chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: DT, HPVX, MNQ
Symptoms: Drug administered to patient of inappropriate age, Headache
Clinical narrative: Initial misuse report received from a healthcare professional on 24 January 2013. An 11-year-old female patient, had received an intramuscular dose of DT pediatric vaccine (lot number, anatomical site of administration were not reported) on an unspecified date. Illness at the time of vaccination and concomitant medications were not reported. The patient had allergy to pertussis component. The patient's had received DT (Diphtheria and Tetanus) for pediatric use instead of Td (Tetanus and Diphtheria) vaccine. It was reported that several days after vaccination, the patient's experienced persistent headache. Corrective treatments and laboratory details were not reported. The patient's outcome was unknown. Follow-up information received from a healthcare professional on 26 March 2013: Patient's date of birth was updated. The patient had no illness at the time of vaccination. The patient had received HPV vaccine and MENACTRA vaccine (lot number, route and site of vaccination was not reported for both the vaccines) along with DTaP vaccine on 18 December 2012. The event of headache had started on 08 January 2013. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red swollen, bicep warm to touch.
Age: 71.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red swollen, bicep warm to touch.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, High risk pregnancy, No adverse event
Clinical narrative: Initial reprot received from a healthcare professional on 28 June 2013. A 24-year old female patient had received an intramuscular dose 1 of MENACTRA vaccine (batch number: U4258AA and site of administration was not reported) on 28 June 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was reported as unknown. The estimated date of delivery was 11 October 2013. At the time of the report, the patient had not experienced any adverse events. It was reported that patient was 'high risk' but did not have the reason why considered high risk. Concomitant medications and past medical history was not reported. Treatment for infertility was not reported. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 June 2013. A child who had received MENACTRA couple of months ago was given another vaccine. No adverse event was reported. Documents held by sender: None.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 April 2013. A patient received first dose of MENACTRA at 11 years of age and second dose at 12 year of age. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 April 2013. A male patient received first dose of MENACTRA in September 2007, second dose in September 2011 and then received third dose in April 2013. No adverse event was reported. List of documents held by sender: none.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 June 2013. A 17-year-old patient had received first dose of MENACTRA in 2007, a booster in 2012 and then received another dose again in 2013 due to record issue. No adverse event was reported. List of documents held by sender: none.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 June 2013. An 18-year-old patient was administered a booster dose of MENACTRA vaccine past expiration date. No adverse event was reported. List of documents held by sender: none.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 1:22 pm Varicella and Measles Mumps and Rubella vaccines->given almost immediate urticarial lesion (2 cm) around site of injection, resolved within 1-2 minutes of giving oral BENADRYL referred to allergist for evaluation.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: No s/s of any adverse event noted to patient. Patient was called for the next 3 weeks after administration of vaccine. Patient has had no adverse reaction thus far.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Intermittent fevers occurring for at least 17 days after vaccination (she was seen 17 days later). No treatment given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Screaming, Vein rupture
Clinical narrative: 3 hours after receiving vaccine developed pinpoint spots around eyes and temple areas. Low grade fever also. 8/6/15 TC. Fever subsided rash areas subsiding. Spoke with physician on 08/05 and physician indicated patient was screaming while imms were given and spots were due to blood vessels rupturing.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain
Clinical narrative: Left arm edema, erythema and pain. Seen in office, tried OTC meds with no relief. Prescribed KEFLEX and MEDROL Pak for Dx: cellulitis.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: This case is linked to case number 2013-07843 and 2013-07842 (same reporter after MENACTRA). Initial misuse report received from a healthcare professional on 01 July 2013. An adult patient had received MENACTRA vaccine in 2009 for traveling. On an unspecified date after 4 years, the patient again received another MENACTRA dose. (No information was provided regarding the patient). The patient did not adverse event was reported. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Left arm pain since the immunization, near the injection site.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Dyspnoea, Rash pruritic
Clinical narrative: Approximately 4 hours after injection of rabies vaccine patient noted rash on chest after getting out of shower-patient stated it was itching-and developed difficulty breathing-no throat, tongue or mouth swelling. Responded to treatment at ER.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swelling of (L) arm (upper) slight redness w/ warmth.
