chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain and heat at injection site, Right upper arm.  Patient reports treatment with ice and Benadryl cream to site.  As of 8/2/13 at 0800, patient states that redness and pain are subsiding.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site reaction, Oedema, Pruritus
Clinical narrative: Vital signs upon presentation were: T-98.1, BP-120/80, HR-93, Sat-98%, Ht:5'4", Lbs, 324.  Pt reports noticing her right upper arm had a small red itchy rash while at the movies around midnight after recieving the Varivax vaccine. Physical exam noted a 50 x 50 mm induration, erythema, edema, pruritic area. She was treated with Depo-Medrol 80 mg IM, Clobetasol topical ointment BID x and Fexofenadine PO daily. Pt instructed to return to clinic in 24 hours if the rash got worse. She denied, fever, chills, difficulties breathing, swelling of mouth, tongue or any other allergic symptoms when asked.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Vital signs upon presentation were: T-98.1, BP-120/80, HR-93, Sat-98%, Ht:5'4", Lbs, 324.  Pt reports noticing her right upper arm had a small red itchy rash while at the movies around midnight after recieving the Varivax vaccine. Physical exam noted a 50 x 50 mm induration, erythema, edema, pruritic area. She was treated with Depo-Medrol 80 mg IM, Clobetasol topical ointment BID x and Fexofenadine PO daily. Pt instructed to return to clinic in 24 hours if the rash got worse. She denied, fever, chills, difficulties breathing, swelling of mouth, tongue or any other allergic symptoms when asked.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient complained of redness, pain, swelling in underarm area where vaccine was administered. She believes she has the shingles now after receiving the vaccination but says there are no blisters, pustules or anything of that nature.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: High pitched scream for 3 hours and fussy for rest of the day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection, Pruritus
Clinical narrative: Nose itching, development of herpes-like breakout under nose.  Breakout is still visible as of 8/2/2013.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Local site reaction with induration, erythema, swelling, pain, itching started the following day.  Treated with Benadryl, ibuprofen, ice, elevation.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Local site reaction with induration, erythema, swelling, pain, itching started the following day.  Treated with Benadryl, ibuprofen, ice, elevation.
Age: 2.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old patient. The nurse reported that on an unspecified date "a 1 year old patient" was administered first doses of M-M-R II and VARIVAX (Merck) and when the patient was 2 year old PROQUAD (Merck) was administered. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. ON 22-APR-2013, the patient was vaccinated with dose 1 of VARIVAX (Merck) (lot #, expiry not reported). On 16-JUL-2013, the patient was vaccinated with dose 2 of VARIVAX (Merck) (lot #, expiry not reported). No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 01-JUN-2010, the patient was vaccinated with the first dose of M-M-R II, lot#, dose and route unspecified and VARIVAX (Merck) subcutaneously, lot#, dose unspecified. On 16-JUL-2013, the patient was inadvertently administered both a 0.5 ml dose of PROQUAD (Merck), lot # and route unspecified and a 0.5 ml dose of VARIVAX (Merck). No adverse effect reported. The outcome of the patient was unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old male patient. On 28-JUN-2013 the patient received the first dose of GARDASIL and received the second dose of GARDASIL 10 days early on 16-JUL-2013. 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 was received from a medical assistant concerning a patient of unknown age and gender. On 08-APR-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and route unspecified). On 15-FEB-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 8/1/13 4cmx3cm red raised, warm at injection site. 8/2/13 8cm x 4.5cm red raised, warm at injection site, with white ring or halo around. Very itchy.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Muscular weakness, Nausea, Pallor
Clinical narrative: Child sat in lobby after receiving vaccines, Tdap and MVC4. After about 5 minutes, mom said child looked pale and was weak in her arms. Upon assessing child. She was pale and said she felt a little dizzy and nauseated. Allow patient to lie down in nurse's office for 15 minutes, and gave her a Coke. BP 122/84, no signs of breathing difficultly. Pt sat back in waiting room for another 15 minutes. Mother took child home.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Fear, Feeling abnormal, Hypoaesthesia, Loss of consciousness
