 hours after administration pt started to feel feverish and injection site started to become sore. Pt reported fever of 101.3 and arm swollen around upper area where shot was given. Remained sore through the night and pt revisited pharmacy around 11:30AM following day of shot. Around injection site skin was pink and swollen and tender but other symptoms had subsided for patient.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Raised welt at injection site, redness that spread around site. Reaction within <5 mins of injection. Provider notified. .4mL BENADRYL PO given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient had redness measuring 2.5 in x 3 in. on left deltoid. Area is warm to touch with burning sensation. No itching. No fever. No other symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation
Clinical narrative: This spontaneous report as received from a Healthcare Student refers to a patient of unknown age. On an unknown date the patient was vaccinated SC in the left deltoid with a 0.65 ml dose of ZOSTAVAX (start date and indication not reported). On an unknown date the patient experienced a sensation of burning on the left side of the body within three minutes of receiving ZOSTAVAX in the left deltoid, and the patient did progress to develop vesicles on the left-side of the face and body. The healthcare student reported that she had already reported this AE to VAERS, and she stated that since this AE occurred "a while ago", the vesicles have already resolved. Varicella Zoster Virus Identification Program (VZIP) discussed, but since the patient's vesicles have healed, the healthcare student declined the packet. No PQC identified. Then is was clarified that the vesicles developed "within 3-5 days" of the receipt of the dose of ZOSTAVAX. On an unspecified date, the patient recovered from the events.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: 1820 on 9/4 N/V x1 advised of worse or not better to seek medical attention. 0914 on 9/5 injection site red/swollen 2cm, Abd pain, N and fever. Patient evaluated by Dr., discharged - possible allergic Rx to shot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: 1820 on 9/4 N/V x1 advised of worse or not better to seek medical attention. 0914 on 9/5 injection site red/swollen 2cm, Abd pain, N and fever. Patient evaluated by Dr., discharged - possible allergic Rx to shot.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients. On an unknown date, the unspecified number of patients were vaccinated with liquid PEDVAXHIB (lot #, dose, route not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Arm red, hot, swollen from shoulder to elbow... Referred patient to family DR.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On an unknown date, the unspecified number of patients were vaccinated with RECOMBIVAX HB (lot #, dose, route not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received from a physician who refers to a female patient in her mid-70's. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, and lot# not reported). The physician reported that on an unknown date the patient ended up with a light rash and then full blown shingles pain and then post herpetic neuralgia (PHN) lingering after. The patient sought medical attention. The patient received LYRICA for adverse events treatment. None lab diagnostic tests were performed. At the time of the report patient's medical status was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who refers to a female patient of unknown age. It was reported that on 05-SEP-2013 the patient was vaccinated intramuscular with a second 0.5 ml dose of GARDASIL (lot number was not reported), four year after she received her first dose of GARDASIL (lot number, route and dose not reported) on an unknown date in September 2009 (four years ago). No adverse effects reported. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: Patient reports headache, nausea, and body aches starting the day of vaccine administration and continuing to day of report (9/12/13).