Age: 0.3
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a non-healthcare professional (patient's parent) on 11 June 2013. A 03-month-old baby was given MENACTRA vaccine in error. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case is linked to case number 2013-07841 and 2013-07842 (same reporter after MENACTRA). Initial misuse report received from a healthcare professional on 01 July 2013. An adult patient had received MENACTRA in 2009 for traveling. On an unspecified date after 4 years, the patient again received another MENACTRA dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 July 2013. An 11-year-old patient's record was not checked and the patient was administered another dose of MENACTRA vaccine 1 year after the primary dose. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: IPV, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 31 May 2013. A patient was administered 0.5 ml MENACTRA vaccine intradermally instead of PPD and then received 0.1 ml IPOL intradermally in the arm. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: None.
Age: 19.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 05 July 2013. A 19-year-old patient was administered a dose of MENACTRA vaccine that had expired in May 2013. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 June 2013. An expired dose of MENACTRA was administered (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Cold sweat, Dizziness, Hyperhidrosis, Skin discolouration
Clinical narrative: 1100-Patient started experiencing dizziness, clammy skin, green in color on face, sweating, patient had drank one soda. Up all night, and anxiety for 3 days prior to vaccine. Patient placed lying on table with water and cracker given. Patient recovered.
Age: 38.0
Sex: F
Vaccine: MMRV
Symptoms: Asthenia, Body temperature increased, Dizziness, Immediate post-injection reaction, Lymphadenopathy
Clinical narrative: Immediately after injection developed swollen glands-sore throat-felt very malaise 2-3d presently c/o dizziness-weak-had 99.7 temp-present 97.9.
Age: 38.0
Sex: F
Vaccine: MMRV
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: Immediately after injection developed swollen glands-sore throat-felt very malaise 2-3d presently c/o dizziness-weak-had 99.7 temp-present 97.9.
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 June 2013. It was reported that MENACTRA was administered to a patient over the age of 55. No more information regarding the patient. No adverse event was reported. Documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 June 2013. A 3-months-old patient was given MENACTRA vaccine inadvertently. No adverse event was reported. List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Diarrhoea, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Significant pain and edema at injection site fever. Decreased appetite. Diarrhea. Malaise.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Significant pain and edema at injection site fever. Decreased appetite. Diarrhea. Malaise.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 13 June 2013. A patient (No information was provided regarding the patient) had received MENACTRA vaccine exposed to 33 degree Fahrenheit. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 June 2013. A patient had received an 'outdated' dose of MENACTRA. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 69.0
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 06 May 2013. A 69-year-old patient had inadvertently administered MENACTRA vaccine. No adverse event was reported. List of documents held by sender: none.
Age: 1.4
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 02 May 2013. It was reported that MENACTRA was inadvertently administered instead of MMR to a 16-month-old patient. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This case is linked to case number 2013-07841 and 2013-07842 (same reporter after MENACTRA). Initial misuse report received from a healthcare professional on 01 July 2013. An adult patient had received MENACTRA vaccine in 2009 for traveling. On an unspecified date after 4 years, the patient again received another MENACTRA dose. (No information was provided regarding the patient). The patient did not report adverse event. List of documents held by sender: none.