Clinical narrative: 1:00- Patient began to "feel funny" and then felt like she was going to vomit. Escorted mother and patient to restroom and instructed to notify me if anything got worse. Patient began to scream and when I went back to check on her she passed out in mothers arms. I helped catch her and we lowered child to the ground. Patient quickly aroused and was able to identify self, birthday, location and several other identifying factors. Cold cloth placed on neck and head. Patient states " I feel sick to my stomach and weak. I am very scared." Blood Pressure WNL 98/62, HR: 78, and R: 18. Pupils reactive to light and appeared to be even and equal in size. After approx 10 min ambulance called because patient could not sit-up and reported she couldn't feel her legs. Remained with patient until ambulance arrived at approx 1:20. Patient taken to ER at this time for evaluation and treatment.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Screaming
Clinical narrative: 1:00- Patient began to "feel funny" and then felt like she was going to vomit. Escorted mother and patient to restroom and instructed to notify me if anything got worse. Patient began to scream and when I went back to check on her she passed out in mothers arms. I helped catch her and we lowered child to the ground. Patient quickly aroused and was able to identify self, birthday, location and several other identifying factors. Cold cloth placed on neck and head. Patient states " I feel sick to my stomach and weak. I am very scared." Blood Pressure WNL 98/62, HR: 78, and R: 18. Pupils reactive to light and appeared to be even and equal in size. After approx 10 min ambulance called because patient could not sit-up and reported she couldn't feel her legs. Remained with patient until ambulance arrived at approx 1:20. Patient taken to ER at this time for evaluation and treatment.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Noticed soreness to arm within hours but did not notice red, swollen area until the next day in the afternoon.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Blister, Injection site erythema, Injection site swelling, Tension
Clinical narrative: Redness and swelling around vaccine injection site started few hours after vaccine and worsened over following 2 days until entire left upper extremity was tense and swollen down to elbow, and surface of skin had very small tense fluid-filled blisters.  Patient was treated with oral prednisone and the following day has noted significant improvement with resolution of redness, decreased swelling, and resolution of blisters.
Age: 11.0
Sex: M
Vaccine: DTAP, HPVX, MEN
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warmth, swelling and erythema (5x5x3cm) on bilat upper extremities at site of vacccination.
Sex: U
Vaccine: MNQ
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2013US016149 is an initial spontaneous report received from a nurse on 26 Jul 2013. This report refers to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12118, expiry date: Aug 2014) intramuscularly on an unspecified date. On an unknown date, after vaccination, the patient experienced cellulitis and was treated with antibiotics (unspecified). The seriousness, outcome and causality of the event were not reported.
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2013US016021 is an initial report received from a consumer via patient oriented program (specialty pharmacy) on 26 Jul 2013: This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. This patient was vaccinated with FLUVIRIN (batch number: unknown) on an undetermined date. On an unspecified date after vaccination, the patient experienced Guillain-Barre syndrome. No additional information about outcome, causality and seriousness was reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 60 year old female patient. There was not pertinent medical history or drug reactions/allergies. On Sunday 28-JUL-2013, the patient was vaccinated with one dose of ZOSTAVAX (lot # not provided) 0.65 ml, subcutaneous. There were not concomitant medications. On Monday 29-JUL-2013, the patient was seen at her physician's office for treatment of cellulitis. There were not laboratory tests performed. The patient was given KEFLEX for the treatment of the event. At the time of the report, the outcome of cellulitis was recovering. The reporter considered the cellulitis to be medically significant. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: None known to date.
Age: 29.0
Sex: F
Vaccine: MMR, TDAP, VARCEL, MMR, TDAP, VARCEL, MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: None known to date.
Age: 1.32
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Day after vaccine started w/rash (L) axilla and has spread had tactile fever day after also.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Rec'd MCV4 in (R) deltoid 7-30-13 (2nd dose). 1st dose 6-26-09 - no reaction. C/o 5 1/2 cm round erythematous area with itching on lower deltoid area.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis contact, Pruritus, Urticaria
Clinical narrative: Itchy welts over forearms (both) and calf of one leg over last 4-5 days. Customer states started 5 days after injection. Pt stated has been working in the yard and MD diagnosed contact dermatitis. Not due to vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Local swelling, Rash
Clinical narrative: Grandparent, noticed arm swollen and red day after vaccine administered. She took him to ER for evaluation was sent home. Later redness spread and she went back to ER and was diagnosed with cellulitis and given antibiotics. He had rash from antibiotics as well on 7/31/13.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Swollen and red.