Age: 25.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Herpes virus infection, Oral herpes, Simplex virus test positive
Clinical narrative: Facial Herpes Breakout in multiple spots. Patient has tested positive for herpes simplex type 1 and has experienced mild outbreaks (cold sores) around 1-2 times/year. Reports possible facial herpes outbreaks when young (4-7) however is unsure.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Urine analysis normal
Clinical narrative: Seizures for approximately 5 hours. Treated with Tylenol and Ativan to stop seizures and tested for all possible causes, perfectly healthy and proved that seizures were caused by vaccines.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, MNQ, PNC, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MCV4 was given to child at 1 year 1 day.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 24-JUN-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown). The patient developed shingles on their back and head at an unspecified time. On 21-AUG-2013, the patient went to an Immediate Care Center. The patient saw a doctor at the center who prescribed valacyclovir hydrochloride. Pharmacist stated the patient's "condition was good". The outcome of event was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth to arm where injection was administered.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Chills, redness, swelling and itching at the site of injection.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 03-SEP-2013 the patient who was a hospital employee was inadvertently vaccinated with a 0.5 ml dose of  M-M-R II (lot # 1251AA, expiration 01-AUG-2013), subcutaneously that had expired on 01-AUG-2013. No adverse effects reported. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal distension, Barium enema, Crying, Intussusception, Pain
Clinical narrative: Presented to the ER on 8/14/13 with symptoms of bloating and crying/pain - diagnosed with intussusception. Treatment included a barium enema - resolved, and had f/u with Gen. Surgery on 8/29/13.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Presented to the ER on 8/14/13 with symptoms of bloating and crying/pain - diagnosed with intussusception. Treatment included a barium enema - resolved, and had f/u with Gen. Surgery on 8/29/13.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Failure to thrive, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of antigenemia in a currently 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Hepatitis B vaccine. Concurrent vaccination included haemophilus influenzae type b vaccine (non-gsk); Merck; unknown; unknown given on 5 September 2013; live attenuated human rotavirus vaccine; GlaxoSmithKline; unknown given on 5 September 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 5 September 2013. Concurrent medications included TRI-VI-SOL. On 5 September 2013 the subject received a dose of PEDIARIX (unknown details). On 5 July 2013 the subject received a dose of Hepatitis B vaccine (unknown details). In 2013, at an unknown time after vaccination with Hepatitis B vaccine, the subject experienced failure to thrive. On 7 September 2013, 2 days after vaccination with PEDIARIX, 64 days after vaccination with Hepatitis B vaccine, the subject experienced antigenemia. In 2013, the subject was hospitalised after administration of hepatitis B vaccine and before administration of PEDIARIX. Relevant test results included hepatitis B surface antigen test positive on 7 September 2013. At the time of reporting the outcome of the events were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 04-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J003483 and 29-JUN-2014 respectively), subcutaneously which was placed in the 32 degrees Fahrenheit (F) conditions since 31-AUG-2013 for 14 days which could not be supported. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Heat and erythema in area that PNEUMOVAX was administered. Swelling and pruritis also noted within 5 hours of administration. Pt treated with ZYRTEC and advised to return if symptoms continue or become worse.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling to (R) upper arm. Patient treated w/ ROCEPHIN per PAC.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a male patient of unknown age. On 01-AUG-2012, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly and would be administered with the second dose of GARDASIL vaccination series today (10-SEP-2013). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 68 year old female patient. Concurrent condition included high blood pressure. On 06-SEP-2013 the patient was vaccinated with ZOSTAVAX. Lot number, dose, route and frequency were not provided. Concomitant therapies included LIPITOR, NORVASC and DIOVAN for an unknown indication. On 10-SEP-2013, the patient experienced swelling around the injection site and redness around the injection site. No treatment was given. The outcome of swelling a round the injection site and redness around the injection site was reported as recovering/resolving. The reporter causality was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a CMA (certified medical assistant) refers to a patient of unknown age and gender (no demographic details were provided). The patient's medical history was unknown. On 28-JUL-2012, 28-FEB-2013 and 28-MAR-2013, the patient was vaccinated with GARDASIL, 0.5 ml. GARDASIL was administered subcutaneously. The administration of GARDASIL on 28-MAR-2013 was a medication error. No adverse effects were reported. 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 pharmacist refers to a patient of unknown age and gender. On 27-AUG-2013 the patient was vaccinated subcutaneous with an expired 0.65 ml dose of ZOSTAVAX lot # 672428/1599AA (exp. date 13-JAN-2013), subcutaneous. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 13 month old patient(gender unknown). On an unknown date, the pediatric patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported) instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Fall, Head injury, Syncope
