chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV, RV5, DTAPH, HEP, IPV, RV5, DTAP, HEP, HIBV, IPV, RV5
Symptoms: Bronchospasm, Respiratory syncytial virus bronchiolitis
Clinical narrative: Information has been received from a literature article via Sanofi Pasteur. This case is about a patient of an unknown age and gender with DiGeorge Syndrome (DGS) who on an unspecified date, was vaccinated with rotavirus vaccine (manufacturer unknown) (dose, lot and route of administration not reported), hepatitis B vaccine (manufacturer unknown) (dose, lot and route of administration not reported), IPV, DTaP and Hib conj vaccine. After vaccination the patient experienced respiratory syncytial virus (RSV) bronchiolitis and bronchospasm and was hospitalized. The outcome for the events was not reported. The study included 194 individuals. The mean observation period was 8.3 years; subjects ranged in age between 0 and 31.5 years. All underwent fluorescencein situ hybridization (FISH) diagnostic confirmation, most (n = 120/194) before 1 year of age. Most (n = 121/194) had hemodynamically significant cardiac disease and underwent cardiac surgery. Many exhibited lymphocyte subsets below or in the low-normal range for healthy individuals. One-third of subjects with available CD4% results (n = 41/121) had evidence of immunosuppression (CD4% <25%); the proportion who were immunosuppressed did not differ based on timing of FISH confirmation. Among the 5% (n = 6/121) with documented severe immunosuppression (CD4% <15%), total lymphocyte counts ranged from low (n = 1) to normal (n = 3), CD3/CD3% ranged from low (n = 4) to normal (n = 1), and CDS/CDS% ranged from low (n = 5) to normal (n = 1). All subjects received at least 1 vaccine, 90% received at 1 live vaccine, and 58% completed the 4:3:1:3:31 vaccination series by 19 to 35 months. Differences in vaccination coverage and/or timelines were noted between select live and inactivated vaccines. Only 157 received IPV. All-IPV vaccination schedule was recommended (January 2000) received 3 IPV doses by that time (P <.01). One-quarter (27%) received a live vaccine before FISH confirmation (among those for whom FISH testing was available at birth, n = 160). Only 2 cases occurred before 1 year of age: 1 received rotavirus vaccine. Forty-four of 175 live-vaccine recipients experienced an Adverse Event Following Live Immunization (AEFLI). There were 91 events, resulting in 6 hospitalizations. All hospitalizations were secondary to respiratory illness. By using causality assessment tools, CISA investigators found sufficient evidence to support a causal relationship between live vaccinations. The 91 events occurred after 5% of rotavirus doses. Receipt of multiple vaccines preceding an event was common (30% received >1 live vaccine; 66% also received an inactivated vaccine). AEFLIs were detected in 43 of 114 individuals (442 live-vaccine doses) at sites using the comprehensive abstraction procedure and in 1 of 80 subjects (198 live-vaccine doses) at sites using the targeted approach (P <001) ED visits and hospitalizations were detected only at sites using the comprehensive approach. Additional information has been requested.
Age: 0.0
Sex: U
Vaccine: FLU3
Symptoms: Foetal exposure during pregnancy, Ventricular septal defect
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 24-Apr-2014), concerns a neonate patient. The patient received concomitant medications in-utero from the mother. The mother's concomitant medications included prenatal vitamins (commenced in 2009), folic acid, calcium citrate, magnesium, ergocalciferol, omega 3 fatty acids, herbal remedies (for "ATW"), etanercept (for rheumatoid arthritis started in 2009), prednisone (for rheumatoid arthritis), methylprednisolone (for rheumatoid arthritis), progesterone (for in-vitro fertilization), estradiol valerate (for in-vitro fertilization), estradiol (for in-vitro fertilization), leuprorelin acetate (for in-vitro fertilization), TYLENOL (for rheumatoid arthritis pain), TUMS (for heartburns), azithromycin (for cough/cold), ibuprofen (for pain), baby acetylsalicyclic acid (for in-vitro fertilization protocol), omeprazole (for acid reflux), glibenclamide (for gestational diabetes), infliximab (for rheumatoid arthritis), iron (for anemia), DTaP (for babies' lungs). The patient's mother had a medical history of anemia (diagnosed in 2003), rheumatoid arthritis (diagnosed in 1989), infertility with diminished ovarian function (diagnosed in 2010), fevers (on 01-Aug-2013 and two times from 15-Sep-2013 to 01-Nov-2013), respiratory infections (15-Sep-2013 to 01-Nov-2013), heartburns, gestational diabetes and ovarian cysts (diagnosed in 2000). The estimated date of conception was 10-Jul-2013 and estimated date of delivery was 02-Apr-2014. The mother underwent ultrasounds on 13-Aug-2013, 18-Sep-2013, 06-Sep-2013 (which showed subchorionic hematoma), 21-Oct-2013, 05-Nov-2013 (which showed possible club foot in one twin), 31-Jan-2014 and 05-Mar-2014 and also underwent first trimester serum screen on 18-Sep-2013 and alfa-fetoprotein test on 05-Nov-2013. She also underwent non-stress/stress test on 10-Jan-2014 and 05-Feb-2014. On 24-Oct-2013, the patient received AFLURIA vaccine (batch number not provided) from the mother in-utero who received the 1 shot 1 day dose of AFLURIA. On 05-Mar-2014, the mother gave birth to twins at a gestational age of 36 weeks. Twin A was healthy without malformation while twin B (also the patient) was born with congenital anomaly. The patient's weight at the time of birth was 1816 grams with Apgars at 1 min and 5 mins as 9. On 05-Mar-2014, the patient was diagnosed with a ventricular septal defect. The medical record confirmation was pending. Outcome was not reported.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a non pregnant 22 years old female patient. On 25-APR-2014 the patient was accidentally vaccinated with a dose of ZOSTAVAX (subcutaneous, dose 0.5ml, lot # J007209, expiry date 20-SEP-2014) instead of VARIVAX (Merck). Concomitant therapies included YAZ and clindamycin. No adverse effect reported. There was no treatment given for the events. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain
Clinical narrative: ADVERSE EVENT REPORTED ON 4/29/14. PATIENT COMPLAINED OF PAIN/SORENESS AT INJECTION SITE EVER SINCE RECEIVING INJECTION 6 MONTHS PRIOR.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Dizziness, Exposure during pregnancy, Fatigue, Foetal disorder
Clinical narrative: This spontaneous retrospective pregnancy report as received from a consumer (patient's husband) refers to a 30 year old female patient with no medical history or concurrent conditions reported. On 14-MAR-2014 the patient was given a urine pregnancy test which came out negative for pregnancy. The patient's husband reported that his wife was send to health department on 14-MAR-2014 to be given M-M-R II vaccine. Before the vaccine was given, the female was given a urine pregnancy test. The husband protested, stating that urine pregnancy tests are not 100% accurate. Both the husband and the patient were reassured that the test was accurate. On 14-MAR-2014 the patient was vaccinated with unspecified dose of M-M-R II (dose number, frequency and lot number not reported). Concomitant medications were not reported. The date of conception was approximately on 14-FEB-2014. On 16-MAR-2014 the patient started throwing up and feeling dizzy, was taken to her primary care physician's (PCP) office and a serum pregnancy test was done which was positive for pregnancy. It was reported that it was determined that the patient was a month and a half pregnant (approximately 6 weeks) at the time of vaccination on 14-MAR-2014. The patient became pregnant with Last Menstrual Period (LMP) of 31-JAN-2014 and Estimated Delivery Date (EDD) of 07-NOV-2014. On 26-APR-2014 the patient was at hospital where she was undergoing sonogram which showed that the fetus had not grown anymore and was dead. It was not known if any additional laboratory work was done confirming this. The reporter stated that the nurse gave them info to return to emergency room if the patient starts experiencing any bleeding or fever. The reporter stated that his wife was at home and is feeling tired and experienced pains in her stomach. The reporter stated as of 27-APR-2014, his wife has not started passing the products of conception. The outcomes of feeling tired, started throwing up, feeling dizzy and pains in her stomach were unknown. The relatedness between the events and M-M-R II was not reported. The reporter considered fetus had not grown anymore and was dead to be medically significant. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Pregnancy test positive, Pregnancy test urine negative, Ultrasound antenatal screen abnormal, Vomiting
Clinical narrative: This spontaneous retrospective pregnancy report as received from a consumer (patient's husband) refers to a 30 year old female patient with no medical history or concurrent conditions reported. On 14-MAR-2014 the patient was given a urine pregnancy test which came out negative for pregnancy. The patient's husband reported that his wife was send to health department on 14-MAR-2014 to be given M-M-R II vaccine. Before the vaccine was given, the female was given a urine pregnancy test. The husband protested, stating that urine pregnancy tests are not 100% accurate. Both the husband and the patient were reassured that the test was accurate. On 14-MAR-2014 the patient was vaccinated with unspecified dose of M-M-R II (dose number, frequency and lot number not reported). Concomitant medications were not reported. The date of conception was approximately on 14-FEB-2014. On 16-MAR-2014 the patient started throwing up and feeling dizzy, was taken to her primary care physician's (PCP) office and a serum pregnancy test was done which was positive for pregnancy. It was reported that it was determined that the patient was a month and a half pregnant (approximately 6 weeks) at the time of vaccination on 14-MAR-2014. The patient became pregnant with Last Menstrual Period (LMP) of 31-JAN-2014 and Estimated Delivery Date (EDD) of 07-NOV-2014. On 26-APR-2014 the patient was at hospital where she was undergoing sonogram which showed that the fetus had not grown anymore and was dead. It was not known if any additional laboratory work was done confirming this. The reporter stated that the nurse gave them info to return to emergency room if the patient starts experiencing any bleeding or fever. The reporter stated that his wife was at home and is feeling tired and experienced pains in her stomach. The reporter stated as of 27-APR-2014, his wife has not started passing the products of conception. The outcomes of feeling tired, started throwing up, feeling dizzy and pains in her stomach were unknown. The relatedness between the events and M-M-R II was not reported. The reporter considered fetus had not grown anymore and was dead to be medically significant. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: DTP
Symptoms: Allergy to vaccine, Dizziness, Nausea, Swelling, Vision blurred
Clinical narrative: Dizziness, blurred vision, swelling, nausea and vomiting.