Age: 0.57
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to an approximately 6 month old patient of unknown gender. On 26-JUL-2013 the patient was vaccinated with PNEUMOVAX23 injection (lot # and expiration date unspecified). The reporter stated that patient (birth date 28-DEC-2012) received the dose of PNEUMOVAX23 in error, child was to receive a pneumococcal vaccine, manufacturer unspecified. No adverse event reported, no product confusion discovered, just medication error. The patient's outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to 7 patients of unspecified ages ranging "from 12 months to 48 months". On an unknown date the patients were vaccinated with first dose of VARIVAX (Merck) (lot number, strength, dose, route and site unspecified). In June 2012 the patients developed chickenpox. The outcome of chickenpox was unknown. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Pt was administered MMRV vaccine instead of MMR, as well as varicella and Hep A vaccines in left thigh at approx. 10AM on 8/2/13. Health Dept. and parents contacted.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with multiple (unspecified) allergies. On an unknown date the patient was vaccinated with an unspecified hepatitis B vaccine (manufacturer unknown). On an unknown date the patient experienced hives. The outcome of hives is unknown. No causality statement was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: The spontaneous report has been received from a physician via company representative and refers to a patient of unknown age and gender. Information on medical history was not reported. On an unknown date the patient received the full series of Hepatitis B Vaccine (Recombinant) vaccine (manufacturer unknown) (lot #, expiry date not reported) (dose number, dose, strength, route, frequency not reported), it was reported that hepatitis B vaccine (recombinant) (RECOMBIVAX HB) could not be rule out. Information on concomitant medication was not reported. On unspecified dates the patient underwent serological testing for immunology resulting in hepatitis B titers as negative and patient was then administered  another dose of Hepatitis B Vaccine (Recombinant) vaccine (manufacturer unknown) (lot # expiry date not reported) (dose number, dose, strength, route, frequency not reported) and again the titers were negative. The outcome of the adverse events was unknown. The reporter did not assess the relationship between the Hepatitis B Vaccine (Recombinant) vaccine (manufacturer unknown) and the adverse events. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, soreness, itching, swelling; warm to touch, questionable cellulitis = treated with antibiotic and diphenhydramine/ZYRTEC.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, itching, swelling; warm to touch, questionable cellulitis = treated with antibiotic and diphenhydramine/ZYRTEC.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient received the first dose of GARDASIL on 05-APR-2013, the second dose of GARDASIL on 05-JUN-2013 and was in the office today, 31-JUL-2013, wanting to get a third dose of GARDASIL (dose, frequency, route and lot# not reported). No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt had a 4 yr WCC with vaccines on 7/31/13 developed redness, increased warmth, tenderness at both vaccine sites on (L) ant thigh.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. Physician reported that the patient was in the office now(30-JUL-2013) to receive dose 3 of GARDASIL (injection, lot#, dose/frequency, route and duration were unspecified) which would be late. Doses 1 and 2 (lot#, dose/frequency, route and duration were unspecified for both doses) were administered sometime in 2011 (unspecified dates). No symptoms reported. Outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) for immunization. The nurse reported her friend received ZOSTAVAX at an unspecified date, and developed a rash all over her body. The patient sought medical attention by office visit and was given no treatment. No lab diagnostics studies were performed. At the time of reporting the patient's outcome was unknown. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 year old female patient with sulfa allergy. No medical history was reported. On 24-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000494, expiry: 14-APR-2014). No concomitant medications were reported. On 28-JUL-2013, the patient developed shingles after receiving ZOSTAVAX. Patient sought medical attention: contacted the pharmacist. Patient received treatment with Atarax and Valtrex. No laboratory diagnostics studies were performed. The outcome of shingles was reported as not recovered. Varicella zoster virus identification program (VZVIP) packet faxed. This is 1 of 3 reports from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 80 year old female patient. The patient has a prior history of shingles preceding the administration of ZOSTAVAX. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # and dose not reported). On an unknown date the patient developed shingles following vaccination of ZOSTAVAX. The patient was given steroid dose pack (manufacturer unknown) for the event. The pharmacist had no other information about the patient's past shingles history, exactly when the dose of ZOSTAVAX was administered or the time frame development of the shingles following vaccination with ZOSTAVAX at the time of the report (the pharmacist did not administered the ZOSTAVAX). The patient sought medical attention by contacting unspecified physician. At the time of report, the outcome of the event was reported as recovering. This is one of several reports from same source.  Additional information is not expected.