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 year old female patient. Patient had no drug reaction reported. On 05-SEP-2013 the patient was vaccinated with a dose 1 of GARDASIL (lot # J005679, expiry: 27-NOV-2015). On 05-SEP-2013, the patient experienced syncopal episode after receiving the first dose in the GARDASIL series. The patient was instructed to stay seated in the examination room for 15 minutes after she received the GARDASIL dose. The patient did not follow the instructions and upon trying to exit the room, experienced a syncopal episode and fell to the floor hitting her head on the floor. The patient was sent to the emergency room to have a CAT scan of her head on 05-SEP-2013. The medical assistant was unsure of the results of the CAT scan or if the patient was admitted. The medical assistant believed that the patient had the emergency room visit and returned home on the same day. The outcome of syncopal episode was reported as recovered (September 2013). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Head injury, Loss of consciousness, Presyncope
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 year old female patient. Patient had no drug reaction reported. On 05-SEP-2013 the patient was vaccinated with a dose 1 of GARDASIL (lot # J005679, expiry: 27-NOV-2015). On 05-SEP-2013, the patient experienced syncopal episode after receiving the first dose in the GARDASIL series. The patient was instructed to stay seated in the examination room for 15 minutes after she received the GARDASIL dose. The patient did not follow the instructions and upon trying to exit the room, experienced a syncopal episode and fell to the floor hitting her head on the floor. The patient was sent to the emergency room to have a CAT scan of her head on 05-SEP-2013. The medical assistant was unsure of the results of the CAT scan or if the patient was admitted. The medical assistant believed that the patient had the emergency room visit and returned home on the same day. The outcome of syncopal episode was reported as recovered (September 2013). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Wrong Vaccine Given. #3 Hep-B instead of the order for Hep-A/B combo (Twinrix). Pt was called requested to return for #3 Hep-A to complete the series. Pt was happy to return.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Wrong Vaccine Given. #3 Hep-B instead of the order for Hep-A/B combo (Twinrix). Pt was called requested to return for #3 Hep-A to complete the series. Pt was happy to return.
Age: 1.51
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Site area was very red and slightly bruised as well as very hot when touched. By the next day the redness subsided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came to pharmacy 5 days after immunization, she presented with a red mark with swelling at the site of injection. When I spoke with patient today, she stated that the doctor told her to apply ice to the spot. She stated that she is doing fine and the swelling and red mark is almost gone.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema abnormal, Enema administration, Intussusception
Clinical narrative: Intussusception; got diagnostic/therapeutic barium enema in emergency department.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction oval raise red area.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around injection site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia, Feeling hot, Flushing, Paraesthesia, Throat irritation
Clinical narrative: Weird, indescribable taste in mouth initially and resolved after 10 minutes, feeling hot, facial flushing, scratchy tingling throat, BP 205/98, HR 70, R 20.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray, Crying, Laboratory test, Lumbar puncture, Mobility decreased
Clinical narrative: Patient could not sit up like she once could. Then around 630 PM patient could not bare weight on her legs and then could not move her legs at all. She was continuously crying.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Posture abnormal, Scan with contrast, Weight bearing difficulty
Clinical narrative: Patient could not sit up like she once could. Then around 630 PM patient could not bare weight on her legs and then could not move her legs at all. She was continuously crying.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Tenderness
Clinical narrative: Patient was giving High Dose flu shot but only 54 years old.  Was feeling "fine, just tender arm, took some tylenol".
