chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: This non-serious medically spontaneous report (initial receipt 12-AUG 2014) concerns a female patient who had tenderness and swelling in her armpit on the evening of 04-AUG-2014 following the administration of a pneumonia vaccine which she thought it was PNEUMOVAX (0.5 ml, batch number J009827). She also had plagues, which looked like hive, that were "about 2-3 inches in diameter around the injection site the next day". She also had one plaque that developed the "next day" on her inner arm that was slightly elevated and very red and tender. The plaque on her inner arm had "gone down today". Following the administration of an unspecified tetanus vaccine on an unspecified date, she had an unspecified arm swelled "2 to 3 times it's previous size".  On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date following the influenza vaccine, the patient developed a "hill" at the injection site. Medical attention was not sought.  Outcome was reported as recovering.   Reporter's comments: The reporter commented that an unspecified pneumonia vaccine was the "harder" of the vaccines to administer to children due to adverse reactions that can develop.  The reporter did not provide any further information about children.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: Case number PHEH2012US021634 is an initial spontaneous report received from an office manager on 24 Oct 2012 with the follow-up received on 27 Nov 2012 and a follow up report from the health care professional received on 15 Apr 2013 with a follow up report received from the physician on 04 Apr 2014: This report refers to a 35 year old female pregnant patient. Her vaccination history included vaccination with an unspecified vaccine and tolerated it. Her concomitant medication included VITAFUSION and Prenatal. Her last menstrual period was reported as 22 May 2012 with expected date of delivery as 02 Mar 2013. She was 22 weeks pregnant when she got vaccinated with an expired FLUVIRIN (batch number: 11161P) at dose of 0.5 ml intramuscularly on 24 Oct 2012 at 15:30 PM. No adverse event was reported following this administration error. She underwent prenatal tests on 19 Jul 2012, 02 Oct 2012, 31 Jan 2013 and 01 Feb 2013 (biophysical profile) and all the results were normal. She had caesarean section on 18 Feb 2013 (nuchal cord x2). She gave birth to a normal healthy male child with 7 lbs/oz weight. The APGAR score was reported as 7 at 1 min and 9 at 5 mins. No malformations were observed in the new born child. The case was reported as a non serious case by the health care professional. No other information was available. Follow-up received on 27 Nov 2012: Updated patient weight and weight, concomitant medication, vaccine dose and time. Follow up report from the health care professional received on 15 Apr 2013: The lab tests, medical history of the patient, last menstrual period, expected date of delivery, delivery details, information related to the new born and seriousness were updated. Follow up report was received from the physician on 04 Apr 2014: The patient's height and the current status of the baby were updated.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy
Clinical narrative: Case number PHEH2012US025188 is an initial spontaneous report received from a nurse on 20 Dec 2012 and follow up information received on 13 Aug 2013 and follow up report from the nurse received on 11 Nov 2013: This report refers to a 25-year-old female pregnant patient. Her previous pregnancy history included normal vaginal delivery at 40 weeks gestation and elective abortion at 8 weeks. In 2010, her Pap test showed an abnormal result as positive human papilloma virus. Concomitant drug included prenatal vitamins daily. Her previous vaccinations were tolerated well without any adverse events. Her last menstrual date was on 11 Oct 2012 and expected date of delivery was reported as 18 Jul 2013. This pregnant patient was vaccinated with FLUVIRIN (batch number: 123104) at a dose of 0.5 ml subcutaneously on 17 Dec 2012 (at 2:15 pm). On 11 Jan 2013, she underwent Afp (alpha-fetoprotein) tetra prenatal test and result was negative. On 07 Jul 2013, the patient delivered a live male neonate via normal delivery. The delivery duration was reported as 4 hours 7 mins and it was full term. The neonate weight was reported as 3400 grams, height as 46.4 cm and Apgar score reported as 8 (at 1 min) and 9 (at 5 mins). No adverse event was reported following this administration error. The nurse reported the case as non serious and causality as not suspected with the FLUVIRIN vaccine. Follow up information received on 13 Aug 2013: Multiple attempts were made to obtain outcome of events without success. This case is considered lost to follow up. Follow up report from the nurse received on 11 Nov 2013: The delivery details and neonate details were updated.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Periarthritis