Sex: U
Vaccine: HEP, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to unspecified patients of unknown age. In July 2013 the patients was vaccinated with GARDASIL and RECOMBIVAX HB which was from 11-JUL-2013 to 22-JUL-2013 that was exposed to multiple fluctuations to 31F each day during this time period which was not supported. No adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Hypopnoea, Hypotonia, Malaise, Nausea
Clinical narrative: Administered GARDASIL vaccine in left arm. Patient stayed in room while vaccine record was updated and after visit summary was being printed out. Patient stood up from sitting for about 10 mins. Patient was standing for less than 2 minutes when she began to complain of not feeling well-mom noticed her face was pale/ashy in color and eyes widened and began to arch back and make a "animalistic noise" per mom. Mom reached to grab her because she thought she was fainting. Mom called for help and Dr rushed to the room, then patient began posturing and was limp with a fixed gaze. Dr laid her down on the ground and elevated patient's legs. Dr used stethoscope and heard minimal air movement and shallow respirations. Dr began to stimulate her chest and patient began to respond. Heart rate was normal and respirations increased. Blood pressure and pulse were taken-BP: 130/84 Pulse: 80 Saturated oxygen: 100%-Both were monitored for 30 mins. Patient was given oxygen for 10 minutes. Patient was also given Gatorade to help with nausea. Blood pressure was taken again 105/52 Pulse: 72 and Saturated O2: 100%. Patient stayed laying down with pillow and blankets. Dr has ordered EKG today and gave information to mom about Merck's website. Mom then told us that patient had not eaten today, we gave her peanut butter crackers that patient ate two crackers and continues to drink Gatorade but continues to feel nauseated.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Opisthotonus, Pallor, Posturing
Clinical narrative: Administered GARDASIL vaccine in left arm. Patient stayed in room while vaccine record was updated and after visit summary was being printed out. Patient stood up from sitting for about 10 mins. Patient was standing for less than 2 minutes when she began to complain of not feeling well-mom noticed her face was pale/ashy in color and eyes widened and began to arch back and make a "animalistic noise" per mom. Mom reached to grab her because she thought she was fainting. Mom called for help and Dr rushed to the room, then patient began posturing and was limp with a fixed gaze. Dr laid her down on the ground and elevated patient's legs. Dr used stethoscope and heard minimal air movement and shallow respirations. Dr began to stimulate her chest and patient began to respond. Heart rate was normal and respirations increased. Blood pressure and pulse were taken-BP: 130/84 Pulse: 80 Saturated oxygen: 100%-Both were monitored for 30 mins. Patient was given oxygen for 10 minutes. Patient was also given Gatorade to help with nausea. Blood pressure was taken again 105/52 Pulse: 72 and Saturated O2: 100%. Patient stayed laying down with pillow and blankets. Dr has ordered EKG today and gave information to mom about Merck's website. Mom then told us that patient had not eaten today, we gave her peanut butter crackers that patient ate two crackers and continues to drink Gatorade but continues to feel nauseated.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a other registered nurse refers to a 4 month old patient (gender unknown). On an unknown date the patient was vaccinated with ROTATEQ dose 2 (dose unspecified). (lot # and exp date was unknown). The reporter stated that ROTATEQ was given to the patient 8 days after the expiration date. The reporter was concerned about the dose could be repeated if immediately or in 6 weeks. The patients outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Information was received from a consumer for VIOXX (1307USA004920). The consumer reported that she know people (NOS) who received ZOSTAVAX and it was "real painful and red" (onset date and outcome of the event not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 83 year old female patient. There were no drug allergies/reactions. On 24-JUL-2013 the patient was vaccinated with ZOSTAVAX, (lot # J000433. expiration date 10-APR-2014), 0.65 ml, subcutaneous, (anatomical location unspecified). Concomitant medications were not reported. On 25-JUL-2013, the patient experienced redness at injection site. The patient sought medical attention and no treatment was given for the event. Lab diagnostics studies were not performed. The outcome of redness at injection site was reported as recovered/resolved on an unspecified date. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a male patient of unknown age. On 24-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # not reported) instead of ZOSTAVAX. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report was received from a female nurse of unknown age reporting on herself with antibiotics allergy and allergy to bee sting. The patient's medical history included herpes zoster. In July 2013 (reported as last Wednesday or Friday), the patient was vaccinated with ZOSTAVAX 19400PFU (lot # not reported) subcutaneous (dose not reported). No other co suspects were reported. Concomitant therapies included many but were not reported). In July 2013, the patient experienced itching and "lump" around the injection site. The patient reported that she experienced arthralgia in both wrists. The patient did not take any treatment for it. The patient did not seek medical attention. Labs diagnostics were not performed.  