Age: 52.0
Sex: F
Vaccine: DTP
Symptoms: Vomiting
Clinical narrative: Dizziness, blurred vision, swelling, nausea and vomiting.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eyelid oedema, Eyelids pruritus, Hypersensitivity, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Vaccine administered by school RN at school.  Tdap and MCV4 IM in Right Deltoid on a Friday afternoon.  On Monday morning, student came to school health office and showed reaction on arm.  Student stated it occurred Friday night and there had been no change over the weekend (not worse or better.)  Denied fever.  Swollen reddened area around site of injection, ~5X5 area.  Spoke with mother and gave ibuprofen and iced twice during day.  Area around injection less swollen and less red and decreased in size.  At 2 pm on Monday, student returned and showed me a new area of redness and swelling on top of right shoulder.  Redness did not connect to original reaction site.  Two white raised areas in middle of reddened circle, ~3x3 in size.  Appeared allergic.  Also eyelids swollen and itchy.  Spoke with mom and gave Benadryl.  Mom took to urgent care that afternoon and was told by doctor that reaction was too long from immunization administration to be related.  Given antibiotic for phlebitis at injection site.  Allergic area on shoulder and eyes resolved after Benadryl administration and did not return.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site phlebitis, Injection site swelling
Clinical narrative: Vaccine administered by school RN at school.  Tdap and MCV4 IM in Right Deltoid on a Friday afternoon.  On Monday morning, student came to school health office and showed reaction on arm.  Student stated it occurred Friday night and there had been no change over the weekend (not worse or better.)  Denied fever.  Swollen reddened area around site of injection, ~5X5 area.  Spoke with mother and gave ibuprofen and iced twice during day.  Area around injection less swollen and less red and decreased in size.  At 2 pm on Monday, student returned and showed me a new area of redness and swelling on top of right shoulder.  Redness did not connect to original reaction site.  Two white raised areas in middle of reddened circle, ~3x3 in size.  Appeared allergic.  Also eyelids swollen and itchy.  Spoke with mom and gave Benadryl.  Mom took to urgent care that afternoon and was told by doctor that reaction was too long from immunization administration to be related.  Given antibiotic for phlebitis at injection site.  Allergic area on shoulder and eyes resolved after Benadryl administration and did not return.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer, the husband of the patient, refers to a 61 year old female patient. On 16-APR-2014 the patient was vaccinated with ZOSTAVAX (dose and lot number were not provided), subcutaneous. Concomitant therapies included lisinopril (manufacturer unknown), simvastatin (manufacturer unknown) and aspirin (manufacturer unknown). On 20-APR-2014 the patient experienced shingles on her lower abdomen. The patient visited her physician. The patient was treated with acyclovir. The outcome of shingles on her lower abdomen was reported as not recovered/not resolved. Action taken relatedness were not provided. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 24-APR-2014 the patient was vaccinated orally with ROTATEQ (lot# reported as H020311) 2 ml expired on 16-APR-2014. No adverse effects. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Red rash approx 3-4 in in diameter just below the injection point (on thigh)... raised and warm to the touch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema at injection site measured 10 cm x 12 cm; tender with mild warmth.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Pallor
Clinical narrative: Within minutes of receiving vaccines pt developed a very pronounced rash from thighs where injections were given down to ankles. Rash was blanchable, red to purple in color, some raised bumps, some flat. Covering entire legs. Resolved on own over about 6 hours.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Chest X-ray normal, Cough, Decreased appetite, Influenza, Influenza A virus test positive
Clinical narrative: Based on additional information received on 24 April 2014, this case initially considered as non-serious was upgraded to serious: confirmed influenza virus infection. Initial report received from healthcare professional on 14 February 2014. A '07-month-old female patient whose medical history and concomitant medication were not reported. The patient had received dose of FLUZONE and the patient had unevaluable event and was tested for type A after administration of vaccine on an unknown date. The laboratory details and corrective treatment were not reported. The outcome of the event was unknown and required emergency room/ doctor visit at the time of report. Follow-up information was received from the healthcare professional on 24 April 2014. The patient received the following vaccines on 28 January 2014: a first intramuscular right thigh injection of FLUZONE (lot number UH906AD); a third intramuscular left thigh injection of PENTACEL (lot number C4560AA); a third intramuscular right thigh injection of ENGERIX (GlaxoSmithKline, lot number AHBVC190BA); a third intramuscular right thigh injection of PREVNAR (Wyeth, lot number G95397); and a third oral dose of Rotavirus vaccine (Merck, lot number J008385). Per the office note, the patient needed an influenza booster vaccine, to be scheduled in one month. On 13 February 2014, i.e. 13 days post-vaccination, the patient presented to the emergency room with complaints of fever, cough, sneezing, fussiness, and poor appetite for several days prior to the visit.  