Clinical narrative: Case number PHEH2013US020171 is an initial spontaneous report received from the nurse on 23 Sep 2013 with a follow-up received from the physician on 20 Nov 2013. This report refers to a 45-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in her left deltoid on 19 Sep 2013. On the same date after vaccination, she experienced frozen shoulder. She had a heavy arm which was painful and she was unable to move the arm. She felt very heavy and painful when she lifted the arm/shoulder. She kept ice on the affected shoulder and she was taking ibuprofen around the clock without relief. It was reported that the pain has worsened over the weekend and she did not take any medical care. The seriousness of the events were not reported. The physician commented that in their opinion this was not a reaction from the vaccine. No additional information was available. Follow-up received from the physician on 20 Nov 2013: Updated causality.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Incorrect product storage
Clinical narrative: Case number PHEH2013US020234 is an initial spontaneous report from the nurse received on 25 Sep 2013 with a follow up information received on 20 Oct 2014. This report refers to a female pregnant patient. The patient's last menstrual date was not reported. This pregnant patient was vaccinated with one dose of frozen FLUVIRIN (batch number: 13371P) from a pre filled syringe, via intramuscular route on 24 Sep 2013. It was reported that patient did not experience any adverse event following this medication error. Upon follow up receipt on 20 Oct 2014, it was reported that multiple attempts were made to obtain follow-up information and outcome of pregnancy event without success and hence the case was considered as lost to follow-up. Follow-up information received on 20 Oct 2014: Lost to follow-up information was updated.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020521 is an initial spontaneous report received from a nurse of 30 Sep 2013 with a follow-up received on 25 Feb 2014. This report refers to a 49-year-old female patient. On 27 Sep 2013, she was vaccinated with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) intramuscularly into her deltoid. It was reported that before vaccination, FLUVIRIN was placed in the shipping container at room temperature for 72 hours and later administered to the patient. No adverse event was reported following this medication error. Follow-up received from a nurse on 25 Feb 2014: Site of vaccination updated. Date of vaccination amended.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020522 is an initial spontaneous report received from a nurse on 30 Sep 2013 with a follow up information received from a nurse on 04 Feb 2014. This report refers to a 21-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) in the deltoid which was placed room temperature on 26 Sep 2013. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and hence the vaccine in shipping container was placed in room temperature for 72 hours. No adverse event was reported following the medication error. Follow up information received from a nurse on 04 Feb 2014: Site of vaccination was updated.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US020527 is an initial spontaneous report received from a nurse on 30 Sep 2013 with the follow-up received on 28 Feb 2014. This report refers to a 43-year old adult female patient. In the morning of 26 Sep 2013, she was vaccinated intramuscularly with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) at 0.5 ml in the deltoid. It was reported that before vaccination, FLUVIRIN was placed in the shipping container at room temperature for 72 hours and later administered to the patient. No adverse event was reported following this medication error. Follow-up received from nurse on 28 Feb 2014: Updated date of birth, vaccination site and time.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity
Clinical narrative: On an unspecified date, the patient received an unspecified flu vaccine (manufacturer and batch number not provided) and unspecified pneumococcal vaccine (manufacturer and batch number not provided). On an unspecified date, the patient developed an allergic reaction to an unspecified pneumococcal vaccine and unspecified flu vaccine. The outcome was reported as recovered (as the patient was "fine"). Company comments: Seriousness: Non-serious. Listedness: Listed. Causality: Unassessable.
Age: 29.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This consumer spontaneous report (initial receipt 29-Jul-2014) concerns a 29-year-old female patient. On 27-Jun-2014, the patient received a total of four vaccines, which included 'flu vaccine' (Influenza virus vaccine, manufacturer and batch number not provided), and one VARIVAX subcutaneous injection (batch number not provided). On 22-Jul-2014, the patient went to her physician who performed 'blood work' and found out that she was pregnant. It was estimated that she was approximately four months pregnant. The reporter was unaware that they should not conceive until after three months of receiving the vaccines. No additional AE information was provided. Outcome was reported as unknown. Reporter comments: The reporter reported the AE onset date as 22-Jul-2014, and medical attention was sought.