The outcome of "lump" around the injection site, the patient experienced arthralgia in both wrists and the patient experienced itching was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age (gender was unknown and it was not sure if the patient was a child or an adult). On an unknown date the patient was vaccinated with a dose of VARIVAX (lot #, dose and route not reported). On an unknown date the patient developed chickenpox after receiving VARIVAX (Merck). The outcome of the event was unknown. This is one of several reports from same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a physician refers to a child patient of unknown age (gender was unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot #, dose and route not reported). On an unknown date the patient developed chickenpox after receiving VARIVAX (Merck). The outcome of the event was unknown. This is one of several reports from same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 22-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose, route unspecified by the reporter). No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient was vaccinated with the second dose of GARDASIL on 20-JUN-2013. No adverse effect was reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a currently  5 years old male patient. On an unknown date, when the patient ws 15 months old, the patient was vaccinated with M-M-R II INJ (albumin status unknown) dose 1 (route, dosage, and lot number unknown). The medical assistant reports that the patient received his second dose of M-M-R II (albumin status unknown) when he was 2 years old on an unspecified date. No adverse events were 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 physician refers to a patient of unknown age. On 05-JUL-2013 the patient was vaccinated with an expired ZOSTAVAX (0.65 ml, subcutaneous) (lot: 670542/0619AA exp. date 26-JUL-2012) for prevention of herpes zoster. No adverse effect was reported. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On 24-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (Lot # not reports) instead of ZOSTAVAX. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician, via field representative, refers to a 5 patients of unknown age and gender. In 2013 (reported as in the past few weeks) the patients were vaccinated with GARDASIL (dose, route and site of administration not reported). On an unknown dates (reported as recommended observation period after GARDASIL administration) the patients fainted. The outcome of fainting was not reported. The relatedness between GARDASIL administration and fainting was not reported. Same reporter link: 1307USA014696. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Irritability
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. In January 2013 the patient was vaccinated with the first dose of ROTATEQ (orally, dosage strength not reported), followed by second dose of ROTATEQ in approximately March or April 2013. It was also reported that the patient was vaccinated with M-M-R II (dose, route, indication and strength not reported) at the age of seven months. The reporter stated that the patient was "irritable" after receiving the first dose of ROTATEQ. On an unknown date the patient recovered. The relatedness between suspect therapies and irritability was not reported. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Convulsion, Diarrhoea, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Seizure occurred involving shaking of head and torso, during otherwise normal sleep, for approximately 5 seconds.  Seizure continued as infant was lifted up out of bouncy seat, but halted as infant was put to the breast to nurse.  Nursing proceeded normally and no recurrence of seizure has occurred.  No fever, rash, or difficulty breathing have been observed.  The injection site has a small, red welt (pea-sized but fairly flat).  Mild diarrhea was noticed earlier in the evening (at approximately 7 PM) but has not recurred thus far.
Age: 0.41
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Tremor
Clinical narrative: Seizure occurred involving shaking of head and torso, during otherwise normal sleep, for approximately 5 seconds.  Seizure continued as infant was lifted up out of bouncy seat, but halted as infant was put to the breast to nurse.  Nursing proceeded normally and no recurrence of seizure has occurred.  No fever, rash, or difficulty breathing have been observed.  The injection site has a small, red welt (pea-sized but fairly flat).  Mild diarrhea was noticed earlier in the evening (at approximately 7 PM) but has not recurred thus far.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Large local reaction, evaluated in ER with no intervention required.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Chest X-ray, Culture, Full blood count
Clinical narrative: Temperature 103.8 orally. Return ER visit. IV fluids and Toradol given. Sent home. Return visit 8/2/13 for cellulitis of right arm. Prescribed Bactrim and Keflex.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Metabolic function test, Urine analysis
Clinical narrative: Temperature 103.8 orally. Return ER visit. IV fluids and Toradol given. Sent home. Return visit 8/2/13 for cellulitis of right arm. Prescribed Bactrim and Keflex.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site joint pain, Weight bearing difficulty
Clinical narrative: Complaint of leg pain at joint where shot for MMR was administered. Unwilling to put weight on leg. There was the same reaction within 48 hours of shot but it went away....