Age: 0.2
Sex: U
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial misuse report received from a healthcare professional on 16 January 2013. A 06-week-old patient (no other information was provided concerning the patient) received a dose of ACTHIB vaccine reconstituted with MENACTRA vaccine on an unspecified date. No adverse event was reported. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Peripheral swelling, Wrong drug administered
Clinical narrative: Initial report was received from a consumer on 16 May 2013. A 19-year-old female patient had received a dose two intradermal injection of MENACTRA, lot number U4593AB, instead of TUBERSOL. On 14 May 2013 (also reported as two days later), the patient came in to have the test read and the arm was swollen with cellulitis. Treatment was BACTRIM twice daily (BID) and to apply cold packs. The patient had no illness at the time of vaccination and no past medical history. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: MNQ
Symptoms: Tic
Clinical narrative: Initial report was received on 14 May 2013 from a health care professional. An adolescent female (name and date of birth not reported) had received MENACTRA (lot number, route, site and date of administration not reported) and unspecified amount of time later developed increasing tics since vaccine up to "100/day". No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Initial report received from healthcare professional on 19 September 2012. An 81-years old female patient, whose illness at the time of vaccination was none and medical history was reported as allergy to penicillin and had a history of elevated blood pressure and whose concomitant medications were not reported, received a dose of ADACEL vaccine, lot number C4023AA (route and site of administration were not reported) on 13 September 2012. It was reported that on 18 September 2012, the patient experienced development of hard knot at injection site with 1 and a half inch area of redness which was hot to touch around injection site with slight soreness. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None. Follow-up information received on 19 November 2012: The patient had received ADACEL vaccine intramuscularly on the right deltoid. The soreness at the injection was no more reported in follow-up information. On 18 September 2012, the patient developed a 1.5-inch diameter red area with heat, swelling and itching at injection site. The severity of the reaction was reported as moderate. The patient was treated with TYLENOL by mouth and BENADRYL cream topical to help with side effects and was instructed to let her doctor know if situation worsens.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from healthcare professional on 19 September 2012. An 81-years old female patient, whose illness at the time of vaccination was none and medical history was reported as allergy to penicillin and had a history of elevated blood pressure and whose concomitant medications were not reported, received a dose of ADACEL vaccine, lot number C4023AA (route and site of administration were not reported) on 13 September 2012. It was reported that on 18 September 2012, the patient experienced development of hard knot at injection site with 1 and a half inch area of redness which was hot to touch around injection site with slight soreness. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None. Follow-up information received on 19 November 2012: The patient had received ADACEL vaccine intramuscularly on the right deltoid. The soreness at the injection was no more reported in follow-up information. On 18 September 2012, the patient developed a 1.5-inch diameter red area with heat, swelling and itching at injection site. The severity of the reaction was reported as moderate. The patient was treated with TYLENOL by mouth and BENADRYL cream topical to help with side effects and was instructed to let her doctor know if situation worsens.
Sex: U
Vaccine: MNQ
Symptoms: Antibody test, Inappropriate schedule of drug administration
Clinical narrative: Initial report received from a healthcare professional on 01 May 2013. This is an invalid case as individual patient identifiers are missing. the patients (four patients whose gender, date of birth and age were not reported), had received dose 2 of MENACTRA vaccine (lot number, route and site of adminsitration) on unspecified date. The patients had received previous dose of MENACTRA vaccine before two months on unspecified date. The patients were HIV positive. Concomitant medication and illness at the time of vaccination were not reported. It was reported that, the patient had received two doses of vaccine in two months apart instead of three months apart leading to inappropriate schedule of drug administration. On unspecified date, "meningitis ab" titer was done and one month after, insufficient range was observed for three of the patients. Corrective treatments and laboratory data were not reported. At the time of this report, the outcome was not reported. List of documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Injecton site reaction-swelling, inflammation and redness at injection site.
Sex: M
Vaccine: MNQ
Symptoms: Adverse event