Symptoms were worse at night.  Parents denied vomiting, diarrhea, rash, or pulling at ears; the patient had no known sick contacts. Physical exam revealed the following: temperature 101.3, heart rate 165, respiratory rate 32, pulse oximetry 98%.  Left tympanic membrane was erythematous and bulging. No rales, wheezes, or rhonchi were noted on auscultation, and mucous membranes were moist. Laboratory testing showed  influenza virus type A (H1N1 and PCR) to be positive.  Respiratory Syncytial Virus antibodies were negative, Influenza Virus type B (PCR) was negative, and chest x-ray was within normal limits. The patient was diagnosed with influenza and prescribed Tamiflu for 5 days. The event subsequently resolved on an unspecified date. Of note, the patient had a history of seborrhea, with no illness at time of vaccination and no concomitant medications. At the time of her office visit on 28 January 2014 she weighed 16.72 pounds and was 26 inches long. Birth weight was 7 pounds. List of documents held by sender: Office note, ER note.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Influenza B virus test, Irritability, Polymerase chain reaction, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Based on additional information received on 24 April 2014, this case initially considered as non-serious was upgraded to serious: confirmed influenza virus infection. Initial report received from healthcare professional on 14 February 2014. A '07-month-old female patient whose medical history and concomitant medication were not reported. The patient had received dose of FLUZONE and the patient had unevaluable event and was tested for type A after administration of vaccine on an unknown date. The laboratory details and corrective treatment were not reported. The outcome of the event was unknown and required emergency room/ doctor visit at the time of report. Follow-up information was received from the healthcare professional on 24 April 2014. The patient received the following vaccines on 28 January 2014: a first intramuscular right thigh injection of FLUZONE (lot number UH906AD); a third intramuscular left thigh injection of PENTACEL (lot number C4560AA); a third intramuscular right thigh injection of ENGERIX (GlaxoSmithKline, lot number AHBVC190BA); a third intramuscular right thigh injection of PREVNAR (Wyeth, lot number G95397); and a third oral dose of Rotavirus vaccine (Merck, lot number J008385). Per the office note, the patient needed an influenza booster vaccine, to be scheduled in one month. On 13 February 2014, i.e. 13 days post-vaccination, the patient presented to the emergency room with complaints of fever, cough, sneezing, fussiness, and poor appetite for several days prior to the visit.  Symptoms were worse at night.  Parents denied vomiting, diarrhea, rash, or pulling at ears; the patient had no known sick contacts. Physical exam revealed the following: temperature 101.3, heart rate 165, respiratory rate 32, pulse oximetry 98%.  Left tympanic membrane was erythematous and bulging. No rales, wheezes, or rhonchi were noted on auscultation, and mucous membranes were moist. Laboratory testing showed  influenza virus type A (H1N1 and PCR) to be positive.  Respiratory Syncytial Virus antibodies were negative, Influenza Virus type B (PCR) was negative, and chest x-ray was within normal limits. The patient was diagnosed with influenza and prescribed Tamiflu for 5 days. The event subsequently resolved on an unspecified date. Of note, the patient had a history of seborrhea, with no illness at time of vaccination and no concomitant medications. At the time of her office visit on 28 January 2014 she weighed 16.72 pounds and was 26 inches long. Birth weight was 7 pounds. List of documents held by sender: Office note, ER note.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Sneezing, Tympanic membrane disorder, Tympanic membrane hyperaemia
Clinical narrative: Based on additional information received on 24 April 2014, this case initially considered as non-serious was upgraded to serious: confirmed influenza virus infection. Initial report received from healthcare professional on 14 February 2014. A '07-month-old female patient whose medical history and concomitant medication were not reported. The patient had received dose of FLUZONE and the patient had unevaluable event and was tested for type A after administration of vaccine on an unknown date. The laboratory details and corrective treatment were not reported. The outcome of the event was unknown and required emergency room/ doctor visit at the time of report. Follow-up information was received from the healthcare professional on 24 April 2014. The patient received the following vaccines on 28 January 2014: a first intramuscular right thigh injection of FLUZONE (lot number UH906AD); a third intramuscular left thigh injection of PENTACEL (lot number C4560AA); a third intramuscular right thigh injection of ENGERIX (GlaxoSmithKline, lot number AHBVC190BA); a third intramuscular right thigh injection of PREVNAR (Wyeth, lot number G95397); and a third oral dose of Rotavirus vaccine (Merck, lot number J008385). Per the office note, the patient needed an influenza booster vaccine, to be scheduled in one month. On 13 February 2014, i.e. 13 days post-vaccination, the patient presented to the emergency room with complaints of fever, cough, sneezing, fussiness, and poor appetite for several days prior to the visit.  