Age: 0.77
Sex: F
Vaccine: DTAP
Symptoms: Crying, Glassy eyes, Inability to crawl, Insomnia
Clinical narrative: Glassy eyes, cried, won't sleep and won't crawl.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash generalised
Clinical narrative: Blistered rash on hands, wrists, knees, diaper line.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Influenza like illness, Nausea, Tenderness, Vomiting
Clinical narrative: Flu like symptoms (nausea, vomited) 9/3/13; left arm tenderness. Shortness of breath 9/5/13.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Pain in extremity
Clinical narrative: Patient called two days after flu shot complaining that her arm was sore. RPh told her to take Ibuprofen and ice area. Ptn went to Dr. later that day - Dr gave Rx for antibiotic and pain medication and told ptn she had a hematoma at injection site.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, abdominal pain.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Fatigue, Vaccination site pain
Clinical narrative: Patient complaint of excessive soreness on the site of vaccination that lasts for more than 5 days. Patient also complaint of longer than 4 days of dizziness and tiredness.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 9/8/13 - Pt came into phcy about 4:30 pm complaining of arm pain at injection site. Observed very red, 2-inch dia. red area at site. 9/11/13 - Pt stated she visited MD on 9/10 and MD said it would heal on its own without treatment.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot and painful to touch to left deltoid which has migrated into the elbow (swelling).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Nasopharyngitis
Clinical narrative: 9/8/13 Patient contacted phcy by phone about 11:00 am. Stated that she woke up 9/7/13 with cold symptoms and stated her arm was very sore and red at the injection site.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Rash and vomiting (+) low grade fever beginning hrs after injection.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Patient called pharmacy on 9/12/13 to report painful and swollen lymph node around arm where she received her flu shot on 9/7/13. Patient was called later in day and she was improving but still swollen nodes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: 9/5/13 - Mom called to report Sx began about 12:00p, 8/31/13. Red, itchy spots, quarter-sized, bilateral lateral thighs. 9:00pm, left lateral thigh had 4-5" of red splotches around injection site, center was raised slightly and hot. Mom administered BENADRYL oral susp. and cream daily, gradual decrease in Sx. Today, 9/11/13, very small pea-sized hardness noted by mom. No itch, pain, redness or swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash macular, Rash pruritic
Clinical narrative: 9/5/13 - Mom called to report Sx began about 12:00p, 8/31/13. Red, itchy spots, quarter-sized, bilateral lateral thighs. 9:00pm, left lateral thigh had 4-5" of red splotches around injection site, center was raised slightly and hot. Mom administered BENADRYL oral susp. and cream daily, gradual decrease in Sx. Today, 9/11/13, very small pea-sized hardness noted by mom. No itch, pain, redness or swelling.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: Patient states nausea with vomiting initiated the evening of 9-9-13, the day of vaccination. On the night of 9-11-13 pt stated nausea with vomiting and fever "low grade" with chills and shaking. Pt had treated symptoms with Pepto Bismol and ibuprofen. Much better today but still with low fever and nausea. Pt still suffering nausea and low fever. No previous reaction to first HBV vaccine.
Age: 8.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: Pt received DTap LUE deltoid on 9/10. Pt seen 9/12 with 10.7 cm x 9.5 cm erythremia area at injection site. MTR informed to monitor for inc. in size or fever. Pt and mother informed to use/take Benadryl 25 mg once every 6 hours PRN. RTC if not better/improved.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: Dad called on 9/5/13 to inform us that he had taken child to the ER on 9/4/13 at 11:00 PM for a possible side effect to the IVP given on left arm on 9/3/13. Stated his son's physical symptoms were a large  red rash with hard area to left upper arm.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Pt presented to pharmacy 2 days after receiving vaccine complaining of severe pain at injection site. Upper arm was red, swollen and tender. Pt also complained of fatigue chills and flu like symptoms. Very similar to other pt vaccinated same day.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Pt presented to pharmacy 2 days after receiving vaccine complaining of severe pain at injection site. Upper arm was red, swollen and tender. Pt also complained of fatigue chills and flu like symptoms. Very similar to other pt vaccinated same day.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Erythema, Influenza like illness, Local swelling
Clinical narrative: Pt clamins to have fainted in shower morning after vaccination. Went to hospital feeling weak and flu like with chills. Pt was monitored and given fluids. Next day arm was red, painful and swollen. Pt could not lift arm laterally. (Similar to other pt. on same day)
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Syncope
Clinical narrative: Pt clamins to have fainted in shower morning after vaccination. Went to hospital feeling weak and flu like with chills. Pt was monitored and given fluids. Next day arm was red, painful and swollen. Pt could not lift arm laterally. (Similar to other pt. on same day)
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 week and 2 day old patient of unknown gender. On 29-AUG-2013 ("today") the patient was vaccinated with ROTATEQ (lot # H016251, expiration date 26-MAR-2014), (dose, frequency and route unspecified). No adverse effect reported. 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 healthcare worker refers to a patient of unknown age. On an unknown date (reported as about a year ago), the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On 11-JUL-2013, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). No adverse event reported was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 16 year old female patient. The patient had no pertinent medical history. On an unknown date in JUL-2013 (reported as 2 months ago) the patient was vaccinated with a first dose of 0.5ml GARDASIL (lot number, expiry date was not reported and route was intramuscular). On an unknown date in 2013 (reported as 2 weeks after first dose), the patient experienced hair loss which was progressively getting worse. There was no treatment rendered for the event. There was no lab diagnostics performed. The outcome of hair loss progressively getting worse was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Oxygen saturation decreased, Rash, Wheezing
Clinical narrative: Sudden onset symptoms: non stop cough with wheezing, oxygen level dropped to 92% (room air), rash on face, chest area and bilateral arms. Tx: 5mg PRELONE PO, 20mg BENADRYL (L) arm IM, 5mL albuterol sulfate via nebulizer.