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This consumer spontaneous report (intial receipt 29-Jul-2014) concerns a female patient. On an unknown date, the patient received AFLURIA (batch number not provided). On an unknown date, the patient developed the flu the day after receiving AFLURIA. It occurred on two separate occasions (specific dates unknown). Outcome was reported as unknown.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021674 is an initial spontaneous report from nurse received on 16 OCT 2013 with a follow-up received on 11 NOV 2013. This case refers to a 43-year-old male patient. He received FLUVIRIN 2013/2014 (batch number 13395P, expiry date: Mar 2014), at a dose of 0.5 ml intramuscularly in to the left deltoid on 15 OCT 2013. The nurse stated that the patient received FLUVIRIN from pre filled syringes which were kept at 54 Fahrenheit for 18 hours (temperature excursion). The reporter stated that there was no adverse drug reaction. The patient received influenza vaccine before it was found that the refrigerator had been out of range. Novartis was contacted only to receive information on the potency of the vaccine following the temperature excursion and the disposition of the remainder vaccine.  Follow-up received from the nurse on 11 NOV 2013. Updated patient demographics, site of application of FLUVIRIN and comment from the reporter.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 31-Aug-2014) concerns a 60 year old female patient. On the 22-Aug-2014, the patient received AFLURIA (batch number T 58806) via the intramuscular route for the protection against seasonal influenza viral infection. On the 22-Aug-2014, a short time after receiving the vaccine on the same day, the patient developed muscle soreness at the injection site, which had persisted to date. No redness or swelling was noted. The patient was referred to her primary healthcare provider to determine whether or not the patient had some type of muscular ailment versus and injection site reaction. Outcome was not yet recovered.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Influenza like illness, Malaise, Oropharyngeal pain, Respiration abnormal
Clinical narrative: This spontaneous consumer case (initial report 02-JUL-2014) concerns a 72-year-old elderly male patient. On an unspecified date, the patient received flu shot (manufacturer and batch number not provided) and also received Zemaira, weekly infusion at a dose of 5658 mg for alpha one (refer to case 2014042841).  On an unspecified date, the patient experienced flu-like symptoms. The events were not severe enough to go to the doctor. The patient stayed in bed until the symptoms subsided. The patient experienced severe headache, sore throat and breathing had not improved. The patient was sick most of the time. Outcome was reported as improving on flu symptoms, however, headache continued to be severe.  Reporter's comments: it was reported that the patient was sick most of the time so his spouse wouldn't know if it was the treatment or not. It was thought the flu-like symptoms were because he had taken the flu shot.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-JUL-2014) concerns a female patient. The patient had a medical history of an unspecified neurologic condition, diabetes, hypothyroid (Hashimoto's disease) and an unspecified autoimmune disease. She had drug reactions/allergies to Metformin (reaction-facial swelling), Carbamazepine (reaction-facial swelling), Losartan (reactions-facial swelling and blisters), penicillin and sulfa drugs.  On an unspecified date, the patient receive unspecified flu vaccine (manufacturer and batch number not reported) and pneumonia vaccine.  On an unspecified date, the patient experienced arm swelling, rash and fever. Outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-JUL-2014) concerns a female patient. On an unspecified date, the patient received unspecified flu vaccine (batch number and manufacturer not provided).  On an unspecified date, the patient experienced flu-like symptoms and became very sick. It was reported that the patient experienced flu-like symptoms and became very sick after receiving an unspecified flu vaccine on two different occasions.  Outcome ws reported as recovered.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-JUL-2014) concerns a 57-year-old male patient. The patient had drug allergy to codeine. On 23-OCT-2013, the patient received AFLURIA (batch number not provided) in the left deltoid. On 27-NOV-2013, the patient received subcutaneous ZOSTAVAX (batch number J008433, expiry date: 11-OCT-2014) at 0.65 ml.  On an unspecified date, after receiving ZOSTAVAX, the patient experienced pain at the injection site of left upper extremity. The pain at injection site had continued. The patient had soreness at the injection site especially when lifting her arm, where he received a flu shot one month earlier. Outcome was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: This non-serious report from study was reported via OTIS Pregnancy Registry (initial receipt 19-Jul-2014) and concerns a 29 year old female pregnant patient. The patient's medical history included depression, anorexia (which resolved in 2013) Ulcerative colitis and respiratory tract infections. Concomitant medications included prenatal vitamins, folic acid, DHA (Docosahexaenoic Acid), vitamin D, vitamin C, azathioprine, amoxicillin, paracetamol, TDAP vaccine and diphenhydramine. On 10-Oct-2013, the pregnant patient received the AFLURIA vaccine (batch number not reported) 1 shot 1 day. The patient gave birth to a baby at the gestational age od 40 weeks. On the 14-Jul-2014, the baby was diagnosed as having 2 hydronephrosis (see case 2014044039). Outcome was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site