Symptoms were worse at night.  Parents denied vomiting, diarrhea, rash, or pulling at ears; the patient had no known sick contacts. Physical exam revealed the following: temperature 101.3, heart rate 165, respiratory rate 32, pulse oximetry 98%.  Left tympanic membrane was erythematous and bulging. No rales, wheezes, or rhonchi were noted on auscultation, and mucous membranes were moist. Laboratory testing showed  influenza virus type A (H1N1 and PCR) to be positive.  Respiratory Syncytial Virus antibodies were negative, Influenza Virus type B (PCR) was negative, and chest x-ray was within normal limits. The patient was diagnosed with influenza and prescribed Tamiflu for 5 days. The event subsequently resolved on an unspecified date. Of note, the patient had a history of seborrhea, with no illness at time of vaccination and no concomitant medications. At the time of her office visit on 28 January 2014 she weighed 16.72 pounds and was 26 inches long. Birth weight was 7 pounds. List of documents held by sender: Office note, ER note.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Gait disturbance, Skin warm, Tenderness
Clinical narrative: Patient had large skin/soft tissue reaction. Area was 8.2 cm x 7.6 cm with a central darker red, tender hot area of 4.0 cm x 3.5 cm caused her to limp. No fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Vaccination complication
Clinical narrative: (R) deltoid area warm to touch, swollen denies pain.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Fatigue, Headache, Nausea, Syncope, Vomiting
Clinical narrative: Nausea, vomiting, syncope, fatigue, headaches 12/2012 - present.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Bedridden, Gastrointestinal disorder, Incomplete course of vaccination, Nausea, Syncope
Clinical narrative: Nausea, vomiting, syncope, fatigue, headaches 12/2012 - present.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, syncope, fatigue, headaches 12/2012 - present.
Age: 23.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: Received Hep A vaccine, walked back to work and dressed in PEP to start work in animal room; he started to feel hot and sweaty, dizzy, and fatigued.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Cough, Erythema, Eye pruritus, Fatigue, Lymph node pain
Clinical narrative: ATARAX 25 mg tab, one tablet by mouth four times a day as needed. Painful lymphnodes in neck and left armpit eight days after imm. Red rings on abdomen and arms two days after inoculation. Runny nose, sore, itchy throat for last five days. The patient is a 23 year old male. "I received the small pox immunization 1 week ago and about 24 hours ago these red pronounced rings just started popping up first showing up on my chest and abdomen." "I have had tenderness to the lymphnode's on my neck and left armpit for 2 days after the immunization." "I have had cold like symptoms for about 5 days recently and nothing other than a sore throat, runny nose and itchy throat." "I have an allergy to latex powder." "When I washed or showered I used my hand and soap rubbing over the immunization and over my whole body." Feeling tired. Neck pain and swollen glands in the neck. Itching of the eyes. Nasal discharge and sore throat. Cough. Rash.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Nasopharyngitis, Neck pain, Oropharyngeal pain, Rash
Clinical narrative: ATARAX 25 mg tab, one tablet by mouth four times a day as needed. Painful lymphnodes in neck and left armpit eight days after imm. Red rings on abdomen and arms two days after inoculation. Runny nose, sore, itchy throat for last five days. The patient is a 23 year old male. "I received the small pox immunization 1 week ago and about 24 hours ago these red pronounced rings just started popping up first showing up on my chest and abdomen." "I have had tenderness to the lymphnode's on my neck and left armpit for 2 days after the immunization." "I have had cold like symptoms for about 5 days recently and nothing other than a sore throat, runny nose and itchy throat." "I have an allergy to latex powder." "When I washed or showered I used my hand and soap rubbing over the immunization and over my whole body." Feeling tired. Neck pain and swollen glands in the neck. Itching of the eyes. Nasal discharge and sore throat. Cough. Rash.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rhinorrhoea, Throat irritation