Age: 2.0
Sex: F
Vaccine: FLU3, HIBV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician, the author of the literature report, concerning a 112 days infant, gender unknown. The infant was preterm baby and had low birth weight of <1000g. This was a progressive observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010, when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic, clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date, the infant was vaccinated despite being older than the recommended age limit at the time of discharge.  Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine, in additional 25% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated. This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to a patient of unknown age and gender. On 19-MAR-2013, VARIVAX (Merck) reconstituted with sterile diluent (lot # 6104Y) that expired on 20-FEB-2013. No adverse symptoms reported. The vaccine VARIVAX (Merck) was not expired, only the sterile diluent was expired. Related adverse events fields are reported on the cases 1308USA014141 and 130USA014146. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. It was reported that on an unknown date, the patient may have received a dose of RECOMBIVAX HB (manufacturer unknown) (lot number, expiry date, dose and route unspecified). It was unclear if the patient received the vaccine. No concomitant therapy was reported. On an unknown date, the patient failed to seroconvert. The outcome of the event was unknown. The relatedness for the event was unknown for RECOMBIVAX HB (manufacturer unknown). Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information has been received from a physician, the author of the literature report, concerning a 110 days infant, gender unknown. The infant was a preterm baby and had low birth weight between 1001-1500g. This was a prospective observational cohort study in all VLBW infants who were discharged from the NICU from May 1, 2008 to April 22, 2010, when rotavirus vaccination (manufacturer unknown) with RV5 was provided at discharge to all age-eligible infants. The medical records of the infants were reviewed, and pertinent demographic , clinical, and laboratory data were recorded. The number of infants who received the rotavirus vaccine, the number of missed opportunities for vaccination, and the number of infants falling outside the recommended time period for vaccination were recorded and analyzed. There were no complications noted on follow-up. On an unknown date, the infant ws vaccinated despite being older than the recommended age limit at the time of discharge. Rotavirus vaccination (manufacturer unknown) is recommended for use in preterm infants at the time of discharge from the NICU as long as they are clinically stable and have an age range of 42 to 104 days V.10. Our study highlights the limitations of the currently recommended schedule for rotavirus vaccination, because 22% of all VLBW infants were too old at discharge to receive the vaccine, in addition, 52% of all ELBW infants discharged from the NICU were older than 104 days and also were not vaccinated.  This is one of four reports received from the same source. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Muscle spasms, Myalgia, Thyroid disorder
Clinical narrative: Patient received influenza vaccination on 10/31/12 in the left arm. Product was from Novartis, Lot #123203 (exp 6/2013). Patient developed myalgia, weakness and musculature cramping shortly after receiving the vaccination. He was not taking any other medications or received any other vaccinations other than annual influenza vaccination. The symptoms progressed over two week period after vaccination. These symptoms persist and only slightly improved after receiving a course of high dose prednisone prescribed by his local MD. Unfortunately the symptoms returned shortly after stopping the prednisone treatment. The local MD also determined slight thyroid dysfunction and synthroid supplementation was initiated. Myalgia and weakness have improved some but still persist.