Clinical narrative: This case is linked to case number 2013-00780 (same reporter after MENACTRA). This case is created from source document of case number 2013-00780. Initial report received from healthcare professional on 03 May 2013. This case is non-valid as adverse event description is missing. A 12 (years/months was not specified) male patient, whose medical history was not reported and had no concomitant medication, received a first dose of MENACTRA vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. Patients 11-year-old sister had received an intramuscular dose of MENACTRA vaccine (batch number- U4291AA, dose number were not reported) in left deltoid and ADACEL vaccine (batch number - U4384AA, dose number-not reported) in left deltoid, both on 10 January 2013. Patients sister developed urticaria on 11 January 2013, i.e. one day after vaccination. It was reported that on an unspecified date of August 2004, after receiving MENACTRA vaccine, the patient experienced unspecified adverse event. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report was received from a licensed practice nurse concerning to a 14 year old female patient. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. On 17-JUL-2015, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose and route of administration were not provided) (lot # K007828 with expiration date of 02-MAR-2017). It was reported that on an unspecified date after the patient received the vaccine, she was discovered to be pregnant with a last menstrual period in an unspecified date in June 2015. At the time of this report, the outcome of the pregnancy was pending. The due date would be probably in March 2016. No adverse event or product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 11 June 2013. A patient had received dose of MENACTRA at age of 11 years, 16 years and eight months later, again on 11 June 2013. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to his son, a male patient of unknown age. On unknown dates, the patient was vaccinated with first, second and third doses of GARDASIL (dose, route, lot # and expiration date were not provided). On 07-AUG-2015, the patient was inadvertently given a fourth dose of GARDASIL. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 April 2013. A patient was administered an expired dose of MENACTRA. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a consumer on 30 April 2013. A female patient received an expired dose of MENACTRA. No more information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent were not reported. On 31-JUL-2015, the patient was vaccinated with M-M-R II, (lot number, dose and route were not reported). The pharmacist reported that the vaccine expiry date was on 12-JUL-2015, but it was properly stored. There was no concomitant medication reported. 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. There was no information about concomitant therapy, pertinent medical history, drug reactions and allergies provided. On 23-JUL-2015, the patient was subcutaneously vaccinated with an expired dose of VARIVAX 0.5ml injection (lot# J008980, expiration date 19-JUL-2015). No adverse experience was reported and no product quality complaints (PQC) were involved. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 06 May 2013. It was reported that MENACTRA was administered to a 04-month-old patient instead of "PREVNAR". No adverse event was reported. Documents held by sender: none.
Age: 13.0
Sex: U
Vaccine: HEPA, MNQ
Symptoms: Drug dose omission, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 15 May 2013. It was planned to give "Hep A" and MENACTRA to a 13-year-old patient but only one vaccine was given. The reporter was unaware as to which vaccine was administered. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that on 07-AUG-2015, a dose of an expired sterile diluent, lot number reported as H021470, (dose not provided) was inadvertently used to reconstitute a dose of ZOSTAVAX that was administered to the patient (dose, route of administration, injection site, lot number and expiration were not reported). No adverse effects were reported. 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 physician refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L006384 and expiration date 25-FEB-2017) (dose and route were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The nurse informed that on an unknown date, the patient received the first dose of PROQUAD (Merck) Subcutaneous Injection (dose, route, lot # and expiration date not reported). Later, on an unspecified date in August 2014, they received the second dose of PROQUAD (Merck) Subcutaneous Injection (lot # K007797, expiration date: 29-NOV-2015; dose and route not reported). Then, on an unspecified date in July 2015 (reported as "which was 11 months after administration of the patient's 2nd dose"), the patient was inadvertently vaccinated with a third dose of PROQUAD (Merck) Subcutaneous Injection (lot # L004007, expiration date: 05-AUG-2016; dose and route not reported). All three doses were given. No adverse effect was reported and no PQC was involved. 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 licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 13-JUL-2015, the patient was vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number L007230, expiration date 03-SEP-2016, (dose and route were not reported). No adverse effects reported. This is one of several reports from the same source. Lot number L007230 has been verified to be a valid lot number for PROQUAD (Merck). 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 Certified Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Neither medical history nor concurrent conditions were reported. On 17-JUL-2015, 20-JUL-2015 and 21-JUL-2015, unspecified number of patients were vaccinated with an improperly stored VARIVAX (Merck) (lot # K021932, expiration date 10-NOV-2016). No adverse effects were reported. No product quality complaints were reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from the father of a 3 year old female patient. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a second dose of VARIVAX (Merck) (dose, route of administration and frequency were not reported), 6 weeks after the first dose (dates were not specified). At the time of the report, no adverse effects were reported and it was stated that the patient did not die. Concomitant therapies were unknown. 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 licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-JUL-2015, the patient was vaccinated with a dose of an improperly stored (Oka/Merck) VARIVAX, lot number K021486, expiration date 03-NOV-2016 (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. 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 licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 21-JUL-2015, the patient was vaccinated with a dose of an improperly stored (Oka/Merck) VARIVAX, lot number K021486, expiration date 03-NOV-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. 