Clinical narrative: ATARAX 25 mg tab, one tablet by mouth four times a day as needed. Painful lymphnodes in neck and left armpit eight days after imm. Red rings on abdomen and arms two days after inoculation. Runny nose, sore, itchy throat for last five days. The patient is a 23 year old male. "I received the small pox immunization 1 week ago and about 24 hours ago these red pronounced rings just started popping up first showing up on my chest and abdomen." "I have had tenderness to the lymphnode's on my neck and left armpit for 2 days after the immunization." "I have had cold like symptoms for about 5 days recently and nothing other than a sore throat, runny nose and itchy throat." "I have an allergy to latex powder." "When I washed or showered I used my hand and soap rubbing over the immunization and over my whole body." Feeling tired. Neck pain and swollen glands in the neck. Itching of the eyes. Nasal discharge and sore throat. Cough. Rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report  as received from a pharmacist refers to a 61 year old female patient. On 08-APR-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and lot number were not provided) subcutaneous in the left arm. On 08-APR-2014 some of the vaccine came out and ran down the patient's left arm. The full dose of vaccine was not given. Staff error only. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site vesicles, Local swelling
Clinical narrative: This spontaneous report as received from a physician refers to one unspecified patient. On unknown dates the patient were vaccinated with ZOSTAVAX (lot #:K000455, Exp date: 30-OCT-2014). 0.65 ml, subcutaneous. The physician reported 4 out of 10 patients were vaccinated with same lot of ZOSTAVAX and developed severe reactions. Multiple injection site reactions which included: angry red swelling at the injection site which cascaded down the arm to the elbow. Redness and swelling circumference around the injected arm. Blisters at the site, which physician confirms was not shingles. Physician stated the last 4 weeks was the most adverse effects she had seen with the ZOSTAVAX vaccine. Physician stated she had seen this change since the last batch label change from 3 piece label to one label. The physician stated one of her patients, who had the reaction to ZOSTAVAX, was scheduled to come into the office today. It was reported that this patient had recovered from the events. ZOSTAVAX Lot Check Request K000455 Exp 30-OCT-2014. This is one of several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 26 year old female consumer refers to herself. The patient had no pertinent medical history and no known drug reactions or allergies. On an unknown date, the patient was vaccinated with the first dose of GARDASIL intramuscular (dose and frequency were not reported) (Lot # was not reported). On an unspecified date, the patient received the second dose of GARDASIL intramuscular (dose and frequency were not reported) (Lot # was not reported). There was no concomitant medication reported. On 21-APR-2014, the patient discovered she was pregnant (onset date was reported as 10-APR-2014). The patient's last menstrual period (LMP) and estimated delivery date (EDD) was not known. No adverse effect was reported. No lab diagnostic studies were performed. The patient's outcome of vaccine exposure during pregnancy was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site mass, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient. The patient has had prior reaction to vaccines. On 27-APR-2014, the patient was vaccinated with ZOSTAVAX one time lot # J013135. On 27-APR-2014, 1 day after onset of therapy the patient experienced golf ball sized lump at the injection site. On 27-APR-2014, the patient also experienced redness and itchiness. The patient did not sought medical attention. The patient was told to take BENADRYL. The outcome of the event was reported as recovering. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old female patient. The patient did not have a pertinent medical history or drug reactions or allergies. On an unknown date the patient was vaccinated with ZOSTAVAX, .65 ml, subcutaneous. There was no concomitant medication. On approximately 26-MAR-2014 (reported as "about three weeks ago"), the patient's arm began to swell and turned bright red. On approximately 09-APR-2014 (reported as "about a week ago"), the patient also began to develop muscle pain and stiffness in her lower back that was worse in the morning than in the evening. Therefore, the patient could no longer sit for long periods of time in the same manner she was able to before receiving the ZOSTAVAX vaccine. The patient did not seek medical attention and used aspirin and hot showers to help remedy the pain. No lab diagnostic studies were performed. The outcome of the events were reported as not recovered/resolved. No further adverse event information was provided. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a pharmacist refers to a 30 year old female patient. The patient had no pertinent medical history or drug allergies. The pharmacist reported this pregnant patient in labor with 39 weeks pregnant gestation, in an unspecified hospital, received RECOMBIVAX HB (strength reported as 10mcg/ml, lot# and dose not reported) intravenously instead of intravenous (IV) PEPCID (manufacturer unknown) on 23-APR-2014. There were no concomitant medications. The pharmacist mentioned the nurse administered the wrong medication. Last menstrual period (LMP) was approximately on 24-JUL-2013 and estimated date of delivery (EDD) would be 30-APR-2014. No adverse symptoms were reported. Pregnancy outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On 20-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) which had expired on 10-APR-2014. No adverse effects were reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Seroconversion test negative