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia, Pyrexia, Rash vesicular
Clinical narrative: Blister type rash with surrounding redness at the site of injection along with systemic symptoms of myalgias and low grade fever.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Gastrointestinal sounds abnormal, Headache, Nausea, Vomiting
Clinical narrative: PATIENT RECEIVED IMMUNIZATION AT 0907 AND PROCEEDED TO THE LABORATORY TO HAVE HIS BLOOD DRAWN. WHILE WAITING TO HAVE HIS BLOOD DRAWN PATIENT STATED HE FELT NAUSEOUS, VOMITED X 1, AND DEVELOPED A HEAD ACHE. PT DID NOT REPORT FEELING THIS WAY AT THIS TIME. PT WENT AND HAD BLOOD DRAWN ANYWAY AND THEN REPORTED TO LAB TECHNICIAN THAT HE DID NOT FEEL WELL AND PATIENT WAS BROUGHT TO DOCTOR TO BE ASSESSED. DR ASSESSED PT AND BP WAS 150/100, HR 80, HEART RRR, NSR ON TELE. LS CTAB, HYPERACTIVE BS NOTED TO ABDOMEN. RESCUE WAS CALLED AND DR RECOMMENED IV FLUIDS ANTIEMETICS, MONITORING. THIS ASSESSMENT WAS PER DR. REPORT. PT LEFT BY RESCUE. WILL F/U.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pain in extremity, Paraesthesia, Rash
Clinical narrative: Tingling, and shooting pains up and down arm. Pain in all old injury areas. Rash under arm. Leg pain on 3rd day.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse refers to a female patient of unknown age. An unspecified female patient was administered the first dose in the GARDASIL vaccination series (dose and lot # was not reported) intramuscularly "in 2009" and subsequently was administered the second dose in the GARDASIL vaccination series (dose and lot # was not reported) intramuscularly on 25-JUL-2013. No adverse effect reported. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Symptoms were consistent with moderate to severe side effects but lasted longer than they should have. Still had symptoms of swelling, redness and soreness around the injection site. My doctor was not available and went to the emergency room and they prescribed me the antibiotics Keflex.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Fall, Gait disturbance, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Leg swollen at injection site to a lump the size of a baseball; redness at injection site to the size of a quarter; fever between 100 and 102 for 5 days; child kept stumbling and falling while attempting to walk.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Leg swollen at injection site to a lump the size of a baseball; redness at injection site to the size of a quarter; fever between 100 and 102 for 5 days; child kept stumbling and falling while attempting to walk.
Age: 0.62
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Diarrhoea, Rotavirus infection, Vomiting, Weight decreased
Clinical narrative: Started with very bad diarrhea, soon after accompanied by vomiting. Child continues to show symptoms 8 days later (10 days after vaccine administered). He has lost more than 10% of his body weight. We took him back to the same doctor 07/31/13, after consulting nurses by phone the two days previously. Nurse practitioner saw my son and said that his vital signs were all good, that symptoms were consistent with full rotavirus and it should "clear up soon." We were told to make sure he exhibited signs of staying hydrated, but nothing else was done. His temperament has been pretty good throughout and no fever. Appetite is so small and ongoing diarrhea and vomiting have us primarily concerned about his weight (he was already very small, the 2 lb weight loss has pushed him off the growth charts entirely, now below the 1st percentile). We are thinking about taking him to the hospital today.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Intense shoulder pain a few hours after getting Pneumovax injection. Made movement of the arm difficult. Severe limitation of range of motion.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain, Pruritus
Clinical narrative: Pt came in on  8/3/13 complaining of itchiness and little pain. I checked her left arm (upper) there was a red spot measures 2 inches x 14 1/4 inch with a lighter circle in middle. It is warm to touch. Pt said it is worse today.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patients of unknown ages. Since February 2012, GARDASIL was exposed to repeated temperature excursions as low as -9C. The GARDASIL was also exposed to temperatures above 8C multiple times. On unknown dates, doses of the vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the time of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patients of unknown ages. Since February 2012, RECOMBIVAX HB was exposed to repeated temperature excursions as low as -9 C. The RECOMBIVAX HB was also exposed to temperatures above 8 C multiple times. On unknown dates, doses of vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the tine of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patients of unknown ages. It was reported that VARIVAX (Merck) was exposed to temperatures below -15 C multiple times. On unknown dates, doses of the vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the time of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It ws unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site hypersensitivity