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 licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-JUL-2015, the patient was vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number L007230, expiration date 03-SEP-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Lot number L007230 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 54 year old female patient. Concurrent condition and medical history were not reported. On 01-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose was unknown, lot# L012478, expiration date 10-JUL-2016) subcutaneously. No concomitant therapy was reported. The pharmacist reported that the patient's husband called the pharmacy on 03-AUG-2015 to reprot that his wife is experiencing experienced headache and a fever of 102F. No lab was performed. The patient's husband gave the patient an unspecified dose of TYLENOL on 03-AUG-2015 to help alleviate the symptoms. The outcome of the events was reported as not recovered. 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 nurse practitioner refers to a patient of unknown age and gender. The patient's medical history, rug reactions or allergies and concurrent conditions were not reported. On 15-JUL-2015, the patient was vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number K003818, expiration date 14-SEP-2015 (confirmed as 15-SEP-2015), (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reprots from the same source. Lot number K003818 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 03-AUG-2015 the patient was vaccinated with PROQUAD (Merck) (dose, dosage #, strength and route were not repotted, lot # L007229, expiry date: 03-SEP-2018). The second suspect therapy included KINRIX (administration date: 03-AUG-2015). The patient came back to the office as the patient had developed a rah all over the body on 04-AUG-2015. The outcome of the event was not reported. The reporter also requested a lot check and that lot check request was time sensitive and the reporter wanted a response quickly. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot was received from a licensed vocational nurse regarding two patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 21-JUL-2015, the patients were vaccinated with a dose of an improperly stored PROQUAD (Merck), lot number L007230, expiration date 03-SEP-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Lot number L007230 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. Concurrent condition and medical history were not reported. On 24-JUL-2015, the patient was inadvertently vaccinated with the first expired dose of RECOMBIVAX HB 10/1.0 mcrg/ml, lot # H017018, expiration date on 11-JUL-2015 (dose, route of administration and anatomical location were not reported). It was unknown if the patient sought medical attention. There was not a quality product complaint involved. No adverse effects were reported. Additional information is not expected because the physician cannot be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional  refers to four unspecified patients of unknown ages and genders.  Concurrent condition and medical history were not reported. On an unknown date, the unspecified patients could have received improperly stored doses of (Oka/Merck) VARIVAX lot # J012377; expiration date on 03-OCT-2015 (strength, dose #, dose, anatomical location and route of administration were not reported). There was not concomitant medication reported. Product quality complaint was not involved. No adverse effects were informed. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 17-JUL-2015, the patient was vaccinated with a dose of an improperly stored ZOSTAVAX, lot number L003216, expiration date 30-APR-2016, (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to approximately 9 patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (dose, route and lot # not reported) that were out of temperature range for 7 days. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Mass, Rash erythematous, Upper extremity mass
Clinical narrative: This case is a part of 2 cluster cases (same reporter, same product: ADACEL, lot number C4344AB) and is linked to case number 2013-04003. Initial report received from a healthcare professional on 11 March 2013. A male patient (date of birth: not available and age at the time of vaccination not reported), had received first dose of ADACEL vaccine (batch number: C4344AB, expiry date: 06/04/2015, site of administration was not reported) intramuscularly on 07 March 2013. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were unknown. The patient's concomitant medications were not reported. On 08 March 2013 (next day after vaccination), the patient felt a knot which was painful at the injection site and had a red rash around the lump with pain in arms in both direction. Corrective treatment and laboratory details were not reported. The patient's outcome was recovered. List of documents held by sender was none.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse concerning a 33 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date the patient was possibly vaccinated with a dose of M-M-R II (dose, route and lot# not provided). On 25-JUL-2015, the patient received an unspecified type of blood test for serological testing of immunity for MMR. The blood test determined the patient to be seronegative for MMR titers. The primary reporter stated that it was unknown whether or not the patient received M-M-R II in the past. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 February 2013. A part of dose was lost during vaccination due to leaking. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial misuse report received from a healthcare professional on 15 January 2013. A 06-week-old patient (no other information was provided regarding the patient) had received ACT-HIB vaccine diluted with MENACTRA vaccine on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 17 January 2013. A patient (No information was provided reagrding the patient) was administered an expired dose of MENACTRA. No adverse event was reported. List of documents held by sender: none.