Clinical narrative: This non-serious consumer report (initial receipt 14-May-2014) concerns a female patient who had a medical history of breast cancer and had lymph nodes under her arms removed. On an unspecified date, the patient received a influenza virus vaccine (manufacturer and batch number not reported) in her hips. The patient had the vaccination in her hips due to having breast cancer and her lymph nodes under her arms were removed. The patient also had the pneumonia vaccine in her hips. Outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: This non-serious medically confirmed report (initial receipt 14-May-2014) concerns a female patient. The patient had development of supraclavicular nodes after administration of GARDASIL and FLUMIST. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date two years ago (in 2012) in patient developed supraclavicular nodes. Outcome was not reported.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: This non-serious consumer report (initial receipt 09-May-2014) concerns a 51 year old male patient. In 2013, the patient received a influenza virus vaccine (manufacturer and batch number not reported). In fall 2013, two weeks after the vaccination, the patient got sick with fever and headaches. Outcome was reported as recovered in fall 2013. Reporter comments: The consumer reported the case to be related to the flu shot.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This non-serious spontaneous report (initial receipt 27-May2014), concerns a 61 or 62-year old female patient. On an unspecified date, (5-6 years ago), the patient received unspecified influenza virus vaccine (manufacturer and batch number not reported) and subcutaneous PNEUMOVAX 23 injection (batch number not reported). On an unspecified date, about three days after vaccination, the patient developed fever and her injection site was red and swollen. The ocutome was reported as recovered.
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain
Clinical narrative: This non-serious consumer report (initial receipt 28-May-2014) concerns a female patient. On an unspecified date 'about 3 years ago', the patient received an injection of unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date '3 years ago', after receiving the vaccination, the patient developed underarm pain in the area of her armpit. She had "pain under armpit". Outcome was reported as not recovered as the patient still had pain underneath her arm once in a while.
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: This non-serious medically confirmed report (initial receipt 02-May-2014) concerns a male patient who had a medical history of egg allergy and would experience a rash with any unspecified injection. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed a rash after receiving the flu vaccine. Outcome was not reported. Reporter comments: The health care practitioner reported that the patient would experience rash with any unspecified injection and this was not related to vaccinations.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: This spontaneous consumer report (initial receipt 29-MAY-2014) concerns a female patient. The patient's past medication includes ZOSTAVAX (received on an unspecified date about 2 years ago) and the patient developed a bladder infection and shingles (both the events developed one year ago0. The patient reported that the shingles rash was on her "butt" and she was using Benzocaine (Dermoplast) to relieve her pain and itching and it was working great. She also developed genital herpes after receiving ZOSTAVAX. Her concomitant medications included duloxetine and allergy shot for seasonal allergies. On an unspecified date in JAN 2014, the patient received an unspecified flu shot (manufacturer and batch number not reported). On an unspecified date after receiving the flu shot in JAN 2014, the patient developed terrible adverse events. The outcome was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Erythema
Clinical narrative: This non-serious medically confirmed report received via a sales representative (initial receipt 10-Jun-2014) concerns a female patient. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported) and PNEUMOVAX 23 (batch number not reported). The vaccines were given in opposite arms. On an unspecified date over one year ago, the patient's whole arm turned red after the administration of the PNEUMOVAX 23. The patient did not report any respiratory issues. The patient saw her primary care physician. Outcome was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Flushing, Nausea, Rash, Swelling, Urticaria
Clinical narrative: This non-serious medically confirmed report (initial receipt 18-Jun-2014) concerns a 49 years old female patient who was on unspecified concomitant medications. The patient had drug reaction/allergies to flu vaccine and no known other allergies. On the 19-Oct-2012, the patient received the influenza vaccine (manufacturer and batch number not reported). On the 20-Oct-2012, one day after the influenza vaccination, the patient had a reaction to influenza vaccine. The patient complained of hives, rash, swelling, nausea, flushing. The patient did not have shortness of breath. Treatment included diphenhydramine and prednisolone. Outcome was reported as recovered.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous consumer report (initial receipt- 25-Jun-2014) concerns a female patient. On an unspecified date, "one time years ago" the patient received miscellaneous influenza virus vaccine (batch number and manufacturer not reported). On an unspecified date, the patient developed an allergic reaction. She experienced a red bump at the injection site under the skin. Outcome was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This non-serious medically confirmed report (initial receipt 26-Jun-2014) concerns a female patient. On an unspecified date, the patient received the influenza vaccine (manufacturer and batch number not provided). On an unspecified date, the patient developed hives to the influenza vaccine. It was reported as an allergy. Outcome was recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist refers to a female patient of unknown age. On 12-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route not reported, lot# reported as K018173). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist refers to a female patient of unknown age. On 13-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route not reported, lot# reported as K018173). Concomitant medication were not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist refers to a female patient of unknown age. On 13-JAN-2015 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route not reported, lot# reported as K018173). Concomitant medications were not provided. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. The reporter reported since 07-NOV-2014, an unspecified number of patients received doses of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously) that had been improperly stored. No adverse events were reported. The outcomes of the events were unknown. This is one of the reports from the same reporter. Additional information has been requested.