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old female patient. The patient was not pregnant and had no drug reaction/allergies. On 22-APR-1994, the patient received her first dose of an unspecified Hepatitis B vaccine (route, dose, frequency, lot # and expired date were not reported). Since the first dose of the Hepatitis B vaccine was unknown, this was being reported as Merck's RECOMBIVAX HB. The patient received a second and third dose of a Hepatitis B vaccine which the nurse confirmed was ENGERIX-B lot#1259A9, on 16-JUN-1994 and a third dose of ENGERIX-B, lot# 1468B2, on 20-OCT-1994. The patient had titers drawn on 22-JUL-2013 and the titers showed that the patient did not "seroconvert". Since the patient's titer showed that the patient did not "seroconvert" on 22-JUL-2013, the patient was administered RECOMBIVAX HB, (batch # H018635, lot # 1722Z, expired date: 16-DEC-2013), on 05-AUG-2013 and a second dose of RECOMBIVAX HB, (batch # H010849, lot# 0334AE, expired date: 28-FEB-2015) on 25-NOV-2013. The nurse reported that the patient would be receiving a third dose of RECOMBIVAX HB "today" (approximately on 21-APR-2014). She stated that the lot# of the RECOMBIVAX HB the patient would be receiving "today" was "0334A3", batch # "H010671" and the expiration date was 28-FEB-2015. The patient was given treatment. The outcome of adverse event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unkonwn age. On 25-APR-2014 the patient was vaccinated with ZOSTAVAX (vial, lot# unspecified), which expired on 22-APR-2014. ZOSTAVAX was supported as per spreadsheet. No adverse effects reported. The outcome was unknown. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 24 year old patient on an unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015, batch number H017436. On 01-APR-2014, patient was the patient was vaccinated with M-M-R II (route was not reported) lot # H017432, expiration date 20-SEP-2014. Co-suspect and concoimitant therapies were not reported. The register nurse reported that M-M-R II went through a supported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were adminsterde to 10 patients. The clinic has contacted the patients and 3 out of 10 patient had received an additional dose of M-M-R II. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1404USA014293, 1404USA012494, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a health care worker/medical assistant refers to a currently 25 year old female patient. On 10-MAY-2013 the patient was vaccinated with first dose of GARDASIL (0.5 ml once, intramuscular, lot # reported as: 01073AA and expiry date reported as: 11-OCT-2013). The reporter stated that the patient was in office to receive second dose of GARDASIL on 23-APR-2014, reported also as "today". Lot number 01073AA is an invalid lot number for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) exposed to 24 Fahrenheit (F) for 3.5 hours. The outcome of unspecified patients received VARIVAX (Merck) exposed to maximum of 24 F for 3.5 hours was unknown. This case is linked to case # 1405USA000225 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX exposed to 24 Fahrenheit (F) for 3.5 hours. The outcome of unspecified patients received ZOSTAVAX  exposed to maximum of 24 F for 3.5 hours was unknown. This case was linked to case # 1404USA015711 (Same reporter link). Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness and swelling and tender axilla of vaccinated arm.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dizziness, Erythema, Headache, Nausea
Clinical narrative: Within a few minutes after receiving the injection, the patient's face became quite red and she reported nausea.  She lay down, then reported severe lower back pain, ie rated at 8/10, as well as pain in bilateral backs of her legs and moderate headache.  One of our physicians was called into the room to evaluate the patient.  No difficulty breathing.  Patient was given diphenhydramine 50 mg IM x 1.  A few minutes later, she reported mild lightheadedness, but did not become hypotensive or lose consciousness. Symptoms improved within 5-10 minutes after the diphenhydramine.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Within a few minutes after receiving the injection, the patient's face became quite red and she reported nausea.  She lay down, then reported severe lower back pain, ie rated at 8/10, as well as pain in bilateral backs of her legs and moderate headache.  One of our physicians was called into the room to evaluate the patient.  No difficulty breathing.  Patient was given diphenhydramine 50 mg IM x 1.  A few minutes later, she reported mild lightheadedness, but did not become hypotensive or lose consciousness. Symptoms improved within 5-10 minutes after the diphenhydramine.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt reported arm swollen in area of injection, quarter size, hurts a little bit.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Dizziness, Malaise, Pain in extremity, Pruritus
Clinical narrative: Vaccine administered at clinic visit 4/3/14. Client also prescribed Metronidazole and reports starting antibiotic same day. C/O rash, itchiness, left leg pain, confusion, dizziness. Rash/itchiness subsided. Client still reports "not feeling well".