Age: 61.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 21 March 2013. A 61-year-old patient received a dose of MENACTRA instead of MENOMUNE. No adverse event was reported. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 February 2013. A 12-year-old male patient was administered MENACTRA and later it was found that he had received a dose of MENVEO 15 months ago as well. No adverse event was reported. List of documents held by sender: none.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 19 February 2013. A 12-year-old patient was administered MENACTRA, ADACEL and VARIVAX vaccines mixed in one syringe and as a single injection in the deltoid. The reporter was not sure if the VARIVAX diluent was added to the mixture. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 March 2013. An 11-year-old patient (no more information was provided regarding the patient) had received a dose of MENACTRA and ADACEL vaccine in August (year not specified) after the patient turned 11 year old and then received both vaccines again while he was still 11 years of age. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 15 March 2013. A patient had received a dose of MENACTRA in the past and inadvertently received a second dose of MENACTRA on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Shock symptom
Clinical narrative: Initial report received from a non-health care professional on 04 March 2013. A female patient of unknown age, had received an intramuscular dose of ADACEL vaccine (lot number, expiry date, dose number and site of vaccination was not reported) on an unspecified date. On an unspecified date, hours after vaccination, the patient developed muscle aches on the left side of the body and beginning in neck. The patient also had a "shock" feeling that goes throughout her body. Muscle aches had spread to shoulders and legs bilaterally. Corrective treatment was not reported. Laboratory investigations were not done. Patient was seen by a neurologist, nothing significant was found. The "shock" feelings had subsided, but the muscle aches were progressively becoming worse. Documents held by sender: none.
Sex: U
Vaccine: MNQ, YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: MENACTRA was used to reconstitute YF VAX vaccine and administered to a patient (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. In approximately 2015 (reported as "on unspecified dates since 08-JUL-2015"), the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, lot # K016131, expiration date 23-SEP-2016 (dose, route of administration were not reported). Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. 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 nurse practitioner and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. In approximately 2015 (reported as "on unspecified dates since 08-JUL-2015"), the patient was vaccinated with improperly stored dose of PROQUAD (Merck), lot # K022446, expiration date 13-MAY-2016 (dose, route of administration were not reported). Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 04 February 2013. A 24-year-old female patient, whose concomitant medications were not reported, had received first dose of ADACEL vaccine (batch number C4327AA, expiry date of 27 March 2015) intramuscularly in left deltoid on 29 January 2013. The patient had a history of Pertussis last summer and illness at the time of vaccination was unknown. On 29 January 2013, after receiving ADACEL vaccine, the patient experienced cough, fever and body aches. On 02 February 2013, the patient had a temperature of 98.3 F, had no nodes and lungs were clear. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles, Injection site warmth, Myalgia
Clinical narrative: Initial report received from healthcare professional on 18-JANURY-2013. A 65-year-old female patient had received an intramuscular dose of ADACEL (batch number UT4421AA) in left deltoid and an intramuscular dose of PNEUMOVAX (manufacturer unknown, batch number was not reported) in right arm, both on 18 DECMBER 2012. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. Concomitant medications were not reported. On 26 DECEMBER 2012, the patient experienced rash of tiny blisters around the injection site, reddened and hot to touch and had severe muscle ache. There were no laboratory investigations/relevant diagnostic tests performed. Corrective treatments were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Upper extremity mass
Clinical narrative: Initial report received from healthcare professional on 15 JANUARY 2013. A 64-year-old female patient, who had no pre-existing physician diagnosed allergies, birth defects and medical conditions, had received a dose 1 of ADACEL (batch number C4251AA, route of administration was not reported) in left deltoid and an intramuscular dose 1 of PNEMOVAX (other manufacturer, batch number 0225AE) in right deltoid, both vaccines were received on 04-JANUARY 2013. The patient had no other illness at the time of vaccination. On 09 JANUARY (5 days after vaccine administration) the patient experienced left arm redness, heat, pain, and felt lump. On 14 JANUARY 2013 the pain came back intensely from her arm to her clavicle. Patient was experiencing hurts with movement and patient was comfortable at rest. Patient had no longer redness, lump or heat on unspecified dates. The patient had received aspirin for a couple days (dose unknown) and pain medication (trade name and dosage unknown) as corrective treatments. The laboratory investigations/relevant diagnostic tests were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None.