Age: 1.67
Sex: F
Vaccine: HEP
Symptoms: Antibody test abnormal, Expired product administered, Extra dose administered, Inflammatory bowel disease
Clinical narrative: This spontaneous report has been received from a physician on 08-JAN-2015 refers to a 10 month old female patient. The patient had no pertinent medical history, drug reaction/allergies or concomitant medication. The patient was vaccinated with three doses of RECOMBIVAX HB on 13-AUG-1992 (at 5 months old), 15-JAN-1993 (at 10 months old) and 15-NOV-1993 (at 20 months old), respectively. On an unspecified date in April 2014 the 22 year old patient developed inflammatory bowel disease. No treatment for the inflammatory bowel disease was reported. On 31-MAY-2014, the result of a "hepatitis B titer" drawn was "6" (unit not provided). As treatment for the "low titer of 6" the patient was administered two additional doses of RECOMBIVAX HB (Lot # 1572AA, expiration date 26-MAY-2014) on 06-JUN-2014 and 08-JUL-2014 which had expired. At the time of the report, the outcome of the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to patient of unknown age. On approximately 01-JAN-2015 (about two weeks ago) the patient was vaccinated with improperly stored GARDASIL (dose and route unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JAN-2015, the patient was vaccinated with a dose of expired VARIVAX (Merck) (dose: 0.5 ml, route subcutaneous, expiration date 07-JAN-2015, lot number not reported). No adverse effects were reported. No product quality complaint was filed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Non-consummation
Clinical narrative: Information has been received from a physician assistant via a company representative refers to a female patient of unknown age. The patient was vaccinated with three doses of GARDASIL (lot#, expiration date, dose and route were unknown) on unspecified dates. No concomitant therapies were reported. The patient claimed sexually inactive and presented with an atypical squamous cells of undetermined significance (ASCUS) lesion on an unspecified date after vaccination. An human papillomavirus (HPV) DNA test was conducted (on an unspecified date) and showed positive for HPV 16 and 18. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrative assistant and a medical assistant concerning multiple unspecified patients of unknown age and gender. On unknown dates these patients received GARDASIL (lot#, dose, route not reported) that were improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrative assistant and a medical assistant concerning multiple unspecified patients of unknown age and gender. On unknown dates these patients received COMVAX (lot#, dose, route not reported) that were improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrative assistant and a medical assistant concerning multiple unspecified patients of unknown age and gender. On unknown dates these patients received ROTATEQ (lot#, dose not reported, oral) that were improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an administrative assistant and a medical assistant concerning multiple unspecified patients of unknown age and gender. On unknown dates these patients received VAQTA (lot#, dose, route not reported) that were improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist refers to a patient of unknown age. Pharmacist reported that an unspecified patient received the 1st dose of the GARDASIL (lot# was not reported) series on an unspecified date in 2007, then the 2nd dose of GARDASIL (lot# was not reported) on an unspecified date in 2013. Pharmacist reported that the patient was presently at an unspecified physician's office to receive the 3rd dose of GARDASIL (lot# was not reported) on 15-JAN-2015. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Approximately on an unspecified dates since 07-JAN-2015, an unspecified number of patients was vaccinated with VARIVAX (Merck) (lot number, strength, dose, frequency and route was not reported) that had been exposed to a supported temperature excursion and additional doses of VARIVAX (Merck) that had been exposed to additional temperature outside of the recommended range. No adverse experiences had been reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse (R.N.) refers to a male patient of unknown age. The R.N. reported on 04-DEC-2014, the patient was vaccinated with MMR II. On 12-DEC-2014, the nurse reported the patient was inadvertently vaccinated with PROQUAD instead of VARIVAX (Merck). No adverse effects reported. No additional information. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on 15-JAN-2015 was inadvertently vaccinated with an expired dose of M-M-R II (lot # H018949, expiration date 18-OCT-2014) (dose and route were not reported). No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 12-JAN-2015 the patient was vaccinated with improperly stored PROQUAD (dose, route of administration, lot number, expiry date were not reported) for prevention of varicella. There were no adverse events reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. On 06-JAN-2015 the patient was vaccinated with second dose of an expired RECOMBIVAX HB injection 10 Y (lot # J014312, expiry date 07-SEP-2014). No concomitant medications were reported. It was also reported that the RECOMBIVAX HB did not have any temperature excursions. No adverse symptoms were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. It was reported that approximately in March 2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). The second dose of RECOMBIVAX HB was administered on 31-OCT-2013. It was reported that the patient was in the facility on 30-DEC-2014 (also reported as today), to receive the third dose of RECOMBIVAX HB. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Incomplete course of vaccination, Swelling, Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year old female patient. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with first and second doses of GARDASIL injection (dose, frequency, lot # and expiration date unspecified). Concomitant medications were not reported. On an unknown date directly after receiving both first and second doses of GARDASIL, the patient experienced dizziness, vomiting and swelling. The patient was not administered with third dose. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to an unspecified group of patients of unknown age and gender. Patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (doses, frequencies and lot numbers were not provided, intramuscularly) which were improperly exposed to 9.7 Celsius degree (C) for 1.25 hours on 09-DEC-2014. Concomitant medications were not reported. No adverse effects were known. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to an unspecified group of patients of unknown age and gender. Patients' medical histories were not provided. On an unknown date, the patients were vaccinated with doses of ROTATEQ (doses, frequencies and lot numbers were not provided, orally) which were improperly exposed to 9.7 Celsius degree (C) for 1.25 hours on 09-DEC-2014. Concomitant medications were not reported. No adverse effects were known. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. On 07-JAN-2015 the patient was vaccinated with an expired dose of ZOSTAVAX lot # J000444, expiration date: 11-APR-2014 (also reported as 10-APR-2014), 0.65 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history or drug reaction/allergies were provided. On an unknown date, the patient was vaccinated with GARDASIL INJ (dose, route and lot number not provided). The medical assistant reported that on an unspecified date, the patient received a dose of GARDASIL that was stored improperly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a company representative. It was reported from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. It was reported that the patient received an expired dose of PNEUMOVAX 23. No adverse experience reported. No further information was reported. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse refers to a 9 month old patient. In DEC-2014 the 9 month old patient was vaccinated with VAQTA, injection, strength 25/0.5 (unit unspecified), (lot#, dose and route not reported); which was coded as "Inappropriate schedule of vaccine administered". No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous stomatitis, Injected limb mobility decreased, Injection site atrophy, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a pharmacist and a 71 year old female patient. The patient had no drug reactions/allergies. On 29-OCT-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # K007989, expiration date 03-SEP-2015, subcutaneous). The patient took no concomitant medication. On 02-NOV-2014 (reported as 4 days after vaccination) the patient experienced arm pain, limited movement and tingling in her left arm where the ZOSTAVAX was administered. The patient stated that the pain went from her shoulder to her wrist. The patient also experienced muscle pain and her arm was weak. The patient also had swelling and tingling in her bottom lip which began when the arm pain began. The patient developed canker sores in her mouth and she tried to treat the canker sores herself with Lysine (manufacturer and dose unspecified) which was unsuccessful. The patient also stated that she had experienced swelling of her lips multiple times on unspecified days (pertinent medical history was also reported as no). The pharmacist reported that the patient saw an unspecified cardiologist who evaluated her and confirmed that the pain and numbness was not from a cardiovascular event. The patient reported that she had seen her primary care physician on 11-DEC-2014 and was diagnosed with "a possible idiopathic shingles reaction". The physician prescribed acyclovir on the same day. No intervention was given to prevent serious criteria. The pharmacist stated that, when she saw the patient, the patient's left arm "had visibly atrophied" since the injection was given. The outcome of the events was reported as not recovered. It was also reported that the pharmacist was unsure if symptoms improved after treatment. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Muscular weakness, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a pharmacist and a 71 year old female patient. The patient had no drug reactions/allergies. On 29-OCT-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # K007989, expiration date 03-SEP-2015, subcutaneous). The patient took no concomitant medication. On 02-NOV-2014 (reported as 4 days after vaccination) the patient experienced arm pain, limited movement and tingling in her left arm where the ZOSTAVAX was administered. The patient stated that the pain went from her shoulder to her wrist. The patient also experienced muscle pain and her arm was weak. The patient also had swelling and tingling in her bottom lip which began when the arm pain began. The patient developed canker sores in her mouth and she tried to treat the canker sores herself with Lysine (manufacturer and dose unspecified) which was unsuccessful. The patient also stated that she had experienced swelling of her lips multiple times on unspecified days (pertinent medical history was also reported as no). The pharmacist reported that the patient saw an unspecified cardiologist who evaluated her and confirmed that the pain and numbness was not from a cardiovascular event. The patient reported that she had seen her primary care physician on 11-DEC-2014 and was diagnosed with "a possible idiopathic shingles reaction". The physician prescribed acyclovir on the same day. No intervention was given to prevent serious criteria. The pharmacist stated that, when she saw the patient, the patient's left arm "had visibly atrophied" since the injection was given. The outcome of the events was reported as not recovered. It was also reported that the pharmacist was unsure if symptoms improved after treatment. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral
Clinical narrative: Information has been received from a pharmacist and a 71 year old female patient. The patient had no drug reactions/allergies. On 29-OCT-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # K007989, expiration date 03-SEP-2015, subcutaneous). The patient took no concomitant medication. On 02-NOV-2014 (reported as 4 days after vaccination) the patient experienced arm pain, limited movement and tingling in her left arm where the ZOSTAVAX was administered. The patient stated that the pain went from her shoulder to her wrist. The patient also experienced muscle pain and her arm was weak. The patient also had swelling and tingling in her bottom lip which began when the arm pain began. The patient developed canker sores in her mouth and she tried to treat the canker sores herself with Lysine (manufacturer and dose unspecified) which was unsuccessful. The patient also stated that she had experienced swelling of her lips multiple times on unspecified days (pertinent medical history was also reported as no). The pharmacist reported that the patient saw an unspecified cardiologist who evaluated her and confirmed that the pain and numbness was not from a cardiovascular event. The patient reported that she had seen her primary care physician on 11-DEC-2014 and was diagnosed with "a possible idiopathic shingles reaction". The physician prescribed acyclovir on the same day. No intervention was given to prevent serious criteria. The pharmacist stated that, when she saw the patient, the patient's left arm "had visibly atrophied" since the injection was given. The outcome of the events was reported as not recovered. It was also reported that the pharmacist was unsure if symptoms improved after treatment. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner, via a company representative, regarding four women, whose ages ranged from about 65 to 82 years. On an unknown date the patients were vaccinated with ZOSTAVAX, (dose 0.65 ml). Concomitant medications were not specified. In approximately December 2014, (reported as last few weeks) the patients experienced shingles after receiving ZOSTAVAX. The women went to an urgent care facility where they were diagnosed with shingles. The nurse went on to explain that all women had shingles before being vaccinated with ZOSTAVAX and were recommended to still receive the vaccine according to CDC (Centre for Disease Control) guidelines. The nurse was concerned that the women were encouraged to get the vaccine despite having shingles before vaccination. However, it was also reported that it was unknown if the four women were experiencing a continuation of their previous shingles infection or if it was a newly developed case of shingles from the shot. There was no mention of the severity of the cases of shingles the women had. The outcome of shingles was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Throat tightness
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 16 January 2014. A 28-year-old female patient received an injection of FLUZONE (lot not reported) intramuscularly in the right deltoid on 29 September 2011 and within "a few minutes" experienced throat constriction and red blotches on her face. Per the reporter, the event was treated with an EPIPEN at the pharmacy where the vaccine had been administered, and the patient was then transported to the ER where she was observed for 6 hours. The event subsequently recovered. No additional information was provided. Documents held by sender: None.