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Vaccine administered at clinic visit 4/3/14. Client also prescribed Metronidazole and reports starting antibiotic same day. C/O rash, itchiness, left leg pain, confusion, dizziness. Rash/itchiness subsided. Client still reports "not feeling well".
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Injection site swelling, Skin exfoliation
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 62 year old female patient. In Fall 2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unspecified date in 2013, after receiving ZOSTAVAX, the patient experienced swelling at the injection site which had since resolved. The patient also stated that she was currently experiencing scaling and cracks kind of like eczema in between the fingers on the hand of the arm that ZOSTAVAX injection was administered (right or left arm was not specified). The outcome of scaling and cracks kind of like eczema in between the fingers on the arm that ZOSTAVAX injection was administered was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 67 year old female patient with amoxicillin allergy. On 01-nov-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J004269, expiration date 12-JUL-2014) subcutaneously in the left arm. On the same date, the patient also was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot # not reported) in the right arm. The pharmacist reported that on an unknown date, the patient experienced intermittent pain on her left arm at injection site of ZOSTAVAX. The patient stated that the pain was most noticeable at night, when she was lying down. There were no Lab diagnosis or studies performed. The outcome of intermittent pain on her left arm at injection site was reported as not recovered/not resolved. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Joint swelling, Rash
Clinical narrative: Vaccines MMR, VAR, HIB and PCV 13 administered on 4/24/14 - Mom noted rash on arms with some swelling of wrist per Mom. Called MD on call and was told to give BENADRYL - F/U in office 4/28/14 - cont BENADRYL.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from the medical assistant refers to a male patient of unknown age. No information about medical history concurrent conditions and concomitant medications were reported. On 24-APR-2014 the patient received a dose of PROQUAD on 24-APR-2014 when he was suppose to receive a dose of MMR II. No dose of MMR II administered. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Swelling, redness, induration at vaccine site.
Age: 55.0
Sex: F
Vaccine: HEP, MNQ, YF
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting (transient).
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Aphasia, Blood test, Burning sensation, Confusional state
Clinical narrative: Hard bumps under the skin. Called nodules. Those were the first weird symptoms. At a softball game in May 2009, I had my first flare up. It stopped the game. I was doing so good that game on 3rd base. It was very hot and sunny. As we were coming into the dugout I felt my chest ears and cheeks burn up to a million degrees. They were beet red as were my eyes, bloodshot. I sat in the dugout everyone's asking me if I'm ok.. I was so confused and dazed I knew what people were saying but I couldn't talk back. Then I got a very severe stomach ache and had to be carried into the bathroom. Months later after lots of blood work and doctors appointments, I tested positive in every way for lupus.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Feeling abnormal, Immunology test abnormal, Laboratory test abnormal, Nodule
Clinical narrative: Hard bumps under the skin. Called nodules. Those were the first weird symptoms. At a softball game in May 2009, I had my first flare up. It stopped the game. I was doing so good that game on 3rd base. It was very hot and sunny. As we were coming into the dugout I felt my chest ears and cheeks burn up to a million degrees. They were beet red as were my eyes, bloodshot. I sat in the dugout everyone's asking me if I'm ok.. I was so confused and dazed I knew what people were saying but I couldn't talk back. Then I got a very severe stomach ache and had to be carried into the bathroom. Months later after lots of blood work and doctors appointments, I tested positive in every way for lupus.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ocular hyperaemia
Clinical narrative: Hard bumps under the skin. Called nodules. Those were the first weird symptoms. At a softball game in May 2009, I had my first flare up. It stopped the game. I was doing so good that game on 3rd base. It was very hot and sunny. As we were coming into the dugout I felt my chest ears and cheeks burn up to a million degrees. They were beet red as were my eyes, bloodshot. I sat in the dugout everyone's asking me if I'm ok.. I was so confused and dazed I knew what people were saying but I couldn't talk back. Then I got a very severe stomach ache and had to be carried into the bathroom. Months later after lots of blood work and doctors appointments, I tested positive in every way for lupus.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient returned to clinic for smallpox check. Patient stated site swollen and sore to touch. Bandage removed to expose a quarter sized round blister similar in appearance to a 2nd degree burn blister. Site around blister with moderate redness and swelling. Patient escorted to clinic for further evaluation by physician.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness just below site of injection.
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Chest discomfort, Electrocardiogram, Pharyngeal erythema, Pruritus
Clinical narrative: Pruritis to scalp and upper arms. Temp. 97.9, BP 135/97. Sent to ER for treatment. Chest tightness and pharynx red.