Clinical narrative: This spontaneous report was received from a 60 year old female licensed practical nurse (patient) regarding herself via a company representative. On 21-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000429 and 10-APR-2014 respectively, dose unspecified), subcutaneously in the left arm. There were no concomitant medications. On 22-JUN-2013, the patient experienced sensitivity to the touch and intermittent skin discoloration around the injection site after receiving ZOSTAVAX. The patient did not seek any medical attention. No treatment was given. It was unspecified if any lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a healthcare worker refers to patients of unknown ages. The M-M-R II was exposed to temperatures above 8 C multiple times. On unknown dates, doses of the vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the time of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, DTAP, FLU3, HEPA, MNQ, ADEN_4_7, DTAP, FLU3, HEPA, MNQ
Symptoms: Breath sounds abnormal, Breath sounds absent, Chest pain, Dyspnoea, Feeling hot
Clinical narrative: C/o chest pain, SOB, DYSPNEA AFTER RECEIVING P-4 DAY VACCINES.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, DTAP, FLU3, HEPA, MNQ, ADEN_4_7, DTAP, FLU3, HEPA, MNQ
Symptoms: Chest pain, Dyspnoea
Clinical narrative: C/o chest pain, SOB, DYSPNEA AFTER RECEIVING P-4 DAY VACCINES.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dysphemia
Clinical narrative: Fever followed by febrile seizure that lasted about 90 secs - 2 min. Lips turned blue. Given mouth to mouth. 911 called. Taken to hospital by ambulance.
Age: 2.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Cyanosis, Febrile convulsion, Pyrexia, Resuscitation
Clinical narrative: Fever followed by febrile seizure that lasted about 90 secs - 2 min. Lips turned blue. Given mouth to mouth. 911 called. Taken to hospital by ambulance.
Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers her husband who was a 90 year old male patient with no pertinent medical history or drug reactions/allergies. On 27-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H011050, EXP date 15-SEP-2013) subcutaneously in the right arm. There were no concomitant medications. On 11-OCT-2012 the patient got red spots with white tips on his right insertion arm onto his torso and back after receiving the vaccine. The patient was given two strength of CORTIZONE. And the patient was still having a red rash on his right arm and red rash behind his legs on the calves and he was extreme itchiness but no other side effects. Patient sought medical attention and clobetasol was also given as treatment. There were no labs performed. The outcome of extreme itchiness was reported as not recovered/not resolved. The outcome of got red spots with white tips on his right insertion arm onto his torso and back after receiving the vaccine and red rash on his right arm and red rash behind his legs on the calves was reported as unknown. Additional information has been requested.
Age: 90.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a consumer refers her husband who was a 90 year old male patient with no pertinent medical history or drug reactions/allergies. On 27-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # H011050, EXP date 15-SEP-2013) subcutaneously in the right arm. There were no concomitant medications. On 11-OCT-2012 the patient got red spots with white tips on his right insertion arm onto his torso and back after receiving the vaccine. The patient was given two strength of CORTIZONE. And the patient was still having a red rash on his right arm and red rash behind his legs on the calves and he was extreme itchiness but no other side effects. Patient sought medical attention and clobetasol was also given as treatment. There were no labs performed. The outcome of extreme itchiness was reported as not recovered/not resolved. The outcome of got red spots with white tips on his right insertion arm onto his torso and back after receiving the vaccine and red rash on his right arm and red rash behind his legs on the calves was reported as unknown. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEPA, HPV4, HPV4
Symptoms: Dizziness, Gaze palsy, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: This spontaneous report as received from a physician and patient's mother refers to a 19 year old patient with no medical history and no drug reactions/allergies. On 26-JUL-2013 the patient was vaccinated with GARDASIL (injection, intramuscular, strength, lot#, dose/frequency and duration were unspecified). No concomitant medication was taken. Physician reported that patient experienced an episode of syncope and loss of consciousness with twitching and seizure-like activity that lasted approximately 5-6 seconds following administration of GARDASIL. The patient was placed in a Trendelenburg position and given juice. The patient was observed for an additional 15 minutes after this episode. The physician also reported that the patient felt light-headed and nauseous both before and after the incident. No lab diagnostics studies were performed. A follow-up phone call to the patient's mother later in the day confirmed that no further incidents had occurred except for the patient feeling fatigued. No further adverse effects reported. The outcome of feeling fatigued was unknown. Upon internal review, loss of consciousness and seizure-like activity were considered as other medical significant events. Additional information has been requested.